Join us for a deep dive into a series of topics specific to CGT.
Registration is currently open for the first three of this series:
For the first webinar in our series, DHC Senior Consultant Uzma Shoukat-Mumtaz presented on the topic of Streamlining Manufacturing Partner Selection.
Watch/download the recording here.
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The Request for Proposal (RFP) process is a prospective strategy for evaluating competitive quotes for services from different CDMOs. A controlled and robust RFP process enables Cell and Gene Therapy Developers to comprehensively compare capabilities and pricing across potential service providers. Although RFPs are a standard business practice, the delivery and evaluation process can be complicated and can lead to confusion if it is not managed properly. DHC has refined a step-by-step methodology to streamline the RFP process and ensure the most suitable CDMO is identified to support your project needs.
DHC Practice Expert David Jasek presented on the topic of Inspection Readiness, Management, and Response: best practices and strategies for successful regulatory inspections.
Watch/download the recording here.
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As part of the clinical development and commercialization of a new CGT/ATMP product, a regulatory inspection is required. Ensuring that inspections are handled appropriately is critical for smooth and timely operations, and an unsuccessful inspection can result in significant delays or additional costs. This webinar covers the best practices of how to prepare for an inspection, manage the inspection in real-time and formally respond to the inspection and final report.
For the third episode of this webinar series, we'll get the chance to hear from not one but two DHC Senior Consultants, Joshua Beckett and Alicja Fiedorowicz MSc,, on the topic of Phase Appropriate Analytics to Support Cell and Gene Therapy Development.
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Wednesday, October 25, 2023
9 am Pacific Time
Presenters will discuss several considerations for implementation of a phase-appropriate analytical strategy to support the development of cell and gene therapies. The concept of phase-appropriateness will 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 will also discuss phase-appropriateness in the context of assay qualification, validation, and potency assay strategy.
Register for Phase Appropriate Analytics to Support Cell and Gene Therapy Development here.
Where Unbridled Excellence and our Regulatory Roundup coincide! Partake in our first Regulatory Roundup LIVE with our unparalleled team of former FDA regulators to discuss the latest and greatest regulatory news. In this edition, expect a view of the FDA's recent comparability guidance document along with a summation of recent AdComms...plus responses to your questions! Join DHC Master Principals Kimberly Benton and Don Fink as well as Senior Principal Heath Coats, Principal Kevin Whittlesey, and Practice Expert Tal Salz for what is certain to be a lively regulatory update.
Tuesday, November 14, 2023
9 am Pacific Time
Register for November's Regulatory Roundup LIVE here.
The final Unbridled Excellence webinar for the year will be DHC Managing Partners: 2023 takeaways, 2024 predictions in mid-December! Join our three Managing Partners—CEO Anthony Davies, COO Katy Spink, and GM of DHC Europe Rob Allen—as they discuss their top big-picture takeaways from 2023 and their list of predictions of what-to-watch for in 2024.
Wednesday, December 13, 2023
9 am Pacific Time
Register for DHC Managing Partners: 2023 takeaways, 2024 predictions here.