Impact of FDA Project FrontRunner on Oncology Drug Development

Discover how early access to investigational therapies can transform cancer treatment, offering patients new hope and improving clinical outcomes. IQVIA’s team of experts will discuss the advantages of early development, including enhanced drug effect assessments and easier comparisons to standard care, all within the framework of the FDA’s Project FrontRunner.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/accelerating-cancer-treatment

Event overview

Discover how early access to investigational therapies can transform cancer treatment, offering patients new hope and improving clinical outcomes. IQVIA’s team of experts will discuss the advantages of early development, including enhanced drug effect assessments and easier comparisons to standard care, all within the framework of the Food and Drug Administration’s (FDA’s) Project FrontRunner initiative.

Learn from IQVIA’s experts about designing robust randomized controlled trials, which will allow expansion of evidence generation earlier in development to establish the benefit-risk profile. The panelists will also share a compelling case study on accelerating development and patient access, showcasing innovative clinical trial strategies for success.

Three key take-aways

• Understand the benefits of early access to investigational cancer therapies, including improved patient outcomes.
  
• Learn best practices for designing robust randomized controlled trials, selecting meaningful endpoints, and ensuring evidence generation in earlier disease settings.
  
• Gain insights into engaging with the FDA early, leveraging the accelerated approval pathway, and successfully navigating the evolving regulatory landscape to bring novel cancer therapies to market faster.

Speakers:

Jeff Hodge, MS
Vice President, Precision Medicine Oncology, Oncology Center of Excellence
IQVIA

Jeff Hodge, MS, is the vice president of precision medicine oncology in the Oncology Center of Excellence at IQVIA. Hodge has 30 years of drug development experience in oncology. Prior to joining IQVIA, he worked at GSK for more than 16 years in various roles and led the early clinical development of 10 molecules from first in human to proof of concept. While at GSK, Hodge was involved in 10 investigational new drugs and 5 new drug applications. He has published more than 100 abstracts and papers in peer-reviewed journals and at international meetings in the field of oncology. Hodge has extensive experience in the development of small molecule tyrosine kinase inhibitors, biologics, novel chemotherapeutics and immuno-oncology therapies. He also leads IQVIA’s dose optimization working group in oncology. Hodge received both his master and bachelor of science degrees in medical microbiology and bacteriology from Virginia Tech in Blacksburg, Virginia.


Patrick Brady, Pharm.D.
Global Head, Therapeutic Innovation and Regulatory Science
IQVIA

Patrick Brady, Pharm.D., is global head of therapeutic innovation and regulatory science at IQVIA. With more than 20 years of experience in regulatory affairs in the biopharmaceutical industry, Brady regularly advises R&D leadership and project teams on global drug development strategies, emerging technologies and the changing regulatory landscape and policies to help inform strategies and decision-making.

Jin Chen, M.D., Ph.D.
Vice President, Therapeutic and Regulatory Strategy
IQVIA

Jin Chen, M.D., Ph.D., is the vice president of therapeutic and regulatory strategy at IQVIA. He is responsible for creating integrated development strategies and solutions for pharmaceutical products across multiple therapeutic areas through preclinical, clinical, regulatory and commercial phases. Chen has more than 20 years of experience working with the FDA and has comprehensive understanding of regulatory science requirements for FDA approval of new drugs/biologics. Chen received his medical degree from Beijing Medical University in Beijing, China, and his doctorate in pharmacology and toxicology from the University of California, Davis. He completed his fellowship in clinical pharmacology Stanford Medicine in Stanford, California.

David Cameron, MPH
Senior Director and Global Head, Novel Trial Design
IQVIA

David Cameron, MPH, is the senior director and global head of novel trial design at IQVIA. In this role, he has global responsibility for developing evidence generation, solution synthesis and messaging in support of innovative design approaches to improving the productivity of clinical research and development. Cameron has more than 14 years of experience consulting worldwide with biopharmaceutical organizations. This experience extends to working with a broad range of stakeholders—including provider associations and patient advocacy groups—on the development of real-world evidence to support regulatory, quality, effectiveness and safety requirements. Cameron holds a master of public health degree from The University of North Carolina at Chapel Hill and a bachelor of science degree in international economics from Georgetown University’s Walsh School of Foreign Service in Washington, D.C. Cameron is a frequent writer and speaker and has guest lectured at New York University’s Stern School of Business and the Tuck School of Business at Dartmouth College.

Register Free: https://www.appliedclinicaltrialsonline.com/act_w/accelerating-cancer-treatment