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10:00am - 3:00pm
International Society of Cardiovascular Pharmacotherapy (ISCP) – CVCT Joint Session
Moderators: Marc Pfeffer (Boston, USA) and David Fitchett (Toronto, CAN)
A series of “neutral” trials showed CV safety of new glucose lowering drug and have fulfilled the FDA requirement of non-inferiority (although Saxagliptin was found unexpectedly to increase the incidence of heart failure events).
More recently, trials powered for superiority showed a cardiovascular benefit.
  • For the Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG) trial of the sodium glucose co-transporter 2 (SGLT2) inhibitor empagliflozin, the benefit was most prominent to heart failure outcomes
  • More recently the analogue of human glucagon-like peptide 1 (GLP-1) Liraglutide LEADER trial and the SUSTAIN-6 trial with semaglutide, in patients at higher cardiovascular risk, showed benefit on the rate of atherosclerotic outcomes
  • Lixisenatide, another GLP-1 agonist did not show any cardiovascular benefit in patients with diabetes and a recent acute coronary syndrome, raising drug-specific issues

All four trials are different and the magnitude and type of effect on CV outcomes were significantly different, raising the possibility that the benefits are not related to the effect on HbA1C, and may involve different CV mechanisms.

With such a variety of trials, it is great time to engage into a cardiology and diabetology (and nephrology) trialists dialogue about the possibility that some of the new glucose lowering drugs might be CV (and may be also renal) disease-modifying drugs. This opens up a host of new issues:

  • Should the many ongoing glucose-lowering drugs trials, initially designed to comply with the FDA CV safety trials guidance move on unchanged?
  • Should diabetologists deviate from the HbA1-only target?
  • Should target populations for the newer glucose lowering drugs, and in future trials, be expanded beyond diabetes type 2 and poor HbA1 control?
  • Could non-diabetic patients with HF benefit from SGLT2 inhibitor?
  • What to expect from renal outcomes endpoints?
Dissecting LEADER, SUSTAIN-6
présentation Alan Charles Moses (Novo Nordisk, DEN)
EMPA-REG further results
présentation David Fitchett (Toronto, CAN)
Target population definition
Javed Butler (New York, USA)
Implementation of the recent trial results in clinical practice
présentation Marc Pfeffer (Boston, USA)
A statistical perspective
présentation Stuart Pocock (London, GBR)
Industry perspective
présentation Hans-Juergen Woerle (Boehringer Ingelheim, GER) and Mads Engelmann (Novo Nordisk, DEN)
Sudden death in diabetes: the case for the MADIT S-ICD trial
Valentina Kutyifa (Rochester, USA)
Diabetes type 2 CKD outcome trials
présentation Vlado Perkovic (Sydney, AUS)
Industry viewpoint
présentation Tomas Andersson (Astrazeneca, SWE) and Stuart Kupfer (Prairie Ridge, USA)
