Ronald A. Salerno, PhD

Ronald A. Salerno, PhD

Group Leader
CMC Development

SUMMARY OF EXPERTISE

  • Twenty-six years of experience in Regulatory Affairs for Vaccines, Biologics and Drugs including regulatory strategy and submissions for product development and licensure
  • Regulatory consultant for FDA IND, BLA, NDA application preparation, review, submission and management, including gap analyses
  • FDA, EMA and WHO regulatory guidance and strategy
  • Joined Biologics Consulting in 2008, providing regulatory affairs strategy and submissions support for small and large biopharmaceutical companies developing vaccines, biologics, drugs or IVDs. Currently Biologics Consulting Team Leader for CMC Manufacturing and Regulatory Strategy Consultants. Prior to Biologics Consulting, worked as the Global Regulatory Therapeutic Area Head for Wyeth Vaccines, leading a regulatory group responsible for bacterial and viral vaccines in early development as well as licensed bacterial vaccines. Employed from June 2001 to June 2006, as Regulatory Director for Translational Medicine Research, applied Pharmacogenomic biomarkers in co-development of drugs and diagnostics for regulatory submissions. Prior to 2001, was employed by Merck & Co., contributing significantly to Merck’s vaccine products while holding various research, manufacturing and quality regulatory positions. While completing a two-year assignment in Germany managing regulatory affairs in Europe for Merck vaccines, directed the first marketing authorization of Hepatitis A vaccine. As Merck’s Biologics Licensing quality director, managed the preparation, submission, and filing strategy for CMC of marketed and developmental vaccines and biologics in US.
  • Examples of product consulting projects include the following:
      • Vaccines: (DNA, Viral and Bacterial): Regulatory Lead consultant, author and reviewer of pre-IND meeting, RAC, CTD and eCTD IND submissions for rDNA HIV vaccines, viral vaccines and gene therapy vectors, eCTD International MAA Dossier for viral and bacterial vaccines, WHO Prequalification of bacterial and viral vaccines
      • Biologics (Cell therapy products, monoclonal antibodies): Regulatory Lead consultant for: 1) autologous cellular therapeutic company focused on the development of cellular products for aesthetic, medical and scientific applications, including management of BLA and several INDs; 2) development of monoclonal antibodies (autoimmunity and oncologic indications); 3) Regulatory EMA scientific advice preparation; 4) Regulatory FDA and EMA advice meetings
      • Drugs (oncology, HCV antiviral, botanical drugs): Lead Regulatory consultant for Biotechnology Pharmaceutical Company for clinical and CMC development of product pipeline of oncology, botanical and gene therapy products
      • Devices (In vitro diagnostic test): Regulatory Lead consultant for Molecular Diagnostic Company for Pharmacogenomic test; and for pharmacogenomics voluntary exploratory data submission for biomarker in co-development project of drug and diagnostic

Education

PhD, Zoology, University of Maryland, College Park, MD (1971)

MS, Zoology, University of Maryland, College Park, MD (1970)

MS, Biology, Villanova University, Villanova, PA (1967)

BA, Biology, Saint Vincent College, Latrobe, PA (1964)