September's Top Content On Cell & Gene
By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1
September has been a busy month here at Cell & Gene. We’ve delivered important content that I want to ensure you’ve read, watched, and heard. Whether it’s new to you or you’d like to revisit it and share it with your colleagues, here are some of the topics we’ve covered just this month:
As you know, our Cell & Gene Live events are interactive forums where the best and brightest people the cell and gene therapy space has to offer convene to discuss the most important technologies and trends impacting cell and gene therapies. Our most recent Cell & Gene Live, Stability To Scalability: The Future Of Viral Vector Therapies, featured expert panelists Dave Maheu, Vice President, Head of Process & Analytical Development at Candel Therapeutics and Curran Simpson, Chief Operating Officer at REGENXBIO for a deep dive discussion on accelerating scale for viral vector production. During the 60-minute presentation, Maheu, Simpson and I covered regulatory compliance for viral vector production, market demand, manufacturing capacity constraints and potential solutions, as well as the difficulties scaling production levels. The on-demand version of the presentation is available now, and it is well worth your time.
This month we shared two of my favorite podcast episodes to date:
Episode 58: Inside Genome Editing with CBER’s Dr. Peter Marks
Episode 59: In Vivo CAR T-Cell Therapeutics With Umoja Biopharma's Dr. Andrew Scharenberg
Let’s start with Episode 58 featuring Dr. Peter Marks. Dr. Marks returned to Cell & Gene: The Podcast (here’s his first visit on Episode 40) to discuss base editing and prime editing as well as their potential to meet unmet medical need. Dr. Marks and I discussed clinical holds and what those holds say about the FDA’s views on gene editing. We also discussed heritable genome editing. Here’s what I’ll say about this episode: yes, it’s informative just as you’d expect from anything Dr. Marks does. It’s so clear that despite being a very busy person with a tremendous amount on his professional plate, he is approachable, thoughtful, and more than willing to share information that will ultimately help bring life-saving therapies to the patients who need them.
In Episode 59, I had the chance to sit down with Umoja Biopharma’s CEO, Dr. Andrew Scharenberg. Andy and I talked through evolution of autologous, in vivo CAR-T cell therapeutics, recent progress in lentiviral vector manufacturing, and more. You’ll learn a great deal from Andy, so be sure to tune in.
Subscribe to Cell & Gene: The Podcast wherever you get your podcasts so you don’t miss an episode.
Here are just a few of the timely articles we’ve shares on Cell & Gene and in our e-newsletter.
Why Repeatability of Dosing Matters for Gene Delivery
By Jonathan Thon, Ph.D., Founder and CEO and Laura Goldberg, M.D., Ph.D., VP of R&D at STRM.BIO
This article shares the prospect of the best dose repeatability available in the gene therapy delivery ecosystem today and the opportunity to expand the landscape of diseases that can be treated.
Comparing FDA And EMA Approaches To AI/ML In Drug Development & Manufacture
By Sean Hilscher, VP of regulatory policy, and Tanvi Mehta, manager of regulatory policy, Greenleaf Health
This article details why collaboration among regulators, manufacturers, and researchers will be pivotal in fostering a transparent, accountable, and efficient AI ecosystem to enhance the development and deployment of medical products for the betterment of global health.
Allogeneic Cell Therapy: Our Strategy, Learnings, & Advice: A conversation with Robert Hariri, M.D., Ph.D., CEO, Celularity
We caught up with Robert Hariri, CEO, founder, and chairperson of Celularity, to discuss the company’s facility site selection strategy, how they transformed the property into a GMP facility, lessons learned in allogeneic cell therapy preclinical and early clinical development, and their advice for allogeneic cell therapy startups.
Base Editing And Prime Editing: How They're Changing Gene Therapy
By Tyler Menichiello, contributing editor, Cell & Gene
This article details a conversation with Cell & Gene’s Tyler Menichiello, Beam CEO, John Evans, and CSO, Dr. Gopi Shanker, as well as Prime’s CSO, Dr. Jeremy Duffield on how prime editing and base editing technologies are changing the gene therapy landscape.
Dr. Jim Wilson At LSPA's Life Sciences Future Conference
I attended Life Science PA’s Life Sciences Future conference, held in King of Prussia, PA, which offered incredibly valuable insight to attendees. This is a recap of the Lunch Plenary featuring gene therapy pioneer, Jim Wilson Ph.D., M.D., Director, Gene Therapy Program Professor of Medicine and Pediatrics, Perelman School of Medicine at the University of Pennsylvania.
This is just a glimpse of the informative content Cell & Gene delivered this month. Subscribe to our e-newsletter to receive the content that will help you perform your role even better. And, as always, reach out to me directly to let me know the cell and gene therapy topics and trends you and your colleagues care about most.