Industry Insights

1. Unlocking New Insights And Treatments For Genetic Eye Diseases: ADOA 6/20/2022

   This article explores how ADOA (Autosomal Dominant Optic Atrophy) occurs, and why it has become a promising target for new approaches to treatment.

2. From Manufacturing Floor To C-Suite: “Scaling Up” Cell & Gene Therapy Communication 6/20/2022

   Though "communicate often" is a commonly offered best practice in the CGT space, it’s rarely discussed what this can and should look like, especially when it comes to elevating information from the manufacturing floor/team up to the C-Suite. My conversation with Mark Gergen, CEO of Poseida Therapeutics, however, gives us a great look of what this can look like for growing CGT companies.

3. Building The Next Breakthrough In The Decades-Old Field Of Transplant 6/16/2022

   The company's lead investigational product is a composition of high-purity regulatory T cells, conventional T cells, and stem cells designed to fight cancer and infection while limiting the risks of graft versus host disease (GvHD).

4. The “Renaissance” Approach To Cell & Gene Therapy Manufacturing 6/13/2022

   We’re all familiar with the concept of the “Renaissance Man/Woman". In the context of the CGT space, however, can there be such a thing as a “Renaissance Company”? My conversation with Poseida Therapeutics' CEO Mark Gergen proves that there can be and establishes why a generalist mindset is necessary to bring the CGT manufacturing paradigm to maturity.

5. How To Leverage RWE To Facilitate Access To Cell & Gene Therapies 6/13/2022

   As more and more cell and gene therapies hit the market, the already intense pressure to figure out how to pay for them will only increase. This article shares how real-world evidence (RWE) can be leveraged to help offset economic uncertainties, facilitate access, and create a sustainable foundation for long-term data generation.

6. How To Test Master Cell Banks As A Starting Material For Gene Therapies 6/10/2022

   BioPhorum’s Cell and Gene Therapy Raw Materials team suggests a platform approach for testing a critical starting material for gene therapies – master cell banks (MCBs). This can ultimately influence and/or aid regulatory agencies when developing guidance or policies around gene therapy development and manufacturing.

7. Natural Killer Cells: Promise For Cancer Immunotherapy 6/6/2022

   Inside why natural killer (NK) cells are uniquely suited for targeted cellular therapies for cancers

8. Weathering The Biotech Storm: Accelerating Manufacturing, Controlling Cost, And Managing Risk With A Strategic CDMO Relationship 6/6/2022

   From manufacturing bottlenecks to staffing challenges, here's why biotech companies are increasingly forming strategic partnerships with CDMOs to help them navigate the challenges impacting their assets.

9. ARW’s C&G (+RNA!) Manufacturing Must-Reads (Dracula Edition!) 6/3/2022

   Day-in and day-out, I write, read, listen to, and watch as much content as I can about C&G therapy manufacturing, in particular, and/or other C&G industry-related topics that you should at least be aware of in the manufacturing facility. Every two weeks, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email. But inboxes can be shifty places. (Cue George Carlin on “Losing Things.”)

10. Addressing The “Achilles Heel” Of Gene Therapy Manufacturing 5/31/2022

    This article explains why an industry-leading CMC package and team is the fundamental success factor enabling all vector technologies.