February 28 – March 1, 2017 | San Francisco

 

 

 

 

Day One
Tuesday, February 28, 2017

Day Two
Wednesday, March 1, 2017

08.00
Co-Chairs’ Opening Remarks

  • Kenneth W. Mahaffey M.D., Professor of Medicine; Vice Chair of Clinical Research; Director, Stanford Center for Clinical Research (SCCR), Stanford University
  • Scott M. Wasserman M.D., FACC, VP, Global Development, Cardiovascular & Metabolic Therapeutic Area Head, Head of Development Design Center, Amgen Inc.

Synopsis

  • Key takeaways & lessons learned from day one
  • The future of cardiovascular research and drug development

Innovative Therapeutic Approaches & Technologies Against Cardiovascular Disease

08.15
Update on the New Developments in the Epigenetic Approach to Treating Cardiovascular Disease

  • Rusty Montgomery Ph.D, Associate Director, Research, miRagen Therapeutics, Inc.

Synopsis

  • An overview of the miRagen cardiovascular portfolio
    • New miRNA-based therapeutics and corresponding mechanisms of action in heart failure and hypertrophic cardiomyopathy
  • Cardiopulmonary miRNA-29 mimicking for cardiac fibrosis

08.45
Cardiovascular Hypoxia & Experimental Therapeutics

Synopsis

  • Understanding the pathophysiology of the vascular endothelial response to hypoxia
  • Exploring therapeutic options involving HIF and novel pathways
  • Introducing Coeurative, Inc. – creating curative strategies for cardiovascular diseases related to cellular hypoxia

09.15
BiowireTM II Platform for the Maturation of Human Engineered Cardiac Tissue for Drug Development, Drug Toxicity and Disease Modeling

  • Rooz Sobbi Ph.D., Senior Research Scientist, TARA Biosystems Inc.

Synopsis

  • The Biowire II platform is a human cardiac 3D tissue array designed to be the next generation in-vitro cardiac screen.
  • Biowire II tissues generated from human induced pluripotent stem cell-derived cardiomyocytes recapitulate many of the physiological hallmarks of the adult human myocardium, including a positive force-frequency relationship, post-rest potentiation, and non-spontaneous contraction.
  • The Biowire II platform allows for non-destructive and direct measurements of contractile force, simultaneous contractile force and Ca2+ transients measurements, and detailed action potential readouts.
  • The BiowireTM II platform is cell source agnostic and conducive to modeling monogenic and idiopathic cardiac diseases, enabling more relevant and predictive drug discovery and toxicity studies.

09.25
Developments in Myosin Activators for the Treatment of Heart Failure

  • Fady I. Malik M.D., Ph.D, Executive VP, Research & Development, Cytokinetics

Synopsis

  • Understanding the therapeutic rationale for cardiac myosin activation in heart failure
  • Discovering omecamtiv mecarbil
  • Exploring the results from the Phase 2 trial, COSMIC-HF
  • Analyzing the rationale and design of the Phase 3 cardiovascular outcomes study, GALACTIC-HF

09.55
Morning Refreshments & Networking

10.25
Patient Specific Stem Cells for Precision Cardiovascular Medicine

  • Joseph C. Wu M.D., Ph.D, Director, Stanford Cardiovascular Institute, Professor of Medicine , (Cardiology) and Radiology, Stanford School of Medicine

Synopsis

  • Understanding how human induced pluripotent stem cells (iPSCs) are generated
  • Exploring how disease-specific iPSCs can be used to elucidate cardiovascular disease mechanisms
  • Discussing how patient-specific iPSCs can be used for precision cardiovascular medicine
  • Understanding how diverse panel of disease- and patient-specific iPSCs can be used for clinical trial in a dish

10.55
Hurdles to Bringing Novel Therapies to the Bedside: The example of Auto-CD34+ Cells

  • Thomas Povsic M.D., Ph.D, Associate Professor of Medicine, Interventional Cardiologist, Duke Clinical Research Institute (DCRI)

Synopsis

  • Understanding why regenerative therapy for heart disease may be a particularly attractive approach
  • Exploring key studies which have defined the use of this therapy for refractory angina and heart failure
  • Analyzing the key limitations to these studies and our understanding of regenerative approaches to CV disease
  • Understanding the hurdles to the development of regenerative and biological approaches to the treatment of CV disease

Precision Medicine Approaches to CV Research & CV Clinical Trial Innovation

11.25
Precision Cardiovascular Medicine at the American Heart Association

  • Prad Prasoon Business Technology Strategist, Institute for Precision Cardiovascular Medicine, American Heart Association

Synopsis

  • Understanding what can be achieve from the Precision Medicine Initiative in cardiovascular research
  • Putting patients at the center – speeding up research and discovery of new therapies for cardiovascular diseases and stroke by sharing health data
  • Exploring the Precision Cardiovascular Medicine Platform – a cloud-based data discovery portal to accelerate cardiovascular research

