Managing Your CMC - Hands On Outsourcing Project Management for Pharmaceutical & Biotech Managers

Monday, September 14
9:30am - 12:30pm
Click here to register

This hands on decision-making exercise will permit you and your fellow sourcing managers to work through a realistic sourcing scenario in small groups of 6-8 persons led by a facilitator. Timelines, budget, chemistry, interpersonal relationships within and outside your pharmaceutical company will all be explored. At the end each group will present its decisions to the whole workshop group for comment and comparison.

There has never been an opportunity for CMC management to work through an extensive exercise like this – this will be a real learning experience!

A biotech has just in-licensed a Phase 2a clinical oncology candidate that has been given fast track status on September 15, 2009 and the company received $100 million in funding to move the candidate through development to commercial.

Your group has been given a budget of $5 million as a part of the total funding to manage the manufacturing. The funding you have will need to be sufficient for you to supply API and Drug for the Phase 2b program, Phase 3 and the work required to scale-up and establish commercial supply. You will need to line up the supply chain for Phase 2b, all Phase 3 clinical trial materials, backup supply of API, intermediates suppliers and formulation/final dose manufacturing. According to the dosing schedule established in Phase 2a, patients are given 16.8 gm API for one cycle (28 days, 3 months).

You have been told the cost of the current manufacturing of API is $65,000 per kg (not including the final dosage manufacturing, packaging) and the projected commercial launch volume is 500 kg. The licensor has also provided two quotes for Phase II API supply from potential commercial suppliers, one for k$45/kg and one for k$40/kg (Toller A and Toller B, respectively). The current API supplier can handle Phase 2 supply and "probably" Phase 3 supply but cannot handle the commercial volumes in their cytotoxic facility.

You will need to start production of the API for the Phase 2b trial (90 patients) as soon as practical since it is the rate-limiting step for the start of your company's clinical trial program. To keep the program on track and avoid delays, you will need to initiate production of Phase III API (750 patients) by 3Q 2010.

This API is dosed as a 100 mg tablet manufactured by wet granulation. The tablet manufacturer has no volume limitations but will need to scale up for commercial production. However, the technical package reveals there are multiple polymorph forms -- all of which have appeared in different API batches manufactured by the current supplier. Tablets, primary and secondary packaging are about $0.75/tablet on a placebo basis.

You have been asked to give an overall development plan from start to finish within the next month to accomplish the timelines and challenges facing this program.

Workshop Leaders:

David Houser
Assistant Director, Business Development
Asymchem
David was previously a sourcing professional at Pfizer and Pharmacia

Deborah Minor, Ph.D.
President
Drug Discovery Alliances, Inc.
Prior to founding her firm, Deborah was a discovery research chemist at Accelyrs, MDL, and Rhone Poulenc

Bob Edmonston
Associate Director, API Development Sourcing
Alkermes, Inc.

Stephen A. Munk, Ph.D.
President & CEO
Ash Stevens Inc

Ned Cheesman
Director, API Development
Lantheus Medical Imaging

Bill Bennett
Principal
Bennett Pharma Solutions

Walt Stalzer
Director Consulting Services
Ricerca Biosciences