8:30 Organizer’s Welcome and Chairpersons’ Introduction
Micah Lieberman, Conference Director, Pharmaceutical Strategy Series, Cambridge Healthtech Institute

8:45 Developing a Global Strategy to Further Innovation
Ross Horsburgh, Regional Medical Director, Asia Pacific & Head CRR-APAC, AstraZeneca

9:30 Assessing Which Regions are Most Attractive and Why: A Perspective
Balu Balasubramanian, Ph.D., Executive Director, Research and Development, Bristol-Myers Squibb Co.

10:45 A Critical Evaluation of Preclinical Testing in China: A Case Study
Dr. Diana Galer, Vice President, Strategic Management Group, Pfizer, Inc.
It is now widely recognized that there are expanding opportunities for the growth of pharmaceutical industry and related businesses in China and other emerging markets. A case study of an evaluation of preclinical testing capabilities in China, based on the implementation of a pilot toxicology testing program, will be presented. This will include a critical appraisal the current state of the testing industry in China, including the physical capacity, technical capabilities and needs, talent development, as well as educational and training gaps. A number of new collaborations between preclinical laboratories in China and Western CROs and pharmaceutical clients may yield near-term improvements. Additional approaches that could yield more long term development of these capabilities will be presented.

11:30 Outsourcing Lead Generation activities in China, India, and Russia
Deborah S. Hartman, Ph.D., Vice President, Lead Generation, AstraZeneca

12:15 PM Interactive Q&A Session with Audience
Attendees can submit questions for the panel ahead of time. Please send questions to mlieberman@pharmaseries.com with the subject line of "Global R&D Congress Keynote Panel."

12:30 Luncheon and Strategic Solutions Presentations
(Sponsorships available, contact Arnold Wolfson at awolfson@healthtech.com or 781.972.5431) or Lunch on Your Own

Breakout Group A: Discovery & Early Development

Breakout Group B: Clinical Development

Tapping into Emerging Capabilities of Academic Centers in Emerging Regions: Case Study for Talent Pool Generation
TBD

Differences and Similarities Between USA and China in New Drug Application Procedures and Regulations
Lee Jia, Ph.D., Project Manager, Toxicology and Pharmacology Branch, DTP, National Cancer Institute/NIH
Regulatory agencies throughout the world are becoming more homogeneous in accepting and approving new drugs as we are approaching pharmaceutical globalization. The mechanics involved in the drug approval process have had a tremendous impact on how new drugs are developed globally. Consideration of the rules, regulations, and guidances in the new drug approval development process must become part of a company’s strategic plan in bringing these products to market. This presentation will address differences and similarities between USA and China in the investigational new drug (IND) application procedures and regulations, and compare in parallel the related data acceptability and facility.

How to Best Manage R&D Operations in China to Maximize Productivity
Samantha Ying Du, Ph.D., CEO, Hutchison MediPharma Ltd.
The capital- and time-consuming nature of drug R&D has become a huge problem for the healthcare industry. That coupled with the high attrition rate has threatened to dampen the enthusiasm for the industry to make large investments from earlier discovery to proof of concept. However, the recent ascent of China in the world economy created opportunities for the industry to re-think its strategy in reducing time and cost by taking advantages of Chinas resources. This presentation will share HMPL’s R&D strategies and how to best manage R&D operations in China to maximize productivity. The author will also describe the opportunities and risks in investing in China.

This presentation will:

• Highlight a successful story of a drug R&D company growing from a start-up to a leading R&D company in China and also an international public company within five years

• Provide a real case study by analyzing China strategies and best ulitizing China resources for the successful global drug development

• Share first-hand experiences in drug R&D development and company management in China

Translational Medicine and Biomarker Development Collaborations and Partnership in China
Jingsong Wang, Ph.D., Director, Clinical Discovery, Bristol-Myers Squibb
Translational Medicine and biomarker development is becoming an area of rapid growth across biopharma industry. Multinational biopharma companies are starting to look for China to set up translational medicine research collaborations; such collaborations have great potential but have unique challenges as well. Challenges include:

• Identifying suitable sites

• Accessing top talent pool

• Interacting with existing clinical study infrastructure

• Protecting IP

• Following SFDA regulations on biosample processing

These challenges can be overcome by utilizing a systematic and integrated approach. In this presentation I will:

• Familiarize attendees to the landscape for translational medicine in China

• Teach attendees how to access the talent pool of translational medicine in China

• Offer attendees strategies on how to overcome obstacles unique to translational research collaboration in China

Drug Discovery Strategy in China to Reduce Cost and Improve Outcome: Case Study
Dr. Ying Luo, CEO, GNI, Ltd. and Shanghai Genomics, Inc.
Although outsourcing-related research has been a hot area of growth, drug discovery has been the focus of overall strategy of the Chinese pharmaceutical industry. After combining with GNI in 2005, Shanghai Genomics has become one of the very few biotech companies who has adopted a hybrid model of both developing novel therapeutic drugs in China and providing contract research to western pharma. Our experience of how to manage research collaboration, licensing, clinical trials, production and sales is a good example for biotech companies in emerging regions of the world.

Industry-Provider Joint Panel:

Beyond chemistry and biology outsourcing, what can be done outside of the US and Europe? What are the true possibilities, costs, constraints and efficiencies in:

Medicinal Chemistry • Pharmacology • Animal Models • GLP Tox • Animal Supply • Discovery Biology

Concurrent roundtables to discuss some of the more poignant questions facing the industry. Each roundtable will be limited to twelve (12) participants and a facilitator. Participants can switch tables after 30 minutes to join a different table for the second round. Additional roundtables and facilitators will be added as needed based on registration.