11.55
Precision Health: Innovative Approaches

  • Kenneth W. Mahaffey M.D., Professor of Medicine; Vice Chair of Clinical Research; Director, Stanford Center for Clinical Research (SCCR), Stanford University

Synopsis

  • Understanding the key molecular markers and what changes in these biomarkers may lead to disease
  • Providing insight on heart disease
  • Pointing out to new methods for early illness detection

12.25
Lunch & Networking

13.25
Beyond Causality: Resolving the Discordance Between Mendelian Randomization Studies & Recent Cardiovascular Outcome Trials

  • Brian A. Ference M.D., MPhil, MSc, FACC, Associate Professor of Medicine; Clinical Chief, Division of Cardiovascular Medicine & Director, Cardiovascular Genomic Research Center, Wayne State University

Synopsis

  • Accelerating drug discovery and development – understanding that demonstrating causality is only the first step in genetic target validation
  • Moving beyond causality – anticipating the efficacy and safety of therapeutics by designing naturally randomized trials
  • De-risking the proposition – helping regulators understand how naturally randomized genetic evidence can be used to inform the design of randomized trials and as the basis for early therapy approval

 

13.55
ADAPTABLE, the Aspirin Study – A Patient-Centered Trial

  • Matthew T. Roe M.D., MHS, FACC, Professor of Medicine, Division of Cardiology, Duke University Medical Center, , Faculty Director, Global Outcomes Commercial Mega Trials, Duke Clinical Research Institute (DCRI)

Synopsis

  • Highlighting the electronic methods that are being used to facilitate the conduct of the ADAPTABLE trial
  • Describing the strong partnership with patients with cardiovascular disease that underlies the ADAPTABLE trial
  • Discussing the lessons learned from ADAPTABLE for the conduct of pragmatic cardiovascular trials

14.25
Panel Discussion: Potential for Digital Health Technologies to Transform Cardiovascular Trials & Post Marketing Surveillance

  • Helina Kassahun M.D., FACC, Senior Medical Scientist in Global Development, Amgen Inc.
  • Matthew T. Roe M.D., MHS, FACC, Professor of Medicine, Division of Cardiology, Duke University Medical Center, , Faculty Director, Global Outcomes Commercial Mega Trials, Duke Clinical Research Institute (DCRI)
  • Mintu P. Turakhia M.D. MAS, Assistant Professor, Senior Director of Research & Innovation, Center for Digital Health, Stanford University School of Medicine
  • Eric Green M.D., Ph.D, Head of Translational Research, MyoKardia, Inc.

Synopsis

  • Streamlining clinical trial conduct with digital technology – current opportunities
  • Defining digital health endpoints
  • Exploring the barriers/challenges to utilizing digital technology in global CV clinical trials

15.15
Afternoon Refreshments & Networking

15.45
Panel Discussion: Addressing the Cost & Complexity of Cardiovascular Trials – An Overview of the Current Challenges & Opportunities in Trial Methodology

  • Brian A. Ference M.D., MPhil, MSc, FACC, Associate Professor of Medicine; Clinical Chief, Division of Cardiovascular Medicine & Director, Cardiovascular Genomic Research Center, Wayne State University
  • Fady I. Malik M.D., Ph.D, Executive VP, Research & Development, Cytokinetics
  • Matthew T. Roe M.D., MHS, FACC, Professor of Medicine, Division of Cardiology, Duke University Medical Center, , Faculty Director, Global Outcomes Commercial Mega Trials, Duke Clinical Research Institute (DCRI)
  • Thomas Povsic M.D., Ph.D, Associate Professor of Medicine, Interventional Cardiologist, Duke Clinical Research Institute (DCRI)

Synopsis

  • Discussing the future of cardiovascular drug development – dead or alive?
  • Dealing with the regulatory burden – how time and cost drastically causes the need for cheaper, more efficient clinical trials
  • Exploring forward looking approaches to improving cardiovascular trials and outcomes:
    • Assessing streamlined and new approaches to outcome studies design
    • Evaluating safety of approach vs. efficacy in cardiovascular research
    • Is proof of hypothesis enough to understand broadness of applicability?
    • Extracting meaningful insight from big data sets to enhance trial outcomes and accelerate drug development
  • Tackling the approval challenges for novel therapies

16.45
Co-Chairs’ Closing Remarks

  • Kenneth W. Mahaffey M.D., Professor of Medicine; Vice Chair of Clinical Research; Director, Stanford Center for Clinical Research (SCCR), Stanford University
  • Scott M. Wasserman M.D., FACC, VP, Global Development, Cardiovascular & Metabolic Therapeutic Area Head, Head of Development Design Center, Amgen Inc.

16.55
Close of Conference Day Two