Cambridge Healthtech Institute’s Twelfth Annual

Molecular Diagnostics

Executive Strategies for Success
The Industry Leader’s Networking Event

February 16-18, 2015 | Moscone North Convention Center | San Francisco, CA
Part of the 22nd Annual Molecular Medicine Tri-Conference

 

The growth in the diagnostics sector and personalized therapy is being driven by opportunities in molecular diagnostics. Today, hospitals and healthcare providers need to stay competitive by taking on large-scale projects to match patients with targeted therapy using next generation sequencing and molecular profiling tools. This conference will feature experts on business strategy, platform development, regulation and reimbursement who will outline the steps needed to take to achieve commercial success in the current environment.

Scientific Advisory Board

Alan B. Carter, Consultant, Sales Performance International
Dalia Cohen, Ph.D., Head, Research, Beryllium


Day 1 | Day 2 | Day 3 | Plenary Session | Download Brochure | Molecular Diagnostics Brochure 

Monday, February 16

10:30 am Conference Program Registration


KEYNOTE FORUM

11:50 Moderator’s Opening Remarks

Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP (AMP 2014 President and Member, AMP Professional Relations Committee)

12:00 pm PANEL DISCUSSION: The Value of Molecular Diagnostics: A Discussion on Clinical Utility

The number and complexity of clinical molecular diagnostic tests (MDx) are increasing at a rapid rate. The health care professional asks: When does MDx make sense for my patient? What scientific evidence is needed to establish the clinical utility of a particular MDx? This keynote session will focus on the clinical utility of MDx in cancer and inherited disease. It is an outgrowth of ongoing discussions on this issue among members of the Association for Molecular Pathology. We will address the contribution of MDx to the care of patients at the present time, and anticipated progress in the near future.

  • Defining and measuring clinical utility from the point of view of both the clinician and the patient
  • MDx of malignancies to offer prognostic and predictive information useful for selecting the optimal therapy
  • Halting the “diagnostic odyssey” by selecting the appropriate genomic MDx for people, often children, with diseases that are difficult or sometimes seemingly impossible to diagnose
  • Establishing the value of MDx as a modality that will not only improve health-care, but do so in a way that will lower costs in the long run

Panelists:

Loren Joseph, M.D., Medical Director, Molecular Diagnostics & Cancer Genetics, Pathology, Laboratory Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School (2014 Chair, AMP Clinical Practice Committee)

Paul G. Rothberg, Ph.D., Professor, Pathology & Lab Medicine, University of Rochester Medical Center (AMP Clinical Practice Committee, Genetics Subdivision Representative)


1:00 Session Break

1:15 Luncheon Presentation I: Rising to the Challenge of Liquid Biopsies Using PointMan DNA Enrichment 

Andrew Webb, CEO, EKF Molecular Diagnostics

Personalised cancer therapies based on tumour genotype have led to unparalleled progress in treatment.  Genotype at diagnosis using solid biopsies is standard, routine monitoring of patient genotype during treatment presents an unmet clinical need.  Here we present data utilising PointMan DNA enrichment using cfDNA and circulating tumour cells and how this rapid and cost effective sample enrichment can be incorporated into routine and next generation sequencing assays for patient monitoring.

1:45 Luncheon Presentation ll (Sponsorship Opportunity Available)

 

2:15 Session Break


Panel Discussion: Generating and Communicating Evidence for Payer Coverage

2:30 Moderator’s Remarks

John W. Hanna, Vice President, Endocrinology, Veracyte

Medical policy is a complex multi-factor decision-making process. In addition to the objective assessment of medical evidence, plans may consider input from their network providers, employers, patients, and their peers. However, labs can be challenged with getting their medical evidence in front of medical policy review committees and decision makers. Obtaining medical policy coverage requires convincing data, but it also requires active participation of other influencers that drive medical policy review and decision making. This session will discuss how to harness some of those influencers in the medical policy review process.

  • Harnessing local providers and KOLs
  • Empowering patients to advocate for coverage
  • Formally communicating medical evidence to medical policy committees

Panelists:

Robin Harper Cowie, Director, Reimbursement, Biodesix, Inc.

Jerry Conway, Vice President, Reimbursement & Payer Strategy, Foundation Medicine, Inc.

Marijke Annis, MSPH, Independent Consultant, Reimbursement and Market Access Strategy Development, CardioDx, Inc.

4:10 Leveraging New Automated Ultra-Sensitive Detection Technologies for Novel LDTs 

Mark Roskey, Ph.D., Vice President & General Manager, Applications & Reagents, Quanterix

With the rapid growth of personalized medicine and the resulting proliferation of novel tests offered in private labs as LDTs, more powerful and efficient tools are required. We will introduce and discuss how Simoa, an ultra-sensitive protein detection platform, meets the specific needs of LDT providers.

4:25 2015 is Here! Reimbursement Lessons for Another Year

Rina Wolf, Vice President, Commercialization Strategies, Consulting and Industry Affairs, XIFIN, Inc.

This session will highlight any updates on PAMA, Medicare and commercial payor trends in coverage and pricing, and what labs should be looking out for this year, and beyond.

