September 7, 2018
8:00am – 8:15am Introduction and Purpose of Think Tank Mitchell Krucoff, MD (Duke)
- Introduction to CSRC
- Anatomy of a Think Tank
8:15am – 8:45am Session I: Overview of shock
Session I Objectives:
- Review what is known and unknown about the pathophysiology of shock.
- Review published literature and identify gaps.
- Discuss current clinical practices and the evidence base.
- Pathophysiology of shock and associated syndromes: From impending shock to futility Navin Kapur, MD (Tufts)(10 min)
- Review of trials to date in cardiogenic shock E. Magnus Ohman, MD (Duke)(10 min)
- Current cardiovascular management tools & best practice for shock: drugs, surgically implanted and percutaneous devices Joseph Rogers, MD (Duke)( 10 min)
8:45am – 9:00am BREAK
9:00am – 10:30am Session II: Defining unmet needs, clinical study barriers, and targets for drug and device therapy for shock: Part I Moderator: Joseph Rogers, MD (Duke)
Session II Objectives:
- Define a population of intended use for drug and device therapies in cardiogenic shock.
- Discuss and identify comparator cohorts for cardiogenic shock trials.
- Discuss and identify primary and secondary outcomes for cardiogenic shock trials.
9:00am – 9:10am Cohorts to study: defining a “population of intended use”
- Clinical/best practice perspective Alexander Truesdell, MD (INOVA)
- Industry perspective Philip Adamson, MD (Abbott)
9:10am – 9:20am Comparators for drug and device trials in shock patients
- Clinical/best practice perspective Judith Hochman, MD (NYU Langone)
9:20am – 9:30am Outcome endpoints: mortality plus?
- Clinical/best practice perspective Ian Gilchrist, MD (Penn State)
9:30am – 9:40am FDA Perspective Ileana Pina, MD
9:40am – 9:50am Health Canada Perspective Roy Masters, MD
9:50am – 10:30am Discussion
- Lead Discussant: Ron Waksman, MD (Medstar Health)
10:30am – 10:45am BREAK
10:45am -12:15pm Session III: Defining unmet needs, clinical study barriers, and targets for drug and device therapy for shock: Part II | Moderator: David Morrow, MD MPH (Harvard)
Session III Objectives:
- Discuss enrollment of patients who may not be capable of providing informed consent.
- Discuss and identify novel evidence structures for future shock trials.
- Discuss and identify novel statistical approaches for trials of shock therapies.
10:45am – 10:55am Informed consent
- Clinical/best practice perspective Timothy Henry, MD (Cedars-Sinai)
10:55am – 11:05am Avenues for real world evidence, pragmatic trials, or novel infrastructure for shock trials
- Clinical/best practice perspective Holger Thiele, MD (University of Leipzig)
11:05am – 11:15am Novel statistical approaches for shock studies
- Clinical/best practice perspective Andrew Althouse, PhD (University of Pittsburgh)
11:15am – 11:20am Improving Patient Outcomes in Cardiogenic Shock as a core mission of clinical development programs Seth Bilazarian, MD (Abiomed)
11:20am-11:30am FDA Perspective John Sapirstein, MD
11:30am – 12:10pm Discussion
- Lead Discussant: Roseann White, MA (Duke)
12:10pm – 1:00pm LUNCH
1:00pm – 2:00pm Session IV: Future directions for device and drug development in shock. Moderator: Sunil Rao, MD (Duke)
Session IV Objectives:
- Identify global collaborators for trials of shock therapies.
- Discuss trial designs incorporating both drug and device therapies for patients with cardiogenic shock.
- Discuss and define “-ARC” definitions of shock (SHARC).
1:00pm – 1:10pm Global collaboration: is it possible? Is it desirable? Clinical/best practice perspective William Abraham, MD (Ohio State)
1:10pm – 1:20pm Factorial device and drug study designs
- Clinical/best practice perspective Roxana Mehran, MD (Mount Sinai)
1:20pm – 1:30pm Definitions: Shock-ARC (SHARC)
- Clinical/best practice perspective George Dangas, MD (Mount Sinai)
1:30pm-1:40pm FDA Perspective Fortunato Senatore, MD, PhD
1:40pm – 2:30pm Discussion
2:30pm – Closing Remarks
An FDA/CSRC/HESI-sponsored think tank meeting was convened in Washington, D.C., on May 21- 22, 2018, to discuss the latest data from the Comprehensive In Vitro Proarrhythmia Assay (CiPA) Initiative. This synopsis provides a very high level report of results presented.
