Skip navigation
Agenda

Limit Study Variability • Streamline Data Collection • Ensure Efficient CEC Review • Minimize Regulatory Approval Timelines

May 1-2, 2018
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, MAY 1, 2018

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS (A-B)

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

A Endpoint Adjudication Bootcamp

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

I. Demonstrate Importance of Endpoint Adjudication

II. Create an Endpoint Adjudication Committee

III. Develop an Adjudication Charter to Describe the Adjudication SOP of a Specific Clinical Trial

IV. Break Down the Packet Submission Process

V. Extended Q&A

Workshop Leader:

Catherine Tyner
Executive Director, Drug Safety and Adjudication Services
Covance

12:00

Close of Workshop A

 
B Best Practices for Adjudication and DMC Conduct and Partnerships

As endpoint adjudication and data monitoring committees grow in prevalence, so too have benefits and challenges associated with them. While these committees monitor critical endpoints and patient safety to provide independent expert assessments and recommendations, there is still a lack of conduct consistency across the industry. Stakeholders are faced with unclear expectations, communication challenges and a lack of direction. This workshop dives into successful partnership constructs for committee management, exploring regulatory guidance and discussing best practices to successfully optimize expert reviews as a resource to improve clinical trial integrity, oversee patient safety and gain competitive leverage.

I. Considerations for Proper Support of Data Monitoring and Endpoint Adjudication Committees

II. Committees Formation and Development

III. Improve Communication and Processes Between Committee Members, Sponsors and Committee Providers

Workshop Leaders:

Shaena Kauffman
Endpoint Adjudication Committee Lead, Director of Project Management
ACI Clinical

Haifa Tyler
Associate Director, GPV, Medical Safety
Otsuka Pharmaceutical Development & Commercialization, Inc.

12:00

Close of Workshop B

There will be a 30-minute networking and refreshment break at 10:00am

12:00

Main Conference Registration and Luncheon

1:00

Chairperson’s Welcome and Opening Remarks

Lynn Perkins
Assistant Director, CEC
Duke Clinical Research Institute

1:15

FDA Keynote Address Event Adjudication in Medical Device Studies – An FDA Perspective Overview of how FDA regulates medical devices and regulatory requirements for conducting studies of investigational devices in the US

Andrew Farb, MD
Medical Officer, Senior Reviewer
US Food and Drug Administration

2:00

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

MODERATOR:

W. Schuyler Jones, MD
Faculty Assistant Director, Duke Clinical Research Institute, Integrated Clinical Events-Safety Surveillance
Duke University and Durham VA Medical Center

PANELISTS:

Bernard R Chaitman, MD
Professor of Medicine, Director of Cardiovascular Research and
Core ECG/Cardiovascular End-Point Laboratory
St. Louis University

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

Claes Held, MD, PhD
Associate Professor, CEC Chair, Uppsala Clinical Research Center,
Department of Medical Sciences, Cardiology
Uppsala University

3:00

Networking and Refreshment Break

3:30

Solutions for Maintaining Quality Assurance of Adjudication Committees

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

4:15

CTTI KEYNOTE ADDRESS Improving Efficiencies in Clinical Trials —
Novel Endpoints Using Mobile Technology

Jennifer Goldsack
Clinical Project Manager
Clinical Trials Transformation Initiative (CTTI)

5:00

Getting the Most out of an Endpoint Adjudication Committee

Keith Usiskin
Executive Director
Celgene

5:45

Close of Day One

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

DAY TWO WEDNESDAY, MAY 2, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Lynn Perkins
Assistant Director, CEC
Duke Clinical Research Institute

THERAPEUTIC AREA SHOWCASE

8:45

Renal Focused

Maria Ali
Global Head, Medical and Regulatory Services and Scientific Leadership
George Clinical

9:30

Animal Health Focused>

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

10:15

Networking and Refreshment Break

10:45

Rare Disease Focused

Speaker TBA

11:30

Overcome Global Endpoint Adjudication Challenges

Abraham Gutman
President and CEO
AG Mednet

12:15

Networking Luncheon

1:30

Reduce Risk of Negatively Adjudicated Events Due to Insufficient Source Documentation

Lynn Perkins
Assistant Director, CEC
Duke Clinical Research Institute

2:30

MULTI-STAKEHOLDER PANEL Improve Program Collaboration to Enhance Endpoint Adjudication and Improve Patient Safety

MODERATOR:

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S

PANELISTS:

CRO Perspective:

Maria Ali
Global Head, Medical and Regulatory Services, and Scientific Leadership
George Clinical

ARO Perspective:

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

Sponsor Perspective:

Keith Usiskin
Executive Director
Celgene

Technology Perspective:

