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saradha.mani@mmactiv.com/ ankit.kankar@mmactiv.com

www.biopectrumasia.com ASIA EDITION

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4 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com



he world is now at the threshold of a revolution in medical treatment in the form
of cell and gene therapies which are fast emerging as new therapeutic modalities.
Various developments surrounding the cell and gene therapies are being reported
with scientists working on solving technical hurdles in the treatment, successes in using
the therapies on different diseases, and companies establishing manufacturing plants.
A new study conducted by Stanford University researchers hopes to solve a major
problem of gene therapy, an autoimmune attack. In an experiment on mouse they have
shown that the gene therapy can be effective without causing a dangerous side effect of
autoimmune reaction which the patient’s immune system is encountering for the first
time. Several such hurdles in the gene therapy development are being eliminated with
Milind Kokje research and innovations.
Chief Editor There have been several reports in the last two years of the encouraging clinical results
milind.kokje@mmactiv.com where the therapy was used in various diseases like haemophilia, sickle cell disease,
multiple cancers, several neurodegenerative disorders and genetic diseases. A teenage
boy in France was cured in March of a genetic disorder using experimental gene therapy.
GSK’s gene therapy Strivelis is available since 2016 for a rare disease among the children.
Spark Therapeutics’s Luxturna is approved for correcting genetic blindness. Three CAR-T
cell therapies are already approved in US by the FDA to treat blood cancers. They include
Novarit’s Kymriah, useful for rare blood cancer treatment, and Kite Pharma’s Yescarta.
Besides these, many more therapies are under clinical investigation. These
developments are also reflecting in the stocks market. Sangamo Therapeutics’s shares
increased by over 33 per cent previous month when it reported interim data for its
haemophilia A therapy. As a result of these developments, MIT declared 2017 as the year
of gene therapy breakthroughs.
Scientists feel that cell and gene therapy is fundamentally different from other regular
therapies since instead of treating symptoms, it corrects the genetic cause of a disease.
So far, these therapies have been introduced for rare diseases and hence the number
of patients is small. But that will not be the case in the future. Successes in CART-cell
therapies demonstrate the need for capacity expansion. Some developments are taking
place on that front too.
Swiss biotech company Lonza opened its cell and gene therapy manufacturing plant
in US in April. The 30,000 sq feet facility will be used for engineering viruses and gene
therapy vectors since its shortages have created bottlenecks in development of the therapy.
A month prior to that Sumitomo Dainippon Pharma completed its manufacturing plant
for Regenerative Medicine and Cell Therapy, which has been built to produce cells for use
in clinical trials.
Although various positive developments are being seen in cell & gene therapies,
few challenges need to be addressed. Developing cell engineered products is one such
challenge due to many aspects including production, delivery, regulatory and testing.
As the field is still young, one of the early challenges is the high price tag these therapies
come with. uniQure’s Glybera, the first gene therapy, was withdrawn last year due to
pricing issue. In order to overcome this hurdle some companies are offering full money
back in case of failures or charging only those patients who are showing positive results
in the first month. But it is a temporary solution that can only be adopted in the initial
According to the experts, another hurdle related to the pricing is reimbursement
of the treatment cost from the insurance company. Establishing health insurance
reimbursement for a new category of products which do not fit the established healthcare
delivery or insurance model is challenging and time consuming.
Once these obstacles and challenges are addressed, cell & gene therapies can become
a common practice. It seems that a new revolution of medicine is around the corner.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 5

Attending to Alzheimer’s proven safe and effective. It would be

The lack of fundamental knowledge great if you could give regular updates
about Alzheimer’s is the key reason on this front in upcoming editions.
why we have not been successful or - Shreya Suresh, Malaysia
close to preventing or slowing down
the disease. But of course worldwide
efforts are being made to validate New AI era
existing therapeutics and discover It seems very likely that artificial
newer targets. Hoping to find a intelligence and machine learning will
solution soon. bring in an era of quicker, cheaper
- Dr Aravind Kishore, Mumbai and more-effective drug discovery.
Pharma companies have a big
solution to look up to. There might
Understanding Stem Cells be initial skepticism but these tools
At present researchers are exploring will eventually become increasingly
many new avenues using stem cells important. Thank you for sharing an
in medicine since there is still a lot to interesting article.
learn about stem cells. Currently, very - Kenith Burn, Singapore
few stem cell treatments have been

Vol 13; Issue 10; October 2018

Publisher & Managing Editor:
Ravindra Boratkar MM Activ Singapore Pte. Ltd.
Singapore India
Chief Editor: Milind Kokje
MM Activ Singapore Pte. Ltd. Alok Srivastava
Saradha Mani Business Head- Ad Sales &
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General Manager Content Creation #08-08, High Street Centre, #9, UNI Building, 3rd Floor, Thimmaiah
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Reprinted in India for private Circulation
6 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


COVERStory 18

A Frost & Sullivan’s recent report forecasts a
growth rate of 19.9 per cent for the contract
research organizations (CROs) industry in Asia
Pacific (APAC) region in the period between

2015 and 2020, while the CRO market in North
America is expected to grow only at 10.4 per
cent CAGR. With a fast-growing pharma market,
large treatment-naïve population, highly skilled

and internationally acclaimed investigators,
high-quality data, and harmonized regulations,
APAC has become a preferred outsourcing
destination for clinical trials.

22 25
“CRO industry is well Growing pharma market
positioned to thrive in Asia” driving CRO industry in APAC

Maree Ward, Karen Chu, Chang Lee,

Senior Director, APAC, PRA Health Sciences and Jonathan Corporate Vice President, Global Vice President,
Newton, Executive Director, EAPA, PRA Health Sciences Clinical Operations, PAREXEL PAREXEL Consulting APAC


“KIHT to support
research and
A bad dose manufacturing
hits Chinese capability to
vaccine player make India self- Dr Jitendar Sharma,
dependent” CEO of KIHT, India
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 7


‘‘CRO industry will develop
vigorously in China’’

Wendy Wang,
Managing Director, Linical Accelovance Group, China

Australia: A growing hub for
early-phase CRO activities

Connect with us

R E G UL A RS BioSpectrumMag
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Regulatory News................08 Academics News................44
Company News..................10 Supplier News.....................45 https://goo.gl/QY4nUp
Finance News......................12 People News........................47 /BS-LinkedIn
Start-Up News.....................13 Bio Event...............................49
World News.........................15 www.biospectrumasia.com
8 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


HSA clears TCR immunotherapy trial for liver cancer

Lion TCR Pte. Ltd., a Singapore- HBV-liver cancer clinician scientist.
based Biotech company has received Several Investigator-sponsored trials
approval from Health Sciences of LioCyx in Singapore and China have
Authority (HSA), Singapore, for its showed results of good safety profile
Phase I/II multi-centre clinical study and encouraging signs of efficacy.
of its product candidate (LioCyx) for “We are very delighted with the
treatment of relapsed liver cancer post- approval of Phase I/II clinical trial
liver transplantation. of our LioCyx, the first engineered
This is the first such trial in Singapore and for TCR-T cell therapy for treatment of liver cancer in
the region that uses precision T cell receptor (TCR) Singapore. It is an utmost encouragement on the
immune cell therapy to target Hepatitis B virus (HBV)- recognition of innovative therapy for patients in need.
related liver cancer, which forms at least 80 per cent of Singapore HSA has been very efficient, transparent
liver cancers in Asia. and professional in reviewing our application for the
LioCyx is developed by Lion TCR’s scientific clinical trial of this innovative immunotherapy”, said
founder, Prof. Antonio Bertoletti, a world-renowned Dr. Victor Li Lietao, founder and CEO of Lion TCR.

Daewoong’s BTX receives Indian Cabinet

nod from Health Canada approves
Korea’s Daewoong Pharmaceutical in Canada in the first half of next MoU with
has received sales approval for
Nabota, its botulinum toxin (BTX)
year and establish its position as a
global brand in the North American Indonesia
product to treat forehead wrinkles, market. Evolus, Daewoong’s U.S. on health
from Health Canada.
Nabota became the first product
partner, will supply products
through Clarion Medical. Canada, cooperation
initially developed by Daewoong a G7 member, is the fifth country The Indian Union Cabinet
to acquire sales approval from an to register at the International chaired by Prime Minister
advanced country. The treatment is Commission on the Regulation of Narendra Modi has
also the first Korean BTX product Medicines (ICH), after the U.S., approved the signing
to enter the Canadian market. EU, Japan, and Switzerland. The of the Memorandum of
Daewoong filed for approval company expects to receive Understanding (MoU)
with the Canadian health sales approval in major between India and the
authorities on July 31 last developed countries Indonesia on health
year, while obtaining GMP such as the U.S. cooperation. The MoU
approval for its Nabota plant and EU by the first covers the following areas
in May. half of next year. of cooperation- Research
The company and development, active
plans to begin pharmaceutical ingredients
sales (API) and IT-based medical
equipment; Human
Resource Development;
Health services; and Any
other area as may be
mutually agreed upon. A
Working Group will be set
up to further elaborate the
details of cooperation and to
oversee the implementation
of this MoU.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 9

CFDA signs exclusive

agreement with UL
Learning’s regulatory content
and training solutions. Following
work to support the CFDAIED
inspector training programme,
UL and CFDAIED will jointly
create and brand China Food
and Drug Administration (CFDA)
regulatory courses for use by Life
Science companies in China as
well as those global Life Science
Victorian Govt
companies looking to meet
regulatory requirements for
products imported into China. with TN
This agreement will ensure
long-term exclusive cooperation
Health Dept
for at least the next five years. The Tamil Nadu State
The cooperation with CFDAIED Health and Family Welfare
The China Food and Drug will help promote UL’s brand Department of India
Administration’s Institute awareness in China, raise UL’s has signed a Statement
of Executive Development profile among manufacturers in of Intent (SOI) with
(CFDAIED) has signed an the Life Science industry, and the Health ministry of
exclusive memorandum of help Chinese authorities improve Victorian Government,
understanding (MoU) with UL to and scale their inspector training Australia, at a recently
develop and deploy UL’s PURE programmes. held event in Melbourne.
The Statement of Intent
signed by the Health
CANbridge Life Sciences to begin minister C Vijaya Baskar
and Minister for health
CAN017 Ib/III Trial in China and ambulance services
of Victorian Government
CANbridge Life Sciences, a biopharmaceutical company developing Jill Hennessy, is aimed at
western drug candidates in China and North Asia, has announced that improving efficient trauma
the China National Drug Administration (CNDA) has approved the system governance, the
Investigational New Drug (IND) application for a Phase Ib/III clinical creation of trauma registry
study of CAN017 in esophageal squamous cell cancer (ESCC). and improving trauma
The Phase Ib/extension study is a multicentre, open label study to care quality and research
evaluate the safety, tolerability, in Tamil Nadu. According
pharmacokinetics and preliminary to the Health Minister,
efficacy of CAN017 in combination the Tamil Nadu Accident
with chemotherapy as the second line and Emergency Initiative
treatment for patients with locally programme is already
advanced or metastatic esophageal being implemented at
squamous cell carcinoma (ESCC). ESCC is the most prevalent form of Rajiv Gandhi Government
esophageal cancer, with 50 per cent of the cases occurring in China. General Hospital, and
The CAN017 IND approval is a key milestone for CANbridge and the in six months of the
second one this year, following the IND approval to commence a trial implementation, mortality
in CAN008 in glioblastoma multiforme (GBM) in April. CAN017 is an due to trauma has been
ErbB3 (HER3) inhibitory antibody humanized IgG1/κ ERBB3 inhibitory reduced to 5.6 per cent
antibody that completed a first-in-human Phase I clinical trial in patients from 8.3 per cent.
with advanced solid tumors in US patients.
10 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Neuron Biohub envisions setting

global standards in life sciences
Neuron Biohub Sdn Bhd has set
up Malaysia’s first state-of-the-art
integrated Life Sciences Logistics &
Testing Biohub in Glenmarie, Shah

Medtronic Alam, to support the healthcare and

life science industries.
introduces Neuron Biohub is specialized
in providing its logistics & testing
IN.PACT services in a cGMP / GDP / GDPmd

Admiral DCB certified hub that ensures the fidelity

of sensitive products and raw
in Japan materials all the way from testing
and production to last mile delivery
Dublin-based in Malaysia. Supporting healthcare freezer rooms capable of regulating
Medtronic has and improving life has been a key temperatures between 8 degrees
announced the driving passion of the company. Celsius and-25 degrees Celsius.
commercial launch of A major challenge faced by In addition, the biohub houses
the IN.PACT Admiral the healthcare industry has been R & D and test laboratories capable
Drug-Coated Balloon the availability of a systematically of providing testing and support
(DCB) in Japan. developed hub with controlled ranging from heavy industrial
IN.PACT Admiral DCB environments and well executed products testing to scientific research
is a clinically proven, processes that provides vital support in a cleanroom environment.
primary endovascular throughout. Neuron Biohub aims to Operational activities and
therapy that treats bridge this critical gap with its biohub environmental conditions within the
femoropopliteal that occupies 88,600 sq ft of land hub as well as delivery are managed
disease, reduces at the Hicom-Glenmarie Industrial and monitored by a state-of-the-art
interventions, and Park in Shah Alam, Selangor. 75,000 command centre that also provides
preserves future sq ft of that includes cold and remote access.
treatment options.
Last year, the
Japanese Ministry
of Health, Labor and
Glenmark inks pact with
Welfare (MHLW) True North for pain management
granted approval for
IN.PACT Admiral Glenmark has formed a joint venture with private equity firm True North for its
for the treatment pain management and orthopedic products business in India and Nepal. Under
of peripheral artery this collaboration, Glenmark’s orthopaedic
disease (PAD) in the and pain management business, valued at Rs
upper leg specifically, 635 crore, will be transferred to a new entity
in the thigh (superficial to-be incorporated by True North. The new
femoral arteries (SFA) entity would be named as ‘Integrace Private
and behind the knee Ltd’ and will market the product portfolio in
(popliteal arteries). India and Nepal. The transaction is expected
This development to be completed in 2-3 months. As part of
follows the completion the deal, Sujesh Vasudevan, President India
of a post-market Formulations, Middle East and Africa at
clinical trial, which Glenmark will join the board of Integrace.
was conducted on 300 Glenmark’s orthopaedic and pain management business in India, consisting
subjects. of brands such as Esoz, Bon K2, Collasmart, and Lizolid, clocked revenue of Rs
155.8 crore in 2017-18.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 11

Crown Bioscience to expand GEM selection through collaboration

Crown Bioscience, a global drug discovery and development
services company providing translational platforms to advance
oncology, inflammation, cardiovascular and metabolic disease
research, has entered a strategic alliance with Shanghai
Model Organisms Center (SMOC) to exclusively license and
commercialize SMOC’s comprehensive collection of genetically
engineered models, including proprietary transgenic and reporter
models for oncology, cardiovascular and immunology research.
SMOC leverages expertise in several gene editing technologies
to develop conventional knockout (KO), conditional KO,
transgenic knock-in and humanized models. These capabilities
are now exclusively available to CrownBio’s international clients
for custom model generation, breeding, IVF, rapid expansion and
re-derivation capabilities. SMOC specializes in model organisms
and is dedicated to gene editing and life decoding. SMOC provides
customized model generation, breeding, phenotype analysis and
high-throughput screening.

