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.
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For experienced professionals, taking on an internship might seem unconventional, but it can be a smart move for career transitions, skill-building, or breaking into a new industry. Here are some creative ways to position yourself as an “intern” while still leveraging your expertise:
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. The vaccine candidate is made of a self-assembling protein nanoparticle displaying the 60 copies of the receptor-binding domain in a structure that resembles the natural virus. The nanoparticle vaccine designed by scientists at the University of Washington (UW) School of Medicine in Seattle, was funded by over a dozen funding sources, and has been transferred to two companies for clinical development.
From a regulatory perspective the computer aided design has the advantage of rationally predicting immune responses and potential immune related potency and safety aspects for the vaccine and facilitates the description of the vaccine structure and components in the clinical trial application (IND/IMPD/CTA). The acceleration of the vaccine development itself (from preclinical through to Phase 1, Phase 2, Phase 3 and licensure) is influenced by the complexity of the processes used to manufacture the selected drug substance and formulate the drug product.
The advantage of structure based vaccines candidates, such as that described by Walls et al, is the potential for superior, by design, selection and development of highly active vaccine products. More active products may require fewer injections, lower dosages, and longer lasting immune responses, clearly a benefit for improved access and prevention of disease in our global community. For the U. Washington COVID-19 candidate, the molecular structure of the nanoparticle vaccine roughly mimics that of the virus, which may account for its enhanced ability to provoke an immune response.
www.sciencedaily.com/releases/2020/11/201102110024.htm
REFERENCES:
https://www.cell.com/cell/fulltext/S0092-8674(20)31450-1
https://newsroom.uw.edu/news/ultrapotent-covid-19-vaccine-candidate-designed-computer
Package Insert: Bexsero https://www.gsksource.com/pharma/content/dam/GlaxoSmithKline/US/en/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF
Package Insert: Menveo
https://gskpro.com/en-us/products/menveo/?cc=ps_XUV67F3Z74511581&mcm=170001&gclid=CPnf0aLb7OwCFbIJiAkdToMH2Q
Package Insert: Shingrix
https://www.shingrix.com/index.html?cc=ps_YAM8LSRMAH421239&mcm=10010&gclid=b71c71acf58a134f16f22e086a4cf0e4&gclsrc=3p.ds
Crank et al. (2019) THE VRC 317 STUDY TEAM SCIENCE02 AUG 2019 : 505-509 https://science.sciencemag.org/content/365/6452/505.full
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 these successful applications is often an underutilized tool in planning for new product applications. The summary basis of approvals are a good place to get started, followed by cross referencing the of NCT (National Clinical Trial) numbers on the clinicaltrials.gov website, and then a deep dive into the CMC information requests and advisory committee minutes.
Note: All text below is extracted from the FDA website.
Imlygic (talimogene laherparepvec) is an attenuated herpes simplex virus type 1 (HSV-1), engineered to express human granulocyte macrophage colony stimulating factor (GM-CSF) to enhance the response to tumor antigens released during virus replication. Imlygic is indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
IND (2005) to BLA approval (2015): 10 years
Luxturna (voretigene neparvovec-rzyl) LUXTURNA is a recombinant adeno-associated virus serotype 2 (AAV2) vector expressing the gene for human retinal pigment epithelium 65 kDa protein (hRPE65), for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy.
IND (2007) to BLA approval (2018): 11 years
Zolgensma (onasemnogene abeparvovec-xioi) is a recombinant adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
IND (2013) to BLA approval (2019): 6 years
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.
“This guidance provides an overview of key considerations to satisfy regulatory requirements set forth in the investigational new drug application (IND) regulations in 21 CFR Part 312 and licensing regulations in 21 CFR Part 601 for chemistry, manufacturing, and controls (CMC), and nonclinical and clinical data through development and licensure, and for post-licensure safety evaluation of COVID-19 preventive vaccines.”
In this document FDA provides guidance on the expectations for COVID related CMC development. In summary, the need for product specific data for your product can be reduced by leveraging the science related to your product, using common sense, and following established guidelines.
Messages:
Leveraging Data for Acceleration:
References in the COVID guidance for industry: