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DAY ONE Monday, October 28, 2019

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

Design Clinical Formats, Practical
Frameworks and Creative Trials

8:45

INDUSTRY LEVEL SET Collaborate with Stakeholders to Define and Optimize Master Protocols

CONVERSATION CONTRIBUTORS:

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

Deborah Collyar
President
Patient Advocates in Research (PAIR)

9:30

Key Considerations for Planning and Designing Complex Trials

Cat Hall
Vice President of Product Strategy
endpoint Clinical

10:15

Networking and Refreshment Break

10:45

INNOVATIVE CASE STUDY Uncover Optimal Two-Stage Designs for Exploratory Basket Trials

Heng Zhou
Senior Scientist, Biostatistics
Merck

11:30

Set Up the Randomization Scheme Within the IRT for Success in
Complex Innovative Trials

Jennifer Ross
Lead Biostatistician
Almac Clinical Technologies

Graham Nicholls
Director, Biostatistics
Almac Group

12:15

Networking Luncheon

Drive Patient-Centered Approaches that Enable Accelerated Access to New Therapies

1:15

CASE STUDY Deep Dive into Lung-MAP —
Adapting to the Changing Scientific Environment

Stacey Adam
Director – Cancer
Foundation for the National Institutes of Health (FNIH)

2:00

PEDIATRIC SPOTLIGHT Evaluate Multi-Pharma Master Protocols for Pediatric Oncology Studies

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

Gregory H. Reaman, MD
Associate Director, Oncology Sciences,
Office of Hematology and Oncology Products, OND, CDER
U.S. Food and Drug Administration (FDA)

3:00

Networking and Refreshment Break

3:30

Platform Trials For All — Introduction, Team Options and
Evaluation of Trial Design in Multiple Disease Indications

J. Kyle Wathen
Scientific Director, Statistical Modeling and Methodology
Janssen R&D

4:15

CASE STUDY Navigate Platform Trial Design and Execution from a Single Sponsor

Melissa E. Spann, PhD
Principal Research Scientist, Statistics Innovation Center (SIC)
Eli Lilly and Company

5:00

Close of Day One

Networking, Wine and
Cheese Reception
immediately following the final session

DAY TWO Tuesday, October 29, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

8:45

NCI-MATCH & NCI PEDIATRIC MATCH PROGRESS REPORT Operationalize Basket and Umbrella Trial Administration —
NCI Perspective Update

Meg Mooney
Chief, Clinical Investigations Branch, CTEP, DCTD
National Cancer Institute (NCI)

9:30

PATIENT VOICE Create a Win-Win for Companies and Patients Through Better Trial Design and Patient Engagement

Deborah Collyar
President
Patient Advocates in Research (PAIR)

10:15

Networking and Refreshment Break

Manage Protocol Design and Efficiencies Across Adaptive Trial Administration

10:45

Explore the Regulatory Considerations and Conduct of
Global Master Protocols

Stacey Adam
Director – Cancer
Foundation for the National Institutes of Health (FNIH)

Gregory H. Reaman, MD
Associate Director, Oncology Sciences,
Office of Hematology and Oncology Products, OND, CDER
U.S. Food and Drug Administration (FDA)

11:30

Review Acceptable Models for Statistical Design in Adaptive Trials

Alex Sverdlov
Director, Statistical Scientist
Novartis

12:15

Networking Luncheon

1:30

Maximize CROs and Streamline Site Management for a Successful Basket Trial

Rhonda Critchlow
Senior Director, Operations
PSI CRO

2:15

Master Biomarker Screening by Learning the Insider Secrets of
Patient Trial Assignments

Amy Burd, PhD
Vice President of Research Strategy, Principal Lead Beat AML
The Leukemia & Lymphoma Society

3:00

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE Monday, October 28, 2019

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

Design Clinical Formats, Practical
Frameworks and Creative Trials

8:45

INDUSTRY LEVEL SET Collaborate with Stakeholders to Define and Optimize Master Protocols

CONVERSATION CONTRIBUTORS:

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

Deborah Collyar
President
Patient Advocates in Research (PAIR)

9:30

Key Considerations for Planning and Designing Complex Trials

Cat Hall
Vice President of Product Strategy
endpoint Clinical

10:15

Networking and Refreshment Break

10:45

INNOVATIVE CASE STUDY Uncover Optimal Two-Stage Designs for Exploratory Basket Trials

Heng Zhou
Senior Scientist, Biostatistics
Merck

11:30

Set Up the Randomization Scheme Within the IRT for Success in
Complex Innovative Trials

Jennifer Ross
Lead Biostatistician
Almac Clinical Technologies

Graham Nicholls
Director, Biostatistics
Almac Group

12:15

Networking Luncheon

Drive Patient-Centered Approaches that Enable Accelerated Access to New Therapies

1:15

CASE STUDY Deep Dive into Lung-MAP —
Adapting to the Changing Scientific Environment

Stacey Adam
Director – Cancer
Foundation for the National Institutes of Health (FNIH)

2:00

PEDIATRIC SPOTLIGHT Evaluate Multi-Pharma Master Protocols for Pediatric Oncology Studies

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

Gregory H. Reaman, MD
Associate Director, Oncology Sciences,
Office of Hematology and Oncology Products, OND, CDER
U.S. Food and Drug Administration (FDA)

3:00

Networking and Refreshment Break

3:30

Platform Trials For All — Introduction, Team Options and
Evaluation of Trial Design in Multiple Disease Indications

J. Kyle Wathen
Scientific Director, Statistical Modeling and Methodology
Janssen R&D

4:15

CASE STUDY Navigate Platform Trial Design and Execution from a Single Sponsor

Melissa E. Spann, PhD
Principal Research Scientist, Statistics Innovation Center (SIC)
Eli Lilly and Company

5:00

Close of Day One

Networking, Wine and
Cheese Reception
immediately following the final session

DAY TWO Tuesday, October 29, 2019

8:00

Continental Breakfast

8:30

Chairperson’s Review of Day One

Pamela Simpkins
Senior Director and Strategy Lead, Pediatrics
Johnson & Johnson

8:45

NCI-MATCH & NCI PEDIATRIC MATCH PROGRESS REPORT Operationalize Basket and Umbrella Trial Administration —
NCI Perspective Update

Meg Mooney
Chief, Clinical Investigations Branch, CTEP, DCTD
National Cancer Institute (NCI)

9:30

PATIENT VOICE Create a Win-Win for Companies and Patients Through Better Trial Design and Patient Engagement

Deborah Collyar
President
Patient Advocates in Research (PAIR)

10:15

Networking and Refreshment Break

Manage Protocol Design and Efficiencies Across Adaptive Trial Administration

10:45

Explore the Regulatory Considerations and Conduct of
Global Master Protocols

Stacey Adam
Director – Cancer
Foundation for the National Institutes of Health (FNIH)

Gregory H. Reaman, MD
Associate Director, Oncology Sciences,
Office of Hematology and Oncology Products, OND, CDER
U.S. Food and Drug Administration (FDA)

11:30

Review Acceptable Models for Statistical Design in Adaptive Trials

Alex Sverdlov
Director, Statistical Scientist
Novartis

12:15

Networking Luncheon

1:30

Maximize CROs and Streamline Site Management for a Successful Basket Trial

Rhonda Critchlow
Senior Director, Operations
PSI CRO

2:15

Master Biomarker Screening by Learning the Insider Secrets of
Patient Trial Assignments

Amy Burd, PhD
Vice President of Research Strategy, Principal Lead Beat AML
The Leukemia & Lymphoma Society

3:00

Close of Conference