Discussion Panel: What Could International Registry/ARO/CRO Collaborations with Industry for EU MDR Submissions look Like?

Saturday, February 25, 2023

9:10 AM – 9:45 AM ET

Panel Moderator(s)

Mami Ho, MD, PhD

Senior Scientist for Clinical Medicione
Pharmacueticals and Medical Devices Agency(PMDA)
Tokyo, Tokyo, Japan

No relationships to disclose
Misti Malone, PhD (she/her/hers)

Asst Director, PIDT
FDA
Silver Spring, Maryland, United States

No relationships to disclose

Panel Discussant(s)

David Erlinge, MD, PhD (he/him/his)

Professor, Consultant Interventional Cardiology
Lund University
Lund, Sweden

Disclosure(s): Abbott Laboratories, Boston Scientific, Covidien, Janssen Pharmaceuticals, The Medicines Company, Sanofi-Aventis: Advisory Committee/Board Member (Ongoing); AstraZeneca: Clinical Trial Investigator (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Bayer: Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); BMS/Pfizer: Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Sanofi: Scientific Advisory Board (Ongoing)
C. Michael Gibson, MD

Professor of Medicine
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States

Disclosure(s): Absolutys: Shareholder (Ongoing); Angel Medical Systems, Inc.: Consultant (Ongoing); AstraZeneca Pharmaceuticals: Consultant (Ongoing); Bayer HealthCare: Consultant (Ongoing); Bioclinica: Consultant (Ongoing); Boston Clinical Research Institute: Consultant (Ongoing), Owner/Co-Owner Founder/Co-Founder (Ongoing); Boston Scientific: Consultant (Ongoing); Bristol Meyers Squibb: Consultant (Ongoing); Caladrius Bioscience: Consultant (Ongoing); Cardiovascular Research Foundation: Consultant (Ongoing); CeleCor Therapeutics: Consultant (Ongoing); CSL-Behring: Consultant (Ongoing), Grant/Research Support (Ongoing); Cytokinetics: Consultant (Ongoing); Daiichi Sankyo, Inc.: Consultant (Ongoing); Duke Clinical Research Institute: Consultant (Ongoing); Dyad Medical: Shareholder (Ongoing); EXCITE International: Advisor (Ongoing); Fortress Biotech: Consultant (Ongoing), Shareholder (Ongoing); Gilead: Consultant (Ongoing); Inari: Consultant (Ongoing); Janssen Research & Development LLC: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Grant/Research Support (Ongoing); MashUP MD: Consultant (Ongoing); MD Magazine: Consultant (Ongoing); MedImmune: Consultant (Ongoing); Medtelligence: Consultant (Ongoing); Merck Pharmaceuticals: Consultant (Ongoing); Microdrop: Consultant (Ongoing); MicroPort Medical: Consultant (Ongoing); Miracor: Consultant (Ongoing); MJH Life Sciences: Consultant (Ongoing); nference: Shareholder (Ongoing); Novartis Pharmaceuticals: Consultant (Ongoing); NovoNordisk: Consultant (Ongoing); Paratek: Consultant (Ongoing); PERT Consortium: Consultant (Ongoing); Pfizer: Consultant (Ongoing); PhaseBio: Consultant (Ongoing); plx pharma: Consultant (Ongoing); Revance Therapeutics: Consultant (Ongoing); Solstic Health/New Amsterdam Pharma: Consultant (Ongoing); Somahlution/Marizyme: Consultant (Ongoing); UpToDate in Cardiovascular Medicine: Royalties (Ongoing); Vecutra: Consultant (Ongoing); WebMD: Consultant (Ongoing); Woman As One: Consultant (Ongoing)
Mitchell Krucoff, MD, FACC (he/him/his)

Professor Medicine/Cardiology
Duke University Medical Center/Duke Clinical Research Institute
Durham, North Carolina, United States

Disclosure(s): Abbott Vascular: Consultant/Advisory Board (Ongoing), Consulting Fees (e.g., advisory boards) (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Boston Scientific: Consultant (Ongoing), Other Research Support (Ongoing); Cook medical: Consultant (Ongoing), Other Research Support (Ongoing); Getinge: Consultant (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); InfraRedx: Clinical Trial Support (Ongoing), Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Medtronic: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant Recipient (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Nipon: Consultant (Ongoing); OrbusNeich Medical Inc.: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); SMT: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Terumo Corporation: Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing)
Ernest Spitzer, MD

Chief Medical Officer
Cardialysis B.V.
Rotterdam, Zuid-Holland, Netherlands

Disclosure(s): Cardialysis: Board Member (Ongoing); European Cardiovascular Research Institute: Board Member (Ongoing)
Holger Thiele, MD

Head of department
Heart Center Leipzig
Leipzig, Sachsen, Germany

No relationships to disclose
FT

Fran Thorpe, DrPH

Disclosure information not submitted.

