Welcome to the July-August 2017 edition of The Protocol Link Newsletter! This issue is packed with Noteworthy Links you may have missed, a review of the new initiative from the FDA called the Digital Health Innovation Plan, dive into the next promising gene therapy (CRISPR), then conclude with a word from our newest Director at Protocol Link, Dr. David McGregor.

Digital Health Innovation Plan: Stimulating Innovation
Christine Shumard-Sauer, Ph.D--Director, Protocol Link

On June 15, 2017, the US Food and Drug Administration (FDA) announced a new initiative called the Digital Health Innovation Plan.  This initiative is intended to foster medical innovation by speeding the process of approvals of new digital heath devices and allowing some lower-risk devices to bypass the approval process altogether.  This effort is part of a broader initiative that will be announced to foster innovation across all medical product centers at the FDA.
Regulation of Emerging Innovative Technologies
Lokesh Kukreja, Ph.D--Sr. Scientist, Protocol Link

Evaluating innovative technology for science, ethics and governance is a top priority of the FDA. The Science and Research branch of the FDA has stated that for the FDA to be ready to evaluate innovative emerging technologies, "regulatory science must be one step ahead to equip FDA with the necessary tools and methods to reliably assess the safety and efficacy of products derived from these new scientific developments, in order to bring the rewards of discovery safely forward to benefit patients". One of the biggest challenges for the FDA is to match the rapid pace at which biotechnology is advancing for human health, while fully grasping potential risks.

A Word From Our Staff...

I was offered the opportunity to join this great team and I am truly excited to lend my expertise in several areas. I have been a Process Analytical Chemist, Methods Developer, Validation Expert, CMC Regulatory, Compliance Project Manager, Auditor, and Investigator. I am excited to leverage my experiences in the Drug Product and API Pharmaceutical experiences, along with Project Management and Six Sigma skill sets to support Protocol Link and our Clients.

These first months with Protocol Link have been fascinating and a great deal of fun. I have always enjoyed problem solving and driving business and product process improvements. We have a great team with diverse subject matter expertise from Chemistry to Regulatory, Drug Substance to Medical Device. I hope that at some point we can work together.

David McGregor, Ph.D
Director, Protocol Link

Protocol Link, Inc.
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