The debate around clinical trial transparency is certainly nothing new. But is the answer, as some call for, "more transparency and oversight?"
While there has been much progress to harmonize EMA and FDA regulations for drug development, there are still areas where the respective agencies differ. And these differences can have a direct impact on pharmaceutical development planning.
To shed some light on the topic, on October 26th YourEncore assembled an all-star panel of industry experts after RAPS Convergence to share their inside perspectives on three particular areas of divergence/convergence:
YourEncore is pleased to announce that Dr. Joseph Lamendola has failed retirement and joined YourEncore on a full-time basis to be Senior Vice President of its Regulatory Practice.
“Dr. Lamendola is a perfect example of the YourEncore model. He's highly experienced, really accomplished, and using his knowledge in new ways to deliver value to biopharma companies,” said Brad Lawson, CEO of YourEncore.
Prior to joining YourEncore, Dr. Lamendola had a career spanning more than 25 years in pharmaceutical regulatory affairs, with extensive interactions with the Food and Drug Administration (FDA). He is the former Vice President, U.S. Regulatory Affairs for Bristol-Myers Squibb and Schering-Plough Research Institute. He is responsible for 20+ FDA approvals across 10+ therapeutic areas, an achievement that many companies don't achieve in total.
As senior vice president of the Regulatory Practice, Dr. Lamendola will lead the practice strategy, advise clients directly, and be a key contributer to YourEncore's thought leadership. Read Dr. Lamendola's latest:
Two weeks ago, I covered “The Top 10 Regulatory Issues for Today’s Drug Developers.” One of the 10 regulatory policy topics that keeps me up at night is patient focused drug development – specifically, how can patients help drive development? This topic is even more relevant and complex in the rare disease space.
At YourEncore, we believe that experience matters. Learn what makes YourEncore different and how we are collaborating with organizations to bring products to market that help individuals live happier, healthier and safer lives.
Short for Relevant Assessments, New Trends, YourEncore’s R.A.N.T. offers a refreshingly pragmatic perspective of regulatory policy strategy from people who understand it from the inside out.
INDIANAPOLIS, IN, Jul 09, 2015 -- YourEncore, a company that helps firms in the life sciences, consumer products and food sciences industries solve complex innovation, compliance and productivity challenges, announced that Mike Lewis has joined the company as Chief Sales & Marketing Officer.
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.
International Flavors & Fragrances Inc. has appointed YourEncore partner Dr. Shekhar Mitra to its Scientific Advisory Board.
Indianapolis - February 19, 2015 - YourEncore, a company that helps firms in the life sciences, consumer products and food sciences industries solve complex innovation, compliance and productivity challenges, announced that Leigh Ann Pagnard has joined the company as vice president of operations.