Luoxin acquires Singapore Diagnostics,

constipation drug Lucence partner to market
in $68M agreement cancer blood tests
US based Synergy Pharmaceuticals Inc. Lucence Diagnostics, a genomic medicine company focused
has entered into a license agreement on inventing advanced cancer diagnostics, and Singapore
with Luoxin Pharmaceutical Group Diagnostics (Philippines), the largest pure clinical laboratory
Co., Ltd., Shandong (Luoxin) providing in the country, have announced a partnership to market
Luoxin exclusive rights to develop Lucence’s advanced cancer blood tests in the Philippines.
and commercialize Synergy’s lead Singapore Diagnostics will distribute Lucence’s range
product TRULANCE (plecanatide) of blood tests for
for the treatment of adults with cancer diagnosis
chronic idiopathic constipation (CIC) and treatment in
and irritable bowel syndrome with the Philippines.
constipation (IBS-C) in mainland China, The blood tests are
Hong Kong and Macau. based on Lucence’s
Under the terms of the agreement, patented liquid
Synergy will receive an upfront payment biopsy technology,
of $12 million. Synergy is also eligible, which detect
in the event that certain regulatory genetic mutations
and commercial milestones are met, to from tumor DNA
receive additional payments of up to circulating in the
$56 million in aggregate. In addition, blood. This allows
Synergy is eligible to receive tiered doctors to select the most appropriate cancer treatment
royalty payments on aggregate net sales. according to the genetic mutations identified.
Luoxin will lead clinical development Compared to conventional tissue biopsy, Lucence’s liquid
in China and be responsible for all biopsy approach is noninvasive and faster. The tests target
activities and expenses relating to the most common cancers in Asia like breast, colon, lung and
clinical development, regulatory nasopharyngeal cancer. Lucence’s blood tests can also diagnose
approval, and commercialization in early stage nasopharyngeal cancer before symptoms show and
China. Yafo Capital acted as a financial check whether a person is predisposed to cancer by detecting
advisor on this transaction. genes commonly associated with increased risk of cancer.
12 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Haisco to make $10M equity investment in Pneuma Respiratory

Haisco Pharmaceutical Group Pneuma Respiratory, Inc. has Pneuma’s go-to-market
Co Ltd, a China-based company developed the PNEUMAHALER strategy is to marry the technology
focused on the research and Breath Actuated Digital Inhaler of its digital platform with off-
development and marketing (BDI) to solve the problems patent drugs and create more
of therapeutic drugs, has of existing metered dose, dry- efficacious treatments for asthma
agreed to make a $10 million powder, and soft-mist inhalers to and COPD. Pneuma’s strategy
equity investment in Pneuma improve the efficacy of currently aims to de-risk its clinical and
Respiratory. As part of the available airway medications. regulatory pathway and create
agreement, Haisco is to receive PNEUMAHALER BDI is the value by rebranding off-patent
rights to distribute Pneuma first pulmonary inhaler to therapeutic treatments within its
Respiratory’s pharmaceutical merge advanced droplet ejector patented PNEUMAHALER system
products in China. Haisco will technology with digitally controlled to improve inhaled treatments for
be responsible for funding China breath-actuation, and package it in patients in the $39+ billion global
regulatory filings. a lightweight, pocket-sized device. asthma and COPD market.

Legend Capital
co-invests $293M
in Chinese DMC
Legend Capital, the venture and
growth capital arm of China’s
Legend Holdings Ltd, has co-led
an RMB2 billion ($293 million)
investment in Chinese Diagnostics
Medical Corporation by joining
China Renaissance’s healthcare fund,
China Money Network reported.
Other investors including Matrix
IHH Healthcare to exit Partners, Ping An Ventures, High
Light Capital, Zhongjin Kangrui
Apollo Gleneagles Hospitals Healthcare Industrial Fund, and
Shanghai Free Trade Zone Equity
Malaysian hospital chain IHH Healthcare, which won the bid Fund (FTZ Fund) also participated
for debt-ridden Fortis Healthcare, will sell its 50 per cent stake in the round. Incorporated in
in Apollo Gleneagles Hospitals in Kolkata and its radiology 1999, Chinese Diagnostics Medical
centre in Hyderabad to its joint venture partner, to abide with Corporation specializes in the design
a non-compete agreement. Apollo Gleneagles is a joint venture and development of diagnostic
between Apollo Hospitals and Parkway Pantai, a subsidiary of testing reagents. The company has
IHH. Apollo has begun to raise resources to fund the acquisition more than 20 medical inspection
of IHH’s stake. The company is in advanced talks to sell unit centers across China. It also has an
Apollo Munich Health Insurance to HDFC Ltd., the country’s R&D team of about 30.
largest mortgage lender, at valuation of Rs 1,000 crore.
Apollo Munich is a joint venture between Chennai-based
Apollo Hospitals promoted by Prathap C Reddy and his
family and Munich Re. It is the second-largest standalone
health insurance provider in the country, with a 1.08 per cent
market share after Star Health, which was recently sold to a
consortium of Westbridge Capital, Madison Capital and India’s
ace stockbroker Rakesh Jhunjhunwala for Rs 6,500 crore.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 13

Impact Therapeutics
completes $30M in Series C
Impact Therapeutics, Phase I clinical trials in Australia
headquartered in Nanjing, China, and China. Impact raised $10 EdiGene
completed a Series C financing million in a Series B round
round worth $30 million. The in 2016, with investors China raises $15M
round was led by Decheng
Capital with participating from
Summit Capital, Guangzhou
Yuexiu Industrial Investment for portfolio
Lilly Asian Ventures (LAV).
The company plans to use the
Fund, Sungent Bioventure,
Haibang Ventures and Lilly Asia
funds raised to advance clinical Ventures. Its Series A round was EdiGene Inc., which develops
development of IMP4297, its in 2014, with investors Lilly Asia genome editing technologies
potential best-in-class PARP Ventures, Cenova Capital and into novel therapeutics for
inhibitor to treat unspecified Wuxi AppTec Ventures, for an a broad range of diseases
cancers. The drug is currently in unspecified amount. and into creative solutions
to advance drug discovery,
recently announced the
successful completion of
approximately $15 million
in a Series pre-B financing.
The financing was led by new
investor Lilly Asia Ventures
(LAV). New investor Huagai
Capital participated in this
round. Series A lead investor
IDG Capital, Series A investor
WI Harper Group and other
insiders also participated in
this round. EdiGene Inc was
founded in 2015, and now
headquartered in Beijing,
with operational subsidiaries
in Guangzhou, China and
Cambridge, USA. The startup
intends to advance their
CureGenetics secures portfolio of therapeutic
programmes based on
$17M in Series A Financing gene-editing technologies.
In addition, EdiGene
Chinese startup Cure Genetics in 2016 to develop medicines will continue to further
recently announced that it has and molecular diagnostics based develop the proprietary
raised $17 million in a Series A on its gene editing and delivery High Throughput Genome
financing round. technologies. The company Screening platforms into a
The round was led by Qiming intends to use the financing to comprehensive solution for
Venture Partners and included further optimize its technology partners in key areas such
investments from CTS Capital platforms, to sponsor regulatory as drug sensitivity, drug
and Ascendin Investment. filings and clinical trials, and to resistance and synthetic
Cure Genetics was founded expand its pipeline. lethality.
14 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Takeda invests $100M in

regenerative medicine startup
Ambys Medicines, a California-
based biotechnology startup
focused on the discovery and
development of therapies for
Merck chronic liver disease, and Takeda
initiates pilot Pharmaceutical Company Limited
have entered into a partnership to
venture with support the advancement of the

Ambys platform and pipeline.
Takeda has committed $100 new drug application created
German pharmaceutical and million to the partnership, which under the partnership. If Takeda
technology company Merck includes participation in Ambys’ elects to exercise an option for a
KGaA has signed a pilot Series A financing. In return, product, Takeda will share in 50
collaboration agreement Takeda receives an option to per cent of the development costs
with Israel-based diabetes commercialization rights outside for any optioned programme
monitoring startup GlucoMe of the US for the first four products and will make development and
Ltd. The collaboration will that reach an investigational regulatory milestone payments.
test GlucoMe’s device in
several hospitals in Vietnam.
GlucoMe develops and
markets a wireless glucose
and insulin monitor that
records blood measurements
and insulin intakes
automatically and syncs
with a mobile app. The
patient’s personalized profile
connects in real-time to a
digital service that includes
a cloud-based diabetes
management software for
health professionals. The
company’s products received
a CE mark and GlucoMe is
Bugworks Research
currently pursuing clearance
from the U.S. Food and Drug
receives $9M in series A
Administration. Previously, Bengaluru and Delaware-based Holdings, 3one4 Capital, along
GlucoMe signed an exclusive drug discovery startup Bugworks with angels Marcus Schabacker,
strategic agreement Research has raised $9 million former chief strategic officer of
with Apollo Sugar, the in series A funding led by Baxter Healthcare, Shrikumar
nationwide diabetes clinic University of Tokyo Edge Capital Suryanarayan, former head
chain of India-based Apollo (UTEC). UTEC is an early-stage of research and development,
Hospitals Enterprise Ltd. technology-focused investment Biocon. The funds raised will be
The company has also firm. It invests in early-stage used to boost its clinical trials
partnered with Norwegian startups helping the global society to test the efficiency of its drugs.
electronic medical record through innovation. The firm Bugworks Research aims to
company DiaMan AS to has around $500 million under combat drug-resistant superbugs
launch its products in management. Other investors that by inventing antibiotics that will
Central America. participated in the round include be effective in combating the
South Africa-based Acquipharma antimicrobial resistance.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 15

Pfizer, Exact
Sciences to
colorectal cancer
diagnostic test
Molecular diagnostics company
Exact Sciences and Pfizer have
signed a multi-year agreement to
co-market the Cologuard test for
diagnosing colorectal cancer in the

Scientists develop platform US. Cologuard is one of the only

US Food and Drug Administration

to kill cancer cells (FDA) approved and non-invasive

stool DNA screening diagnostics
An interdisciplinary group of scientists from NUST MISIS, for cancer. By promoting the test,
Lomonosov Moscow State University, Pirogov Russian National Exact Sciences and Pfizer intend to
Research Medical University (RNRMU), and the University of boost colorectal cancer screening
Duisburg-Essen (Germany) has shown that a hybrid nanomaterial rates. Exact Science’s sales force,
based on magnetite-gold particles can serve as a universal platform the science of Cologuard and a
to both detect cancer cells anywhere in the body and to complete direct-to-consumer marketing
targeted deliveries of drugs to these cells. The discovery makes it campaign will be combined with
possible to create and implement a completely new generation of Pfizer’s health systems network
cancer treatments in the coming years. and marketing expertise. Exact
This manmade nanohybrid has been tested both in vitro and Sciences will continue to carry out
in vivo. Laboratory tests on mice with grafted tumors have already all manufacturing and laboratory
been completed. According to the scientists, it will be possible to operations of the test. Pfizer will
proceed to pre-clinical trials in just two to three year’s time, as there evenly share gross profits and
is a few years’ of work remaining to be completed before clinical marketing costs above an agreed
trials on real patients. baseline.

Multi- institutional alliance to develop anti-aging drugs

The Buck Institute, Juvenescence, and Insilico
Medicine have announced a research collaboration
utilizing artificial intelligence (AI) to discover and
develop novel anti-aging therapeutics targeting a new
molecular pathway.
The three organizations have announced the
formation of Napa Therapeutics, Ltd, a company
that would commercialize the results of the research
collaboration. The collaboration will utilize an end-to-
end machine learning system to identify the molecular
targets and generate the novel compounds.
The Buck Institute is one of the leading research
centres in the world focused solely on research on
aging and the elimination of age-related disease.
Insilico Medicine is an AI company focused on a range should the program be successful. Juvenescence is a
of verticals devoted to aging. Insilico Medicine stands company focused on developing drugs to modify aging
to earn more than $100 million in milestone payments and the diseases of aging.
16 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Sudan steps
up Ebola
South Sudan’s Health
Ministry has stepped up Ebola
surveillance following an
outbreak of the deadly virus
in its southern neighbour,
the Democratic Republic
of Congo (DRC). The
government has teamed up
with partners to strengthen
Merck continues to
disease surveillance in key
entry points and border
strengthen presence in Africa
areas shared with the DRC. Merck Foundation, the Programme in partnership with
The government has formed philanthropic arm of Merck KGaA African ministries of health
a national response team Germany continues their long and First Ladies offices to be
composed of the World term commitment to improve conducted in the University of
Health Organization (WHO) access to cancer care and to build Nairobi, Kenya, Tata Memorial
and other aid organizations capacity through their Merck Centre, India, University of
to draft an emergency Access Programme in Africa. Malaya, Malaysia, and Cairo
response plan to respond to So far, more than 30 University, Egypt.
any suspected case of Ebola candidates from Niger, Chad, Merck Foundation has
in the war-torn East African Guinea, Kenya, Ethiopia, conducted the Merck Oncology
nation. Despite the ongoing Rwanda, Uganda, Liberia, Fellowship Programme that
insecurity that has engulfed Botswana, South Africa, Gambia, focuses on building professional
South Sudan since 2013, the Senegal, Zambia, Namibia, cancer care capacity with the aim
country is preparing to tackle Mauritius and Ghana have been to increase the limited number
any outbreak with the support enrolled in the one year and of oncologists in Africa and
of aid organizations. two year Oncology Fellowship Developing Countries.

Kenya to reduce HIV incidence

Kenya’s Ministry of Health and will be able to test an estimated
private sector partners have 1million people a year.
launched a state-of-the-art The significant burden of HIV
laboratory to enhance screening in Kenya is driving the investment
of the HIV virus with the aim to in the prevention and treatment of
eliminate the disease by 2030. The the disease in the country. Kenya’s
new HIV diagnostic laboratory expenditure on HIV totaled $1,170
equipment, called cobas 8800, million in 2017, with a significant
will be installed at Kenya Medical proportion ($741 million) coming
Research Institute (KEMRI). from international sources. The
Kenya aims to achieve a 100 increased investment in the country
per cent HIV testing target in the has seen the rate of new infections
near future through investments drop since 2010, down by 32 per
in modern diagnostic equipment. cent, but the country still has one
The new HIV diagnostic laboratory of the highest infection rates.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 17

WHO recommends Ravidasvir for HCV treatment

Ascletis Pharma Inc recently announced that Ravidasvir is
recommended by the World Health Organization (WHO) Guidelines
for the Care and Treatment of Persons Diagnosed with Chronic
Hepatitis C Virus Infection as a future pan-genotypic direct-acting
antivirals agent (DAA). Ravidasvir is a next-generation, best-in-class
and pan-genotypic HCV NS5A inhibitor with a high genetic barrier
to resistance. Globally, Ravidasvir has completed three phase III
clinical trials with more than 1000 patients enrolled. Ravidasvir in
combination with Ganovo (RDV/DNV Regimen) is the first all-oral
interferon-free HCV regimen developed by a domestic company in
China. A phase II/III clinical trial in China has shown that RDV/
DNV Regimen demonstrated a cure rate of 99 per cent (SVR12)
with a short treatment duration of 12 weeks in genotype 1 patients.
In patients with baseline NS5A resistance mutations, RDV/DNV
Regimen demonstrated a cure rate of 100 per cent (SVR12).

