Chem Outsourcing Conference Home Page

Pre-Conference Workshop

Sunday, September 7, 2008

2:00 – 5:30

Outsourcing Intermediates, API and Chemical Development

This interactive workshop is designed for both the new entrant into the outsourcing arena and those already experienced that are seeking to strength their skills in outsourcing of preclinical and clinical API portfolio. The question is not whether one should outsource or not, but rather how and where to outsource to maximize ROI in the drug development process. A stepwise process for vendor selection, business documentation, tech transfer, project execution and management will be discussed along with some case studies. In the global climate, customers now have a better choice for selecting the right partner for obtaining services under two different business models – Fee for Service (FFS) and Full Time Equivalent (FTE). A comparative scenario will be described to explain and weigh the (dis)advantages of FFS vs. FTE. Small to mid size Pharma, biotech and biopharma also rely on outsourcing offshore. Such companies, who have limited internal resources, have to develop different models; albeit, the learning’s from big Pharma can be of great use. What are the current outsourcing trends – types of services, geographic location, major players in the fields continue to evolve and will play a big role in shaping the entire industry in coming years. A final thought on “What is next” will be discussed in an open forum with the workshop attendees.

Bharat K. Shah, Ph.D.

Bharat Shah received B.S. (1978) and M.S. (1980), both from the University of Bombay, and his in Ph.D. in Organic Chemistry in 1984 from the University of Akron, Ohio. He then joined Pfizer where he worked in chemical and process R&D and commercial manufacture divisions for over 21 years. During the last thirteen years tenure at Pfizer, Bharat developed cost effective outsourcing strategies and implemented best business practices to support Pfizer’s early clinical portfolio. In February 2007, Bharat accepted the position of President at Calyx Chemicals and Pharmaceuticals, Ltd. which is a CRO/CMO based in India. Bharat is located in Connecticut, USA from where he oversees Business Development and sales in N. America

2:00 – 5:30

Outsourcing Medicinal Chemistry for the Beginner and Advanced Outsourcing Manager

Designed for both the new entrant into the outsourcing arena and those already experienced that are seeking specialized skills in the medicinal chemistry sourcing area, this workshop focuses on the multitude of questions that an outsourcing manager faces. Where will I get the highest value for my outsourcing budget: North America, Europe, China, India, or Russia? Should I audit the companies I will be working with, and if so, what am I looking for when I audit? What is the difference between contracting FTEs (full time equivalents) and FFS (fee for service), and what gives me the best value? By what criteria should I select my CRO and how should its performance be evaluated? What about IP, quality, speed, and ease of communications considerations? Which CROs have the best track record? How do I assign values to my compounds and what about Harmonized Tariff System Codes? Finally, how do I get raw materials into India in 7-10 business days, and compounds from India in 4-5 days?

Over the last decade, Chemistry outsourcing has gone through many stages of transformation. Big Pharma has gone from only outsourcing development raw materials and API to outsourcing Discovery intermediates, analogs, reference compounds, libraries, and metabolites. Big Pharma has moved much of its chemistry outsourcing from North America and Europe to Asia. The small biotech companies have the dilemma of deciding if their interests are better met in Asia, or if their money is better spent in higher cost regions. Both scenarios will be examined in depth through examples of each shared for more complete understanding. The workshop will address chemistry sourcing from Discovery through to IND filing.

During three and a half hours of open discussion and instruction the attendee may expect to leave with practical information that may be implemented immediately. The workshop leader brings 20 years of big pharma experience and 10 years of outsourcing experience. Attendee participation is key to developing active discussion around the topic to facilitate learning through your real life sourcing challenges wherever in the R&D pipeline you may be working.

Mark Creswell – President & CEO
International Discovery Sourcing Consultants (IDSC)

Mark Creswell gained 20 years experience at Pfizer, many of which were in chemistry outsourcing.