8:00 – 8:20 Morning Coffee
PLENARY INTELLECTUAL PROPERTY PRESENTATIONS & PANEL:
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Planning a Global Strategy Around Intellectual Property Law: IP Barriers, and Trends
8:20 – 8:30 IP Talk 1: Introduction
 Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D
8:30 – 9:00 IP Talk 2: India
 Gregory E. Kalbaugh, Director and Counsel, U.S.-India Business Council
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 Chris Israel, International Intellectual Property Enforcement, US Dept Of Commerce
9:00 – 9:25 IP Talk 3: India and Beyond
Impact of Indian Patent Law on Global Pharma Companies / MNC
 Vijay Soni, Executive Vice President – IP, Glenmark Pharma
Post 2005 India became an exciting market for MNC’s willing to launch new drugs to capitalize on the new market opportunity. The new launches were expected to gather momentum by 2007 reaching a critical mass by 2010 but now the opposition procedure, though not halting manufacturing and marketing of the specific drug, definitely casts a shadow by the MNC becoming cautious over the introduction of new drugs. Section 3(d) as amended by the Patents Amendment Act 2005 has left global pharma companies with no option but to re-strategize their patent applications in line to section 3(d) requiring additional condition of enhanced efficacy.
Section 3 (d) under Indian Patent Act. Impact of section 3 (d) in Pharma R&D. Patentability of isomers, polymorphs, metabolites, prodrugs, hydrates and other substances, etc Opposition on Patents/Application under Section 3(d) and various decisions. Effect on MNC of the Pre Grant / Post Grant oppositions. Status of Indian Patent Office on ISA and IPEA. Data Exclusivity
9:25– 9:35 IP Talk 4: China
 Ningling Wang, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
9:35– 10:00 Interactive Q&A Session with Audience
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: mlieberman@pharmaseris.com
Subject: 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
Panelists:
Mak Jawadekar, Ph.D., Director, WWPM, Pfizer Global R&D
Gregory E. Kalbaugh, Director and Counsel, U.S.-India Business Council
Vijay Soni, Executive Vice President – IP, Glenmark Pharma
Ningling Wang, Attorney, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
Chris Israel, International Intellectual Property Enforcement, US Dept Of Commerce
 D. Christopher Ohly, Partner, Schiff Hardin LLP
 Shamnad Basheer, Research Associate, Oxford IP Research Center (OIPRC)
10:00 – 10:40 Networking Coffee Break
BREAKOUT GROUP A:
DISCOVERY
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BREAKOUT GROUP B:
DEVELOPMENT
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| 10:40 – 10:45 |
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Chairperson’s Introduction
Mr. Omar Vikin, Director, Global Strategic Accounts, Sigma-Aldrich Corporation, Sigma-Aldrich Corporation |
Chairperson’s Introduction
Donald Swankie, Director, Neeman Medical International |
| 10:45 – 11:30 |
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| 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, Sigma-Aldrich Corporation
 Mr. Brian K. Ramey, CPIM, Associate Sourcing Consultant, Global Procurement, Lilly Research Laboratories
 Matthew T. Reding, Ph.D., Site Chemistry Sourcing Lead, Pfizer Global R&D
.jpg "deborah_hartman.jpg") Deborah S. Hartman, Ph.D., Vice President, Lead Generation, AstraZeneca
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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.
Emerging markets, including India, are strategic alternatives for global clinical trials. This is due to respective regulatory interaction [FDA and DCGI], strong biotechnology sector growth, and large pool of English-trained graduate and PhD / MD level resources. Within this dynamic environment, challenges and opportunities abound. This session shares insights, successes, and opportunities from two renown CRO’s; Beardsworth in the USA and Neeman Medical International in India, working collaboratively on global clinical trials.
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| 11:30 – 12:00 |
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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.
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Case Study: Clinical Trials in Central Eastern Europe and Commonwealth Independent States; an insider view
 Pavle Vukojevic, M.D., Global Medical Director, Pharm-Olam International Ltd.
The European Clinical Trial Directive brought about massive change in the conduct of clinical trials in EU member states but what about the other (non-EU) European countries? Holding Clinical Trials in non-EU countries and in the CIS brings its own challenges, brought about by the immense differences in neighboring states, but also unquestionable rewards. Are high recruitment rates, treatment naïve populations and highly skilled investigators at competitive cost still available in an area where the number of Clinical Trials is constantly growing? How much differences, advantages and prejudges is really left from old-time definitions of (Central) Eastern European countries? Finally, is data quality really unquestioned in CEE and CIS?
- How have Clinical Trials developed in CEE and CIS
- Where are these Emerging markets now in terms of clinical trial conduct?
- What does the future hold in these two regions for clinical trials?
- Holding Clinical trials in CEE and CIS: the advantages and challenges of these Emerging Markets
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| 12:00 – 12:30 |
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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.
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CASE STUDY: Critical Success Factors for Planning and Conducting Clinical Trials in Ocular Disorders Outside the West
 M. (Ken) Kengatharan, Ph.D., MBA, Vice President, Scientific Affairs, CoMentis Inc.
Some of the perceived advantages in conducting clinical trials outside the West include access to a large pool of patients, rapid initiation and reduced cost of conducting clinical trials. In reality, as many companies have learnt, these perceived advantages do not always lead to rapid conclusion of clinical trials at a reduced cost. Many issues which are taken for granted in the West tend to be very important when conducting clinical trials outside the West and in many cases lead to significant problems that could lead to a complete failure of a program. It is therefore important to critically evaluate factors that determine the success or failure of clinical trials conducted outside the West.