4:40 Break and Transition to Plenary Session

5:00 Plenary Session

6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:30 Close of Day


Day 1 | Day 2 | Day 3 | Plenary Session | Download Brochure | Molecular Diagnostics Brochure 

Tuesday, February 17

7:00 am Registration and Morning Coffee

8:00 Plenary Session

Slone Partners9:00 Refreshment Break in the Exhibit Hall with Poster Viewing 


NEW INSIGHTS INTO DISEASE
FROM NON-CODING RNA

10:05 Chairperson’s Remarks

Dalia Cohen, Ph.D., Head, Research, Beryllium

10:15 About Noam Chomsky, DNA Patterns, Noncoding RNAs and Cancer Patients

George Calin, M.D., Ph.D., Professor, Experimental Therapeutics and Leukemia, MD Anderson Cancer Center

This talk will review the newly discovered differential expression in numerous tissues, key cellular processes and multiple diseases for several families of long and short non-coding RNAs (ncRNAs, RNAs that do not codify for proteins but for RNAs with regulatory functions), including the already famous class of microRNAs (miRNAs). These strongly suggest that the scientific and medical communities have significantly underestimated the spectrum of ncRNAs whose altered expression has significant consequences in diseases. This talk will review the recent studies on miRNAs and non-coding genes.

10:45 Journeys through Space and Time: Ultra High-Resolution Expression Profiling of Long Noncoding RNAs

Marcel E. Dinger, Ph.D., Head, Clinical Genomics & Genome Informatics, Garvan Institute of Medical Research

Long noncoding RNAs (lncRNAs) are increasingly recognized as having key regulatory roles in development and disease. However, these regulatory molecules often have short half lives and are expressed only in specific tissues or cell types, resulting in the poor representation of lncRNAs in transcriptomic datasets. Using novel detection and sampling approaches, we reveal a high-resolution spatiotemportal view of the long noncoding transcriptome that provides fresh insights into their roles in development and disease.

11:15 Exosomic microRNAs Orchestrate the Biology of the Tumor Microenvironment

Muller Fabbri, M.D, Ph.D., St. Baldrick’s Foundation Scholar; Assistant Professor, Pediatrics and Molecular Microbiology & Immunology, Norris Comprehensive Cancer Center, University of Southern California- Keck School of Medicine; Children’s Hospital Los Angeles

MicroRNAs (miRNAs) are secreted by cells within microvesicles called exosomes. Cancer cells are selective in defining the miRNA cargo within their exosomes. The function of exosomic miRNAs within the Tumor Microenvironment is currently not completely understood. We discovered that in addition to their “traditional” gene expression regulatory mechanism of action, exosomic miRNAs can also function as ligands of miRNA receptors in surrounding cells, leading to a pro-tumoral response. These findings identify a new mechanism of action of miRNAs and lead to the identification of new targets.

11:45 Sponsored Presentations (Opportunities Available)

12:15 pm Session Break

12:25 Luncheon Presentation I

Speaker to be Announced

12:55 Luncheon Presentation ll : CLIA Waived Molecular Diagnostics: A Ripe Opportunity in the Age of Affordable Health Care 

Ihor Boszko, Vice President, Business Development, Xagenic Inc.

Katherine Tynan, Ph.D., President, Tynan Consulting LLC 

Fran White, President, MDC Associates 

The molecular diagnostic industry has been evolving toward point-of-care diagnostics for the past decade. However, because most MDx systems rely on PCR and similar enzymatic methods, no system has been simple enough to attain CLIA-waived status.  Emerging MDx technologies enable simpler engineering and workflows, broadening access to POC diagnostics to larger markets like physicians’ offices. This session will explore commercial, regulatory, reimbursement and health economic aspects of CLIA-waived MDx testing.  


 


 

1:25 Refreshment Break in the Exhibit Hall with Poster Viewing



PANEL DISCUSSION: MOLECULAR DIAGNOSTIC TESTS: IMPROVING PATIENT CARE AND SAVING COSTS

2:00 Moderator’s Remarks

Edward Abrahams, Ph.D., President, Personalized Medicine Coalition

  • What are the new tests?
  • Why are they important?
  • How are they transforming care?
  • Do they save money?
  • Current obstacles to medical adoption

Panelists:

Mark Monane, M.D., MS, Chief Medical Officer, CardioDx, Inc.

Donald G. Munroe, Ph.D., Senior Vice President, Business Development; Chief Scientific Officer, R&D, Vermillion, Inc.

Albert A. Luderer, Ph.D., Chief Executive Officer, Integrated Diagnostics (IndiDx)

3:40 Discovery, Development and Commercialization of Multiplex Diagnostics

Austin Tanney, Ph.D., Marketing Manager, Almac Discovery and Diagnostics, Almac

This presentation will highlight Almac’s experience and expertise in the discovery, development and commercialization of multiplex diagnostics and companion diagnostics. Detail will be shown on the discovery and development of Almacs test for Angiogenesis drug response (AADx).

