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Agenda

Leverage the Paradigm Shift to Transform Your Clinical Trials — New Technology. Patient Engagement. Clinical Collaboration.

August 8-9, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, AUGUST 8, 2019

7:45

Conference Registration and Continental Breakfast

8:30

Chairperson’s Opening Remarks

Frank Leu
CEO
Novapeutics

8:45

CASE STUDY Radical Modernization of Complex Oncology Clinical Trials —
A Master Trial Case Study

Len Rosenberg, PhD, RPh
Head Clinical Operations
Beat AML, LLC – division of The Leukemia and Lymphoma Society

9:30

Fireside Chat with Stefanie Joho

Stefanie Joho
Cancer Survivor, Patient Advocate

10:15

Networking and Refreshment Break

11:00

PANEL DISCUSSION The Future Evolution of Partnerships and Collaborations — Accelerate Timelines, Reduce Costs and Increase Engagement and Success in Your Clinical Trials

MODERATOR:

Dr. Shiko Ben-Menahem, PhD
Senior Researcher and Lecturer, ETH Zurich;
Adjunct Assistant Professor, New York University Stern School of Busines

PANELISTS:

Joseph Kim, BS, MBA
Sr. Advisor, Patient Experience and Design Innovation, Design Hub Foundations
Eli Lilly and Company

Dennis Salotti, MS, MBA, CCRA
Chief Operating Officer
The Avoca Group

Cynthia Verst, PharmD, MS
President, Design and Delivery Innovation
IQVIA

MarlaJan Wexler, BSN, RN, CPN
Patient and Survivor, CEO/Founder, Luck Fupus, LLC;
Registered Nurse, The Children’s Hospital of Philadelphia

Schiffon Wong
Executive Director, Global Evidence & Value Development,
Global Research & Development
EMD Serono

12:00

Networking Luncheon

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A or B)

Track A: Transformative Technology and Applications for Clinical Trials — Case Studies and Solutions

1:10

Chairperson’s Opening Remarks

Richard Veal
Global Director, Head of Pharma Consulting
Pharma Intelligence

 
Track B: Putting the Patient First — Utilizing Feedback

1:10

Chairperson’s Opening Remarks

Kevonna Hayes
Senior Program Coordinator
The Greater Gift

1:15

CASE STUDY Technology as a Conduit to Patient-Focused Clinical Development —
The Future Is Now

Cynthia Verst, PharmD, MS
President, Design and Delivery Innovation
IQVIA

April Lewis
Sr. Director, R&D Clinical Technology
GlaxoSmithKline

 

1:15

FDA PERSPECTIVE FDA Perspective on Patient Engagement

CDR Eleni Anagnostiadis, RPh, MPM
Director, Professional Affairs and Stakeholder Engagement
CDER

1:35

CASE STUDY Optimize Your Recruitment Efforts for Highly Competitive Patient Populations

Dr. Ted Search
CEO
Skipta

Loni Branon
Senior Director,
Sitetrove and Strategic Partnerships
Citeline, Pharma Intelligence

 

1:35

Best Practices and Innovative Ideas for Recruitment and Engagement in the Digital Age

Trisha Devlin
Director,
Patient Advocacy & Engagement
Dermira

1:55

PANEL DISCUSSION Bold Experimentation in Clinical Trials — Reduce Costs and Risks Using Technology and Digital Applications

MODERATOR:

Richard Veal
Global Director,
Head of Pharma Consulting
Pharma Intelligence

PANELISTS:

Xuemei Cai, MD
Head of Clinical Research, Digital Medicine & Translational Imaging, Worldwide Research, Development & Medical
Pfizer & Scientific Leadership Board,
Digital Medicine (DiMe) Society

Jacob LaPorte, PhD
Co-Founder, Managing Director of
BIOME - The Digital Innovation Lab;
VP, Global Head of Digital Development
Novartis

Christine Manta
Research Project Manager
Elektra Labs

 

1:55

PANEL DISCUSSION Challenges and Innovative Solutions to Put the Patient First in Trials

MODERATOR:

Sheila Bose
Patient Advocate & Life Science Consultant
(Specializing in Rare Disease)

PANELISTS:

Rachel Weitzner, MPH
Research Associate
Center for Information & Study on Clinical Research Participation (CISCRP)