Svetlana Gorodetsky
Vice President, Sales
Merge Healthcare, an IBM Company

3:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE TUESDAY, MAY 1, 2018

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS (A-B)

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

A Endpoint Adjudication Bootcamp

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

I. Demonstrate Importance of Endpoint Adjudication

II. Create an Endpoint Adjudication Committee

III. Develop an Adjudication Charter to Describe the Adjudication SOP of a Specific Clinical Trial

IV. Break Down the Packet Submission Process

V. Extended Q&A

Workshop Leader:

Catherine Tyner
Executive Director, Drug Safety and Adjudication Services
Covance

12:00

Close of Workshop A

 
B Best Practices for Adjudication and DMC Conduct and Partnerships

As endpoint adjudication and data monitoring committees grow in prevalence, so too have benefits and challenges associated with them. While these committees monitor critical endpoints and patient safety to provide independent expert assessments and recommendations, there is still a lack of conduct consistency across the industry. Stakeholders are faced with unclear expectations, communication challenges and a lack of direction. This workshop dives into successful partnership constructs for committee management, exploring regulatory guidance and discussing best practices to successfully optimize expert reviews as a resource to improve clinical trial integrity, oversee patient safety and gain competitive leverage.

I. Considerations for Proper Support of Data Monitoring and Endpoint Adjudication Committees

II. Committees Formation and Development

III. Improve Communication and Processes Between Committee Members, Sponsors and Committee Providers

Workshop Leaders:

Shaena Kauffman
Endpoint Adjudication Committee Lead, Director of Project Management
ACI Clinical

Haifa Tyler
Associate Director, GPV, Medical Safety
Otsuka Pharmaceutical Development & Commercialization, Inc.

12:00

Close of Workshop B

There will be a 30-minute networking and refreshment break at 10:00am

12:00

Main Conference Registration and Luncheon

1:00

Chairperson’s Welcome and Opening Remarks

Lynn Perkins
Assistant Director, CEC
Duke Clinical Research Institute

1:15

FDA Keynote Address Event Adjudication in Medical Device Studies – An FDA Perspective Overview of how FDA regulates medical devices and regulatory requirements for conducting studies of investigational devices in the US

Andrew Farb, MD
Medical Officer, Senior Reviewer
US Food and Drug Administration

2:00

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

MODERATOR:

W. Schuyler Jones, MD
Faculty Assistant Director, Duke Clinical Research Institute, Integrated Clinical Events-Safety Surveillance
Duke University and Durham VA Medical Center

PANELISTS:

Bernard R Chaitman, MD
Professor of Medicine, Director of Cardiovascular Research and
Core ECG/Cardiovascular End-Point Laboratory
St. Louis University

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

Claes Held, MD, PhD
Associate Professor, CEC Chair, Uppsala Clinical Research Center,
Department of Medical Sciences, Cardiology
Uppsala University

3:00

Networking and Refreshment Break

3:30

Solutions for Maintaining Quality Assurance of Adjudication Committees

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

4:15

CTTI KEYNOTE ADDRESS Improving Efficiencies in Clinical Trials —
Novel Endpoints Using Mobile Technology

Jennifer Goldsack
Clinical Project Manager
Clinical Trials Transformation Initiative (CTTI)

5:00

Getting the Most out of an Endpoint Adjudication Committee

Keith Usiskin
Executive Director
Celgene

5:45

Close of Day One

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

DAY TWO WEDNESDAY, MAY 2, 2018

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Lynn Perkins
Assistant Director, CEC
Duke Clinical Research Institute

THERAPEUTIC AREA SHOWCASE

8:45

Renal Focused

Maria Ali
Global Head, Medical and Regulatory Services and Scientific Leadership
George Clinical

9:30

Animal Health Focused>

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

10:15

Networking and Refreshment Break

10:45

Rare Disease Focused

Speaker TBA

11:30

Overcome Global Endpoint Adjudication Challenges

Abraham Gutman
President and CEO
AG Mednet

12:15

Networking Luncheon

1:30

Reduce Risk of Negatively Adjudicated Events Due to Insufficient Source Documentation

Lynn Perkins
Assistant Director, CEC
Duke Clinical Research Institute

2:30

MULTI-STAKEHOLDER PANEL Improve Program Collaboration to Enhance Endpoint Adjudication and Improve Patient Safety

MODERATOR:

Mads Engelmann, MD, PhD
International Medical Vice President
Novo Nordisk A/S

PANELISTS:

CRO Perspective:

Maria Ali
Global Head, Medical and Regulatory Services, and Scientific Leadership
George Clinical

ARO Perspective:

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

Sponsor Perspective:

Keith Usiskin
Executive Director
Celgene

Technology Perspective:

Svetlana Gorodetsky
Vice President, Sales
Merge Healthcare, an IBM Company

3:30

Close of Conference