Conference Day 1 - November 7, 20 17
Day One
COLLABORATIONS IN PRECISION HEALTH
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
Katherine Donigan, Personalized Medicine Staff, U.S. Food and Drug Administration
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
Speed Networking
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
Contact Mike Shackil on +1.646.619.1809 or email: michael.shackil@terrapinn.com
10:10
10:20 NETWORKING COFFEE BREAK
PRE-CLINICAL PRECISION
COMPANION DIAGNOSTICS
Discovery & Development
11:00Validating exploratory biomarker hypotheses in pre-clinical research
- Implementing predictive biomarkers into early phase clinical research to improve trial efficacy
- Define and validate assay requirements to increase accuracy in drug discovery
Roopa Srinivasan, Head of Translational Research, Immunotherapy R&D, GSK
Diagnostics & Data
11:00Exploring 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
11:20Bridging 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
11:20Realtime 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
Discovery & Development
11:40Leveraging 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
11:40Whole 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
12:00PANEL: Precision paediatric genomics
- Ethical perspectives on paediatric genetics
- Current research from three of the most established children’s hospitals
- Accelerating translation of genomic findings to clinical care
- Establishing a culture of collaborative genomic medicine across pediatrics
Olaf Bodamer, Park Gerald Chair in Genetics & Genomics; Associate Chief of Genetics & Genomics Associate Professor, Harvard Medical School
Ian Krantz, Co-director, Roberts Individualized Medical Genetics Center. He holds a Distinguished Chair Pediatric Medicine, The Children's Hospital of Philadelphia
Diagnostics & Data
12:00NGS 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
12:20
INTERACTIVE ROUNDTABLE DISCUSSIONS
Bioinformatics – empowering target-based drug discovery
Ying Chen, Senior Bioinformatics Specialist, Rutgers Cancer Institute of New Jersey
Ct-DNA and Liquid biopsies- Making a pipe dream a reality
Pashtoon Kasi, Assistant Professor, Gastrointestinal Malignancies, Mayo Clinic
Diagnostic algorithms – the power of predictive analytics
Domain Analysis Model for Clinical Sequencing
Educating physicians –guidelines around personalized care pathways
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?
Minority inclusion – the need to bring racial and ethnic comparators into precision trials
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
Drew Levy, Senior Medical Science Director, Genentech
Utilization of visualization tools in precision medicine
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
14:20Beyond 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
Adele Mitchell, Associate Director, Discovery Data Science, Eisai Inc
Diagnostics & Data
14:20Transforming Shared Data into Useful Data Resources
- Data is often silo-ed by the disease being studied due to the study protocol
- Lack of standardization of ontologies and data definitions complicate inter-study aggregation
- Challenges remain for sharing of data due to differing laws and participant concerns
- Collection of additional data designed to enhance the ability to connect data sets can be transformational
- Repurposing extant clinical and observational trial data for secondary projects can broaden impact
- Building networks of data sets between disease areas can advance precision medicine
Discovery & Development
14:40Informing drug discovery through genetics
- Emerging strategies for using genetics to inform drug discovery
- Accelerating the genetic evaluation of clinically important outcomes
Diagnostics & Data
14:40Actionable 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
15:00Neuroscience: 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
15:00Reimbursement 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
15:20The 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
MULTIOMIC DATA
15:20ORIGIN: Strategy for Allogeneic Cell Therapy
- Cell therapy has a lot of promise for impacting the future of medicine for repairing damage cells, tissues, and organs.
- This talk will address the issues associated with autologous versus allogeneic approaches for cell therapy.
IMMUNOTHERAPY
BIG DATA
Discovery & Development
15:40Combination 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
15:40The 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
16:00The extreme personalization potential in microbiome and Immunotherapy
- How are the trillions of bacteria in our bodies creating unique individual makeups?
- Are drug immunotherapies reacting to the microflora of our gut?
- What promising efforts have been made to align with immunotherapy?
Jennifer Wargo, Associate Professor of Department of Surgical Oncology and Division of Surgery for The University of Texas, M.D. Anderson Cancer
Diagnostics & Data
16:00Advancing 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
16:20
NETWORKING COFFEE BREAK
Discovery & Development
16:20Novel 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
16:20Teaching computers to recognize the sick gut
- What advantages do Machine learning offer us in Microbiome?
- How do you train systems to identify Healthy bacteria communities?
- What relationships are we looking for as we are rarely looking at just one molecule?
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
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
17:40
CLOSING REMARKS
18:00
NETWORKING DRINKS RECEPTION
19:00
END OF CONFERENCE DAY ONE
last published: 31/Oct/17 23:05 GMT
Organiser