présentation Tomas Andersson (Astrazeneca, SWE)
Regulatory viewpoint
présentation Angeles Alonso (EMA, GBR) and Jean-Marc Guettier (FDA, USA)
Payer viewpoint: willingness-to-pay for CV prevention and beyond glycaemic control
présentation Loïc Guillevin (HAS, FRA)
The Forum: Moderated discussion with the audience
Transitioning from glucose lowering to CV prevention
Panelists: Angeles Alonso (EMA, GBR), Tomas Andersson (Astrazeneca, SWE), , Uli Broedl (Boehringer Ingelheim, GER), Javed Butler (New York, USA), Mads Engelmann (Novo Nordisk, DEN), David Fitchett (Toronto, CAN), David Gordon (NHLBI, USA), Jean-Marc Guettier (FDA, USA), Loïc Guillevin (HAS, FRA), Stuart Kupfer (Prairie Ridge, USA), Valentina Kutyifa (Rochester, USA), Eckhard Leifke (Sanofi, USA), Felipe Martinez (Cordoba, ARG), Alan Charles Moses (Novo Nordisk, DEN), Vlado Perkovic (Sydney, AUS), Marc Pfeffer (Boston, USA), Stuart Pocock (London, GBR), Rick Turner (Quintiles, USA), Hans-Juergen Woerle (Boehringer Ingelheim, GER)
10:00am – 3:00 pm
Moderators: Michael Gibson (Boston, USA) and Cecilia Linde (Stockholm, SWE)
The concepts of AF burden and AF density: measurement and relationship to adverse outcomes
présentation Rod S. Passman (Chicago, USA)
présentation Paul Ziegler (Medtronic, USA)
Ablation and LAA closure trials
présentation Cecilia Linde (Stockholm, SWE)
Registries vs. trials in atrial fibrillation
présentation John Camm (London, GBR)
PCI in AF patients
présentation Michael Gibson (Boston, USA)
Targeting device-detected AF in stroke prevention trials: what is the treatment threshold?
présentation Jeff Healey (Hamilton, CAN)
Duration of DAPT post PCI: how to generate further needed evidence?
présentation Roxana Mehran (New York, USA)
Secondary prevention of VTE: should we switch from recurrence studies to larger mortality/morbidity studies?
présentation Joseph Emmerich (EMA, FRA)
Industry viewpoint
présentation Pete DiBattiste (Janssen, USA), Charlotte Jones-Burton (BMS, USA)
Kenneth Stein (Boston Scientific, USA)
Regulatory viewpoint
présentation Karsten Bruins (EMA, NOR), Andrew Farb (FDA, USA), Robert Temple (FDA, USA) and Ellis Unger (FDA, USA)
Payer viewpoint
Jyme H. Schafer (CMS, USA)
The Forum: Moderated discussion with the audience
Assessing net benefit and implementation issues
Panelists: Karsten Bruins (EMA, NOR), John Camm (London, GBR), Pete DiBattiste (Janssen, USA), Amany El-Gazayerly (EMA, NED), Joseph Emmerich (EMA, FRA), Andrew Farb (FDA, USA), Michael Gibson (Boston, USA), Jeff Healey (Hamilton, CAN), Charlotte Jones-Burton (BMS, USA), Cecilia Linde (Stockholm, SWE), Roxana Mehran (New York, USA), Puneet Mohan (PPD, USA), Rod S. Passman (Chicago, USA), Yves Rosenberg (NHLBI, USA), Jyme H. Schafer (CMS, USA), Alex Shalaurov (INC Research, USA), Kenneth Stein (Boston Scientific, USA), Robert Temple (FDA, USA), Ellis Unger (FDA, USA), Robert Welsh (Edmonton, CAN), Paul Ziegler (Medtronic, USA)
3:30 - 4:00pm