The four components of CiPA collectively seek to characterize more clearly the torsadogenic risk of drugs by providing a more comprehensive assessment of a drug’s effect on multiple cardiac ionic currents rather than just hERG. In vitro assessment of drug-induced effects on ionic currents focuses primarily on hERG, late sodium, and L‐type calcium (calcium) currents. In silico computer modeling integrates individual ion channel data to predict the clinical risk of Torsade. ECG biomarkers, e.g., the heart rate-corrected J-Tpeak interval (J-Tpeakc), are studied in Phase 1 clinical trials to check for unanticipated effects compared with nonclinical ion channel data and in silico modeling predictions. In vitro drug effects on human induced pluripotent stem cell-derived ventricular cardiomyocytes can be optionally examined for the same purposes.
May 21, 2018 – Day 1
8:00am – Continental Breakfast
Welcome and Introduction
Philip Sager, MD (Stanford University) (15 min)
8:15am-9:45am Session I: Overview
Moderator: Gary Gintant, PhD (AbbVie)
- TdP mechanisms and insights- scientific rationale for CiPA: Gary Gintant, PhD (Abbvie) (15 min)
- The need for a new approach to assessing the proarrhythmic potential of drugs and overview of CiPA: Philip Sager, MD (Stanford University) (15 min)
- The potential role of CIPA on drug discovery, development, and regulatory pathways: David Strauss, MD, PhD (US FDA) (20 min)
Q&A / Panel Discussion (40 min) Speakers and
- Krishna Prasad, MD (EMA)
- Corina Dota, MD (AstraZeneca)
- Peter Kowey, MD (Lankenau Heart Institute)
10:00am-12:00pm Session II: In Silico Modeling and Ion Channel Approaches
Moderator: Gary Mirams, PhD (University of Nottingham)
- In Silico modeling- state of the art: Gary Mirams, PhD (University of Nottingham) (15 min)
- Summary of In Silico model approach and validation study; In Silico Results: Zhihua Li, PhD (US FDA) (30 min)
- Ion Channel Assays and Data – lessons learned and data quality criteria: Wendy Wu, PhD (US FDA) (30 min)
Q&A / Panel Discussion (45 min) Speakers and
- Najah Abi Gerges, PhD (AnaBios)
- Jim Kramer, PhD (Charles River)
- Takashi Yoshinaga, PhD (Eisai)
12:00pm-12:30pm Working Lunch
12:30pm-2:30pm Session III: IPS-Stem Cells and Phase 1 ECG
Moderators: David Strauss, MD, PhD (US FDA)
- IPS-Stem Cells: Summary of approach, Detailed results and implications: Ksenia Blinova, PhD (US FDA) (30min)
- New ECG biomarkers and their potential role in CiPA; Results and implications: Jose Vicente Ruiz, PhD (US FDA)(30 min)
- Implementation of ECG biomarkers: Borje Darpo, MD, PhD (ERT) (10 min)
Q&A / Panel Discussion (50 min) Speakers and
- Gary Gintant, PhD (Abbvie)
- Yasunari Kanda, PhD (Japan NIHS)
- Charles Benson, MD, PhD (Eli Lilly)
2:45pm-4:50pm Session IV: Regulatory Evaluation and Potential Implementation
Moderator: Philip Sager, MD (Stanford University)
- Data summary overview: David Strauss, MD, PhD (US FDA) (15 min)
- How CiPA might impact pre-clinical safety testing and S7B: Derek Leishman, PhD (Eli Lilly) (20 min)
- How CiPA might be implemented in clinical development and regulatory decision making: Christine Garnett, PharmD (US FDA) (20 min)
- Regulatory considerations and next steps: Krishna Prasad, MD (MHRA) (10 min)
Q&A/Panel discussion (60 min) Speakers and
- Colette Strnadova, PhD (Health Canada)
- Kaori Shinagawa, MD, PhD (PMDA)
- Jean-Pierre Valentin, PhD (UCB, EFPIA)
- Maki Ito MD, PhD (JPMA, Merck)
May 22, 2018 – Day 2
7:30am-8:00am Continental Breakfast
8:00am-8:10am General Instructions
8:10am–10:30am Work Stream Breakouts
Breakout 1 – In Silico
Leaders: Zhihua Li, PhD (US FDA); Gary Mirams, PhD (University of Nottingham); Takashi Yoshinaga, PhD (Eisai)
The In Silico Breakout Session discussion will focus the on:
- Considerations of implementing the proposed CiPA model and qNet metric
