About ARC

The Academic Research Consortium (ARC) is an international collaborative forum across medical device stakeholders that includes academics, clinical trialists, regulatory bodies and industry.

The purpose of the ARC is to create a dynamic, transparent and collaborative forum for stakeholders to develop consensus definitions and standard nomenclature in pivotal clinical trials of medical devices and to disseminate such definitions and recommended processes into the public domain.

Where is ARC located

The ARC Board includes representatives from Baim Institute for Clinical Research (Boston, USA), Cardialysis & European Cardiovascular Research Institute - ECRI (Rotterdam, The Netherlands), Cardiovascular Research Foundation (New York, USA), Duke Clinical Research Institute (Raleigh, USA), CERC - Cardiovascular European Research Center (Massy, France); and, in an advisory role, a representative from the United States Food and Drug Administration.

Name	Donald E. Cutlip
Function	Chief Medical Officer at Baim Institute for Clinical Research

Baim Institute

Boston, USA

Affiliations: Division of Cardiology, Department of Medicine, Beth Israel Deaconess Medical Center & Baim Institute for Clinical Research, Boston, Massachusetts, USA
Dr. Donald E. Cutlip received his MD from the University of South Florida, followed by an internal medicine residency at the University of Connecticut and fellowships in cardiology and interventional cardiology at Beth Israel Hospital, Boston, MA.
Dr. Cutlip is Professor of Medicine at Harvard Medical School and a Vice Chair in the Department of Medicine at Beth Israel Deaconess Medical Center. He is Chief Medical Officer at Baim Institute for Clinical Research.
In 2006, he co-founded the Academic Research Consortium, which has promoted standardization of endpoints and clinical trial methods for cardiac device clinical trials among academic research organizations, industry sponsors and regulatory agencies.

Name	Roxana Mehran
Function	Director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai

Cardiovascular Research Foundation (CRF)

New York, USA

Affiliations: Cardiovascular Research Foundation & Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York, USA
Prof. Roxana Mehran is an internationally renowned interventional cardiologist and clinical research expert in the field of cardiovascular disease. Director of the Center for Interventional Cardiovascular Research and Clinical Trials at Mount Sinai, she has built a globally respected academic research center focused on developing randomized clinical trials, outcomes research projects and high-impact academic publications. Prof. Mehran has served as principal investigator for numerous global studies, developed risk scores for bleeding and acute kidney injury, and participates regularly in developing national clinical guidelines.
In 2006, she co-founded the Academic Research Consortium, which has promoted standardization of endpoints and clinical trial methods for cardiac device clinical trials among academic research organizations, industry sponsors and regulatory agencies.

Name	Ernest Spitzer, MD
Function	Chief Medical Officer at Cardialysis

Cardialysis

Rotterdam, The Netherlands

Affiliations: Cardialysis & European Cardiovascular Research Institute (ECRI) & Thoraxcenter, Erasmus University Medical Center, Rotterdam, The Netherlands
Dr. Spitzer is a cardiologist and clinical trialist currently appointed chief medical officer at Cardialysis, a renowned cardiovascular research organization and core laboratory, and director at the European Cardiovascular Research Institute (ECRI), a platform of clinical and scientific leaders in the execution of large cardiovascular clinical trials in Europe.
Dr. Spitzer graduated summa cum laude from the Catholic University of Saint Mary, Arequipa, Peru, and served at the Peruvian Armed Forces. He completed his cardiology training at the University Hospital Miguel Servet, Zaragoza, Spain. Subsequently, he completed advanced training in cardiovascular imaging in Vienna, Austria, and a research fellowship in interventional cardiology in Bern, Switzerland, supported by a research fellowship of the European Association of Percutaneous Cardiovascular Interventions of the European Society of Cardiology (EAPCI) and a research fellowship from the Spanish Society of Cardiology.
He completed a master program in statistics and research methodology at the Autonomous University of Barcelona. He has contributed with 80+ articles in peer-reviewed journals.
Dr. Spitzer serves as board member at ARC since 2019, succeeding Gerrit-Anne van Es, PhD, who co-founded ARC on behalf of Cardialysis.

Name	Marie-Claude Morice
Function	Chief Executive Officer at CERC - Cardiovascular European Research Center

CERC - Cardiovascular European Research Center

Massy, France

Affiliation: Cardiovascular European Research Center, Massy, France
Dr. Marie-Claude Morice, MD, FESC, FACC was head of Interventional Cardiology at CCN (1986-95) and ICPS-Ramsay Santé (1995-2015), the highest volume PCI centers in the Greater Paris area. She is the President of the European Center for Cardiovascular Research. She was voted Best Clinical Researcher in 1995 (Erasmus) and Cardiologist of the year in 1997. Her clinical research work has resulted in more than 300 peer-reviewed publications. She was the co-founder of the French study group ‘Coronary Stenting Without Coumadin’, the PI of the Ravel Trial, the Reality Study and the co-PI of the Syntax Trial in charge of the Left Main publications.
She received the CHIEN award and the Geoffrey O. Hartzler Master Operator Award in 2014 and the Gruntzig Award at EuroPCR 2021. She gave the Gruntzig Lecture at the 2017 ESC congress. She was gold medalist at ESC 2022.
Dr. Morice serves as board member at ARC since 2019.

Name	Mitchell W. Krucoff
Function	Professor of Cardiology at Duke University Medical Center

Duke Clinical Research Institute

Durham, North Carolina

Affiliations: Division of Cardiology, Department of Medicine, Duke University Medical Center & Duke Clinical Research Institute, Durham, North Carolina, USA
Dr. Mitchell W. Krucoff, M.D., F.A.C.C., F.A.H.A, F.S.C.A.I. is Professor of Medicine/Cardiology and an Interventional Cardiologist at Duke University Medical Center and is internationally recognized for his pioneering research in several areas including complementary therapies in patients with heart disease, computer-assisted heart monitoring, and new modalities of coronary revascularization.
His clinical trials include patients and hospitals in five continents, and he lectures globally on these and related topics. Author of more than 250 publications in the cardiology literature and book chapters in medical texts. Dr. Krucoff is Director of the Cardiovascular Devices Group at the Duke Clinical Research Institute. In 2007 he received a Distinguished Service Award from the United States Food and Drug Administration for his tenure on the Circulatory Devices Advisory Panel, and in 2008 was named the Hein Wellens Distinguished Professor by the University of Maastricht, the Netherlands.
In 2006, he co-founded the Academic Research Consortium, which has promoted standardization of endpoints and clinical trial methods for cardiac device clinical trials among academic research organizations, industry sponsors and regulatory agencies.

Name	Andrew Farb
Function	Chief Medical Officer at the Office of Cardiovascular Devices at CDRH FDA Liaison to the ARC Board

Office of Cardiovascular Devices at the Center for Devices and Radiological Health (CDRH) – United States Food and Drug Administration (FDA)

Maryland, USA

Graduated from Dartmouth College (BA) and Cornell University Medical College (MD)
Internship and residency in internal medicine, training in anatomic pathology, cardiology fellowship at The New York Hospital – Cornell University Medical Center, and fellowship in cardiovascular pathology at The Armed Forces Institute of Pathology (AFIP)
Served as a staff cardiovascular pathologist at AFIP
Board-certified in Internal Medicine and Cardiovascular Diseases.
Co-Leader of the FDA CDRH Early Feasibility Study Program
Attending physician in clinical cardiology