April 4-5, 2013
8:00 am - 5:00 pm
National Institutes of Health Campus (Masur Auditorium)
Bethesda, MD
Watch Dr. Samir N. Khleif discuss the program here. |
Download the CICT Syllabus here. |
Thomas A. Davis, MD - Celldex Therapeutics, Inc.
Samir N. Khleif, MD - Georgia Regents University
Howard Streicher, MD - National Institutes of Health
David F. Stroncek, MD - National Institutes of Health
The unprecedented success of several therapeutic trials has highlighted a resurgence in human tumor immunology. As is often the case, long held notions and explanations needed to be changed when confronted by new data.
Emerging approaches to employing vaccines immune modulators, cytokines, antibodies and adoptive T cell therapy have presented new challenges to developing effective clinical trials. Used as single agents, the pattern of response, determining optimal dosing and schedules, and end points challenge the traditional plan of phased studies. Understanding and managing immunologically mediated adverse events has revealed a spectrum of clinical pathology and created a new vocabulary. As clinical activity has extended the range of activity beyond minimal disease and beyond melanoma and renal cell carcinoma, the need to understand mechanism of activity becomes an essential part of any study. Furthermore, it is clear that targeting an effective immune response against cancer will require new and innovative immune combination strategies. Developing innovative efficient designs to test such combinations pose further challenges to the field.
This two-day workshop outlined the current challenges posed by the development of therapeutic trials in immunotherapy. Several of these questions were examined in greater detail, including preclinical testing requirements for clinical development, innovative clinical trial design, appropriate patient selection, end point determination, and developing combination therapies to improve long term disease management and survival. Accelerating anticancer agent development, validation and approvals were also discussed. It was expected that, at the conclusion of the workshop, participants and speakers would have developed a framework or recommendations on how to design better clinical trials.
The target audience for this program included academic researchers, industry and biotech company representatives, preclinical pharmaceutical developers, oncologists, investors/venture capitalists, biopharmaceutical consultants and health care professionals engaged in clinical trials of cancer therapeutics.
Upon completion of this program, the participants should be able to:
This program was funded by unrestricted educational grants from these supporters.