Michael Lauer, Deputy Director for Extramural Research, NIH, USA
4:00 - 7:00pm
Heart Failure Society of America (HFSA) – CVCT Joint Session
Moderators: Michael Gibson (Boston, USA) and Cecilia Linde (Stockholm, SWE)

Following the development of continuous flow LVADs and the publication of recent clinical trial evidence, LVAD therapy is growing from an intervention offered to few, highly selected young patients awaiting transplantation to become the treatment of choice for a broader spectrum of patients with advanced heart failure who are transplant ineligible.

There are, however, many unresolved issues such as patient selection, caregiver burden, complications and costs.

Recently, choice of device has also become a relevant issue.

The aim of this session is to give an overview of existing trial evidence and ongoing trials in the field and to discuss hot topics, in particular timing (implantation in stable class IIIb patients), the elderly patient and device selection. The session should be focused on issues relevant to referring cardiologists, rather than surgeons or anesthesiologists, and the panelists should reflect this.

When to start first-in-man proof of principle trials? The value of preclinical testing of devices
présentation Bud Frazier (Houston, USA)
MOMENTUM 3: an innovative clinical trial and other LVAD trials
présentation Mandeep R. Mehra (Boston, USA)
Post-op complications: how to define them in an RCT and assess them prospectively?
présentation JoAnn Lindenfeld (Nashville, USA)
Patient selection for future trials: are we ready for the “less sick”?
présentation Christian Spaulding (Paris, FRA)
Industry perspective
Christian Latremouille (Paris, FRA), and Tom Vassiliades (Medtronic, USA)
présentation John O'Connell (St. Jude Medical, USA)
NIH/NHLBI perspective and INTERMACS
Marissa Miller (NHLBI, USA)
Regulatory perspective.
présentation Alan Fraser (Cardiff, GBR)
présentation John Sapirstein (FDA, USA) and Bernard Vasseur (FDA, USA)
Payer perspective
présentation Jacques Belghiti (HAS, FRA)
J Linda Gousis (CMS, USA) and Jyme H. Schafer (CMS, USA)
Patient perspective
présentation Cynthia Chauhan (Wichita, USA)
The Forum: Moderated discussion with the audience
New LVADs, safety, approvability and payers requirements
Panelists: Jacques Belghiti (HAS, FRA), Cynthia Chauhan (Wichita, USA), Alan Fraser (Cardiff, GBR), Bud Frazier (Houston, USA), Linda Gousis (CMS, USA), John Laschinger (FDA, USA), Christian Latremouille (Paris, FRA), JoAnn Lindenfeld (Nashville, USA), Marissa Miller (NHLBI, USA), Mandeep R. Mehra (Boston, USA), John O'Connell (St. Jude Medical, USA), John Sapirstein (FDA, USA), Jyme H. Schafer (CMS, USA), Poornima Sood (St. Jude Medical, USA), Christian Spaulding (Paris, FRA), Bernard Vasseur (FDA, USA), Tom Vassiliades (Medtronic, USA)
4:00 - 7:00pm
International Society of Cardiovascular Pharmacology (ISCP) – CVCT Joint Session
Moderators: Antoni Martinez-Rubio (Barcelona, ESP) and Joseph A. Hill (Dallas, USA)
Should globally generated evidence be tested further in specific regional trials?
  • Epidemiology of the disease matters
    Felipe Martinez (Cordoba, ARG)
  • Ethnicity and genetic matters
    Clyde Yancy (Chicago, USA)
  • Dosing and pharmacokinetic matters
    Naoki Sato (Tokyo, JPN)
  • Dosing and pharmacokinetic matters
    Kiyoshi Nobori (PMDA, Tokyo, JPN)
  • Regional subgroup analyses in heart failure triaIs: countries’ level of income vs. geography
    Faiez Zannad (Nancy, FRA)
Methodological considerations
Stuart Pocock (London, GBR)
Why do we need a new approach to generalizing evidence from clinical trials?
présentation Anthony Rodgers (Sydney, AUS)
ePublication, "medscape" and social media: new tools for trial results dissemination - science or marketing?
présentation Joseph A. Hill (Dallas, USA)
Industry viewpoint
présentation Xingli Wang (Novartis, USA)
Regulatory viewpoint
Robert Temple (FDA, USA)
The Forum: Moderated discussion with the audience
How to engage all regions in evidence generation?
Panelists: Joseph A. Hill (Dallas, USA), Patricia Kay-Mugford (Novartis, USA), Felipe Martinez (Cordoba, ARG), Antoni Martinez-Rubio (Barcelona, ESP), Kiyoshi Nobori (PMDA, JPN), Stuart Pocock (London, GBR), Anthony Rodgers (Syndey, AUS), Naoki Sato (Tokyo, JPN), Stuart Spencer (London, GBR), Robert Temple (FDA, USA), Xingli Wang (Novartis, USA), Clyde Yancy (Chicago, USA), Faiez Zannad (Nancy, FRA)
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8:00 - 12:30pm
Moderators: William Abraham (Colombus, USA) and Alan Fraser (Cardiff, GBR)

On April 13, 2015, the “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions (EAP)” document was issued as guidance for industry and FDA staff. The EAP was designed as a new program for medical devices that demonstrated the potential to address unmet medical needs for life threatening or irreversibly debilitating conditions. The FDA stated that the EAP program would “help patients have more timely access to these medical devices by expediting their development, assessment and review, while preserving FDAs statutory standard for premarket approval”. This guidance document also described the types of clinical evidence that might be used to support approval of a device under the EAP and in particular discussed the use of intermediate endpoints. The FDA would consider assessments of a device‘s effect on intermediate endpoints that, when improving in a congruent fashion, are “reasonably likely to predict clinical benefit”. The proposal to use intermediate endpoints should include evidence that is reasonably likely to predict clinical benefit that is generally of value to patients “even if this does not lead to reduced morbidity or mortality”.

Getting the right balance between premarket and postmarket data collection — specifically, where appropriate, a greater reliance on postmarket collection — can reduce the extent of premarket data submission and directly impact when patients will have access to high quality, safe and effective medical devices.

