Day 1 | Day 2 | Download Brochure | Short Courses
Scientific Advisory Board
Alain Huriez, M.D., Chairman, EPEMED: European Personalized Medicine Association
Iain D. Miller, Ph.D., Global Head, Personalized Healthcare Strategy and Partnerships, GE Healthcare Amersham, UK
Patrick F. Terry, Principal, Pricing & Market Access Practice, Scientia Advisors
Recommended Pre-Conference Short Course*
*Separate registration required
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WEDNESDAY, AUGUST 22
11:00 am Registration
» 11:50 PLENARY KEYNOTE DISCUSSION
Regulation of LDTs and RUOs
Alberto Gutierrez, Ph.D., Deputy Director, Office of in vitro Diagnostic Device Evaluation and Safety, Food & Drug Administration
Moderated by: Franklin R. Cockerill, III, M.D., Ann and Leo Markin Professor of Microbiology & Medicine; Chair, Department of Laboratory Medicine and Pathology, Mayo Clinic College of Medicine; President and CEO, Mayo Medical Laboratories and Mayo Collaborative Services, Inc.
12:45 pm Enjoy Lunch on Your Own
» PLENARY KEYNOTE
1:45 Position of IVDs on Regulatory Issues
Alan Mertz, President, American Clinical Laboratory Association (ACLA)
2:10 Diagnostic Manufacturers: Key Regulatory Issues
Andrew C. Fish, Executive Director, AdvaMedDx
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2:30 Refreshment Break in the Exhibit Hall with Poster Viewing
3:00 Chairperson’s Opening Remarks
Patrick F. Terry, Principal, Pricing & Market Access Practice, Scientia Advisors
3:05 Sponsored Presentation
Speaker to be Announced
3:20 Launching Diagnostics into a Global Marketplace
Patrick F. Terry, Principal, Pricing & Market Access Practice, Scientia Advisors
This presentation will provide an overview of the necessary clinical, delivery model, business, and financial considerations for informed decisionmaking in entering new geographic markets.
3:50 Translating Good Science into Good Business: What Do You Need for Successful Commercialization in a Changing Environment?
Rina Wolf, Vice President, Commercialization Strategies, Consulting & Industry Affairs, Xifin
In this era of change, learn about recent updates on coding, coverage, reimbursement and pricing and discover how you can prepare yourself to respond. Through discussions of case studies, gain insights into what data and strategies are most effective to fully bring a test to market. This is the perfect session for our changing environment to find out what you will need to be successful in commercialization and techniques to translate your good science into good business.
4:20 Sponsored Presentation
Speaker to be Announced
4:50 Industrialization of Next-Generation Diagnostics
Ali Tinazli, Ph.D., Director, Business Development & Sales, Sony DADC
Smart Consumables with microfluidic or optical features are prerequisites for emerging applications in the biomedical markets. The increasing complexity of such new products requires new manufacturing technologies. Sony DADC is applying its excellence in customized mass manufacturing to these highly sophisticated consumables in its new OEM business.
5:05 Multiplex Molecular Assays from Discovery to the Clinic on FFPE Samples: Extraction-Free
Tom Vasicek, Ph.D., Vice President, Clinical Programs & Product Innovation, HTG Molecular Diagnostics, Inc.
HTG’s qNPA enables analysis of FFPE tissue samples in a simple workflow process. The ability to measure dozens to hundreds of genes in a single micro well, along with the flexibility to use old or degraded samples, permits the use of retrospective cohorts in discovery and validation, and is important in clinical practice. HTG has an extensive publication record and clinical labs use qNPA today.
5:20 What Defines Value Capture in Drug Diagnostic Co-Development
Peter Collins, Vice President, Personalized Medicine Diagnostics, GlaxoSmithKline
This talk will describe the fundamental components of Value Capture in an Rx/Dx setting. What is the value proposition to various stakeholders? What are the challenges involved in establishing value for drug, diagnostic and the combination? An assessment of the differences between commercializing a drug versus a typical diagnostic will be considered.
5:50 Addressing the Challenges of CDx Development and Commercialization: Perspectives from a Global IVD Leader
John F. Beeler, Ph.D., Director, Theranostics and Business Development, bioMerieux
The speaker will discuss bioMerieux’s successful theranostic partnering strategy with pharmaceutical developers. bioMerieux has developed a real-world knowledge of win-win deal terms, co-development strategies and alliance management. The speaker will discuss theranostic development issues from the diagnostic developer perspective and will comment on the likely future evolution of commercializing companion diagnostics in this field.
6:30- 8:30 pm Dinner Short Courses*
The Future of Point-of-Care Diagnostics
*Separate registration required
Day 1 | Day 2 | Download Brochure | Short Courses