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Cambridge Healthtech Institute’s Inaugural

Precision Medicine

Research, Clinical Trials, and Implementation to Deliver Personalized Therapies

August 23-24, 2018 | Grand Hyatt Washington | Washington, DC

Precision medicine is a revolutionary field of modern medicine, but without large-scale patient access, it cannot affect large-scale change. Cambridge Healthtech Institute’s Inaugural Precision Medicine conference aims to bring together top researchers and experts discuss ways to move precision medicine into the hands of clinicians and patients through laboratory tests and clinical trial access. We will examine barriers in science such as utilizing advances beyond genomics, infrastructure, reimbursement and coverage, and the pharmaceutical industry’s role in advancing the field.

Final Agenda

THURSDAY, AUGUST 23

10:00 am Registration (Independence Foyer)

PLENARY SESSION
Constitution A&B

11:15 am Chairperson’s Remarks

 

11:20 am - 12:00 pm TECHNOLOGY PANEL: Disruptive Technologies in Lab Medicine

Moderator: Gregory J. Tsongalis, PhD, HCLD, CC, Professor, Pathology; Director, Laboratory for Clinical Genomics and Advanced Technology (CGAT), Department of Pathology and Laboratory Medicine, Dartmouth Hitchcock Medical Center and The Audrey and Theodor Geisel School of Medicine at Dartmouth

  • What is appropriate test utilization?
  • How do you ensure both user and patient safety?
  • How are tests implemented in the clinical setting?
  • How do they get regulated?
  • How do results get reported?
  • How do you enforce quality control in implementation?
  • How does it impact emerging applications such as liquid biopsies, infectious disease outbreaks, and POC diagnostics?

Panelists:

Nagarajan RakeshRakesh Nagarajan, MD, PhD, Chief Biomedical Informatics Officer, PierianDx


Richard_GregGreg Richard, Chief Commercial Officer, Interpace Diagnostics


Icenhour_CrystalCrystal R. Icenhour, PhD, CEO, Aperiomics, Inc.


Additional Panelists to be Announced

12:00 - 12:45 pm Changing Approaches to Sustainable Funding in Diagnostics

Moderator: Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates

Today, many innovators in the diagnostics industry struggle for funding, and yet news of large scale acquisitions or large (over $30M) funding rounds pops up regularly. How can innovators better understand the changing dynamics of the funding environment to succeed? How can investors know if they are getting exposed to the potentially best investments? Whether government or private, what drives the final difficult decisions and how can companies raise their chances of success? This session features leaders from several different channels of funding for innovators, including the NIH, other federal programs, and corporate and traditional venture investors.

Panelists:

Alex DeWinter, PhD, Managing Director, GE Ventures

Tyler Merkeley, BARDA’s CARB-X Program Manager, Health Scientist, Division of CBRN Countermeasures, BARDA

Todd Haim, PhD, Program Director, National Cancer Institute SBIR Development Center

Wouter Meuleman, PhD, Director, Venture Investments, Illumina Ventures

David Sans, PhD, MBA, F.A.A.R.M., Managing Director, Healthcare Capital Markets, THINK EQUITY (A Division of Fordham Financial Mgmt., Inc.)

12:45 pm Enjoy Lunch on Your Own

1:15 Ice Cream and Cookie Break in the Exhibit Hall with Poster Viewing (Independence Ballroom)

BEYOND GENOMICS: NOVEL APPROACHES TO PRECISION MEDICINE
Franklin/McPherson

2:00 Chairperson’s Opening Remarks

Emanuel Petricoin, PhD, Co-Director, Center for Applied Proteomics and Molecular Medicine, George Mason University


2:05 KEYNOTE PRESENTATION: Genomic Medicine: Access, Coverage, and Ethics

Christine_LuChristine Lu, PhD, Associate Professor, Department of Population Medicine, Harvard Medical School/Harvard Pilgrim Health Care Institute

Genomic technologies are increasingly used in clinical care and are highly relevant to public health because of their potential use in assessing risk, diagnosing, and developing treatment plans. Access to genomic tests often depends on cost and coverage of services by the health plan. Differences in access to genomic tests can influence subsequent treatments and may lead to health care-related disparities. Dr. Lu will provide an overview on patient access to genomic testing and sequencing, including coverage and reimbursement issues and disparities in access.

2:35 Protein Pathway Activation Mapping for Precision Cancer Medicine: Applications at the Bedside

Emanuel_PetricoinEmanuel Petricoin, PhD, Co-Director, Center for Applied Proteomics and Molecular Medicine, George Mason University

Since genomic and transcriptomic profiling cannot predict functional protein activation, a critical need exists to develop technologies and approaches to accurately quantify and map the activated protein signaling architecture- to provide a direct read out of drug target activation. We have developed reverse phase protein microarray technology that we now utilize at the bedside to rapidly uncover the drug target activation landscape from microscopic quantities of cells and use this information to guide therapy decisions and predictive markers.

