The establishment of a robust Active Pharmaceutical Ingredient (API) development program is an integral part of drug development. A well-planned API development program that is properly integrated with the drug product, clinical, non-clinical and marketing programs is essential to prevent delays that can result in lost time, revenues and market life cycle.

This audio conference provides an overview of the scientific, regulatory and compliance requirements of API development at the various phases of development. The speaker also discusses special considerations associated with API development such as APIs manufactured from biological sources, the use of DMFs, and the management of manufacturing contractors.

This audio conference covers:

• API activities at various phases of development
• Regulatory requirements for APIs
• The use of DMFs for APIs
• Considerations for APIs manufactured at CMOs
• Considerations for APIs derived from biological sources

About the speaker:

William C. (Trey) Putnam, PhD, is Director, Executive Consultant, Scientific Consulting at Beckloff Associates, Inc. Since joining BAI in 2005, Dr. Putnam has been involved in consulting associated with drug substance and drug product development. He has directed the preparation of regulatory submissions including Drug Master Files, Investigational New Drug Applications, New Drug Applications and Abbreviated New Drug Applications. In his current position at BAI, he is responsible for managerial, business and technical aspects of the Chemistry, Manufacturing and Control Group.

Dr. Putnam joined the Midwest Research Institute (MRI) as Staff Chemist immediately after obtaining his doctorate, and later moved to Texas Tech University where he was an Assistant Professor in the School of Pharmacy and Laboratory Director of the Pediatric Pharmacology Research and Development Center. He holds a Doctorate and Master’s Degree in Organic Chemistry, both from Washington University.

Who should attend?

• API Manufacturing Specialists
• Product Development Specialists
• Regulatory Affairs Specialists
• Clinical Trial Material Specialists
• Quality Assurance & Quality Control Specialists

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.