Day Two: Friday, May 30, 2008

Breakfast Workshop:

7:45 AM TBD (Sponsorship Avaialable)

Planning a Global Strategy Around Intellectual Property Law: IP Barriers, and Trends
8:30 IP Talk 1: Introduction
Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D

8:45 IP Talk 2: India
Gregory E. Kalbaugh, Associate Director and Counsel, Intellectual Property, Trade and Labor, U.S.-India Business Council

9:05 IP Talk 3: India and Beyond
Vijay Soni, Executive Vice President – IP, Glenmark Pharma

9:25 IP Talk 4: China
TBD

Interactive Panel:

Intellectual property is the heart of the pharmaceutical industry. With the advent of the TRIPS Agreement, India and China have recently made changes to their intellectual property laws.

This session will assess the impact of these changes. Attendees can submit questions ahead of time to the panel via this link: submit questions for IP panel.

• What is the current state of IP protection in China and India? Will your IP be adequately protected?

• How is this likely to evolve in the future?

• How should this impact your investment decisions when deciding whether to conduct clinical trials, introduce new products or conduct R&D in China and India?

• How can you leverage the present environment to ensure the greatest protection for your IP?

• Interactive Q&A with audience

Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D
Gregory E. Kalbaugh, Associate Director and Counsel, Intellectual Property, Trade and Labor, U.S.-India Business Council
Vijay Soni, Executive Vice President – IP, Glenmark Pharma
Shamnad Basheer, Research Associate, Oxford IP Research Center (OIPRC)

Breakout Group A: Discovery & Early Development

Breakout Group B: Clinical Development

Interactive Working Group:
Overcoming Supply Chain Obstacles and Regulatory Constraints in Global Drug Development
Interactive working group and panel discussion on managing shift from the US and Europe to Emerging Regions from a logistics and supply chain perspective. The challenges and solutions in supply chain management and the mechanics of leveraging emerging regions to further innovation will be discussed in a structured format.

Facilitator:
Mr. Omar Vikin, Director, Global Strategic Accounts,
Sigma-Aldrich Corporation

In-Depth Co-Presentation:
A Strategy for USA and India-Based Collaboration - Leveraging Strengths and Synergies of Global Clinical Research for Sponsors and CRO’s
Donald Swankie, Director, Neeman Medical International

Art Gertel, Vice President, Clinical Services, Regulatory, & Medical Writing Beardsworth Consulting Group, Inc.

Phyto-Therapeutics: New Drug Leads and Lead Optimization Opportunities in a US-India Collaboration
Col. Aizen J. Marrogi, M.D., Department of Pathology and Area Laboratory Service, Walter Reed Army Medical Center
The emerging markets can offer many opportunities for up-stream phases of drug development including identifying leads and their optimization. The ancient Ayurvedic Indian and Classic Chinese systems of Medicine, specifically, can offer great opportunity. Our Indian collaborators have provided us with legitimate and potential leads in treatment of several disease entities such as Cancer and diseases with military relevance including, Malaria, Leishmania, Wound Healing and Post-Traumatic Stress Syndrome. In so far, we have found several single and complex botanical drug products to inhibit the growth of several human cancer cell lines in vitro such as those of Ovary, Lung, Prostate, and malignant melanoma. This and other aspects of the collaboration and research will be discussed.

Case Study:
Clinical Development and Data Quality in Russia, CIS and Eastern Europe
TBD

A Peer-Reviewed Virtual Pharmaceutical Company (tm)
Dr. David Moskowitz, CEO, GenoMed, Inc.
At a time when more drug targets are being discovered every day, there
is no funding to develop new drugs. An international scientific team, including members from India and/or China, should be able to bring drugs to market more quickly and at lower cost than Big Pharma currently manages. Starting from the several thousand genes which contribute to common diseases, it should be possible to design a cocktail of non-toxic drugs to treat any disease more effectively yet safely. A novel business organization is required as well as a novel therapeutic approach. Scientists in China and India can participate in a "virtual" pharma company. Their participation ("peer review"), plus the large number of causative gene targets, should greatly reduce the risk for any investor.

Overcoming the Logistical Challenges of Transferring Technology and Training Staff
Dr. Vyas Shingatgeri, Director, Drug Safety Evaluation, Ranbaxy Research Laboratories

• Challenges in drug discovery & development – Thinking out of box

• Case Study of one of the drugs we had

• Training of individuals

• Amalgamation – Adaptive, Receptive, Talented work force

12:45 Luncheon and Strategic Solutions Presentations
(Sponsorships available, cont act Arnold Wolfson at awolfson@healthtech.com or 781.972.5431) or Lunch on Your Own

Closing Plenary Presentations:

3:00 R&D in Russia Today: Regulatory Overview and Best Practices when Working with Local Authorities
Deputy Director, Office for Registration of Drugs and Medical Devices, Ministry of Health, Russian Federation (to be confirmed)

3:30 Strategies for Successful Outsourcing of Chemistry and Biology: An Integrated Project Case Study