A companion diagnostic is defined as one where the use of a diagnostic test is essential for the therapeutic products to meet its labeled safety and effectiveness claims. The use of companion diagnostics have become increasing common in the recent years due to the obvious benefit of customizing a given treatment options to a given patient assuring positive outcomes and avoiding side effects. This kind of personalized medicine has a strong support from FDA and industry alike. For FDA reviewers, the use of the companion diagnostic tests eases the determination of relevant patient populations for a given product in terms of positive benefit to risk ratio. These new technologies are making it increasingly possible to individualize, or personalize, medical therapy by identifying patients who are most likely to respond, or who are at varying degrees of risk for a particular side effect. For drugmakers, the use of companion diagnostics could reduce the risk of failure by identifying the specific target population for clinical trials and marketing. Per the current regulations, a companion diagnostic can be developed both concurrently or independent of a given therapeutic product.

However, the need to have both a drug and device ready to be brought to market at the same time adds to the complexity of the program and can potentially delay approvals. Unsuccessful development of one can adversely affect the market approval of the other.

Why should you attend:
There is a lot of confusion regarding the regulatory requirements for developing companion diagnostics. The development steps, testing requirements prior to approval, and scientific basis for approval depend on the need for the therapy and the resources available with the developers. Recently FDA published a guidance document describing the salient elements of a companion diagnostic development program. This seminar will discuss the latest FDA guidance using case studies and examples to highlight key areas of FDA’s interest and tips to comply with FDA’s requirements.

This seminar is intended for general instructions to all companion diagnostic developers, laboratories, clinics, physicians, hospitals, reimbursement experts, clinical trial users, and regulators who wish to have a better understanding of how FDA regulate such tests.

Areas Covered in the Session:

• Outline of FDA’s regulations governing companion diagnostics
• The recent FDA guidance on companion diagnostics
• Challenges for genetic and protein based companion diagnostics
• FDA’s recommendations for assessing analytical and clinical performance such assays
• The role for the FDA interactions in companion diagnostic Development
• Common issues with regulatory submission for companion diagnostics

Who will benefit:

The following individuals or disciplines will benefit from attending this Webinar:

• Senior management of companion diagnostic providers
• Project Managers
• Regulatory Vice Presidents, Directors and Managers
• Lab testing professionals
• Compliance professionals
• Auditors
• Attorneys – In-house or Outside Counsel