Program and Project Management for Vaccine Testing Laboratories
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…
Infectious Disease Research Paved the Way for Gene Therapy Innovation
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 in…
Hidden Opportunities: Internships for Experienced Scientists Seeking New Employment
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 op…
FDA Viral and Gene Therapy Approvals
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.
Understanding the regulatory history for…
FDA Guidance for Industry
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 In…
COVID-19 vaccine candidate designed via computer
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 ca…