Molecular diagnostics, genomics and omics introduced tools and technologies that have the potential to guide clinical decisions and trials, and to re-shape healthcare in general. The technologies have matured, and they are widely available. Implemented and adopted they warrant a new era in medicine and drug development. The process of molecular diagnostics integration into healthcare delivery systems as well as in drug discovery and development goes hand in hand with the big data-driven healthcare revolution. Another important condition of advantageous use of clinical sequencing are the regulatory and reimbursement outlooks. Cambridge Healthtech Institute’s Molecular Diagnostics Strategy and Outlook conference is designed to bring together major stakeholders in the field of molecular diagnostics and personalized medicine such as pharma and IVD executives, payers, regulators, healthcare executives and scientific leaders, to come up with solutions to unleash the potential of molecular testing and to integrate it in the next generation healthcare and drug development.

Final Agenda

Monday, March 11

10:30 am Conference Program Registration Open  (South Lobby)

NEW FDA OFFICE DIRECTOR INTRODUCTION
101 & 102

11:50 Chairperson’s Opening Remarks

Jamie Platt, PhD, Chief Executive Officer, BRIDGenomics

12:00 pm FDA Updates: Now and Looking to the Future

Tim StenzelTim Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.

1:00 Session Break

thermofisherscientific_no_tagline 1:10 Luncheon Presentation: Recent Advances in Lyophilized qPCR Reagents

Geist_WillWill Geist, Vice President, General Manager, Genetic Science Division, ThermoFisher Scientific

The use of qPCR for detecting infectious diseases has become routine practice in recent years due to the simple workflow, sensitivity and cost. Molecular Diagnostics companies are seeking solutions to overcome thermo labile properties of standard qPCR reagents. We have developed lyophilization-ready (lyo-ready) polymerase and reverse transcriptase formulation. In addition to lyo-ready components, we will showcase lyo-ready RT-qPCR Master Mix and lyophilized Multiplex PCR assays for infectious disease detection.


1:40 Session Break

MOLECULAR DIAGNOSTICS TO INTEGRATE INTO CHANGING HEALTHCARE ENVIRONMENT
101 & 102

2:30 Diagnostics in an Instant - Meeting the Changing Expectations of Laboratory Testing in Today’s Healthcare Environment

Kaminski_TomTom Kaminski, Senior Vice President, Corporate Strategy, LabCorp

There are a number of factors that are impacting the role of diagnostics in healthcare. One is growing consumerism. Individuals are looking for ways to manage their health in a convenient and affordable way. Where or how do you collect a sample, how do you report the result? In our instant environment you need to provide personalization, on-demand support, convenience of the testing itself and a complete experience.

3:00 Implementing a Genomic Precision Health Program in an Integrated Delivery System

Williams_MarcMarc S. Williams, MD, Director, Geisinger Genomic Medicine Institute

Precision health is an emerging concept in healthcare. While not synonymous with genomic medicine, genomic information represents an essential component to inform risk assessment and intervention. This talk will present the experience of a large integrated healthcare delivery system’s Precision Health program implementation. Preliminary data about the impact on health outcomes will be presented.

3:30 CO-PRESENTATION: How the GEHC/Roche Partnership Aims to Save Lives: Enabling Clinicians to Do What They Do Best

Cobb_BryanBryan Cobb, PhD, FACMG, Global Partner Lead,  Diagnostics Information Solutions, Roche


Sundararajan_ManiSundararajan Mani, General Manager, Oncology, GE Healthcare

The GEHC-Roche Acute Care team is focused on using approaches such as machine learning plus real-time patient data to better predict who needs sepsis prevention care. By developing tools that will enable HCPs to predict patients that are at-risk for developing sepsis sooner, intervention can be deployed for the right patient at the right time, improving patient outcomes and hospital costs. This talk will discuss R&D models along with prototype plans. The GEHC-Roche Oncology team is focused on using data across multiple sources to enable clinicians to diagnose and treat patients in a consistent, cost effective fashion that is accessible to all communities across the world. The team will be developing solutions leveraging the latest digital technologies including machine learning and plans to provide solutions dedicated to the Oncology team and patients.

