Oncology Biologics Development Primer

Primer Main Page   |   Presentations Slides & Schedule   |   Program Purpose  |  Faculty

February 28-29, 2008
Gaithersburg Marriott Washingtonian Center
Gaithersburg, MD

The iSBTc Oncology Biologics Development Primer (OBDP) was a key forum for continuing to explore and discuss best practices for worldwide biologics development. Through the expertise of the invited speakers, panel members and attendees, this rigorous and challenging program curriculum facilitated understanding, open discussion and exploration of the development issues surrounding biologic agents for cancer.

iSBTc developed the OBDP to meet the needs of the biological therapy community by educating physicians and researchers on the worldwide regulatory paths for biological therapy development. Further, through facilitating collaborative interactions between regulators, pre-clinical scientists, clinical investigators and industry, the iSBTc Oncology Biologics Development Primer helped ensure that active, innovative new therapies are rapidly and appropriately moved into worldwide clinical testing.

Target Audience:
Physicians and scientists in academia, industry and regulatory agencies with an interest in the strategic, pre-clinical, clinical and regulatory aspects of efficient oncology biologics development.

Topics to be Addressed: (Click here for a detailed schedule)

• Regulatory expectations in the US, EU and Japan for oncology biologics therapeutics development
• Pre-clinical development strategies
• Clinical trial design and regulatory expectations
• Good Clinical Practice (GCP) standards
• Regulatory strategies in the US, EU, and Japan
• Moving from bench to bedside
• In-licensing and out-licensing expectations and opportunities for academia and industry

Meeting Outcomes:

• Provided a framework for dissemination of information on best practices in pre-clinical testing and clinical trial design for those actively involved in the development of biologic oncology therapeutics.
• Created a forum for dialogue among regulatory agencies, industry and academic investigators regarding efficient strategies for oncology biologics development.
• Encouraged and enhanced strategic thinking for oncology biologic therapeutics development by case studies of pre-clinical and clinical development roadmap to achieve the desired goals.
• Attendees gained an understanding of the latest regulatory expectations and requirements in the development process for oncology biologic therapeutics.

The OBDP was Supported by: