About Us

Joanne Broadhead is the founder of BioCMC Consulting Ltd, established in January 2022. Jo has over 30 years’ experience across the pharmaceutical, biopharmaceutical and advanced therapy sectors.

 

Jo has extensive experience in CMC development and CMC regulatory strategy for AAV gene therapies, including the authoring/review of CMC regulatory documentation, representing CMC at agency meetings and preparing responses to RFIs. She has also worked closely with start-up companies, guiding their progression towards and through clinical trials.

 

She is highly experienced in the oversight and management of outsourced GMP services, including manufacture, testing and secondary packaging, labelling, and clinical distribution, with extensive involvement in supplier governance, technical and quality oversight, and regulatory expectations.

 

Jo also has significant expertise in parenteral product development and manufacture (fill/finish), including lyophilisation.

 

Prior to establishing BioCMC Consulting Ltd, Jo spent over five years at Freeline Therapeutics, where she led the CMC projects and CMC regulatory teams, and supported multiple clinical trial submissions in Europe and the US for the company’s AAV gene therapy portfolio. 

 

Earlier in her career, Jo played a key role in late-phase product development for an MVA viral vaccine developer and spent over a decade at AstraZeneca in a range of parenteral product development and manufacturing roles. She also held an academic position as a lecturer at DeMontfort University.

 

Throughout her career, Jo has been an active member of industry organisations, including the Academy of Pharmaceutical Scientists and the American Society of Cell and Gene Therapy.