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September 15, 2023  •  Webinar


Over the past several years, novel cell and gene therapy (CGT) products have rapidly progressed through the clinic, and several have gained regulatory approval. Advances in both cell and molecular biology as well as immunology and more efficient manufacturing paradigms have led to an explosion in new CGT products.

Gone are the days of relatively straightforward plasmid DNA and stem cell therapies. Today, new product paradigms including CAR-Ts, novel viral vectors, microbiome-derived bacterial products, phage therapies and mRNA therapies constantly provide new challenges to product developers.

What are some of the scientific, quality, and regulatory hurdles developers face with novel CGT products and how can biotech work most effectively with regulators to get these promising products into patients? Our panel will discuss some of the CMC and nonclinical challenges commonly faced with novel CGT products and how we might overcome them to bring these complex, but promising therapies to the clinic.
Listen in to Mike Grace, David Pepperl, Diana Colleluori, Robert Kutner, and Chris Scull as they discuss the challenges and some solutions.

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January 10, 2023  •  Podcast

“Understanding The IND Review Process” with Dr. Emily Place

On this episode of Insight at Biologics, Senior Consultant and industry expert Dr. Emily Noonan Place from Biologics Consulting chats with James Taylor about IND submissions and the review process. The fact is that the regulatory agency doesn't get a lot of time with your IND submission. How, then, does one optimize their IND submission to make the most of the allotted time in the review? And, how do you avoid the most common pitfalls? Find out all of this and more on this episode of Insight at Biologics.

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