Join us for a deep dive into a series of topics specific to CGT.
Navigating nonclinical development for CGT products: common challenges & lessons learned
When it comes to nonclinical development strategy for cell and gene therapy (CGT) products, a ‘one size fits all’ approach generally does not apply. However, as an increasing number of CGT products reach the clinic, we can look back on their preclinical paths to identify common pitfalls and how to overcome them. This webinar explores the current state of nonclinical development for CGT products, focusing on big picture questions, such as selection of suitable model systems, dose determination, and design of GLP tox studies. We will discuss how developers are approaching these challenges for different types of CGT products, highlighting key considerations for both cell- and gene-based therapeutics and in the context of the evolving regulatory landscape.
Developing a novel enabling technology for the cell and gene therapy industry? This webinar provided a practical discussion on how to understand and navigate key issues. Our team has deep experience supporting CGT enabling technology companies to successfully commercialize their products, from which we will share lessons learned and best practices that we’ve developed.
The final Unbridled Excellence webinar for 2023 featured DHC Managing Partners—CEO Anthony Davies, COO Katy Spink, and GM of DHC Europe Rob Allen—on the topic of 2023 takeaways, 2024 predictions! Our MPs discussed their top big-picture takeaways from 2023 and their list of predictions of what-to-watch for in 2024.
Thank you for being a part of our first Regulatory Roundup LIVE along with our unparalleled team of former FDA regulators, discussing the latest and greatest regulatory news. And also, thank you to DHC Master Principal Kimberly Benton and Master Practice Expert Don Fink, as well as Senior Principal Heath Coats, Principal Kevin Whittlesey, and Practice Expert Tal Salz.
In this third episode of the DHC webinar series, we heard from DHC Principal Brent Morse in conjunction with Senior Consultant Joshua Beckett (featuring content from Senior Consultant Alicja Fiedorowicz MSc) on the topic of Phase Appropriate Analytics to Support Cell and Gene Therapy Development.
Former Dark Horse David Jasek presented on the topic of Inspection Readiness, Management, and Response: best practices and strategies for successful regulatory inspections.
For the first webinar in our series, DHC Senior Consultant Uzma Shoukat-Mumtaz presented on the topic of Streamlining Manufacturing Partner Selection