Jim Wang

Jim Wang

Company: Regeneron Pharmaceuticals Inc

Job title: Vice President, Regulatory Affairs, Genetic Medicines


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

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