12.10.19
Parexel has appointed four key experts to its Regulatory Consulting group, bringing additional expertise in quality and compliance from the U.S. FDA and the Medicines and Healthcare products Regulatory Agency (MHRA) to help biopharmaceutical customers navigate the regulatory process. The new hires will serve as technical vice presidents.
Mark Birse joins the company 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. 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. 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, Ph.D., brings 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.
Yuexia Li, Ph.D., 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.”
Mark Birse joins the company 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. 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. 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, Ph.D., brings 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.
Yuexia Li, Ph.D., 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.”
