NDA Partners is a ProPharma company.
Dr. Salazar-Fontana’s extensive industry and regulatory experience in the development and regulation of biotherapeutic drugs will be valuable to clients developing biotherapeutics such as recombinant enzymes, monoclonal antibodies, biosimilars, and cell and gene therapy products.
WASHINGTON (PRWEB)
July 20, 2023
NDA Partners’ Vice President and General Manager, Eric Fish, announced today that Dr. Laura Salazar-Fontana, a regulatory science professional with over 15 years of experience in the development of biotherapeutic drugs acquired as FDA regulator, biotechnology regulatory lead, and independent consultant, has joined the firm as an Expert Consultant. Dr. Salazar-Fontana was formerly a CMC and Immunogenicity Reviewer at the US Food and Drug Administration (CDER) and has held multiple leadership roles in large and mid-size pharma companies both as regulator and as translational scientist for immunology and biomarkers. She has extensive experience preparing CMC and immunogenicity regulatory documentation for biotherapeutics, including biosimilars, and cell and gene therapy products.
According to Dr. Ellen Feigal, Manager of the firm’s biologics practice, “Dr. Salazar-Fontana’s extensive industry and regulatory experience in the development and regulation of biotherapeutic drugs will be valuable to clients developing biotherapeutics such as recombinant enzymes, monoclonal antibodies, biosimilars, and cell and gene therapy products. We are pleased to welcome Dr. Salazar-Fontana to NDA Partners and to the Biologics Practice.”
Dr. Salazar-Fontana received her PhD in Biochemistry and Molecular Biology from the Universidad Autónoma de Madrid (Spain) and bachelor’s degree in Biological Sciences, Biochemistry, and Molecular Biology from the Universidad Autónoma de Madrid (UAM). She is a member of the American Association of Pharmaceutical Sciences (AAPS) and part of the Immune Responses to Gene & Cell Therapy committee within the American Society of Gene & Cell Therapy (ASGCT).
About NDA Partners
NDA Partners, a ProPharma 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, Vice President & General Manager
Office: 540-738-2550
FishEric@ndapartners.com
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