LOUIS W. YU, Ph.D

Executive Director

Corporate Quality & Compliance

Forest Laboratories, Inc

Dr. Louis Yu is currently an Executive Director, Corporate Quality & Compliance at Forest Laboratories, Inc. where he directs and oversees global commercial and R&D quality/compliance matters. In this role, he establishes company-wide policies and advises other departments and subsidiaries in compliance and quality matters. Prior to this, he was Vice President of Quality & Compliance at Solvay Pharmaceuticals, a subsidiary of a Belgium based conglomerate. Dr. Yu began his career as a Research Analytical Chemist for the Naylor Dana Cancer Research Institute in Valhalla, NY. After working for over fifteen years in the Research & Development laboratories at Johnson & Johnson, he then moved to the quality assurance laboratories of Ortho Pharmaceutical Corp. J&J, where he was Director of Laboratory and Technical Operations. From there, he moved to head up the National Analytical Services and Corporate Compliance at J&J’s McNeil CPC. Later, he was first named Vice President, Analytical R&D/QC, then Vice President, Scientific Affairs, at one of the largest independent generic pharmaceutical companies in New York. In that position, he was responsible for Analytical R&D, pharmaceutics & formulation development, clinical bioequivalence program and regulatory affairs for the company. Dr. Yu was born in Canton, China. He grew up in China and Hong Kong. He attended primary and secondary schools in Hong Kong and was educated by the Jesuits. Having been awarded academic scholarship from the University of Wisconsin, he received his B.S. degree in Chemistry from UW, Madison, Wisconsin. In 1985, he completed his formal education by receiving his M.S., Ph.D. degrees in Analytical Chemistry at Rutgers University. He is a currently a member of ACS, AAPS, RAPS, ASQ and Sigma Xi professional associations. Since 1989, he has been a member of the Land Of Lakes Pharmaceutical Analysis Conference Planning Committee and as Conference adjunct faculty with the Extension Services in Pharmacy, School of Pharmacy, University of Wisconsin.

Abstract

Protein/peptide based approaches to finding new cures for diseases have not turned out to be the rich potential they once seemed to be. While the human genome project certainly holds future promise of gene based therapy, DNA and gene-based therapy are too immature at this juncture to offer an immediate alternative to the existing avenues for therapeutic discovery. And so, in the late nineteenth and early twenty-first century, the rich new-drug pipelines big pharma companies relied on to power un-interrupted high double-digit organic sales and profit growth has stalled.

Threatened by patent expirations and generic competition, drug companies have had to explore creative strategies to prolong the commercial value of existing intellectual properties and brands they have created via past investments in research, development and marketing activities. Proactive life cycle management has become an important tool in the armamentarium and the new battle cry to fully harness the potential of pharmaceutical products. This paper is a general survey and provides a review of the myriad strategies and tactics that had been used by analyzing the case studies of companies that have successfully prolonged the commercial life and profit potential of major products and brands.