3:55 Sponsored Presentation (Opportunity Available)

Mardi Gras4:10 Mardi Gras Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall

This interactive session provides attendees an opportunity to choose a specific discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

IVD Clinical Study Design: Recent Feedback from FDA


Gail Radcliffe, President, Consulting, Radcliffe Consulting, Inc.


• Defining “truth” in IVD clinical studies
• Complexities of Next-Gen regulatory requirements
• CLIA Waiver POC studies: can you perform a 510(k) study at the same time?
• Controls and analytical study requirements for molecular tests

FDA Proposed Regulatory Oversight of LDT


Michael C. Little, Ph.D., Senior Advisor, Popper & Co
William Pignato, Regulatory Affairs Consultant, W.J. Pignato & Associates, LLC


• Laboratory readiness, approaches and plans
• Instrument and reagent supplier plans
• Impact to the clinical lab testing competitive space
• Development of future LDTs  and immediate impact on CDx and CDx/Rx Trials

 

6:00 Close of Day


Day 1 | Day 2 | Day 3 | Plenary Session | Download Brochure 

Wednesday, February 18

7:00 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:00 Plenary Session Panel

9:45 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

10:35 "Swimming with the Sharks" Evaluating Start-ups with Funders, Users and Payers


Swimming with the Sharks 


Alan B. CarterModerator: Alan B. Carter, Consultant, Sales Performance International

Twelve finalists have been chosen to compete in front of a panel of industry leaders at the Inaugural Swimming with the Sharks competition. These start-up companies seeking venture funding will pitch their company’s value proposition to a panel of judges. The top place winner will receive recognition as the "2015 Tri-Con Most Promising Company", and services valued up to $15,000 from Sales Performance International (SPI) for personalized consulting. The second place winner will receive $5,000 in SPI services. SPI is the global leader in evidence-based solution selling with clients including Agilent, IBM, Novozymes, US Oncology and Phillips.

The top finalists are:

  • Magnetic Insight
  • Disease Diagnostic Group
  • HeatSeq
  • Beacon Biomedical
  • Nanovega
  • Solano Pharmaceuticals
  • oncgnostics
  • DxUpClose
  • Fluoresentric
  • FibroTx
  • Molecular Assemblies
  • NextGxDx

Qualifying Criteria:

Start-up companies will be judged on 3 criteria:
1) Clinical Utility
2) Investor readiness
3) Healthcare impact

Judge Biographies 

Panel of Judges:

Mark Boguski,Mark Boguski, M.D., Ph.D., Founder & CMO, Genome Health Solutions

 




Paul D. GrossmanPaul D. Grossman, Ph.D., Venture Partner, Telegraph Hill Partners

 




Stan RoseStan Rose, Ph.D., CEO, Transplant Genomics

 




Enrico PicozzaEnrico Picozza, MS, Venture Partner, HLM Venture Partners





 

Harry GlorikianHarry Glorikian, Healthcare Consultant





12:15 pm Session Break

12:25 Luncheon Presentation: From Biomarkers to Business Success: Strategies to Maximize Clinical Impact and Market Uptake 

Speaker to be Announced

1:00 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

1:40 Competition by Selected Finalists: 10 minute presentations

2:40 Summary and Award for Top Start-Up

First and Second Place Awards
Presented by the Judges Panel

3:20 Sponsored Presentation (Opportunity Available)

 

3:50 Refreshment Break


PANEL DiSCUSSION: WHAT DO YOU HAVE TO DO TO GET A TEST COVERED AROUND HERE?

Insights from Proponents, Payers, and the PMC

4:00 Moderator’s Remarks

Lon Castle, M.D., CMO, Molecular Genetics and Personalized Medicine, CareCore National, LLC

Diagnostic companies, health systems, and payers have all been impacted in different ways by the advent of genomics. Their views on how to best incorporate these emerging tests stem from their unique roles within the healthcare system. Insights on how they assess when a test provides enough value to include it as a covered benefit for their members will be explored. The metrics for getting a molecular diagnostic test covered continue to evolve. Hearing from payers on how they evaluate tests and what factors are most important in demonstrating value would provide good insights into the process for the conference attendees

  • Determine how health systems evaluate data to determine benefits of a genomic test
  • Appreciate the key elements that determine success (or failure) when creating new genomic tests
  • Understand how payers think about the inclusion of new genomic tests into the medical benefit
  • Hear how organizations like the Personalized Medicine Coalition are working to guide diagnostic companies in their evidence development process

Panelists:

Charles Stemple, DO, MBS, Corporate Medical Director, Commercial Clinical Policy, Humana

Sherie Smalley, M.D., Chief, Medical Policy & Benefits Branch, UPMC Health Plan

5:40 Close of Conference Program



Day 1 | Day 2 | Day 3 | Plenary Session | Download Brochure | Molecular Diagnostics Brochure 

Japan-Flag Korea-Flag China-Simplified-Flag China-Traditional-Flag 

 

2015 Brochure cover 

Premier Sponsors:

Abbott Molecular 

 

Elsevier  


Jackson Laboratory - small logo 

Leica Biosystems 
 

 NanoString2   

 

Silicon Biosystems 

 

Singulex 

Thomson Reuters-Large