Alliance management has long been a core competency in many drug companies, as a way of helping to ensure that compounds discovered by biotech partners make their way to the market. Yet the relationship between drug and diagnostics companies has been a challenge for both sides. Understanding how to manage these strategic relationships is critical to the successful development of a companion diagnostic test, and there can be consequences for a drug company not taking an active role in these alliances.

In this audio conference presentation, our speaker examines the issue, and discusses when and how to start looking for a diagnostics partner, how to structure the relationship, and how best to work together for mutual benefit.

This audio conference covers:

• What to look for in a good diagnostics partner
• Understanding when to start the strategic relationship
• Identifying what milestones should be in the contract, and when are they required
• Tools for integrating the drug and diagnostic development processes

About the speaker:

David Kern, RAC MBA is Senior Director with Myraqa, a full-service IVD regulatory consulting firm. Dave has nearly 20 years of experience developing IVD and life science products. His experience in product development, project management, business development and relationship management grants him a wide view of the entire life-cycle management process. He has designed and implemented product development processes for both FDA and ISO environments, in both large and small companies. He also has extensive experience in creating and implementing governance structures to manage co-development and outsourcing relationships within both the IVD and therapeutics industries.

Dave holds a BS in Biochemistry from San Francisco State University, and a MBA from San Jose State University. He has extensive training in project management, facilitation and conflict resolution, and holds a Regulatory Affairs Certification.

Who should attend?

• Regulatory Affairs
• Quality
• Clinical Affairs
• Development Directors
• Marketing Directors
• Business Development Directors