SEPTEMBER 2008 VOL.

1 ISSUE 3

BIO OUTSOURCING ASIA

Biopharmaceutical Outsourcing Opportunities and Challenges

Bio Outsourcing Asia TABLE OF CONTENTS September 2008 Vol. 1 Issue 3 CanBiotech Inc.

CHINA
Page 4 Outsourcing to Asia: China and Indias BioPharma Growth Based On Home Grown Expertise By Eric S. Langer, President, BioPlan Associates, Inc. Page 7 Chinas Intellectual Property RegimeCause for Concern or Optimism? By CanBiotech Page 10 Regulatory Processes in ChinaRoom for Improvement? By CanBiotech Page 11 The Drive toward Outsourcing: The State of the Chinese Industry-Case Studies By CanBiotech

Formats: Online, Digital, and Print Subscription: 25,000 Content: Feature Stories, Trends and Analysis, Case Studies, Technology Profiles, Company Profiles, News, Events Access: Free UPCOMING ISSUE: November-December 2008: Opportunities in and Challenges Facing Malaysia Contact the Editor at editor@canbiotech.com to participate in this issue.

INDIA
Page 19 India Unlocking the Power of Pharmacovigilance By Dr. Anjali Shukla, Accure Labs Pvt. Ltd., India

JAPAN
Page 22 21st INTERPHEX JAPAN, 7th INTL BIO FORUM & BIO EXPO JAPAN, and 2nd INTL PHARMACEUTICAL INGREDIENTS EXPO & CONFERENCE: Asias Largest Pharmaceutical/Biotechnology Event held in Japan!

TAIWAN
Page 24 Taiwans Biotechnology Plan By CanBiotech

INDUSTRY UPDATES
Page 27 BIOASIA NEWS Page 29 UPCOMING BIOASIA EVENTS
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Outsourcing to Asia: China and Indias BioPharma Growth Based On Home Grown Expertise Eric S. Langer, President, BioPlan Associates, Inc. www.bioplanassociates.com

in India. Indian biopharmaceuticals today are largely confined to the areas of traditional biotechnology like fermentation and vaccines. However, with India ranking 11th in the world and 3rd in the Asia-Pacific in terms of company count with over 300 biotechnology-related firms, we expect increased attention from potential Western partners will be paid to these companies. These organizations are playing an integral part in outsourcing as India establishes its grass-roots, unique position in manufacturing, and technology.

Outsourcing has traditionally been driven by cost factors. But China and India are breaking that mould, using indigenous advantages, and home-grown expertise developed over decades to establish their competitiveness. Western decisions to outsource to Asia are increasingly based on strategic factors, and India and China are positioning themselves with their respective specialized expertise, and growing these segments on their own terms. This, according to newly released studies, Top 60 Biopharmaceutical Manufacturers in China, and Top 60 Biopharmaceutical Manufacturers in India, by BioPlan Associates (www.bioplanassociates.com). The reports indicate that Chinas and Indias growth are becoming increasingly attractive to investors, but for entirely different reasons, and unique to each country. To understand this paradigm, we explore both countries assets from different perspectives. Indian Biopharmaceutical Industry History and Outsourcing India has been involved in biopharmaceuticals since 1925 when Haffkine Institute (Plague Research Laboratory) began producing vaccines in Mumbai. Vaccines have since become a backbone of the industry. Then, in 1953, Unichem began exporting hormonal products, and later on, the focus shifted toward the enzyme market, with companies such as Biocon and Advanced Enzymes. Now, with strong IT experience, India is pushing the bioinformatics technology envelope. Outsourcing to India has thus moved in line with the regions needs and expertise. Today, for example, vaccine competence in India has resulted in a local vaccine market pegged at USD$100 million and growing at more than 20% annually. India is now the largest producer of recombinant Hepatitis B vaccine in the world, and Serum Institute, reports to be the second largest manufacturer of vaccines, claiming that 1 of every 2 kids in the world is vaccinated by Serums vaccine. So it should not be a surprise that international companies involved in vaccines, such as Merck and others are establishing R&D and production

This specific R&D knowledge is creating an engine for outsourcing and partnering. Relatively few drug candidates are coming from internal labs of large-bio/pharma. So companies like Amgen, which recently partnered with Jubilant, are seeking to access R&D and drug discovery expertise offshore. This insourcingcapturing R&D competence through investment, allows companies to develop research-based partnerships as a way of sourcing expertise. Merck and Advinus Therapeutics (India), are collaborating at early-stages, and Indian companies such as Ranbaxy and Dr Reddy's have established geRecognizing the potential of Indian companies, neric drug manufacturing, and are now competseveral foreign companies are working with do- ing in new drug discovery. Indias widely acmestic manufacturers. For example, Acambis cepted chemistry skills offer services that can Plc., a UK-based vaccine developer, has a manu- match global standards in some areas. Outfacturing and marketing agreement with Bharat sourcing chemistry services partnerships include Biotech for its investigational vaccine against AstraZeneca-Ranbaxy and GSK-Torrent Pharma. Japanese Encephalitis. Panacea Biotech is partnering to develop a fully liquid pentavalent Challenges Ahead combination vaccine for five infectious diseases. In fact, India now exports vaccines to more than The Indian Biopharma industry faces several 100 countries around the world. The focus is challenges regarding adequate infrastructure now on obtaining a share of the underdeveland financial support. Financial support is reoped market, as well as supplying the World quired for bio-entrepreneurs and trained manHealth Organization (WHO), UNICEF, and othpower is still required, despite the 300 biotech ers. educational and training institutes across the country. In addition, there is still an unclear Strengths in Outsourcing regulatory environment; intellectual property protection is far from perfect; and the slow Today, India has established itself as a potential pace of integration between academic and compartner in biopharma, particularly in contract mercial science still exists. research and clinical trials, vaccine production, and IT. This fundamental expertise has develFor India, the near future opportunities are oped strong pharmaceutical industry ties that based on their existing expertise, and we should bode well for future integrations. It is these fu- continue to see East-West partnerships based ture relationships that are likely to become a on these relative synergies. These partnerships, solid base for the regions biopharma industry. in the long-term, are likely to springboard this country to become a major force in global bioIndias biotech industry has been strengthened pharma, as its economy grows. with support from scientific institutions such as the National Centre for Biological Sciences China (NCBS), the Institute of Science (IISc), and the Centre of Cellular and Molecular Biology. The Nineteen years have passed since the first modIndian Biopharma sector presents numerous ern biotech firm, Shenzhen Kexing Biotech Co., opportunities in outsourcing, which come with Ltd., Chinas biotech pioneer, brought the first several economical and political advantages. Chinese-developed protein therapeutic Political advantages include a government pol- (Recombinant Human Interferon a1b) to the icy that encourages 100% foreign direct invest- market in the early 1990s. What followed were ment in Special Economic Zones (SEZs); exemp- the fruits of nearly 200 modern biotech drug tion of import duties on certain R&D equipfirms that to date have launched 35 domestic ments; improved patent laws; a simplified regu- biotech drugs. But it is the Chinese biotech seclatory system, and other economic advantages. tors innovation focus that is differentiating its outsourcing potential. Indian companies have also started venturing into areas of grass-roots R&D competence, in Major Drivers for Innovation and Outsourcing order to remain competitive in the vaccines segment. Many institutes are researching vaccines Based on our study of the Top 60 Chinese biofor cholera, tuberculosis, rabies, HIV, malaria pharma companies, we predict that innovation and Japanese Encephalitis. Scientists at the Na- and outsourcing services will become major tional Institute of Immunology (NII), New Delhi, drivers for Chinas biotech industry over the have developed a vaccine based on the Indian next 5-10 years. At present, the potential for strain of Japanese Encephalitis Virus (JEV), and a Chinese biotechs to become world-competitive prototype candidate vaccine for the HIVhas not yet been realized. Figuratively, Chinese Subtype C has been developed based on plas- biotech companies remain diamonds in the mid DNA and MVA (Modified Vaccinia Ankara) rough. However, it is likely that, based on their approaches at the All India Institute of Medical grass-roots competences, Chinese biotech firms Sciences (AIIMS). Several institutes have possi- will become influential players in the global bilities for the development of commercially market. We will not be surprised if five or ten viable technologies for the Malaria Vaccine Ini- years from now, some of the Chinese compatiative (MVI), and development of a diagnostic nies on our Top 60 directory will have become kit for Dengue. well-known names in the international biotech
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community. Some of this growth is being driven by foreign influence and investment. AstraZeneca plans to step up outsourcing in big ways. In fact, David Brennan, chief executive, said that all active pharmaceutical ingredients would be produced externally within a decade as part of his strategy of supply chain management, quality, and security of supply. AstraZeneca plans to increase its outsourcing drastically from both China and India. Chinese Biotech Growth The first Chinese biotech companies were mostly vaccine providers, as were Indias. These Chinese organizations have a relatively long history, and, because of the domestic healthcare and vaccine needs of the worlds largest population, they tend to be much larger in size. National Serum and Vaccine Institute (NVSI), was founded in 1919. With more than 9,000 employees and worldwide revenues of $421 million in 2006, CNBG is the largest producer of vaccines and blood derivatives in China.

return to their motherland to set up or take senior positions in Chinese biotech companies. The growing number of international biotechs partnering with Chinese companies in R&D and production has provided opportunities for Chinese biotechs to gain world-level management know-how from their Western partners. As an emerging biopharmaceutical outsourcing hub, China is rapidly gaining importance among multinationals as part of their global strategies. In the old days (e.g., before 2002), Western companies tended to come to China for the lower cost of labour and raw materials for manufacturing. Today, what makes China attractive to foreign biotechs looking to boost their productivity are Chinas more open economic and political landscape coupled with a large biotech talent pool. Threats and Weaknesses

