CMC Support

Mr. Gordon Arbuthnot, senior director of CMC, has 35 years of commercial experience in the pharmaceutical industry. His career of more than 32 years at Eli Lilly and Company included CMC work on compounds covering the entire spectrum of drug development, from preclinical research to the successful registration and launch of new pharmaceuticals. After retirement, he consulted on a number of CMC projects and worked for the startup company Marcadia Biotech. Mr. Arbuthnot has published in the CMC discipline, is a registered professional engineer in the state of Indiana, and is an inventor on a number of patents.

• 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.