- General principles to qualify any new models and metrics to be used under the CiPA paradigm
Breakout 2 – Ion Channel
Leaders: Wendy Wu, PhD (US FDA); James Kramer, PhD (Charles River); Najah Abi-Gerges, PhD (AnaBios)
The Ion Channel Breakout Session discussion will focus the on:
- Data quality standards (for consideration of cell integrity and recording quality)
- Current run-up, run-down, steady state
- Unified experimental protocol for CiPA
- Temperature for hERG channel recording
- Agonist for late NaV1.5 current
- Charge carrier for CaV1.2 current
- Where and how drug effects are measured during the voltage protocols
Breakout 3 – Myocyte
Leaders: Gary Gintant, PhD (Abbvie); Ksenia Blinova, PhD (US FDA); Yasunari Kanda, PhD (Japan NIHS)
The Myocyte Breakout Session discussion will focus the on:
- Brief review of Validation Study results
- Findings of JiCSA study results
- Comparison of JiCSA and Validation study results (points of concordance, discordance, models)
- Comparison of sensitivity of different cell lines (noncore sites study)
- Setting best practices and calibration standards
- Roles of myocytes (internal decision-making vs. regulatory perspectives, flow chart examples, benefits vs. current regulatory paradigm)
Breakout 4 – Phase 1 ECG
Leaders: Jose Vicente Ruiz, PhD (US FDA); Christine Garnett, PharmD (US FDA)
The ECG Breakout Session will focus on:
- Summary of results supporting J-Tpeak use to inform multi-ion channel effects
- Heart rate dependency of J-Tpeak interval
- J-Tpeak/RR adaptation and hysteresis
- Population vs. subject-specific corrections
- Challenges in concentration-ECG-response models
- Identifying nonlinear relationships in small sized trials
- Impact on interpretation of results
- Role of ECG in a potential implementation of CiPA
- Integrated risk assessment, context of use and potential thresholds
- How to handle discrepancies
- Are we ready?
11:00am-12:00pm Reports from Work Stream Breakouts
12:00pm-12:30pm Working Lunch
12:30pm-2:30pm Advances in Clinical QTc Assessments and Updates from the FDA QT Interdisciplinary Review Team (IRT)
Moderator: Philip Sager, MD (Stanford University)
- Recent insights from the FDA QT IRT on ConcentrationQTc analysis and requirements for obtaining a ‘TQT study waiver:’ Dhananjay Marathe, PhD (US FDA) (15 min)
- Application of bias metrics during IRT review: Lars Johannesen, PhD (US FDA) (10 min)
- Issues with exposure-response analysis, how we can close the gap: Georg Ferber, PhD (Consultant) (20 min)
- QTc evaluation for drugs with a substantial heart rate effect: Marek Malik, MD, PhD (University of London) (15 min)
Q&A / Panel Discussion (60 min)
- Christine Garnett, PharmD (US FDA)
- Borje Darpo, MD, PhD (ERT)
- Dalong Huang, PhD (US FDA)
2:30 pm Adjourn
|Topic||Date||Title||Slides and Agendas|
|Cardiogenic Shock||September 7, 2018||Defining the Clinical and Regulatory Landscape for Cardiogenic Shock||Slides and Agenda|
|Arrhythmia, Proarrhythmia, CiPA||May 21-22, 2018||New Advances in the Assessment of Drug-Induced Arrhythmias and the Comprehensive In Vitro Proarrhythmia Assay (CiPA)||Slides and Agenda|
|Topic||Date||Title||Slides and Agendas|
|Sudden Cardiac Death||February 10, 2017||CSRC Prevention of Sudden Cardiac Death in the Young: National Cardiac Screening Warehouse Pilot Study||Slides & Agenda|
|Cardiovascular Regenerative Medicine||September 15 -16, 2017||Co-sponsored Symposium with the Texas Heart Institute on Cardiovascular Regenerative Medicine||Event Information|
|Oncology Drug Development||October 24-25, 2017||CSRC Meeting and Detection, Assessment, and Risk Mitigation of Cardiac Safety Signals in Oncology Drug Development Think Tanks||Slides & Agenda|
Please read the following synopsis, “CSRC Think Tank: Real World Data to Assess Cardiovascular Safety- Can We Improve Efficiencies in Phase 3 Development?”