In Europe, Medical device manufacturers will soon be confronted with major changes in the EU‘s decades-old regulatory framework, which governs market access to the European Union (EU). A new medical device regulation (MDR) is making its way through final tri-party negotiations between the EU Commission, the European Council and the European Parliament. Once final approval is achieved, the MDR will replace the EU‘s current Medical Device Directive (93/42/EEC) and the EU‘s Directive on active implantable medical devices (90/385/EEC). The MDR will require device manufacturers to conduct clinical performance studies and provide evidence of safety and performance proportionate with the risk associated with a given device. Device manufacturers will also be required to collect and retain post-market clinical data as part of the ongoing assessment of potential safety risks.

One of the biggest issues that device industry is increasingly facing is the disconnect between data requirements for payers and regulators. Regulatory approval is often the easier of the two and paradoxically regulatory approval may be easy enough, but payers may still consider the technology investigational. Alignment between regulatory approval needs and payers‘ needs is an area of intense debate particularly for new technologies.

The objective of this session is to examine how these new regulatory frameworks may profoundly affect the CV device trials design, conduct and environment, how payers and health technology assessment agencies may align and how other international regulations may evolve.

The new FDA “Expedited Access for Premarket Approval”
présentation Erin Cutts (FDA, USA)
Case study: heart failure devices
  • The value of intermediate endpoints in EAP protocols
    Faiez Zannad (Nancy, FRA)
  • BEAT HF: Baroreflex stimulation in heart failure EAP trial
    Mike Zile (Charleston, USA)
Post market data accrual: what data and how?
présentation JoAnn Lindenfeld (Nashville, USA)
Industry viewpoint
Nadim Yared (CVRx, USA)
FDA viewpoint
présentation Bram Zuckerman (FDA, USA)
EU viewpoint
présentation Alan Fraser (Cardiff, GBR)
Other international agencies‘ viewpoint
Thomas Clutton-Brock (NICE, GBR)
Payer viewpoint
présentation Jacques Belghiti (HAS, FRA) and Daniel Caños (CMS, USA)
The Forum: Moderated discussion with the audience
What evidence is acceptable for medical devices use in patients?
Panelists: William Abraham (Colombus, USA), Jacques Belghiti (HAS, FRA), John Bisognano (Rochester, USA), Daniel Caños (CMS, USA), Thomas Clutton-Brock (NICE, GBR), Erin Cutts (FDA, USA), Alan Fraser (Cardiff, GBR), Jerry Griffin (Cardiokinetix, USA), JoAnn Lindenfeld (Nashville, USA), Lazar Mandinov (PAREXEL, USA), Cyrus Mehta (Cytel, USA), Barathi Sethuraman (St. Jude Medical, USA), Bernard Vasseur (FDA, USA), Nadim Yared (CVRx, USA), Faiez Zannad (Nancy, FRA), Mike Zile (Charleston, USA), Bram Zuckerman (FDA, USA)
8:00am - 12:30pm

American Society of Nephrology (ASN) and INI CRCT — CVCT Joint Session
Moderators: Patrick Rossignol (Nancy, FRA) and Prabir Roy-Chaudhury (Tucson, USA)
Exclusion of patients with later stages of CKD from recent CVOT: the extent and consequences of the issue
présentation Ron Gansevoort (Gröningen, NED)
Recent and ongoing CV prevention trials in CKD patients
présentation Patrick Rossignol (Nancy, FRA)
Hyperkalemia in heart failure CKD patients
présentation Dahlia Garza (Relypsa, USA)
Approvability of CV drugs in CKD populations: claiming a new indication vs. addition to label description
présentation Aliza Thompson (FDA, USA)
Greater inclusivity of CKD patients in CV trials
présentation Julie Ishida (San Francisco, USA)

Consideration of ways in the post-marketing setting and, absent conducting RCTs, to obtain data supporting use and dosing recommendations of novel medications in later CKD stages


Case studies:

