CMC Support

• Extensive experience in R&D of biologics and therapeutics, including development of viral and bacterial vaccines, gene therapies for oncology, and protein and peptide-based therapeutic products.
• Leadership of Assay Development and Quality Control functions in small, mid-sized and large biopharmaceutical companies (including study design, method and equipment qualification and validation, product release, and stability tracking and trending).
• International Project Team experience.

For more than 20 years Dr. Staples has helped transform scientifically interesting projects into commercial products serving unmet medical needs. His product development activities include pharmaceutical development of proteins and peptides and project management of the technical (CMC) portion of regulatory submissions. He has participated in five early stage companies. He held Director and Vice President level positions at several start-up companies 1997-2007, and has been a consultant since 2007.