Challenges face Chinese biotechs as they attempt to expand beyond their borders. These include a higher tax rate, increases in raw material costs, and potential government-imposed drug price cuts. In addition, Other vaccine providers manufacture polio, hepatitis A vaccines, and the shortage of a strong, mature capital market and the use of governmost other vaccines available world-wide. According to the SFDA, ment investments to fund biotech research also hinder the development Chinese vaccine producers have marketed 49 vaccines to fight 26 infec- of Chinese commercial biotechs. Chinese biotech firms need to overtious diseases, with over 1 billion doses annual output. China has become the following weaknesses before they are able to effectively comcome the worlds largest vaccine manufacturing country in terms of pro- pete in the global market: duction scale. Size: In general, Chinese biotech firms remain small (except for CNGB), Outsourcing Biotech to China compared with conventional pharma companies; Western companies have not failed to recognize these competences. Sanofi-Pasteur set up an influenza vaccine facility in Shenzhen in 1996. In November 2007, the company announced it would invest 700 million RMB (US$94 million) in expanding facilities in Shenzhen, with the goal of producing seasonal influenza vaccines for the Chinese market by 2012. A number of multinational biotech players have established their presence in China, lured by opportunities. Novo Nordisk, which entered the Chinese market in 1993 opened its first production facility in Tianjin in 1996. The company has dominated approximately 82% of the human insulin market in China for many years (compared to 52% market share in the global market), with 1.9 billion RMB ($261 million) sales in 2006. Higher-end Innovation Eli Lilly has increased R&D capacity and accelerated product development for small molecule drugs by outsourcing early-stage development work to China and India. At the same time, the company is pioneering new ways to share risks and rewards, such as its partnership with Nicholas Piramal, and with collaborations with Suven Pharmaceuticals in Hyderabad. GlaxoSmithKline (GSK) located research activities in Shanghai, China, pointing to Chinas growing talent pool of scientific expertise as the reason for this shift. According to a GSK press release, We dont want to give them the crumbsWithin five to 10 years we will be moving from made in China to discovered in China. The GSK investment follows similar moves by Roche, Novartis, AstraZeneca, NovoNordisk, Sanofi-Aventis, and others who are investing in Chinese R&D. Despite these specific advantages, they may actually be outweighed by the general, strategic benefits of establishing in China. According to Dr. Xiaoqing Sun, Managing Director at Shanghai Genomics in China, The real grass-roots benefit that China offers Western biopharma companies is the fact that the market in China has the potential to grow much faster than it is currently; but Western organizations have to participate to be part of that opportunity in the future. Changing Biotech Environment The Chinese biotech industry has established critical mass and is now aggressively working to catch up with their foreign competitors from developed countries. The government has realized the importance of biotechnology and has prioritized the biotech industry on its agenda. China has attracted many high-caliber China born biotech employees, with many years of education, research, and work experience in the West to
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Financing: Most companies dont have sufficient funds to foster intensive R&D and facility upgrading; and Management and Marketing: Many companies dont have managers with international managerial, or marketing experiences. Summary There are inherent risks associated with outsourcing to India and China; however, based on our study of the Top-60 Chinese and Top-60 Indian biopharma companies, we predict that grass-roots competitive advantages in specific production systems, R&D innovation, trained workforces, and experience in outsourcing will become major drivers for both the Chinese and Indian biotech industries over the next five to 10 years. Forward-thinking Western companies who want to participate in the growth of these Asian markets are going to need to establish a presence in the region, learn to navigate the risks, and identify the synergies that will create global advantages for them as partners. About the Author: Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences publishing and marketing research firm established in 1989, and located in Rockville, MD. 301-921-9074. www.bioplanassociates.com

Chinas Intellectual Property RegimeCause for Concern or Optimism? By CanBiotech

Chinas action plan with respect to IPR protection for 2008 has as one goal the revision of laws and regulations regarding patent protection including: 1. The completion of the revisions to the Patent Law. 2. The revision of rules for implementation of the Patent Law. 3. The revision of the Regulations of Traditional Chinese Medicines. 4. The drafting of related measures for administration to coordinate with the implementation of the Measures for the Administration of Drug Registration. With regard to advancing IPR protection at the business level, 17 measures in total will be introduced to direct businesses in structuring their IPR regimes and boost their competency for competing on the merit of such regimes. 4 Specific tasks with respect to sectors such as biology, medicine, new materials, advanced manufacturing, new energy, environmental protection, and modern agriculture include the development of advanced development plans according to the nations strategic needs and the acquisition of a group of patents in these core areas of technology to support the development of Chinas high technology industries. 7 References:

Although the government keeps intellectual property concerns high on its agenda since its commitment to the rules of the WTO, namely the Trade-Related Aspects of Intellectual Property Rights (TRIPS), enforcement of intellectual property protection is still thought to be problematic. Consequently, while intellectual property protection is improving in China, most investors remain cautious. Patent reforms are essential to encourage entry into China, partnerships, and collaborations including outsourcing contracts, technology transfer deals, and technology licensing.1, 2, 3 China-based outsourcing service providers must therefore, keep intellectual property concerns in mind when partnering with Western biopharmaceutical companies. Any partnership or contract should address and alleviate the concerns that Sponsors may have regarding the protection of technology.

1) Chervenak, Matthew. An emerging biotech giant. The China Business Review. May-June 2005. 2) Santini, Laura. Drug companies look to China for cheap R&D. The Wall Street Journal. November 2004. 3) Hepeng, Jia. Pharmaceutical giants outsourcing R&D. China Business Weekly. September 2004. 4) China's Action Plan on IPR Protection 2008. State Intellectual Property The establishment and implementation of the intellectual property sys- Office. March 2008. 5) Langer, Eric. China Today: Intellectual Property Protection in China: tem have helped to standardize China's market order, stimulate inventions, promote the importation of knowledge resources, and have played Does it Warrant Worry? Biopharm International. May 2007. an important role in Chinas economic and social development. However, 6) China's Intellectual Property Protection in 2007. State Intellectual the quality and quantity of the self-relied intellectual property still can- Property Office. April 2008. not meet the demands of economic and social development; the public 7) Outline of the National Intellectual Property Strategy. State Council of the People's Republic of China. June 2008. awareness of the importance of intellectual property is comparatively weak; the capacity of market entities to utilize intellectual property is not very strong; infringement of intellectual property is still a relatively serious problem; there are still some cases of abuse of intellectual property; the intellectual property service and support system and training for all types of intellectual property personnel lag behind its development; and the role of intellectual property in promoting economic and social development needs to be strengthened. 4 However, the third round of amendments to the PRC patent law, to be finalized, this year, is thought to be cause for optimism. The changes are expected to include amendments to the patent application process, amendments regarding legal requirements for patentability, amendments regarding exemptions to patent infringements, and amendments to establish a special appellate court to handle intellectual property rights (IPR) cases.5 Furthermore, the recent rise in patent application filings by domestic and foreign applicants reflects increased confidence in expected patent protection and enforcement in China. 5 In 2007, China made tremendous progress in the field of intellectual property rights. Laws and regulations concerning intellectual property rights were further refined. The number of patent applications from home and abroad handled by China reached 4 million, up from 3 million in just 18 months. According to the Party Central Committee and the State Council, the national intellectual property rights strategy has now shifted from formulation to implementation, which indicates that China is now entering a new development phase. 6 In 2007, the number of patent applications received by the State Intellectual Property Office (SIPO) was 694,153, with an increase of 21.1% compared with last year; the number of PCT applications totalled 5,401 over the year and 364 international preliminary reports were issued. A total of 351,782 patents were granted in the year, an increase of 31.3% on the previous year; wherein, 301,632 patents were granted at home, an increase of 34.7% compared with the previous year, and 50,150 foreign patents were granted, an increase of 13.6%. 6
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Regulatory Processes in ChinaRoom for Improvement? By CanBiotech

drug safety evaluations must be conducted in GLP-accredited laboratories. Only 23 laboratories in China are GLP certified. 3 China today is a $10-$13 billion pharmaceutical market, which puts it in the top 10 worldwide, with plenty of room for growth (estimated growth rate 25% per year). 4 While Americans spend an average of more than $500 on prescription drugs annually, the Chinese spend just $6. The market is growing at double-digit rates and is likely to be the worlds third largest, after the U.S. and Japan. 4,5,6 Hence, great opportunities exist to treat the Chinese consumer. The Western biopharmaceutical industry is noticing the advantages of accessing these patients earlier in the drug discovery and development process including: running clinical trials in China, manufacturing in China, and increasingly conducting drug discovery research to address the specific health needs of the Chinese population. Partnerships with Chinese outsourcing service providers and Chinese biopharmaceutical companies will be essential as the West taps into this market. With the growth of the middle class in urban centers, the demand for higher education has similarly increased. 5 In response, Chinese leaders have made a serious investment in higher learning academies that will train the type of people that will be employed in the outsourcing sector. It is anticipated that this large research talent pool will soon have the technological knowledge and skills to meet the outsourcing needs of the Western biopharmaceutical industry. Given the relatively low wages associated with this talent pool, China has become a viable competitor to India as an outsourcing service provider. References: 1) Lout, Sabine. Can China bring its own pipeline to the market? Nature Biotechnology. December 2004. 2) Hepeng, Jia. China beckons to clinical trial sponsors. Nature Biotechnology. July 2005. 3) Langer, Eric. China as a Biopharmaceutical Powerhouse: Just a Matter of Time. Biopharm International. December 2007. 4) Gardner, Jack. Outsourcing in Drug Discovery 2nd Edition. A Kalorama Information Market Intelligence Report. January 2006. 5) Furniss, Todd. China: The next big wave in offshore outsourcing. Outsourcing Asia. June 2003. 6) Einhorn, Bruce, P. Magnusson, A. Barrett, and K. Capell. Go east, big pharma. Business Week. December 2004.

