News & Insights

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.

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.

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

Christina Vessely and Vijay Jethwa to co-host Covance's Drug Development Symposium covering CMC issues for early stage companies. Register Now

  Join Biologics Consulting's Christina Vessely, PhD, Senior Consultant, CMC Analytics & Formulation Development, as she leads a three-part Virtual Workshop Series with Cambridge Healthtech Institute titled "Regulatory Requirements Across the Product Development Lifecycle."   Part 1: Tuesday, October…

Overview Interested in gaining access to the European market with your medical device or combination product? This multi-part webinar series details the requirements for obtaining approval to market medical devices in the European Economic Area (EEA). Topics will include comparison of CE Marking requirements…

Overview Interested in gaining access to the European market with your medical device or combination product? This multi-part webinar series details the requirements for obtaining approval to market medical devices in the European Economic Area (EEA). Topics will include comparison of CE Marking requirements…

Overview After decades of setbacks, Cell and Gene Therapy (CGT) - one of the most talked-about innovations in the industry - has made major strides in recent months. Since August 2017, the FDA has approved three gene therapy products. Most recently, the Agency announced the approval of Luxturna, which…

Overview The risk-based approach to analytical and formulation development fundamentally shifts the way many sponsors and manufacturers think about the product development process for biopharmaceutical products, moving away from a minimalistic approach and toward a strategic, forward-looking methodology…

Overview The development of Orphan Drugs - those developed specifically to treat rare medical conditions - is growing at an astounding rate. In 2014, nearly 41%1 of all new product approvals from the FDA were for the treatment of rare diseases - a trend that is expected to continue as the exclusivity…