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PLENARY KEYNOTE
& PANEL:
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Partnering
and Investing Strategies by Big Pharma and Large Biotech Companies
9:00 –
9:40 Strategic Planning for China and India Entry: Perspectives from a
Large Biotechnology Company
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Whaijen
Soo, M.D., Ph.D., Senior Vice President, Medical Research, Biogen Idec
With fast growth in commercial opportunities, R&D talent
pools and cost effectiveness, and improvement in business
environment, China and India can no longer be ignored by any
biopharmaceutical companies
in their expansion of global reach. The strategic planning
process for entering China and India, remaining questions, as
well as challenges for implementation, will be discussed. |
INTERACTIVE
PANEL:
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9:40 –
10:20
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Partner, Buy or Build Your Own? Identifying Suitable Partners,
Effectively Managing Alliances, and Creating Successful Outsourcing,
In-licensing,
Out-licensing, and Risk-sharing Partnerships
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Sundeep
Lal, Ph.D., MBA, Senior Director, New Products /
Licensing, Global Human Health, Merck & Co. |
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Balu
Balasubramanian, Ph.D., Director, Discovery Chemistry, Bristol-
Myers Squibb
Co. |
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Laura
Meyerson, Ph.D., Vice President and Head of Biometrics,
Biogen Idec |
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Kamesh
Venugopal, President, North American, Torrent Pharmaceuticals
Ltd |
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10:20 – 10:50 Coffee Break
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TRACK
A
BASIC RESEARCH & DISCOVERY |
TRACK
B
PRECLINICAL DEVELOPMENT |
TRACK
C
CLINICAL OPERATIONS |
| 10:50 –
10:55 |
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Chairperson's Introduction
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Chairperson's Introduction
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Chairperson's
Introduction |
| 10:55 –
11:30 |
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Practical Implications of Moving from Traditional to Transformational Outsourcing Models
Kenneth Savin, Head of the Discovery Chemistry Global Operations Group,
Discovery Chemistry, Eli Lilly and Co.
The real future of outsourcing is in transformational rather than the traditional models. Currently, traditional models
dominate outsourcing in most industries as they do in the pharmaceutical industry. Eli Lilly and Co. is moving away
from traditional outsourcing models and has had to make significant (practical) changes to our sourcing operations.
Aspects of the models we are using and some of the changes that we have had to make will be presented.
- Capturing the right metrics and acting based on the data
- Relationships at all levels count
- Look for ways to share risk
- Don't forget about logistics
- Reallocate resources between internal and external development groups to maximize asset development
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Translational Medicine and India: Steps to Conduct Omics- Based Studies
Gene Williams, Chief Executive Officer, Cambridge Healthtech Associates
Opportunities exist in India to conduct cost-effective translational research as well as improve primary care in certain urban
and rural areas of the country. This presentation will talk about opportunities to effectively create a drug development strategy
by leveraging -omics studies in India. Discussion areas will include:
- Overview of the regulatory landscape that fosters translation medicine studies
- Is my product IP protected?
- Reducing drug development timelines
- IRB approval
- regulatory approval from FDA
- patient recruitment
- How to integrate India into your development strategy
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Clinical Development in Asia Pacific: Opportunities and Challenges
Lily W. Lee, Ph.D., Vice President, Head of Asia Pacific, Johnson
and Johnson
Asia Pacific presents a blend of unique opportunities and challenges
for clinical development for pharmaceutical companies. The region is a highly diversified, old in culture, yet young and
extremely dynamic in its current path of development. To be successful in this dynamic region, one must be able to differentiate
among the opportunities the different countries present, and must command an in-depth appreciation of the challenges
of operating a multi-national, multi-cultural region.
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Understand the regulatory and clinical environment in the
Asia Pacific region
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Design winning strategies to manage the challenges in the
region
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Addressing the resistance and anxiety of including Asia
Pacific in the global development programs
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TRACK
A
BASIC RESEARCH & DISCOVERY |
TRACK
B
PRECLINICAL DEVELOPMENT |
TRACK
C
CLINICAL OPERATIONS
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| 11:30 –
12:15 |
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Strategies for Procurement for Discovery and Development in a Free-Market Economy
Sara Friedlander, Ph.D., Director, Global Strategic Sourcing, Bristol-Myers Squibb Co.