3:05 Functional Patient-Derived Cell Models for Cancer Precision Medicine

Xuefeng_LiuXuefeng Liu, MD, Professor, Pathology, Georgetown University

Functional testing is an unmet need for the majority of patients without targetable driver genes as well as patients who become resistant to targeting therapies. We developed a method which allows us to establish rapid functional analyses of patient-derived tumor cells (including CTCs and urine cancer cells), especially for predicting drugs/drug combinations, using Conditional Reprogramming (CR) technology. This rapid and efficient method for generating cancer cell cultures (non-invasion approach for culturing bladder cancer cells) can be used potentially for high-throughput drug screening, predicting patient clinical responses, and for monitoring tumor initiation and recurrence.

3:35 Signaling Complexes: From Biology to Biomarkers

Smith_MattMatthew A. Smith, PhD, MSPH, Research Scientist, Thoracic Oncology, Moffitt Cancer Center

I will present data related to our assays for the detection of signaling-associated protein complexes using proximity-based readouts in lung cancer cell lines, xenograft models and patient specimens. By monitoring the association of oncogenic receptor tyrosine kinases with the adaptor protein GRB2, we show proof-of-principle that it is possible to assess signaling activity in FFPE tissues. Ongoing work is developing automated CLIA-compliant assay platforms that may have predictive value in lung cancer

4:05 Networking Refreshment Break (Independence Foyer)

4:30 Omics-Based Identification of Clinically Informative Lung Cancer Biomarkers

Ana_RoblesAna I. Robles, PhD, Staff Scientist, Laboratory of Human Carcinogenesis, National Cancer Institute

Comprehensive genomic characterization has revealed the vast heterogeneity associated with lung cancer development, that poses challenges but also offers new opportunities to selectively target molecular alterations and disease subtypes. Clinically relevant biomarkers of lung cancer detection, patient prognosis and response to therapy can be identified through bioinformatics and statistical analyses of “omics” data to aid patient diagnosis and management.

THE ROLE OF PRECISION MEDICINE IN DRUG DEVELOPMENT AND CLINICAL TRIALS
Franklin/McPherson
 

5:00 Precision Medicine Strategies Including Multi-Omics to Drive Efficient Drug Development

Pallavi_SachdevPallavi Sachdev, MPH, PhD, Director, Clinical Pharmacology and Translational Medicine, Oncology, Eisai Inc.

This talk will discuss deep molecular subtyping and immune-infiltrate characterization to aid immunotherapy combinations to combat resistance or immune escape mechanisms.


5:30 Technologies to Deliver Precision Medicine

Seyda_AgnesAgnes Seyda, PhD, Director, Precision Medicine and Companion Diagnostics, Celgene

This talk will provide an overview of Celgene’s initiatives to partner with other industry stakeholders to harmonize diagnostic methods. Several examples as well as a general collaboration model will be shared.


6:00 Close of Day

6:00 Dinner Short Course Registration (Independence Foyer)


6:30 - 9:00 pm Recommended Dinner Short Course*

SC10: Leveraging Key Opinion Leaders (KOLs): Building a Bridge Between R&D and Commercialization of Companion and Non-Companion Diagnostics

Lawrence J. Worden, Principal, IVD Logix

Charles Mathews, Principal, ClearView Healthcare Partners

Peggy Robinson, Vice President, Angle PLC

*Separate registration required

FRIDAY, AUGUST 24

8:00 am Registration and Morning Coffee (Independence Foyer)

TECHNOLOGIES FOR PRECISION MEDICINE
Franklin/McPherson

8:25 Chairperson’s Remarks

Lynn G. Dressler, DrPH, Director, Personalized Medicine and Pharmacogenomics, Mission Health

8:30 NEW: Updates from the New Director of the Office of In Vitro Diagnostics and Radiological Health (OIR)

Stenzel_TimTimothy T. Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH/FDA/HHS

This talk will provide an introduction and background of the new Office Director of OIR. Updates on Precision Medicine at the FDA will also be shared.

9:00 Microfluidic Cell Tethering to Rapidly Analyze Patient Tumor Cell Drug Response

Stuart_MartinStuart Martin, PhD, Professor, Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine

We have recently developed a novel microfluidic device with a nanometer-thin, optically-clear coating that prevents cell attachment. Integration of hydrophobic lipids into the engineered surface tethers tumor cells to improve high-resolution imaging but preserves the dynamic cytoskeletal behavior of non-adherent tumor cells. Live patient tumor cells can be characterized with dyes or antibodies without displacing cells and rapidly analyzed for drug responses in less than one hour.

9:30 A New Approach to Personalized Medicine for Cancer

Cliff_ReidClifford A. Reid, PhD, CEO, Travera

Travera is using a breakthrough single-cell measurement technology to determine which cancer drugs work against each individual’s unique cancer cells. We are developing a universal biomarker for enabling oncologists to quickly determine which drugs to prescribe based on the actual responses of their patients’ tumor cells to candidate drugs.