    Vlado Perkovic (Sydney, AUS)
  • New oral glucose lowering agents
    George Bakris (Chicago, USA)
  • RAS inhibitors, mineralocorticoid receptor antagonists and valsartan/sacubutril
    Patrick Rossignol (Nancy, FRA)
  • Lipid lowering agents and PCSK9 inhibitors
    Alan Jardine (Glasgow, GBR)
Industry viewpoint
présentation Salim Shah (Sarfez, USA)
Regulatory viewpoint
présentation Antonio Gómez-Outes (EMA, ESP)
présentation Raj Madabushi (FDA, USA)
Investigator viewpoint
présentation Brian Claggett (Boston, USA)
The Forum: Moderated discussion with the audience
Cardiorenal alliance for CV trials in CKD patients
Panelists: George Bakris (Chicago, USA), Cynthia Chauhan (Wichita, USA), Brian Claggett (Boston, USA), Ron Gansevoort (Gröningen, NED), Dahlia Garza (Relypsa, USA), Barbara Gillespie (Quintiles, USA), Antonio Gómez-Outes (EMA, ESP), Julie Ishida (San Francisco, USA), Alan Jardine (Glasgow, GBR), Raj Madabushi (FDA, USA), Vlado Perkovic (Sydney, AUS), Patrick Rossignol (Nancy, FRA), Prabir Roy-Chaudhury (Tucson, USA), Salim Shah (Sarfez, USA), Bhupinder Singh (ZS Pharma, USA); Aliza Thompson (FDA, USA), Faiez Zannad (Nancy, FRA)
1:30 - 7:00pm
Moderators: Patrick Rossignol (Nancy, FRA) and Prabir Roy-Chaudhury (Tucson, USA)

Progressing from Phase II to Phase III: how can we maximize chances of success?

Endpoint related issues
Alexandre Mebazaa (Paris, FRA)
Target population related issues
présentation John Teerlink (San Francisco, USA)
Trial design related issues: the virtues of adaptive design
présentation Cyrus Mehta (Cytel, USA)
Case Study
  • Nitroxyl — HNO donor
    Paul Kessler (BMS, USA)
  • Neladenoson bialanate
    Michael van der Laan (Bayer, GER)
  • Omecamtiv mecarbil
    Fady Malik (Cytokinetics, USA)
  • Vericiguat
    Mahesh J. Patel (Merck, USA)
  • Endothelin receptor antagonists in heart failure: is there a way forward?
    Sebastien Roux (Actelion, CHE)
Investigator perspective
présentation Milton Packer (Dallas, USA)
Regulatory perspective
présentation Krishna Prasad (EMA, GBR) and Norman Stockbridge (FDA, USA)
Trials in progress: how is it going so far?
    Scott Solomon (Boston, USA)
    John Teerlink (San Francisco, USA)
    Faiez Zannad (Nancy, FRA)
New trials
    Marc Pfeffer (Boston, USA)
    Hans-Juergen Woerle (Boehringer Ingelheim, GER)
  • Ambulatory furosemide pump
    Bertram Pitt (Ann Arbor, USA)
  • Diuretic and non diuretic effects of torasemide
    Christopher Wilcox (Washington, USA)
The Forum: Moderated discussion with the audience
How to maximize likelihood of success?
Panelists: John Cleland (Glasgow, GBR), Amany El-Gazayerly (EMA, NED), Paul Kessler (BMS, USA), Martin Lefkowitz (Novartis, USA), Fady Malik (Cytokinetics, USA), Alexandre Mebazaa (Paris, FRA), Cyrus Mehta (Cytel, USA), Christopher O‘Connor (Washington, USA), Milton Packer (Dallas, USA), Mahesh J. Patel (Merck, USA), Marc Pfeffer (Boston, USA), Bertram Pitt (Ann Arbor, USA), Krishna Prasad (EMA, GBR), Sebastien Roux (Actelion, CHE), Scott Solomon (Boston, USA), Kenneth Stein (Boston Scientific, USA), Norman Stockbridge (FDA, USA), John Teerlink (San Francisco, USA), Michael van der Laan (Bayer, GER), Christopher Wilcox (Washington, USA), Hans Juergen Woerle (Boehringer Ingelheim, GER), Faiez Zannad (Nancy, FRA)
1:30 - 7:00pm
Critical Markers Of Disease (CMOD) — CVCT Joint Session
Moderators: Wolfgang Koenig (Ulm, GER) and Jean-Claude Tardif (Montreal, CAN)

Despite aggressive polypharmacotherapy and complete revascularization of stenotic lesions in patients presenting with ACS but also in those with stable CHD and persisting ischemia considerable residual risk exists. Several additional strategies are presently being tested in large clinical trials like further substantial lowering of LDL cholesterol (LDL-C) by PCSK9 inhibition on one hand and on the other hand anti-inflammatory treatment on top of standard of care.

