Oncology Drug Development: Identifying Regulator and Payer Evidence Needs

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/oncology

Event Overview:

The industry-wide focus on cancer has placed it at the forefront of regulatory, scientific, and clinical advances, from expedited mechanisms to biomarkers to adaptive trials. And the coronavirus pandemic has accelerated adoption of further innovations, such as decentralized clinical trials (DCTs) and real-world evidence (RWE), that regulators and payers are increasingly accepting. There will be no going back to a pre-COVID world. To succeed, developers need to create cancer drugs that are both approvable and reimbursable. This requires a solid, integrated evidence strategy that accommodates the data to support the safety, quality and efficacy requirements of regulators, a coherent, data-driven value story for payers, and one that ultimately demonstrates how your new therapy is relevant to patients’ real lives.

Key Learning Objectives:

• The benefits of early advice in oncology strategy development
• Regulator and payer acceptance of novel trial designs versus traditional evidentiary standards
• Evidence considerations in more expensive cancer types (immuno-oncology, precision medicines, and cell and gene therapies)
• Options for filling evidence gaps in late-stage development

Who Should Attend:

• Small to mid-sized biotech and pharma
• Clinical Operations, Regulatory, HEOR and Market Access and Medical Affairs functions
• Manager and above

Speakers

Amy McKee, M.D.
Head of Regulatory Oncology
Parexel

Amy has 11 years of experience in the U.S. Food and Drug Administration, most recently in the role of Deputy Center Director, Oncology Center of Excellence (OCE) and Supervisory Associate Director, Office of Hematology and Oncology Products (OHOP), Center for Drug Evaluation and Research (CDER). She was the signatory authority for products within OHOP, responsible for four divisions performing the scientific review and evaluation of hematology and oncology therapeutic drugs and biologics subject to regulation by the CDER. Amy received her M.D. from Tulane University.

Sangeeta Budhia
Vice President, Pricing & Market Access
Parexel

Sangeeta has more than 16 years of experience of working within market access and health economics and outcomes research (HEOR), helping companies position their products for maximum uptake at an optimal price in the shortest possible time. She develops global strategies, including pivotal clinical trials, long-term data collection studies, real-world evidence generation plans, and HEOR strategies prepared for the reimbursement challenges that each product will face. Sangeeta holds a Ph.D. from the University of Otago.

Register Free: http://www.appliedclinicaltrialsonline.com/act_w/oncology