Formulation Strategies for Life Cycle Management

Extending the life cycle of a drug product has paved the way for "the new pharmaceutical industry" according a Tuesday AAPS Annual Meeting session, "Formulation Approaches to Life Cycle Management."

"The pharmaceutical industry has become an industry of innovation, knowledge, and technical know-how," observed Keith Chan, PhD, president of GloboAsia LLC (Rockville, MD, www.globoasia.com) and adjunct professor at the University of Maryland. Merely having the technology is not enough, he says: companies must now think about life cycle management during early stages of product development. "Timing is everything," says Chan, and companies must take a proactive approach.

Quoting the proverb, "there are no forever friends, there are no forever enemies," Chan outlined the importance of defining competitors, which include not only generic companies but also other innovator companies or potential innovators. He emphasized the importance of understanding life cycle management from a scientific perspective and the legal basis for generic drug approvals, including patent listing and patent certification. "Just because there is no patent listed in the Orange Book doesn't mean there isn't a patent," he warns. "It just means that the patent doesn't qualify to be in the book." Chan also discussed the "Pharmaceutical Monopoly" of exclusivity under Title I and Title II extensions and restorations, the 1984 Hatch-Waxman Amendment, and common techniques for life cycle management such as exclusivity management, new formulations, creating new patents, new combinations, and launching self generic products or "authorized" generics.

Two case studies presented valuable lessons learned. Jayne Hastedt, PhD (Alza Corp.) described the successful extension of Ditropan XL using the company's OROS release technology. Joel Tune (BioPharma Solutions, Baxter Healthcare Corp.) showed how a net present value gain of 15% was obtained by formulation and product presentation.

The session concluded with a marketing view of life cycle management. Thomas F. Krol, PharmD (Verenta Pharamaceuticals LLC and KrolPharma Resources), provided commercial considerations, objectives, and the importance of early stage collaborative discussions of life cycle management. "The right time to start talking about it, is when a lead is identified," says Krol. "Start early, start often; life cycle management is a process."

Presenters at the symposium were:
Moderator: William J. Lambert, PhD, Eisai Inc.

An Oral Controlled-Release LCM Case Study: Ditropan XLJayne E. Hastedt, PhD, ALZA Corporation

Maximizing Your Drug's Life Cycle through Diversity and Integration with Parenteral and Pulmonary Delivery SystemsJoel Tune, Baxter Healthcare Corporation

Integrating Science, Regulatory, Legal, and Other Factors into Drug Product Life Cycle ManagementKeith Chan, PhD, GloboAsia LLC

The Business of Life Cycle ManagementThomas F. Krol, Verenta Pharmaceuticals LLC and KrolPharma Resources