Agenda at a Glance

Thursday, September 23, 2010 - Workshop
7:30	Registration and Morning Coffee for Workshop participants
8:00	Step-by-Step Strategies to Protect & Profit in Partner Contract Development Michael Gross, Senior Consultant, BIOLOGICS CONSULTING GROUP Robin Hwang, Ph.D., Executive Director, Head of Drug Delivery, HALOZYME THERAPEUTICS, INC. Frank Isaksson, General Manager, SHL GROUP Asif Sidiqui, Director, Regulatory Affairs, ROCHE MOLECULAR SYSTEMS
12:00	Lunch for Speakers & Workshop Participants

Thursday, September 23, 2010 - Main Conference, Day 1

1:15	Chairperson’s Opening Remarks Suzanne Kiani, Senior Scientist, CMC Regulatory Affairs, GENENTECH
1:45	Understand and Anticipate Combination Product Activity at the FDA Angela C. Krueger, Regulatory Advisor, CDRH PRODUCT JURISDICTIONAL OFFICER, OFFICE OF DEVICE EVALUATION, FDA Bradley Merrill Thompson, Shareholder, Health Care & Life Sciences Practice, EPSTEIN EIN EIN , BECKER & GREEN EEN EEN , P.C. Michael Swit, Vice President, THE WEINBERG GROUP INC.
2:30	Establish Common Product Goals With Your Partners to Ensure Easy & Efficient FDA Relations Terry Dagnon, Senior Director, Regulatory Affairs, ALCON LABORATORIES
3:15	30-Minute Networking Break
3:45	Learn What the FDA Looks For in Combination Product Clinical Trials to Avoid Early Life-Cycle Missteps
4:15	15–Minute Break
4:30	Effectively Navigate Registration & Listing Requirements to Steer Clear of FDA Scrutiny Frank Isaksson, General Manager, SHL GROUP
5:15	Day One Concludes

Friday, September 24, 2010 - Main Conference, Day 2
8:30	Morning Coffee
9:00	Chair’s Day One Recap Suzanne Kiani, Senior Scientist, CMC Regulatory Affairs, GENENTECH
9:15	Interpret Auto-Injector Guidance Ambiguities to Compliantly Adapt Best Practices Lee Leichter, President, P/L BIOMEDICAL
10:00	Networking & Refreshment Break
10:45	Minimize Enforcement Risk Through cGMP Compliance Suzanne Kiani, Senior Scientist, CMC Regulatory Affairs, GENENTECH Michael Gross, Senior Consultant, BIOLOGICS CONSULTING GROUP
11:15	Understand Global Regulations to Achieve Successful Marketing of Combination Products Chris Brodrick, President, CE MARKETING (Former Product Expert, BSI, Inc.) Von Nakayama, Industry Advisor (Former FDA Reviewer and Inspector)
12:00	Luncheon
1:00	Advance Your Business Strategies For Cellular Based Combinations Products Rachel Halych, Manager, Global BioTherapeutics Technologies, PFIZER
1:45	Coverage and Coding Policy: Getting Reimbursed for a Combination Product Nancy L. Reaven, President and Founder, STRATEGIC HEALTH RESOURCES
2:30	Conference Concludes