San Francisco Bay Area Chapter of American Statistical Association

Monthly Seminar

Co-sponsored by DahShu (



Statistical Challenges in Immuno-Oncology, a Cellular Therapies Perspective


Immuno-oncology, or cancer immunotherapy, uses a patientŐs own immune system to help fight their cancer.  While a relationship between infections and cancer regression has been observed for centuries, greater understanding of the immune system and how it recognizes—or fails to recognize—cancer cells has allowed development of multiple immunotherapy approaches.  Antibodies, cytokines and cellular therapies have been developed to treat a variety of cancers.  More recently, checkpoint inhibitors and chimeric antigen receptor t-cell (CAR-T) therapies have demonstrated remarkable levels of activity in patients with relapsed/refractory solid tumors and hematologic malignancies, and the evaluation of the combination of immuno-oncology agents is well underway.


Cellular therapies, such as the recently approved CAR-T therapy tisagenlecleucel and the cancer vaccine sipuleucel-T, present unique development challenges, since each patientŐs product is manufactured from their own cells.  The ability to manufacture and the time required to deliver the product to a patient impacts the definition of efficacy and safety populations and the evaluation of these products versus historical or concurrent controls.  Further, as each patient represents a unique lot, and with a manufacturing process that may still be in development during the conduct of early trials, process monitoring and evaluation versus patient outcomes plays an important role.  Their distinct safety profiles, the possibility for pseudo-progression or lack of effect on traditional clinical markers, and cost, suggests subset identification and biomarker development will be useful in managing treatment decisions.  Finally, manufacturing process and safety monitoring in a post-approval setting may offer unique opportunities to better understand these products.



4:30 – 6:00 pm, Thursday, October 19, 2017

(4:30-5:00 social networking, 5:00-6:00 seminar)


Genomic Health, Inc.: Buzz Lightyear Conference Room

101Galveston Drive, Redwood City, CA 94063 Free parking


Register online at (registration required)



James B. Whitmore, Ph.D.

Vice President, Biostatistics & Data Management

Genomic Health, Inc.


Speaker bio: Since July of this year, Dr. Whitmore has been Vice President of Biostatistics & Data Management at Genomic Health.  After receiving his M.S. and Ph.D. in Statistics from Colorado State University, he spent 25 years in the pharma and biotech industries, including roles with Hoechst Marion Roussel, Immunex, Amgen, Berlex, Gilead Sciences, Dendreon, and Juno Therapeutics.  During his career, he has supported all phases of clinical development, research, manufacturing, medical affairs and global regulatory submissions across the rheumatology, dermatology, cardiology, infectious diseases, pulmonology, and oncology therapeutic areas.  Most recently at Dendreon and Juno Therapeutics, Dr. Whitmore oversaw biostatistics and data management support for cellular immunotherapy products in genitourinary and hematologic oncology.  In addition to the ASA, he is an active member of the Drug Information Association (DIA) and the American Society of Clinical Oncology (AS