YourEncore Insights - Life Sciences

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YourEncore Announces Addition of Michelle DeJonge and Dr. James Wood as Strategic Advisors for Medical Devices & Diagnostics Practice

Posted by YourEncore on 4/13/17 4:24 PM

INDIANAPOLIS, IN--YourEncore (www.yourencore.com), a company that helps firms in the life sciences, consumer products and food sciences industries solve complex innovation, compliance and productivity challenges, announced that both Michelle DeJonge and James (Jimmy) Wood, M.D., have joined the company as Strategic Advisors for YourEncore’s Medical Devices & Diagnostics practice.

YourEncore recognizes the importance of providing cross-functional expertise for their clients, and focuses on nurturing a network of Experts rich in technical and strategic expertise.

DeJonge has an extensive background in Supply Chain and Operations leadership, which will be extremely valuable to medical devices companies. With a career spanning more than 30 years in supply chain and manufacturing for medical devices, pharmaceutical, and CPG  companies, she is the former VP of the Office of Strategy & Execution for Johnson & Johnson Supply Chain, where she was responsible for managing supply chain and operations across all segments of the organization, with a primary focus in the Medical Devices & Diagnostics division.

"I am excited to bring 30+ years of supply chain experience in solving complex challenges the medical device industry is facing. Now, more than ever, is the need for customer focused solutions in assuring continuity of quality products and services throughout the globe,” says DeJonge on her decision to join YourEncore.

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Topics: Press Release

Dr. Joseph Lamendola Fails Retirement:  Joins YourEncore as SVP of Regulatory Practice

Posted by YourEncore on 11/12/15 8:06 AM

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:

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Topics: Pharmaceutical Industry, Expert, Regulatory

Expanding Expanded Access

Posted by YourEncore on 10/5/15 4:21 PM

 

Over the past few weeks I have been covering some of “The Top 10 Regulatory Issues for Today’s Drug Developers” that keep me up at night. One is patient-focused drug development.

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Topics: Pharmaceutical Industry, Regulatory

The Patient Voice in 21st Century (Rare Disease) Drug Development

Posted by YourEncore on 9/24/15 2:36 PM

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.

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Topics: Pharmaceutical Industry, Expert, Regulatory

The FDA’s Quality Revolution

Posted by YourEncore on 9/18/15 1:24 PM

 

Last week in this space I recounted the top 10 regulatory issues that keep my mind churning at night. One of these is the FDA’s new Super Office of Pharmaceutical Quality (OPQ), which Center for Drug Evaluation and Research (CDER) Director Dr. Janet Woodcock calls a “regulatory revolution.”

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All Things Regulatory: Is Bad Data Behind Pharma’s Negative Image?

Posted by YourEncore on 9/3/15 1:32 PM

Once among the most admired industries, pharmaceutical companies today have reputations that rival those of banking and the airline industry. Why does an industry that has such a noble mission and saves lives have such a negative and much-assailed reputation?

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Topics: Regulatory

All Things Regulatory: Introducing Our Experts

Posted by YourEncore on 8/12/15 9:34 PM

Welcome to the weekly blog contribution from our experts at YourEncore that will address "all things regulated" in life science product development.

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Topics: Regulatory