Statistical challenges for clinical development of cell and gene therapies for oncology indications
*Yuqun Abigail Luo, FDA/CBER Keywords: cell therapy, gene therapy, oncology Cell and gene therapies are investigated for unlimited indications, including cancers, both solid tumors and hematological malignancies. These products present both tremendous hypothesized therapeutic potentials and unprecedented challenges and questions in clinical development. The product is often personalized, either autologous or from matched donors, therefore not all eligible subjects may have a “product” successfully manufactured. The product can be expensive. The product may be studied in subjects that are refractory to existing therapies and may thus represent a smaller subject population that is also harder to study. Often the understanding of the potential mechanism of action is preliminary. Increasingly, these products are targeted therapies requiring assessment of certain biomarkers. This talk will discuss the statistical challenges that is unique to cell and gene therapies in developing oncologic products.
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Key Dates
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November 1 - December 17, 2013
Online proposal submission for a session, short course and Town Hall Open -
January 6 - March 11, 2014
Online proposal submission for Roundtables Open -
April 30 - May 28, 2014
Abstract Submission Open -
June 4, 2014
Online Registration Opens -
August 8 - August 22, 2014
Invited Abstract Editing -
August 11, 2014
Short Course materials due from Instructors -
September 1, 2014
Housing Deadline -
September 15, 2014
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 22 - September 24, 2014
Marriott Wardman Park, Washington, DC