The Eleventh CBA Annual Conference
For online registration, please click here For a list of sponsorship, click hereMay 13-14, 2006 University of Maryland Shady Groove Conference Center 9630 Gudelsky Drive, Rockville, Maryland, USA Rockville, MD USA
FINAL PROGRAM
Saturday, May 13, 2006
Registration, Continental Breakfast, Exhibition
7:30 AM – 9:00 AM Continental Breakfast, Coffee and Tea
7:30 AM – 9:00 PM Registration and Exhibition
9:00 AM – 9:20 AM Welcome to CBA 11th Annual Conference
Dajun Yang, M.D., Ph.D., CBA President
Opening Remarks
Bob Eaton, President, MdBio, Inc
2006 CBA Brilliant Achievement Award and Presidential Lecture
9:20 AM – 10:05 AM Origins of Biotechnology and Future Perspective
Paul Schimmel, Ph. D., Member of the Academy of Sciences, Ernest and Jean Hahn Professor, The Skaggs Institute for Chemical Biology, The Scripps Research Institute
10:05 AM – 10:10 AM Presentation of the 2006 CBA Brilliant Achievement Award to
Dr. Paul Schimmel
Plenary Keynote Presentations
10:10 AM –10:40 AM The Lure of China for Biotechnology Start-ups
Gerald Chan, Ph.D., Chairman, Morningside Technology Advisory
Introduction: Dan Zhang, M.D., MPH, CBA President-Elect
10:40 AM –11:10 AM An Alternative Approach for Development of Novel Rotavirus Vaccine
Hung Tao, M.D., Ph.D., Member of Chinese Academy of Engineering, Professor and Chairman, Department of Virus Morphology and Viral Diarrhea, Institute for Viral Disease Control and Prevention, China CDC
Introduction: Richard Zhao, Ph.D., CBA Vice-President, Associate Professor, Division Head of Molecular Pathology Division, Director of Molecular Diagnostics Laboratory, University of Maryland Medical Center
11:10 AM –11:40 AM Pharmaceutical R&D Challenges: Role for Global Partnerships
David Bredt, M.D., Ph.D., Vice President, Integrative Biology,
Eli Lilly and Company
Introduction: Lin Sun-Hoffman, Ph.D., J.D. Managing Patent Attorney, Rockville, Celera Genomics, Applera Corporation
11:40 AM –12:10 AM Developing Novel Therapeutics for the Impending Influenza Pandemics
Fang Fang, M.D., Ph.D., Founder, CSO & CMO, NexBio, Inc.
Introduction: Dan Zhang, M.D., MPH
Break for Lunch, Exhibitions and Networking
12:10 AM –1:00 PM
Concurrent Afternoon Sessions
1:00 PM – 3:00 PM Session 1 & 2
3:30 PM – 5:30 PM Session 3 & 4
Session 1 New Insights on Biotechnology
Chairs: Richard Y. Zhao, Ph.D. CBA Vice-President, CBA Vice-President, Associate Professor, Division Head of Molecular Pathology Division, Director of Molecular Diagnostics Laboratory, University of Maryland Medical Center
Qiao Y. Bobo, Ph.D., Manager, Regulatory Affairs, MedImmune Inc.
Program Description: This session is designed to provide an update of the current technologies for our understanding of human and medicine.
1:00 PM – 1:30 PM The Human Genome: Implications for Understanding Human Biology and Medicine
Samuel Broder, M.D., Executive VP of Celera Genomics, Applera Corporation
1:30 PM – 2:00 PM Innovative Cloning and Expression Technologies from Invitrogen
Li Tian, Ph.D, Sr. Product Manager, Invitrogen Corporation
2:00 PM – 2:30 PM The Mechanism of Double-Stranded RNA Processing by Ribonuclease III: How Dicer Dices
Xinhua Ji, Ph.D., Chief, Biomolecular Structure Section, Macromolecular Crystallography Laboratory, National Cancer Institute
2:30 PM – 3: 00 PM Special Legal Issues in Developing Anti-Viral Therapies and Vaccines
Steve Parker, ESQ, Senior Partner, Arnold & Porter, LLP
Session 2 Generics and Bio-generics
Chair: Yuling Li, Senior Director, Human Genome Sciences, Inc. and Lin Sun-Hoffman, Ph.D., J.D.
Program Description: Bio-generics (also known as Follow-on biologics, Biosimilar) represent great business opportunities and significant challenges. This session will explore development strategies, and discuss relevant regulatory guidelines and their legal implications. Speakers will present key viewpoints from both the "Pro" and "Con" sides.
1:00 PM – 1:30 PM Follow-On Biologics - An Overview
Steve Bende, Ph.D., Science & Policy Strategies, LLP
1:30 PM – 2:00 PM Question-based Review for Regulatory Quality Assessment
Lawrence Yu, Ph.D., Director for Science, Office of Generic Drugs,
Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
Adda Gogoris, J.D., Partner, Darby & Darby,LLP
Break for Exhibitions and Networking
3:00 PM – 3:30 PM
Session 3 Critical Path Initiative / Phase 0 and Exploratory IND (Joint meeting by CAHOH and CBA)
Chairs: Yali Fu, Ph.D., Program Director, National Cancer Institute, NIH, and
Ke Liu, M.D., Medical Reviewer, Oncology Division, FDA
Program Description: Recently, new guidelines from FDA have been set up to ease the rules for drug testing and reduce the time and cost for drug clinical trials. This new “phase 0” trial method will allow a clinical trial with small quantities of a given drug to be conducted to help researchers to understand the pathways of the drug in the body and its efficacy. If the drug is proved to be effective in small quantities, researchers can then proceed with a phase I clinical trial. Will this new “phase 0 trial” actually help in understanding therapeutic effect in humans? And what are the risks, precautions, cost, and time in comparing with the regular clinical trial method.
