News & Insights

When you have an anomalous lab result, you just might be in trouble. However, Chris Vessely can help you close the case of what went wrong, help you find a way to save the day, and help keep you from getting in trouble in the first place.

Watch our on-demand webinar, "New FDA CAR-T Guidance: What Sponsors Need To Know"

Biologics Consulting is thrilled to announce

Security from cyberattack for medical devices is paramount. And the FDA wants you to have a plan for it. Becky Ditty and Donna-Bea Tillman tell you how to be prepared.

How prepared is your facility? Being prepared is crucial and in this episode Vince Narbut takes you through commercial readiness.

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!