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Vice President, Global Product Development, Cell, Gene and Protein therapies, Catalent

Vinci has more than 30 years’ technical and leadership experience in the pharmaceutical industry. He joined Catalent following the company’s acquisition of Cook Pharmica, LLC, where he served as Vice President of Product and Process Development. 

Vinci has led cross-company and FDA QbD collaborations, including the A-Mab case study exercise, where he and a consortium laid the foundation for QbD from proof of principle to BLA filing, and later for life cycle management for antibodies. This was in 2009, and the industry has been following these guiding principles since. The framework was later used to develop the guiding principles of QbD for other modalities.

During the pandemic, Vinci led Catalent’s development, MSAT and project management teams through the onboarding, tech transfer, and scale-up of the critical production of the Moderna, Johnson & Johnson, and AstraZeneca COVID-19 vaccines and investigational therapies across multiple sites. By the end of 2021, Catalent had produced over a billion COVID-19 vaccines and treatments, while simultaneously keeping plants operational and manufacturing all regular products.

We asked… 

What are the biggest challenges affecting the field?

Science is moving so fast with respect to technology innovation and new applications that it creates challenges in establishing the tools to develop, manufacture, and scale up these therapies for clinical trials and potential commercial launch. Cell and gene therapy innovators and CDMOs are investing a lot of time and energy to develop robust platforms, processes, and analytical packages to help accelerate process scale-up and GMP manufacturing. AAVs and lentivirus processing schemes are starting to reach the level of platforms, but for cell therapy processing, there will be more than one platform and significant improvements in closed, connected, and more automated or digitally linked equipment is needed.

If you weren’t in the pharma industry, what would you be doing?

I have been a history and art buff since I was young. I was a history major for all of one quarter in college. Whenever possible, I try to visit museums or historical sites when I travel. So now I mostly read a lot of historical biographies, so maybe I could have been a historian.