Collaborating with Academia

From sparring with shadows to waltzing with Wanda

Pharma R&D World Asia Congress

Summary
Academia has always been a major source of pharmaceutical innovations With new changes in the research environment, this dependence is set to increase Support for academic R&D in OECD countries is decelerating India/China are ramping up support for academic R&D; this is coupled to rapid expansion in GDP The academic sector in emerging nations is poised to play an important role as a source of innovation The translational gap is still to be effectively bridged: Examples of innovative Indian models being created within the academic/GOI sector to bridge this gap How can we use the clean stage for a waltz rather than a sparring session: Some examples from Merck What more could Pharma do?

Industry R&D owes its origins to academia

Alfred Newton Richards, 1876 1966 Prof of Pharmacology Univ of Pennsylvania And Consultant and Board Member, Merck and Co., Inc.

Support for academic R&D in the US is decelerating Funding by source: 2003-2007

Dorsey, E. R. et al. JAMA 2010;303:137-143

Support for academic R&D in the US is decelerating

NIH budget appropriation (1960-2010)

35,000,000 30,000,000 25,000,000 20,000,000 15,000,000 10,000,000 5,000,000 0 1950

1960

1970

1980

1990

2000

2010

2020

Source: NIH

Growth of articles published in peer-reviewed journals

% CHANGE

China is catching up

Why drug discovery in academia

Increasing specialization of knowledge and research skills in life science Specialists have a natural home in academia Synergy/complementarity between applied and basic aspects Cost of exploratory science

Who will mind the translational gap?

quality

Educational governance

quantity DATA GAP Academia

Regulatory governance

Industry

Innovative Organization Structures Examples from India

OSDD Open Source Drug Discovery CCAMP Center for Advanced Molecular Platforms THSTI Translational Health Sciences and Technology Institute ILS Institute for Life Sciences

 Sponsored by CSIR/GOI (USD 38 million) Collaborative platform for Indian scientists and their global counterparts for solving problems related to neglected tropical diseases Aggregation of biological and genetic information to hasten drug discovery

MECHANICS

The sub-division of activities into work packages enables a divide and conquer approach

SHARING REWARDS

PEER REVIEW BASED MICROATTRIBUTION USING WEIGHTED CREDITS TIERED MEMBERSHIP MONETARY + NONMONETARY REWARDS

Translational Health Sciences and Technology Institute Faridabad, India

Translational research focus Collaboration with Harvard-MIT Centers: Vaccine and infectious disease Clinical Development Services Pediatric biology Biodesign

A Component of the Bangalore Bio-Cluster

Invention

Innovation

Technology Platforms

Confocal & Fluorescence Microscopy (Services and Training)

Transgenic Fly Facility (Services)

Flow Cytometry (Services and Training)

High Throughput Screening (Services)

Mass Spectrometry and Proteomics (Services)

High-end Genomics (Next Generation Sequencing) Intellectual Property Management Office (IPMO) and Technology Transfer Office

Activities

Develop and establish new high-end technologies Cater scientific technologies and expertise Provide technology education/training Promote entrepreneurship with Innovation Accelerator

Public-Private Partnership
PUBLIC PRIVATE

Govt. of Andhra Pradesh

University of Hyderabad

MISSION and OBJECTIVES

To find solutions to improve human health through the application of cutting edge research by integrating various disciplines of Sciences (Life, Information, Chemical & Physical) Translational Research Bridge the gap between industry and academic centres Aligned to the needs of Pharma / Biotech industry

Merck is Dedicated to Academic Partnerships

Merck scientists welcome the opportunity to collaborate with our academic colleagues to advance the state of the art in biomedical research. Together with our academic partners, we are exploring novel research models to advance cutting-edge science into new medicines that address important unmet medical needs.

For Academic Collaborations, Mercks Approach is Driven by Strategy

Defining goals, delivering against a work plan, and respecting intellectual property are the keys to a successful collaboration. Well defined goals are critical Objective to produce new knowledge advancing research/product development May be strategic (breakthrough science) or tactical (an accepted approach, but elegantly executed) Funding is based on the work plan, not for general lab support Milestones / Renewal based on delivering on objectives

Providing Flexibility for our Partners

Intellectual property is important, but not the whole story Generation of actionable knowledge is the key objective License to pre-existing IP sometimes, but not always, needed Merck requires, minimally, an exclusive option period to license new IP arising from Sponsored Research Merck is mindful of the universitys mission and obligations We will not try to force-fit a structure that conflicts with university policy Need to build additional vehicles for exceptional opportunities

Moffitt Collaboration: Personalized Medicine to Treat Cancer (2006)

Collaboration to link molecular technology and clinical data to enhance the ability to diagnose and treat patients, and to discover and develop new targeted therapies (Dec. 2006) Identify the right drug for the right patient - individualize treatment for patients with various types of cancer Partnership between patients, community providers, industry and government to personalize and improve cancer care