10:00 Combining Molecular and Tissue-based Technologies in order to provide Improved Diagnostic Yields for Clinical Trials

Pearce_MarisaMarisa Pearce, CDx Marketing, MolecularMD

The use of biomarkers earlier in the drug development cycle improves the probability of success for the candidate drug’s approval by two-fold. Advances in the field have culminated in multiple biomarkers and methods for interrogation of targeted and immunotherapies. Standardization and practical considerations to improve diagnostic yields in clinical trials will be highlighted.


10:30 Networking Coffee Break (Constitution Foyer)

PRECISION MEDICINE IN THE CLINIC: IMPLEMENTATION AND ACTIONABLE TOOLS
Franklin/McPherson

11:00 Implementing a Personalized Medicine Program in a Rural Community Health System

Lynn_DresslerLynn G. Dressler, DrPH, Director, Personalized Medicine and Pharmacogenomics, Mission Health

This presentation will summarize strategies, challenges and lessons learned implementing a personalized medicine program in oncology and non-cancer service lines in a community health system. Our focus has been utilizing genetics and genomics to predict response to drug therapy, including drug effectiveness and drug side effects. In oncology, we provide expert consultation on cancer genomic profiling, standardization of tumor marker testing and conduct QI studies to assess compliance with national guidelines. In the non-oncology service lines, we focus on safety related to drug-gene pairs with the highest evidence base. Services include clinical consultation, education/training and conducting pilot feasibility studies.

11:30 Making Precision Medicine in Oncology More Precise: Development of the CNS-TAP Tool for Selection of Targeted Therapies

Bernard_MariniBernard L. Marini, PharmD, BCOP, Clinical Pharmacist Specialist, Inpatient Hematology/Oncology, Adjunct Clinical Assistant Professor, Pharmacy, University of Michigan Health System

The number of potential targeted therapies in precision medicine continues to multiply. This presentation will discuss the development of the CNS TAP (Central Nervous System Targeted Agent Prediction) algorithm for selecting precision medicine therapies based on genomic data, in an effort to optimize precision medicine efforts, with the potential to be expanded to multiple tumor types. Attention will also be given to optimizing selection of targeted therapies with CNS penetration.

12:00 Enjoy Lunch on Your Own

1:00 Session Break

HEALTH ECONOMICS OF PRECISION MEDICINE
Constitution CDE

1:30 Chairperson’s Remarks

Daryl Pritchard, PhD, Senior Vice President, Science Policy, PMC

1:35 Clinical and Economic Value of NGS in Cancer Care

Daryl_PritchardDaryl Pritchard, PhD, Senior Vice President, Science Policy, PMC

To provide evidence of the clinical and economic value of mNGS-based diagnostic testing for developers, payers, and providers, we developed a value model to compare the costs and effects of mNGS testing to those of single-marker testing. Given the rapid advance of mutation testing and targeted therapies in metastatic non-small cell lung cancer (mNSCLC), we first analyzed the clinical and cost-effectiveness of mNGS in this cancer type and validated the model with existing real-world data. In this session, we discuss the clinical and economic value of mNGS-based diagnostic testing and discuss how the results of our analysis have been and can be affected by clinical practice patterns. These findings provide evidence that helps demonstrate the potential role and utility of mNGS testing in cancer care.

2:05 CO-PRESENTATION: IIllumina/Harvard Pilgrim on NIPT: Addressing the Biggest Commercial Problem in Diagnostics

Ammar Qadan, Vice President, Global Market Access, Illumina

Roger Longman, CEO, RealEndpoints

Flooded with new and often expensive diagnostics, most without much clinical or economic proof of utility, payers have put the brakes on payment. The result: a commercial pile-up of unreimbursed tests. Illumina and Harvard Pilgrim decided to tackle the problem head on in a major risk-sharing deal for a screening test that can both save money for a plan and improve outcomes. HP, in a competitive payer market, will be able to provide a new, major benefit with Illumina taking much of the risk around additional costs – and Illumina will get the real-world evidence other plans need to prove NIPT’s value. Illumina’s Ammar Qadan, who created and spearheaded the deal, and Roger Longman of Real Endpoints, the independent 3rd party which brokered the deal and will provide the analytics and financial reconciliation for it, will provide a case study in how genetic diagnostic companies can address their single biggest commercial challenge: reimbursement.

2:35 Operational and Economic Considerations Impacting the Decision to Implement NGS Testing in the Clinical Laboratory

Anthony Sireci, MD, MSc, Physician Manager, Personalized Genomic Medicine, Assistant Professor of Pathology Columbia UniversityMedical Director, Medical Affairs, Loxo Oncology

NGS technology has been rapidly adopted in the care of cancer patients. While the technology has matured rapidly, its effective integration into the clinical laboratory is challenged by unique infrastructure and informatics requirements and uncertain coverage and reimbursement by payers. This talk highlights the challenges faced by a large, academic medical center in introducing clinical NGS testing in oncology testing.

3:05 End of Summit



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