Presenters include Richard Klein, formerly of FDA, and Marjorie Speers of WCGF
ATLANTA, Ga., Jan. 9, 2018—WCG Foundation will host free webinars Jan. 25 and Feb. 5 on how to streamline the application process for experimental medications for intermediate-size populations of desperately ill patients.
The webinars—“Intermediate-Size Patient Populations INDs: What Are They, When Should They Be Used, and Who May Apply for Them?”—feature Richard Klein, former director of the Food and Drug Administration Patient Liaison Program Office, and Marjorie A. Speers, Ph.D., executive director, WCGF.
Both sessions will be held from 2 to 3 p.m. Eastern Standard Time. Registration is required.
Under FDA’s expanded access program, a physician/investigator, drug manufacturer or patient advocacy group may submit an intermediate-size patient population investigational new drug application when the investigational drug will be given to several patients. Because it requires less paperwork per patient, this type of IND can streamline the approval process for the drug manufacturer, FDA and institutional review board—resulting in faster treatment for patients.
Klein recently retired from FDA after 41 years with the agency. As director of the FDA’s Patient Liaison Program in the Office of Health and Constituent Affairs, he oversaw patient advocacy and engagement and addressed issues including access to unapproved drugs, product safety and clinical trial design. Klein also played a key role in revising expanded access regulations, creating the FDA expanded access website, streamlining the application for individual patient access, and developing the Expanded Access Navigator.
As executive director of WCGF, Speers launched the foundation’s Expanded Access Project. The goal is to transform the expanded access process by making it more transparent, efficient, equitable and accessible. Offering free webinars is one of many ways that WCGF seeks to meet the needs of those involved in expanded access, from patients and physicians/investigators to drug manufactures and IRBs.
To register for a webinar or for more information, please email [email protected].
About WCG Foundation: WCG Foundation is a 501(3)(c) nonprofit organization that raises funds and implements programs to help improve lives by delivering on the promise of clinical research. Based in Princeton, N.J., the Foundation focuses on three core areas: Compassion, to help desperately ill patients gain access to experimental drugs through the expanded access process; Inclusion, to increase opportunities for people to benefit from clinical research regardless of race, ethnicity, nationality, age or gender; and Education, to provide training and other efforts to ensure that research involving humans is conducted safely and ethically, and puts participants first. For more information about WCGF, visit wcgfoundation.org. To sign up to receive news, click here.