Experts indicate that the approval process takes from five to eight years in China, in contrast to an average of eight to ten years in the U.S. 1 Despite the shorter timeframe, the approval process is similar to that of the U.S. and includes Investigational New Drug (IND) applications as well as three phases of clinical trials. These advantages are being used effectively by contract research organizations and regulatory specialists. Since the market demand (including ability to pay) for biotechnology drugs is insufficient in China alone, and the fact that some Chinese consumers perceive that only Western drugs are developed at international standards, high international compliance is necessary for Chinese companies to increase local demand. Public relations firms may serve as good partners to change this perception among Chinese consumers. Industry stakeholders believe that in the future, Chinese companies will be more strategically competitive in their work at both the Chinese and international standards levels. The Chinese State Food and Drug Administration (SFDA) has further taken on the role of enabling innovative drugs to reach the market and plays an indirect role to control the status of intellectual property associated with drugs submitted for approval. Failure to provide evidence of patent status on a drug application may still result in the approval of a drug, but denial of a manufacturing permit. 1 The support of outsourcing service providers familiar with the regulatory process can enable Western and Chinese biopharmaceutical companies to successfully navigate the process. There are signs that the SFDA is trying to accelerate the approval process of innovative medicines as part of their commitment to research and development of innovative drugs. As well, the SFDA has increased its efforts to promote Good Clinical Practice (GCP) by releasing standard rules in 2003 and 2004 and introducing compulsory GCP training requirements in 2004. 2 But despite the attempt to harmonize clinical trial standards, analysts indicate that it remains to be seen whether or not the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMEA) will accept clinical data from trials based in China. 2 Regulatory specialists knowledgeable about GCP standards, international clinical standards, and regulatory submissions will therefore be critical as the industry matures. As of 2007, China's SFDA issued long-awaited regulations on drug registration that (1) increased requirements for drug safety; (2) integrated supervision resources and clarified responsibilities; and (3) enhanced drug evaluation and approval standards. 3 China announced a new fiveyear plan to tighten food and drug safety and to contain illegal activities in production and the sale of pharmaceuticals. To implement the new regulations, China established a four-level drug administration and inspection system involving 3,509 institutions. The SFDA also enacted new regulations on drug oversight, including new regulations covering exhibitions, channels, cold chain transportation, quality, and other measures. And as an example of a working system, the government revoked 353 licenses for therapeutics for various reasons, including quality, and rejected 3,049 applications for new drugs from August 2006 through February 2007. 3 China's SFDA also issued new GLP standards. As of January 2007, all new

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The Drive toward Outsourcing: The State of the Chinese Industry-Case Studies By CanBiotech

Centre for Clinical and Basic Research Location: Beijing Founded: 2005 Target Area: Clinical Research, Clinical Testing

In November of 2004, Novartis and Shanghai Institute of Materia Medica (SIMM) at the Chinese Academy of Sciences, signed an agreement to extend joint research to develop natural compounds herbs to 2007. [5]

Greater complexity in drug discovery, development, and regulatory processes is encouraging the view that outsourcing is the means to easily and cost-effectively gain access to specialized resources, technology and expertise. In this section we discuss outsourcing opportunities along the biopharmaceutical value chain. Selected company case studies are used in this section to specifically illustrate the current state of the Chinese industry. CASE STUDIES I: Contract Research (CRO)

Novartis has been bringing experts from Europe to establish centers in hospitals with good clinical practice to enable the company to conduct and an international clinical testing laboratory clinical trials in China. As of November 2004, the in Beijing. With a $10 million budget, this is the company had 800 patients in trial and expects first clinical laboratory that is independent from the number to rise to 3,000. Given the need to access large numbers of patients in clinical trihospitals in China. Until recently, only major state-run hospitals have been authorized to per- als, companies such as Novartis view China as a strategic component of global clinical trials. form clinical trials in China. It is expected that with more independent clinical trial providers, Chinas population of 1.3 billion provides a biotechnology companies can avoid the limita- strong base for clinical trials of almost all new tions of certain hospitals designing clinical trials drugs. [6] and the poor coordination between different hospitals. CCBR opted for China over other Pfizer Inc. countries in Asia because of better medical and transportation infrastructures, as well as easier Location: Shanghai access to patients. [3] Founded: 2004 AstraZeneca China Location: Shanghai Founded: 2002 Target Area: Clinical Research

AstraZeneca opened a Clinical Research UnitEast Asia (ACRU-EA) in Shanghai in 2002. The Specialized resources and expertise will be required to enable for the rapid screening of leads unit was the first clinical research center from against properly validated targets and to discard an international pharmaceutical company spanning East Asia (Mainland China, Hong Kong, Taifailing compounds during the preclinical or wan, and Korea). With its establishment, AstraPhase I stage where risk and cost can be managed. CROs or preclinical service providers that Zeneca became the first international pharmaceutical company in China to localize not only can complete studies more effectively than manufacturing and sales and marketing funcSponsor companies should take advantage of this need to kill fast, kill early and ensure that tions, but also an R&D center overseeing East Asia clinical research and development. the most promising compounds are advanced into a company's pipeline. The need to reach a The research center seeks to develop closer reglobal market will also encourage partnering lations with Chinese health institutions and orwith international CROs with local presence in new markets such as China and India, to enable ganizations. The significant number of high quality medical talent available in Shanghai was companies to pursue approvals in parallel in the reason that AstraZeneca chose to locate the these countries, and to maximize their profit center there. potential. International patient recruitment, particularly when based on pharmacogenomic Employing 1,000 staff members in 2002, Astradata, will provide new opportunities for CROs Zeneca China operation began around 100 years that distinguish themselves as being internaago. Its Wuxi manufacturing Center opened in tionally focused. 2001 with an investment of $100 million. This represented the companys largest investment China, with the largest population in Asia, is conducting the greatest number of trials in this in Asia, and one of the largest investments in China by a multinational pharmaceutical comregion. Phase II through IV studies are being conducted in areas such as: oncology, hepatitis pany. [4] Since opening the clinical trial center in Shanghai, AstraZeneca has conducted tests B, cardiovascular, endocrine and antiinflammatory diseases, as well as diabetes, and on 50,000 patients. metabolic diseases. [1] Interestingly, it is expected that the Chinese biotechnology sector will also benefit through the provision of contract research outsourcing services to foreign biopharmaceutical companies to finance the development of locally developed drugs. [2] The Danish Centre for Clinical and Basic Research (CCBR) announced in July of 2005 its intention to establish a clinical research center Novartis China Location: Beijing Founded: 2004 Target Area: Clinical Trials

Pfizer Inc. is spending $175 million on establishing a new regional headquarters in Shanghai. Although the office will oversee existing manufacturing and marketing operations, Pfizer said late 2004 it also is considering building its own R&D center in China. As of 2003, Pfizer offered 40 innovative products in China and another 13 new drugs are planned to be introduced to Chinese consumers within five years. Hence, the need for a clinical trial center in Shanghai. China's clinical trial center will not only be concerned with developing drugs for local approval, but will also be part of Pfizer's global R&D (research and development) network, said Allan Gabor, chairman and general manager of Pfizer Pharmaceuticals Ltd China. Pfizer is the second multinational pharmaceutical company to set up a clinical trial center in China, following in the footsteps of AstraZeneca. [7] Quintiles Laboratories Asia Location: Beijing Founded: 2005 Services Offered: Central Laboratory Services

Quintiles Transnational Corp. announced in 2005 that Quintiles Laboratories Asia (QLAB Asia) had amended its existing agreement with Peking Union Medical College Hospital (PUMCH) to enhance central laboratory services in China. The new amended agreement enhances services for customers by allowing Quintiles central laboratory (QLAB) facilities in China to operate under the same standardized processes, controls, and reporting mechanisms as other QLAB
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facilities. Quintiles operates the largest and most comprehensive central lab testing facility in Asia at its Singapore base and has been providing central lab services in China under the initial agreement with PUMCH signed in October 2003. Anand Tharmaratnam, M.D., CEO of Quintiles Southeast Asia and QLAB Asia, said: The new agreement represents true growth and quality standardization of our Asia central lab service. It consolidates our position as the most comprehensive central lab group in Asia and very nicely complements our clinical business, which is the largest pharmaceutical development group in Asia. Alan Ong, Vice President and General Manager, QLAB Asia, said of the enhanced services: QLAB Asia performed nearly a million tests in 2004, of which 400,000 tests were for China trials. We are excited that our new enhanced services will now allow our customers to participate in the growth of clinical trials in Asia, freed from the problems and difficulties of exporting blood samples out of China. *8+

new biomaterials for drug release.

Bridge Pharmaceuticals Inc. Location: Beijing Founded: 2004

Bridge Pharmaceutical Inc. is a contract research organization spun out of SRI International in 2004. This company opened a 100,000 square foot facility in December of 2005 in the Beijing Zhongguancun Life Science Park. The facility provides preclinical research including animal testing for Western clients, meeting U.S. regulatory standards both for laboratory experiments and animal testing. The central goal is to provide lower costing but compliant research services to both U.S. and E.U. clients. As evidence, earlier in 2005 the company received FDA clearance for clinical studies for two drug candidates. According to the company, this was the first instance of the FDA approving clinical trials based on preclinical data generated entirely in China. [9] Shanghai Genomics Inc. Location: Shanghai Founded: 2001 Services Offered: Contract Research

Shanghai Genomics was founded in August 2001 by returning overseas biotech veterans, Drs. Ying Luo and Jun Wu, with funding from two prestigious Chinese venture capital funds, Shanghai Venture Capital Company and Shanghai Zhangjiang Hi-Tech Park Corp. The company mission is to develop novel therapeutic products for fibrosis, infectious disease, cancer, and

