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:
- Signs the FDA Dislikes Your Development Plan: Ignore at Your Risk
- Four NDA Mistakes to Avoid
- YourEncore Pharm-ers Almanac 2015
Dr. Lamendola will focus the practice strategy to serve the pharmaceutical industry in a number of underserved areas across the drug development process, including:
- Development of regulatory strategy for new assets
- Support for regulatory policy and operations
- Guidance and support for FDA communications and interactions
- Assistance in the development of new drug applications, including the review and validation of
strategy before submission to FDA
- Strategy and preparation for FDA meeting
"During my career, I've observed a great need in the pharmaceutical industry for unbiased support
and the value of experience during the development of new assets and interactions with FDA," said
Dr. Lamendola. "The goal of the YourEncore Regulatory Practice is to provide this support, and in
doing so, to facilitate the development and approval process to get new medicines to patients
YourEncore launched the Regulatory Practice earlier this year, bringing together a group of high profile pharmaceutical, consumer packaged goods (CPG) and FDA executives and opinion leaders with deep experience running regulatory departments for the world's largest pharmaceutical companies.
"Joe has been a significant contributor to our Regulatory Practice since joining as an expert earlier
this year, and we are delighted that he has agreed to lead the practice," said Brad Lawson, CEO
of YourEncore. "Very few people understand the FDA the way Joe does, and his insight is very
valuable to our clients."