In pharmaceutical development, much effort is focused on delivering the right molecule to the market in the shortest possible time. Product development has been compressed to take place in 4 to 6 years, when not long ago timelines for similar efforts were 7 to 9 years. The demands placed on process development and optimization for Active Pharmaceuticals Ingredients (API’s) have increased, as the pressure to meet aggressive timelines has become commonplace. API development of all but the simplest molecule is on the critical path. There is very little room for error, and any inefficiency in the chemical synthesis has a larger impact on the timeline than in the past. A good synthesis, discovered early in the development process, will allow for the timely delivery of clinical and tox supplies, smooth the regulatory filing process, result in a successful compliance inspection, and will lead to less waste and higher profits after the drug is launched.

The 23 years of experience in process development for Parke-Davis and then Pfizer has afforded me a unique and diverse perspective in evaluating the efficiency and cost implications of a chemical synthesis as well as experience in later stages of manufacturing and drug approval. These experiences include:

• Redesign of inefficient or cost prohibitive syntheses to improve the quality of API produced, making it much easier to prepare clinical supplies.
• Transfer of robust and scalable processes to manufacturing facilities
• Interaction with regulatory bodies

Significant reduction of production costs after launch. Specifically, my accomplishments include:

• Conception and development of the synthesis used to launch and manufacture gabapentin (Neurontin). This synthesis was employed by Parke-Davis and later Pfizer to make millions of kilograms of gabapentin over its exclusivity period.
• Team Leader for the atorvastatin (Lipitor) Drug Development API team; responsible for the late-stage development of atorvastatin for Parke-Davis and later Pfizer. At Park-Davis, I headed the atorvastatin Drug Development API team and was responsible for the late-stage development of atorvastatin (Lipitor).
• Redesign of the quinapril (Accupril) synthesis, resulting in one of the few post-marketing synthesis changes in Parke-Davis’s history. The new and improved synthesis reduced cycle time by a factor of five, and cut waste and equipment usage by a large percentage.
• Oversight of process change to the atorvastatin process, that increased throughput so remarkably that a manufacturing facility no longer needed the planned expansion to meet the growing market demands.

With this experience, I am poised to help guide your lead API to the marketplace.