iSBTc Oncology Biologics Development Primer

February 28-29, 2008 ~ Gaithersburg, MD

iSBTc created the Oncology Biologics Development Primer (OBDP) to meet the needs of the biological therapy community by educating physicians and researchers on the worldwide regulatory paths for biological therapy development. Through facilitating collaborative interactions between regulators, preclinical scientists, clinical investigators and industry, the OBDP will help ensure that active, innovative new therapies are rapidly and appropriately moved into clinical testing.

The program will be held over two full days on February 28 and 29, 2008 in Gaithersburg, MD. It will be a key forum to explore and discuss best practices for worldwide biologics development. Through the expertise of the invited speakers, panel members and course attendees, this rigorous and challenging program curriculum will facilitate understanding, open discussion, and exploration of the development issues surrounding biologic agents for cancer.

Please visit the iSBTc website for more information on registration, housing and a detailed schedule for this educational session.

Target Audience:

Physicians and scientists in academia, industry and regulatory agencies with an interest in the preclinical, clinical and regulatory aspects of efficient oncology biologics development.

Topics to be Addressed:

Regulatory expectations in the US, EU, and Japan for oncology biologics therapeutic development
Preclinical development strategies
Clinical trial design and regulatory expectations
Good Clinical Practice (GCP) standards
Moving from bench to bedside
Case studies to illustrate strategic development solutions for cytokines, monoclonal antibodies, therapeutic vaccines, cell-based therapies and gene therapy
In-licensing and out-licensing expectations and opportunities for academia and industry

Meeting Goals:

Provide a framework for dissemination of information on best practices in preclinical testing and clinical trial design to those actively involved in the development of biologic oncology therapeutics.
Create a forum for dialogue among regulatory agencies, industry and academic investigators regarding efficient strategies for oncology biologics development.
Encourage and enhance strategic thinking for oncology biologic therapeutics development by case studies of preclinical and clinical development roadmaps to achieve the desired goals.
Attendees will gain an understanding of the latest regulatory expectations and requirements in the development process for oncology biologic therapeutics.

Meeting Organizers:

Susan Jerian, MD
OncoRD, Inc

Carl H. June, MD
University of Pennsylvania

Mercedes Serabian, MS, DABT
Food and Drug Administration – CBER

Robert J. Zimmerman, SD
Zimmerman Consulting

22nd Annual Meeting and Associated Programs

The International Society for Biological Therapy of Cancer’s recent 22nd Annual Meeting and Associated Programs in Boston were attended by 450 delegates from academia, industry, and regulatory agencies from around the world. If you weren’t able to attend the meeting or were in Boston and would like updates from these events, please visit our website for items such as:

Presentation slides from many of the Workshop, Primer and Annual Meeting speakers
Award winner listing
Link to claim your CME credits
PDF version of the Final Program
News releases
Published documents
Meeting pictures

SAVE THE DATE!!
23rd Annual Meeting and Associated Programs

October 30 – November 2, 2008
San Diego, CA

Information on the organizers, meeting schedule, and important dates and deadlines can be found on our website.

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