Conference Day 1 - November 7, 20 17

Day One

COLLABORATIONS IN PRECISION HEALTH

David Litwack
09:00

The FDA’s role in empowering precision medicine for all

  •     How reducing premarket approval review times has promoted faster patient access to personalized drugs
  •     Improving clinical trial performance by encouraging the use of adaptive trial design
  •     Including patient preferences in evaluating benefit-risk of medical devices in order to facilitate access 
Scott Josephs
09:20

Building a multi-stakeholder policy for personalized health

  •     How precision medicine will revolutionize health insurance on a patient-by-patient basis
  •     Where – and why – health plans can support efforts to develop personalized medicines
  •     The cost-containment opportunity for payers in the long-term: why investment is needed in the short-term
09:40

PLATINUM SPONSORSHIP AVAILABLE

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10:00

10:00 SPEED NETWORKING

10:20

10:20 NETWORKING COFFEE BREAK

PRE-CLINICAL PRECISION

COMPANION DIAGNOSTICS

Discovery & Development
11:00

Validating exploratory biomarker hypotheses in pre-clinical research

  •     Implementing predictive biomarkers into early phase clinical research to improve trial efficacy
  •     Building multi-disciplinary teams to streamline assay development
  •     Define and validate assay requirements to increase accuracy in drug discovery 
Diagnostics & Data
11:00

Exploring oncology companion diagnostics from signal transduction inhibitors to immuno-oncology

  •     Analyzing and comparing tyrosine kinase inhibitors and checkpoint inhibitors
  •     Increasing Dx test complexity from single analytes to complex molecular profiles
  •     How novel clinical development strategies impact the discovery and validation of predictive biomarkers
Discovery & Development
11:20

Bridging the gap between translational and precision medicine

  •     Focusing on potential precision medicine targets as early as phase I and II of clinical trials
  •     Determining which targets are amenable to precision medicine in order to ensure a streamlined transition from pre-clinical to clinical research
  •     Recruiting specific disciplinary talent for improved organizational structure 
Diagnostics & Data
11:20

Companion diagnostics ex-oncology

  •     Qualifying the opportunity for manufacturers in the growing use of companion diagnostics ex-oncology
  •     Aligning incentives in companion diagnostic co-development for cost containment and increased efficacy
Discovery & Development
11:40

Leveraging pharmacogenetics in drug development

  • Application of routine genotyping analyses across the pipeline
  • Understanding contribution of ADME PGx in development programs
  • Improving benefit-risk considerations by identifying response variants
Diagnostics & Data
11:40

Whole genome sequencing as the clinical test

  •     Whole genome sequencing on the Complete Genomics Platform: analysing strengths, weaknesses and alternative platforms 
  •     Determining clinical standards around whole genomic sequencing to ensure ethical compliance  
Discovery & Development
12:00

SPONSORSHIP AVAILABLE

Do you have a solution that you would like to share with our audience?
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Diagnostics & Data
12:00

NGS in the clinic – regulatory challenges

  •     What we know now: how matching improves outcomes
  •     What we still do not know: how to align decision support algorithms
  •     Aligning clinical workflows with regulatory concerns to impact patient care 
round tables
12:20

INTERACTIVE ROUNDTABLE DISCUSSIONS

  • Bioinformatics – empowering target-based drug discovery
  • Ying Chen

    Ying Chen, Senior Bioinformatics Specialist, Rutgers Cancer Institute of New Jersey

  • Ct-DNA and Liquid biopsies- Making a pipe dream a reality
  • Pashtoon Kasi

    Pashtoon Kasi, Assistant Professor, Gastrointestinal Malignancies, Mayo Clinic

  • Diagnostic algorithms – the power of predictive analytics
  • Educating physicians –guidelines around personalized care pathways
  • David Smith

    David Smith, Professor of Laboratory Medicine And Pathology, Mayo Clinic

  • European biobanks – the lesson for US data initiatives
  • Genetic counselling – how to shape and inform crucial services
  • Imaging Phenotype - Is Precision Medicine actually that precise?
  • Mark Punyanitya

    Mark Punyanitya, President &CEO, PhenoMx

  • Minority inclusion – the need to bring racial and ethnic comparators into precision trials
  • Linda Bulone

    Linda Bulone, Research Nurse Manager, Queens Hospital Cancer Center

  • Mobile data – enabling sharing across consumers
  • Next-generation tech – the platforms that will revolutionize healthcare
  • Patient stratification – sourcing support from patient organizations
  • Payer priorities – is precision an opportunity for payers?
  • Prevention or Cure – how far can precision medicine go?
  • Standards in genetic testing – Setting the benchmark in quality data sets
  • Mark Jensen

    Mark Jensen, Director/Genomic Data Programs, NIH

  • Utilization of visualization tools in precision medicine
  • Dr Ena Bromley

    Dr Ena Bromley, President and Chief Scientific Officer, BioStat Solutions Inc

    13:00

    NETWORKING LUNCH

    GENOMICS & GENETICS IN R&D

    NEXT-GEN SEQUENCING

    Discovery & Development
    14:20

    Beyond target validation: Genetics for compound identification and clinical development

    •     Impacting compound screening using genetics
    •     Genetically-guided identification of PD biomarkers for Phase 1
    •     Optimizing clinical trial patient selection by using an integrative genetics approach 
    Diagnostics & Data
    14:20