Since these two drug classes have not yet been tested in combination, the question remains what residual risk will remain after additional application of PCSK9 inhibitors or interleukin-1β antagonists.

Thus, the paradigm of a residual cholesterol risk on the one hand and a residual inflammatory risk on the other hand, based on persistently elevated LDL-C or markers of inflammation has been put forward.

At AHA this year, GLAGOV, a large scale IVUS study with evolocumab in almost 1000 patients was presented and results indicated whether additional plaque regression can be achieved in patients with a baseline LDL-C of appr. 90 mg/dL after maximal doses of statin (+/- ezetimibe). Positive results from this study might also suggest positive outcomes of forthcoming endpoint studies like FOURIER which will be presented during ACC in early 2017. However, one large PCSK9 inhibition programme, SPIRE, has just been terminated because of long-term attenuation of LDL-C lowering, increased immunogenicity and local side effects. Thus, there may be clinically relevant differences between humanized and fully human monoclonal antibodies.

Future additional strategies, assuming positive outcomes from the major endpoint trials of evolocumab and later on alirocumab on one hand and of anti-inflammatory therapy by an interleukin-1 inhibitor will be discussed in detail. Also, beyond these important approaches, strategies focusing on therapeutic lowering of Lp(a), inhibition of CETP and a personalized pharmacogenomics approach using dalcetrapib in carriers of the AA genotype of the adenylatcyclase-9 gene are on the horizon. Lastly, the discussion of a recently failed large scale clinical trial focusing on oxidative stress by intervening with a MAP-kinase inhibitor, Latitude TIMI-60 will be a topic for the interdisciplinary panel.

Novel approaches to treat Lp(a): antisense technology and PCSK9 inhibition
Sotirios Tsimikas (San Diego, USA) and Robert Rosenson (New York, USA)
Insight from GLAGOV: vascular effects of profoundly lowering LDL cholesterol with evolocumab
présentation Steve Nissen (Cleveland, USA)
More on PCSK9 inhibition: FOURIER, ODYSSEY, SPIRE
présentation Jean-Claude Tardif (Montreal, CAN)
CETP-Inhibition to reduce CV events
  • After ACCELERATE and before REVEAL
    Evan Stein (Cincinnati, USA)
  • Pharmacogenomics-guided Dal-GenE
    Marc Pfeffer (Boston, USA)
How to interpret the failure of LATITUDE-TIMI-60?
Michelle O‘Donoghue (Boston, USA)
Other therapeutic targets in cardiovascular inflammation: CANTOS, COLCOT, CIRT
présentation Paul Ridker (Boston, USA)
présentation Philippe L‘Allier (Montreal, CAN)
Industry viewpoint
présentation Donald Black (DalCor, USA) and Andrew Hamer (Amgen, USA),
Regulatory viewpoint
présentation Pieter de Graeff (EMA, NED) and Jean-Marc Guettier (FDA, USA)
Payer perspective: willingness-to-pay for future innovations?
présentation Joseph Chin (CMS, USA)
The Forum: Moderated discussion with the audience
How to cope with so many biotargets?
Panelists: Donald Black (DalCor, USA), Joseph Chin (CMS, USA), Pieter de Graeff (EMA, NED), Nancy Geller (NHLBI, USA), David Gordon (NHLBI, USA), Jean Marc Guettier (FDA, USA), Andrew Hamer (Amgen, USA), Wolfgang Koenig (Munich, GER), Philippe L'Allier (Montreal, CAN), Eckhard Leifke (Sanofi, USA), Steve Nissen (Cleveland, USA), Michelle O'Donoghue (Boston, USA), Marc Pfeffer (Boston, US), Paul Ridker (Boston, USA), Yves Rosenberg (NHLBI, USA), Robert Rosenson (New York, USA), Tabassome Simon (Paris, FRA), Evan Stein (Cincinnati, USA), Jean-Claude Tardif (Montreal, CAN), Sotirios Tsimikas (San Diego, USA)
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8:00am - 12:00pm

Moderators: Linda Ricci (FDA, USA) and Alan Fraser (Cardiff, GBR)

Mobile health (“mHealth”) technologies that employ portable devices such as smartphones and tablets for medical purposes are rapidly transforming the medical profession. Yet adapting existing regulatory processes to ensure the safety and efficacy of this new set of products has proved challenging for the U.S. Food and Drug Administration (FDA).

mHealth is suggested to help with patient selection, enrollment, and monitoring. Is there a role for social media?

