Madison, Virginia (July 24, 2013) - Carl Peck, MD, Chairman of NDA Partners LLC (NDAP), today announced the addition of three senior industry executives to its roster of Premier Expert consultants. NDA Partners Premier Experts are top tier consultants whose expertise and professional stature enable them to bring extraordinary value to the company's clients. Premier Experts collaborate to design and implement critical solutions to help clients successfully develop their medical products, pursue optimal regulatory pathways, build a company that is attractive to professional investors, and initiate access to global markets.
Dwaine Rieves, MD, FCCP - Dr Rieves is an expert in drug and biological product development, diagnostic imaging drug development, regulatory strategies, and the medical subspecialties of hematology, critical care medicine, radiation medical countermeasures and pulmonary medicine. Dr Rieves has extensive experience within the US Food & Drug Administration (FDA) including Director, Division of Medical Imaging Products (CDER), Director, Division of Medical Imaging and Hematology Products (CDER), and Chief, Clinical Trials Branch, Division of Clinical Trials and Analysis, Office of Cellular and Gene Therapy (CBER).
Anthony Di Santo, PhD - Dr Di Santo is an expert in bioavailability/pharmacokinetic studies to meet regulatory requirements in the development of NCE's from IND onward. His scope of expertise includes early interaction with marketing research to implementing the manufacture of bulk drug for preclinical pharmacology, toxicology and formulation development, up to the contracting of phase I/II clinical studies. He has extensive industry experience including positions as Vice President, Worldwide Drug Delivery Research & Development for the Upjohn Company and interim senior operations roles in several mid-size biopharmaceutical companies.
Joachim Vollmar, MSc - Mr Vollamr is an internationally recognized biostatistician and a co-founder of PRESCOS, an AAALAC accredited contract preclinical research lab. He was previously Executive Vice President of Global Product Development Services and Managing Director of European Operations for PRA International, where he was a company co-founder. Prior to PRA Mr Vollmar served as Head of the Department of Risk Analysis Therapeutics at Boehringer Mannheim (Mannheim, Germany). He was Co-Chair of the DIA Statistics SIAC, a Member of the Commission "Coordination Centers of Clinical Trials" of the German Federal Ministry of Education and Research (BMFT Gutachterausschuss "Koordinierungszentren für klinische Studien" (KKS)), and a Member of Commission B4 (Endocrinology) of the Federal Agency of Public Health (BGA) in Berlin, Germany.
"Our new Premier Experts further strengthen our international roster of highly-experienced medical product development experts and will play a key role in the delivery of high-impact services to our clients", said Dr Peck. "These individuals represent some of the very best in their fields of expertise and we are pleased with their decision to become part of the NDA Partners team."
About NDA Partners
NDAP 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 and investment funds. The highly experienced Principals and Premier Experts of NDA Partners include two former FDA Center Directors and an extensive international team of former pharmaceutical and medical device industry senior executives and regulators. Services include expert consulting, product development planning, regulatory strategy, advisory boards, product assessments and due diligence, litigation and patent support, and associated support projects.
Earle Martin, General Manager