Applying Real-World Evidence to Regulatory and Drug Development Challenges
Friday, October 25, 12:30 PM EDT
In response to patient needs, technological advances, regulatory mandates and drug-development pressures, the role of Real-World Evidence (RWE) is rapidly evolving in the United States and around the globe. Real World Data (RWD) about patient outcomes may be particularly important when randomized controlled trials are infeasible, impractical or unethical for specific populations. Multiple stakeholders (regulators, life-science companies, payers, patient advocates, academics, data vendors, health care systems, etc.) are investing to curate rich RWD sources and develop robust RWE methods.
Dr. Rebecca Miksad, Senior Medical Director, Flatiron Health, will discuss a recent oncology use case of Electronic Health record (EHR)-derived RWE in the regulatory context. She will also recommend key considerations for the effective application of RWE approaches. In addition, Dr. Miksad will explore the future landscape of RWE in late clinical drug development.
Through examples and discussion, this webinar will help life science business leaders and regulators to assess the value (and challenges) of RWE to drive better decisions and better patient care.
Rebecca Miksad is a medical oncologist and health outcomes researcher who serves as senior medical director at Flatiron Health. In this role, Dr. Miksad focuses on generating Real-World Evidence, establishing regulatory-grade quality standards and contributing to the development of clinically-relevant methods to real-world data evaluation and analyses. She maintains a clinical practice at Boston Medical Center.
Prior to joining Flatiron Health, Rebecca was an assistant professor at Harvard Medical School, senior scientist at the Institute for Technology Assessment at Massachusetts General Hospital and director of gastrointestinal oncology and gastrointestinal oncology clinical trials at Beth Israel Deaconess Medical Center (BIDMC).