San Francisco Bay Area Chapter of
American Statistical Association
Monthly Seminar
Co-sponsored by DahShu
(www.dahshu.org)
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Title: |
Statistical Challenges
in Immuno-Oncology, a Cellular Therapies
Perspective |
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Abstract: |
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. |
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Time: |
4:30
– 6:00 pm, Thursday, October 19, 2017 (4:30-5:00
social networking, 5:00-6:00 seminar) |
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Location: |
Genomic
Health, Inc.: Buzz Lightyear Conference Room 101Galveston
Drive, Redwood City, CA 94063 Free
parking |
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Registration: |
Register
online at (registration required) |
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Speaker: |
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
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