    A new era of data sharing: informatics for a common goal

    •     Repurposing extant clinical trial data for secondary projects: measuring the effort involved against the broader impact
    •     Building networks of data-sharing stakeholders to advance precision medicine collaborations 
    Discovery & Development
    14:40

    Informing drug discovery through genetics

    •     Identifying health economic benefit through population health studies and large genetic data sets
    •     Diversity: ensuring ethnic and racial heterogeneity in patient cohorts to improve accuracy in discovery
    Diagnostics & Data
    14:40

    Actionable data: transforming genomic sequencing for tangible outcomes

    •     Allying molecular data with detailed clinical phenotypic information to provide a complete picture of NGS efficacy
    •     Building a robust pipeline to sequence, analyse and interpret a wide range of tumor samples for faster data collection and improved outcomes
    Discovery & Development
    15:00

    Neuroscience: how advances in genomics are changing discovery and development

    •     Developing human-relevant animal and in- vitro models to enable wider research in the field of neuroscience
    •     Circumvent issues around drug safety with proper use of preclinical efficacy biomarkers 
    MULTIOMIC DATA
    15:00

    Reimbursement for companion diagnostics

    •     Understanding payer definitions of companion diagnostic value by aligning the diagnostic to health outcomes
    •     Developing robust value dossiers for companion diagnostics that guarantee reimbursement
    •     Where payer and developer interests diverge and how to re-align definitions of value 
    Discovery & Development
    15:20

    The Common Rule in the 21st century

    • Charting regulatory developments: how revisions to the Common Rule affect the advancement of precision medicine and genomics in US healthcare
    • Ensuring access to tumor samples: how the use of identified and de-identified biospecimens is impacted by the revision to the Common Rule 
    Diagnostics & Data
    15:20

    Realtime application of ctDNA and pharmacogenomic testing for patients with GI malignancies

    • Illustration of results of feasibility and value of realtime application of ctDNA testing in patients with GI malignancies
    • Feasibility and value of realtime application of pharmacogenomic testing in patients with GI malignancies
    • Current applications and options with available liquid biopsy platforms and integration into practice

    IMMUNOTHERAPY

    BIG DATA

    Discovery & Development
    15:30

    Combination precision therapies in oncology

    •     Combining molecular and biological technology to identify patient cohorts
    •     Personalized protection against cancer relapse and metastases
    •     Understanding how to target resistance mechanisms
    Diagnostics & Data
    15:30

    The Million Veterans Project - transforming genomics in the clinic

    •     Building one of the world's largest medical databases by safely collecting blood samples and health information from one million Veteran volunteers.
    •     How to manipulate one of the largest genomic data sets in the world
    •     Future use of MVP data to enhance the health of veterans 
    Discovery & Development
    15:50

    Novel personalized immune therapies for solid tumors

    •     Mobilizing the immune system through patient specific biomarkers
    •     Designing Ph III immunotherapy trials incorporating lessons from Ph II
    •     Manufacturing: why producing sufficient cells is a challenge and how to overcome this through optimized mixing, aeration, and perfusion
    Diagnostics & Data
    15:50

    Advancing pediatric precision genomics with data-sharing

    •     Driving rare disease research in pediatrics by building collaborative networks of patients and physicians
    •     Expanding the role of the healthcare institution in genomics to facilitate integrated data-sharing between hospital networks
    •     Focusing clinical oncology research on relapse patients to elicit more personalized outcomes
    Discovery & Development
    16:10

    Barriers to access and reimbursement for genomic testing

    •     Why the push towards precision medicine will continue to increase and why policymakers must align their efforts 
    •     Solving the issue of reimbursement for diagnostics
    •     How definitions of precision value in Europe and the USA have diverged  
    Diagnostics & Data
    16:10

    SPONSORSHIP AVAILABLE

    Do you have a solution that you would like to share with our audience?
    Contact Mike Shackil on +1.646.619.1809 or email: michael.shackil@terrapinn.com
    16:20

    NETWORKING COFFEE BREAK

    17:00

    PLATINUM SPONSORSHIP AVAILABLE

    Do you have a solution that you would like to share with our audience?
    Contact Mike Shackil on +1.646.619.1809 or email: michael.shackil@terrapinn.com
    Sylvia Trujillo
    17:00

    Regulatory modernization in the precision medicine era

    •     Discussing CLIA modernization and congressional debates on laboratory developed testing services for genomics 
    •     Exploring specific opportunities in the oversight and regulation of telegenetics services
    Sylvia Trujillo, Senior Washington Counsel, American Medical Association
    Dr Alexa T. McCray
    17:20

    Biomedical informatics in the quest to solve the mystery of undiagnosed disease

    •     Hear how the Undiagnosed Diseases Network uses biomedical informatics to combine phenotypic and genomic information
    •     Why traditional disease areas must be disaggregated in order to fully understand causality and provide personalized treatment
    •     The challenge and global opportunity of sharing disease data across multiple networks – and how it empowers patients to make their own decisions
    17:50

    CLOSING REMARKS

    17:55

    NETWORKING DRINKS RECEPTION

    19:00

    END OF CONFERENCE DAY ONE

    last published: 22/Sep/17 18:35 GMT