providers are able to better master new discovery techniques and tools that can overwhelm Aiming to become a major player in the frageven the largest of biopharmaceutical compamented Chinese pharmaceutical industry, nies. With the advantage that discovery work Shanghai Genomics has built an integrated drug can be conducted faster and cheaper through discovery platform. The companys technology such outsourcing service providers, it is no platform includes signalling pathway mapping, longer a question of whether or not to outgene expression profile studies, protein expres- source discovery work, but a question of finding sion and purification, animal modeling, medici- the right partners. [4] nal chemistry, and bioinformatics. The company leverages this highly efficient and low-cost plat- Chinas pipeline in 2004 included 139 drugs; 60 form to provide collaboration/contract research of these drug candidates were biologics. [2] The services for its international partners. Research emergence of this pipeline, given that China has reagents generated by this platform, such as traditionally only produced generics, is the rerecombinant proteins and antibodies, are also sult of the central and provincial governments very useful tools for partner research. [10] efforts to support the biotechnology industry by funding both research and the early stage of product development as well as enabling better Starvax Inc. intellectual property protection. [2] New drug development focuses on the following areas: Location: Beijing gene therapy, antibodies, and traditional ChiFounded: 2003 nese medicine (TCM) modernization. [14] It is anticipated that early discovery service providServices Offered: Toxicology, Pharmacology, ers that specialize in these technological arenas Animal Studies will be strategically positioned to partner with Western biopharmaceutical companies seeking investment opportunities in China and looking Starvax is one of a handful of Chinese biotech- to partners familiar with local technology and nology companies trying to convince Western market needs. Analysts also believe that the drug companies that scientific research can be modernization of traditional Chinese medicines, easily outsourced. Starvax, in turn, is typical of a the development of high-throughput screening, new breed of Chinese biotechnology companies and other drug discovery technologies will prorun by entrepreneurial Chinese returnees. vide China with a competitive advantage in new drug discovery. [14] Though Starvax's chief scientist is eager to start several proprietary research projects, he underEli Lilly and Company stands cash flow for the first few years will come through contract work. The company curLocation: Shanghai rently is conducting toxicology, pharmacology, Founded: 2003 and animal studies for several drug companies under pay-as-you-go agreements. *11, 12+ Target Area: Research Partnership with Starvax's major coup to date has been a partShanghai ChemExplorer nership with Mologen Inc., a German biotechnology company that has a colon cancer drug undergoing clinical trials in Europe. Starvax has In 2003, Eli Lilly opened its research laboratory licensed the drug for China and East Asia and building in the Zhangjiang New and Hihas expanded research on the compound to see TechTechnological Park in Shanghai's Pudong if it might work against other forms of cancer. New District. The multinational pharmaceutical [12] Rather than spending on expanded R&D in company set up the 4,000 square meters Eli Lilly Europe, Mologen is having Starvax conduct the Research Laboratory in cooperation with its Chipreliminary screening. nese partner Shanghai ChemExplorer, a chemical research company. Lilly provides funding and CASE STUDIES II: Early Drug Discovery technical support; its Chinese partner is responIndustry experts claim that while traditionally sible for organizing teams of researchers and most outsourcing partnerships have involved experts and implementing scientific research the later stages of drug development-Phase I, II plans. [15] Shanghai ChemExplorer provides in or III, early drug discovery partnerships are on vivo ADME services, in vitro assays (solubility, the rise. The market for outsourced drug discov- metabolic stability), and toxicology services. ery in 2005 was $4 U.S.D. billion, and is pro[13] jected to grow at a 15% rate to reach $7 billion U.S.D. in 2009 according to Kalorama Informa- Shanghai Bio-Explorer Inc. the sister company to tion. [1, 13] Improving the drug discovery proc- Shanghai ChemExplorer, was started in 2002 ess should improve the hit-to-lead conversion, and is in Shanghai Research Park between the expand the number of high quality compounds DuPont and Roche facilities. Shanghai Biothat do enter the preclinical and clinical stages, Explorer provides ADME services and conducts and result in the early elimination of comanimal studies. [13] pounds that are likely to fail. Roche announced in 2004 the opening of Roche To assist companies in their early drug discovery R&D (China) Ltd at the Shanghai Zhangjiang Hiprocess are service providers that can screen Tech Park to help celebrate the 10th anniverthrough and test compounds against the large sary of Shanghai Roche Pharmaceutical Ltd. numbers of targets now available. These service Roche's drug innovation center is its 5th global
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pharmaceutical R&D facility in addition to such facilities in the U.S. and Europe. It is the first in Asia. [16] Roche China Ltd. Location: Shanghai Founded: 2004 Target Area: Medicinal Chemistry At Roche's new Shanghai operation, scientists will focus on medicinal chemistry and the screening of compounds demonstrating promise as antiviral or cancer treatments. The group will cooperate with the drug giant's other research centers in Basel, Switzerland, and Nutley, New Jersey. There is very good chemistry done in China, says Jonathan Knowles, the company's global head of research. The laboratory also should help Roche establish strong ties with Chinese authorities, something that could prove valuable as the company seeks to expand operations in China, as well as explore new market opportunities there. [17] After the R&D center gains more experience within the next five years, it will become more active in participating in Roche's global projects according to Roche Pharmaceuticals Shanghai Ltd General Manager Antonio Chow. These may include projects of special concern to China, such as AIDS and hepatitis B. Traditional Chinese medicine will also be a key area of research in the future, according to Andreas Tschirky, who has been responsible for Roche's R&D in China for the last few years. Roche is collaborating with the Chinese National Genome Centres in Shanghai and Beijing on epidemiology studies into genetic predispositions to conditions such as diabetes and Alzheimer's disease. [16]

pervise the setting up of joint units with both institutions... The new Servier Center has two purposes: one is to accelerate the discovery - on a partnership basis - of new compounds native to traditional Chinese medicine, especially for diabetes, cancer, and cerebral aging; the other is to incorporate China into the international clinical development program of Servier Research compounds through the establishment of Servier's 12th world International Center for Therapeutic Research (ICTR). [18]

ceutical companies as they progress from lateclinical trials, to production, and then to the market. [20, 21]

As the biomanufacturing industry develops, contractors will be in a position to fully utilize their manufacturing capacities serving multiple customers, with lower overhead costs for all customers. The development of new expertise and use of new technologies will increase efficiencies and lower costs for such customers. Future contract manufacturers will develop a one-stop shopping facility, including large facilities with economies of scale, cost-effective supCASE STUDIES III: Contract Manufacturing plier agreements based on volume purchases, (CMO) and flexible processes to meet increases and Many biotechnology and pharmaceutical com- decreases in demand. New technologies will panies, both small and large, are increasingly include the use of transgenics, better producrelying on third party contract manufacturers to tion processes for mammalian cell culture, as develop their biopharmaceutical products. well as microbial fermentation. Given the significant capital investment and potential high operating costs, contract manufac- According to government statistics, Chinas bioturing has become a viable option to keep costs logics market exceeded $2.5 billion in 2004 and low and ensure a rapid time to market for prod- is growing at a rate of 13% per year. [2] This ucts. Outsourcing partnerships can include the market is primarily dominated by generic manuuse of contract manufacturers to conduct all facturers. Most players are small domestic playactivities from preclinical development to com- ers that compete on price and tend to have exmercial manufacturing or the use of contractors cess manufacturing capacity. With excess capacto manufacture material for specific phases of ity and compressed margins, Chinese biopharclinical development or for commercial develmaceutical manufacturers are ideal to partner opment. with or acquire. [14] Wuxi PharmaTech Co. Ltd. Location: Shanghai Founded: 2000 Services Offered: Combinatorial, medicinal, synthetic chemistry, and manufacturing

Domestic consumption levels and recognition of China as a supplier base for active pharmaceutical ingredients (APIs) and intermediates have further attracted the attention of global pharmaceutical and biotechnology companies. [19] The Chinese fine chemicals industry has traditionally focused on basic building blocks and commodity types of active ingredients. However, Chinese fine chemical companies are increasingly moving into more complex areas of this sector providing early phase development services and custom synthesis. Industry experts Roche has been active in China for the last dec- indicate that large biopharmaceutical compaade in diagnostics and pharmaceuticals. It is one nies are planning to substantially increase their of the leading suppliers of prescription medishare of fine chemicals outsourcing to both cines in China. The Roche Group employs a total China and India. This share was expected to of 1,200 people in Hong Kong and Shanghai. reach 20 to 30% by 2006-2007. Just as the fine chemicals service industry is evolving in China, large biopharmaceutical companies will not only Servier Beijing source basic building blocks or APIs, but also the more advanced intermediates as well as early Location: Beijing phase development services. [19] Founded: 2001

Shanghai-based WuXi PharmaTech Co., Ltd. offers global biopharmaceutical companies diverse outsourcing services in combinatorial, medicinal, synthetic chemistry, and manufacturing. WuXi PharmaTech's rapidly expanding line of services ranges from early stage discovery chemistry through lead optimization chemistry, all the way to process research and development, and bulk manufacture of active pharmaceutical ingredients. With the addition of a new GMP plant at Jinshan in Shanghai, the company has further increased its bulk production capacity to meet rapidly growing customer demand. To meet capacity demand, pharmaceutical and WuXi PharmaTech's strong capabilities enable biotechnology companies are using an intethe company to provide a broad spectrum of Target Area: Drug Discovery grated strategy that involves in-house manufac- integrated development services from milligram turing capacity development and the develop- quantities to metric ton scaled active pharmaServier, Frances largest independent drug com- ment of long-term partnerships with contract ceutical ingredients, intermediates, and raw pany, established the Servier (Beijing) Pharma- manufacturers. Using this strategy, companies materials. Currently, WuXi PharmaTech's client ceutical Research & Development Company Ltd can prioritize which products are targets for in- list includes over 60 leading drug discovery in 2001. The new company, a wholly owned house manufacturing and which products are companies including a majority of the world's Servier Group subsidiary, participates in all the targets for outsourced manufacturing. Some largest pharmaceutical companies. [22] groups research activities and is actively incompanies may opt to build capacity for clinical volved in new therapies sourced from the trial product manufacturing and then outsource For example, TargeGen of San Diego, is developChinese pharmacopoeia. In the research field, commercial manufacturing. Other companies ing small-molecule drugs for treating cardiovasstates Paul Vanhoutte, Group Vice-President of without the capacity to build may have to rely cular disease and has shifted chemical screening R&D and Chairman of the new company, the entirely on outsourcing biomanufacturing serof various compounds to Shanghai's WuXi Pharcompany's mission will be not only to adminis- vices. Capacity development is key to ensure maTech Co. We pay WuXi to do research on ter the new collaborative agreements we have that products do not end up on the shelf beour compounds and then use the results for furentered into with Chinese university departcause of lack of production and to ensure the ther development in the U.S., says Enterprise ments and scientific institutes, but also to sufinancial growth of biotechnology and pharma- Partners' Drew Senyei, a venture-capitalist in14

vestor in TargeGen. Through companies such as WuXi, Western drug companies will soon be able to conduct complex animal testing in China. [17] CASE STUDIES IV: Regulation and Marketing

relations firms can share scientific knowledge about the drug with the medical community and advocacy groups, thereby increasing the understanding of a product's potential.

