Dr. Seth Whitelaw has more than 25 years of industry experience in the life sciences and healthcare sectors, as an attorney,New Headshot compliance officer, and consultant. His career has focused on food and drug law and corporate governance, as well as designing and running compliance programs within medical devices, pharmaceutical sales, and marketing and pharmaceutical R&D. He is a licensed food and drug attorney, with a doctorate in Health Law. A former Food and Drug Law Institute (FDLI) fellow, he also worked for the FDA’s Office of Chief Counsel and Deloitte & Touche LLP.

Dr. Whitelaw has served as a compliance officer for several pharmaceutical and medical device companies including as the Chief Compliance Officer (C.R., Bard, Inc. and Misonix, Inc.), head of pharmaceutical commercial compliance (SmithKline Beecham Pharmaceuticals North America), and global compliance officer for R&D (GlaxoSmithKline). In each case, he has designed, built and implemented a compliance program from a “blank sheet of paper.”

In addition, he teaches at the Mitchell Hamline School of Law and edits for the Life Science Compliance Update, a monthly publication providing comprehensive, up-to-date compliance information for pharmaceutical, biotechnology, and medical device manufacturers.

PUBLICATIONS

Whitelaw, et al., Drug Pricing – The Next Compliance Waterloo, 44 Mitchell Hamline L. Rev. (2018 Forthcoming). Available at SSRN: https://ssrn.com/abstract=3127733

Whitelaw, et al., A Bright Future or Unfulfilled Promise – An Update on Biosimilars and Their Prospects for Contributing to Meaningful Cost Reduction, Life Science Compliance Update, Vol. 4.3 (Mar. 2018).

“One Purpose to Rule Them All – A Resounding ‘Yes’ According to the District Court in U.S. ex rel. Cairns,” Life Science Compliance Update, Vol. 4.2 (Feb. 2018).

“On a Collision Course – FDA Clinical Investigator Disclosure and Open Payments,” Life Science Compliance Update, Vol. 2.9 (Sep. 2016).

“The Board of Directors’ Role in Pharmaceutical Compliance,” Pharmaceutical Compliance Monitor (Dec. 10, 2012).

“How Can FDA Improve Its Financial Disclosure Rules for Clinical Investigators in this New Era of Transparency?”, Food and Drug Law Institute Policy Forum (Jun. 2011).

“Evaluating IRB’s and Their Roles,” 16 Food, Drug, Cosmetic and Medical Device Law Digest

“Proposition 65 v. Industry: David Against Goliath or a Misled Public Run Amok?,” 44 Food Drug Cosmetic Law Journal 677

 

REPRESENTATIVE SPEAKING ENGAGEMENTS

 Guest lecturer at Temple University, Ursinus College and Medical Devices Section, Food and Drug Law, Rutgers-Camden Law School

Mitchell Hamline School of Law, National Speaker Series (Oct. 2016)

Mitchell Hamline’s Health Law Institute Symposium – Hot Topics in Healthcare Compliance (2018)

CBI 2nd Annual Drug Pricing Transparency Conference (2018)

CBI Annual Pharmaceutical Compliance Congress (multiple years)

Pharmaceutical Regulatory and Compliance Congress (multiple years)

Food and Drug Law Institute Advertising and Promotion Conference (multiple years)