Apex Biologics Consulting Ltd was founded by Gordon in April 2019 with the main focus of providing expert CMC support to companies looking to develop novel Biologics for the first time, as well as established sponsors. Gordon is an expert in regulatory and development CMC with more than twenty one years of experience in the development of clinical products. Five years at Novartis Pharma as Technical Project Leader and Global Programme Technical Director; ten years in the SME Biotech Industry; three years in regulatory consulting. He has a proven track record as a CMC programme leader promoting operational excellence in the development of Biologic medicines; he has developed products with six of the top global Biologics CMOs. Most recently, Gordon spent four years at Abzena, a leading biologics target to GMP partner research organisation, as VP Alliance and Programme Management where he championed technical programme planning innovation for the company's ADC and antibody platforms.
Gordon is an expert in the production of monoclonal antibodies, antibody fragments, growth factors, PEG proteins and antibody drug conjugates; energising & empowering highly performing teams behind a common vision; formulation development; processing technology; cell culture; microbial cell substrate genetics & production technology; support for due diligence activities world-wide. Extensive expertise in the implementation of MS Project Online for resource, cost and project planning/execution in a global operational environment.
Regulatory: Gordon filed his first CTA in the UK in 2002 & his first MAA in the EU in 2006, which included participating as the Sponsor’s CMC lead in pre-approval inspections & oral presentations to the BWP & CHMP. Since then, he has lead CMC teams filing numerous INDs & IMPDs for Biologics worldwide, in diverse indications, supporting the successful filing/approval of MAA/BLAs for Biosimilars in the EU as a Senior Regulatory Consultant at Parexel Consulting.