Rochelle, Virginia (July 11, 2016) – NDA Partners Chairman Carl Peck, MD, announced today the formation of a specialized practice area in biologics development and regulation to address the needs of its clients in this rapidly growing area of medical product development. Biologics comprise a very heterogeneous and broad spectrum of therapeutic and diagnostic medical products, and each type of product requires a unique regulatory approach based on scientific challenges for specific biologic therapeutics. NDA Partners has assembled a team of Expert Consultants with unsurpassed capabilities to provide strategic advice and operational support in this area.
NDA Partners’ services are custom-designed to meet the unique requirements of each of its clients, and are performed by top-tier Expert Consultants. The company helps clients formulate effective development strategies, determine optimal regulatory pathways, plan and manage key projects, prepare and submit US and EU regulatory filings, manage regulatory affairs, and address critical issues that arise during their development programs.
“Recent additions to our team have strengthened our ability to provide world-class strategic development and global regulatory advice for all classes of biologics products”, said Dr. Peck. "We believe the capabilities and experience of this extraordinary group of experts is unsurpassed in the industry.”
The biologics practice area is led by Ellen Feigal, MD, a Partner in the company since June of 2015. Dr. Feigal formerly directed the Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI); Senior VP of Research and Development at the California Institute for Regenerative Medicine (CIRM); Executive Medical Director at Amgen; Deputy Director for Science and Vice President of Clinical Sciences, Translational Genomics Research Institute, and founding Director of the American Course on Drug Development and Regulatory Sciences (ACDRS).
Members of the biologics practice area include:
Ellen Areman, MS, former Expert Biologist and Product Reviewer, FDA Office of Cellular, Tissue and Gene Therapies, CBER, and an expert on product and facility development, regulatory requirements, and technical method implementation for the manufacture of cellular biological products and therapies.
Kathryn Stein, PhD, former Director, FDA Division of Monoclonal Antibodies (CBER), former Senior Vice President, Product Development, Regulatory Affairs, and Manufacturing, MacroGenics, Inc., and an expert in vaccines, monoclonal antibodies, and other recombinant DNA-derived products.
David Feigal, MD, MPH, a Partner in NDA Partners, former Director of FDA CDRH and CDER, Deputy Director of CBER, and senior executive at Amgen and Elan Corporation, with more than 30 years of drug and device development experience.
Richard Lewis, PhD, former Deputy Director, FDA Office of Blood Regulation and Review (CBER), and regulatory reviewer, FDA Division of Hematology. Dr. Lewis also served as a chemist for the United States Army Research Institute of Infectious Diseases, and is an expert in medical devices related to blood products, ranging from diagnostics to medical equipment and blood components used in medical devices.
Mary Ellen Cosenza, PhD, former Executive Director, US Regulatory Affairs, Amgen and an expert in regulatory affairs in the U.S. and internationally, with expertise in preclinical development, particularly toxicology.
Richard Siegel, PhD, former Vice President and Global Head of Portfolio Management at Janssen Research & Development; Vice President of API Technical Operations at the Global Pharmaceutical Supply Group (a J&J company); and Vice President Pharmaceutical Development, Centocor Research & Development, Inc. Biologics CMC expert in both early and late stage development activities, and technical expert in process development and manufacture of monoclonal antibodies, therapeutic proteins and conjugates, peptides, cellular products and oligonucleotides.
Joy Cavagnaro, PhD, former Senior Pharmacologist & Director of QA, FDA Center for Biologics Evaluation & Research (CBER), and Vice President, Regulatory Affairs & Integrated Compliance, Human Genome Sciences, Inc. Preclinical expert in protein and oligonucleotide-based therapeutics, vaccines, and cellular and gene-based therapies.
Theresa Gerrard, PhD, former Director, FDA Division Cytokine Biology (CBER), and Director of Development, Amgen.
About NDA Partners
NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.
Earle Martin, Chief Executive Officer