VectusBio Consulting is led by Dr Patrick Ginty, a regulatory affairs professional with 20 years experience in the development of cell and gene therapy and complex biological products. 

Patrick has led the regulatory affairs depts / advanced therapy activity at multiple organisations including the Cell and Gene Therapy Catapult, AviadoBio, Boyds and Adaptimmune. He is currently also serving on the advisory board at Forge Genetics, a company developing novel genetic engineering tools. 

A summary of Patrick's experience and achievements is provided below: 

- 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 EU, UK and US

- Regulatory expertise includes modules 1-5 (BLA, MAA, IND), EU CTR, GMO, GXPs, ILAP, PRIME, RMAT, fast track designation, RPDD, orphan drug designations with experience of over 30 scientific advice meetings (FDA, EMA, MHRA, 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

- Served as the chair of both the Alliance for Regenerative Medicine (ARM) European regulatory affairs committee and the BIA Regulatory Affairs Advisory Committee (RAAC) between 2017 and 2021 and was the regulatory lead for the Global Alliance for iPSC Therapies (GAiT) during the same period.

- 40 scientific articles, abstracts, standards and patents published in life and materials sciences 

- Co-authored the single Common Application Form (CAF) for EU GMO submissions to support clinical trials as part of an EU industry body-led consortium 

- Received certification in US regulatory affairs from RAPS (regulatory affairs professionals society) in 2009

VectusBio Consulting

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VectusBio Consulting

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