Jim Wang
Company: Regeneron Pharmaceuticals Inc
Job title: Vice President, Regulatory Affairs, Genetic Medicines
Seminars:
How Can We Move Towards Harmonization Between Regulatory Bodies to Streamline Global Approval? 1:05 pm
Global approval for a gene therapy is something very few drug candidates have achieved, and with many diseases remaining untreated, widening patient access is crucially important. A concerted effort of international collaboration from stakeholders across regulatory authorities and industry is needed to align on safety, efficacy and quality regulations. Regulatory convergence on policies and further…Read more
day: Pre-Conference Workshop Day
Navigating the Regulatory Route and Challenges for Gene Therapies Targeting Common Diseases 1:30 pm
Overview of regulatory challenges and strategies for gene therapies targeting common disease Establishing long-term safety and efficacy of gene therapies to overcome safety concerns in larger patient cohort over extended periods Identifying new approaches to upscale manufacturing to serve a larger market Confirming additional requirements on clinical data and post-marketing surveillance that would be required…Read more
day: Conference Day One