8:00am-9:50am Session I: Tailoring best practices for the evaluation of endpoints in clinical device trials.
- Introductory Remarks:
William Maisel, MD, MPH (FDA) (10min)
Danica Marinac-Dabic MD, PhD (FDA) (10min)
- Introduction: Current State of Endpoint Adjudication in Device Trials
- What are the key components of the adjudication process including study endpoints and CEC elements (committee membership, charter, voting, QA, interactions with other clinical study committees, and independence from study sponsors/funders) Jonathan Seltzer, MD, MBA (ACI Clinical) (10min)
- How do the following study elements add bias or variability to the adjudication of endpoints in device clinical trials? What types of trial designs and clinical study operational factors help to minimize bias/variation? Are there other aspects of device trials which might contribute to or reduce endpoint variability? George Dangas , MD (Mt Sanai Medical Center)(10min)
- Study Blinding Challenges
- Variability in Operator Expertise and Operator Learning Curve Issues.
- Gathering the Necessary Data for Adjudication
- Role of Core Labs
- Sham/Mock Intervention
Standardized Endpoint Definitions. Karen Hicks, MD (FDA) (10min)
Panel Discussion: All Speakers
Lead Discussant: Pascal Vranckx, MD (Cardialysis)
What features of device trials would assist in the adjudication of endpoints? When do we need adjudication to determine if an event occurred? When do we need adjudication to ascertain device-related causality? Is adjudication helpful in determining the impact the operator expertise or technique on outcomes?
10:00am-12:10 pm Session II- Practical Issues in the adjudication of events in device trials: Case studies which highlight the issues involved with adjudicating event occurrence, causality, blinding, operator variability, committee composition, endpoint definitions, gathering endpoint data, and clinical study operational issues.
- Therapeutic Device Trials (e.g., Companion CHF) Peter Carson, MD (Washington, D.C. VA Medical Center)(10min)
- Implantable Diagnostic Device (e.g., Chronicle, CardioMems)- Alan Miller, MD (Health Science Center) (10min)
- Diagnostic Devices (e.g. Troponin, other biomarkers) Jim Januzzi, MD (Massachusetts General Hospital)(10min)
- Drug-Device Combination Products (e.g., Bio absorbable Drug-Eluting Stents) – Ted Heise, PhD, RAC (Cook Medical)(10min)
- FDA Perspective Bram Zuckerman, MD (FDA)(10min)
Panel Discussion: All Speakers & Rochelle Fink, MD, JD (FDA)
Lead Discussant: Wojciech Zareba, MD, PhD (University of Rochester Medical Center)
What practical issues should influence our thinking about adjudication? Are there critical clinical study issues in which adjudication is required? Are there issues in which adjudication is practically impossible? Do these issues differ among clinical studies of stents, valves, diagnostics, pacers, and non-implantable devices used for procedures (e.g. ablation)?
Working Lunch 12:10pm-12:40pm
12:40pm- 3:00 pm Session III: The Role of Adjudication in Efforts to Streamline the Process of Making Beneficial Devices Available to the Public: Regulatory and Reimbursement Issues
Post Market approval: Safety/Efficacy Data collection to support development and expanded labelling: The role of Big-Data in assessing post-marketing safety and effectiveness outcomes: What types of post-market data is susceptible to bias in reporting? Is it likely that adjudication would reduce this bias? How reliable are claims data or other large patient care databases to determine event rates without independent adjudication?
- Claims based data– Matthew Brennan, MD,MPH (Duke University) (10min)
- Registry (e.g. TAVR) Mitchell Krucoff, MD (Duke University) (10min)
- Big-Data (e.g. EMR data, data consolidators) Jo Carol Hiatt, MD, MBA (Kaiser Permanente) (10min)
- Industry Perspective/Emerging data sources (e.g. PCORI, patient reported outcomes data) Richard Kuntz, MD (Medtronic)(10min)
Panel Discussion: All Speakers
Lead Discussant: Mitch Krucoff, MD (Duke University)
What types of post marketing events require adjudication? What are the characteristics of types of devices that might require adjudication? What are the key factors that provide for practical endpoint adjudication in the post-market setting? Does the statistical power of databases obviate the need for adjudication? If not, what are potential strategies for adjudication? Can databases be used to identify potential events (reducing the burdens and costs associated with on-site study monitoring), which can then be independently adjudicated by a CEC? Can database strategies replace registries?