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11:30
- 12:00
Understanding the Opportunities, True Costs and
Limitations of In Vivo Preclinical Testing in Asia: Regulatory Challenges in Establishing and Running
the Show
Suresh Poosala DVM, Ph.D., Chief of
Comparative Medicine and Animal Program Director, NIH
This talk will feature the dynamic growth of preclinical testing and safety evaluation of drugs and lack of coordinated effort to keep the animal welfare and regulatory standards on par with this dynamism. Ways and means to achieve a global harmonization of this scenario is almost impractical but necessary. Some basic features that can be easily harmonized between several facilities on this front will be presented and discussed. There has been an increase in awareness on this front this year and it is critical for the CROs and drug companies to realize what is at stake if this is not the case.
12:00 - 12:15
Preclinical Drug Development in China
Ada H. C. Kung, Ph.D.,DABT,
MBA, Chief Technical Officer, Senior Vice President, Operations
and Product Development, Bridge Pharmaceuticals, Inc.
Most high tech industries have successfully outsourcedproduct development and services to Asia- except for biotechnology and pharmaceutical drug development. This is probably largely due to the fact that drug development is a 'zero defects game', unlike microprocessor fabrication or software development. This talk will summarize the state of the art of the China preclinical drug development outsourcing market and examine the critical components of work force, regulatory issues, costs, productivity, intellectual property protection, language, culture and communication, government support, infrastructure and understanding and knowledge of quality assurance and FDA regulations. An important and emerging role exists for outsourcing certain drug development tasks in Asia, and this lecture will focus on a status update on the state of the art of preclinical outsourcing in China.
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Supplying Clinical Products for Global Trials
Ted Quiroz, Director, Clinical Supply Chain, Amgen
Duke Danont, Senior Project Manager, Global Distribution, Amgen
During recent years, clinical trials have been dramatically expanding away from common regions – North America, Europe, Japan – towards Latin America, Asia, & other relatively newer regions for the biotech industry. This sudden shift is primarily driven by demand & competition for new patient pools per given diseases. Further, particularly to the biotech industry, the cold-chain infrastructures to support clinical trials in such regions have not caught up to requirements & demands. From a supply chain perspective this industrial shift, combined with unique requirements & lack of solid infrastructure, creates many unique challenges. This session highlights such challenges & the approach employed to ensure successful support of the Development community. From a supply chain perspective, the audience will:
- Learn about requirements to successfully conduct cold-chain trials
- Be informed of the unique challenges of internationally supplying
cold-chain product
- Understand some solutions being employed by Amgen to
help ensure international clinical trials success
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| 12:15
- 1:00 |
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| Executive Panel:
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Executive Panel:
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Executive Panel:
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Value Chain of Outsourcing R&D Services in Russia: Outsourcing to Outpartnering
Over the last 20 years in life sciences, Russian CROs have developed a number of advantages that distinguish them in a
global competition. Those include a long and successful services track record, broad expertise with emphasis on medicinal
chemistry, transparent research integration, established network relationships and close cooperation with
Pharmaceutical/Biotech companies and Academia. This panel will provide major pharma and biotech view of current
dynamics, regional specifics and strategies, competitive edge of the Russian CROs in global markets. The examples of new
synergistic approaches for “outpartnering” and “risk and market sharing” will be highlighted among other things.
- From “Outsourcing” to “Outpartnering”: approaches for big
pharma and small biotech
- Infrastructure climate in Russia: government role and support
of innovation in healthcare, potential of Russian pharmaceutical market
- Russian trends in global services distribution: comparative analysis
Nikolay
Savchuk, Ph.D.,
President & Chief Executive Officer, ChemDiv, Inc.
Kenneth Savin, Head of the Discovery Chemistry Global Operations Group,
Discovery Chemistry, Eli Lilly and Co.
Katsumi Ishiguro, Manager, Licensing & Business
Development, Kaken Pharmaceutical Co., Ltd.
