The complexity of cell and gene therapies, combined with limited regulatory precedent, makes these treatments especially challenging to develop. With the right partner, however, there’s no need to reinvent the wheel.
Our recent two-day seminar covered specialized delivery, testing, and other considerations to help build a program tailored to your specific therapy. In case you missed any presentations from our team of early discovery and preclinical scientific, regulatory, and therapeutic area specialists, they are now available on demand.
Get their expert advice and see how we can help you design and execute a robust, efficient program that delivers accurate data to authorities.
Considerations for Program Development | Shawna Jackman, Senior Principal Research Scientist, Safety
Biologics Testing for Cellular Therapy (Starting Material to Product Pre-Manufacturing) | Steve Miklasz, Advanced Therapy and Key Account Development Director, Biologics & Dominic Clarke, Director, Global Cell Therapy Strategy & Innovation
In Vitro Pharmacology and Safety for CAR-T IND-Enabling Studies | Sanne Holt, Group Leader
Diving into Cell Therapy Programs: Practical Considerations | Simon Authier, Senior Director of Scientific Operations and Veterinary Science
Cellular Therapy Regulatory Development | Shawna Jackman, Senior Principal Research Scientist, Safety
Considerations for Program Development | Keith Sutton, Scientific Advisor
Bioanalysis and Biodistribution for Gene Therapies | Philippe Ancian, Director, Biomarkers
Gene Therapy Delivery in the CNS: From Rodents to NHPs | Gunnar Flik, Site Director, Discovery
Gene Therapy and Preclinical Studies: Application and Examples of In Situ Hybridization and Immunohistochemistry Assays | Frederic Gervais, Senior Veterinary Pathologist
Analytical Challenges for Preclinical and Clinical Sample Analyses | Philippe Ancian, Director, Biomarkers
Challenges Associated with the Development of nAb Assays in Support of Gene Therapies Using Adenovirus Vectors; Mitigating the Impact of Pre-Existing Antibodies | Marie-Eve Poupart, Senior Research Scientist, Immunology