Data from devices in patients with implanted devices or wearable devices may help identifying patients that meet the enrollment criteria in trials.

Remote data collection can be useful in clinical trials and wearable technologies are being developed to help in the conduct/data collection for CV trials.

How can data from mHealth devices be used to assess efficacy of a novel treatment or as the endpoint itself?

Biosensor technologies and how they may help Phase II CV clinical trials
Kenneth Stein (Boston Scientific, USA)
What is required for regulatory clearance? How are clinical trial tools assessed in a regulatory context?
présentation Ken Skodacek (FDA, USA)
présentation Alan Fraser (Cardiff, USA)
Incorporation of general wellness/fitness tools into clinical trial monitoring: what are the pros and cons?
présentation Morgan Reed (Washington, USA)
présentation Matthew Diamond (San Francisco, USA)
How does the incorporation of mHealth impact the overall clinical trial conduct?
Richard Clark (Medtronic, USA)
Should mHealth and eHealth solutions be submitted to clinical trials? Level of evidence and approvability issues
présentation Maulik Majumdar (Boston, USA)
présentation Anthony Rodgers (Sydney, AUS)
NHLBI perspective
Yves Rosenberg (NHLBI, USA)
Regulatory perspective
présentation Linda Ricci (FDA, USA) and Christopher Scully (FDA, USA)
Payer perspective
Thomas Clutton-Brock (NICE, GBR)
The Forum: Moderated discussion with the audience
How might eTechnologies and biosensors help CV clinical trials?
Panelists: William Abraham (Columbus, USA), Richard Clark (Medtronic, USA), Thomas Clutton-Brock (NICE, GBR), Matthew Diamond (San Francisco, USA), Alan Fraser (Cardiff, GBR), Nancy Geller (NHLBI, USA), David Guez (Servier, FRA), Maulik Majumdar (Boston, USA), Bakul Patel (FDA, USA), Linda Ricci (FDA, USA), Anthony Rodgers (Syndey, AUS), Yves Rosenberg (NHLBI, USA), Christopher Scully (FDA, USA), Tamara Shipman (St Jude Medical), Ken Skodacek (FDA, USA), Kenneth Stein (Boston Scientific, USA)
8:00am — 12:00pm
Critical Markers Of Disease (CMOD) — CVCT Joint Session
Moderators: Kirkwood Adams (Chapel Hill, USA) and Alexandre Mebazaa (Paris, FRA)

There is a big enthusiasm surrounding biomarkers for a wide range of purposes, including screening patients for disease susceptibility, guiding therapy based on disease severity, stratifying mechanistic sub-population profiles of patients in order to predict drug efficacy and toxicity and identifying novel drug targets.

Biomarker research intensity has delivered only a handful of CV actionable biomarkers

There are many challenges that may have been overlooked, including the speed of technological changes, the sophistication of trial methodology and the rise in regulatory and payers requirements.

A new research paradigm is needed that may capture the promise and deliver the benefits of biomarker-driven clinical decision-making.

Working collaboratively to expedite the generation of resources (e.g. cohorts, data, biosamples, assay platforms and bioinformatics), is essential, within consortia synergizing stakeholders from academia, industry, non-profit foundations, professional societies, advocacy groups and others.