Six countries in WHO South-East

Asia achieve rubella control WHO warns of
In a significant win against childhood killer diseases, two measles epidemic
countries of WHO South-East Asia Region, DPR Korea and
Timor-Leste, were verified for eliminating measles, and six in Europe
countries certified for controlling rubella and congenital rubella According to the World Health
syndrome, two years ahead of the target year 2020. Last year Organisation, the measles epidemic
Bhutan and Maldives became the first two countries in the sweeping Europe has reached an
Region to eliminate measles. Recently, four of the 11 member eight-year high, with more than
countries of WHO South-East Asia have now eliminated 41,000 cases reported in the first
measles. Bangladesh, Bhutan, Maldives, Nepal, Sri Lanka and six months of the year. This far-
Timor-Leste are the first six countries in the WHO South-East exceeds the end of year totals from
Asia Region to control rubella and congenital rubella syndrome. every other year this decade and
Bhutan, Maldives and Timor-Leste, have become the first at least 37 people are believed to
three countries in the Region to achieve both elimination of have died from the disease, which
measles and control of rubella and can be almost entirely prevented
congenital rubella syndrome. All with vaccination. Seven countries,
countries in the Region have introduced including France, Italy and Greece
two doses of measles containing have had more than 1,000 infections
vaccines in their immunization this year and all have reported
schedule. Eight of the 11 countries at least one death. Ukraine has
have introduced rubella reported the largest number of cases
vaccines in their immunization with more than 23,000 children
programmes, and the remaining and adults infected, although
countries are in the process Serbia has seen 14 measles-related
of doing so. Nearly deaths, the highest in Europe. After
400 million children the WHO warning, Public Health
are planned to be England has declared that anyone
vaccinated through who has not completed both doses
mass campaigns of their measles, mumps and
with measles and rubella (MMR) vaccination should
rubella vaccine contact their General Practitioner
in 2018-19 in the for ensuring protection.
18 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


A Frost & Sullivan’s recent report ver the past several years, there has been
forecasts a growth rate of 19.9 per cent tremendous growth in the number of Asian
companies offering outsourcing services to the
for the contract research organizations
global pharmaceutical and biotechnology industries.
(CROs) industry in Asia Pacific (APAC) The increasing cost of research, the loss of revenue
region in the period between 2015 and from leading blockbusters going off patent and the lack
2020, while the CRO market in North of extensive in-house R&D infrastructure has driven
America is expected to grow only at many biotechnology companies to outsource clinical
trials to contract research organizations (CROs) in
10.4 per cent CAGR. With a fast-growing
Asia. The year, 2017 saw a huge market competition
pharma market, large treatment- in Asia’s CRO industry, with many mergers and
naïve population, highly skilled and acquisitions and CROs competing for market share by
internationally acclaimed investigators, enhancing therapeutic expertise, geographical reach,
high-quality data, and harmonized technology, and increased functional capability.
With pharma companies moving toward CROs and
regulations, APAC has become a preferred
specialists for their clinical development services,
outsourcing destination for clinical trials. clinical outsourcing penetration has increased from 43
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 19

percent in 2016 to 45 per cent in 2017 says a Clinical AS PER FIGURES RELEASED BY A RECENT
Leader’s report.
Globally, clinical trials industry is expected to STUDY ON CLINICAL TRIALS SECTOR
grow at a compound annual growth rate (CAGR)
of 12.4 per cent to reach $57.0 billion in revenue in
2020 from $31.8 billion in 2015. A quick analysis of OBSERVED THAT, ASIA WAS THE LEADER
the last few years in clinical research reveals some
encouraging news. ClinicalTrials.gov currently boasts IN GROWTH, WITH CLINICAL TRIALS
nearly 300,000 registered studies as organizations THERE INCREASING BY 188 PER CENT.
race to bring in life-saving medical products to market
for populations in need. As per figures released by a CHINA AND JAPAN HAD ABOUT 1,000
recent study on clinical trials sector growth across AND 2,500 CLINICAL TRIALS IN 2010,
geographies it was observed that, Asia was the leader
in growth, with clinical trials there increasing by 188 RESPECTIVELY, BUT BOTH ENDED UP
per cent. China and Japan had about 1,000 and 2,500
clinical trials in 2010, respectively, but both ended up
near 6,000 by 2017. India remained stagnant until STAGNANT UNTIL 2016, AND SOME
2016, and some policy modifications helped triple the
figures in just one year. On the contrary, in the West, POLICY MODIFICATIONS HELPED TRIPLE
the picture looks quite different. The West hasn’t seen THE FIGURES IN JUST ONE YEAR.
nearly the level of growth that Asia has during this
time frame. Compared to Asia’s growth of 188 per
cent, the study found that North America experienced
only a modest increase of 12 per cent, and that Europe Asia an ideal hotspot for conducting clinical trials,
actually decreased by about 2 per cent. in comparison to the West. Few of these are large
treatment-naive patient pools, numerous clinical trial
Asia’s growing clinical trial landscape centers with advanced equipment and technology,
A Frost & Sullivan’s recent report forecasts a growth comparable incidence and prevalence of Western
rate of 19.9 per cent for the CRO industry in APAC diseases. Apart from this, Asia’s skilled labour and key
region in the period between 2015 and 2020, while opinion leaders with subject expertise make the region
the CRO market in North America is expected to attractive for conducting clinical trials. Data from
grow only at 10.4 per cent CAGR. Beside an increase clinical trials conducted in Asia is routinely accepted
in home grown R&D activities, the crucial reason for as part of US Food and Drug Administration (FDA)
this rapid development is a shift in clinical trials from and European Medicines Agency (EMA) regulatory
Western markets to Asian ones. Many factors make submissions. Asia also has some of the world’s
20 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


highest number of state-of-the-art Current Good

Manufacturing Practice (CGMP) compliant facilities
outside the US. Quality inspections conducted in
Asian companies by US FDA and EMA show low levels
of adverse findings, indicating high international
compliance to standards. Costs in Asia for procedures,
diagnostic tests and visits are generally 30- 40 per
cent lower than the US and European countries. Also
moving from being a generic maker Asian companies
have now embarked on innovating new drugs adding
to the number of clinical trials registered in the region.
Moreover, Asians are beginning to show similar or
higher incidence rates of major lifestyle diseases
like the Western nations, providing a comparable
environment to conduct clinical trials.

Barriers in conducting trials in the West

Broadly, some of the major barriers to conducting
clinical trials in the US and Western Europe involve
challenges in participant recruitment and retention,
resulting in longer time and high costs. Recent
statistics indicate that only 6 per cent of eligible
patients in the US actually participate in clinical trials. research, with 72 ongoing trials. Many such factors
As a result, 87 per cent of trials in the US are behind are instrumental in placing Asia on the world’s clinical
in their recruitment and enrollment. Asia is uniquely trials map.
positioned to address this problem, with over 60 per
cent of the world’s population found in this region. Many Asian nations
Nearly 2 billion people live in Asia’s high-density are top destinations for clinical trials
cities, where they can be more easily recruited for In Asia, Japan is the leader in clinical trials. Japan’s
clinical trials. improved clinical trial infrastructure offers a conducive
As we know, drug development process is a environment for pharmaceutical, biotechnology, and
long-drawn process, taking an average of 10 years medical device companies. Addressing a downward
with clinical trials alone taking six to seven years on trend in clinical trial registrations and a lag in the
average. The average cost of developing a new drug is availability of drugs within the country as compared to
over $2.6 billion, and is only getting more expensive. other developed nations, Japan’s Ministry of Health,
While this upward trend is true globally, Asia offers Labor and Welfare (MHLW) ushered in significant
immediate cost savings. Resources and staffing are far changes. These changes included creating a more
cheaper, in China and India, which makes it more cost welcoming and efficient approach to trials, new
effective to bring a new product to market. consultation systems, and offering new subsidies to
Not only is Asia cost-effective but is also rich in lower the regulatory and clinical cost for expedited
skilled therapeutic experts. Many Asian nations and review while maintaining global standards such as the
sites are global leaders developing drugs for certain ICH-GCP. These changes have helped Japan to attract
indications. The National Taiwan University (NTU) more clinical trials and the Japanese CRO market has
Hospital is a leading facility for cardiovascular been expanding for the past over 10 years, and reached
treatments and has carried out more than 500 heart ¥172 billion in 2016.
transplants as of 2014 with a success rate exceeding Though less mature than the land of the rising sun,
90 per cent. NTU’s College of Medicine specializes in Asia’s other countries- South Korea, India, China,
cancer research and clinical trials for novel drugs in Taiwan have also made significant progress and are
parallel with Western countries. promising candidates for increased growth in Asia’s
Japan, China, Singapore and South Korea are CRO landscape. Among 10 ASEAN countries, Thailand
front-runners in stem cell therapy due to market- has registered highest number of clinical trials in the
friendly government regulations and significant region. Thailand now has a world-class infrastructure,
funding. China alone has 17 academic institutions and a universal healthcare system, and national policies
hospitals that contribute to regenerative medicine that support a developing clinical research industry.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 21

in 2011 to 53 in 2016. Currently there are 27 CROs

have been present in this country, including global
market players such as Parexel, Covance, and IQVIA.
The government is paying serious attention to clinical
research, with 134 hospitals throughout the country
approved by Taiwan Food and Drug Administration
(TFDA) to conduct trials.
Though India saw a huge downward trend in
conducting clinical trials in the past few years,
significant regulatory changes have made the
country one of the top clinical trial destinations in
Asia. With key policy changes, India has reopened
doors to conduct global clinical trials. What’s more,
India now has the largest number of FDA-approved
pharmaceutical manufacturing facilities outside the
US, specifically 119 units. India also has nearly 5,628
commercial clinical trial sites.
China is not behind too! Though grappling with
quality issues and scandals, China too is showing
positive growth in clinical trials space. Following
China’s 2017 implementation of Circular 53, huge
number of clinical studies in China can be expected in
South Korea ranked sixth in the world for the the coming years, say experts. Circular 53 will continue
number of clinical trials conducted in the country, and to expand the country’s clinical trial infrastructure,
Seoul topped the list with the most clinical trials per removing previous regulatory hurdles and greatly
city last year. United Nations Educational, Scientific reduce clinical trial timelines. Changes delivered by
and Cultural Organization (UNESCO)’s market Circular 53 include the simplification and expansion
research report states that South Korea ranks first in of clinical trial sites and infrastructure, simplified
R&D spending with regard to gross domestic products ethics committee review processes and an acceptance
(GDP) at 4.3 per cent of GDP. Marked for its high level of foreign data. Besides changes in the regulatory
of technological and social development, South Korea pathways, China is showing a promising evolution
is attracting more Phase I trials. Since early-phase of its R&D activities. It is shifting away from generic
trials are only allowed in countries where the medicine drug development and focusing more intensely on the
is originally developed, this upward trend means development of innovative products. China is investing
that this country is making remarkable progress in heavily in immuno-oncology research and is a leader
researching on new drugs and therapies. in chimeric antigen receptor T-cell (CAR-T) therapy
Moreover, Korea also has one of the world’s most where they have over 60 clinical trials underway.
efficient clinical trial approvals (30 working days), This trend is supported by a surge in both private and
and its medical institutions and practices meet the public financing with Chinese venture capital and
highest international standards. Korea has a research- private equity funds having raised over $45 billion for
intensive ecosystem complemented by some of the investment in healthcare since 2015.
most advanced IT infrastructure and training. With Globalization of clinical trials, development of new
a highly educated and motivated workforce, Korean treatments such as personalized medicine, augmenting
companies have proven track records in quality evolution in technology, are some of the key drivers of
and efficiency in clinical trials. Another significant APAC CRO market. Asia’s pharmaceutical market in
advantage is the extensive support provided by the general and clinical trial market, in particular, is on
Korean government for the pharmaceutical R&D the rise, with South Korea, Taiwan, India and China
industry and clinical trials thus further propelling the being the major contributors. Since governments in
sector. these countries are all paying much more attention and
Taiwan, too, is showing positive signs in clinical optimizing regulations to create the most favorable
trial market with a constant growth trend from 2011. environment for clinical trials, APAC’s CRO industry
Similar to South Korea, Taiwan also saw a large is expected to flourish in the years to come.
number of early-phase trials, specifically from 11 Aishwarya Venkatesh
Phase I approved investigational new drugs (IND) aishwarya.venkatesh@mmactiv.com
22 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


“CRO industry is well

positioned to thrive in Asia”
will give companies greater access.
« The Asian market has a reputation for having
Maree Ward, complex healthcare systems with a less uniform
Senior Director, APAC, approach than the European Directive. Traditionally,
PRA Health Sciences one of the biggest challenges has been the variability
and Jonathan in what is defined as a “healthy” normal, culture and
Newton, Executive healthcare infrastructure. However, this is changing.
Director, EAPA, PRA Technology driven countries such as Japan and South
Health Sciences Korea are pairing with efficiency driven countries
like China and factor driven countries like India,
and together they are making progress in developing
strategies that can overcome drug development
At more than 4 billion people, the Asian hurdles in the region, particularly now that the
population accounts for more than 60 per market is open to making changes. Collectively, there
cent of the world population and carries an has been a focus on simplifying regulatory approval
increasing disease burden in cardiovascular processes, increasing government support, and
disease, cancers and Type II diabetes. improving clinical trial industry infrastructure.
These patient populations were previously The most significant growth in Asia’s CRO
challenging to reach; expansion into the Asian landscape can be seen in China. With a population
market will give companies greater access. of nearly 1.4 billion, and changes underway in their
regulatory environment, the drug development
Now the governments are becoming more
industry is seeing a long-anticipated growth curve
aware of the economic benefit and positive taking shape. In anticipation of an increase in
healthcare impact a growing clinical research clinical trial work, there has been some movement
industry can have. This expansion of trials
has resulted in continued growth for the CRO
market in the region.

s the number of clinical trials increases
globally, the need for Asia as a region for
clinical trial conduct and sites also continues
to grow creating an intensively competitive trial
landscape. There has been diversification among
sponsor companies to file new drug applications in
the Asian markets, requiring local trials and patients.
In parallel, the governments are becoming more
aware of the economic benefit and positive healthcare
impact a growing clinical research industry can have.
This expansion of trials has resulted in continued
growth for the CRO market in the region.
At more than 4 billion people, the Asian
population accounts for more than 60 per cent of the
world population and carries an increasing disease
burden in cardiovascular disease, cancers and Type II
diabetes. These patient populations were previously
challenging to reach; expansion into the Asian market
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 23

of sponsors setting up hubs in Beijing and making talent. CROs will view both as a potential option to
investment in the development of the Chinese clinical support training, monitoring support, leadership, etc.
trial environment. In Japan, the clinical trial market is facing
In line with many other Asian countries, the considerable challenges due to a lack of available,
regulatory environment in China is undergoing experienced, clinical trial resources. The rapid
changes which will result in changes to the trial expansion of trials in Japan has put significant
approval process, most notably, a reduced regulatory pressure on the labour market that supports these
timeline to 60 days to run in parallel to ethics trials. Limited availability of experienced, Japanese
submissions, increased site selection flexibility, and speaking clinical and medical staff for direct site
the ability to utilize foreign data. This will improve interactions, coupled with an outdated resourcing
the trial environment by making it simpler and less model by local CROs, has made reliable and
time consuming. consistent staffing a bottleneck for some providers in
If China Food and Drug Administration (CFDA) the country.
regulatory reforms are enacted, China represents However, there continue to be collaborations
one of the largest potential growth regions for between regulatory authorities in Japan and other
clinical trials and the CRO market in the next five countries in the region to accept early clinical
years. The access to large numbers of patients, supportive data as justification for Pharmaceuticals
both disease specific and treatment naïve, in urban and Medical Devices Agency (PMDA) applications.
settings will continue to make China attractive The ability to share safety data between countries
for trials. However, Good Clinical Practice (GCP) such as China, Taiwan, Japan and Korea may
and quality challenges can be an issue at trial sites help streamline clinical trial applications as well
with limited trial experience. Therefore, the use of as marketing applications in Japan. Both the
Site Management Organizations (SMOs) and the limitations in available staff and the increase in
provision of GCP training and site support will be demand for trial sites in Japan present growth
critical to ensure high quality data is produced at opportunities in the country for global CRO market
these sites. In addition to CRO growth in the country, expansion.
SMO growth will also be required to meet these Currently, approximately 1.4 per cent of
needs. global clinical trials are conducted in India; the
From a resourcing perspective, Taiwan and Hong country has a population of 1.3 billion and carries
Kong will likely benefit from growth in China since approximately 20 per cent disease burden in
both locations have demonstrated strong quality and the world. This low percentage is the result of a
previously unstable clinical trial environment.
The number of trials running in India peaked with
clinical trial applications in 2010 however, changes
to clinical trial regulation, and a lack of stability
within India, resulted in a significant decrease in
trial activity. Today the number of clinical trials in
India has been steadily increasing and is expected to
continue to grow in 2018-19 as a result of clinical trial
regulatory changes that are helping them become
more secure and predictable. The regulatory process
has eliminated the three-tier approval system and
now requires only a single approval following an
electronic application, resulting in faster timelines
and therefore faster access to patients.
South Korea continues to be a country of choice
to conduct clinical trials. It has seen steady growth
in the number of trials registered largely due to the
country’s sophisticated infrastructure, high level
medical care, and access to experienced staff. Korea
has conducted more trials than any other Asian
country in the last five years and has ranked in the
top 10 countries in the world since 2011.
Singapore also continues to be a high-quality
24 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


