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Day Two: Tuesday, September 11, 2007

7:30 am Breakfast Workshop or Morning Coffee
(Sponsorship Available. Contact Arnold Wolfson at 781.972.5431)

8:25 Chairperson’s Remarks

8:30 CASE STUDY: Building a New Model of Regulatory Agency Interaction in China

Zili Li, M.D., Ph.D., Director, Clinical Research Operations, Asia-Pacific, Merck

9:00 Opportunities and Challenges of Conducting Clinical Studies, Drug Development, and Business Development in China

Michael Chen, President, TCM Group, Inc., former Associate Director, Biostatistics and Data Management, Wyeth
In this presentation I will discuss strategies and practical guidance to biopharma companies who would like to conduct business in China. My main focus will be on how to establish realistic goals from a global perspective, and how to execute the strategies. I will also discuss real life cases of successes and failures in conducting clinical studies and other business developments. 
  • Opportunities that China can offer
  • Potential pitfalls to avoid
  • Practical guidance on establishing goals and business execution
  • Real life examples of successes and failures in China
  • Recommendations
9:30 The Optimal Combination – Outsourcing and Subsidiary Approach for Pharmaceutical Sciences Tasks

Ming Guo, Vice President, Pharmaceutical Science and Manufacturing, Ascenta Therapeutics, Inc.
Ascenta, a development stage biotech company focused on oncology NME drug development, has been heavily relying on outsourcing for all its > 3-years history. At the meantime, Ascenta also established its wholly owned R&D center in Shanghai in 2005. This presentation will discuss Ascenta's efficient business model and provide a case study on combination of outsourcing and subsidiary approach for pharmaceutical sciences tasks, including the business justification, site selection and set-up, site management and project management, and interactions between the pharmaceutical sciences function with pharmacology and toxicology research in China.

10:00 Networking Coffee Break
10:45 Current State of In Vivo Tox and Path Contract Research in China

Suresh Poosala DVM, Ph.D., Chief of Comparative Medicine and Animal Program Director, NIH
After presenting several talks and attending several meetings, it has become clear that the trend in outsourcing of drug development is real and also fruitful. Over the last two years, the hurdles followed by achievements of several CROs in facilitating in vivo animal safety studies in preclinical development has hit somewhat of an unheard proportion. This presentation will highlight this and revisit the accreditations, standards, and regulations required to create the same.

11:15 CASE STUDY: Collaborating to Assess Options for Conducting Preclinical Safety Studies in China

Eric Meyers, Vice President, Global Initiatives, Cambridge Healthtech Associates
The following is a case study outlining how six major biopharmaceutical companies worked together to identify and evaluate external resources in China with the potential to conduct animal safety testing studies in Shanghai, Beijing, Guangzhou and other major cities. Key steps presented will include: 

  • Determining key criteria to be used in the evaluation process 
  • Identification and evaluation of facilities 
  • Avoiding obvious and not-so-obvious pitfalls 
  • Financial and other modeling of options 
  • Results and findings

11:45 Interactive Panel Discussion#3:

Strategies for Successful Outsourcing of Chemistry and Biology: A Discussion and Evaluation of Integrated Global Projects

Balu Balasubramanian, Ph.D.,
Discovery Chemistry,
Bristol-Myers Squibb Co.

Chris Song, 
Pharmaceutical Segment, Applied Biosystems, former Special Project Manager, AstraZeneca R&D, China

Guoxin Zhu, Ph.D., 
CSO / Head of China Chemistry,
Discovery Chemistry Research & Technology,
Eli Lilly Asia, Inc., Shanghai Rep. Office

Zili Li, M.D., Ph.D.,
Clinical Research Operations,
Asia-Pacific, Merck

12:15 Luncheon and Strategic Solutions Presentations (Sponsorships available) or Lunch on Your Own
1:45 Address Regulatory Challenges to Conduct Global Clinical Trials in China

Hua Zheng, M.D., Ph.D., Director, Global Regulatory Affairs, Tibotec, Inc. (J&J)
Global CTA submission requires strategic planning and coordinated execution to address different country-specific regulatory requirements. China presented a good opportunity as growing sources for global trials, especially for specific therapeutic areas where incidence and prevalence for the disease condition is high. However, country-specific regulatory challenge in the preparation of Chinese CTA process needs to be well understood and addressed before, during and after the CTA submission. The regulatory strategy for China should be proactively formulated and managed as a critical component of the global CTA strategy. The CTA outcome has big business impact when planning for pivotal trials supporting global registration. The roles of Global Regulatory will be presented along with the real case experiences. Discussion will focus on:
  • Review the regulatory environment in China for clinical trials
  • Review relevant regulatory process to open Chinese IND in support of global trials
  • Manage strategic regulatory planning for CTA and for major CTA amendment
  • Share experiences on how to manage regulatory planning and interaction with SFDA based on actual cases
2:15 CASE STUDY: Place of China in Global Drug Development Strategy

Edmund Tsuei, Ph.D., Regional Head, Pharma Development Operations, Asia-Pacific-Africa, Roche Products Pty Limited 
Low drug development productivity is a major problem facing the pharmaceutical industry with increasing costs and decreasing number of NME reaching the market. One of the major drivers of the increased costs is patient recruitment and retention. Emerging markets with large patient population will play an increasing role. The place of China in global drug development strategy will be discussed covering the following points:

  • Commercial potential
  • Clinical trial potential
  • Headroom for increased drug development activities
  • Obstacles and challenges
  • Experience over the past 10 years

2:45 Networking Refreshment Break
3:15 Clinical Trials in China – Trends, Opportunities and Lessons

Mark Engel, Chairman, Excel PharmaStudies
This presentation will review the drivers behind the estimated 50% per annum growth in the number of clinical trials coming to China. The presentation will go on to track trends among these trials, including a look at early phase work, proof of concept studies, and trials utilizing adaptive designs. Lastly, the presentation will look at lessons learned including a touch on regulatory, logistics, central labs, recruitment and investigators.

  • Drivers for rapid growth of clinical trials coming to China 
  • Myth vs. Reality: Clarifying common misconceptions related to timelines and cost 
  • Examples of unusual ways to take advantage of the China opportunity 
    • ROI driven trials including proof of concept trials 
    • Dual development trials 
    • Additional labeling trials 

3:45 Interactive Panel Discussion #4:

Practical Considerations for Launching and Managing Clinical Operations in China

  • GCP environment in China and its evolution
  • SFDA history
  • Patients, how are populations different, relationship with PI
  • Strategy – Outsourcing vs. Insourcing
  • Companies doing global trials now in China – regional trials vs. China trials vs. Global trials
  • Using China as a rescue site

Helen Niu, M.D., Ph.D., 
Global Development Operations Asia & Latin America,
Amgen, Inc.
Mark Engel, 
Excel PharmaStudies
Hua Zheng, M.D., Ph.D., 
Global Regulatory Affairs,
Tibotec, Inc. (Johnson & Johnson)

Zili Li, M.D., Ph.D.,
Clinical Research Operations, Asia-Pacific,

4:45 Close of Executive Forum

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