4:10 Challenges and Opportunities for Increasing Synergy in Molecular Diagnostics and Digital Health: Expert Panel Discussion

Moderator: Jamie Platt, PhD, Chief Executive Officer, BRIDGenomics

Panelists: Speakers of the Session

4:40 Refreshment Break and Transition to Plenary Session  


5:00 Plenary Keynote Session   (Room Location: 3 & 7)

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

7:30 Close of Day

Tuesday, March 12

7:30 am Registration Open and Morning Coffee  (South Lobby)


8:00 Plenary Keynote Session (Room Location: 3 & 7)

9:15 Refreshment Break in the Exhibit Hall with Poster Viewing

UNLEASHING THE POWER OF NGS
101 & 102

10:15 Chairperson’s Remarks

Phil Febbo, MD, CMO, Senior Vice President, Clinical Genomics, Illumina

10:25 The Path to Clinical Whole Genome Analysis as Standard of Care

Febbo_PhillipPhil Febbo, MD, CMO, Senior Vice President, Clinical Genomics, Illumina

Clinical whole genomes are feasible and affordable and will become the standard of care when there is utility to having a definitive and comprehensive genomic assessment. With continued application and publication of results, health care providers will become more informed about the feasibility and utility of clinical whole genome sequencing; with improved sample-to-answer sequencing technologies, more laboratories will be able to perform whole genomes; and, through significant collaborative and industry efforts, there will be more robust annotation, interpretation, and actionability of the genome. When these initial barriers are overcome, use will increase, the benefit to patients assessed, and adoption will occur in those settings where patient outcomes improve.

10:55 Translating Human Genetic Insights into Drug Discovery Impact

Janna Hutz, PhD, Senior Director, Head of Data Sciences & Scientific Infrastructure, Eisai

It is well established that therapeutic targets supported by robust genetic association data are more likely to result in approved medicines than therapeutic targets that are not. There is now a growing appreciation of how insights from human genetics can go beyond target discovery and validation, to impact across the spectrum of drug discovery and development. We have unprecedented substrate and opportunity to realize a new paradigm in human genetics guided discovery and development of precision therapeutics.

11:25 AI Genomics: Changing the Cancer Landscape

Riley Ennis, COO, Freenome

Traditional cancer screening test development has yielded major gaps in performance and patient outcomes. This is due, in part, to the limitations of analyzing a small, fixed number of genes or proteins, limiting the inputs necessary to evolve and compensate for false positive results. Come hear how AI genomic approaches are being leveraged to create smart, blood-based diagnostic tests that improve in performance over time with each sample processed.

Millipore-Sigma-green 11:55 Faster Together: Avoid Development Roadblocks by Partnering Early with MilliporeSigma

Bagga_SavitaSavita Bagga, PhD, MBA, Invitro Diagnostics Segment, Marketing Manager, MilliporeSigma

Explore how we connect researchers with MilliporeSigma experts to exchange challenges/perspectives on IVD development.  With more understanding of customer pain points, our R&D teams can offer customized solutions for the IVD industry's specific needs and  accelerate the path to commercialization.


12:25 pm Session Break

interspace-disagnostics 12:35 Luncheon Presentation I: Seeking Coverage and Reimbursement for New Technologies

Greg Richard, Chief Commercial Officer, Interpace Diagnostics

Securing coverage and reimbursement for new technologies is a difficult and arduous process for providers.  While payers have adopted favorable coverage policies for some molecular diagnostics, strategies such as requiring pre-authorization and delegating decision-making for laboratory services to third parties make the process more complex and less transparent. However, there are some tactics that can potentially be useful in overcoming these challenges; this talk will review these options and provide examples of their success.

1:05 Session Break

1:35 Refreshment Break in the Exhibit Hall with Poster Viewing

FDA AND PAYERS
101 & 102

2:05 Chairperson’s Remarks

Kathryn Phillips, PhD, Professor of Health Economics and Founding Director, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California San Francisco

2:10 PANEL DISCUSSION: FDA and Payers: Does FDA Approval and CMS Coverage Mean More Than Before?

In 2017, the FDA and CMS announced joint approval and coverage decisions for tumor sequencing tests. This decision generated intense controversy and has important implications that go well beyond a specific test. This panel will have a lively discussion about the implications of this coverage determination from the perspectives of regulators, payers, industry, and policymakers.

