Enabling Access Through Innovation – Cell and Gene Therapy in 2023 and Beyond

Dr. Jörg Schneider, Director – Principal Consultant at BioPharma Excellence, previews the opening plenary session at the upcoming Advanced Therapies Week, which will discuss critical facilitators in bringing groundbreaking new treatments to market, and the latest developments driving progress.

At the fast-approaching Advanced Therapies Week, I have the honor to be chairing the Opening Plenary: Enabling Access Through Innovation – Cell and Gene Therapy in 2023 and Beyond, introducing some impressive speakers and moderating what’s guaranteed to be a lively and enlightening panel and Q&A session.

This is a chance to hear about the very latest approaches to transforming market access for critical new therapies, directly from those at the front line – including the CEO of the American Society for Gene and Cell Therapies (the largest organization of its kind globally), as well as very senior individuals from leading cell and gene therapy developers. Together, these esteemed speakers will share the details of the very latest research, trends and developments.

From the whole to the specific

There are two parts to the plenary session – a roundup of all the very latest events and research in cell and gene therapy, followed by a deep-dive into what is happening at the cutting edge to enable development and patient access to groundbreaking therapies from a technical and manufacturing perspective.

Susan Nichols, Chief Business Officer at ViroCell Biologics, will start by summarizing the Top Ten Events of 2022 from a developer’s perspective, leading into a presentation by David Barrett, CEO of American Society for Gene and Cell Therapies on The Research Landscape for Cell and Gene Therapies.

Against this backdrop, Cynthia Pussinen, Former Chief Technology Officer at Spark Therapeutics, will then go on to discuss The Keys to Realizing the Full Potential of Advanced Therapies. Through the lens of technical development & operations, or CMC, she will consider the most pressing obstacles the advanced therapies sector needs to unlock to accelerate progress.

Finally, leading into the panel Q&A, Dominic Clarke, Chief Technical Officer at Cell and Gene Therapy, Discovery Life Sciences, will ask, Is Characterization the Cure to Effectively Industrializing Cell & Gene Therapies?

The ensuing panel with Q&A will ask, How Are We Enabling Innovation for Cell and Gene Therapies? It will distil five critical enablers of innovation, from the more obvious facilitators such as funding, investment and suitable regulatory frameworks, to education and training.

Bolstering the skills pipeline

This last area will be especially interesting and poignant, given the goal to have more than 60 cell and gene therapies approved by the end of this decade. Certainly, there is a need for more trained professionals who are knowledgeable about cell and gene therapies. The FDA has said it will recruit 125 additional staff members to handle cell and gene therapies, the majority destined for the new Super Office, the Office of Therapeutic Products, whose six subdivisions now need staffing with appropriate experts.

To meet this demand, universities and professional organizations are offering education and training programs in this area, helping to ensure that there will be a qualified workforce ready to work on the development and delivery of these therapies.

Unmissable opportunities to connect & brainstorm

I’m immensely excited about the opening plenary session, and about the event as a whole – being one of the major conferences in this field at the start of the year. Hot on the heels of the JP Morgan Healthcare Conference, Advanced Therapies Week builds on that event with a closer look at the strategic and commercial aspects of bringing cell and gene therapies to market.

What’s so powerful about this event is that it brings together all of the latest thinking across all aspects of the domain, from technology in manufacturing to policy and pricing. For attendees from across the industry, it’s a chance to step outside of their respective individual bubbles of interest and soak up a wealth of fresh ideas, inspiration and trend information in a short space of time.

I hope to see you there!


Opening Plenary: Enabling Access Through Innovation – Cell and Gene Therapy in 2023 will take place on Wednesday January 18, 2023 at 9am ET. Phacilitate Advanced Therapies Week will take place at the Miami Beach Convention Center in Miami Beach, Florida, running January 18-20. On Friday January 20, from 11am ET, my colleague, Brad Carlin, Senior Advisor, Data Science & Statistics, at PharmaLex, will chair a session entitled, How Do We Best Serve Rare and Small Patient Populations.

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