About Event
The 8th Gene Therapy Development Summit – What to Expect in 2025:
As the gene therapy field accelerates with a growing number of programs advancing through clinical trials and nearing approval, the 8th Gene Therapy Development Summit stands as the industry’s definitive meeting for addressing the key hurdles impacting gene therapy development today.
From groundbreaking presentations to dynamic panel discussions and expert-led roundtables, this event offers you invaluable insights into the challenges and opportunities across the gene therapy landscape. Whether it’s overcoming clinical trial complexities, navigating evolving regulatory requirements, or optimizing manufacturing scalability, this summit equips you with the knowledge needed to mitigate risks, avoid costly setbacks, and accelerate your gene therapy pipeline.
Join Your Peers this March to:
Understand Expediting Gene Therapy Approvals with Peter Marks, Director at FDA's CBER, he will be discussing recent regulatory streamlining efforts, strategies for working with the FDA, and key trends impacting gene therapy approvals.
Explore Designing Clinical Trials for Immunogenicity with Delphine Agathon, Senior Director at Pfizer, who will cover how to include endpoints for immunogenicity in clinical trials, assess immunogenic adverse events, and identify significant reactions in patients, with or without anti-drug antibodies.
Uncover the differences between In-process vs. Release Assays with Uditha deAlwis, VP at Sarepta, who will address the alignment of in-process and release assays, the impact of matrix effects on data, and how rushing proof of concept may affect BLA submissions.
Master Addressing AAV Limitations with Ligand-Capsid Bioconjugation with Niccolò Bacchi, CEO of Borea Therapeutics, who will explain the chemistry and process behind ligand-capsid bioconjugation, showcase examples of ligands improving AAV characteristics, and explore future applications of this bioconjugation technique.
What Previous Attendees Have to Say:
“Great mix of CMC, preclinical and clinical data with top leaders from various leading gene therapy companies”
SVP & Head of Technical Operations
“Meeting CGT professionals and informal conversations/networking was great. Organization of the conference and the execution was smooth and well done. Meeting parents of children with rare diseases who were attendees was impactful”
Principal Engineer
“The content was very good. I appreciated that there were three tracks so I could find a number of talks highly relevant to my specific field of interest. I also appreciated the speed networking.”
VP Regulatory Affairs
“This was quite possibly one of the best conferences I have ever attended. The calibre of the presentations combined with the smaller conference size made it very easy to interact with speakers and attendees”
Director of Research
“Very cross-functional participation and speakers across 150 gene therapy clinical, regulatory, Mfg, reimbursement, FDA, NIH, legal, patient advocacy experts”
Senior VP, Business Development & Strategy
“I really enjoyed the interactive workshop on the first day. It allowed us to share our difficulties and experiences in the day-to-day management of rare disease clinical trials”
Medical Affairs Manager