YourEncore reported that it is bringing together a group of high profile pharmaceutical, consumer packaged goods (CPG) and FDA executives and opinion leaders to launch a Regulatory Practice.
YourEncore noted that its Regulatory Practice will be comprised of experts who have deep experience running regulatory departments for pharmaceutical companies. In addition, experts will include former senior Food & Drug Administration (FDA) officials and policy thought leaders, with expertise spanning the entirety of drug development.
In a release, the Company noted that members of the YourEncore Regulatory Practice will help YourEncore better inform and serve its clients by anticipating trends, needs and new directions, and include:
-Don Ashbrook, Ph.D., RAC, a 30-year pharmaceutical industry veteran with experience in international drug, device and biotech development. He is the CEO of Triligent International, which focuses on compliance issues management.
-Brian Daniels, M.D., former senior vice president, global development and medical affairs for Bristol-Myers Squibb with extensive drug development experience.
-Joe Lamendola, Ph.D., former vice president, regulatory affairs for Bristol-Myers Squibb and Schering-Plough Research Institute. He has more than 25 years experience in pharmaceutical regulatory affairs, with extensive interactions with the FDA.
-Neal Matheson, former chief technology officer (CTO) global R&D at Unilever, CTO consumer companies at Johnson & Johnson and head of beauty care at Procter & Gamble. Matheson currently is an advisor to multiple start ups.
-Bob Meyer, M.D., director of the Virginia Center for Regulatory and Translational Science at the University of Virginia School of Medicine, a strategic advisor to YourEncore and not currently available for client consulting. His previous positions include chair of PhRMA's regulatory affairs committee, vice president of global regulatory strategy at Merck, and director of drug evaluation for the U.S. Food & Drug Administration.
-Peter Pitts, president of the Center for Medicine in the Public Interest and chief regulatory officer at Adherent Health Strategies. He is the former associate commissioner for external relations at the Food & Drug Administration.
-Don Therasse, M.D., a 16-year veteran of Eli Lilly & Co., where he served as vice president, global patient safety; vice president, global medical affairs; and executive director, U.S. medical.
The Regulatory Practice will be led by Tim Franson, M.D., YourEncore's chief medical officer. Franson also is the president of the U.S. Pharmacopeial Convention, and was a key voice in the reauthorization of the Prescription Drug User Fee Act (PDUFA).
"There is a need among biopharma companies for highly experienced and immediately effective regulatory professionals to help accelerate new therapies or products to market while driving quality, safety and regulatory compliance," said Franson. "The need for experience is especially important with patient care and billions of dollars at stake. The YourEncore Regulatory Practice team alone has filed more than 75 new drug applications."
YourEncore helps companies in the life sciences, consumer products and food industries solve complex compliance and productivity challenges by deploying industry-accomplished experts who are highly experienced and immediately effective.
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