In the last decade, tremendous attention has been placed on Personalized Medicine, a new approach using an individual’s genetic makeup to define a more targeted treatment. The value of Companion Diagnostic (CDx) tests as a class of diagnostics driving clinical management of patients is taking hold with CDx tests such as a HER2 helping positive breast cancer patients to gain access to Herceptin. All the noise around personalized medicine, however has only yielded 22 FDA approved CDx tests with a drug, with 10 of these being HER2 tests for Herceptin breast cancer and gastric cancer patient selection. This means only 12 distinct CDx drug approvals have launched since 1998 when HercepTest®, the first CDx , was launched. Despite the few tests which have passed the rigor of FDA as a Companion Diagnostic, there are more than 85 drugs utilizing pharmacogenomic information in their label today suggesting the importance of biomarkers to drug development and treatment. Personalized Medicine is hitting its stride and is poised for rapid growth.
During the past 15 years we have supported both Pharma (Rx) and Diagnostic (Dx) clients in partnering and commercializing their CDx tests. This experience provides us with key insights to the needs of both players. Before either side consider entering into a CDx engagement, they must be aware of the potential market opportunity and associated technical risks prior to allocating resources for a CDx project. Following this research, it is critical to include 5 Must-Haves in order to achieve a successful Rx-Dx partnership. Without these in place both sides are at a disadvantage, and obtaining the goal of launching a successful project becomes less likely.
1. MUST HAVE #1 – Joint Rx-Dx Steering Committee
Successful CDx launches require a coordinated effort from both parties. It is critical that activities are aligned and that members include both Rx and Dx for each discipline providing input on the approval and monitoring of commercial, development and regulatory plans and milestones.
2. MUST HAVE #2 – Commercial Alignment
Sides must work together when determining strategies for roll-out and coordinating evidence based communication to key opinion leaders (KOLs) and patients. In addition, cultivating an effective sales team having demonstrated achievement using a “clinical solution” approach is vital for success.
3. MUST HAVE #3 – Clinical Coordination
A coordinated Rx-CDx clinical plan in conjunction with harmonized data collection and reporting is crucial. This requires dedicated CDx leads within both organizations that together define strategies prior to initiating studies.
4. MUST HAVE #4 – Development and Supply Chain Expertise
Plans for development and technology transfer must be synchronized. Ensuring production facilities are ISO, FDA and EU regulatory compliant reduces the risk of launch delay. Working with suppliers operating under design and manufacturing controls provides greater confidence that supply will be uninterrupted.
5. MUST HAVE #5 – Regulatory Experience
Matched messaging to regulatory agencies reduces delays due to lack of experience. Dedicated CDx personnel leading validation and approval processes contribute to a streamlined approach and expedited results.
2014 offered a number of emerging partnerships. We will be watching them closely to see how these partnerships navigate their companion diagnostic launch.
Companion Diagnostics are here to stay. Launching a CDx requires discipline and hard work to align a coordinated launch globally.
****For more information on how Market Ready Rx can help you to develop a Companion Diagnostic Go to Market Plan, visit www.marketreadyrx.com.