- Identifying the right CRO partner and rapidly initiating pre-trial activities
- Coordinating the site evaluation and performing needs and quality assessments
- Managing clinical trial site expectations
- Focusing on site specific issues during clinical trial execution (think globally but act locally)
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| 12:30 – 2:00 |
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Hosted Luncheon
Combining the Best on Both Sides of the World in Drug Discovery: Western-based Project Management with China-based Capabilities
 Dr. Paul D’Sylva, CEO, Commonwealth Biotechnologies, Inc. (CBI)
Commonwealth Biotechnologies, Inc.(“CBI”) is a leading contract research services provider which recently launched a joint venture in China with Venturepharm Laboratories, Ltd. (“VPL”), a leading clinical services provider. The joint venture is establishing a 150,000 ft2 research facility with a staff of 200 scientists by the end of 2008 to provide chemistry and biology research services for clients. This presentation will focus on the changing dynamic in the Contract Research Services industry which has shifted almost entirely to Eastern located facilities with an emphasis on cost savings, an integrated service offering, high quality innovative science, with Western located project management and support staff. Example client company structures will be presented and a process proposed for selecting the optimal contract research organization to fit your needs.
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CLOSING PLENARY PRESENTATIONS:
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2:00 Chairperson’s Opening Remarks
Art Gertel, Vice President, Clinical Services, Regulatory, & Medical Writing Beardsworth Consulting Group, Inc.
2:05 Quality vs. Speed: A Regulatory Perspective on the Future Direction of Chinese SFDA and Role of China in Global Drug Development
 Zili Li, M.D., M.P.H., Director of Clinical Research Operations-Asia Pacific/Head of China Regulatory Policy, Merck
Given recent changes in SFDA drug registration regulation and the planned introduction of the special review procedures, the regulatory perspective, especially balancing both internal and external challenges for MNCs, must be considered and understood when planning for a future development model in China.
2:45 R&D in Russia Today: Regulatory Overview and Best Practices when Working with Local Authorities
 Elena Barmanova, Deputy Director, Office for Registration of Drugs and Medical Devices, Federal department for Surveillance in Healthcare, Roszdravnadzor, Russia
- Clinical and preclinical research in Russia today
- Russia is on the threshold of entering the WTO : developing the normative documents
- Preclinical and Clinical Research in accordance with international standards ( GLP)
- Today's problems
- Ways of solving them
3:20 Operational Challenges when Sourcing the Globe for Discovery Efforts
 Gilles Cottier, President, Sigma-Aldrich
The dynamic needs of a truly global research community require a constantly evolving approach to supply chain operations. Through consistent monitoring of regulatory trends, research foci and customer service requirements operational evolution can be assured. However, current approaches have fostered a reactionary supply environment and although these efforts are largely successful the ideal situation would likely require a unified strategic vision for global research.
3:50 How to Access Brazilian R&D Potential: A Critical Evaluation of How to Best Manage and Operate in Latin America’s Largest Country
 Alberto Wainstein, M.D., Ph.D., Chief Medical Officer, Biocancer Clinical Research
Accessing R&D in countries with strong potential implies some risk but also can provide very attractive possibilities. If one is aware of the weaknesses and promises of the country and has a well-prepared management plan, Brazil can provide unique and critical advantages:
- Gain exclusive access to well trained researchers and clinicians.
- Be the pioneer in accessing naïve populations, orphan diseases, and high-demand patients motivated and interested in participating in innovative clinical trials.
- Establish partnerships with universities and research centers with little tradition in R&D but high-qualified staff, completely up-to-date state-of-the-art equipment, and tradition and experience in basic research. These Institutions have all the tools for a successful R&D project and are eager for partnership and collaborations with Biotech and Big Pharma in scientific projects.
The key learning points of this presentation will focus on how to build long-lasting and effective R&D projects in Brazil. Key points:
- What to expect now and in the near future from regulatory agencies and government
- What are the best approaches to take advantage of the current environment
- How to achieve good results with a very competitive budget
- What capabilities exist in Brazil and what are lacking
- How to gain access to bioactive molecules and promising research at Universities and research centers
4:20 Case Study: Accessing Development Capabilities and Licensing Opportunties In India
Robert Ward, Vice President, Alliance Management, NPS Pharmaceuticals
Biodollars go farther to create value when new product opportunities and capacity is accessed in India. With the global migration of talent, Indian firms being increasingly staffed with experienced pharmaceutical personnel. The team you used to access in New Jersey may now be residing in India. Historically, the Indian generic industry has established strengths in CMC, formulation technologies and intellectual property rights (designing around). Today the influx of repatriated talent has added capacities in drug discovery and development.
Capitalizing on these opportunities can allow biotechnology companies to expand the development pipeline and grow the product portfolio. We will share the process that has allowed NPS to establish productive partnerships for working in India.
4:45 Close of Conference
VIEW DAY ONE AGENDA
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