Parexel Expands Network of Global Regulatory Experts
Five former regulators join Parexel’s Regulatory & Access Consulting team to help customers navigate the complex and evolving global regulatory landscape
BOSTON and DURHAM, N.C., Sept. 08, 2022 (GLOBE NEWSWIRE) -- Parexel, a leading global clinical research organization (CRO) focused on development and delivery of innovative new therapies to advance patient health, today announced the appointment of five former regulators to its Regulatory & Access Consulting team, further accelerating the advancement of new treatments for patients worldwide.
“Parexel has proven to be a reliable and effective regulatory partner in helping our enterprise and biotech customers address ever-evolving regulatory changes and compete on a global scale,” said Paul Bridges, Executive Vice President, Regulatory & Access, Parexel. “These new colleagues bring the critical first-hand and global experience our customers need to seamlessly navigate the regulatory landscape, de-risk their portfolios and ultimately deliver innovative new therapies to patients around the world.”
The new leaders join Parexel’s more than 1,000 seasoned experts whose combined knowledge, skill and experience in quality and compliance expertly guide customers through complex global and in-country regulations. They will provide their insight and expertise on key aspects of the regulatory process, including navigating rapidly evolving landscapes related to regulatory meetings and submissions, compliance and market access.
“Innovation in drug development creates new pathways to bring more targeted medicines to market and improve the design and efficiency of clinical trials,” said Jamie Macdonald, Chief Executive Officer, Parexel. “Our new regulatory experts bring significant tenure with global health authorities along with a breadth of therapeutic expertise — from rare disease to oncology and hematology and including complex modalities such as cell and gene therapy and monoclonal antibodies — to leverage this innovation and navigate global regulatory processes to bring new therapies to patients faster.”
The recent appointments include:
- Mohamed Ghorab, Ph.D., who brings nine years of experience with Food and Drug Administration (FDA), having served as Branch Chief and, most recently, acting Director for the Division of Regulations, Guidance and Standards. Dr. Ghorab possesses broad expertise in Chemistry Manufacturing and Controls (CMC) for small molecules and biologics; addressing CMC-related policy issues for complex drug products, including New Drug Applications (NDA), Biologic License Applications (BLA) and Abbreviated New Drug Applications (ANDA); and regulatory review of generic drug applications.
- Belen Gracia, MSc., who was former Head of the Non-Clinical Area in the Spanish Medicines Agency (AEMPS). Ms. Gracia has more than 30 years of experience in the non-clinical aspects of assessment and across all therapeutic areas, including innovative therapies, rare diseases, monoclonal antibodies and biosimilars. A former longstanding member of the Safety Working Party at EMA, she has an unparalleled depth and breadth of experience in the non-clinical regulatory arena, including European marketing authorization procedures, clinical trials applications for authorization and the provision of EU Scientific Advice concerning non-clinical aspects of medicinal products during its development.
- Peter Kiely, M.D., MSc., who served as a Clinical Assessment Manager in Ireland’s Health Products Regulatory Authority (HPRA). Dr. Kiely has more than 17 years of regulatory experience and served as an alternate member of the Committee for Human Medicinal Products (CHMP) at the EMA. His experience also includes serving as an alternate member of the Scientific Advice Working Party at EMA and the Rheumatology Immunology Working Group. Dr. Kiely has extensive expertise in assessment of applications seeking marketing authorization, extension of indications, clinical trials, evaluation of combination products and the provision of scientific advice, both nationally and at an EU level.
- Ramesh Potla, Ph.D., who joins Parexel as a product quality (CMC) expert. His experience includes more than 12 years in the lifecycle CMC management of biologic products, including monoclonal antibodies, fusion proteins, antibody-drug conjugates, cytokines, enzymes, hormones and growth factors. Dr. Potla is the former FDA Team Leader and Acting Chief for CMC biologics review and brings more than 10 years of experience at the agency as well as industry experience serving as Global Drug Product (DP) CMC lead for biologics with GSK.
- Sinan B. Sarac, M.D., MSc., Ph.D., who has worked for more than a decade at the heart of medicines regulation in the EU. Dr. Sarac was most recently Chief Medical Officer with the Danish Medicines Agency and a longstanding member of CHMP with experience working across all therapeutic areas — including innovative therapies, rare diseases, monoclonal antibodies and biosimilars. Having primary expertise in oncology and hematology, Dr. Sarac chaired EMA’s Oncology Working Party and was a member of the Committee for Advanced Therapies.
One of the largest clinical research organizations, Parexel supports the development of innovative new medicines to improve the health of patients. We provide services to help life sciences and biopharmaceutical clients everywhere transform scientific discoveries into new treatments. From decentralized clinical trials to regulatory consulting services to leveraging real world insights, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. For more information, visit parexel.com and follow us on LinkedIn, Twitter, and Instagram.
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