As the drug gains market approval, PR firms are partners that can augment a clients marketing Regulation: Changes brought about by the and sales efforts. At this point, building brand United States Food and Drug Administration loyalty becomes critical. The establishment of a (FDA) and the International Conference on Har- connection to the consumer and his/her needs monization (ICH) have created challenges for will enable a product to gain market exclusivity; companies in keeping up with federal regulathis is particularly important in the face of metions and guidelines regarding drug regulation too competition. An understanding of consumer and submission data requirements. These chal- attitude to health and nutrition, preventative lenges are encouraging companies to seek part- medicines, drug therapy, and disease manageners that can assist them with regulatory subment is necessary to create a strong connection missions. Small companies are particularly look- with the patient during the launch campaign. ing to contract this work lacking the resources to handle the regulatory worklet alone keep- The experienced PR firm will also be able to ing up with new federal regulations and guide- identify and select the best media channels and lines. With the ICH attempting to develop con- outreach mechanisms given the target market. sistency among regulatory documentation sub- Varying media channels as a function of type of mitted to authorities in the U.S., Europe, and patient can provide greater impact, particularly Japan, the streamlining of regulatory processes, when it is possible to segment a drug's market and a movement toward electronic submisinto different groups e.g. young and old. sions, regulatory specialists may be the best partners to monitor and then implement these Chinas healthcare system is also rapidly changchanges for their clients. [23] Consequently, ser- ing to enable better access for consumers once vice providers that provide a breadth of services drugs are approved. From 1978-2004, Chinas should be sought. The best partners will be health care sector expanded at 17.4% CAGR. committed to maintaining current knowledge of [24] Drug distribution has traditionally been the changes in Chinese regulatory standards highly regulated with hospitals prescribing as including submission processes, guidance docu- many expensive drugs as possible to generate ments, and global efforts at harmonization. revenues. However, increasingly hospitals are being privatized, allowing the state to divest Marketing: Biopharmaceutical companies need itself of inefficient and low-quality assets in the to be perceived as trusted sources of informa- healthcare system. The pressure from market tion as they recruit patients for clinical trials, competition, meanwhile, will compel the reseek approval for drugs, and then launch drugs maining public hospitals to improve their own onto the market. Public confidence in the relistandards of service and efficiency. [25] ability of clinical data and the information provided by the industry can be affected by how Having joined the World Trade Organization information is com- (WTO), China will lower tariffs on biopharmamunicated to the ceutical products and lift restrictions on foreign public, who provides distributors and retailers. As most biopharmathis information, and ceutical giants establish a marketing presence in when that informa- China, opportunities exist for direct distribution tion is provided. to reach consumers rapidly and effectively. [24] Given that the public is undecided about Here, contract sales organizations can help the goals of the inWestern biopharmaceutical companies better dustry as aiding and understand how to reach Chinese consumers. enabling medicine or Contract sales organizations retain full-time and simply putting profits part-time sales representatives and can target before patients, inmultiple audiences to increase a product's performation dissemina- ceived value and encourage sales. Through parttion during the development cycle is key to the nerships with PR and communication firms, success of products on the market. such contract sales organizations can not only provide sales support, but also medical educaThe right public relations (PR) service provider tion, public relations, event planning, and marcan assist a biopharmaceutical company in the keting for biopharmaceutical clients. These evaluation of potential partners given a compartners can bring varied experience, wider pany's objectives and can develop a strong me- reach, and better contact with the Chinese pubdia and public outreach campaign. A public rela- lic and Chinese medical community at a cost tions company with a strong reputation and effective price. broad experience in advocacy relationship development should be selected. References: These PR firms should maximize communication opportunities during clinical trials, patient recruitment, drug approval, and then drug launch. A climate of anticipation of a new drug should be fostered well in advance of the launch. Public 1) Dolan, Kerry A. The drug research war. Forbes. May 2004. 2) Lout, Sabine. Can China bring its own pipeline to the market? Nature Biotechnology. December 2004.

3) Hepeng, Jia. China beckons to clinical trial sponsors. Nature Biotechnology. July 2005. 4) AstraZeneca opens East Asia clinical research centre in Shanghai. http://astrazeneca.com. November 2002. 5) Novartis China ambitions. Business Week. November 2004. 6) Yan, Hu. Drug firms bolster R&D facilities. China Daily. November 2004. 7) Shanghai to get new Pfizer clinical trial centre. China Daily. November 2003. 8) Quintiles Laboratories Asia enhances services in China. PR Newswire. June 2005. 9) Levine, Daniel S. Building a bridge to biooutsourcing. San Francisco Times. November 2005. 10) Shanghai Genomics. www.shanghaigenomics.com. 11) Hundley, Kris. Chinas lure, and its challenge. St. Petersburg Times. September 2005. 12) Santini, Laura. Birth of a biotech industry: Western drug makers outsource R&D to scientists in Shanghai and Beijing. The Wall Street Journal. November 2004. 13) Gardner, Jack. Outsourcing in Drug Discovery 2nd Edition. A Kalorama Information Market Intelligence Report. January 2006. 14) Chervenak, Matthew. An emerging biotech giant. The China Business Review. May-June 2005. 15) Eli Lilly, Chinese partner set up research lab in Shanghai. Peoples Daily Online. October 2003. 16) Weihua, Chen. Roche sets up R&D centre in Shanghai. China Daily. January 2004. 17) Santini, Laura. Drug companies look to China for cheap R&D. The Wall Street Journal. November 2004. 18) Servier opens a drug production center for the Chinese market near Beijing. www.servier. Com. 19) Opportunities for European pharmaceutical and biotechnology companies in Indian and Chinese markets. Pharmaceutical News. March 2005. 20) Outsourcing-The pharmaceutical industrys strategy of choice for managing risk and rapid change. Business Briefings Ltd.: Pharma Outsourcing. INTERPHEX 2004. 21) Budd, Steven K. In or out: Outsourcing in todays biopharmaceutical industry. Business Briefings Ltd.: Pharma Outsourcing. January 2004. 22) WuXi PharmaTech added to prestigious Deloitte technology fast 500 Asia Pacific. WallStreetReporter. November 2004. 23) Regulatory submissions and global harmonization. CanBiotech BioMed Outsourcing Report. December 2003. 24) A sober look at China. Burrill & Company Presentation. China Access Forums. 2005. 25) Lipson, Roberta. Investing in Chinas hospital. The China Business Review. NovemberDecember 2004.

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India Unlocking the power of Pharmacovigilance Written by Dr. Anjali Shukla, Accure Labs Pvt. Ltd., India
No drug is completely safe. Drugs may contribute to 5-10% of all hospital admissions. Approximately 10-20% of all inpatients may suffer a serious adverse drug reaction (ADR) in hospital. Some ADRs lead to death, and also may contribute 5-10% of hospital costs. Therefore, the monitoring of the adverse effects of drugs becomes crucial for Good Medical Practice. Therefore, the pharmaceutical industry has entered a new era of Pharmacovigilance (PV). Pharmacovigilance provides comprehensive, risk-based, flexible solutions for the management of product safety, risk, and patient health during the entire lifecycle of a medicinal product. Pharmacovigilance = Phase I safety considerations + Safety strategy + Clinical Trial Safety + Risk Management Planning + Post marketing Surveillance + Signal Detection + Pharmacovigilance System Description

are occurring during the developmental and marketing periods of a drug, such as Suspected Unexpected Serious Adverse Reaction (SUSAR) in clinical development or other immediately reporting events in later stages of a drug's lifecycle.

training programme and regular interactions with the core product team of the pharmaceutical firm.

A series of high profile safety concerns, like withdrawal of certain drugs and the link between antidepressants and suicidal thoughts in children over the last 2 years, has made drug safety a major issue for governments, regulatory authorities and pharmaceutical companies. Hence, pharmaceutical companies are highly emphasizing pharmacovigilance in the wake of Even if a pharmaceutical company decides to product recalls, black box warnings, and litiga- develop their own drug safety group in house tion. over time, often there is need for external advice and possibly provisional coverage until the An inventory of legislative requirements has team gets up to speed. been enforced during the last few years in the ICH regions, naturally emphasizing the early What are the benefits of outsourcing PV? stages of a new drug's life cycle. Pharmacovigilance planning has by now become a substanThe most important benefits for an outsourcing tive issue for the long term success of any drug solution are the ease of managing certain peaks on the market, as malfunction of pharmacovigi- and new demands, and the reduced cost for dalance systems and communication channels tabase infrastructure and license cost for softmay lead to license retraction. Modern instant ware programs. These key benefits allow a firm communication channels rightly position manu- to keep the internal headcount low, as negligifacturers and marketers of medicinal drugs and ble corporate infrastructure is required. medical devices to report adverse drug reactions immediately to their competent authori- Usually the pharmacovigilance provider lacks ties. the specific product knowledge, and so an effective transfer of drug information data is necesPresent-day legislation requires from the liable sary. This can be facilitated when liaising with a manufacturer to inform concerned authorities structurally competent partner who is able to rapidly about serious Adverse Drug Reactions assimilate the necessary product knowledge (ADR) and other drug safety related events that easilyfor example, with a comprehensive

Until recently, the outsourcing of pharmacovigilance responsibilities and activities fell far behind the comfort zone of pharmaceutical comFailures in compliance with these requirements panies, as drug safety has traditionally been an could make the difference between keeping independent entity in those companies. your drug on the market and being forced to withdraw it. Therefore, early planning of your Moreover, this field opens to unfamiliar pharmacovigilance strategy is essential to the grounds of difficult legal ramifications requiring success of pharmaceutical products. high levels of inter disciplinary know-how. All the same, as legislation and regulatory bodies How is it difficult to operate PV in-house in are increasingly demanding more and more companies? functions and tools to detect and to respond to safety concerns with any drug, the benefits of Pharmacovigilance involves proficient individu- pharmacovigilance outsourcing become more als, from registered nurses to specialist doctors evident. who are performing relatively clerical functions, such as sifting through data and probing case The first significant pharmacovigilance outreports; but despite the clerical nature of the sourcing deal in the industry was the Bristolwork, it requires such a high level of compeMyers Squibb agreement with Accenture, in tency that a company must pay lavishly for it if which the work is being done in India. the work is done domestically. Who are the providers of PV outsourcing serThe requirements, and the stakes, of this kind of vices? work continue to rise. Each new drug is put under dissection, aggravated by negative media As pharmacovigilance is a relatively new funccoverage. The volume of events to be reviewed tion in terms of outsourcing, there are not a and addressed is going up at an phenomenal large number of providers presently able to do rate, and so is the cost. the work. In essence, there are two classes of providers capable of moving tactically: How do companies reduce the cost of PV? Contract Research Organizations (CROs): The era of outsourcing has enabled pharma Contract Research Business Process companies to hire third party vendors to perOrganizations (CROs) Outsourcing (BPO) form non-core processes at lower cost and These companies are These include those higher quality. Outsourcing of the pharmafocused on drug deorganizations based covigilance process provides a cost effective sovelopment and manentirely in India. lution, especially for small and medium sized aging trials through Examples are Cap pharmaceutical companies. This would avoid their various steps Gemini, Tata Consulthe high upfront investments and fixed overand processes, and so tancy Services, Infohead costs connected with setting up an in are well suited to sys, and Keane. house drug safety system. Above and beyond step up and address meeting the regulatory requirements, outsourcpharmacovigilance. ing would allow immediate participation in the These cover Quintiles, efficiencies provided through the looming imCovance, and MDS plementation of electronic SAE reporting. Pharma Services. These companies are focused on drug development and managing trials through their various steps and processes, and so are well suited to step up and address pharmacovigilance. These cover Quintiles, Covance, and MDS Pharma Services. Business Process Outsourcing (BPO): These include those organizations particularly based entirely in India. Examples are Cap Gemini, Tata Consultancy Services, Infosys, and Keane. Why is India considered the most obvious choice? India is well known for delivering high quality IT and IT-related services, and now India is becoming a hub for offshore outsourcing of pharmacovigilance activities and responsibilities. India-based operations have tremendous lan17