Ongoing large biomarkers collaborative programs
  • Trans-Omics for Precision Medicine (TOPMed) Program
    Cashell Jaquish (NHLBI, USA)
  • European academic perspective
    Faiez Zannad (Nancy, FRA)
  • US academic perspective
    Daniel Levy (Boston, USA)
Precision proteomics for targeted biomarker discovery and protein profiling
présentation Annalotta Schiller (Olink, SWE)
Precompetitive industry collaboration
présentation Sven Moosmang (Bayer, USA)
Biomarkers in atherosclerosis disease
présentation Jean-Claude Tardif (Montreal CAN)
Biomarkers in emergencies
  • Time to result matters
    Alexandre Mebazaa (Paris, FRA)
  • Changes over time are better than one time point
    James Januzzi (Boston, USA)
Biomarker development and industrialization
présentation Gillian Murtagh (Abbott, USA)
Clinical validation of biomarkers prediction of drug response, methodological challenges
présentation Mona Fiuzat (Washington, USA)
Industry viewpoint
Julian Braz (Roche Diagnostics, CHE)
Regulatory viewpoint
présentation Ileana Piña (FDA, USA) and Krishna Prasad (EMA, GBR)
Payer viewpoint
Katherine Szarama (CMS, USA)
The Forum: Moderated discussion with the audience
What evidence is needed to get a biomarker approved, reimbursed, and used in clinical practice
Panelists: Kirkwood Adams (Chapel Hill, USA), Agim Beshiri (Abbott, USA), Julian Braz (Roche Diagnostics, CHE), Mona Fiuzat (Washington, USA), James Januzzi (Boston, USA), Cashell Jaquish (NHLBI, USA), Daniel Levy (Boston, USA), Alexandre Mebazaa (Paris, FRA), Sven Moosmang (Bayer, USA), Gillian Murtagh (Abbott, USA), Ileana Pia (FDA, USA), Yigal Pinto (ACS biomarkers, NED), Krishna Prasad (EMA, GBR), Annalotta Schiller (Olink, SWE), Katherine Szarama (CMS, USA), Jean-Claude Tardif (Montreal CAN), Martin Unverdorben (Daiichi Sankyo, USA), Stephen Williams (Somalogic, USA), Faiez Zannad (Nancy, FRA)
12:00 — 12:30pm

mHealth and eHealth and how they may help rethinking clinical trials
Rob Califf (FDA, USA)
1:30 — 2:00pm

The artificial heart
Alain Carpentier (Paris, FRA)
2:00 — 7:00pm
Heart Failure Society of America (HFSA) — CVCT Joint Session
Moderators: John Cleland (Glasgow, GBR) and Mandeep R. Mehra (Boston, USA)
My understanding and issues I have with guidelines
  • A fellow from Europe
    João Ferreira (Nancy, FRA)
  • A fellow from the US
    Abhinav Sharma (Durham, USA)
Guideliner perspective
présentation John Cleland (Glasgow, GBR)
What do we do about HFmrEF? A target for future trials?
Carolyn Lam (Singapore, SGP)
Is PARADIGM-HF changing clinical practice?
présentation Milton Packer (Dallas, USA)
Are Ivabradine trials changing clinical practice?
présentation Jeffrey Borer (New York, USA) and Karl Swedberg (Gothenburg, SWE)
Shall we revise ICD therapy guidelines post DANISH? The case for a risk-guided ICD implantation approach
présentation Fania Mela (Boston, USA)
How to do a better job with implementing existing beneficial therapies?
  • Remote monitoring
    William Abraham (Columbus, USA)
  • Multisense and novel technologies
    Yi Zhang (Boston Scientific, USA)
  • Cardiac resynchronization therapy optimization: RESPOND
    Alberto Borri (LivaNova, ITA)
  • BNP guided-trials
    James Januzzi (Boston, USA)
  • Are potassium binders the solution?
    Bertram Pitt (Ann Arbor, USA)
  • Disease management programs
    Faiez Zannad (Nancy, FRA)
Patient perspective
présentation Cynthia Chauhan (Wichita, USA)
The Forum: Moderated discussion with the audience
How to overcome barriers, challenges and disincentives to implementation?
Panelists: William Abraham (Columbus, USA), Jeffrey Borer (New York, USA), Alberto Borri (LivaNova, ITA), Cynthia Chauhan (Wichita, USA), John Cleland (Glasgow, GBR), Nihar Desai (New Haven, USA), João Ferreira (Nancy, FRA), Phil Galtry (INC Research, GBR), James Januzzi (Boston, USA), John Jarcho (Boston, USA), Carolyn Lam (Singapore, SGP), Mandeep R. Mehra (Boston, USA), Fania Mela (Boston, USA), Milton Packer (Dallas, USA), Bertram Pitt (Ann Arbor, USA), Jean Claude Provost (GE Healthcare, GBR), Abhinav Sharma (Durham, USA), Bhupinder Singh (ZS Pharma, USA), Karl Swedberg (Gothenburg, SWE), Yi Zhang (Boston Scientific, USA), Faiez Zannad (Nancy, FRA)