VIRTUAL TRIALS AND MOBILE PLATFORMS A key opportunity for APAC is to embrace
ARE A VIABLE OPTION FOR MANY TRIALS technology at the client, site, CRO, and patient level.
Everyone should be considering how technology can
AND AN OPPORTUNITY IN APAC TO assist with faster drug development. Patients are
MAKE THE PATIENT EXPERIENCE MORE consumers and we need to offer them ways to access
REWARDING. INTEGRATED HEALTH DATA these trials in an easier way, technology can help us
to do that. In every trial we see sites which fail to
AND ANALYTICS DELIVERED AS CLOUD- recruit patients. This is a waste of time and money.
BASED SOLUTIONS DEMONSTRATE A MORE There has also been a lazy approach to patient
recruitment where we wait for patients to approach
AGILE, FLEXIBLE AND ADAPTIVE FUTURE OF us to enroll in a trial. There is opportunity to use
CLINICAL DEVELOPMENT. CROS NEED TO USE data to help with patient recruitment, retention, site
TECHNOLOGY TO PROVIDE DEEP, DATADRIVEN selection, the ability to evaluate trends with adverse
events, etc.
INSIGHTS TO OPTIMIZE GLOBAL CLINICAL In the US, data is more easily accessible. In
STUDIES AND DRUG COMMERCIALIZATION APAC, we need to look for ways to access or utilize
FROM CONCEPT TO COMPOUND TO CURE. data such as patient claims and outcome data,
social listening, internal databases, licensing, or
purchase data from external sources, media outreach,
study websites, educational videos/assets, mobile
country for clinical research. While there is platforms, wearables, EDC integration, etc. This will
significant investment and infrastructure to support enable us to select the best sites, proactively engage
clinical trials, participation remains limited due to its patients to participate in research, collect data in real
size. time, and retain those subjects throughout the trial
The remaining Southeast Asian countries, lifecycle. Along with the usual systems like clinical
(Malaysia, the Philippines, Cambodia, Vietnam, trial management system (CTMS)/ interactive web
Myanamar, Thailand, Laos, the Indonesia, Sri Lanka response system (IWRS), dashboards would provide
and Bangladesh) all represent a small number of a clear overview of study progress, review current
active clinical trial sites. However, with respect to and past recruitment rates, and training. The use of
populations and access to treat naïve patients, as well artificial intelligence/robotics would reduce tasks on
as certain therapeutic indications (tropical disease, staff and should be more commonplace within CROs.
infectious disease, certain cancers), these countries Virtual trials and mobile platforms are a viable
present excellent growth opportunities for CROs. option for many trials and an opportunity in APAC
The challenge remains infrastructure, and access to make the patient experience more rewarding.
to well-trained clinical sites and staff. In many of Integrated health data and analytics delivered as
these countries, the clinical trial models are still cloud-based solutions demonstrate a more agile,
relatively new, and thus access to talent for CROs for flexible and adaptive future of clinical development.
hiring experienced, GCP trained staff can be difficult. CROs need to use technology to provide deep, data-
Malaysia, Thailand, and the Philippines represent the driven insights to optimize global clinical studies and
best option for most indications, but Vietnam is also drug commercialization from concept to compound
attracting some interest. to cure. Virtually connecting patients who are beyond
In the last few years we have seen the introduction the clinical setting through Bluetooth wearables
of adaptive monitoring across the globe, the and connected home devices reduces participation
biggest change to the industry since e case report burden and fosters patient engagement throughout
forms (eCRFs) came into play. There have been the continuum of care, while also supporting the
large investments in technology around Adaptive collection of billions of data endpoints.
Monitoring but implementation across Asia has been The CRO industry is well positioned to thrive in
challenging. While there have been enormous steps the Asian market, with some positive momentum
forward in improving the speed of clinical trials and already being seen in many of the countries to
the way each country embraces trials, this new way of welcome clinical trials. It is this diversity and
managing them has required new solutions to ensure complexity that creates a great opportunity for
smooth implementation and adherence to local ethics CROs to provide subject matter expertise to sponsor
requirements. These challenges will continue through companies to help guide them in successfully
the next few years as the industry adapts. conducting clinical research in Asia.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 25

Growing pharma market

driving CRO industry in APAC
regulatory strategy, and clinical operations. With the
China National Drug Administration (CDA) adopting
ICH-GCP, the workforce need to be well-versed in
these procedures and be able to operate at a more
advanced level.
In contrast, Japan’s R&D is much more well-
established and robust, especially in the last decade,
and regulations have also been more stable. As
Karen Chu, Chang Lee, a result, in Japan there is greater need for talent
Corporate Vice Vice President, with a regional and global project management
President, Global PAREXEL skillset. English-speaking ability is also a mandatory
Clinical Operations, Consulting APAC component. In addition, as simultaneous global
PAREXEL trials are running in Japan, the country is in need
of operational staff who are able to address the
differences in various cultures and different clinical
trial landscapes.

t 31 per cent of the total, Asia Pacific has the Chang Lee: The biggest challenge CROs in the
second largest share of the CRO production APAC region, especially in China, face today is the
market. Much of this growth is driven by lack of adequate clinical research infrastructure
pharmaceutical and biotechnology companies in specifically limited clinical research sites, lack of
the United States and Western Europe increasingly qualified Principal Investigator (PI) and research
outsourcing their core research activities to staff, and inefficient IRB/EC processes, among other
CROs in developing countries in order to contain challenges.
costs. It is seen that many multinational CROs
are themselves now expanding their operations What according to you are some of the key
to developing countries in Asia Pacific, taking drivers and restraints of APAC CRO industry?
advantage of lower costs for conducting clinical Karen Chu: Key drivers of the APAC CRO industry
trials in these regions compared to the US and continue to be the pharmaceutical market in the
European countries. Speaking to BioSpectrum Asia region. China is anticipated to become the largest
Magazine, Karen Chu, Corporate Vice President, pharmaceutical market by 2020, and Japan still
Global Clinical Operations, PAREXEL and Chang remains in the top five. In addition, both have large
Lee, Vice President, PAREXEL Consulting APAC patient populations which allow clinical trials to
elaborated on opportunities, growth and challenges enroll much faster than other markets, and both
of the APAC CRO market. Edited excerpts; countries continue to be an attractive region for
biopharmaceutical companies to conduct clinical
In your opinion, what are the biggest challenges Another key driver for CROs are the capital
CROs in the APAC region face today? investments pouring into Chinese biopharmaceutical
Karen Chu: In the APAC region, a small talent companies, as well as the traditional local
pool continues to be the biggest challenge CROs are pharmaceutical companies investing in transforming
facing as the pharmaceutical R&D market grows in themselves into more innovative companies. Many of
this area. Both China and Japan are experiencing these companies lack the manpower to design drug
a lack of talent in the drug development industry. development strategies and efficiently execute trials,
In China, due to the most recent regulatory change which is another driver of opportunity for CROs in
and significant investment into small to mid-sized the industry. It is worthy to note that in previous
biotech/pharmaceutical companies, talent is needed years, China seemed to also offer another benefit
in research and development, project management, of low costs, however recently as competition has
26 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


a hallmark of industrial-research facilities — and

sophisticated, state-of-the-art equipment.

What do you envision as the future for the CRO

industry – 10 years from now?
Karen Chu: In China, I envision that the CRO
industry will mimic that of the western countries
– consolidation of local CROs and vendors. The
service provider will become more of one-stop-
shop with global expertise sitting locally for the
biopharmaceutical companies to tap into. In addition,
we can expect very innovative ways to conduct trials
with technology and tap into the large population
in China. In 10 years, big data becomes even more
powerful. We can also expect much more rigor in
post-marketing surveillance – if that term still means
the same thing in 10 years. Basically, there will be
much more “management” from the government on
increased, this benefit has diminished. This presents products that are marketed.
a potential restraint for CROs, as clients in this region Chang Lee: In the future, I envision that the
often expect a more cost-effective solution. One of traditional CRO model (i.e., clinical trial focused) is
the ways to curb the cost and also to ensure a steady going to be changed to CRO plus (something else)
in-flow of talent, PAREXEL has been investing in model. For example, this might include CRO +
multiple fronts to development its own pipeline of Marketing Data; CRO + Clinical Lab; CRO + CMO;
talent, under strategic work force planning. In the CRO + technology (e.g., AI, big data).
past two years, there has been significant investment
place into local talent development programs, Could you please highlight some of the key
exchange programs, etc. milestones PAREXEL has crossed in the last 2-3
Chang Lee: In my opinion, the major drivers years? And how do these provide the company
of the APAC CRO industry include the growing of leverage in the APAC region?
pharmaceutical market size, regulatory reform in Karen Chu: In the last 2-3 years, PAREXEL has
China, increased investment and innovation in drug successfully brought all its business services into
developments and more global pharma companies Asia. Now, not only are the traditional clinical
coming to APAC. Restraints include the shortage research services PAREXEL has delivered in the
of adequate expertise, high turn-over rate in staff, region for 20+ years, but also PAREXEL’s regulatory
increased study cost and selection of right technology and market access services are able to support our
for the region. clients in Asia. This is very meaningful as PAREXEL
delivers an integrated service offering and one-stop-
What are the countries in Asia exhibiting shop for our clients based in Asia. PAREXEL’s long-
promising growth in CRO space and why? time presence and depth of expertise in the region
Karen Chu: China exhibits some of the most has enabled trust amongst our clients in APAC, and
promising growth in the pre-clinical, clinical, and big we look forward to continuing to advance these
data space. There may even be a potential uptick in partnerships.
medical device development and trials. The second is
Japan, where the most growth might concentrate in Does PAREXEL have any plans for further
big data, new technology platforms and innovation. expansion in Asia?
Chang Lee: Yes, China has the largest Karen Chu: The APAC region is a top priority for
opportunity for growth, due to the recent regulatory PAREXEL and will continue to be as the industry
reforms and increased investment in innovation. grows. The region shows great promise and we are
Another growth area is Korea. The success of prepared to meet the needs of our clients as they
Samsung’s bio-tech venture has stimulated flows work to deliver important new therapies across the
of investments from enterprises and government. globe.
These investments have resulted in ample lab spaces Aishwarya Venkatesh
at many biopharmaceutical research complexes — aishwarya.venkatesh@mmactiv.com
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 27

‘‘CRO industry will develop

vigorously in China’’
with a 19 per cent year-on-year growth compared with
2016, according to the report published by Prospective
Industry Research Institute. According to the data of
WuXi AppTec, Tigermed, JOINN Lab, and Boji Phar.,
« in 2017, the business income of the four enterprises in
Wendy Wang, the contract R&D service totaled more than 7 billion
Managing Director, RMB (excluding non CRO business), which accounted
Linical Accelovance for 10.04 per cent, 3.02 per cent, 0.52 per cent and 0.22
Group, China per cent of the total Chinese CRO market, respectively.

What are the key drivers and restraints affecting

CRO business in China?

linical trial activity in China has been on the rise The clinical trials in China include global multicenter
since 2007, and the number of Phase I–IV trials clinical trials, import registration clinical trials,
revealed a clear upward climb year-on-year, and the registered clinical trials of domestic generic
from 487 trials in 2007 to over 1,300 trials in 2016. pharmaceutical enterprises, in which clinical trials
Despite the bumps and regulatory hurdles that it faced in domestic pharmaceutical enterprises mainly
this past decade, China is recognizably the second- based on generic drugs are the mainstream. Only in
largest pharma market in the world, and its market the first half of 2018, there are 291 Bio Equivalence
value is forecasted to reach $200 billion by 2020. The (BE) notification submitted to China Food and Drug
current landscape of clinical trials registered in the Administration (CFDA), which is the result of reform
country paints a well-balanced, healthy pipeline of of drug registration. Approximately 2793 clinical
drug innovations. Speaking to Aishwarya Venkatesh trials have been registered in Chinese Clinical Trial
of BioSpectrum Asia, Wendy Wang, Managing Register (ChiCTR) in the first half of this year, an
Director, Linical Accelovance Group, elaborates on increase of 81.63 per cent over the same period of last
opportunities and challenges of China’s CRO industry. year. There are approximately 880 registered in CDE
China-based Linical Accelovance is an award- Drug Clinical Trial Register (CTR) in the first half of
winning, niche Contract Research Organization (CRO) 2018, an increase of 45.45 per cent compared with
focused primarily on oncology, vaccines, and general those in the same period of 2017. These registered
medicine. With a presence in the US and China, clinical trials consist of post-marketing drugs, clinical
Linical Accelovance has been honored as a Best CRO trials on new therapy, and others. All this indicates
ViE Award nominee by industry leaders for the past 11 that clinical trials have had a huge burst in China. At
consecutive years, after being evaluated against global the same time, there will be more global multicenter
CROs for quality of services and performance. Edited clinical trials because of relatively cheaper Chinese
excerpts; manpower and huge patients’ pool since China joined
ICH in 2017. This means more opportunities for CRO
What is the current market size and trends in companies in China.
China’s CRO space? There are many factors affecting the development
The CRO market in China started to develop in of the CRO industry in China. First, the domestic
1990s, later than those in Europe and America. CRO pharmaceutical market is gradually integrating with
companies can be divided into 3 categories in China: the international market, and the investment of
preclinical CRO, clinical CRO, and drug registration multinational pharmaceutical enterprises in China
and approval agent CRO. The first two companies has been increasing. Multinational pharmaceutical
usually include the third one, a smaller share, in their companies such as Bayer, Merck, Pfizer and Novo
“one-stop service”. In 2017, the size of China’s CRO Nordisk have invested more than 10 billion RMB in
market was over 55 billion RMB (~9 billion USD), China, and dozens of research centers have been set up
28 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


for China CROs. These include the patent expiration

of innovative drugs, booming Traditional Chinese
Medicine (TCM) research, CFDA improved
supervision and requirements on clinical trial quality,
and the government’s policy on the encouragement of
innovative drug development.
In 2019, patents of 11 NCE drugs are to expire
in China. Patent cliff will make pharmaceutical
companies face fierce competition in generic drugs.
CROs can help pharmaceutical enterprises achieve
accelerated progress in the limited patent period,
shorten the R&D cycle, and help bring new drugs
on market sooner, which translates into increased
demands for CROs. The research and development of
since 2000. Second, domestic policy reform, generic TCM is also booming. A few of famous domestic TCM
drug consistency evaluation and other policy factors companies have already begun to explore promoting
make the clinical trial outsourcing market expand TCM to global markets, which provide opportunities
rapidly. The domestic drug market is transforming from for CROs not only within China but also overseas.
“generic drugs” to “innovative drugs”, and government Since July 22, 2016, then CFDA (now National
policies encourage innovation. This brings more CROs Drug Administration- NDA) has carried out a self-
involved in drug research to reduce uncertainty risks examination and verification of clinical trial data of
associated with these huge investments and improve drugs, exposing some problems in the field of clinical
research and development efficiency. Furthermore, research in China, such as poor quality of research,
the large treatment naïve patient pool and lower costs lack of research capacity, and nonstandard research
also provide abundant opportunities. On the contrary, behavior to falsification. These findings are helping
there are many constraints affecting the development pave the way for improvements to the quality of clinical
of CROs. The level of cognition and acceptance is research and a stricter regulatory system, which have
limited. Only about 50 per cent potential subjects are brought both challenges and opportunities to the CRO
willing to take part in a clinical trial. The development industry.
and operation of CROs are not mature. Compared with The CRO market in China is closely related to
the foreign CRO companies, the local CRO services the growth trend of innovative drug development.
are less comprehensive, and the quality of service can The generic drug consistency evaluation and the
be poor. There is a big gap between the authenticity acceleration of drug review has promoted many large
and reliability of clinical trial data. The government pharmaceutical companies to transform actively
supervision system is imperfect. In recent years, many from generic medicines to new drug research since
regulations are being revised to make up for defects. 2010, which brings huge opportunities for the CRO
There are also common problems, such as the quality market. More CRO companies are getting involved in
of industry personnel, the poor execution of clinical production and sales. The model of new drug research
projects, frequent turnover of personnel and low price is emerging, that is, VC plus IP plus CRO plus OS.
competition. This mode combines venture capital (VC), intellectual
property (IP), R&D outsourcing and operation support
Where do you see China’s CRO industry in the (OS), which bring lots of pressure to small and medium
next five years? sized pharmaceutical companies.
The CRO industry will develop vigorously in China, In addition, the reform of drug regulatory policy
with the improvement of the relevant regulations has helped shape the Chinese pharmaceutical industry.
and policies of new drug research and development, The self-examination and verification of clinical
the comprehensive reform of the medical and health trials imposed by CFDA, and the new regulation
system, and the development of overseas research and recommendation of GCP clinical trial institution
development centers. The growth is expected to be in notification instead of certification by CFDA will
double digits over the next five years. enable more hospitals to undertake clinical trials. All
these factors contribute to growth opportunities for
Can we expect a CRO industry boom in China in CROs in China.
the coming years? Aishwarya Venkatesh
There are many opportunities as well as challenges aishwarya.venkatesh@mmactiv.com
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 29

Australia is one of the most

mature markets in Asia-Pacific
for conducting clinical trials.
The country has a rich research
environment, coupled with
highly experienced investigators
and research professionals,
and an excellent health care
infrastructure. According to a
report by Frost & Sullivan (2016),
Australia is the country of choice
for early-stage pharma, biotech
and CRO research given its low
tax status compared to the U.S.

