Archived Content

Track 4: Executive Summit:
Companion Diagnostics*
 


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Sunday, May 5


5:00-6:00 pm Conference Pre-Registration


Monday, May 6


7:30-8:30 am Conference Registration and Morning Coffee

8:30-8:40 Welcome Remarks from Conference Director

Julia Boguslavsky, Executive Director, Conferences, Cambridge Healthtech Institute


Commercialization of Companion Diagnostics 

8:40-8:45 Chairperson’s Opening Remarks

8:45-9:10 Companion Diagnostic Success: Biomarker Discovery to Global Commercialization

Chris Jowett, General Manager, Commercial Operations, Abbott Molecular

Developing a successful global commercialization strategy for a companion diagnostic can be a significant challenge. Critical capability factors need to be discussed prior to entering into the partnership to minimize risk. Understanding the IVD manufacturers’ capabilities to develop, manage the required clinical trials, navigate the regulatory environment for approval, and drive sales and marketing efforts in all targeted countries for the therapeutic launch is essential. This talk will focus on a variety of strategies to support a successful launch of a companion diagnostic program.

9:10-9:35 The Payor’s Role in Personalized Medicine

Carol S. Palackdharry, M.D., MS, Medical Director, ActiveHealth Management; Clinical Lead, Oncology Condition Analysis, Aetna

Targeted cancer treatment is already changing the standard of care for many cancers. Personalized therapies are costly and generally have anti-tumor activity only in patients with the specific targeted abnormality. Most targeted agents require pre-certification, with coverage dependent on appropriate results on approved companion diagnostic tests. Development of rigorous, evidence-based recommendations for usage of such tests, as well as new contracting strategies with high-quality laboratories, will avoid wasted expenditures and assure access to personalized therapies for all qualified patients.

9:35-10:00 Meeting Evidence Demands for Diagnostics in an Evolving Payment Environment

Andrew C. Fish, Executive Director, AdvaMedDx

Payer reimbursement of diagnostics is critical to ensuring a robust market for innovation. As advanced molecular diagnostics proliferate, a growing appreciation of the importance of these tests is tempered by rising payer concerns about coding transparency, evidence of clinical utility, and utilization of and payment for these tests. This talk will review the reimbursement challenges faced by test developers and initiatives underway by payers and in Congress to address those challenges.

10:00-10:30 Networking Coffee Break

10:30-10:55 Creating a Companion Diagnostic Regulatory Strategy: Biomarker to Commercial Test

Debra Rasmussen, Senior Director, Regulatory Affairs, Johnson & Johnson

Validated biomarkers (diagnostic tests) that can serve as intermediate or surrogate endpoints to acquire rapid regulatory approval are needed to help move research into the clinic. This is especially true if such biomarkers could be measured easily, rapidly and were generally accessible. Pharmaceutical companies could gain from biomarkers and diagnostic co-development efforts. In an increasingly challenging regulatory environment, diagnostic led treatment can improve the chance that drugs are reimbursed or approved in the first place. As companion diagnostics these could also potentially identify patient benefits from a novel therapeutic strategy earlier, assist in early discontinuation of ineffective strategies, and identify active drugs more efficiently. New concerns could include: 1) designing a definitive clinical study for a joint therapeutic–diagnostic that allows for assessment of the therapeutic’s safety and efficacy, as well as for validation of the clinical utility of the biomarker guiding the therapeutic’s use or 2) regulatory bodies requiring a diagnostic test before a prescription may be written for a patient.

10:55-11:20 Oncology and Beyond: Where Next with Companion Diagnostics?

Bruce Jordan, Ph.D., FIBMS, Vice President, International Business Leader, Companion Diagnostics, Roche Diagnostics International Ltd.