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guage skills, superb education, and a large number of doctors who are looking for higher-dollar work in a related field. Heres one more instance in which what is considered in India to be expensive, high-dollar work is, by U.S. standards, inexpensive.

support of pharmaceutical products worldwide. Why outsourcing PV is beneficial?

Outsourcing allows pharmaceutical companies to focus attention where While pharmacovigilance can be performed in offshore locations other it is needed most i.e. a proactive, not reactive approach that ensures than India, Indias stability makes it the most appealing locale, as proved drug performance and overall safety. They gain access to specific experby the Bristol-Myers Squibb deal. The nature of this work makes it a con- tise and place responsibility upon the supplier to meet the cost of items servative, risk-management function where extreme care and caution such as coding dictionaries. are essential. Regulatory Authorities are becoming more sophisticated by including SWOT ANALYSIS OF INDIA AS AN OUTSOURCING DESTINATION FOR electronic reporting, MedDRA coding and reporting and 21 CFR Part 11 PHARMACOVIGILANCE compliance. These pressures are felt more keenly in companies with low case volumes who are unable to justify a full time pharmacovigilance specialist. STRENGTHS (S) WEAKNESSES (W) 1. Large talent pool of life sciences graduates. 1. Cost advantage, as labour costs are 1/7th of those in US or Europe. 2. Rapidly developing wired communications. 3. Stable business environment. OPPORTUNITIES (O) 1. Vendors can take advantage of the influx of talent through reverse brain-drain, i.e. Indian graduates who have worked abroad and are now returning in large numbers. 2. Pharmacovigilance is a rapidly evolving field. 1. Comparatively new concept. 2. Imprecise documentation system. 3. Non-adherence to time schedules and secrecy modalities. Software licenses and system operation can be expensive: System maintenance, management, and validation are expensive noncore activities for a pharmacovigilance department. IT support staff in many small and medium-sized companies are either unable or under significant pressure to provide complete service to their users. All said and done, let the outsourced provider bear the cost of the initial license, software upgrades, system management, and the management of whole of the product safety reporting requirements. India poised to become destination of choice for outsourcing pharmacovigilance Currently, India is poised to become the destination of choice for the outsourcing activities along the entire value chain of drug safety. The outsourcing of pharmacovigilance is a trend that is clearly gaining momentum, as pharmaceutical companies reach deeper into their business processes to reduce costs and enhance performance. As BPO organizations make every effort in these types of deals, and CROs endeavour to compete with BPOs on equal footing, both types of provider organizations will enhance their operations with the right people.

THREATS (T) 1. Expected load. 2. Level of capabilities. 3. Organization structure. 4. Key decision-making processes. 5. Little understanding of the intricacies of global regulatory requirements.

What should a company assess when selecting a service provider? In making a selection of a service provider, more emphasis must be placed on the levels of training each provides to its people, scalability, and the comparative rates of turnover. For these reasons, pharmaceutical companies are making much more use of outside resources as they craft agreements with service providers, build their governance organizations, and manage the agreement over time. Outside advisors with expertise in the market, the nature of the work, and the legal aspects of the relationships are being used extensively both by pharmaceutical organizations and service providers. Some companies first achieve a comfort level in outsourcing and then deal directly with their existing providers or additional providers to expand agreements. However, pharmaceutical companies, even those who outsource heavily in other areas, still feel they are walking on new ground when it comes to pharmacovigilance outsourcing. Why companies are afraid of hiring servicing providers or outsourcing PV? This is due to fear of the legal ramifications if the outsourcing partner 'gets it wrong', and a reluctance to be the first to adopt the outsourcing model. It was also a reflection of the limited choice of both service providers and scope of services available at the time. But today's marketplace offers a wide range of pharmacovigilance services provided by both large and small companies. These may form part of a suite of services offered by CROs, be the core business of specialist companies, or form part of the expertise available through the growing network of freelance individuals, many of whom are former pharmaceutical company employees. This growth in the services available for pharmacovigilance outsourcing has been driven by the annual increase in the volume of data generated both in terms of number of individual adverse event case reports and contributing organizations. This has prompted both the regulatory authorities and the pharmaceutical industry to seek more efficient methods of processing product adverse event data with the goal of both improving public safety and reducing the cost overhead for marketing and

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Asias Largest Pharmaceutical/Biotechnology Event held in Japan!

Bio-Imaging Zone This area, consisting of companies dealing with microscopes, cameras, image processing systems/software, and microscope peripheral equipments, especially attracted attention. Companies such as Olympus Corp. brought in new products including a system for live cell imagines in incubator, which allows you to check and analyze the cell image. Welcoming its 7th year, INTL BIO FORUM & BIO EXPO JAPAN holds an established position as the Asias largest bio event. With the newly launched Genetic Testing & Diagnostics 2008, which is the one and only exhibition specialized in genetic testing and diagnostics in Japan, the show attracted specialists and professionals from home and abroad more than ever. INTL BIO FORUM & BIO EXPO JAPAN consisted not only of specific zone layout, in addition, BIO VENTURE FORUM, ACADEMIC FORUM, and PHARMA PATNERING were held concurrently within the exhibition. Overall, this show is not only about business meetings to discuss about purchasing and selling the products, but also an indispensible place to announce the latest achievement, alliance/partnering for pharmaceutical companies and ventures, and for networking. The following are some of the zones and forums which especially attracted attention.

On July 2 (Wed) 4 (Fri), Asias largest show in the Pharmaceutical/ Biotechnology industry, 21st INTERPHEX JAPAN, 7th INTL BIO FORUM & BIO EXPO JAPAN, and 2nd INTL PHARMACEUTICAL INGREDIENTS EXPO & CONFERENCE was grandly held with the record number of 1334 exhibitors and 55,202 visitors. At the show venue, many scenes were witnessed where exhibitors and visitors did concrete business meetings during the show. The three exhibitions are a must visit for professionals within the pharmaceutical, bio, and cosmetic manufacturers industry, as this is the one and only event throughout Japan where you can see the upstream to downstream of this industry. INTERPHEX JAPAN is an international exhibition and conference for pharmaceutical, cosmetic and detergent R&D and manufacturing technology. The exhibition consists of various zones as the following; Sterilizing Equipment & Clean Room Zone, Plant Engineering Zone, Supplies/ Transfer Zones, Materials Process Zone, Process Inspection/Testing Equipment Zone, and Laboratory Measurement/Analysis Equipment Zone.

Genetic Testing & Diagnostics 2008 NEW! The development of genetic testing technology is striking, as the application of this business is rapidly growing with its realization of low-cost and the improvement of inspection accuracy efficiency. Under these circumstances, Genetic Testing & Diagnostics 2008 was newly launched this year as the Japans one and only event. From disorder such as cancer, to beauty business such as diet, the expansion of the business is anticipated for the genetic testing and diagnostics technology. PHARMA PARTNERING Due to the high demand of the alliance/partnering of pharmaceutical companies, venture companies, and venture capitals, the partnering forum was held concurrently within BIO EXPO JAPAN. Some of the leading companies, such as Eli Lilly and Company and Merck & Co., Inc., Whitehouse Station, N.J., U.S.A/Banyu Pharmaceutical Co., Ltd. delivered presentations to visitors interested in alliance/partnering. Various meetings were held where pharmaceutical companies and visitors discussed the possibilities of partnering.

In 2008, Factory Facility & Equipment Zone and Bioprocess/Biopharma Manufacturing Technology Zone were newly established inside INTERPHEX JAPAN, along with Pharma RFID/Barcode Fair, Pharma & Cosmetic Packaging/ Container Fair which was held within Pharma Pack 2008. Growing Demand of API 2008

Due to the amendment of the Pharmaceutical Lawin enforcement next April, pharmaceutical chemists will no longer need to sell drugs. Instead, second-class drug dealings will take place. From this change, places such RFID/Barcode Fair was newly launched inside Pharma Pack 2008, due to as convenience stores, drug stores, and super markets will be able to the high demand of RFID (Radio Frequency Identification), which is a sys- handle products with only second-class drug dealers present. Therefore, tem for controlling products. One of the leading printing companies, Dai the needs of pharmaceutical ingredients are emerging, as more selling Nippon Printing Co., Ltd. introduced a product specialized for the pharpoints are in existence. Under these circumstances, API 2008 is actively maceutical industry market. in application, with visitors in search of suppliers and for serious business meetings held within the exhibition area. Pharma IT Solutions Expo Highlights of the Exhibitors This expo gathers all IT solutions specialized for pharmaceutical industries. Companies gathers products concerning IT solutions, such as moA great deal of new companies exhibited this year for the first time, such bile and new services for medical representatives. Companies such as as Roche Diagnostics K.K, Nippon-Soda Co., Ltd, Asahi Kasei Fibers CorpoNomura Research Institute Ltd., Matsushita Electric Works Information ration, Fuso Chemical Co., Ltd, Yamaha Motor Co., Ltd. and more. Systems Co., Ltd, and TIS INC. gathered in this area. In addition, many companies brought in new products, which are striking since new products in the pharmaceutical industry companies do not apPharma Sourcing pear so often. This proves the market is in high demands for the suppliers; hence the exhibition will be in greater needs in the coming future. This area is the largest event in Japan specialized in outsourcing of pharmaceutical manufacturing. Large companies such as Nipro Corp., Fujiyakuhin Co., Ltd Toyama Plant, and Taiyo Pharmaceutical Industry Co., Ltd. gathered in this area. From overseas, companies such as Patheon Inc., a company based in Canada, also exhibited here. RFID/Barcode Fair NEW!

