YourEncore Insights - Life Sciences

YourEncore Assembles Regulatory Experts

Posted by lindsay.noell on 4/29/15 2:40 PM

blog-21

Indianapolis – April 29, 2015 – YourEncore, a company that helps life sciences, consumer products and food companies solve complex product development and regulatory challenges, is bringing together a group of high profile pharmaceutical, consumer packaged goods (CPG) and FDA executives and opinion leaders to launch a Regulatory Practice.

The YourEncore Regulatory Practice will be comprised of experts who have deep experience running regulatory departments for the world’s largest 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.

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 26-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 has been directly involved in the filing of more than 75 regulatory approvals, which were approved.”

 

About YourEncore

Indianapolis-based YourEncore, an Inc. 5000 company, helps companies in the life sciences, consumer products and food industries solve complex innovation, compliance and productivity challenges by deploying industry-accomplished experts who are highly experienced and immediately effective. YourEncore experts, which include MDs, PhDs, executives and practitioners, have on average 25 years of experience and are behind many of the most successful products on the market. In addition to advisory services, the company also offers the resources to act on its recommendations. Founded in 2003, YourEncore today works with 12 of the 15 leading global pharmaceutical companies and four of the six top consumer care companies. For more information, visit www.yourencore.com and follow us on Facebook and LinkedIn.

Topics: All, Expert, Media, Regulatory