New executives bring strategic and cross-disciplinary expertise to navigate changing regulatory environments
PRINCETON, N.J.—2020年5月21日. Certara®, the global leader in model-informed drug development and regulatory science announced the appointments of Terrance (Terry) Ocheltree, Ph.D., R.Ph. as vice president of regulatory strategy and chemistry, manufacturing and controls (CMC) and Lynne Georgopoulos, R.N., B.S., R.A.C. as vice president of regulatory strategy. Terry and Lynne join a large and growing team of regulatory experts who advise across Certara’s portfolio of services and technology to make the drug development process more efficient and accelerate patient access to medicines across the globe.
“I am excited to welcome two extraordinary regulatory professionals to Certara,” said William F. Feehery, Ph.D., Certara’s chief executive officer. “With over 60 years of combined experience, they significantly expand our established and leading regulatory practice and bring unique strengths to advance strategic decision making to help our biopharma clients better navigate the regulatory landscape.”
In his new role, Dr. Ocheltree provides technical and strategic advice on CMC activities to support product development from pre-investigational new drug (IND) submission to commercialization and the establishment of supply chains. He has extensive experience in biopharmaceutical development and regulatory strategy, including five years at AbbVie as senior director in regulatory and eight years at the U.S. Food and Drug Administration (FDA) in the Office of New Drug Quality Assessment as a reviewer and division director. At the FDA, Dr. Ocheltree reviewed and took action on INDs, new drug applications (NDA), and supplemental NDAs (sNDA), and developed interdisciplinary guidances for transdermals, polymers, excipients, and more.
In her new role at Certara, Ms. Georgopoulos will drive strategy and implementation of the cross-functional pediatrics services program from start to finish, leveraging Certara’s extensive pediatrics experience. She has over 30 years of diverse biopharmaceutical and clinical research organization (CRO) industry experience providing strategic guidance and clinical and regulatory advice at all stages of product development. Previously, Ms. Georgopoulos held regulatory affairs leadership positions at Synteract and Kinderpharm to accelerate pediatric drug development.
Dr. Ocheltree and Ms. Georgopoulos report to Fran Brown Ph.D., senior vice president of drug development science at Certara. Certara’s approach to drug development integrates functional disciplines such as CMC, nonclinical, clinical, regulatory strategy with model informed drug development (MIDD) to enable sound decision-making and to expedite the development process. Certara has supported over 200 novel new FDA drug approvals with its software and services in the past six years and authored over 200 global regulatory and payer submissions in the past three years.
“The addition of Terry and Lynne grows the depth and breadth of our full-service regulatory strategy and science footprint, including our expertise working with the FDA, the European Medicines Agency (EMA), and the Pharmaceuticals and Medical Devices Agency (PMDA). Our unique, multi-disciplinary program integrates model-informed drug development and regulatory strategy to streamline the process and achieve approval more efficiently and effectively,” said Dr. Brown.
Certara optimizes R&D productivity, commercial value and patient outcomes through its unique portfolio of model-informed drug development, regulatory science, and market access solutions. 過去6年間に米国FDAが承認した新薬承認申請の90%以上をサターラのソフトウェアやサービスがサポートしています。Its clients include 1,600 global biopharmaceutical companies, leading academic institutions, and key regulatory agencies across 60 countries. For more information, visit www.certara.com.