Venture capital equity investing and pharmaceutical product-based investing are risky businesses, requiring careful evaluation of both the potential investment and the prospective partner company. The process of investigating an investment or partnership opportunity to identify and mitigate risk is called “due diligence.” This webcast will discuss due diligence and its subset, competitive intelligence, to enable regulatory professionals to be better able to support investment decisions that need to be made by upper management within their organizations. It will also discuss how to read (and write) regulatory articles and how to turn that information into competitive intelligence.
Learning Level(s): Intermediate
Upon the webcast's conclusion, you should be able to:
- Understand the role of the regulatory professional in the process of due diligence for risk-based, product-based investments
- Understand the two most important outputs of the entire process: 1) estimating the probability of success and 2) understanding how the regulatory professional assists with the sales forecast
- Understand the importance of looking at surrogates in order to make investment decisions, for example, using regulatory information from other ICH countries in regions such as Europe, to help evaluate US opportunities (e.g., biosimilars)
- Understand the difference between reviewing data and competitive intelligence
- Liaise with other team members on a due diligence team and have a general overview of what is expected from each of the other functional area experts on the team
Who Should Attend:
- Regulatory professionals who are new to due diligence teams or want to learn more
- Regulatory professionals who have been on due diligence teams but need to know more to understand the entire process
- Regulatory professionals who want to challenge themselves by writing articles and getting the most from those exercises in order to benefit their careers and their employers
Raymond A. Huml, MS, DVM, RAC, executive director and head of global due diligence, Quintiles Capital Solutions
Raymond A. Huml, MS, DVM, RAC, is executive director of global due diligence at Quintiles Capital Solutions. Huml identifies risks associated with Quintiles’ global product-based investments, working with specialists on all components of due diligence. He has worked on transactions involving more than $2.7bn. Huml has authored numerous scientific publications, including 30 articles for Regulatory Focus magazine and a book for RAPS entitled, Introduction to the Due Diligence Process. He has served on the RAPS Ethics and Awards Committees. In 2004, Huml was awarded the RAPS New Professional Award; he has also received the North Carolina Veterinary Medical Association's Young Veterinarian of the Year Award, Quintiles Clinical Development Services President's Award and the Quintiles Chairman's Award. Huml holds an MS in Biology from East Stroudsburg University and a DVM from NC State University’s College of Veterinary Medicine. He has earned the RAC (US) Certification.