3:30 PM – 4:00 PM Re-Engineering the Drug Development Process
Jerry M. Collins, Ph.D., Associate Director, DTP, National Cancer Institute
Ke Liu, M.D., Ph.D., Medical Officer and Clinical Reviewer, Office of Cellular, Tissue and Gene Therapies, Center for Biologics Evaluation and Research, FDA
4:30 PM – 5:00 PM Drug Development in Oncology: Successes and Challenges
Mihail Obrocea, M.D., VP of Medical Affairs-Oncology, MedImmune Inc.
Session 4 Outsourcing Activities Across the Pacific Ocean: its Impact to the Global Biopharmaceutical Development Process
Chairs: Kevin Li, Ph.D. Vice President, Business Development, Fountain Pharmaceuticals and Xiaobin Lu, Ph.D., Director, VIRxSYS Corp.
Program Description: Clinical development is a lengthy and costly process. Reducing development time and cost while maintaining the quality of data, is a constant challenge for drug developers. This session is to share ideas between speakers and audiences for a speedy clinical development process, including discussions on better drug development planning, outsourcing, global consideration, and better protection of IP in global market.
3:30 PM – 4:00 PM Clinical Operations in US and China
Stephen J. Trevisan, CEO & President, Accelovance
Angela Wong, Ph.D., Vice President of Service Biology, Wuxi Pharmatech
4:30 PM
– 5:00 PM
R&D outsourcing to China
John
V. Oyler, Chief Executive Officer, BioDuro, Inc.
5:00 PM
– 5:30 PM
Drug Development in China: Drivers and Unique Market Opportunities
Jenny
Zhang, M.D., Director of
Business Development, Excel PharmaStudies
Cocktail Reception
5:30 PM – 6:30 PM
CBA Banquet and Entertainment
6:30 PM – 9:30 PM
Banquet Master: Dan Zhang, M.D., MPH, CBA President-Elect
Featured Speaker for Mother’s Day
6:30 PM – 6:45 PM Sujuan Ba, Ph.D., CSO & COO, National Foundation for Cancer Research
6:55 PM – 9:30 PM Entertainment
Registration, Continental Breakfast, Exhibition
7:30 AM – 8 :00 AM Continental Breakfast, Coffee and Tea
7:30 AM – 11:30 AM Registration and Exhibition
CBA Business Session
8:00 AM – 8:20 AM CBA Organizational Activities
Session 5 Strategies on Antiviral Therapies and Vaccine Development (Joint Meeting of CBA with Great Washington SCBA)
Chairs: Kuan-Teh Jeang, M.D., Ph.D., Chief, Molecular Virology Section, LMM, NIAID, NIH and Jake Liang, M.D. Chief, Liver Diseases Branch, NIDDK, NIH
Program Description: This session is designed to provide a forum on the current strategies of antiviral therapies and vaccine development.
8: 20 AM – 8: 35 AM Prospect and Strategy of Vaccine Development for Hepatitis C
Jake T. Liang, M.D., Chief, Liver Diseases Branch, NIDDK, NIH
8 :35 AM – 8: 50 AM Selective Suppression of Human Papillomavirus Oncogene Expression by Small Interfering RNAs
Zhi-Ming Zheng, M.D., Ph.D., Principal investigator, HIV and AIDS Malignancy Branch, National Cancer Institute, NIH
8:50 AM – 9:05 AM Exploring Protein Glycosylation: the Biotechnology’s Sweet Spot
Lai-Xi Wang, Ph.D., Associate Professor, Institute of Human Virology
University of Maryland Biotechnology Institute
Session 6 Haigui ( 海龟 ) and Doing Business in China
Chairs: Yingxian Xiao, Ph.D., Assistant Professor, Department of Pharmacology, Georgetown University and Shoupeng Lai, Ph.D., AnGes, Inc.
Program Description: Chinese biotech companies have been making headlines with the approval in China of some pioneering products, including p53 gene therapy, oncolytic viruses, and endostatin, that generated strong interest on Wall Street because of solid service performance and revenue growth of these drugs. Who are the people behind these stories? How did they get there? What is it like to be a “sea turtle”? Where are the real opportunities for Chinese scientists and biotech entrepreneurs? What are the challenges?
9:05 AM – 9:25 AM Alternative Models for Drug Discovery in China
Ying Luo, Ph.D., CEO & President, Shanghai Genomics
9:25 AM – 9:45 AM Preclinical Service from China and its Role in Trans-pacific Drug Development Effort
Dongxu (Don) Qiu, Ph.D., MBA, CEO, Beijing Joinn Pharmaceutical Center
9:45 AM –
10:05 AM
TEDA
- A Bridge Between US and Chinese Business
Jianning
Li,
Project
Manager, TEDA-USA
Break for Exhibitions and Networking
10:05 AM – 10: 10 AM
Conference Keynote Speech
Chair: Sujuan Ba, Ph.D., CSO & COO, National Foundation for Cancer Research
10:10 AM – 10: 40 AM TNX-355 as a Humanized, CD4 Antagonist Antibody to Treat HIV and AIDS
Danong Chen, Ph.D., MBA., President & CEO, Tanox Inc.
2006 CBA Outstanding Service Award
Chair: Patrick Y. Lu, Ph.D., CBA Past President (1997 – 1999)
10:40 AM – 11:10 PM Building Successful Biotech Companies