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Thursday, November 15, 2007

Organizer’s Welcoming Remarks
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series, Cambridge Healthtech Institute

STRATEGIES FOR PARTNERING AND OUTSOURCING

Critical Components of Successful Entry Strategy
Rajiv Gulati, Director, China-India Strategy, Corporate Strategic Planning, Eli Lilly & Co.
In this presentation the assumption is that the key drivers of the globalization of drug discovery and development in emerging regions will have been covered. At this point, the discussion will be beyond whether your company should go to Asia and India and will focus on how to develop a sound strategy for entry. Each company will come to a different conclusion on the "how" and it is this internal discussion that is key. It is where mistakes are often made. Topics to be covered include:

  • Identifying the right Business Model (that suits your unique requirements)
  • Identifying the right partner
  • Putting processes in place to ensure continued success

R&D Service Organization to International R&D Network Partner: Survival Strategies for a Captive R&D Center in India
Antal K. Hajos, Ph.D., Managing Director, ALTANA Pharma Priv. Ltd., a Nycomed Company
Offshoring R&D to India today has almost become a standard, yet there is the need for selecting the right areas for value creation under performance, capability and risk perspectives. As India’s capabilities further emerge, adjustments in strategy become necessary. This session will follow on from the initial set up of a MNC captive R&D center in India and describe strategic changes to position it as a strategic network partner in an international post-merger R&D organization:The Indian R&D business environment from a Western MNC perspective

  • Changes and trends in Indian R&D business environment from a Western MNC perspective
  • Strategies to monitor operations, extend services, and increase value creation
  • Right-shoring central functions instead of off-shoring tasks
  • Interfacing across international locations, intercultural aspects, and the headquarter syndrome

Opportunities in Pharmaceutical Development Outsourcing – BMS Approach and Experiences
Pankaj Shah, Ph.D., Executive Director, Analytical R&D – Pharmaceutical Development, Bristol-Myers Squibb
Highlight the approach BMS has taken with respect to off-shoring pharmaceutical development activities to India. In this presentation, I will share our approaches, lessons learned, critical business processes that one must pay attention to, etc.

  • Learn how to approach off-shoring
  • Learn key elements of a successful off-shoring activity
  • What are the key business processes, and how long does it take to implement an off-shore project?
  • Key benefits that we have realized and the challenges we have faced

CASE STUDY: Pharmaceutical Research and Development Environment in India: The Contribution of Academic Institutes
Gangadhar Sunkara, Ph.D., MBA, Associate Director, Exploratory Development, Novartis
In this session, pharmaceutical R&D activity in India by the non-profit (non-industrial) organizations, primarily the academic institutes, will be reviewed. On the basis of this review, the following areas will be highlighted:

  • Identify the active areas of pharmaceutical R&D in India 
  • Evaluate the possible opportunities of potential collaborations 
  • Understand key capabilities that must be in place to successfully manage collaborations with academic institutes 
  • Summarize the opportunities for Western biopharmaceutical companies

SMALL COMPANY PERSPECTIVES

CASE STUDY: Building an Innovation-Driven Biopharmaceutical Startup with a US/India Drug Discovery and Development Model: Issues and Considerations
Vijay Ramakrishnan, Ph.D., Founder and CEO, Pikamab, Inc.

  • Is there a real competitive advantage in the long run with this model?
  • Who are the stakeholders in this?
  • Is it investor friendly?
  • Managing the R&D innovation culture
  • Managing the operations
  • IP and Regulatory strategies--making a sense of it

A Small Molecule Discovery Company’s Experience in Leveraging India for R&D – Clinical, Regulatory, GCP and Operational Considerations
Dileep Bhagwat, Ph.D., M.B.A., Senior Vice President, Pharmaceutical Development, EpiCept Corp.
India affords a significant opportunity to US/European companies for conducting R&D. This is especially true in clinical studies because of faster patient recruitment with significant reduction in overall costs. However, venturing into India can be a daunting challenge -- with unknowns about GCP compliance, regulatory process and timing, operational and communication concerns. This talk details EpiCept's recent experience venturing into India. Our approach was to assess India as well as Eastern Europe for discovery, preclinical and clinical opportunities and resources to improve our internal R&D efforts in cancer and pain. As a first step we have jumped into India for clinical studies. There is a lot of opportunity and promise but it is challenging. Learning from others’ successes and mistakes is crucial for companies considering India for R&D.

PROTECTING AND MANAGING YOUR IP

INTERACTIVE PRESENTATION AND DISCUSSION: Planning a Global Strategy Around Intellectual Property Legislation IP Barriers and Trends in India

  • Understanding Important Intellectual Property Laws in India
  • Best Approaches to Implementation – Protecting your IP
  • Outsourcing
  • Risk Sharing Partnerships

Gregory E. Kalbaugh, Associate Director and Counsel, Intellectual Property, Trade and Labor, U.S.-India Business Council
Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D

INTERACTIVE PANEL: Partnership and Outsourcing
Deals in India – Successes and Failures

  • Overcoming cultural differences and infrastructure obstacles
  • Key cost drivers and less obvious budgetary pitfalls
  • Choosing a worthy partner and performing capability assessment
  • Making the most of your partnerships
  • Addressing IP concerns and ensuring patent protection 
  • Training staff and transferring technology
  • Effectively controlling quality

Gangadhar Sunkara, Ph.D., MBA, Associate Director, Exploratory Development, Novartis
Antal K. Hajos, Ph.D., Managing Director, ALTANA Pharma Priv. Ltd., a Nycomed Company
Rajiv Gulati, Director, China-India Strategy, Corporate Strategic Planning, Eli Lilly & Co.
Pankaj Shah, Ph.D., Executive Director, Analytical R&D – Pharmaceutical Development, Bristol-Myers Squibb

Networking Cocktail Reception & Close of Day One

View Day 2

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