11:20-11:50 Panel Discussion: Strategies for Regulatory and Reimbursement Challenges in Commercialization of CDx

Panelists:

Bruce Jordan, Ph.D., FIBMS, Vice President, International Business Leader, Companion Diagnostics, Roche Professional Diagnostics

Chris Jowett, General Manager, Commercial Operations, Abbott Molecular

Carol S. Palackdharry, M.D., MS, Medical Director, ActiveHealth Management; Clinical Lead, Oncology Condition Analysis, Aetna

Debra Rasmussen, Senior Director, Regulatory Affairs, Johnson & Johnson

Andrew C. Fish, Executive Director, AdvaMedDx

11:50-1:20 pm Enjoy Lunch on Your Own


Strategies for Rx-Dx Partnerships 

1:20-1:25 Chairperson’s Remarks

1:25-1:50 Synchronizing Drug Development and Companion Diagnostics: Challenges and Solutions

George Bashirians, Ph.D., Director, Diagnostics Lead, Clinical Research and Precision Medicine, Worldwide R&D, Pfizer

Last year witnessed simultaneous regulatory approvals of Rx and Dx and it is expected that such approvals will be more commonplace in the near future. Synchronizing the drug development phases with those for Dx development presents many challenges. This talk will attempt to outline these challenges and offer solutions based on the Xalkori Rx/Dx program.

1:50-2:15 Managing Pharma/Diagnostic Partnerships in Companion Diagnostic Development

George A. Green IV, Ph.D., Director, Pharmacodiagnostics, Bristol-Myers Squibb

The development of CDx assays minimally requires a partnership between a pharmaceutical and a diagnostic company. It is not uncommon for the drug to be developed through an alliance of two pharmaceutical companies, and diagnostic assay development programs may include separate companies for design of the assay and development of the platform. To ensure effective delivery of the CDx within this complex environment, highly matrixed teams must be formed to address strategic and technical issues, and to deliver a quality product coordinated with the drug development schedule.

Luminex 2:15-2:45 Key Considerations for Selecting a Diagnostic Partner in Rx-Dx Program Commercialization

Jeremy Bridge-Cook, Ph.D., Senior Vice President, Research & Development, Luminex

What are the optimal capabilities and expertise required of diagnostic partners for the development and commercialization of companion diagnostic devices? Key considerations include prototype assay development, analytical and clinical validation, regulatory filing, approval and market launch. The speaker will discuss how each of these elements can impact the success of a companion diagnostic program.

2:45-3:40 Refreshment Break in the Exhibit Hall with Poster Viewing

Life_Technologies3:40-3:55 CDx Development-Are You Ready?  Key Considerations for Rx/Dx Co-Development From the Dx Partner Perspective

Todd Krueger, Strategy Leader, Medical Sciences, Life Technologies

Successful co-development of CDx products requires many decisions be made long before development begins.  Key considerations from the IVD development partner perspective will be explored including locking down the marker set, choosing the right platforms and reagents, when to move from RUO to IUO, what is proper commercialization strategy to match the needs of the drug.

Unilabs3:55-4:10 CoDx: Getting the Samples to the Test. Role of the Service Provider.

Henrik Tommerup, M.Sc., Ph.D., EMBA, Business Developer, Unilabs Bioanalytical Solutions

CoDx strategies engage expert teams at pharmaceutical and diagnostic companies. How do we ensure fast patient access to high quality testing across all markets? The speaker presents how a centralized solution provides global access and facilitates earlier capture of drug revenue.

4:10-5:00 Panel Discussion: Strategies for Initiating and Managing Successful Rx-Dx Partnerships

Panelists:

George Bashirians, Ph.D., Director, Diagnostics Lead, Clinical Research and Precision Medicine, Worldwide R&D, Pfizer

George A. Green IV, Ph.D., Director, Pharmacodiagnostics, Bristol-Myers Squibb

Jeremy Bridge-Cook, Senior Vice President, Research & Development, Luminex

Karen M. Becker, Ph.D., Managing Director, Translational & Regulatory Sciences, Precision for Medicine
Panelist to be announced

5:00-6:00 Welcome Reception in the Exhibit Hall with Poster Viewing

6:00-9:00 Dinner Courses

Fit-for-Purpose Biomarker Assay Development and Validation
Next-Generation Sequencing as a Clinical Test

(Separate registration required)

*Executive pricing registration required 



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