The Eleventh CBA Annual Conference

"Dynamic Changes in the Biopharmaceutical Industry: Challenges and Opportunities"

May 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

Welcome and Opening Remarks 

9:00 AM – 9:20 AM       Welcome to CBA 11^th 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

                                    Chair: Dajun Yang, M.D., Ph.D.

       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) 

2:00 PM – 2:30 PM           A Brief Overview of the Preparation and Strategy for Launching a Generic Drug in the U.S. Market

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

4:00 PM  – 4:30 PM   FDA CBER Regulations on Oncology-Related Products

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

4:00 PM  – 4:30 PM   A Case Study of R&D Outsourcing in China

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 

Guests of Honors

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  

Master of Ceremony:  Patrick Y. Lu, Ph.D., CBA Past President (1997 – 1999)

New CBA President – Election Announcement

Sunday, May 14, 2006

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: T-C Wu, M.D., Ph.D., Professor, John Hopkins University 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

Wei-Wu He, Ph.D., Founder, Emerging Technology Partners LLC 

11:10 AM – 11:15 PM     Presentation of the 2006 CBA Outstanding Service Award

to Dr. Wei-Wu He 

Closing Featured Presentation  

11:15 AM – 12:00 PM      Haigui, What Do You Expect and What are You Expected in China?

An Pu Ruo (安普若), Renowned Novelist, VC Investor and  Deal Maker Introduction: Kai Chen, Ph.D. Vice President, Business Development, Iomai Corp. and Victor Li, Ph.D., Portfolio Manager, Friedman, Billings, Ramsey Group, Inc.

Concluding Remarks          

12:00 PM – 12:05 PM       Dan Zhang, M.D., MPH., CBA President (2006 – 2007)

CBA 2006 Annual Conference Registration
For online registration, click here; If you will have any questions, please contact Dr. Xiaobin Lu at xiaobinvlu@gmail.com or Dr. Richard Zhao at gene2man2004@yahoo.com. Your registration will be confirmed upon receipt of your registration. Thank you.

Registration for the CBA 11th Annual Conference 

I. Registration Procedure and Options

We are pleased to announce that all registrations for the 11th CBA Annual Conference will be processed on the newly integrated CBA Online Membership/Event Management system. We offer two registration options: Advance or On-site. We highly recommend the Advance Registration to save you time and money.

1. Pre-Registration

Advance registrants will receive their entry badge and the CBA 11th Annual
Conference Program at the registration desk on May 13-14, 2006. Please fill
out an online registration form (click here), print a copy of the form when the online
registration is completed, then mail the form with a check for your
registration fee to CBA-USA, PO Box 61362, Potomac, MD 20859-1362 Post-mark
by 5:00pm May 11th, 2006. Advance Registration Deadline: the registration
form and fee must be received by CBA before or on May 11th, 2006.

2. On-site Registration

Attendees who do not register using the Advance Registration may register on-site. Please fill out an online registration form, print a copy of the form when the online registration is completed, then take the form with a check for your registration fee plus a $20 surcharge to the registration desk in the conference site during the following hours:

                Saturday, May 13, 2006 7:30 am – 3:00 pm
                Sunday,   May 14, 2006 7:00 am – 10:00 am

II. Registration Categories

The CBA 11th Annual Conference is a member only event. The registration will bring you accesses to all conference activities. The conference will provide all attendee four free meals, including two breakfasts, two lunches and a dinner banquet. 

1. Regular Member

$80 for the meeting registration and one-year membership.

2. Current Lifetime Member (must be a Lifetime Member before October 2003)

$50 for the meeting registration.

3. Postdoctoral Member (must be in post doctoral training currently)

$50 for the meeting registration and one-year membership.

4. Student Member (must be a full time student in a graduate program)

$40 for the meeting registration and one-year membership.

5. Member in China

$50 for the meeting registration and one-year membership.

6. CBA Conference Sponsors

Registration is free, but it does need to register. For the list of sponsors, click here.

A non-professional family member or a friend of a conference attendee may register as a Nonprofessional Guest. The registration fee for a Nonprofessional Guest is $30.00.

There are members who have paid their 2006 membership dues. To those members, they may deduct the membership amounts that they have paid (Regular Member, $30; Postdoctoral Member, $20; Student Member, $10; and Member in China, $20) from the registration fees listed above when they register for the annual conference.

 Please note there is a $20 surcharge for all late (after May 11th, 2006) and on-site registration

Payment Options:

Option 1: Personal check payable to CBA-USA, PO Box 61362, Potomac, MD 20859-1362 Post-marked by May 11th, 2006 (for pre-registration ONLY)

Option 2: Pay onsite with check or cash

Option 3: Online credit card payment via secure PayPal service (you need to sign up the PayPal service to use this option). First calculate the amount you are going to pay and then click on the "Buy Now" button. Please remember to add $20 for late registration after May 11th (please print a receipt as proof of payment)