This webinar will examine the evolving science of gene therapy, covering current approaches such as gene transfer and gene silencing, safety considerations, and delayed adverse events.
September 15, 2020
Though gene therapy has been around for decades, it continues to pose extraordinary challenges in the areas of R&D, clinical development, and operation of clinical trials. Sponsors and CROs face shifting operational and regulatory demands amid rapid advances in the science of precision medicine.
This webinar will examine the evolving science of gene therapy, covering current approaches such as gene transfer and gene silencing, safety considerations, and delayed adverse events. It will describe the current (and ever-changing) regulatory landscape, identify opportunities for sponsors to more closely engage with regulators, and explore operational challenges such as patient recruitment and retention and use of sham medical procedures.
Other topics will include:
Understanding the disease burden and patients’ treatment goals
- Designing studies that identify relevant endpoints and meet regulatory and safety requirements
- Discussing unique case studies that address operational challenges in gene therapy trials
Join Allan Valmonte, MBA, Executive Director, Program Strategy – Rare Disease & Pediatrics, Premier Research, Mesaki Kenneth “Ken” Ndugga-Kabuye, MD, FACMG, Medical Director, Rare Disease/Pediatrics, Premier Research and Naomi Kautz, Director, Regulatory Affairs, Regulatory Professionals in a live webinar on Monday, September 28, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Achieving the Promise of Gene Therapy: New Pathways to Overcome Patient Enrollment and Safety Challenges.
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