- Efficient use of premarket data sets to meet both FDA-CMS requirements:
- Engagement with CMS and FDA: What is it and what is its current status in device trials? When can we use clinical study data to support both CMS and FDA requirements? When would endpoint adjudication be helpful?
CDRH’s Expedited Access PMA (EAP) Program. What is it? Since the focus is to speed approval of devices meeting unmet medical need with less pre-market data than typically required for a PMA but with enriched post-market data collection, what is the role of adjudication in these situations to satisfy FDA data requirements post-market? What is the role of adjudication in these situations to satisfy coverage with evidence development (CED) for CMS? Is there a difference in adjudicating safety vs. effectiveness? In what cases could the additional effort needed for endpoint adjudication reduce the length or breadth of post-market follow-up?
3:00pm-3:30pm Summary and Next Steps
|Topic||Date||Title||Slides and Agendas|
|Sudden Cardiac Death||February 18, 2016||The 2nd Annual Think Tank on Prevention of Sudden Cardiac Death in the Young: Developing A Rational, Reliable and Sustainable National Health Care Resource||Slides & Agenda|
|Endpoint Adjudication||March 11, 2016||CSRC and MDEpiNet Thinktank Meeting: “The Role of Endpoint Adjudication in Medical Device Clinical Trials”||Slides & Agenda|
|Proarrhythmia||April 6, 2016||CSRC/FDA Workshop: The Proarrhythmic Assessment of New Chemical Entities||Slides & Agenda|
|Social Listening||June 3, 2016||CSRC/DIA Think Tank: Enabling Social Listening for Cardiac Safety||Slides & Agenda|
|Annual Meeting||October 18, 2016||CSRC 10th Annual Meeting||Slides & Agenda|
|Efficiencies in Phase 3 Development||October 19, 2016||CSRC Think Tank: Real World Data to Assess Cardiovascular Safety- Can We Improve Efficiencies in Phase 3 Development?||Slides & Agenda|
|Drug-induced Arrhythmia and CiPA||December 6, 2016||Critical Discussion- Future of the Assessment of Drug-Induced Arrhythmias and the Comprehensive in Vitro Proarrhythmia Assay (CiPA)||Slides & Agenda|
|QTc ER Modeling and VT/VF||December 7, 2016||Part A: QTc Exposure-Response Modeling Workshop: What is Required?
Part B: Endpoints When Treating VT/VF in Patients with ICDs
|Slides & Agenda|
Friday, October 23, 2015
Final agenda and links to presentation
8:30am-9:00am- Registration and continental breakfast
9:00am-9:10am– Introduction -Philip Sager, MD (Stanford University) (10min)
9:10am-10:35am– Session I: Risk Profiling
Safety Considerations in Development of Cell Therapies for Cardiovascular Indications. Steve Winitsky, MD (FDA/CBER) (10min)
Risk as related to source of cells (autologous vs. allogeneic), manipulation, and harvesting procedures. Marc Penn, MD, PhD (Summa Cardiovascular Institute) (10min)
Proposals for approaching risk profiling based on preclinical and clinical data. Joseph Wu, MD, PhD (Stanford University) (10 min)
Device-therapeutic combination challenge. Amit Patel, MD (University of Utah) (10min)
Expert panel discussion (45min)
10:35am-11:50pm– Session II: Dose Finding in Cell Therapies Development
Is demonstration of dose dependency required for establishing safety and bioactivity? Douglas Losordo, MD (Caladrius) (10min)
Role and unique challenges of potency assays in cardiovascular cell therapy. Andreas Zeiher, MD (University of Frankfurt) (10min)
Dose scaling based on non-human assays. Thomas Povsic, MD (Duke University) (10min)
Expert panel discussion (to include FDA representation) (45min)
11:50pm-12:00pm– Final remarks, and next steps
Thursday, December 3, 2015
Final agenda and links to presentations:
8:00am-8:10am– Introduction and goals of the Think Tank– Philip Sager, M.D. (Stanford University)
8:10am-10:40am– Session I: What does the current information tell us about NOAC dosing? What evidence is there that there of the variable clinical responses to PK parameters? What conclusions can we draw from these data?
