Perspectives

In response to workforce challenges in vaccine testing laboratories, I spearheaded an international project aimed at upskilling teams facing employment displacement. This initiative not only safeguarded expertise in public health but also fostered cross-disciplinary collaboration between architects, biological scientists, and regulatory professionals to optimize laboratory efficiency and compliance with global standards.

Decades of infectious disease research have shaped gene therapy by refining immune modulation—while vaccines stimulate immunity, gene therapy must avoid immune activation for safety. These insights, alongside public health infrastructure, have accelerated gene therapies for SMA, vision loss, and infectious diseases. With vaccine-based manufacturing and regulatory pathways, gene therapy is now poised to deliver transformative treatments worldwide.

Disclaimer: The ideas here are tried and true based on my own or colleagues direct experiences. They are not theoretical.

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Linked in Message, text 

Hi Tom , I Hope you're doing well! I'm exploring ways to transition into a new role and was curious if your company or network might have opportunities like short-term consulting projects, pilot initiatives, or advisory roles where I could contribute while learning.

Would love to hear your thoughts or any leads you might have! Let’s catch up soon.

Over the last decade structure based protein platforms have been viewed as a potential catalyst for vaccine development. To this end, computer aided vaccine engineering has been applied for the design of recently licensed vaccines for meningitis and shingles prophylaxis and for a Phase 1 vaccine candidate for Respiratory Syncytial Virus (RSV). Recently the team of Walls et al. published results in the journal Cell demonstrating promising immune responses in animals injected with a vaccine candidate generated by computer modeling of the COVID-19 and associated proteins.

One virus therapy and two gene therapies have been approved by FDA in the last 10 years. The FDA website contains public information on the CMC review discussions, information requests, manufacturing inspections, and the advisory committee discussions. 

Regulatory professionals and product developers, scientists and investors are all wondering, how does/will the urgent need for a COVID vaccine affect the CMC regulatory landscape, are rules changing, are standards changing, what does ‘acceleration’ mean? Today FDA released the Final Guidance for Industry:  Development and Licensure of Vaccines to Prevent COVID-19.