2009 Conference » Speakers and Topics


Conference Agenda

Thursday, September 24

8:30-9:15         Continental Breakfast
                           Sponsored by Norwich Pharmaceuticals

9:15-9:20         Welcome and Opening Remarks
                           Conference Moderator Dr. Frank A. Chrzanowski

9:20-10:00       Pfizer Keynote: Global Pharmaceutical Outsourcing Trends & Drivers
                           Mac Lynch, Vice President, Contract Manufacturing, Pfizer Global Manufacturing

10:00-11:15     Exhibit Hall Open
                            Coffee Break  Sponsored by Ben Venue Laboratories

11:15-11:45     The Impact of Outsourcing on Drug Development Performance and Economics   
                            Rachael Zuckerman, Tufts CSDD

11:45-12:00     Q&A and Discussion 
                            Morning Speakers

12:00-1:30        Luncheon in Exhibit Hall
                            Sponsored by CPL

1:30-2:00          Managing the Core: How to Effectively Deploy an Outsourcing Strategy
                            Chris Driscoll - Driscoll Consulting Group (fmr. Amgen)

2:00-2:30          Case Study: Developing a New CMO Life Cycle Model
                              Cindy McNab, Amylin Pharmaceuticals

2:30-3:00          FDA Keynote Address: PAT, QbD and CMOs
                            Ali M. Afnan, Ph.D. - Process Analytical Technologist, FDA/CDER/OPS

3:00-3:45          Exhibit Break & Refreshments in Exhibit Hall
                            Sponsored by Ben Venue Laboratories with Grand Prize drawing sponsored by HollisterStier

4:00-5:15          Networking and Cocktail Reception
                            Sponsored by Catalent Pharma Solutions

Friday, September 25

7:30-8:30           Continental Breakfast
                             Sponsored by DPT Labs

8:30-9:15           FDA Keynote Address: Tips & Advice for Pre-Approval Inspections
                             Douglas Kovacs, Consumer Safety Officer, FDA

9:15-9:45           Kiss and Tell: How to Prove to the FDA Your Outsourcing Oversight Works
                           John Avellanet, Director, Cerulean Associates

9:45-10:00         Mid-morning Break
                             Sponsored by Ben Venue Laboratories

10:00-10:25       CROs, CMOs and the Art of the (M&A) Deal
                              Michael Martorelli, Director, Fairmount Partners

10:25-10:50       Scorecarding Your CMOs: Manage Risk and Secure Supply Chains
                              Bonni Kirkwood, Deloitte Consulting

10:50-11:15       Lessons Learned: Going from a Provider to a Sponsor
                              Mark Ginski, Alba Therapeutics

11:15-11:40        Managing the Clinical Material Supply Chain
                              Deirdre Ogorzalek, Celgene Corp.

11:40-noon        Q&A, Discussion and Wrap-Up
                              Morning speakers and conference moderator Frank Chrzanowski


Presentations and schedule subject to change

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