Specialist consulting services in cell and gene therapy
“VectusBio” is led by Dr Patrick Ginty, a regulatory affairs professional with 20 years’ experience in the development of cell and gene therapy and other complex biological products.
Patrick has led regulatory affairs departments / advanced therapy activity at multiple organisations, including Cell and Gene Therapy Catapult, AviadoBio, Boyds and Adaptimmune.
Specific experience and expertise includes the following:
– Supported and or led the progression of more than 50 products into the clinic and the development of 7 approved cell and gene therapy and biological products across the UK, EU and US
– Regulatory expertise includes CTD modules 1-5 (BLA, MAA, IND), EU CTR, GMO, GXPs, ILAP, PRIME, RMAT, fast track designation, RPDD, orphan drug designations and over 30 scientific advice meetings (FDA, EMA, MHRA, PEI, etc.)
– Product expertise includes in-vivo and ex-vivo gene therapies (including AAV, CAR-T and TCR-T), pluripotent stem cells, somatic cell therapies and combination products
– Therapeutic expertise includes CNS, bleeding disorders, oncology, ophthalmic, cardiac, respiratory and numerous rare diseases (including lysosomal storage and metabolic disorders)
Services include but are not limited to:
✔ Regulatory strategy and roadmap generation (UK, EU and US)
✔ Leading and supporting scientific advice procedures and agency interactions, including preparation and review of briefing books
✔ Product classification advice
✔ CMC and non-clinical regulatory support and advice
✔ Novel early-phase clinical trial design
✔ Review and preparation of clinical trial application packages e.g. clinical protocols, IBs, IMPDs, etc.
✔ Review and preparation of technical documents and regulatory filings e.g. CTD modules 1-5, orphan drug applications, GMO dossiers, product designations e.g. PRIME, RMAT
✔ Due diligence on data packages and regulatory filings
✔ Gap analyses
✔ Grant application preparation and review
VectusBio is the trading name of VectusBio Consulting, a limited company registered in England and Wales, registration number: 16845149.
Registered Address: 20 Wenlock Road, London, N1 7GU, UK