Thanks to regulatory frameworks and driven by high unmet patient needs, the pace for clinical development of gene therapies (GT) is often greatly accelerated. This presents GT innovators with the opportunity to reach their patients faster, but it also raises the bar for critical decision points such as around trial design, endpoint selection and population definition. To avoid commercial disappointment, clinical strategy, regulatory and commercial executives must operate in tight alignment, addressing various hurdles leading up to ultimate product success in the real world. Commercial GT leaders are thus expected to engage early and often in product development and regulatory strategy. In this session, experts from the leading drug development platform Certara offer a case-study and best-practice-driven tutorial to help them streamline, accelerate and de-risk clinical development for GT.
Emily Jean Woodward, PhD
Director, Customer Engagement
Emily has 15 years of experience in biotech, pharmaceuticals, and diagnostic devices spanning R&D, clinical development, and regulatory affairs. As the Director of the Customer Engagement group, she pairs her diverse industry experience with her scientific background to build teams of scientists, writers, and consultants who are tailored to meet clients’ evolving needs. Her passion lies in accelerating clinical programs for rare and orphan disease therapeutics by identifying efficiencies leveraging a lean, but compliant, approach.
Sr. Director, US Access Strategy
Maximilian Vargas, PhD MBA, is a Senior Director, US Access Strategy and Account Management within Certara’s Evidence and Access Group since 2012. He brings both scientific training and experience in healthcare product development that are important for evidence-based value and access strategies for pipeline and marketed products.