Oncology Biologics Development Primer

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

Program Purpose

There is a continuing need to have new agents that are more effective and less toxic than current treatments for many oncology indications. Biologic therapies, including monoclonal antibodies, cytokines, gene therapy, cell-based therapy, and vaccines, are of great interest in this regard. Many new technologies, therapeutic targets, and treatment modalities arise in academic centers and start-up companies. Frequently, the individuals in these organizations are highly skilled physicians and researchers with insufficient experience in biopharmaceutical development to rapidly move these promising innovative approaches into clinical testing. There is a significant need to bring these innovations into clinical testing as quickly and efficiently as possible. This primer addressed these issues in the following manner:

• An introduction to the preclinical development considerations for the testing of oncology biologic therapeutics to enable initiation of early phase clinical trials was presented.
• Clinical trial design strategies and regulatory expectations for first-in-man studies and later trials were presented and discussed.
• Responsibilities of investigators were discussed in the context of adherence to Good Clinical Practice (GCP) standards.
• The key regulatory steps in the development of oncology biologic therapeutics in the US, the EU, and Japan were presented by experts with development experience in those regions.
• Panel discussions promoted the exchange of information and in-depth dialogue between relevant stakeholders regarding strategies for meeting regulatory requirements, and efficiently moving from bench to bedside.
• Case studies in cytokines, monoclonal antibodies, therapeutic vaccines, cell-based therapies, and gene therapy were presented to illustrate how development issues are addressed and managed.
• Participants were given the opportunity to learn what industry is looking for when considering in-licensing opportunities in order to effectively work together to bring innovative biologic agents to the clinic.
• Small group, interactive settings facilitated communication and understanding among constituents regarding oncology biologics development.
• This primer served as a key forum for the continued and evolving dialogue regarding best practices for worldwide oncology biologics development.

By addressing and fulfilling these needs, iSBTc has assisted in enabling productive, effective and efficient development of innovative oncology biologic agents to improve the therapeutic outcome of patients. At the conclusion of this session, attendees were able to:

• Understand where to find key informational resources and implement best practices regarding the development of oncology biological therapeutics.
• Form important relationships between regulatory agencies, industry members and academic investigators that result in effective strategies for oncology biologics development.
• Understand the concepts and processes for achieving the scientific and regulatory objectives by focusing both preclinical and clinical strategies to drive efficient development of oncology biologic therapeutics.
• Understand regulatory expectations and requirements and incorporate these ideas into the clinical trial design.