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.