Senior Global Regulatory Affairs Executive, Dr. Daniela Drago, Joins NDA Partners as Expert Consultant


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Dr. Drago’s extensive global regulatory experience will be valuable to our clients developing biologics, cell and gene therapy products, and small molecules.

NDA Partners’ General Manager, Eric Fish, announced today that Dr. Daniela Drago, a senior global regulatory affairs executive, has joined the firm as an Expert Consultant. Dr. Drago is a regulatory affairs executive with a history of accomplishments spanning pharmaceutical, biotech, and academic roles. She has held senior global regulatory and medical affairs positions at Biogen, Roche, Vifor Pharma, Reckitt Benckiser, Aurion Biotech, and Bausch & Lomb. She was formerly an Associate Professor at George Washington University’s School of Medicine where she redesigned and led the regulatory affairs program. Currently, she is an Adjunct Faculty for the University of California, San Francisco (UCSF), American Course on Drug Development and Regulatory Sciences (ACDRS), and the University of Basel, European Center of Pharmaceutical Medicine (ECPM).

Dr. Drago has significant global expertise in the development of small molecules, biologics, cell and gene therapies, and combination products in multiple rare and common disease areas, including ophthalmology, neurology, immunology, and oncology. “Dr. Drago’s extensive global regulatory experience will be valuable to our clients developing biologics and cell and gene therapy products, and small molecules. We are pleased to welcome her to NDA Partners and our Biologics Practice,” said Dr. Ellen Feigal, who leads the firm’s Biologics Development Practice.

Dr. Drago serves on the Regulatory Affairs Committee of the American Society of Gene and Cell Therapy (ASGCT), the Regulatory Affairs Certification Board of Directors, and the Executive Committee of ACDRS. She is a TOPRA Fellow (FTOPRA) and a Fellow of the Regulatory Affairs Professional Society (FRAPS). She has received several awards, including the TOPRA Award for Regulatory Excellence and the RAPS Community Leadership Award. She received her PhD in chemistry from the Swiss Federal Institute of Technology (ETH) in Zurich and MS in Chemistry from the University of Messina in Italy.

About NDA Partners

NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); 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, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.

Contact

Eric Fish, General Manager

Office: 540-738-2550

FishEric@ndapartners.com

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