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Conferences and Seminars

management with insight into quality and safety.

One of the other events attracting attention every year is the conference Investing in Innovation: Biocons Focus on Novel Biopharmaceuticals held inside the conference hall next to the exhibition. This year, some of Chief Operating Officer, Biocon Ltd. the worlds top leaders came to speak within the 3 days, with 9,960 atDr. Arun Chandavarkar tendees gathering to catch up on the latest trends, cutting-edge technologies, and companies strategies. Some of the seminars are described below. Abstract: Biocon entered the bio-pharmaceutical space in 1999 with microbial fermentation derived generic APIs. It Future Prospects of the Japanese Pharmaceutical Industry and Tips for soon expanded its capabilities to large volume recombinant Further Development proteins like human insulin. Biocon has partnered with many early stage discovery companies to develop novel biological products in Challenges Associated with Globalization of a Japanese Pharma Company diabetes, oncology, and immunology. This differentiated approach at-Globalization of the Value Chain Functionstempts to leverage the scientific and engineering talent base in India to develop best-in-class products for global markets while minimizing the President & CEO, Daiichi Sankyo Co., Ltd. financial strain on the healthcare delivery system. Mr. Takashi Shoda The Challenges of Leadership in the Cycle of Innovation and Competition Abstract: Pharmaceutical corporations engaging in drug-discovery need Advisor to the Board of Directors (Former President & CEO), strategic management and strengthening of global value Teva Pharmaceutical industries Ltd./Chairman, Given Imaging, Ltd chain from R&D through sales for successful global management. The speaker offered real life examples of his company Abstract: Has the pharmaceutical industry begun to fall short and discussed topics such as the pharmaceutical process on its promise to improve quality of life and make drugs technology that bridges R&D and manufacturing. more widely accessible? What role does generics play in the cycle of innovation and competition? Business Expansion Strategy of NOVARTIS in Japan and the World Market President & CEO, Novartis Pharma K.K. Now and Future of Process Development Mr. Hiroyuki Mitani -Key Technologies Underlying Pharmaceutical DevelopmentInnovation Leaders who Connect up Drug Discovery with Drug ProducAbstract: Pharmaceutical companies are asked for a drastic strategic shift tion in response to the rapid change in the global pharmaceutical industry. -Science for Actualization into Business & Process Chemistry for MediWhile the Japanese ethical drug market is experiencing drug cine Productionprice revisions and diffusion of generics, the managements Senior Advisor, Discovery & Development Research Headquarters of Jaare now facing a decision about their future strategies for pan, Eisai Co., Ltd, Mr. Shigeru Soda business expansion. The speech provided an outlook of the current world and JaAbstract: The pharmaceutical industry holds growth potenpan market, and presented a global strategy for Novartis tial as a core industry in many countries because it contribPharma. utes to the health and welfare of humanity. Pharmaceutical process chemistry, positioned between drug discovery and production, is a business actualization science, where poThe Emerging Era of Genomic/Cell Medication and Innovative Pharmatential drug compounds are translated into pharmaceutical ceutical Development products. In this lecture, the challenges and possibilities in pharmaceuti-Convergence and Co-development of the US, Europe and Asiacal process chemistry were illustrated as the hub technology that links drug discovery and production. Systems Science will Transform Both Biology and Medicine President, Institute for Systems Biology, Dr. Leroy Hood Hopes for API Manufacturer from the Generics Viewpoints Director, Drug Development Labs., OHARA Pharmaceutical Co., Ltd. Dr. Koji Kagara Abstract: A systems approach to biology and disease is transforming how we understand the deep mechanism of biology Abstract: With the national policy incentive, the generic inand medicine. These systems approaches coupled with dustry has moved closer to the center stage of the pharmaemerging measurement and visualization technologies and ceutical industry. A majority of generic companies used to new computational and mathematical tools will propel medioutsource bulk drug from bulk manufacturers. However, cine from its current reactive state to one that is predictive, since the revision of the Pharmaceutical Law, generic manupersonalized, preventive and participatory. facturers have been obligated to meet additional requirements. The speaker discussed his expectations toward bulk drug manufacturers from Perspectives of Personalized Medicine his perspective as a generic drug manufacturer. President, Baylor Research Institute Dr. Michael Ramsay For full information on the seminar, please visit the below website. http://www.interphex.jp/ipj/english/conference2008/ http://www.bio-expo.jp/bio/english/conference2008/ Abstract: In the next 10 years, the practice of medicine will change more than it has in the last 50 years. Outstanding biomedical discoveries resulting from the study of the immune system and the mapping of the human genome together with advances in information technology, are converging to create the vision of personalized health care. Enhanced screening and profiling technology will allow individuals to make choices about their health
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Taiwans Biotechnology Plan By CanBiotech

in Asia. To establish Taiwan as a worldwide subtropical floriculture center. To establish the most vibrant biotech-focused venture capital industry in Asia. 1

In addition, the Promotion Plan set the following growth goals: US$4.5 billion in new biotech/pharmaceutical industry investment by 2010. By 2010 at least 18 international-standard biotech companies are to be established in Taiwan, being either fully locally owned, or mixed local-overseas ownership joint ventures or collaborations. 1 Supporting Programs and Infrastructure Taiwans objective is to achieve the same kind of success and global standing in biotechnology as it has in the development and production of Life-science focused national development programs initiated by the electronic, information technology, computer, and semiconductor prod- government include: ucts.1
The National Research Program for Genomic Medicine, Frost & Sullivan indicates that the industry generated revenue worth The National Science and Technology Program for Agricultural BioUS$947 million in 2003. This is expected to reach US$1.9 billion in 2010. 2 technology and, According to a survey conducted by the Taiwan Institute of Economic The National Science and Technology Program for Biotechnology Research, Taiwan currently has around 6,100 people involved in biotech and Pharmaceuticals. R&D and an average of 1,800 students are expected to graduate annually with biotech-related training. 2 Of these, the National Research Program for Genomic Medicine is the most recent, and is a major part of Taiwan's goal to become the Asian Taiwans biotech industry currently consists of a number of mediumcenter for genomic research. sized companies, biotech start-ups, and contract research organizations (CROs). Multinational pharmaceutical firms and CROs have been explor- The National Science and Technology Program for Agricultural Bioteching Asian sites for clinical studies. Hence, the existence of a wellnology is devoted to research in seven major fields: floriculture and ornadeveloped scientific and medical infrastructure in Taiwan has promoted mental plants, plant protection, aquaculture, livestock vaccines, plant the growth of a number of Taiwanese CROs. 3 genetic improvement and modification, environmental protection, and

Taiwans strengths are due to a combination of existing conditions and deliberate planning on the part of the government and include:

medicinal plants. 1

The National Science and Technology Program for Biotechnology and Pharmaceuticals focuses on the development of new drugs, herbal mediExisting expertise in high technology, easily transferred to biotech- cine, and on biochip technologies and analysis methodologies. 1 nology; Strategic location; close to China and straddling Northeast and The government has committed to spending $4.48 billion on biotechnolSoutheast Asia; ogy by 2010 and has created an infrastructure consisting of three comStrong legal framework; ponents 3: A highly educated workforce; World-class research facilities; Basic Research: Academia Sinica is a complex of government-funded reAbundant capital and Asias most vibrant venture capital industry; search institutes of which seven are in the biological sciences. Herbal medicine knowledge and experience. Applied Research and Technology Transfer: Three major technology development institutes (TDI) have been created to commercialize scientific discoveries and transfer technology to local companies: The Development Center for Biotechnology, The Pharmaceutical Industry Technology and Development Center and, The Industrial Technology Research Institute.

Interestingly, many manufacturers of Western pharmaceuticals in Taiwan are also producing Chinese medicinal ingredients and formulations. Similarly, many new biotech start-ups are conducting research on the modern medical uses of traditional Chinese herbs and medicines. 1 Government Policy

In 2002, the government allocated US$495 million to bioscience research Science Parks: Creation of biotech industrial parks, including the Hsinchu and development, approximately 29% of the total national science Biomedical Park and the Agricultural Biotech Park. 3 budget and an increase of 46% over the previous years allocation of US$339 million. 1 The government in Taiwan is further keen on establishing biotech parks with unique features. Our vision is to create a National Biotechnology The funds were allocated as follows: 30.4% to the R&D budget of the Park with a total investment up to $900 million in the building of the National Science Council, 20.4% to the Department of Health, 16.1% to park. The Ministry of National Defense will make 25 hectares of its propthe Ministry of Economic Affairs, 21.6% to the Council of Agriculture, and erty at the Military 202 Armament Factory in Nankang available for the 11.5% to Academia Sinica. 1 establishment of a biotech science park, stated Mr Chen Shui-bian, President of Taiwan at the BioBusiness Asia 2007 summit in Taipei. 4 Industry, institutions, and government bodies all follow developmental guidelines as set forth in the Promotion Plan for the Biotechnology InThe President further stated that, The National Science Council will industry. This document is a road map defining national industry goals and vest $400 million to plan the layout for the parks biomedical compound, clearly detailing the corresponding action steps required to get there. and will be in charge of the construction of the parks basic infrastructure In compiling the Promotion Plan, Taiwans strengths and capabilities were examined. Four major goals are established in this document:

To establish Taiwan as the center for genomic research and development in Asia. To establish Taiwan as the leading location for human clinical trials The President also pointed that it was planning on building two more

and education center. At the same time, the Academia Sinica, on its part, will invest around $500 million to build the parks research and development center and clinical laboratories, and introduce research on new pharmaceuticals and special biotech disciplines, such as translational medicine and genomic medicine. 4

