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DAY ONE WEDNESDAY, MAY 1, 2019 PRE-CONFERENCE WORKSHOP

7:30

Workshop Registration and Continental Breakfast

8:30

Endpoint Adjudication Bootcamp —
Overcome Common Hurdles, Gain Cutting Edge Strategies and Seamlessly Integrate Best Practices

Perfect for anyone new to endpoint adjudication or companies considering implementing adjudication processes, this workshop gives a cohesive overview of what endpoint adjudication entails, the benefits of implementing this process, creating an Endpoint Adjudication Committee (EAC) also known as a Clinical Endpoint Committee (CEC) and developing submission packets. Bring your questions or specific challenges and concerns to be workshopped in this interactive boot camp.

Workshop Outline:

I. Demonstrate Importance of Endpoint Adjudication

II. Create an Endpoint Adjudication Committee

III. Create an Endpoint Adjudication Committee

IV. Extended Q&A

Workshop Leaders:

Shaena Kauffman
Director, Project Management and Adjudication Lead
ACI Clinical

Mandy Moran
Manager, Innovation and Technology
ACI Clinical

Lisa Boron, RN, BSN
Senior Manager, Clinical Specialists
ACI Clinical

*There will be a 30-minute refreshment break at 10:00

12:00

Networking Luncheon and Main Conference Registration

1:15

Chairman’s Welcome and Opening Remarks

Mads Engelmann, BSc, MD, PhD
International Medical Vice President
Novo Nordisk

Strategies for Successful Endpoint
Adjudication Processes

1:30

Structure of Clinical Trials — Management and Oversight Committees

Peter Carson, MD
Cardiologist
Washington VA Medical Center/Georgetown University

2:00

Small Studies Need Technology Too — Reducing Cost with Technology

Kelly Donham, PhD
Manager, PVG, Pharmacovigilance – Specialty Committees
PPD

2:30

ADJUDICATOR PANEL Adjudicator Perspectives on Undetermined Deaths, Process Bottlenecks and Adjudication Challenges

Moderator:

Jonathan Seltzer, MD, MBA, MA, FACC
President and CEO
ACI Clinical

Panelists:

James L. Januzzi, Jr., MD, FACC, FESC
Hutter Family Professor of Medicine, Harvard Medical School;
Physician, Cardiology Division, Massachusetts General Hospital;
Senior Medical Director, Baim Institute for Clinical Research

Peter Carson, MD
Cardiologist
Washington VA Medical Center/Georgetown University

Donald E. Cutlip
Vice Chair, Department of Medicine, Beth Israel Deaconess Medical Center;
Chief Medical Officer, Baim Institute for Clinical Research

3:30

Networking and Refreshment Break

4:00

Address Endpoint Challenges and Nuances Across Medical Categories

Venu Menon, MD, FACC, FAHA
Mehdi Razavi Endowed Educational Chair, Director Cardiac Intensive Care Unit,
Director Cardiovascular Fellowship, Associate Director C5, Professor Medicine
Lerner College of Medicine, Case Western Reserve University, Cleveland Clinic

Align Endpoint Best Practices to
Specific Therapeutic Disciplines

4:45

Conversation on Conundrums in CEC Adjudication of Myocardial Infarction

Moderator:

Mads Engelmann, BSc, MD, PhD
International Medical Vice President
Novo Nordisk

Conversation Contributors:

Bernard Chaitman
Professor of Medicine and Director of Cardiovascular Research
St. Louis University School of Medicine

James L. Januzzi, Jr., MD, FACC, FESC
Hutter Family Professor of Medicine, Harvard Medical School;
Physician, Cardiology Division, Massachusetts General Hospital;
Senior Medical Director, Baim Institute for Clinical Research

Peter Carson, MD
Cardiologist
Washington VA Medical Center/Georgetown University

5:30

Close of Day One

Networking, Wine and
Cheese Reception
immediately following the final session on day one

DAY TWO THURSDAY, MAY 2, 2019

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Mads Engelmann, BSc, MD, PhD
International Medical Vice President
Novo Nordisk

8:15

Optimizing Clinical Endpoint Adjudication Programs through Seamless Communication Flows

Ernest Spitzer, MD
Department of Cardiology, Thoraxcenter,
Erasmus University Medical Center, Rotterdam, The Netherlands;
Director of Clinical Endpoint Adjudication and Data Monitoring,
Cardialysis, Rotterdam, The Netherlands

9:00

New Adjudication Considerations in Cardio-Oncology

Jonathan Seltzer, MD, MBA, MA, FACC
President and CEO
ACI Clinical

9:45

Source Documentation — Too Little, Too Much

Kim Brown, RN, C5R CEC
Manager, Research Programs
Cleveland Clinic

10:30

Networking and Refreshment Break

11:00

Neurology Adjudicator Perspective

Waimei A. Tai, MD, FAHA
Christiana Care Health System

Promote Efficiency, Collaboration and
Excellence in Adjudication

11:45

Networking Luncheon

12:45

Adjudication in Blinded Independent Central Review of Oncology Studies — Reasons, Rates, Significance, Monitoring and Improvement

Robert Ford, MD
Founder and Principal
Clinical Trials Imaging Consulting, LLC

1:30

Develop Data Trust and Security in Adjudication to Reduce Errors and
Improve Outcomes

Terry Katz
Director, Head of Global Data Management and Statistics
Merck Animal Health

2:15

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, MAY 1, 2019 PRE-CONFERENCE WORKSHOP

7:30

Workshop Registration and Continental Breakfast

8:30

Endpoint Adjudication Bootcamp —
Overcome Common Hurdles, Gain Cutting Edge Strategies and Seamlessly Integrate Best Practices

Perfect for anyone new to endpoint adjudication or companies considering implementing adjudication processes, this workshop gives a cohesive overview of what endpoint adjudication entails, the benefits of implementing this process, creating an Endpoint Adjudication Committee (EAC) also known as a Clinical Endpoint Committee (CEC) and developing submission packets. Bring your questions or specific challenges and concerns to be workshopped in this interactive boot camp.