Australia: A growing hub for

early-phase CRO activities
ustralia is recognised as the hub for early phase orphan drug research activity undertaken outside of the
clinical trials worldwide. Every year more U.S. Finally, repatriation of cash held overseas may fuel
than 1,000 research projects are carried out mergers and acquisitions in the biopharma sector and
in Australia by pharmaceutical, medical devices and a greater acceleration of R&D investments. On balance
biotechnology companies, with a spend of more than we see these factors leading to a higher level of biotech
$ 1 billion on clinical trials according to a report from funding in the U.S., and this funding will take biotechs
Frost & Sullivan (F&S). Australia is fast-becoming the a lot further in Australia, reducing the need for dilutive
preferred choice for many biotech and pharmaceutical capital raisings.”
companies that see the benefit of conducting early He further says “With biotech companies investing
stage clinical trials in the country. However, every in more complex and global programmes, we expect the
country may have varying reasons to choose Australia number of outsourced projects to continue growing and
as their outsourcing spot. One universal appeal is the sponsors to increasingly consider Asia-Pacific as a key
fast approval times with lower costs and comparable location for their trials. In Australia, the recent tax reform
quality. There are many advantageous reasons as to why has further reinforced the R&D expense refund scheme,
companies continue to choose Australia as a destination, which is considered as one of the most supportive in the
particularly for early phase development. world for clinical trials and which drives many small
Cost-efficiency: The Australian government offers and medium sized biotech companies to run their early
attractive R&D tax incentives including cash rebates. phase trials in Australia.”
According to a cost comparison study, Australia is 28 Regulatory speed and flexibility: The
per cent cheaper than the US before tax incentives; and Australian clinical trial process allows flexibility
60 per cent cheaper after tax incentives. without compromising quality. It avoids duplication
Elaborating on the global legislative priorities on of processes, saving the sponsors both time and
tax reforms and how is it impacting the CRO industry money. Australia also has a unique and collaborative
in Australia, Dr John Moller, Chief Executive Officer, approach to trials. There are currently over 86 specialist
Novotech, Sydney,says, “In the U.S., the reduction of the clinical trial networks that offer efficient access to the
statutory corporate tax rate is likely to support further capabilities of many therapeutic areas and quick turn
R&D investments from US-domiciled biotech companies around on feasibility information, making the selection
in 2018 and onwards. However, amendments to the US of Australian sites relatively hassle-free. In addition,
Orphan Drug act will be reducing the tax credit allowed many of these networks also offer value added options
for clinical testing expenses from 50 to 25 per cent of such as being able to negotiate the trial costs on behalf
qualified clinical testing expenses. The halving of this of all member sites.
financial support is expected to increase the number of Clinical trial quality: Clinical trials continue to be
30 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Key CRO Players in Australia global CRO businesses are structured to serve complex
multinational pharmaceutical companies. Small
● ClinResearch GmbH to medium sized biopharma research companies
● Datapharm Australia Pty Ltd typically have a leaner clinical trial infrastructure
● Kendle International Inc. and the focus is on speed, cost, the ability to adapt to
● Novotech new operational requirements quickly, and reducing
● PAREXEL International operational risk. Because of these fundamental
● Mobius Medical Pty Ltd differences, biopharma companies can be side-lined
● George Clinical and not receive the attention they may from a regional
specialist such as Novotech”, adds Dr Moller.

a strength of the Australian research and development Model to support innovation

landscape. The clinical trial ecosystem in Australia is Given that the investment in terms of time and money to
an intricate web involving pharma companies, CROs, develop a new therapeutic or device are significant and
clinical trial sites, patients, ethics committees, and many that the milestones during development can be difficult
branches of the government. Australia has a network of to reach, a collaborative approach, which implements all
universities, independent medical research institutes, available resources to help ensure the success of clinical
clinical trial networks, biobanks, and CROs. Scientific research for Australian innovations is a sound idea.
research conducted in Australia ranks the highest in With the next generation of therapies comes higher level
Asia-Pacific in terms of productivity, impact, and one of of protocol complexity and patient recruitment hurdles.
the most rigorous patent protection systems in the world. Dr Moller adds, “Novotech focuses on structuring
relationship with key investigators, other regional CRO
Multiple drawcards as a CRO location specialists, and on providing best in class systems to its
Increased R&D activity and a shift towards outsourcing clients. This ensures smooth management of large and
are key drivers of the exponential growth of Asia Pacific complex trials.”
CRO market. According to F&S report, this growth has
the potential to outsource more than three-quarters The Next Decade
of R&D spending by biotech and pharma companies. With a strong research environment, Australia is a
It is understood that there is a connect between CRO vibrant, world-recognized destination for early phase
and pharma and biotech companies in achieving their clinical trials. A leader across the key dimensions of
R&D targets. Talking about the future relationship speed, quality and cost, Australia has fast, flexible
of a CRO with pharma and biopharma companies to clinical trial approval processes at a competitive global
achieve their mutual targets, Dr Moller notes, “The cost. Dr Moller believes, “One of the most important
outcome of clinical trials strongly relies on how the trends that we see is an increasing investment in upfront
study is managed operationally by the CRO and which clinical development strategy, including the use of
investigators are involved in the trial. Novotech heavily carefully designed adaptive protocols. In our view, an
invests in building formal partnerships with major efficient approach to clinical trial design will have the
hospital and medical specialist sites through formal site greatest impact in containing the escalating cost of drug
partnership agreements, as well as in site management development.”
services which facilitate rapid start-up activities and Many biotech companies are also turning towards
patient recruitment to meet the sponsor’s objectives.” a regional CRO alliance model to execute their global
Companies intending to conduct clinical trials in studies. The government also provides attractive
Australia look for experience in the specific phase incentive schemes to boost R&D. Dr Moller is very
and therapy area. Experience of working with smaller positive. “After the major slowdown for capital raised
biotech firms and multinational companies is a must by biotech companies in 2016, looks like 2018 will be
for a CRO. This provides sponsors the assurance a record year with equity financing that totalled $35
that the CRO thoroughly understands the challenges billion during the first two quarters compared with $ 22
working with smaller foreign biotech firms and billion over the same period in 2017.”
businesses in a different time zone. However, there is Australia’s superior scientific talent and excellent
a catch. “Biotech companies are sometimes attracted medical infrastructure makes it a preferred destination
to global CROs for large-scale late phase trials for for early phase clinical trials, and the prevalence of CRO
their perceived ability, systems, global reach, and companies.
regulatory expertise. A challenge they often face, Priyanka Bajpai
however, is a mismatch in strategic alignment because priyanka.bajpai@mmactiv.com
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 31

n July 5, based on the clues, the China State
Food and Drug Administration (CFDA),
China’s drug regulator and the Jilin

Provincial Bureau, conducted a flight inspection of
Changchun Changsheng Biotechnology Co., Ltd,
engaged in research, development, production and
sale of human vaccine products. The company’s
main products include live attenuated freeze-dried

varicella vaccine, freeze-dried human rabies vaccine
(Vero cells), freeze-dried live attenuated hepatitis
A vaccine, influenza lysis vaccine, DTP vaccine,
adsorption of cell-free diphtheria combined vaccine

and ACYW Group 135 meningococcal polysaccharide
vaccine. The company distributes its products in the
domestic market as well as overseas markets.
Again on July 15, both the agencies formed

an investigation team to conduct comprehensive
investigations and issued the “Notice on July 22 on
Changchun Changsheng Biotechnology Co., Ltd.’s
illegal production of freeze-dried human rabies

It has been found that the company fabricates
production records and product inspection records,
and arbitrarily changes process parameters and
equipment. The above acts are a serious violation of
The Chinese government has detained the relevant provisions of the Drug Administration
Law of the People’s Republic of China and the
all the vaccines involved, avoided
Regulations on the Quality Management of
giving patients a problem vaccine, and
Pharmaceutical Production. The drug regulator has
stopped the Changchun Changsheng ordered enterprises to stop production, recover the
Biotechnology Co., Ltd’s vaccine GMP certificate for drugs, and recall unused rabies
production when it conducted a flight vaccines. The CFDA and the Jilin Provincial Bureau
inspection of the production site of have filed investigations on enterprises, and the
the company and it was found that the suspected crimes have been transferred to the public
company had record fraud during the security
production of the batch of
rabies vaccine.

to the
seriousness of
this issue and to timely
discover and eliminate potential
risks in the production of vaccines, the
CFDA has conducted comprehensive and
thorough risk investigation in less than
six weeks. The results of the investigation
showed that the existing vaccine varieties
in the production enterprises are normal,
and no problems affecting the quality and
safety of the vaccine have been found.
32 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


WHO supports Chinese vaccine organs for criminal responsibility.

players to meet global standards The person in charge of the investigations said
that it was the second time in a year that the quality
The regulation of vaccines is extremely of the company’s product was found to be not of good
important. It is the main means for the quality. In October last year, the original food and
government to ensure that vaccines produced drug supervision bureau found in the sampling test
and used in China are safe, high quality and that the batch of Baibai broken vaccine produced
effective. This incident shows that potential by the company was unqualified, and the product is
risks can be circumvented when regulation still in production. The former National Health and
is effective. Effective drug production quality Safety Commission and the original food medicine
management and regulation is to prevent are related to the replanting work. The General
problems and ensure vaccine quality. But once Administration of Supervision has deployed in
problems are discovered, regulators must take February this year.
action. WHO commends the China State Food According to the relevant regulations on vaccine
and Drug Administration for taking swift and management, the vaccines for sale and marketing of
transparent action to stop its production and all enterprises must be submitted to the China Food
investigate the incident. and Drug Control Research Institute for approval.
WHO conducted two assessments of China’s The safety of all batches of vaccines should be
national drug regulatory authorities in 2010 and tested during the batch issuance process, and the
2014. The results show that effectiveness of a certain proportion
the national drug regulatory of batches of vaccines should be
department has met the tested. The company has been legally
standards of the WHO’s fully tested for the sale and use of vaccines,
functioning regulatory body and no quality problems have been
and has clearly promised to found. In order to further confirm the
continue to improve. WHO effectiveness of the vaccines already
welcomes the continued in the market, a laboratory evaluation
cooperation of the China of samples has been initiated.
National Food and Drug Reacting to the developments,
Administration with WHO’s on the afternoon of July 23, the
strengthening of national nation’s drug regulator held an
regulatory authorities, enlarged meeting to convey the spirit
which has been under way of the important instructions of Xi
for nearly 20 years. This Jinping, President of China on the
incident is undoubtedly regrettable, but the Jilin Changchun Longevity Vaccine Case and to study
incident was discovered by flight inspection. It and implement the measures. Li Li, secretary of the
also shows that the system supervision and on- party group and deputy director, presided over the
site inspection of the regulatory authorities can meeting. Xu Jinghe, a member of the party group and
effectively protect people’s health. deputy director, attended the meeting. The director
WHO reiterates that reliable vaccines are Jiao Hong attended the meeting and the person in
essential for disease prevention and encourages charge of the relevant department of the bureau was
countries to continue to adopt this cost-effective also present.
public health intervention. China’s expanded According to the reports, the meeting pointed
immunization program has been effective, out that the important instructions of Xi Jinping,
allowing China to achieve polio-free status President of China and attaches great importance to
and significantly reducing vaccine-preventable the health of the people, and further investigates and
diseases such as measles, mumps, rubella, handles cases, investigates potential risks, improves
hepatitis A and hepatitis B among children. To the vaccine management system, and responds
this end, WHO also supports Chinese vaccine to society. Concerns, pointed out the direction,
manufacturers to meet international standards and provided compliance. The CFDA should
and WHO pre-certification requirements. conscientiously implement the spirit of the important
- Dr. Gao Li, World Health Organization instructions of the incumbent General Secretary Ping
Representative in China Ping and the instructions of Premier Li Keqiang,
firmly establish the “four awarenesses”, improve the
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 33

political position, enhance political acumen, and

have a high sense of responsibility and mission, in
accordance with the “four awarenesses”. The most
stringent requirements are to fully protect the overall
safety of the people in drug use and social security
and stability.
The meeting decided that first, on the basis of
the preliminary work, further increase the number
of personnel, enrich the strength of the investigation
and handling work leading group, and fully cooperate
with the investigation team of the State Council.
The second is to conduct a thorough investigation
of the entire process of production and sales of all
Changchun Changsheng vaccines, to find out the
truth as soon as possible, and to lock up evidence Highlights
clues. The third is to persistently attack with heavy
punches, severely punish those who are not punished, ● July 5 - CFDA and the Jilin Provincial
and use them to be effective. The fourth is to solve Bureau conducted a flight inspection of
the hot issues of concern to the people and do a Changchun Changsheng Biotechnology Co.,
good job in solving problems. The fifth is to make a Ltd
comprehensive investigation of the national vaccine ● July 15 - CFDA and the Jilin Provincial
production enterprises, and strictly investigate Bureau conducted comprehensive
the risks. The sixth is to systematically analyze the investigations
vaccine life cycle supervision system, analyze the crux ● July 22 – issued notice on Changchun
of the problem one by one, and study and improve Changsheng Biotechnology Co., Ltd. for its
the vaccine management system in China. illegal production of freeze-dried human
The State Council investigation team investigated rabies vaccine
that the company’s production of unqualified ● July 23 - nation’s drug regulator held an
Baibai broken vaccine involves the same batch of enlarged meeting to study and implement
201605014-01 and 201605014-02 the batch number the measures
of products totalled 499,800. ● August 7 - CFDA issued a circular related to
The investigation found that company produced re administration of formulated Vaccination
a total of 252,600 batches of 201605014-01 Baibai programme in the affected locations
Breaking Vaccine, all of which were sold to Shandong ● August 17 - State Administration of Market
Province, 247,359 pieces have been used, and 5,241 Supervision dismissed 6 senior SFDA
losses and storages have been used. Batch number officials
201605014-02 Baibai broken vaccine has a total of ● September 7 – SFDA said after thorough
247,200, of which 223,800 are sold to Shandong, investigation of the vaccine production
and more than 10,000 are sealed; 23,400 are sold to enterprises and found no impact on the
Anhui, and 3,277 are lost and sealed. quality and safety of vaccines.
On August 7, CFDA issued a circular stating
that the National Health Committee and the State
Food and Drug Administration have formulated determined according to the actual vaccination
Vaccination programme in all localities, where rabies situation of the affected children.
vaccines from Changchun Changsheng Company The National Health Commission and the CFDA
were administered. have made arrangements for the replanting of
The children who were inoculated with the children who have been inoculated with Changchun
batch number 201605014-01 unqualified DTP Changsheng Company’s batch number 201605014-
(diphtheria-tetanus-pertussis) vaccine produced by 02.
the company have been replanted according to the In order to comprehensively evaluate the risk of
replanting work notice on February 6 this year. As vaccination of Changbai Changsheng Co., Ltd., the
of now, 76.2 per cent of the total number of children China Food and Drug Administration Institute used
to be rehabilitated has been completed. The follow- the rapid vaccine test method for all batches of DTP
up doses that have not been replanted need to be vaccine during the validity period of the company for
34 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


