Rochelle, Virginia (March 17, 2016) - NDA Partners Chairman Carl Peck, MD, announced today the formation of a specialized practice area in chemistry, manufacturing, and controls (CMC) to address the needs of its early-stage biopharma clients for top-tier experts in this important area of drug and biologic development. Services include phase-appropriate CMC development and regulatory strategies; assessment of requirements for nonclinical and clinical testing; evaluation of dosage form, route of administration, and delivery technologies; manufacturing scale-up planning; regulatory readiness reviews and submissions; regulatory compliance; submission of data for pharmacopeial authorities that aid in the development of pharmacopeial standards for drug substances and drug products; and quality assurance systems. In addition, clients will have access to top Expert Consultants to assist in addressing critical issues that arise during their development programs, and in responding to and remediating regulatory agency inspection issues, infractions, and warning letters.
“We believe the depth of experience and strategic expertise of our CMC team is unmatched in the industry”, said Dr. Peck. “We are pleased to be able to offer our clients access to this extraordinary group of experts.”
The CMC practice area will be led by David Savello, PhD, a founder and Partner in NDA Partners. Dr. Savello formerly served as Senior Vice President for Development Operations at XenoPort, Inc., Executive Vice President and Chief Scientific Officer for Cardinal Health, and Vice President Drug Development and VP Regulatory Affairs at Glaxo and Glaxo Wellcome.
Members of the CMC team include:
Philip Goliber, PhD, a Partner in the company and former Vice President Pharmaceutical & Analytical Sciences, UCB Pharma SA
Terry Gerrard, PhD, former Director, FDA Division of Cytokine Biology (now called Therapeutic Proteins), CBER, and Director of Development, Amgen
Srini Srinivasan, PhD, former Executive Vice President & Chief Science Officer, Managing Director - India, and Vice President, International Sites and Global Verification Programs at US Pharmacopeial Convention (USP)
Katy Stein, PhD, former Director, FDA Division of Monoclonal Antibodies (CBER), and former Senior Vice President, Product Development, Regulatory Affairs and Manufacturing, MacroGenics, Inc.
Ellen Areman, MS, former Expert Biologist and Product Reviewer, FDA Office of Cellular, Tissue and Gene Therapies, CBER
Frank Manella, MBA, former President of Coldstream Laboratories, an aseptic product CMO, where, before becoming CEO, he designed, built, commissioned, validated and started up the operation
Richard Siegel, PhD, former Vice President & Global Head, Portfolio Management, Janssen R&D, and Vice President Pharmaceutical Development, Centocor R&D, Inc.
Daniela Drago, PhD, former Global Associate Director Regulatory Affairs CMC, Bausch & Lomb AG and Assistant Professor and Director Regulatory Affairs, GW University School of Medicine & Health Sciences
Royal Hathaway, former Senior Manager, Technical Services & Process Development at Otsuka Pharma, and Manager of Technical Operations at Cardinal Health
Richard Keenan, PhD, former Vice President, Center of Excellence for External Drug Discovery, and Director of Medical Chemistry, GlaxoSmithKline
Leo Lucisano, former Director, Quality Systems & Compliance, Global Manufacturing & Supply, and CMC Post-Approval Regulatory Affairs at GlaxoSmithKline
Suva Roy, PhD, former Senior Director Regulatory Affairs CMC, Otsuka Pharma, Director Regulatory Affairs, GlaxoSmithKline, and Supervisory Chemist, FDA Office of New Drug Chemistry, Division of Anti infective Drug Products.
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 Expert Consultants at 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 approximately 60 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, 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