CMC Consulting for Cell and Gene Therapy Products
About us
Advanced Biologics Consulting offers independent consulting services for CMC activities throughout all stages of the product lifecycle (pre-clinical through to post authorisation) for biological medicinal products with a comprehensive experience in Advanced Therapy Medicincal Products (ATMPs).
Sharon Longhurst is the founder and principal consultant of Advanced Biologics Consulting. She has more than 20 years' experience in product development, encompassing viral vectors, cell therapy and recombinant protein products. She has worked in leadership roles as Head of CMC and VP of Development.
She has comprehensive experience of EMA/national EU regulatory agencies and was a member of the Gene Therapy Working party at EMA. She also has FDA regulatory experience and represented the EMA at ICH when working at the MHRA.
Sharon Longhurst
Technical excellence
- 20+ years in CMC development of biological products, specializing in ATMPs. Specifically process and analytical development/validation, product characterization, stability testing, specification setting.
- Experience with dendritic and T cell therapies as well a viral vectors (LV, AAV and Adenovirus).
- Supply and logistics (for clinical studies and longer-term commercial supply strategies)
Regulatory experience
- Review and authoring of M3 for CTA/IND, MAA/BLA and scientific advice briefing packs and acting as company representative at scientific advice meetings.
- 6 years’ experience as pharmaceutical assessor at MHRA; including centralised (EMA) MAA reviews and writing EMA regulatory guidance for ATMPs
- 5 years’ CMC consulting for biological products including biosimilar MAbs as well as ATMPs, and co-authored 5 biological MAA
- Completed CMC assessments of new applications and variations as well as provision of scientific advice for European and national regulatory procedures for biological medicinal products including vaccines, recombinant proteins, blood products and MAb, and specializing in Advanced Therapy Medicinal Products.
Leadership
- Leads by example; is an enthusiastic team player; approachable, knowledgeable, engaged and supportive.
- Has overseen product quality / process development strategies for a dendritic cell therapy and genetically modified T cell products
- Leadership roles as VP of Development and Head of CMC in SME biotech companies.
- Has led a CMC team of 7 and been a member of the Management Team in previous roles.
Team player
- Keeps all stakeholders informed and gives each team member a voice to be heard.
- Clear delineation of roles and responsibilities and expectations.
- Enjoys cross functional teamwork which is critical to product development.
Strong communication skills
- Ability to communicate the higher-level overarching principles, for example board presentations or overarching company strategies to a team, while also understanding and articulating the potential impact of those strategies at a more detailed level as required.
- Regularly presenting at conferences and supporting workshops.