Workshop Outline:

I. Demonstrate Importance of Endpoint Adjudication

II. Create an Endpoint Adjudication Committee

III. Create an Endpoint Adjudication Committee

IV. Extended Q&A

Workshop Leaders:

Shaena Kauffman
Director, Project Management and Adjudication Lead
ACI Clinical

Mandy Moran
Manager, Innovation and Technology
ACI Clinical

Lisa Boron, RN, BSN
Senior Manager, Clinical Specialists
ACI Clinical

*There will be a 30-minute refreshment break at 10:00

12:00

Networking Luncheon and Main Conference Registration

1:15

Chairman’s Welcome and Opening Remarks

Mads Engelmann, BSc, MD, PhD
International Medical Vice President
Novo Nordisk

Strategies for Successful Endpoint
Adjudication Processes

1:30

Structure of Clinical Trials — Management and Oversight Committees

Peter Carson, MD
Cardiologist
Washington VA Medical Center/Georgetown University

2:00

Small Studies Need Technology Too — Reducing Cost with Technology

Kelly Donham, PhD
Manager, PVG, Pharmacovigilance – Specialty Committees
PPD

2:30

ADJUDICATOR PANEL Adjudicator Perspectives on Undetermined Deaths, Process Bottlenecks and Adjudication Challenges

Moderator:

Jonathan Seltzer, MD, MBA, MA, FACC
President and CEO
ACI Clinical

Panelists:

James L. Januzzi, Jr., MD, FACC, FESC
Hutter Family Professor of Medicine, Harvard Medical School;
Physician, Cardiology Division, Massachusetts General Hospital;
Senior Medical Director, Baim Institute for Clinical Research

Peter Carson, MD
Cardiologist
Washington VA Medical Center/Georgetown University

Donald E. Cutlip
Vice Chair, Department of Medicine, Beth Israel Deaconess Medical Center;
Chief Medical Officer, Baim Institute for Clinical Research

3:30

Networking and Refreshment Break

4:00

Address Endpoint Challenges and Nuances Across Medical Categories

Venu Menon, MD, FACC, FAHA
Mehdi Razavi Endowed Educational Chair, Director Cardiac Intensive Care Unit,
Director Cardiovascular Fellowship, Associate Director C5, Professor Medicine
Lerner College of Medicine, Case Western Reserve University, Cleveland Clinic

Align Endpoint Best Practices to
Specific Therapeutic Disciplines

4:45

Conversation on Conundrums in CEC Adjudication of Myocardial Infarction

Moderator:

Mads Engelmann, BSc, MD, PhD
International Medical Vice President
Novo Nordisk

Conversation Contributors:

Bernard Chaitman
Professor of Medicine and Director of Cardiovascular Research
St. Louis University School of Medicine

James L. Januzzi, Jr., MD, FACC, FESC
Hutter Family Professor of Medicine, Harvard Medical School;
Physician, Cardiology Division, Massachusetts General Hospital;
Senior Medical Director, Baim Institute for Clinical Research

Peter Carson, MD
Cardiologist
Washington VA Medical Center/Georgetown University

5:30

Close of Day One

Networking, Wine and
Cheese Reception
immediately following the final session on day one

DAY TWO THURSDAY, MAY 2, 2019

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Mads Engelmann, BSc, MD, PhD
International Medical Vice President
Novo Nordisk

8:15

Optimizing Clinical Endpoint Adjudication Programs through Seamless Communication Flows

Ernest Spitzer, MD
Department of Cardiology, Thoraxcenter,
Erasmus University Medical Center, Rotterdam, The Netherlands;
Director of Clinical Endpoint Adjudication and Data Monitoring,
Cardialysis, Rotterdam, The Netherlands

9:00

New Adjudication Considerations in Cardio-Oncology

Jonathan Seltzer, MD, MBA, MA, FACC
President and CEO
ACI Clinical

9:45

Source Documentation — Too Little, Too Much

Kim Brown, RN, C5R CEC
Manager, Research Programs
Cleveland Clinic

10:30

Networking and Refreshment Break

11:00

Neurology Adjudicator Perspective

Waimei A. Tai, MD, FAHA
Christiana Care Health System

Promote Efficiency, Collaboration and
Excellence in Adjudication

11:45

Networking Luncheon

12:45

Adjudication in Blinded Independent Central Review of Oncology Studies — Reasons, Rates, Significance, Monitoring and Improvement

Robert Ford, MD
Founder and Principal
Clinical Trials Imaging Consulting, LLC

1:30

Develop Data Trust and Security in Adjudication to Reduce Errors and
Improve Outcomes

Terry Katz
Director, Head of Global Data Management and Statistics
Merck Animal Health

2:15

Close of Conference