Pharmaceutical Competitive Intelligence for the Regulatory Affairs Professional

This Brief defines competitive intelligence (CI) as a tool for making investment decisions within the pharmaceutical industry. It provides an overview of processes that the regulatory affairs professional must take into account when evaluating data impacting product-based risk evaluations. These apply particularly to evaluations that focus on outputs such as regulatory approval, or the commercial impact of product labeling on the sales forecast over a limited timeframe. The Brief also provides an overview of intellectual property assessment that can impact a product's lifespan on the market due to patent protection itself (or loss of patent protection) or via regulatory exclusivity. Case examples are discussed to illustrate the importance of keeping up with the ever-changing regulations, and how to interpret them in the context of CI. In addition, there is a section on virtual data rooms (VDRs) which currently function as the cornerstone of due diligence investigations. While aimed primarily at regulatory affairs professionals in the United States, this publication provides a useful adjunct for other pharmaceutical executives, especially those new to product-based investments, and regulatory affairs professionals in other regions.

Table of contents:

Introduction to Competitive Intelligence.- Overall Perspective of Due Diligence Investigations and Processes.- The Regulatory Functional Review - Primary Roles.- The On-Site Due Diligence/Data Room Meeting and Interactions with other Functional Area Experts.- Intellectual Property.- The Final Report.- Competitive Intelligence Summary.

Raymond A. Huml, MS, DVM, RAC is Executive Director of Global Due Diligence in Quintiles Capital Solutions ("Capital") for Quintiles Transnational Corp. Dr. Huml has over 20 years of experience in the biopharmaceutical industry. In his current position, Dr. Huml identifies risks associated with Quintiles global (US, EU and Japan) product-based investments, working with specialists on all components of the due diligence process, including research and development, commercial, intellectual property, and conflict of interest. He previously worked in Biostatistics, Medical Writing, and Regulatory Affairs Departments in Quintiles Clinical Development Services group. Dr. Huml has authored and co-authored numerous scientific publications, and is a strong supporter of the Regulatory Affairs Professional's Society (RAPS). He holds an MS in Biology from East Stroudsburg University and his DVM from North Carolina State University's College of Veterinary Medicine, and has earned the RAC (US) Certification.