antigen detection. No abnormalities were found. Jianhua, Director of the Drug and Cosmetics
At present, an in-depth investigation into the Supervision Department of the State Food and Drug
suspected violations of law by company for the Administration (the State Drug Administration)
production of unqualified DTP vaccine is underway. and Director of the Food and Drug Inspection and
The violations of laws and regulations and personnel Inspection Center; Dong Runsheng, deputy director
shall be severely punished according to the law, and of the Drug and Cosmetics Supervision Department
the local governments and competent authorities of the former State Food and Drug Administration
with supervisory responsibilities shall be held (the State Drug Administration); Sun Jinglin, deputy
accountable for their dereliction of duty, default, director of the Department of Drug and Cosmetic
oversight and inaction. Supervision of the former State Food and Drug
According to the investigation team, since Administration (National Drug Administration)
April 2014, Changchun Changsheng Company has (November 2014 to April 2017, deputy director of
seriously violated the relevant regulations on the the Food and Drug Inspection and Inspection Center
quality management regulations for pharmaceutical of the former State Food and Drug Administration)
production and the national drug standards in the Dismissal; Ye Guoqing, the director of the Special
process of producing rabies vaccine. Some batches Drug Supervision Division of the Drug and Cosmetics
are mixed with expired stock solution, and the date Supervision Department of the former State
and batch number are not truthfully filled. Some Food and Drug Administration (the State Drug
batches are marked backwards with the date of Administration); Guo Xiuxia, an investigator of the
manufacture. Currently, the recall is in progress. The Special Drug Supervision Department of the Drug
vaccines involved in the case were sold abroad, and and Cosmetic Supervision Department of the former
the notification and recall work was initiated. State Food and Drug Administration (National Drug
In order to assess the safety and effectiveness risks Administration) and Wang Youchun, vice president
of the vaccines that have been marketed, the State of China Food and Drug Administration Research
Council investigation team has established an expert Institute.
group consisting of experts in virology, vaccinology, Li Bo, the dean (Director) of the China Food and
epidemiology, clinical medicine, vaccination, Drug Administration Research Institute (formerly
health emergency, and quality control. In-depth
investigation and analysis were conducted. Experts China - World’s largest vaccine player
comprehensively evaluated and recommended
that the vaccination unit has not completed the China is the world’s largest vaccine producer.
vaccination programme, and the vaccination unit will There are 45 vaccine manufacturers, which can
continue to continually administer other qualified produce 63 kinds of vaccines and prevent 34 kinds
vaccines. of infectious diseases. The annual production
According to the characteristics of rabies, those capacity exceeds 1 billion doses. It is one of the
who have completed the vaccination program do not few in the world that can solve all of them by
need to replant. If the recipient has the willingness its own ability. One of the countries planning
to replant, the inoculation unit can replenish the immunization vaccines, domestic vaccines
seed free of charge after notifying the prevention and account for more than 95 per cent of the
control knowledge, the protection of the vaccine, and actual national inoculation.
the precautions after inoculation. China has strict management systems
According to the World Health Organization’s and review mechanisms for the “R&D-
report on rabies published in April 2018, the production-distribution-inoculation”
incubation period for rabies is usually 1-3 months, of vaccines. In 2011,
rarely more than 1 year. the Chinese vaccine
After continuing its investigation in this case regulatory system
revealed many loopholes such as the lack of passed the World
supervision by the former State Food and Drug Health Organization
Administration and the State Drug Administration, (WHO) vaccine national
the lack of supervision and guidance, and the regulatory system
oversight of the company. On August 17, 2018, it assessment, and in
was decided by the State Administration of Market 2014 passed the WHO
Supervision to dismiss six senior officials in the reassessment. This
administration. The dismissed ones include Ding
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 35

the State Food and Drug Administration General and no problems affecting the quality and safety of
Administration of Medical Device Standards the vaccine have been found.
Management), was asked to make an in-depth According to CFDA release on September 7, after
examination in the case. investigation, among the 45 vaccine manufacturers,
The investigation team, on August 23 has 38 vaccine manufacturers can organize production
suspected of serious violations of the law by Wang according to the requirements of drug GMP, and
Lifeng, former director of the Drug and Cosmetics establish a relatively complete quality management
Registration and Management Department of the system; staffing, facilities and equipment meet
State Food and Drug Administration, and is currently production requirements, and production and design
undergoing disciplinary review and surveillance capacity match. The quality of the vaccine can be
investigations. controlled in accordance with the requirements of
According to the monitoring by the Chinese the Chinese Pharmacopoeia and the drug registration
Center for Disease Control and Prevention, the standards. Seven vaccine production enterprises have
incidence of rabies in China has gradually declined in been suspended for more than three years due to
recent years. the expiration of the license, the failure to apply for
In order to timely discover and eliminate replacement, the poor management of the company,
potential risks in the production of vaccines, the and the renovation of the workshop. No products are
State Food and Drug Administration has sent 45 circulating in the market.
inspection teams from July 23 to August 9, and has The State Food and Drug Administration said that
45 vaccine production enterprises in the country it will resolutely implement the central government’s
(excluding Changchun Changsheng Biotechnology decision on the investigation and handling of
Co., Ltd.) to conduct comprehensive and thorough the vaccine case of Jilin Changchun Changsheng
risk investigation. According to the drug production Company, effectively strengthen the supervision
quality management standard (drug GMP) criteria, of vaccine quality, timely identify and eliminate
the results of the investigation showed that the potential risks, and ensure the safety of the people.
existing vaccine varieties in the It is necessary to implement the daily supervision
production enterprises are normal, responsibility of the provincial drug regulatory
authorities for vaccine manufacturers, maintain
the high pressure on the supervision of vaccine
products; implement the main responsibility of
assessment enterprises, further improve the quality management
is not only a system, establish a quality and safety traceability
comprehensive system, and implement a product risk reporting
consideration of the system; Guidelines for the issuance of vaccines for
capacity of a national batches of vaccines, especially for rabies vaccines,
vaccine regulatory agency, rabies vaccines, polio vaccines, etc., which are more
but also the basis and complex in production processes and quality control,
premise for the country’s comprehensively enhance risk control; increase
vaccine manufacturers to apply the intensity of flight inspections and follow-up
for WHO product pre-certification inspections, and timely strictly investigate and deal
and access to international procurement with violations of laws and regulations.
channels. Up to now, China’s production of The Food and Drug Administration has deployed
live attenuated Japanese encephalitis vaccine, national vaccine production enterprises to conduct
oral type I polio vaccine, influenza self-inspection to ensure that enterprises organize
vaccine and hepatitis A inactivated production according to the approved technology,
vaccine have been pre-certified strictly abide by GMP production standards, and all
by WHO products, UNICEF, production inspection process data should be true,
Global Alliance for Vaccines complete, reliable and traceable. The State Food
and Immunization These and Drug Administration will organize the flight
vaccines are being purchased inspection of all vaccine production enterprises, and
in succession for disease seriously investigate and deal with violations of laws
prevention and control in and regulations.
other countries. Narayan Kulkarni
36 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Indian startups advancing

women health & hygiene
through innovation!
Women’s hygiene in India has always been a topic that has raised a lot of controversy and hearsay.
Around 70 per cent of all reproductive diseases in India are caused by poor menstrual hygiene and
women continue to put their health, livelihood and dignity at risk. In a country where women have
reached the frontiers of space, basic necessities such as access to clean drinking water, toilets,
basic education, fundamental knowledge and products for feminine hygiene are still unavailable to
women in rural areas.

ccording to the PeeBuddy PeeBuddy Private Limited
World Health Another startup operating in the has reported a turnover of Rs 1
Organisation women hygiene and wellness crore in 2016-2017 and is poised
(WHO), reproductive space since 2015 is PeeBuddy to finish at around Rs 2.5 crore in
tract infections (RTIs) whose funnel-shaped female 2017-2018. Though Indian retail
are extremely common urination device helps women stores might need some more time
among women and urinate while standing. The to come around, PeeBuddy got its
are reported to affect startup has recently secured a initial break online. E-commerce
one third of women funding of Rs 2.96 crore from websites, like Healthkart,
of reproductive age Indian Angel Network. Snapdeal, and Amazon.in,
around the world. “Women do multiple things to were more than willing to offer
Sexually transmitted avoid the menace of using public it to their customers. Soon
infections, of which toilets while men have it easy. retail stores like Modern trade,
RTI is a significant PeeBuddy, a simple urination WHSmith, and NewU in Delhi
contributor, are also funnel-like device that enables also started selling the product.
classified among women to go while standing This patent-protected,
the ‘top five disease has come as a merciful and portable, disposable product
categories’ by WHO. much-needed solution. Besides has won multiple awards, made
The risk of women PeeBuddy, our company has now headlines, and is recommended by
contracting RTIs are started making products like wet the medical fraternity. And 2018
high in rural India, wipes, underarm sweat began on yet another golden note,
where, in the absence pads, menstrual with Deep Bajaj declared as
of toilets in villages, cups, tampons, the winner at the Lufthansa
access to sanitation is and herbal pain Runway to Success
still limited. relief patches. Season 5. The grand prize
In this context All in all, these includes sponsorship to
some entrepreneurs products have a business programme
have taken the lead been created at the prestigious
to make an impact. A keeping in Cambridge University
number of healthcare mind the in the UK, as well as
based startups are personal needs a much sought-after
working towards of women”, shares mentorship from
providing better Deep Bajaj, TiE (The Indus
hygienic conditions for Co-Founder, Entrepreneurs).
women in India. PeeBuddy.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 37

Redcliffe Hygiene Pvt Ltd, which manufactures
toilet seat sanitiser spray PeeSafe, recently
raised Rs 6.3 crore in a fresh round of funding.
Founded in 2015 by the husband-wife duo
of Vikas and Srijana Bagaria, PeeSafe is an
isopropyl alcohol-based toilet seat sanitiser in
the form of a quick-drying aerosol.
“Women hygiene is crucial, as women
are considered to be the backbone of society.
Around 70 per cent of all reproductive diseases
L-R: Grace Kane Co-Founder, Amrita Saigal Co-Founder CFO,
Kristin Kagetsu Co-Founder CEO, Tarun Bothra Co-Founder, in India are caused by poor menstrual hygiene
CTO. and women continue to put their health, dignity
and livelihood at risk. The scenario has changed
Saathi in the past few years, even the Government
Saathi began in 2015, when its co-founders came of India is taking initiative to aware masses
together on a mission to create fully eco-friendly, about the need of improved sanitation, daily
compostable sanitary napkins using locally sourced and personal hygiene with the help of both
banana fiber from the state of Gujarat, where online and offline media. Private companies
Saathi is based. Saathi pads are Biodegradable & are also playing a major role in empowering
Compostable, using plant-based materials for the women. There is a lot of scope when it comes
leak-proof outer layers of the napkin. Saathi pads to improving health and wellness industry.
are made with banana fibre because of its highly Combining various elements like proper
absorbent properties, and the environmental and education, awareness, easy availability of
social benefits of its supply chain. affordable and user friendly hygiene products,
“Our product can be used safely and responsibly together will eventually create a huge impact
by women everywhere because it is sustainable. and will lead India towards a positive change”
It is an all-natural product that doesn’t cause any points out Vikas Bagaria, Founder, Pee
irritation or rashes or have long term negative effects Safe.
on women’s health like the commercial chemical “In order to empower Indian women, we
filled plastic pads. In that way, it is a healthy option. need to tackle challenges such as fighting
In addition to that, we are running our one million against social taboos and myths related to
pads campaign to provide pads to women in rural women during their menstruation period,
Jharkhand through our partnership with Ekal fighting against the invisible germs over a clean
Vidyalaya and Arogya Foundation. This is the first toilet seat to reduce the risk of infection and lack
step towards being able to provide these to rural of knowledge about proper use of product, its
women all over India”, shares Tarun Bothra and longevity and risk involved if used in improper
Kristin Kagetsu, co-founders of Saathi. way”, adds Vikas Bagaria.
“Now the government and other large The brand PeeSafe is the
organizations are understanding the importance of first in the category of daily
feminine hygiene and taking measures to improve hygiene and aims at creating
women’s health and hygiene. We believe it will take an environment where
time but it is definitely improving. It is not just an women can be helped to
issue about sanitary pad access and awareness but also reduce the risk of infections
about access to toilets as well so women have a safe with the use of daily
place to use those products”, Bothra and Kagetsu add. hygiene products. PeeSafe
The startup has bagged a number of laurels in the is presently focusing on
three years since its inception, including winning the improving hygiene habits
IP Start-Up of the Year - 2018, Expo Live 2020- 2018, among women and
the Global Cleantech Innovation Program 2018, the looks up to create a
Asia Social Innovation Award 2017, National Bio cleaner and better
Entrepreneurship Competition 2017, the 3M Young India where women
Innovators Challenge 2016 and the Harvard Business have good health
School New Venture Competition, 2014. and life overall.
38 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Module Innovations Chemical Laboratory Innovation park,

Module Innovations, which was founded in Pune.
2014, has developed USense, a credit card size He adds, “While our technology does not
test designed to detect presence of 4 major build clean toilets or affordable sanitary pads, it
Uropathogens (E.coli, does much more to alleviate the pain a women
S.aureus, Klebsiella and encounters when she is gripped by UTI. USense
Enterococci) causing 96 per in its current version will aid doctors to ascertain
cent cases of Urinary Tract UTI in females at the clinic. Often many females
Infection (UTI) in India. cannot go to work and lose daily wages further
The innovative design worsening their financial condition. USense in
allows for the detection of its later version would help females keep track of
these organisms by a simple their wellness, allowing them to check regularly for
blue to red color change. UTI. This in turn is an indicator of good hygiene.
The compact dimensions Being affordable, rapid and easily usable in normal
makes USense portable. settings USense would mark the beginning of a
USense boasts of innovative and unique features of time where Indian women take charge of their
being rapid with detection in only 30-60 minutes, wellness.”
affordable with nanofibers technology, portable Module Innovations has so far raised funds
and simple to use, making it reachable and usable worth Rs 3.15 crore. Recently, USense emerged
in every setting and intellectual depth. as a winner along with few other startups at the
“Hygiene is a big word in India. With 1 in 3 Design: Impact Awards (DIA) for Social Change
women under 24 contracting a UTI, and over 150 event organised by Titan in collaboration with Tata
million cases globally, UTI continues to deeply Trusts.
affect women in India. Poor menstrual hygiene The startup has received money from Grand
is the breeding ground for bacteria and can lead Challenges Canada (GCC), National Science &
to UTIs. Due to unavailability of clean toilets Technology Entrepreneurship Development Board
on highways, many females either do not drink (NSTEDB) CIIEI, Nesta, Unitus Seed Fund and
water or tend to hold urine in their bladder for Indian Institute of Management (IIM) Ahmedabad
increased duration severely increasing the risk as product development support. The startup
of catching a Urinary Tract Infection”, points out has also secured funding from BIRAC through its
Sachin Dubey, CEO, Module Innovations, Biotechnology Ignition Grant (BIG) scheme and
a healthcare startup based out of National SBIRI.

OmiX Labs UTI today is a problem that affects 1 in 5 women

Last year, Omix Research and Diagnostics during their lifetime, with pregnant women being at a
Laboratories received Rs 49 lakh from Karnataka much higher risk. With rising antibiotic resistance in
Government for the India, it is becoming an ever increasing need to have
development of a novel tool rapid antibiotic resistance detection that can be easily
for detection and surveillance deployed in every lab. And that is what OmiX Labs
of antimicrobial resistance is bringing to the market”, highlights Dr Sudeshna
among UTI. Besides that, in Adak, CEO & Director, OmiX Labs.
2015 after its inception, social “At OmiX Labs, we started working on a platform
enterprise incubator Villgro technology that is aimed to diagnose urinary tract
Innovations Foundation infection and provide antibiotic susceptibility in 3
invested Rs 50 lakh in this hours instead of 3 days, and very easy to use. Today,
Bengaluru based healthcare without doing culturing, we can test urine samples
startup. Over the years, for presence of bacteria, identify the organism and
the startup has been focusing on setting up a tech provide an antibiotic susceptibility profile in 3 hours”,
platform for DNA testing to diagnose a wide range of she adds.
“Our journey started with looking at little girls Dr Manbeena Chawla
who get UTI, especially those below the age of 5. But manbeena.chawla@mmactiv.com
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 39

“KIHT to support indigenous research

and manufacturing capability to
make India self-dependent”
efforts on industrial promotion in the medical devices
So far, KIHT has facilitated convergence of
available technologies to bring increased access to
affordable health products to citizens and a thriving
medical devices manufacturing sector in India. The
« institution has created a knowledge repository for trade
Dr Jitendar Sharma, information, and has analysed emerging trends in trade
CEO of KIHT, India and investments and provided policy enabling inputs to
the government.
KIHT has been instrumental in launching a pioneer

ndian biomedical industry is undergoing a initiative named NIPUN certificate, i.e. Non-regulatory
positive transformation over the few years. The Innovation Potential Utility and Novelty certificate,
change has been felt with Kalam Institute of to act as a single point window for all non-regulatory
Health Technologies’ (KIHT) tremendous efforts. requirements of the medical technology sector and
India, a country which projects as being extremely provide a simplified approach to the current process in
import-dependent for medical devices, is no more the commercialization of a product. It takes care of all
the same. The efforts of KIHT has changed that the processes relating to regulatory filing for a certified
paradigm and in just one year since its formation, product in hand for gaining market access.
significant MoUs and agreements have been inked KIHT promulgated Health Technology as one of
that aim at creating a more indigenous research the core component of market access, which adds value
and manufacturing environment and capability to the product credibility by giving them comparative
for India. Supporting biomedical startups, skilling overview of clinical and economic effectiveness of
India’s young biomedical workforce, nurturing talent, the innovation with its systematic, transparent and
interacting with policy makers and most of all being evidence based decision making process.
the face of India’s biomedical industry is serious Following are few achievements in space of
business for KIHT. Health Technology Assessment (HTA):
Celebrating its first birth anniversary and 1) KIHT got collaborated with The Joanna Briggs
its recent agreement with Cuban counterparts Institute (JBI), and Institute of the University of
has prompted BioSpectrum to interact with Dr Adelaide as JBI Affiliated group member for applying
Jitendar Sharma, CEO of KIHT. Dr Sharma in an international standard and methodology to conduct
interactive session reveals the goals of KIHT and its systematic reviews & meta-analysis.
accomplishments done so far. Edited excerpts; 2) KIHT is now regional hub for conducting HTA
for Department of Health Research, Ministry of Health
and Family Welfare.
With what purpose was KIHT formed and so 3) KIHT has organized two international fellowship
far how has the institute kept in lines with its programme on HTA and has collaborated with Tata
objectives? Institute of Social Science (TISS), Mumbai for taking
KIHT was formed to facilitate focused research on fellowship programme to next level by converting it to
critical components pertaining to medical devices by Executive programme on Health Technology Policy,
supporting institutions involved with R&D, industry, assessment and outcomes research. This programme
policy makers and knowledge repositories. KIHT would give holistic approach in understanding public
successfully created the world’s first e-auction platform health policies and how to utilize evidence based
for transfer of Intellectual Property, material and research for decision making.
prototypes and bringing strategic and coherent synergy 4) As part of NIPUN certification, KIHT is well
of scientific facilities and institutions to complement equipped to evaluate technologies with highest
40 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


international standards and provide recommendation

for innovations on the basis of evidences.
As part of its constant endeavour to cater to the
needs of the medical devices industry, KIHT has
come out with unique type of dossiers to disseminate
information specific to devices in healthcare which are
complex in technology and import dependent. These
dossiers capture key features of a product like design,
technology, market share, etc. and facilitates users like
startups, researchers, academicians, manufacturers
and other stakeholders in taking decisions on R&D,
investment, potential market, innovations etc. KIHT
periodically conducts training sessions and workshops
on medical devices and their functionality with hands
on session by experts on the actual device itself. Such
level of close proximity to actual operating medical
devices and in depth learning has been unprecedented.

