2013 Archived Content
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TUESDAY, AUGUST 20
7:30 am Registration and Morning Coffee
8:30 Chairperson’s Opening RemarksSushma Selvarajan, Head, Business Development & Strategy, Roche Molecular Systems
8:40 Challenges in Developing Companion Diagnostics with the Complexity of Cancer
J. Carl Barrett, Ph.D., Vice President, Translational Sciences Onc iMed, AstraZeneca
9:10 Validating Biomarkers in an Era of Regulatory and Reimbursement Uncertainty
Felix Frueh, Entrepreneur-in-Residence, Third Rock Ventures
9:40 Accelerate Market Introduction of Your Drug and Accompanying Diagnostic Test
Yvonne Lech, M.D., CEO, Unilabs Bioanalytical Solutions
How can Pharmaceutical companies optimize value creation and ensure fast patient access to high quality testing across markets outside US? The speaker presents a centralized service solution that not only provides instant pan-European access to testing, but also facilitates earlier capture of revenues even with reimbursement uncertainty for the CoDx.
10:10 Coffee Break
10:55 Chairperson’s Remarks
11:00 Seeking Companionship for Personalized Healthcare: Companion Diagnostics Partnership between AstraZeneca and Roche Diagnostics
Cecilia Schott, Executive Business Development Director, Personalized Healthcare, AstraZeneca
Sushma Selvarajan, Head, Business Development & Strategy, Roche Molecular Systems
This presentation will cover the road traveled by AstraZeneca and Roche Diagnostics to create an innovative partnership in the area of Companion Diagnostics. The aim was to create a framework for seamless collaborations between the companies by facilitating open dialogue and knowledge sharing. The speakers will share the key considerations on each side and share their experience in reaching common ground.
11:40 Strategies to Align Drug and Diagnostic Development
John F. Beeler, Ph.D., Director, Theranostics & Business Development, bioMerieux
Jonathan Pan, Ph.D., Director, Oncology Companion Diagnostic and Disease Strategy, GlaxoSmithKline
Precision medicine is a unique marriage between a targeted therapeutic and its companion diagnostic assay. The partnership to create these precision medicines requires a well-orchestrated relationship from development through commercialization. Here we address some of the key considerations in the Rx-Dx partnership to achieve successful commercialization of a precision medicine.
12:20 pm Co-Development of Therapeutics and IVDs: Three Partners, Two Products, One Goal
Andrea Lauber, Ph.D., Global Head, Transactions for Clinical Biomarkers and Pharmacodiagnostics, Bristol-Myers Squibb
Kevin M. Harter, President and CEO, Saladax Biomedical
Alignment is key to building successful partnerships. This is ever more the case when two or more companies join together to develop and commercialize separate but interrelated products that have different financial considerations, regulatory paths and markets. Mutually shared goals and open communication are the glue for building alignment, especially as the process of co-development of companion products takes on a life of its own. We will discuss the importance of these elements with examples of how it is possible to build productive collaborations that can withstand continually changing landscapes.
1:00 Luncheon Presentation I: Overcoming the Challenges of Complex Cancers in Companion Diagnostics
Lilly Kong, D.V.M., CSO, PrimeraDx
1:30 Luncheon Presentation II
(Sponsorship Opportunity Available)
2:00 Session Break
2:15 Chairperson’s RemarksMaureen Cronin, Ph.D., Executive Director, Strategic Information Management, Celgene
2:20 Clinical Development of a Drug with a Companion Diagnostic: It’s Not Just about the Drug!
Kenneth Emancipator, M.D., Director, Companion Diagnostics, Merck
When a companion diagnostic is co-developed with a therapeutic (drug or biologic), the clinic development program must support the registration requirements for both products. This presentation discusses the regulatory concepts, the key elements for planning successful clinical trials, various options for clinical trial design, and, most importantly, the common pitfalls encountered during the course of co-development programs.
2:50 Use of NGS as a Biomarker Tool for Oncology Drug Development
Premal Shah, Ph.D., Director, Business Development, Genomic Health, Inc.
Oncology therapeutic development will become increasingly challenging with rising costs and an even lower percentage of development projects being approved. The evolving reimbursement and healthcare landscapes will also put cost pressures on drugs. Biomarkers will be necessary to alleviate these pressures and companies—given the emergence of successful diagnostics companies—should look to outsource and partner to incorporate biomarkers into clinical development.
3:20 Outsourcing the Development of Companion Diagnostics
Philip D. Cotter, Ph.D., FACMG, FFSc(RCPA), Principal, ResearchDx
Regulatory and economic interest in personalized medicine is driving the co-development of therapeutics and companion diagnostic (CDx) assays. Many pharmaceutical companies look to outsource their CDx needs and the Contract Diagnostic Organization provides a one-stop vendor for this development. The presentation focuses on the use of a CDO for outsourcing CDx development with examples.
3:35 Refreshment Break in the Exhibit Hall with Poster Viewing
4:10 Panel Discussion: Incorporating Companion Diagnostics Considerations Early in Product Development
Moderator: Maureen Cronin, Ph.D., Executive Director, Strategic Information Management, Celgene
Panelists: Session Speakers
- Understanding the routine clinical management of the targeted disease and what biospecimens are generally available
- Ascertaining that there are realistic diagnostic biomarkers in the available patient specimens
- Selecting the most informative modality for the diagnostic test (is it protein, DNA or RNA markers)
- Understand the population ranges and prevalence for the selected diagnostic marker and its precision for testing the appropriate clinical endpoints
- Beginning the pharmacodynamic testing of the diagnostic biomarkers at the earliest stages of the drug development process
5:10 Wine and Cheese Pairing Welcome Reception in the Exhibit Hall with Poster Viewing
6:10 Close of Day
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