Trisha Devlin
Director,
Patient Advocacy & Engagement
Dermira

MarlaJan Wexler, BSN, RN, CPN
Patient and Survivor, CEO/Founder,
Luck Fupus, LLC;
Registered Nurse,
The Children’s Hospital of Philadelphia

Dr. Ted Search
CEO
Skipta

Shawn Tedman
Director, Clinical Trials Business
23andMe

2:45

Networking and Refreshment Break

Track A: Transformative Technology and Applications for Clinical Trials — Digital Health, Monitoring
and Analysis

3:15

CASE STUDY Asthma App Trial Studies — Findings from the HealthKit Data Analysis

Yvonne (Yu-Feng) Chan, MD, PhD, FACEP
Director, Center for Digital Health;
Associate Professor, Genetics &
Genomic Sciences; Associate Professor, Emergency Medicine
Icahn School of Medicine at Mount Sinai

3:45

CASE STUDY Digital Health Landscape — Partnership with the VA

Dr. Joe Ronzio, DHSc, CPHIMS
Deputy Chief Technology Officer
Department of Veterans Affairs (invited)

 
Track B: Putting the Patient First — Expanding Diversity in
Clinical Trials

3:15

PANEL DISCUSSION Global Diversity and Quality in Clinical Trials — How to Achieve it and Not Break the Bank

PANELISTS:

Cassandra Smith
Associate Director,
Diversity and Inclusion, Clinical Trials
Janssen

Nancy Meyerson-Hess
Chief Compliance & Regulatory Officer
eMQT Emerging Markets Quality Trials

Anne Marie Inglis, PhD
Senior Director, US Clinical Operations
GlaxoSmithKline

Track A: Transformative Technology and Applications for Clinical Trials

4:15

State of the Industry Report — Analysis of The Avoca Group’s Survey of Emerging Technology and Data Sources in Clinical Trials

Dennis Salotti, MS, MBA, CCRA
Chief Operating Officer
The Avoca Group

 
Track B: Putting the Patient First —
Rare Disease Perspective

4:15

Best Practices in Rare Disease Patient Engagement, Roadmap and Governance NORD Workstream Project Update

Rob Metz
Senior Vice President External Affairs
Horizon Pharma

Track A: Transformative Technology and Applications for Clinical Trials — Sponsored Presentation

4:45

CASE STUDY Closing the Gap of Recruitment and Engagement with Patients and Physicians

Speaker TBA
Elligo Health Research

 
Track B: Putting the Patient First — Sponsored Presentation

4:45

Sponsored Presentation Available

Contact John Egan at [email protected] for more information.

5:15

Close of Day One

Networking, Wine and
Cheese Reception
Immediately Following the Conclusion of Day One

DAY TWO FRIDAY, AUGUST 9, 2019

8:00

Registration and Continental Breakfast

8:30

Chairperson’s Opening Remarks

Darren Cowan
Area Head, Americas Global Site & Study Operations,
Clinical Development & Operations, GP
Pfizer Inc

8:45

FDA PERSPECTIVE Clinical Trial Innovation and the Current Regulatory Landscape

Isaac Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Policy Development
FDA-CDER

9:15

PANEL DISCUSSION Global Highlights —
Gain an Update on Local and Global Regulations Impacting Your Clinical Trials

Isaac Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Policy Development
FDA-CDER

Bradley Davidsen
Counsel, Clinical R&D
AbbVie

Chris Markus
King & Spalding

Maureen Bennett
Co-Life Sciences Leader, Health Care & Life Sciences Practice Group
Jones Day

10:15

Session Reserved for 23andMe

Shawn Tedman
Director, Clinical Trials Business
23andMe

10:45

Networking Refreshment Break in the Exhibit Hall

11:15

Behavioral Analysis and Precision Medicine —
The Need for Innovative Trial Design Models

Michelle Everill
Senior Director, Head of Global Feasibility
Janssen

12:00

Networking Luncheon

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A or C)

Track A: Transformative Technology and Applications for Clinical Trials — What’s so Great About Blockchain and AI?

12:55

Chairperson's Remarks

 
Track C: Clinical Trial Brainstorm Pods — Creative Solutions to Your Biggest Pain Points

12:55

Chairperson's Remarks

Heidi Floyd
Patient and Advocate

1:00

SPONSORED PRESENTATION Redefining Pharmaceutical Research Objectives to Deliver Precision Medicine through Launching AI Enhanced Medical Software Products

Mary E. Dixon
CEO/President
Innovenn Inc.