Moderator: Philip Sager, M.D. (Stanford University)
Lead Discussant: Norman Stockbridge, M.D., Ph.D. (FDA)
Setting the Stage: What is the problem we are trying to address regarding NOAC dosing? Christopher Granger, M.D. (Duke University) (20min)
Summary from the EMA/CHMP Workshop on the role of PK and PD in the use of direct oral anticoagulants – Jens Heisterberg, M.D. (CHMP) (10min)
For whom are the current dosages optimal? Who might benefit from alternative dosing strategies? Noel Chan, M.D. (Monash University/McMaster University) (10min)
What evidence is there that variable clinical responses to PK parameters exist for NOACs? What conclusions can we draw from these data?
(Which PK/PD factors associated with bleeding and thrombotic events? What patient factors are associated with stroke/thrombotic events? What is the extent of Intra-individual PK variability? Can PK/PD be used as a guide for dosing?)
Review of Data from
Dabigatran- Paul Reilly, Ph.D. (Boehringer Ingelheim Pharmaceuticals) (10min)
Rivaroxaban- Dagmar Kubitza, M.D. (Bayer) (10min)
Apixaban- Jack Lawrence, M.D. (Bristol-Myers Squibb) (10min)
Edoxaban- Michele Mercuri, M.D.,Ph.D (Daiichi Sankyo) (10min)
FDA Interpretation- Jeffry Florian, Ph.D. (FDA) (10min)
Discussion: What are the problems with the current NOAC dosing strategy? How big they; what groups or patients are most effected? If there are issues, what data will we need moving forward?
10:55am-1:00pm–Session II: Is it possible that with better precision dosing we can do better in avoiding strokes and bleeds? What types of clinical evidence would be necessary to support PK/PD dosing? How do we ensure we are not hurting anyone?
Moderator: Jonathan Seltzer, M.D., M.B.A. (ACI Clinical)
Lead Discussant: Michele Mercuri, M.D., Ph.D. (Daiichi Sankyo)
Point/Counterpoint: PK-based dosing strategy should be recommended for certain patient populations to improve public health vs. PK based dosing strategy is impractical and may will not add value. Pro-Robert Temple, M.D. (FDA) (15min); Con-Scott Berkowitz, M.D. (Bayer Healthcare) (15min)
Initial PK measurement—should we do it?
Is there a rationale for monitoring?
Is it possible to measure and/or monitor?
What are the potential regulatory pathways for labeling PK based approaches? Since it is impractical to think that large trials would be undertaken to prove the benefit of PK driven dosing in already approved NOACS, what can or should be done? Do we need more evidence and what level of evidence? Is it necessary to do new clinical trial(s)? What outcomes or other endpoints would be necessary? What sort of evidence, if any, are needed to show that testing makes a difference?
Regulatory Speaker- Martin Rose, M.D. (FDA) (10min)
Academic/Industry Speaker- John Eikelboom, M.D., M.B.B.S. (McMaster University) (10min)
Discussion: What are reasonable goals to pursue for regulatory approval? What types of evidence are necessary for new labeling indications? What types of evidence will be required for new diagnostic tests? What are the pathways available? What are the obstacles?
2:00pm-4:00pm– Session III: Additional key issues impacting potential implementation
Moderator: Scott Berkowitz, M.D. (Bayer Healthcare);
Lead Discussant: Paul Reilly, Ph.D (Boehringer Ingelheim)
What is the pathway for approval of point of care test or companion diagnostic? What would the study look like? Lea Carrington, M.S., M.B.A. (FDA) (10min)
What is the pathway for approval of tests for measuring the specific anticoagulant activity of NOAC? Francois Depasse,PharmD (Stago)(10min)
What are the current measurement technologies/assays? What might be needed? Which tests might be appropriate? Thomas Ortel, M.D., Ph.D. (Duke University) (10min)
How are doctors actually going to do this, i.e. adjust PK with patient bleeding risk – what are patient risk factor (biologic, cultural, con meds) What are the challenges and potential solutions to support PK/PD dosing? Peter Kowey, M.D. (Lankenau) (10min)
Would payers (e.g. Medicare) be willing to support additional cost in order to enhance NOAC dosing? What type of evidence would be needed? James Rollins, M.D., Ph.D, (CMS) (10min)
4:00pm-4:30pm-Wrap-Up, Next Steps