Evolution of Best Practices and Collaborations
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As we move beyond “CDx 1.0” (clinical trials and market approvals), researchers are poised to launch CDx 2.0 (Precision Medicine and Mobile Health). Our committee of selected experts have designed an event that captures the current state and the nascent transition to CDx 2.0. Presenters were consequently recruited to discuss their work leveraging lessons learned and current best practices. Based on data and experience gained during CDx 1.0, speakers will also address the evolution of execution, implementation and business models as the foundation for moving on to CDx 2.0.
Companion Diagnostics have clearly reached a benchmark in clinical use, as evidenced by the FDA's "List of Cleared or Approved Companion Diagnostic Devices." Technology platforms, protocols, and paths to approval have been established.
Less clear is the maturity of the business models and best practices. Several business models are currently being deployed, primarily through collaborations among pharma, diagnostic, and CRO companies. Companies are currently gathering data to learn from the initial launches of CDx on labels and in trials. Analysis and review of these data are expected to lead to the models that work best, and under which conditions they are most effective; we anticipate that approaches will be updated and refined from lessons learned.
This symposium highlights collaborations among partners: speakers will focus on the mechanics of forming partnerships, coordinating projects among teams, and steps required to launch the companion drug and diagnostic. Speakers will review lessons learned from experience, as well as from the FDA list of marketed products.
Companion Diagnostics have gained a foothold in clinical use, as evidenced by FDA's "List of Cleared or Approved Companion Diagnostic Devices." Several business models are currently being deployed to derisk applications of the approach, primarily by leveraging collaborations among pharma, diagnostic, and CRO companies.
Talks will highlight collaborations with solution providers and the deployment of emerging technology platforms for companion diagnostics, as well as a session on approvals and lessons learned from the FDA list of marketed products.
The event will focus on the partnerships and collaborations needed for this enterprise. All parties recognize the critical need to partner, and they have been working through the details of implementation and execution. Many lessons have been learned in the course of the CDx 1.0 roll-out. We welcome all to come hear what’s worked, what’s not worked, and what’s next as groups prepare to launch CDx 2.0.
1. CDx 2016 focuses on the importance of partnerships formed between and among pharma, diagnostics, and CROs to coordinate development and implementation of the drug-diagnostics pair. Talks will highlight strategy, tactics, and lessons learned as clinical trials and marketing efforts unfold.
2. Hand-in hand with partnerships, the players in this enterprise are developing and revising implementation and business models. Pharma, diagnostics, and CROs are assessing evolving models during the current round of trials with an eye on uptake, costs, and regulatory oversight. As more experience is gained and built into models, we anticipate that the dynamics will stabilize in the next few years. The payoff for current efforts will be a portfolio of approaches for planning the next generation of offerings.
3. Finally, hear directly from those who have experienced successes to emulate as well as pitfalls to avoid - that is, what has worked and what hasn’t. You may find out about a company you might consider for future partnering.Register Now Sessions will cover: