Taken from Executive Platforms Biomanufacturing World Summit, November 2021

I am Jack Garvey, Founder and Managing Partner of Compliance Architects.

Some trends occurred before the COVID crisis, and I think the COVID crisis really exacerbated and crystallized the importance of biopharmaceuticals to modern public health. What we have seen, and again, it was starting prior. Still, certainly during the COVID crisis, and now it's evident that we get into the later stages, is that the future of therapies for the American public and the global community will be biopharmaceutical-based.

The amount of innovation, inventiveness, and determination relative to new and exciting cell and gene therapy therapies, genetic engineering, and traditional biologics is just mind-blowing. Combining that with the digital revolution, which is also kind of in its, I don't know what phase, third or fourth phase of maturity there, there's just some really exciting alignment between those two that is driving both innovation and exciting opportunities for the future.

One of the other things we see is that there is a distinct gap in talent and resources available to support these industries. There's a lot of great science going on out there, but science is not a product. Science is a concept that requires a profound knowledge of how to commercialize products, and that's hard to find these days. I think that's a real challenge for the biopharmaceutical industry and one of the trends that we're seeing all across the board. People need the expertise they need, guidance, a deep understanding of the regulatory framework, the operational essential lifecycle, and how to get a product from concept through the early stages of regulatory review and consideration, through the CMC process, and into commercial production.

That's really where some of the challenges are.
Chapters:
00:00:00 - Introduction to Compliance Architects
00:00:12 - The Importance of Biopharmaceuticals to Modern Public Health
00:00:24 - The Future of Biopharmaceutical Therapies
00:00:38 - Innovation in Cell and Gene Therapy and Genetic Engineering
00:00:54 - The Mind-Blowing Combination of Traditional Biologics and the Digital Revolution
00:01:06 - Exciting Alignment Opportunities
00:01:20 - The Gap in Talent and Resources in Supporting Industries
00:01:32 - The Challenges of Commercializing Scientific Products
00:01:46 - Trends in the Biopharmaceutical Industry
00:01:58 - The Life Cycle of a Product
00:02:10 - Addressing Challenges