Oncology drug development: Identifying regulator and payer evidence needs 2

Online

April 19, 2022

Online |

ACT Oncology Webinar Social Tile 1.jpgLive Webinar: Oncology Evidence Requirements

April 12: 11am EDT | 5pm CEST

April 19: 8:30am CST | 5:30 PDT

To succeed in this competitive market, 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 regulators' safety, quality, and efficacy requirements, a coherent, data-driven value story for payers, and one that ultimately demonstrates how your new therapy is relevant to patients real lives.

In this webinar, former FDA regulator Amy McKee and HTA expert Sangeeta Budhia share top tips and first-hand experiences, including:

  • 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

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