Second Annual Biologics Clinical and Regulatory Conference

Navigating the Complex Process of Biologic Clinical Trials to Ensure Safe and Beneficial Therapies with Proven & Supported Cost-Effectiveness

February 22-23, 2010

Baltimore, MD

About the Conference

Biologics comprise one of the fastest growing and most expensive categories of drugs, making them a desirable addition to any biotech or pharmaceutical company’s product portfolio. These products are highly complex derivatives that present extraordinary challenges in their discovery, testing and ultimately their clinical applications. At the same time, these products also present outstanding opportunities and improvements in patient care and disease states; making the discovery and utilization of these products indispensable. This conference program will address many of the challenges that companies face in conducting successful clinical studies in order to obtain regulatory and reimbursement approvals for their therapy. Through intensive research, the Q1 productions team has identified key challenges within clinical research that are unique to biologics development, and the conference will focus on these specific challenges, providing case studies and round table discussions on methods and tools for alleviating these hurdles.

 

The first and potentially most pressing challenge is the escalating cost of biologic clinical studies. It is commonly accepted that clinical research in all medical fields are continuing to rise in the eventual cost of the clinical study. For many organizations, especially smaller, privately funded companies, these spiraling costs are of great detriment to the overall health of the corporation. Strategic budgeting, planning, site selection and better site management in order to improve overall financial outcomes will be of great importance within the sessions focusing on reducing study costs. Finally, the safety considerations inherent to biologic clinical studies will also be discussed, with emphasis on the mitigation of risk in adverse events, as well as the required reporting pathways.

 

Also relevant to this portion of the conference will be a dialogue from the FDA related to increased surveillance of biologic products as well as the challenges in required postmarket surveillance. In all, this conference will address the wide spectrum of challenges that the developers of biologic therapies currently face, through insightful case studies, regulatory presentations as well as panel discussions where attendees, speakers and sponsors can create a true dialogue resulting in the identification of solutions to many of today’s pressing challenges in biologic clinical trials.

 

Topics to Included

• Understanding the Regulatory Pathway for Follow-On Biologics
• PhRMA (The Pharmaceutical Research and Manufacturers of America) Perspective on the Future of Follow-On Biologics
• Understanding FDA Guidelines for Combination Products
• Panel Discussion: Oncology Clinical Trials
• Addressing Oncology Biologic Regulatory Concerns
• Streamlining Recruitment Strategies for Oncology Clinical Trials
• Designing Oncology Clinical Trials that Ensure Patient Safety and Product Efficacy
• Working with the FDA to Secure Approval of Orphan Biologic Drugs
• Creating a Successful Risk Evaluation Mitigation Strategy in Biologic Therapies
• Outlining Toxicity Issues in Drug Development of Biologics
• Immunogenicity Testing in Biologic Clinical Trials
• Strategies for Conducting Global Clinical Research for Biologic Products
• Creating a Successful Adaptive Clinical Trial Design for Biologics
• Ensuring Accurate Data to Support Regulatory Approval of New Biologic Products
• Best Practices in Working with the FDA Biologic Team to Secure Regulatory Approval

Speakers to Include

 

Brian Harvey
Vice President U.S. Regulatory Policy
Sanofi Aventis

 

Marilyn R. Pitts, Pharm.D.,
Health Science Administrator/Office of Orphan Products Development
FDA

 

Paul Beninger M.D., F.A.C.P
Vice President Global Patient Safety & Risk Management
Genzyme

 

And More...

 

For more information please contact:
Paul Hernandez, Marketing Manager
phernandez@Q1productions.com
312-602-9684