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communities of leading biotech enterprises. One community is to be located in the Hsinchu Biomedical Science Parkwith the objective of attracting major biotech companies, vaccine manufacturers, pharmaceutical companies, electronic and telecommunications-based medical equipment manufacturers, and animal laboratories. The other community will be located in the Kaohsiung Science Park, which is part of the Southern Taiwan Science Parkwith the objective of attracting manufacturers of dental and orthopedic equipment, scalpels, and microelectromechanical systems. 4 Opportunities and Challenges With its large pool of bioscientists and high-tech talent, an impressive medical research base including world-class research institutions, its entrepreneurial culture, and the commitment of the government to the industry, opportunities are abound in Taiwan. Furthermore, its proximity to mainland China, the language, ethnic, and business connections between the two countries, should encourage investors to include Taiwan as part of their strategy to entering China. In its effort to carve out a niche, Taiwan is also emphasising a local approach, by pairing biotechnology with traditional Chinese medicine or by giving biomedical research priority to regionally significant diseases. Therefore, on its own, Taiwan is a sound investment location. With ascension to the World Trade Organization (WTO) in 2002, Taiwan has gained increased exposure to international practices such as the WTO dispute resolution procedures. However, one critical problem for Taiwan is the increasing need for trained personnel. Educated Chinese living abroad link the country's researchers with colleagues in the US and mainland China. This community has provided an important network for information exchange, research collaboration, and business opportunities in Taiwan. As a consequence of the increased demand for technology transfer, there is specifically a focus on the recruitment of top-level managers and

scientists, the import of innovative research equipment, and development of partnerships with biotechnology advanced countries. However, several concerns regarding the management of personnel need to be addressed before a wide-scale recruitment effort is undertaken. References: 1) www.biotecheast.com, 2005. 2) www.biotech.frost.com, 2005. 3) Yuan, Robert. Asian Biotech: Taiwan Seeks Successful Business Models. Genetic Engineering and Biotechnology News. April 1 2006. 4) Kulkarni, Narayan. Taiwan to develop $900 mn biotech park. BioSpectrum. September 1 2007.

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REGULATORY NEWS BY BIOPLAN ASSOCIATES

FDA announces permanent office in Beijing -US FDA announced plans to open a 13-member branch office in the US Embassy in Beijing. This will be the first foreign-located branch for the agency. The main priority for the new office will be to prevent China-related safety problems before they happen or become widespread. Source: US FDA site, Sept. 2008 New responsibilities and structure for SFDA -The Chinese government released a state council document granting new responsibilities and an internal structure for the State Food and Drug Administration (SFDA). The SFDA will now be a vice-ministry level agency governed by the Ministry of Health. Changes include state institutions now controlling technical evaluation of drugs and medical devices. New responsibilities include formulating policies for safety regulations of drugs and medical devices, and developing and implementing quality control guidelines on R&D, production, distribution and applications of drugs and medical devices. Source: China SFDA website, Sept. 2008

CANADA AND INDIA ANNOUNCE NEW JOINT SCIENCE AND TECHNOLOGY INITIATIVES
The Honourable David Emerson, Minister of Foreign Affairs and International Trade and Minister for the Pacific Gateway and the Vancouver-Whistler Olympics, and the Honourable Kapil Sibal, Indias Union Minister of Science & Technology and Earth Sciences, recently announced the launch of 10 new Canada-India science and technology (S&T) joint initiatives worth $17 million. Our government understands the importance of establishing international research partners and the critical role science and technology play in the new economy, said Minister Emerson. These joint projects will enhance the collaboration between our scientists and commercialize their discoveries. Eight of the initiatives are joint research and development projects, and two are partnership-development activities. The Canadian portion of both projects and partnerships is funded through the International Science and Technology Partnerships Program and is delivered by International Science and Technology Partnerships Canada (ISTPCanada)an arms-length organization. International Science and Technology Partnerships Canadas mission is to build productive partnerships and todays announcement is the result of close collaboration between officials in Canada and India, added Henri Rothschild, President and Chief Executive Officer of ISTPCanada. We are grateful that both governments have made science and technology a priority, and we know that these agreements will benefit business-to-business relations and, ultimately, overall economic, trade, and political relations. These projects form the basis of the networking opportunities that lead to strong research linkages with high potential for commercial success. The joint activities will lead to an increase of commercially viable research and development initiatives, and will assist in the organization of scientific seminars, conferences, and workshops. Canada and India S&T relations have made good progress at the federal, provincial, academic and private-sector levels since the signing of an overarching agreement on science and technology cooperation in November 2005. In addition to India, Canada has S&T agreements with five other countries and the European Union. The S&T agreement with India is now one of the most active partnerships between the two countries. Areas of cooperation under the Agreement include biotechnology, health research, medical devices, nanoscience and nanomedicine, sustainable and alternate energy and environmental technologies, information and communications technology, and earth sciences and disaster management. In March 2008, aerospace, biopharmaceuticals, photonics and synchrotron science were added to the list. For further information contact: Lynn Meahan Press Secretary Office of the Minister of Foreign Affairs and International Trade and Minister for the Pacific Gateway and the Vancouver-Whistler Olympics 613-992-7332 Trade Media Relations Office Foreign Affairs and International Trade Canada 613-996-2000 www.international.gc.ca/index.aspx

BIOBUSINESS NEWS BY BIOPLAN ASSOCIATES

Merck KGaA to increase investments in pharma sector in China -Merck KGaA CEO Dr. Marl-Ludwig Kley announced plans for Merck KGaA to increase investments in the pharmaceutical sector in China. The company hopes that Merck Serono, the pharma arm of Merck KGaA, will become one of the leading 15 pharma companies in China by 2012. In order to be cost effective, the company plans on adjusting its pricing of chemical and life science products. Currently, more than half of Merck KGaA's chemical business revenues come from Asia, including China, Taiwan, Japan, and South Korea. Merck's oncology drug Erbitux has exceeded over 70% growth in Chinaone of the ten largest global markets of the drug. Source: Pharma China Sept. 9, 2008 Chinese govt. to transform pharma industry into super power by 2020 The Chinese government released a grant application guide that includes goals for major drug innovations for the 11th Five Year Plan period (20062010.) New goals set for the local pharma industry include development of 30 new innovative drugs targeting ten disease areas including diabetes, oncology, and the cardiovascular system. Plan goals also include establishing up to ten new national drug R&D comprehensive platforms and up to 20 new drug R&D incubators. The government proposed changes for the largely generic pharma industry will occur in three phases to be completed by 2020. Source: Various Sources, Sept. 9, 2008

CENTRE FOR PROTEOMIC AND GENOMIC RESEARCH AND CAPITALBIO CORPORATION TO COLLABORATE IN THE FIELD OF GENOMIC MEDICINE AND BIOMARKER DISCOVERY
The Centre for Proteomic & Genomic Research (CPGR), a South African Government sponsored, not for profit, core technology facility in Cape Town, South Africa, and CapitalBio (CB), a leading biotech company in Beijing, China, announce that they are entering into a mutual agreement in the field of Genomic Medicine and Biomarker Discovery. Under the agreement, CB will grant CPGR access to its complete microarray assay platform, including biochip readers, together with a range of proprietary DNA microarrays. In return, CPGR will form a reference centre for CB microarray applications in Southern Africa, including custom-designed applications for tuberculosis (TB) strain typing and drug resistance testing. The association between CapitalBio and the CPGR represents a major step forward in our efforts to bring better diagnostics to the emerging and developing lands in Africa said Professor Jing Cheng, CEO of CapitalBio. CapitalBio has worked closely with the National Tuberculosis Reference Laboratory of the China Center for Disease Control and Prevention to provide assays of international relevance, and we see enormous potential for the worldwide use of this technology to bring effective diagnostics to TB sufferers. For further information contact: Dr. Reinhard Hiller Managing Director reinhard.hiller@cpgr.org.za www.cpgr.org.za

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CHINA TRIALS 2008: Global Clinical Development Summit Crowne Plaza Century Park- Shanghai, China 09/11/2008 - 11/11/2008 http://www.chinatrialsevent.com/
CHINA TRIALS 2008 is the new annual meeting place to network with hundreds of global emerging biotech and big pharma companies and discuss how integrating China into your global clinical development strategy can help bring innovative new therapies to market faster and more costeffectively. And with a speaking faculty of over 50 clinical experts, it will by far be the most comprehensive event on the topic in 2008.

bioLOGIC India 2008 Marriott Hyderabad, India 17/11/2008 - 20/11/2008 http://www.terrapinn.com/2008/bioindia/

Specially tailored to meet the explicit needs of both Indian and International biopharmaceutical professionals, bioLOGIC India 2008 brings together a mixed portfolio of biopharmaceutical business leaders, manufacturers, CMOs, service, and technology providers from across the globe to discuss partnership opportunities and best practices in biologics development and manufacturing.

Contact Information: Lychee Group Jon E. Liong jon.liong@lycheegroup.com

Contact Information: Haslinda Haniffa Tel: (65) 6322 2702 Fax: (65) 6223 3554 haslinda.haniffa@terrapinn.com

2nd Annual Vaccines Asia 2008 Beijing, China 10/11/2008 - 13/11/2008 http://www.ibc-asia.com/vaccines
IBCs 2nd Annual Vaccine Asia 2008 will enable you to pinpoint and identify opportunities and market needs, explore Asian diseases, and get updates on latest breakthroughs in vaccine R&Ds. The worlds leading organizations will share with you the latest advancements in viral studies and their strategic approaches to win the race to bring in the next blockbuster vaccine to market.

DIA's 3rd Annual Conference on Drug Discovery and Clinical Development in India Mumbai, India 07/12/2008 - 10/12/2008 http://www.diahome.org/
This conference will continue to serve as an international and neutral forum to address current solid scientific research in India pertaining to global development of drugs and biologics. Global participation from leading thought leaders and experts across the pharmaceutical, academia and regulatory agencies will convene to present drug discovery, global clinical research, and scientific working groups. Keynote lectures, workshops, and parallel discussion will highlight the conference.

Contact Information: Email: register@ibcasia.com.sg Tel: +65 6514 3180 Fax: +65 6733 5087

Contact Information: Leena Amanna Leena.Amanna@diaindia.org

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