Advancing Biologics from the Lab to the Clinic

The development of biologics encounter the same familiar hurdles as their small molecule counterparts: escalating development costs, identifying novel targets with unproven therapeutic potential, and regulatory agencies demanding more compelling demonstrations of the value of new products. However, clinical development for biologics is considered to be more challenging, expensive, and risky than small molecule development. Besides the standard considerations of safety and efficacy, a clinical development program should also consider immunogenicity, optimal dosage levels, and the evaluation of available biomarkers and imaging technologies to measure the effects on a given target. These critical issues have many biopharma companies rethinking their clinical development strategies in order to design a program that caters to the unique properties of biologics.

This two day event will provide essential industry, regulatory and scientific perspectives in terms of what the factors are that hinder the progression of biologics in clinical development. Industry experts will talk about their experiences and give insight into the vital components that make up a successful early-stage strategy for biologic studies. The attendees of this event will obtain an advanced understanding of how to strategically incorporate the requirements that are specific to biologics into the operational planning for an early-phase clinical trial that provides the best opportunity to save time, reduce risk, cut costs, and demonstrate product value early in development.

Why Attend

• Discover the most efficient methods to inject more biologic drugs into your portfolio
• Meet highly experienced experts that are directly involved in biologic trial design and implementation
• Learn about the regulatory requirements in the USA and Canada regarding the level of proof required to satisfy the governing bodies.
• Find out how to educate regulators on your specific biologic product and how considering ethical issues can expedite approval
• Understand the perspectives of all stakeholders involved in biologics including regulators, sponsors, CROs, central labs, ethics committees, and biologic investigators
• Come to benchmark, share experiences, and help to develop a “best-practice” approach that fits into your clinical development program

Who Will Benefit

Experienced executives from Pharma, Biotechs and Academia involved in Biologic development

VPs, Professors, Senior Directors and Managers involved in biologics, discovery, pre-clinical development, exploratory development, early phase clinical development, clinical operations, clinical science, clinical pharmacology, immunogenicity, biomarkers, translational medicine, regulatory affairs, therapy area heads, and R&D.

Expert Speaking Panel