  • Will private payers and regional Medicare contractors follow the national CMS policy – and should they?
  • Will the CMS decision, which ties coverage to FDA approval/clearance, impede the use of lab-developed tests that do not have FDA approval/coverage? What will be the impact on access for patients?
  • Will FDA/CMS parallel review become the norm in the future and if so, what does that mean for industry and test developers?

 

Moderator:
Phillips_KathrynKathryn Phillips, PhD, Professor of Health Economics and Founding Director, UCSF Center for Translational and Policy Research on Personalized Medicine (TRANSPERS), Department of Clinical Pharmacy, University of California San Francisco


Panelists:

Lin_ErickErick Lin, MD, Medical Director, Clinical Content at Blue Cross Blue Shield Association


Nussbaum_RobertRobert Nussbaum, MD, CMO, Invitae


Aubry_WadeWade M. Aubry, MD, Associate Clinical Professor of Medicine and Core Faculty, PRL-IHPS, University of California San Francisco; Former BCBS and Medicare Medical Director


Stenzel_TimTim Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration


4:10 St. Patrick’s Day Celebration in the Exhibit Hall with Poster Viewing

5:00 Breakout Discussions in the Exhibit Hall

6:00 Close of Day

Wednesday, March 13

7:30 am Registration Open and Morning Coffee  (South Lobby)


8:00 Plenary Keynote Session (Room Location: 3 & 7)

10:00 Refreshment Break and Poster Competition Winner Announced in the Exhibit Hall

INTERSECTION OF BIG DATA/DIGITAL HEALTH AND LABORATORY MEDICINE
101 & 102

10:50 Chairperson’s Remarks

Mark Nunes, MD, Division Chief, Medical Genetics, Kaiser Permanente

11:00 CO-PRESENTATION: Promise vs. Pragmatics for Precision Medicine in the Electronic Medical Record

Nunes_MarkMark Nunes, MD, Division Chief, Medical Genetics, Kaiser Permanente


Alvarado_MonicaMonica Alvarado, MS, LCGC, Regional Genetic Services Administrator, Kaiser Permanente

Precision medicine’s promise depends on backstage integration and exploitation of genetic information in Electronic Medical Records (EMR). Ideally, an individual’s genetic or genomic information informs risk stratification, prevention, medical management, and therapy. The Learning Healthcare System drives innovation and quality, each iteration creating the collective “crowd sourced” evidence base. However, dreams quickly meet reality. We will discuss the precision medicine challenges and solutions engaged by Kaiser’s large integrated healthcare system: family history, cascade testing, DNA results in the EMR, management guidelines for rare and common disease, PharmacoGenomics (PGx), facilitating genome wide association studies (GWAS), and education.

11:30 What’s Data Got To Do With It

Suzanne BelinsonSuzanne Belinson, PhD, Vice President, Commercial Market, Tempus

The value from genetic testing is not from the consumable good, it is not inherent in the test itself but in the insights that can be gained through interpretation of the results and the aggregation of those results with the results of others. Tempus is a technology company that has build the world’s largest library of clinical and molecular data and an operating system to make that data accessible and useful, starting with cancer. Dr. Belinson will discuss how these insights can make precision medicine a reality for patients, providers and payers.

12:00 pm Linked Clinical and Genomic Data: A Major Step towards Personalized Cancer Care

Carson_KenKen Carson, MD, PhD, Senior Medical Director, Flatiron

Moving from precision medicine to personalized medicine will require incorporation and synthesis of data from a variety of channels. The widespread adoption of Electronic Health Records (EHRs) provides an opportunity to match real-world data on cancer treatments, toxicities, and outcomes to high-quality genomic, transcriptomic, and proteomic data. However, stringent data curation is necessary to ensure datasets are of sufficient quality to drive discovery and clinical decision making. Dr. Carson will explore insights we are able to draw today from a combination of real-world clinical evidence from the patient’s EHR, matched with genomic analysis. This data pairing transforms cross-sectional genomic data into a longitudinal dataset capable of generating novel insights, many of which could previously be assessed only through clinical trials or patient registries. Expansion of this platform will be a major part of the evolution to truly personalized healthcare.