Disclosure(s):

David Erlinge, MD, PhD: Abbott Laboratories, Boston Scientific, Covidien, Janssen Pharmaceuticals, The Medicines Company, Sanofi-Aventis: Advisory Committee/Board Member (Ongoing); AstraZeneca: Clinical Trial Investigator (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Bayer: Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); BMS/Pfizer: Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Sanofi: Scientific Advisory Board (Ongoing)

C. Michael Gibson, MD: Absolutys: Shareholder (Ongoing); Angel Medical Systems, Inc.: Consultant (Ongoing); AstraZeneca Pharmaceuticals: Consultant (Ongoing); Bayer HealthCare: Consultant (Ongoing); Bioclinica: Consultant (Ongoing); Boston Clinical Research Institute: Consultant (Ongoing), Owner/Co-Owner Founder/Co-Founder (Ongoing); Boston Scientific: Consultant (Ongoing); Bristol Meyers Squibb: Consultant (Ongoing); Caladrius Bioscience: Consultant (Ongoing); Cardiovascular Research Foundation: Consultant (Ongoing); CeleCor Therapeutics: Consultant (Ongoing); CSL-Behring: Consultant (Ongoing), Grant/Research Support (Ongoing); Cytokinetics: Consultant (Ongoing); Daiichi Sankyo, Inc.: Consultant (Ongoing); Duke Clinical Research Institute: Consultant (Ongoing); Dyad Medical: Shareholder (Ongoing); EXCITE International: Advisor (Ongoing); Fortress Biotech: Consultant (Ongoing), Shareholder (Ongoing); Gilead: Consultant (Ongoing); Inari: Consultant (Ongoing); Janssen Research & Development LLC: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Grant/Research Support (Ongoing); MashUP MD: Consultant (Ongoing); MD Magazine: Consultant (Ongoing); MedImmune: Consultant (Ongoing); Medtelligence: Consultant (Ongoing); Merck Pharmaceuticals: Consultant (Ongoing); Microdrop: Consultant (Ongoing); MicroPort Medical: Consultant (Ongoing); Miracor: Consultant (Ongoing); MJH Life Sciences: Consultant (Ongoing); nference: Shareholder (Ongoing); Novartis Pharmaceuticals: Consultant (Ongoing); NovoNordisk: Consultant (Ongoing); Paratek: Consultant (Ongoing); PERT Consortium: Consultant (Ongoing); Pfizer: Consultant (Ongoing); PhaseBio: Consultant (Ongoing); plx pharma: Consultant (Ongoing); Revance Therapeutics: Consultant (Ongoing); Solstic Health/New Amsterdam Pharma: Consultant (Ongoing); Somahlution/Marizyme: Consultant (Ongoing); UpToDate in Cardiovascular Medicine: Royalties (Ongoing); Vecutra: Consultant (Ongoing); WebMD: Consultant (Ongoing); Woman As One: Consultant (Ongoing)

Mitchell Krucoff, MD, FACC: Abbott Vascular: Consultant/Advisory Board (Ongoing), Consulting Fees (e.g., advisory boards) (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Boston Scientific: Consultant (Ongoing), Other Research Support (Ongoing); Cook medical: Consultant (Ongoing), Other Research Support (Ongoing); Getinge: Consultant (Ongoing), Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); InfraRedx: Clinical Trial Support (Ongoing), Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Johnson & Johnson: Consultant (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Medtronic: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant Recipient (Ongoing), Other Research Support (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); Nipon: Consultant (Ongoing); OrbusNeich Medical Inc.: Clinical Trial Support (Ongoing), Consultant (Ongoing), Grant/Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing); SMT: Consultant (Ongoing), Research Grant (includes principal investigator, collaborator or consultant and pending grants as well as grants already received) (Ongoing); Terumo Corporation: Other Research Support (Ongoing), Speaker/Honoraria (includes speakers bureau, symposia, and expert witness) (Ongoing)

Ernest Spitzer, MD: Cardialysis: Board Member (Ongoing); European Cardiovascular Research Institute: Board Member (Ongoing)