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Phil Vanek is responsible for technical due diligence and evaluation of potential investments, as well as guiding operational, R&D and strategic initiatives carried out at portfolio companies. An entrepreneurial and strategic international business leader, Phil joins Gamma Biosciences from GE Healthcare’s Cell and Gene Therapy business unit where he directed strategy and portfolio growth. Phil received his Ph.D. in Biochemistry and Molecular Biology at Georgetown University Medical Center followed by an IRTA fellowship at the National Cancer Institute in Maryland, and at the Hollings Cancer Center in Charleston, SC. Phil was an instructor for Johns Hopkins University Advanced Academic Programs teaching Biotechnology Marketing in the Masters of Biotechnology/MBA program, and has held leadership positions in a number of life sciences companies including Life Technologies, Becton Dickinson, and Lonza. Phil is a Board Member of CCRM in Toronto, Canada, and a Board Member of the ARM Foundation.

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Charles Dickens could just as easily have been describing our world amidst COVID when he wrote “It was the best of times, it was the worst of times.” The past several months have taught us a lot about humanity, about science, and about the challenges of adjusting, at a grand scale, to new ways of working and interacting.

In the first quarter of 2020, COVID-19 (then broadly described as simply Coronavirus) was something happening “over there;” reported more often in brief health care news segments than as a global headline. As a cell and gene therapy (CGT) community we were going about our business, attending Phacilitate in Miami, booking travel to the Alliance for Regenerative Medicine (ARM) Meeting on the Med, planning for ASGCT and ISCT conferences, and closely tracking news from our colleagues at the forefront of our fast-paced industry.

Then, like a burning wildfire, COVID-19 erupted, and made us realize how susceptible to a world pandemic we really are. It was no longer “over there;” it was in our midst. And, like everyone else around the world, the CGT community reacted, mobilized and quickly adapted, professionally and personally, to our situation. For me, having recently departed my position at GE Healthcare to pursue a new career at Gamma Biosciences, it was time to take stock, absorb and analyze data, and squeeze some lemons into lemonade.

Here are a few of my reflections.

Our exploration over the years into systems-level biology, inflammation, immunology, Big Data, and cell and gene therapy has enabled our rapid response to the COVID-19 situation. And, like the often-touted, lightning-fast Mumps vaccine development in the ‘60s, progress in developing a COVID-19 vaccine was going to depend on all the technological learnings and advances leading up to it.

The ability to transform sequence data, published on a broadly accessible database into a vaccine candidate, in only a few short weeks, is an exemplar of how far the scientific community has advanced. Without the information, tools and technologies we deployed against SARS-1 and SARS-2, it would be difficult to predict what immunogen would produce a robust and lasting response in human subjects, and to come up with strategies for vaccination in such a short period of time. All of this progress was made possible by investment – public and private – into the life sciences and pharmaceutical fields, and by the innovators in the life-sciences tools space that are providing the equipment and reagents to move at such a pace.

So, what tools do we have available to us in the advanced therapy field that are being redeployed or repurposed to support the fight against COVID-19 (and other urgent health care challenges)?

Let’s start with single-use bioreactors for viral vector manufacturing.

To produce enough vaccine to manufacture the doses required to stanch the spread of COVID-19, we need huge amounts of bioreactor capacity. Years ago, only clean-in-place stainless steel would afford the capacity needed but, over the past decade, improvements in bioreactor design – sparked partly by the need to lower the cost of viral vector manufacturing – have made single-use systems contenders in the rapid deployment of a new vaccine.

Gamma’s investment into Univercells Technologies, Scale-X, and NevoLine platforms were driven in large part by the recognition that cell culture technologies to support highly efficient vaccine and viral vector manufacturing were going to be needed if gene therapies were to become a standard of care in our health systems. While the Univercells Technologies’ platforms were designed to support affordable vaccines in the developing world, the core technologies are modular, quickly deployable and scalable to support both development and manufacturing across broad categories of vaccines, and CGTs.

Rapid advancement against the COVID-19 pandemic also required leveraging of cell line development methodologies to assure that once a vaccine candidate was identified, it was safely manufacturable at scale and readily deployable to all parts of the globe. Cell lines that have been engineered to better control the producer-line growth phase in culture, and to optimize productivity once induced, have been steadily improving over the years. This improvement has been driven in part by the demand for higher productivity in biologics, and CGT manufacturing. It’s no surprise that the same principles would be highly prized when it came to our COVID-19 response.

Manufacturing capacity and supply chain management challenges – issues facing the CGT industry for a number of years now – have also been stressed during the pandemic response.  While the headlines around the world were around the shortages of ventilators and personal protection equipment (PPE), the availability of clean room space, which was rapidly adaptable to manufacture vaccines, also showcased that we had yet to optimize the available capacity for clean rooms, and exposed the fragility of our supply chain.

The CGT industry is no stranger to supply chain challenges, and I predict that many of the tools designed to improve the supply of advanced therapies – from logistics management to facility optimization and scheduling – will be utilized in the coming months in our fight against COVID-19.

All in all, between the relentless Zoom calls and the virtual conferences, I’ve been comforted to know that we live in a world of biological possibility with therapeutic developers and life science innovators coming together in creative ways to solve this world crisis. The scientific community is building upon a legacy of technological advancements designed and built, in part, to help advance the CGT industry.

While we’re not out of the woods yet, it is reassuring to know that there is a silver lining to our shared COVID-19 experience – one that will drive continued innovation, discovery and investment in advanced therapies for years to come.

My blog is just one of many covering the opportunities and challenges for the regenerative medicine field arising from COVID-19, as part of Signal’s fifth annual blog carnival. Please click here to read what other bloggers think about this.

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Guest

Signals accepts guest blog posts on topics relevant to stem cells and regenerative medicine, as well as submissions for its Right Turn Friday feature. The opinions, accuracy, completeness and validity of any statements made in guest posts are the responsibility of the author only and not the editor of Signals or CCRM, publisher of Signals. The copyright of this content belongs to the author and any liability with regards to infringement of intellectual property rights remains with the author. To reach the publisher, email info(at)CCRM.ca