12:30 Enjoy Lunch on Your Own

1:10 Refreshment Break in the Exhibit Hall and Last Chance for Poster Viewing

LDT REGULATION DEBATE
101 & 102

1:50 Chairperson’s Remarks

Alex Vadas, PhD, Managing Director, L.E.K. Consulting

2:00 SESSION PANEL: What Should be the FDA’s Role in Oversight of LDTs? A Town Hall Discussion

There are multiple ways in which the industry strives for quality including FDA, CLIA and CAP accreditations, clinical quality controls, and laboratory medicine training programs. The purpose of these approaches is to limit risk from bad actors and poor laboratory medicine and are necessary. However diagnostics innovation is evolving at rapid pace and there are (and will continue to be) a number of areas where oversight mechanisms fall short, these may include:

  • Tests with evolutionary content and interpretation (e.g., BRCA, F1CDx, opioid monitoring)
  • Personalized tests that are designed uniquely for each patient (e.g., Signatera)

TriConference has assembled a panel of experts coming from different industry vantage points which gives us a unique opportunity to discuss the role of oversight, situations where current approaches fall short, and potential solutions to address deficiencies going forward. The topics to be discussed include:

  • What is the purpose of oversight in diagnostics?
  • What mechanisms are in place to ensure quality?
  • What are ongoing legislative or other changes that may impact laboratory oversight?
  • What is the role of LDTs (e.g., fill a gap, address deficiencies with FDA-approved tests)?
  • What are situations where existing regulatory or oversight approaches fall short (panel to identify specific examples and highlight key issues)? For example:
  • What are real-world issues that may arise from these shortfalls? How do they impact various stakeholders?
  • Picking two specific examples of evolutionary content and personalized tests what is the path forward?
  • What are insights for diagnostics companies? What about pharma?

Moderator:
Alex VadasAlex Vadas, PhD, Managing Director, L.E.K. Consulting


Participants:

Putcha_GirishGirish Putcha, MD,  PhD, CMO & Clinical Laboratory Director, Freenome


Gutierrez_AlbertoAlberto Gutierrez, PhD, Partner, NDA Partners LLC; Former Director, Office of In Vitro Diagnostics and Radiological Health, FDA


Abbott_BrianBrian Abbott, Global Regulatory Lead, CDx Advisor, Amgen


Pratt_VickyVictoria Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Medical and Molecular Genetics, Indiana University School of Medicine; President, AMP


Dietzen_DennisDennis Dietzen, PhD, Associate Professor of Pediatrics and Pathology, Washington University, President, AACC


Moshkevich_SolomonSolomon Moshkevich, General Manager, Oncology & Transplant Businesses, Natera


3:30 Session Break

AI to SUPPORT CLINICAL DECISION MAKING
101 & 102

3:40 Chairperson’s Remarks

Glorikian_HarryHarry Glorikian, Healthcare Consultant


3:45 Digitizing Human Health with Molecular and Phenome Data

Renee Deehan KenneyRenee Deehan Kenney, PhD, Vice President, Computational Biology, PatientsLikeMe

PatientsLikeMe has over a decade of experience collecting patient-generated health data to help individuals track information about their health and improve their outcomes. In order to leverage concomitant advances in molecular measurement technology, we have begun collecting and analyzing biosamples on a diverse array of omics platforms, including DNA and RNA sequencing, methylomics, immunosignature, metabolomics and proteomics measurements. In this session, we will discuss the development of a biocomputing platform that applies machine learning and other modeling techniques to aid researchers in extracting meaningful health insights from complex biological and phenomic data sets, and a case study that demonstrates the utility of the platform.

4:15 Cancer Deep Phenotype Extraction from Electronic Medical Records (DeepPhe)

Savova_GuerganaGuergana Savova, PhD, FACMI, Associate Professor, PI Natural Language Processing Lab, Boston Children’s Hospital and Harvard Medical School

We present the DeepPhe software for extracting deep phenotype information from EMRs. The software is a significant departure from other efforts in the field, as it enables comprehensive longitudinal data processing from various sources. The envisioned applications are far-reaching, from translational clinical investigations to cancer surveillance and precision oncology initiatives.

4:45 PANEL DISCUSSION: Transformation Revolution in Laboratory Medicine

Moderator: Harry Glorikian, MBA, Healthcare Consultant; Author, MoneyBall Medicine: Thriving in the New Data-Driven Healthcare Market

Panelists: Speakers of the Session

5:15 Close of Conference Program

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