News & Insights

Biologics Consulting Group, Inc. is pleased to announce the appointment of Dr. Margaret K. Vernon as Chief Executive Officer, effective September 18, 2023.

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.

Join our team on Thursday September 14 for a virtual panel focused on Advanced CGT Development.

SaMD developers often face the challenge of determining whether a new marketing submission is necessary for certain software modifications. In a LinkedIn audio event, several experts from Biologics Consulting’s Medical Device Business Unit will discuss insights on how a PCCP can save you valuable time and resources by eliminating the need for post-market assessments and potential delays in the future. Connect with fellow industry leaders, learn from experts, and gain the knowledge you need to optimize your software modification processes and stay ahead in the ever-changing world of AI/ML SaMD.

Help celebrate Biologics Consulting's 30th Anniversary by making a donation to Carpenter's Shelter during our 30 Days of Giving!

Watch an on-demand webinar hosted by Biologics Consulting on the IND Review Timeline from a Former FDA Reviewer's Perspective.

Join our Medical Device team on Wednesday September 6 for a Lunch & Learn covering PCCP for AI-based SaMDs.

Changes are coming to regulatory submissions publishing and we talk about two of them, eCTD 4.0 and standardized data, with Ben Wimmer.

Join our medical device experts for a LinkedIn Live event on Wednesday June 21 covering Predetermined Change Control Plans (PCCP) for AI/ML Software as Medical Devices (SaMD).

On this episode of Insight at Biologics, Bruce Pearce continues sharing his insight about the new ICH guidance which may allow you to forego animal carcinogenicity testing in favor of a weight of the evidence argument.