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Merck/Moffitt Collaboration: Direct patient selection from database matching molecular signatures to clinical trials
Profiles stored at hospital

Clinical trial Portfolio

Trial sig A

Disease recurrence and trial eligibility Validation of molecular hypotheses Patient selection on available profiling data

Trial sig B Trial sig C

Dana-Farber and Merck Create Team Approach to Cancer Drug Treatment (2008)
To improve the success rate of investigational cancer drugs entering clinical trials, the Belfer Institute for Applied Cancer Science (BIACS) of the Dana-Farber Cancer Institute and Merck and Co., Inc., have established a collaboration to identify promising drug targets, and develop therapeutic candidates to reach those targets. The BIACS will investigate drug targets using integrative and crossspecies genomic analysis and stringent multi-level functional and clinicopathological validation testing. The BIACS will work together with Merck to shepherd the drug assay development of lead compound discovery and then work together to test these drugs in BIACS's highly sophisticated model systems that closely replicate human disease.

Driving Innovation through Partnering

Mercks agreement with Harvard University on new treatments for osteoporosis Example of a new breed of industry-academia alliances with close connections between the teams Jointly design project proposals, jointly do research, patent and publish results together Translational Medicine: Accelerate the move from basic biology drug targets medicines

Harvard/Merck Collaboration
Merck is using their enormous resources to help us assemble huge expression arrays and integrate the signaling pathways in samples we give them. The two lead Harvard scientists on the project interact with Merck almost daily. The team gets together once a month, and all participants have access to a virtual meeting room where they can post data. We feel like it really is a research collaboration.
Dr. Laurie H. Glimcher Professor, Harvard Medical School Professor of Immunology, Harvard School of Public Health
Chemical & Engineering News (Nov. 17, 2008)

Abacus Project -- Imperial College London

Abacus is a unique forum for exchange of ideas between MRL and selected Imperial College faculty Goals are to build an open exchange of ideas and people on a foundation of trust and collaboration resulting in inspired innovative thinking that ultimately translates into the design of novel healthcare solutions

Develop novel approaches that improve patient care/outcomes and are valued in the market place Active exchange of individuals who benefit from the exposure to the respective environments.

Abacus Project -- Imperial College London

ABACUS Develop novel approaches that improve patient care/outcomes and are valued in the market place Active exchange of individuals who benefit from the exposure to the respective environments. IMPERIAL COLLEGE Catalyze and facilitate interactions between diverse departments in the area of systems biology Potential for financial reward through commercial viability Publications Educational exchange opportunities selected faculty and students Leverage additional resources from e.g government/charity MERCK Participation in a new model of academic interactions External linkages Access to and collaboration with experts outside of Merck core competencies Access to unique knowledge not targeted to a product: seed of blue skies innovation New ideas Sabbatical opportunities Publications
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Medarex and Mass Biologic Labs: Agreement with Merck for Investigational Antibody for C. difficile Infection (April 09)
Exclusive worldwide licensing agreement for CDA-1 and CDB-1, an investigational fully human monoclonal antibody combination developed to target and neutralize Clostridium difficile toxins A and B, for the treatment of C. difficile infection (CDI). CDA-1 and CDB-1 were co-developed by Medarex and MBL. Merck gains worldwide rights to develop and commercialize CDA-1 and CDB-1. Top-line results from a Phase II multicenter, randomized, double-blind, placebo-controlled trial evaluating CDA-1/CDB-1 provided evidence of a statistically significant reduction in the rate of recurrence of CDI compared with placebo. This agreement underscores Mercks ongoing commitment to infectious disease research and the licensing of promising candidates with the potential to address serious unmet medical needs.

UTSA, Health Science Center: Collaboration with Merck to Develop Chlamydia Vaccine (April 09)
The University of Texas at San Antonio (UTSA) and the University of Health Science Center at San Antonio (Health Science Center) will work with Merck on a vaccine for chlamydia, targeting the common sexually transmitted bacterium Chlamydia trachomatis. Merck will fund research at UTSA and the Health Science Center and collaborate closely with their team of researchers who have demonstrated that, in animal models of genital chlamydial infection, a vaccine composed of a select group of recombinant C. trachomatis antigens can successfully accelerate bacterial clearance, and importantly, preserve female reproductive function. The partnership is an exciting development in the fight against infectious disease and aligns with Mercks commitment to R&D in areas of unmet medical need.

What Pharma can do (better) in Emerging Markets academic sector engagements

Relationship building is still important Customize relationships to unique needs while taking advantage of unique situations Help catalyze the development of novel organization structures (do not wait for things to happen!) Be sensitive/respectful towards the primary mission of emerging market institutions