How does the Chandrababu Naidu-headed Andhra Transfer Convention 2017, Beijing, China. China’s
Pradesh Government support developments at largest technology transfer forum to streamline the
KIHT? innovative healthcare technologies to India.
The land and infrastructural support for KIHT has NIPUN Certification came as a boon to start-ups,
been provided for within the Andhra Pradesh MedTech innovators and MSMEs of medical device industry for
Zone, which is an enterprise of AP Government. KIHT commercializing their products. Since the industry
was the knowledge partner for AP Health festival in is still in its infancy stage, the exposure towards
Visakhapatnam and are often consulted for essential standardization is limited and therefore the innovators
decisions in the health department. are finding difficulty in putting their product in the
market. Soon after the official launch of NIPUN by
What are the significant milestones accomplished PSA on April 30, 2018, an overwhelming response
by the Institute so far? from various people have been observed. The services
KIHT has been recognized by the Principal Scientific of NIPUN include: conformity testing, HTA, Market
Advisor (PSA) to the Government of India as official Research, Patenting, Rapid Prototyping and other
Project Analysis Unit for all Health Technology Projects related services in order for the product to conform to a
in the country. The PSA himself held a consultative particular standard. As a part of the continuous growth
meeting at the KIHT campus, where a host of phase, KIHT has entered into 22 associations with
institutions and organizations were called in for an in several institutions and organizations pan India and
depth discussion on the status of projects that received have offered trainings, workshops, conference speech
government funding in the health technology domain. at many events in order to bring more open-ended
Apart from the NIPUN certification and HTA discussions in the MedTech space.
initiative, KIHT takes pride in successfully launching
the first ever e-auction for medical technologies What is the USP of KIHT and how it is different
on February 15, 2018, by Ananth Kumar, Union from other institutes?
Minister for Chemicals & Fertilizers on India Medical No other organization, in any realm of any discipline
Device 2018, the largest exhibition and conference of science, has accomplished what KIHT has in this
on the Indian Medical Devices Sector Organized by short span of time. KIHT has mapped the core health
Department of Pharmaceuticals, Ministry of Chemicals technology space, offered solutions and various aspects
and Fertilizers, Government of India in partnership of policy support, along with the parent organization,
with Federation of Indian Chambers of Commerce & Andhra Pradesh MedTech Zone Ltd (AMTZ) has
Industry (FICCI). The e-Auction web portal hosts 22 created a bandwidth of bench to bedside transition
technologies for technology transfer as on date. KIHT and has opened up medical technology as a formidable
has signed MoU with 12 institutes/ company for the discipline to contribute to the Indian dream.
purpose of technology transfer so far and more in
progress to bring more technologies to market. The institute has been instrumental in shaping the
KIHT also participated in International Technology biomedical skill sector of India. How, according
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 41

medical devices are imported from Europe, primarily

Germany and nearly 30 per cent come from China and
Japan collectively. Indian startups/companies can
play a major role in providing better and cost-effective
solutions through mutual collaborations in the field
of medical devices and other biotechnology related
technologies/products. In view of the above a tripartite
MoU between KIHT, BIRAC and ‘BioCubaFarma’ was
signed to facilitate several stakeholders, including
industry, R&D Institutes and Technology Transfer
offices and pave the way for technological & industrial
progress in Biotechnology sector. Some of the
companies have been identified to interact with Cuban
technology enterprises for licensing, manufacturing,
R&D and program uptakes.

What is KIHT’s vision/goal for the next five years?

KIHT has few set goals to accomplish in the next five
to you, has this been accomplished? years.
KIHT along with AMTZ, National Accreditation Board a) Create a self-dependency module for Medical
for Certification Bodies (NABCB), Quality Council of Technologies.
India (QCI) and Association of Indian Manufacturers b) Consolidate all government funded health
of Medical Devices (AIMED) joined hands to form the technology projects and facilitate their successful
Indian Biomedical Skill Consortium on February 16, completion.
2018 with an objective to reinforce biomedical skill c) Enable more and more health technology
sector in the country. Institutional Bio Safety Committee innovations to reach out to their industry partners.
(IBSC) brings an equivalence system of value-based d) Create testing and validation bandwidth for all
assessment covering educational qualification, work innovators so that they can take their prototypes to the
experience and competency possessed by practitioners next phase, thus enabling start-up’s in this technology
of biomedical engineering skills. To facilitate this, driven segment.
50 assessment centres with a total testing capacity of e) Make HTA a mandatory module for procurement
14,000 to take load of certification of more than 2 lakh for medical devices.
biomedical engineering practitioners is planned across f) Enable early researchers’ access to medical
several states in India. devices so that further innovations can be carried out.

Could you elaborate on the recent collaboration How do you see accomplishing those goals as a
with BioCubaFarma? How is this collaboration boost to India’s biomedical industry?
benefitting India and its relationship with Cuba? The Indian biomedical industry is extremely import
The President of India visited Cuba from June 21- dependent. The efforts of KIHT can potentially
23, 2018. An MoU on collaboration in the field of motivate more indigenous research and manufacturing
Biotechnology was signed between the two countries on capability and in turn make the nation come out of this
June 22, 2018. It is to be emphasized that this is a great import dependency.
opportunity for Indian startups and industries in the
field of Biotechnology to collaborate with their Cuban Besides BioCubaFarma are there any other
counterparts and vice versa. partnerships KIHT has entered into? If yes, how
A delegation comprising experts from the have those partnerships supported the growth of
Biotechnology Industry Research Assistance Council KIHT?
(BIRAC) and KIHT, participated in discussions with KIHT has so far partnered with 22 institutions through
‘BioCubaFarma’, the Cuban Industry promotion which innovations can reach out to market place for
institute for health sector for further potential possible health and market access avenues. The disease
collaboration in areas of mutually interest. burden and trade deficit amalgamated model by KIHT
It has been observed that owing to its limited created the National Priority List which was the first-of-
domestic production, Cuba is highly dependent on its-kind need and trade-based grant released for R&D
medical device imports. More than 40 per cent of in any sector of science.
42 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


NUS scientists create

AI technology for myeloma
design combinations
targeted at
sensor to individual
measure using small

inflammation experimental data

sets. With just
A team of researchers led a small amount
by Dr Paddy Chan Kwok- of blood or bone
leung of the Mechanical marrow sample
Engineering Department from patients, the
at the University of platform is able
Hong Kong (HKU) has to map the drug
developed a sensor that response that a
detects and measures A multidisciplinary team of set of drug combinations will have
the amount of C-reactive scientists from the National on the specific patient’s cancer cells.
protein (CRP) in the University of Singapore (NUS) has The other NUS research
blood of human patients. developed an artificial intelligence institutes involved in the
The level of CRP in the (AI) technology platform that could development of QPOP include
blood is an important potentially change the way drug the Singapore Institute for
indicator reflecting the combinations are being designed, Neurotechnology (SINAPSE) and
level of the inflammation hence enabling doctors to determine the Biomedical Institute for Global
of patients. It is currently the most effective drug combination Health Research and Technology
tested by blood analysis, for a patient quickly. (BIGHEART). The research was
which cannot provide The AI technology platform, conducted in collaboration with the
real-time information Quadratic Phenotypic Optimisation Agency for Science, Technology and
of the patients. The Platform (QPOP), has been Research, the National University
mechanically-flexible developed to speed up drug Cancer Institute, Singapore, and
organic electronic device combination design and to the University of California, Los
measures biological identify the most effective drug Angeles.
information in real-
time and can detect the
amount of CRP in the
blood down to 1 µg/mL.
Japanese group invents device for
The organic sensor is hemodialysis catheter placement
less than one micrometer
thick and saves sample Researchers at Okayama University in Japan have developed a supporting
and data collection time, device for accurately placing hemodialysis catheters on kidney patients. The
giving a readout more device was successfully used on a group of 10 patients and is expected to
than 30 times faster than become an essential tool in situations where other, catheter-free hemodialysis
conventional methods. approaches are not possible. The device has been made from a material
called expanded polytetrafluoroethylene (ePTFE), having the property of
maintained plasticity. It can be described as a bendable ribbon with holes
spaced 1 cm apart; the holes allow making markings on the patient’s body
with a felt-tip pen. The device helps to reduce catheter waste and the overall
cost of hemodialysis. In addition, as the attachment of a catheter requires
exposure to X-rays, it reduces accumulated radiation doses for both patients
and physicians. Although the study was only carried out for 10 patients in a
short observation period, the scientists anticipate that this new device can be
used for catheter intervention in many fields.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 43

Singapore team develops saliva test for detecting HFMD

A group of scientists from the National University
of Singapore (NUS) have found a way to identify
children with hand, foot and mouth disease (HFMD)
from just a few drops of saliva, even before symptoms
show. The group hopes to eventually make HFMD
test kits commonly available in pre-schools and
childcare centres so cases can be picked up early to
prevent the disease from spreading. The test has been
developed by NUS as part of a collaboration with the
Institute of Molecular and Cell Biology at the Agency
for Science, Technology and Research, KK Women’s
and Children’s Hospital and Taiwan’s Chang Gung
University. The test works by picking up on the
body’s reaction to being infected with HFMD. This
reaction remains the same even if the virus strain
changes. The test delivers results within two hours.

Indian scientists to develop Researchers modify

effective TB treatment nanoparticles
The Indian Institute of Technology-Bombay (IIT-B), along with
for GI tract uptake
three other renowned national institutes, is running clinical trials Researchers at Sungkyunkwan
of a breakthrough medicine that aims at treating multi-drug University, South Korea; Fuji
resistance (MDR) tuberculosis (TB) and killing the bacteria in Research Laboratories, Japan; and
the lungs more quickly, if taken along with regular medication. the University of Utah, US, have
The research modified nanoparticles to improve
holds promise their uptake in the gastrointestinal
as it would tract. They have developed
significantly polystyrene nanoparticles that
shorten the could hitch a ride with bile acids,
current two- small molecules that help move
year treatment, digested fats from the intestine
and the easy into special cells called enterocytes,
mode of where fats are processed before
administration entering the circulation. The
would researchers have demonstrated that
persuade the bile acids on the nanoparticles
more patients interact with a bile acid transporter
to complete found on the surface of enterocytes,
their course of medication. Currently, MDR-TB treatment involves which might help the nanoparticles
16 tablets a day and daily injections for the first six months. move through the cells and into
This research began last year and the first phase of the trials has the circulation. Till date, most
been completed at the National Institute of Tuberculosis and nanoparticles had to be injected
Respiratory Diseases, New Delhi, which is also conducting the into the bloodstream because
study with the National Jalma Institute of Leprosy and Other they were not easily absorbed
Mycobacterial Diseases in Agra, and the Delhi-based Indian when administered orally. It
Council of Medical Research (ICMR). The study is being funded seems that the recent finding has
by Tata Trusts (Rs 2 crore) and the Ministry of Human Resource finally managed to overcome this
Development (Rs 2.5 crore). limitation.
44 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


HUJI gets ultra-high resolution U-CT system

A MILabs dual-energy, ultra- research projects in the Blum
high resolution U-CT system has Lab combine chemical synthesis,
been installed at The Hebrew cell biology, biochemistry,
University of Jerusalem Israel microscopy and in vivo imaging.
(HUJI). Under the direction of The researchers at Blum Lab will
Prof Galia Blum, this institute has be using the MILabs’ ultra-high
established an internationally resolution CT to detect novel
renowned research programme, gold labeled probes in cancerous
focused on drug design, delivery tissue as well as in atherosclerotic
and therapy. plaques. With the addition of
The Blum Lab uses synthetic MILabs’ latest U-CT system,
chemistry methods for the HUJI expects to further
generating new probes that will accelerate drug discoveries in
be used for simultaneous non- several pathologies such as
invasive imaging and real-time cancer, atherosclerosis, arthritis
treatment of pathologies. Most and autoimmune diseases.

Myanmar, South
Korea to collaborate
in health sector
Myanmar’s Yangon University of
Pharmacy and South Korea’s Chung-Ang
University have reached a memorandum
of understanding (MoU) to cooperate in
the health sector. Under the MoU signed
in Yangon recently, the two universities
will cooperate in detecting and treating
diseases in regions and states in Myanmar
Duke-NUS joins Global Virus and improve health education. Myanmar
and South Korea have been stepping up
Network as Centre of Excellence cooperation in the health sector including
A coalition of seven virology research institutions in joint medical research, upgrading
Singapore, including Duke-NUS Medical School, has laboratories in Myanmar, sending health staff
been inducted into the Global Virus Network as a Centre to South Korea for education. South Korea
of Excellence, joining 42 other Centres of Excellence has helped Myanmar build a laboratory for
and seven Affiliates in 27 countries. The seven virology research on communicable diseases and
research institutes comprise Duke-NUS Medical School, the laboratory equipment were installed
the Singapore Immunology Network (SIgN) from with the support of the Korea International
A*STAR, the Environmental Health Institute (EHI) Cooperation Agency (KOICA).
from the National Environment Agency, the National
Public Health Laboratory (NHPL) of the Ministry of
Health, DSO National Laboratories under the Ministry
of Defence, the Lee Kong Chian School of Medicine
(LKCMedicine), and NUS’ Yong Loo Lin School of
Medicine. The GVN is a global authority and resource for
the identification and investigation, interpretation and
explanation, control and suppression, of viral diseases
posing threats to mankind.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 45

Oliver Healthcare Packaging

strengthens presence in Asia
Oliver Healthcare Packaging, a leading provider of sterile barrier flexible
packaging for the global healthcare industry, recently announced the
opening of a new office in Singapore to support their growing customer
base in the Asia Pacific market. This expansion is a part of Oliver’s