Simon Greenwood, Ph.D., Senior Manager, Business Development, Genentech, Inc. Martin
Hauses, Ph.D., Outsourcing Manager, Merck KGaA |
Strategies for Optimizing Preclinical Outsourcing:
Working with your Provider to Kill Unsuccessful Compounds and Promote Promising Candidates Faster
- From IND to FIH: CMC Strategy and Requirements in
China versus other emerging countries
- Outsourcing Preclinical Development activities in China
and India: Pros and Con
- Preclinical (Safety) data requirements to begin clinical trials
in this region
Parimal R. Desai, Ph.D., Vice President, Analytical and Quality Sciences, Wyeth
Pharmaceuticals
Gene Williams, Chief Executive Officer, Cambridge Healthtech Associates
Suresh Poosala DVM, Ph.D., Chief of Comparative Medicine and Animal Program
Director, NIH
Gopala Krishna, PhD, DABT, MBA, Senior Director and Head, Department of Preclinical Candidate Evaluation, Supernus Pharmaceuticals, Inc. |
Effective Organizational Models and Strategies to Leverage Global Capabilities in Different Regions
Developing clinical resources and capability in China and
geographies outside of NA starts with local resources managed through NA organizations. Using both local and global
resources to manage clinical studies, on the ground resources can be leveraged and training programs can be implemented
to expand clinical capabilities.
- Effectively use Chief Executive Officer’s and local resources
- Leverage technical centers and on-the-ground resources
- Expand clinical capabilities
Beth Bookland, Ph.D., Director, Clinical Operations, Procter & Gamble Pharmaceuticals
Ahsan A. Awan, JD, MBA, Chief Executive Officer, Global CINRG, Inc.
Lily W. Lee, Ph.D., Vice President, Head of Asia Pacific, Johnson
and Johnson
Dr. Mamata Gokhale, Director, India Development Operations, Amgen
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1:00 – 2:30 Lunch on your own
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CLOSING
KEYNOTE PRESENTATIONS: |
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2:30 – 2:45 Chairperson's Opening Remarks
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2:45 - 3:15
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Developing an Approach to Asia for R&D |
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Judith Reece, Ph.D., Director, R&D Strategic Planning, Development Affairs, AstraZeneca |
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3:15 – 3:45 |
Can Pharma Industry Drive Its R&D Business Model of Parterning with Asia on the Roads that were Built by the IT, Auto and
Banking Industries: A Retrospective Analysis |
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Gangadhar Sunkara, Ph.D., MBA, Associate Director, Exploratory Development, Novartis
Common elements of business models between the pharmaceutical industry and other industry sectors in terms of West-East partnership will be discussed. |
- Learning from the global IT, banking and auto industries
- Is it necessary to reinvent the wheel in the case of pharma or can we take the partnering, business development and licensing strategies and tactics from our predecessors?
- How are the problems being faced not unique to pharma (example: retention of talent)?
- Besides the strategy and motivation for partnering, what are the actual mechanics (examples from industry)?
- How can we use all the existing intellectual property and capacity in India and Asia in general to discovery, develop and market a pharmaceutical product?
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3:45 – 4:15 |
Quantifying R&D
Globalization |
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Kenneth A. Getz, Ph.D., Senior Research Fellow, Tufts Center for the Study of Drug Development and Chairman and Founder, CISCRP
This session will review actual development spending and activity data and metrics. In addition we will discuss trends driving regional growth and the evolution of various barriers that
are hindering regional adoption. The session will conclude with a discussion of projected regional change and their implications for drug development strategies and practices. |
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4:15 - 4:30
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Closing Discussion and Remarks |
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View
Day 1 |
For questions or suggestions about the meeting, please contact:
Micah Lieberman
Conference Director, Pharmaceutical Strategy Series
Cambridge Healthtech Institute
T: (+1) 541.665.1236
E: mlieberman@pharmaseries.com
For partnering and sponsorship information, please contact:
Laura Ames
Business Development Manager
T: (+1) 781-972-5479
E: lames@healthtech.com.
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