Join us for a deep dive into a series of topics specific to CGT.
While providing phase-appropriate considerations and recommendations for IND authorship, DHC’s experts included a survey of the recommended general structure of a CGT IND, discussed defining and codifying drug substance and drug product, reviewed best practices for streamlining authorship, and provideed insight into what to expect after IND submission.
Practical considerations for implementing advanced characterization techniques into rAAV release panels: This webinar, hosted by Principal Jacob Staudhammer, focused on best practices and trends for implementing advanced methods for empty/full analysis, next-generation sequencing, and post translational modification analysis into AAV release panels throughout clinical development. Jacob also discussed some of the technical hurdles, regulatory considerations, industry trends, and advantages for implementing novel methods.
Navigating nonclinical development for CGT products: common challenges & lessons learned
When it comes to nonclinical development strategy for CGT products, a ‘one size fits all’ approach generally does not apply. 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, co-hosted by Senior Principal and Head of Nonclincal Nathan Manley and Senior Consultant Sean O'Farrell, explored 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.
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 Master Practice Expert Richard Grant, Principal Michael Kinzie, and Senior Consultant Madeline St. Onge shared lessons learned and best practices 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 of the day. And also, thank you to DHC Master Principal Kimberly Benton and Master Practice Expert Don Fink, as well as Senior Principal Heath Coats, former Dark Horse 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. Presenters discussed considerations for implementation of a phase-appropriate analytical strategy to support the development of cell and gene therapies. The concept of phase-appropriateness was be introduced, along with a discussion of how this concept may influence the strategy for release and characterization testing as a product proceeds through development. Presenters also discussed phase-appropriateness in the context of assay qualification, validation, and potency assay strategy.
How ready are you for inspection?
In our 2nd webinar, former Dark Horse David Jasek presented on the topic of Inspection Readiness, Management, and Response: best practices and strategies for successful regulatory inspections.
One of the most important early decisions you will make is the selection of your CDMO partner. Not all CDMOs are created equal, and there is no easy answer to which is the best suited for your program. Performing a detailed, rigorous, and comparative quantitative analysis of proposals must be paired with real-world knowledge and insight into the operating history and track record of the candidate CDMOs. DHC has a long track record of working with CDMOs and helping clients to choose the right CDMO partner, granting us an extensive knowledge of the growing CDMO landscape.
For the first in our expert webinar series, DHC Senior Consultant Uzma Shoukat-Mumtaz presented on the topic of Streamlining Manufacturing Partner Selection.