Qiagen, SRL
long-term strategic plan to deliver high quality materials and expertise
to medical device and pharmaceutical companies around the world.
This is especially important in
this region, where regulatory
to accelerate
requirements are increasing, launch of
and an emphasis on cleaner
medical packaging is driving
the market.
To support this effort, the
Oliver team in Singapore, Qiagen N.V. has announced a
and throughout Asia, has collaboration with SRL, Inc.,
expanded to include local sales, the largest clinical testing
marketing, and technical representatives. Earlier this year, Oliver laboratory company in Japan,
opened a new, state-of-the-art manufacturing facility in Suzhou, China, to prepare for introduction of
where 100 per cent of the manufacturing takes places within an ISO-7 new companion diagnostics
certified cleanroom. simultaneous with new drug
approvals. The non-exclusive
master collaboration agreement
Royal Philips introduces for clinical laboratory research
services will enable rapid
cardiovascular ultrasound system implementation by SRL of
Qiagen´s companion diagnostic
Royal Philips, a global leader in health technology, has introduced the workflows upon approval of
EPIQ CVx cardiovascular ultrasound system. Built on the powerful the drugs and tests by Japan’s
EPIQ ultrasound platform, EPIQ CVx is specifically designed to Pharmaceutical and Medical
increase diagnostic confidence and simplify workflow for clinicians, Devices Agency (PMDA).
giving them more time to interact Several tests Qiagen is co-
with their patients and reducing developing with pharmaceutical
the need for repeat scans. The partners are expected to enter
initial response to the new registration in Japan in the
system has been overwhelmingly coming years. Qiagen’s Day-
positive- 95 per cent of a group One Lab Readiness initiative
of clinicians who were shown the with SRL includes strategic
new EPIQ CVx believed it offered planning for market access
improved image quality: sharper to companion diagnostics,
and clearer images. Philips is filing for reimbursement,
also introducing the EPIQ CVxi, and alignment of medical
specifically tailored for use in the communication by SRL, Qiagen
interventional lab. EPIQ CVx and and pharmaceutical partners.
EPIQ CVxi are CE marked and have received 510(k) clearance from the The agreement will cover a
U.S. Food and Drug Administration (FDA). The EPIQ CVx includes a range of Qiagen companion
cardiology-specific user interface which simplifies the exam experience diagnostics, including real-
through a user-configurable touch-screen interface, allowing clinicians time polymerase chain reaction
to personalize their controls and improve workflow for their cardiology (PCR) and next-generation
exams. Philips also reaffirms its dedication to privacy and security by sequencing (NGS) solutions for
providing strong security capabilities and protocols. Personalized Healthcare.
46 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Roche receives FDA approval for cobas EGFR Mutation Test v2

Roche recently announced liquid biopsy. EGFR testing in
approval from the U.S. Food and plasma offers a non-invasive
Drug Administration (FDA) for the option for patients using a simple
cobas EGFR Mutation Test v2 as a blood draw for those who are not
companion diagnostic test (CDx) eligible for a tissue biopsy.
with IRESSA. A CDx test provides The cobas EGFR Mutation
information that is essential for Test v2 is a real-time polymerase
the safe and effective use of a chain reaction (PCR) test for the
corresponding therapeutic product. qualitative detection of 42 defined
Clinical studies have demonstrated mutations of the EGFR gene in
that patients diagnosed with exons 18-21, including L858R,
NSCLC who test positive for defined mutations of the exon 19 deletions, and T790M mutations. This in-
epidermal growth factor receptor (EGFR) gene benefit vitro diagnostic (IVD) test is the first and currently the
from tyrosine kinase inhibitor (TKI) therapies. only FDA-approved EGFR test to include both tissue
The cobas EGFR Mutation Test v2 is currently the and liquid biopsy (plasma) as patient sample types for
only FDA-approved diagnostic test for NSCLC using testing.

GE Healthcare to open Siemens,

Innovation Centre in Uppsala NuVasive announce
GE Healthcare has partnered with the government of Sweden to
open a $15.9 million centre in Uppsala that focuses on advancing Spine Precision
manufacturing capabilities and the commercialization of new
technologies in life sciences.
Testa Centre is a 2,500 square-meter facility that houses four Siemens Healthineers has formed
bioprocessing laboratories with GE Healthcare technologies for a strategic alliance with spine
testing new discoveries intended to enable the production of technology firm NuVasive to boost
biopharmaceuticals, including bioreactors with working volumes clinical outcomes during minimally
up to 500 L for mammalian cell cultures, 50 L for bacterial and invasive spine surgery. Under
chromatography equipment from lab to pilot scale. the Spine Precision Partnership,
Open to academia, startups, and industry, Testa Centre is the partners will jointly work on
designed to help organizations achieve a more time and cost- technology development, marketing
effective way to reduce the risks of securing industrial Proof-of- and commercial activities. NuVasive
Concept, in order to support the development of digital, technical, develops minimally disruptive,
and biological innovations. predictable and clinically reproducible
solutions for spine surgery. Siemens
provides a portfolio of imaging
systems such as 3D imaging for
complex spine cases. The companies
will strengthen their respective
technologies and will focus on
developing solutions to enhance
operating room (OR) workflow
efficiency and precision in minimally
disruptive spine surgery technologies.
It is expected that the integrated
solution will deliver advanced
clinical benefits and superior patient
outcomes with better visualisation
and access to the anatomy as well as
spinal implant placement.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 47

FSD Pharma hires

Dr Raza Bokhari as director
FSD Pharma Inc., headquartered at the former Kraft plant
in Cobourg, Ontario, Canada, has recently announced the
appointment of Dr Raza Bokhari to its Board of Directors.
Dr Bokhari currently serves as the Chairman & CEO of PCL,
a global diagnostic provider of addiction screening and opioid Lixte Biotech
prescription medication monitoring, including designer drugs
and synthetic cannabinoids. He is also the managing partner of
RBx Capital, LP. Recipient of Philadelphia Business Journal’s
“40 under 40” award, physician turned entrepreneur, Dr
board members
Bokhari has over the past several years developed outstanding Lixte Biotechnology Holdings, Inc.
expertise in aggregating and accelerating life sciences and has announced the appointments
healthcare services companies. of two new members to the Board
With several years of experience and expertise in start-up of Directors of Lixte; Dr Yun Yen,
and turn-around businesses, he is adept at turning around and Dr Winson (Sze Chun) Ho. Dr
financially struggling companies. Dr Bokhari recognizes the Yun Yen, is a physician, scientist,
special role of private equity funds, venture capital money, and innovator, and philanthropist. He
leveraged debt partners in executing accelerated growth trends is widely regarded as an expert
in healthcare services and cancer diagnostics and therapeutics. in ribonucleotide reductase,
a critical target in cancer
therapy and diagnostics. He is
Daniel Tu to serve as President Emeritus of Taipei
Medical University (TMU) and
ED at autonomous_ID Chair Professor of the Ph.D.
Programme for Cancer Biology
Daniel Tu, former group chief innovation officer of Ping An and Drug Discovery. He has
Insurance (Group) Company of China Ltd, has joined the published more than 300 peer-
Ottawa-based technology group autonomous_ID as executive reviewed articles, holds over 60
advisor to the chairman, Todd Gray. Tu drove rapid growth patents, and has commercialized
through innovation and technology at Ping An, China’s multiple methodologies involving
largest insurance company. He forged strategic partnerships, nanoparticles, small and large
identified new business opportunities, molecule drugs, biomarkers, stem
oversaw relationships with key cells, and medical devices. Dr
global research institutions, and Winson Ho, is presently a pediatric
supervised PA Ventures, Ping neurosurgery fellow at the University
An’s venture-capital arm. of Utah School of Medicine.
In addition, he co-led Ping After receiving his MD from Yale
An’s artificial-intelligence University School of Medicine,
and blockchain initiatives. he had four years of training in
As executive advisor, he Neurosurgery at the University of
will focus on the company’s Virginia, Charlottesville, VA. Prior
partnerships across the to his final year as chief resident at
global Internet-of-Things UVA, Dr. Ho spent three years doing
ecosystem, including mobile molecular pharmacologic research
health and wellness, on methods to enhance the efficacy
insurance, of cancer therapy as a Clinical and
connected living Research Fellow in the Surgical
and the Neurology Branch, National Institute
utility of Neurological Disorders and
of Stroke, NIH.
48 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


Ajay Bhatt joins Intas

as Global HR President INNS honours
Intas Pharmaceuticals has appointed Ajay Kenji Doya for
Bhatt as President- Global Human Resources
to spearhead HR for its complete global
lifetime contribution
portfolio consisting of India, Europe, US Professor Kenji Doya of Okinawa Institute of Science
& Emerging markets. A pharma industry and Technology (OIST) has received the Donald O.
veteran, Ajay brings with him more than two Hebb Award from the International Neural Network
decades of HR leadership experience with Society (INNS) for his lifetime contribution to
some of the most respected names in Indian the field of neural networks. The Donald O. Hebb
and global Award recognizes outstanding achievements in
pharma. Prior biological learning. A graduate of the University
to this, he was of Tokyo, Doya has conducted
Director HR- research that has taken
Innovation & him from the University of
Development California, San Diego, the Salk
with Abbott Institute and the Advanced
Laboratories Telecommunications
based out Research Institute
of Basel, International.
Switzerland. Doya is the leader of OIST’s
He has Neural Computation Unit, and
previously been associated with leading Indian his work bridges the worlds
pharmaceutical majors including Sun Pharma, of artificial intelligence
Zydus Cadila and Torrent Pharmaceuticals. and neurobiology. His
Ajay is a Masters in Social Work in the field research interests
of Personnel Management from Maharaja revolve around the role
Sayajirao University of Baroda. Besides of striatal neurons in
rapidly growing in domestic prominence, reinforcement learning,
Intas is present in more than 70 countries serotonin signaling in
worldwide in markets like North America, the reward pathway of
Europe, Central & Latin America, Africa, the brain and dynamic
Australia, New Zealand, Asia-Pacific as well as Bayesian inference in the
CIS and MENA countries. cerebral cortex.

CBT Pharma announces leadership structure

CBT Pharmaceuticals, a U.S. the manufacturing facility in at Human Genome Sciences,
and China-based innovative Hangzhou, China. Dr Li joins CBT Inc. (now GlaxoSmithKline)
biopharmaceutical company from MedImmune/Astra Zeneca with increasing roles and
committed to becoming a leader in where she spent almost 10 years responsibilities. She has been
the discovery and development of as a Research and Development involved in four approved
oncology combination therapies, Director and Fellow in products, more than twenty
recently announced a new global BioPharmaceutical Development. development programs, has over
leadership structure and the In that role, she served as forty publications, and is the
appointment of Dr Yuling Li, as chemistry, manufacturing and primary inventor for seven issued
Senior Vice President, Process controls (CMC) team leader and patents. Dr Li also has extensive
Development and Manufacturing. provided strategic and scientific exposure in the biopharmaceutical
Dr Li will be responsible leadership across numerous manufacturing industry as a
for the manufacturing and biopharmaceutical process recipient of multiple awards and as
supply of CBT’s global products development and CMC activities. a member of several professional
and will oversee building of Previously, she spent 15 years organizations.
BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com 49


Private Sector support critical

for Ayushman Bharat: J P Nadda
he Indian Health & Family Welfare Minister J
P Nadda said that the government was keen to
formalise a multi-stakeholder forum to arrive
at policy decisions and formulate implementable
strategies to make healthcare affordable and accessible
to all.
He was addressing FICCI HEAL 2018 with the
theme ‘Healthcare at Crossroads’, jointly organised by
FICCI and NITI Aayog.
“There is no formal structure for policy interaction
and very soon we will have a forum where multi- Sangita Reddy, Vice President, FICCI and Joint MD, Apollo Hospitals
stakeholders will join hands with the government for Enterprise Ltd is having word with J P Nadda, Health & Family Welfare
Minister, Government of India at FICCI HEAL 2018 in New Delhi.
policy decisions and program implementation plans,”
he said and added that such synergies would be
important to achieve a hepatitis-free India by 2030. Setting theme of the conference, (Hony) Brig. Dr
The Minister added that Ayushman Bharat Arvind Lal, Chair, FICCI Health Services Committee
(Pradhan Mantri Jan Arogya Yojna) looks at health and CMD, Dr Lal PathLabs said that in order to
holistically with twin pillars of Health and Wellness ensure appropriate costs for procedures covered under
Centres for comprehensive Primary health Care and the Pradhan Mantri Jan Arogya Abhiyaan, while
financial protection for secondary and tertiary care maintaining the quality of services, it is important to
hospitalisation. derive rational and sustainable package rates. “There is
“Ayushman Bharat is a historic decision and has a strong need to understand costs from the perspective
two pillars of preventive and promotive healthcare and of all relevant stakeholders, the government, the
converting 1.5 lakh sub-centres and PHCs into health providers and the consumer.”
and wellness centres. All support should be given to Prof (Dr) Dinesh Bhugra, CBE, President, British
health centres to ensure preventive care. For this we Medical Association said, “there is need to shift the
are going for universal health screening at the age focus from secondary healthcare and hospitals to
of 30. This is a paradigm shift as far as healthcare is primary care. There is also a need to change the way
concerned and this is one area where the private sector we train the next generation of doctors and medical
can come in.” students.”
He said that healthcare services should also be The Health Minister also released the ‘FICCI Code
credible accompanied by affordability, accessibility and of Ethics for the Health Services Industry. A FICCI
quality. White Paper ‘Demystifying Healthcare Costs’, was also
Dr V K Paul, Member (Health), NITI Aayog, released during the session.
Government of India said that as course correction in A major concern that the healthcare sector is
healthcare takes place, quality and ethics will be the facing today is the rising trust deficit - between the
guiding force. He urged the private sector to engage with private sector and the government as well as between
the government in providing quality care at reasonable the provider and the patient. Hence, the FICCI Task
rates, monitored by the government. He said, “PMJAY Force on Accountability, along with the stakeholders
is not possible without the engagement of the private from the government and industry, has developed the
sector. We need to create a pipeline of specialists and ‘Code of Ethics for the health services industry’, which
private sector can help in filling that gap.” encourages members to voluntarily and collectively
Sangita Reddy, Vice President, FICCI and Joint commit to ethical professional conduct for patient care.
MD, Apollo Hospitals Enterprise Ltd. in her welcome Already, 7 other Associations, with more than 30,000
address, said, “India is no longer at crossroads with the institutional and individual members and more than
launch of Ayushman Bharat. Healthcare has entered 15 healthcare organizations from across India, have
the Universal Collective Super Highway.” endorsed the FICCI Code of Ethics.
50 BIOSPECTRUM | OCTOBER 2018 | www.biospectrumasia.com


“India is creating viable PPP model to

implement Ayushman Bharat scheme”
Anupriya Patel reiterated the benefits of Ayushman
Bharat scheme.
The Lieutenant Governor of Delhi, Anil Baijal, gave
away the 10th FICCI Healthcare Excellence Awards to
16 healthcare professionals and institutions. Speaking
on the occasion, Baijal urged to remove paradoxical
situations present on the ground in providing quality
healthcare to all.
He said “development of a country is predicted on
the basis of the healthcare situation in the country. We
need right policy and regulatory framework to achieve
remarkable growth.”
Indian Minister of State for Health and Family Welfare, Anupriya Patel Emphasising on the importance of start-ups, he
addressing the gathering at 10th FICCI Healthcare Excellence Awards in said that they are redefining the healthcare sector and
New Delhi on August 30.
urged the private sector to come forward and work in
collaboration with the government to take healthcare

ndia is working towards strengthening Public to the next level.
Private Partnership to achieve success of Tina Ambani, Chairperson, Kokilaben Dhirubhai
Ayushman Bharat scheme and creating Ambani Hospital & Medical Research Institute,
workable and viable PPP model which can be Mumbai, in her address emphasised on five A’s for
implemented in next two-three years,” said Indian the benefit of the healthcare sector. She further said
Minister of State for Health and Family Welfare, “accessibility, affordability, awareness, aspiration and
Anupriya Patel. association are the five pillars that will help to bridge
Speaking at 10th FICCI Healthcare Excellence the gap in providing quality healthcare to the common
Awards ceremony held in New Delhi on August 30, man.”


Patient Safety - Hospital NU Hospital
Medical Technology /Devices Vita Pathfinders Consultants LLP
Health Insurance Products Religare Health Insurance Co. Ltd
Healthcare Start Up Leowin Solutions Pvt. Ltd.
Environment Friendly Hospital Aravind Eye Hospital, Pondicherry
Service Excellence - Diagnostic Centre Dr Lal PathLabs
Service Excellence - Private Hospital Artemis Hospitals
Service Excellence - Private Hospital Max Healthcare Institute Limited
Service Excellence - Public Government Spine Institute, Ahmedabad
Skill Development Public Health Foundation of India
Social Initiative - Corporate Fortis Healthcare Limited
Social Initiative - Corporate HealthMaP Diagnostics Private Ltd
Social Initiative - Not for Profit ICARE Eye Hospital & Postgraduate Institute (Unit of Ishwar Charitable Trust)
Healthcare Humanitarian Award Dr Abhay Bang & Dr Rani Bang - Founders ? SEARCH
Healthcare Personality of the Year Dr Girdhar J Gyani - Director General, AHPI
Lifetime Achievement Dr Azad Moopen - Chairman, Aster DM Healthcare