Former FDA and MHRA experts will provide Parexel’s customers expertise in the development of strategies to minimize risk and disruption in bringing new therapies to market
Former FDA and MHRA experts will provide Parexel’s customers expertise in the development of strategies to minimize risk and disruption in bringing new therapies to market
BOSTON and DURHAM, N.C., Dec. 10, 2019 (GLOBE NEWSWIRE) -- Parexel, a leading provider of solutions to accelerate the development and delivery of innovative new therapies to improve world health, from Clinical through Commercialization, today announced the appointment of four key experts to its Regulatory Consulting group, bringing additional expertise in quality and compliance from the U.S. Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA) to help biopharmaceutical customers efficiently navigate the regulatory process and ultimately accelerate important new treatments to patients.
“Parexel understands that working with experts who have insight into the needs of regulatory authorities from the perspective of the agencies enables our customers to design trials and clinical programs that help them reach their goals and get new medicines to patients sooner,” said Jamie Macdonald, CEO of Parexel. “We are delighted to add to our impressive group of former regulators on staff who are helping transform the regulatory process for our customers.”
The new hires will serve as Technical Vice Presidents and join Parexel’s team of more than 1,000 experts, bringing experience in many facets of quality and compliance ranging from Quality Management Systems (QMS) to Chemistry Manufacturing and Controls (CMC). They include:
Mark Birse: Mr. Birse joins Parexel from the MHRA where he served as Deputy Director of the Inspection, Enforcement and Standards Division and Head of the MHRA Inspectorate & Process Licensing Group, which employs more than 75 Inspectors. Mark led the creation of the compliance management and risk-based inspection principles at MHRA and worked extensively with international regulators, with a focus on inspection collaboration and reliance, including being on the PIC/S Executive Bureau and leading the EU assessment team for the US-EU MRA. He joined the MHRA in 2002 as a GMP Inspector, having previously worked in the pharmaceutical industry for more than 10 years.
Philip E.M. Crooker, J.D.: Mr. Crooker is a scientifically trained drug development attorney bringing experience identifying, analyzing and resolving complex legal, regulatory and technical issues within the private sector as well as the FDA. Mr. Crooker has worked with pharmaceutical and biotechnology companies throughout various aspects and phases of the drug development process, including CMC, product quality strategy, manufacturing compliance, health authority engagement and more.
Lynne A. Ensor, PhD: Dr. Ensor joins Parexel with 21 years of FDA experience, most recently having served as the Acting Deputy Director of the Office of Process and Facilities in the Office of Pharmaceutical Quality/CDER. Lynne was responsible for the oversight of new, generic, biologic and biosimilar drug assessment, including both product quality application review and facility CGMP compliance. As a CDER Master CMC reviewer, her areas of expertise include biopharmaceutical sterile product manufacturing and testing, pharmaceutical microbiology, pharmacy compounding, radiopharmaceuticals, regulatory policy development, and remediation strategies for sterile drug and facility challenges. Lynne has seven years of post-graduate industry experience in environmental and clinical microbiology research and served as a Discovery Channel script consultant.
Yuexia Li, PhD: Dr. Li most recently served at the FDA as the Deputy Director of the Office of Program and Regulatory Operations (OPRO) in the Office of Compliance (OC)/CDER. In this role she led the implementation of QMS for process improvement and efficiency enhancements related to the issuing of warning letters, the recall process, and enforcement actions issued by the OC in CDER. Prior to FDA, Yuexia was the senior director of QMS for an in vitro diagnostics medical device company and QC Director for an HIV gene therapy company.
“In today’s complex regulatory environment, it is absolutely critical that compliance be incorporated into drug development strategies from the outset. Companies must have a proactive compliance and quality strategy that enables them to ensure that development timelines are met, and therapies make it to the patients who need them,” said Paul Bridges, PhD, Senior Vice President, Regulatory & Access Consulting, Parexel. “With experts on staff who provide the regulatory agency perspective on quality and compliance guidelines, Parexel can help life sciences companies more effectively interpret and apply regulations and develop the proactive strategies necessary to minimize disruptions on the pathway to regulatory approval.”
Parexel’s Regulatory Consulting team provides a deep understanding of intricate regulatory requirements to help customers mitigate risks by helping build regulatory strategy, interpret regulatory guidance, optimize product development, maintain compliance and manage submissions. To learn more about Parexel’s regulatory consulting team and insights, visit https://regulatory.parexel.com/.
About Parexel
Parexel is focused on supporting the development of innovative new therapies to improve patient health. We do this through a suite of services that help life science and biopharmaceutical customers across the globe transform scientific discoveries into new treatments for patients. From clinical trials to regulatory and consulting services to commercial and market access, our therapeutic, technical and functional ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn, Twitter and Instagram.
Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.
Parexel Contacts:
Media:
Wendy Ryan
Tel.: +1 781-434-5104
Email: Wendy.Ryan@parexel.com
Kathryn McMahon Arrigg, PAN Communications
Tel.: +1 617-502-4300
Email: PAREXEL@pancomm.com
