Richard Francis

· Over 44 years’ experience in the biopharmaceutical industry and 15 year’s experience as an expert CMC consultant having works with 30+ companies from early to late-stage programs.

· Involved in leading or as part of multi-disciplined teams in gaining regulatory licensure for 18+ products such as OKT3, Remicade, Reopro, Caplacizumab, many recombinant proteins and gene therapy products.

· Well experienced in guiding CMC development from early stage through to commercialisation.

· Well experienced in development and manufacture all forms of antibody type products including nanobodies, multiple fusion proteins, bispecific and ADC forms (linker chemistry, payload optimisation and characterisation / stability).

· Experienced in the manufacture of fusion proteins and nanobodies using E. Coli and CHO cell culture substrates and developing processes using the ICH Quality guidance principles to enable identification of critical quality attributes and process control strategies based on the enhanced process development approaches. A recent example was performed to the approval of FDA, MHRA and EMEA for the product Caplacizumab (previously Ablynx now Sanofi).

· Subject Matter Expert in Analytical characterisation / comparability, Upstream, Downstream and final drug product manufacture of biopharmaceutical products.

· Experienced in managing contract manufacturing activities for drug substance and product at all phases of a products development and lifecycle.

· Managed and delivered many Process Performance Qualification campaigns which passed regulatory agency (FDA, EMA and MHRA) scrutiny.

· Significant involvement in the regulatory agency submissions both preparation of content and interaction with regulatory agency staff. This covers many FDA, EMEA, Japanese and rest of the world approved biological products.

· Direct involvement in manufacturing site Pre Approval agency inspections and compliance audits.