Linda McCormick
Director Global Medical Affairs,
Renal and Oncology
Otsuka Pharmaceutical Company

1:30

Blockchain for Clinical Trials —
The Who, the What, the How

Frank Leu
CEO
Novapeutics

2:15

This Track ends, please move to another Track.

 

1:00

Breakout Groups on Key Pain Points

MODERATOR:

Heidi Floyd
Patient and Advocate

PANELISTS:

Renee Leverty, BSN, MA
Program Lead CDRI
Stakeholder Engagement
Duke Clinical Research Institute

Han Phan, MD
Pediatric Advisory Committee, FDA;
Clinician Consultant and Guest Researcher, CDC

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, AUGUST 8, 2019

7:45

Conference Registration and Continental Breakfast

8:30

Chairperson’s Opening Remarks

Frank Leu
CEO
Novapeutics

8:45

CASE STUDY Radical Modernization of Complex Oncology Clinical Trials —
A Master Trial Case Study

Len Rosenberg, PhD, RPh
Head Clinical Operations
Beat AML, LLC – division of The Leukemia and Lymphoma Society

9:30

Fireside Chat with Stefanie Joho

Stefanie Joho
Cancer Survivor, Patient Advocate

10:15

Networking and Refreshment Break

11:00

PANEL DISCUSSION The Future Evolution of Partnerships and Collaborations — Accelerate Timelines, Reduce Costs and Increase Engagement and Success in Your Clinical Trials

MODERATOR:

Dr. Shiko Ben-Menahem, PhD
Senior Researcher and Lecturer, ETH Zurich;
Adjunct Assistant Professor, New York University Stern School of Busines

PANELISTS:

Joseph Kim, BS, MBA
Sr. Advisor, Patient Experience and Design Innovation, Design Hub Foundations
Eli Lilly and Company

Dennis Salotti, MS, MBA, CCRA
Chief Operating Officer
The Avoca Group

Cynthia Verst, PharmD, MS
President, Design and Delivery Innovation
IQVIA

MarlaJan Wexler, BSN, RN, CPN
Patient and Survivor, CEO/Founder, Luck Fupus, LLC;
Registered Nurse, The Children’s Hospital of Philadelphia

Schiffon Wong
Executive Director, Global Evidence & Value Development,
Global Research & Development
EMD Serono

12:00

Networking Luncheon

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A or B)

Track A: Transformative Technology and Applications for Clinical Trials — Case Studies and Solutions

1:10

Chairperson’s Opening Remarks

Richard Veal
Global Director, Head of Pharma Consulting
Pharma Intelligence

 
Track B: Putting the Patient First — Utilizing Feedback

1:10

Chairperson’s Opening Remarks

Kevonna Hayes
Senior Program Coordinator
The Greater Gift

1:15

CASE STUDY Technology as a Conduit to Patient-Focused Clinical Development —
The Future Is Now

Cynthia Verst, PharmD, MS
President, Design and Delivery Innovation
IQVIA

April Lewis
Sr. Director, R&D Clinical Technology
GlaxoSmithKline

 

1:15

FDA PERSPECTIVE FDA Perspective on Patient Engagement

CDR Eleni Anagnostiadis, RPh, MPM
Director, Professional Affairs and Stakeholder Engagement
CDER

1:35

CASE STUDY Optimize Your Recruitment Efforts for Highly Competitive Patient Populations

Dr. Ted Search
CEO
Skipta

Loni Branon
Senior Director,
Sitetrove and Strategic Partnerships
Citeline, Pharma Intelligence

 

1:35

Best Practices and Innovative Ideas for Recruitment and Engagement in the Digital Age

Trisha Devlin
Director,
Patient Advocacy & Engagement
Dermira

1:55

PANEL DISCUSSION Bold Experimentation in Clinical Trials — Reduce Costs and Risks Using Technology and Digital Applications

MODERATOR:

Richard Veal
Global Director,
Head of Pharma Consulting
Pharma Intelligence

PANELISTS:

Xuemei Cai, MD
Head of Clinical Research, Digital Medicine & Translational Imaging, Worldwide Research, Development & Medical
Pfizer & Scientific Leadership Board,
Digital Medicine (DiMe) Society

Jacob LaPorte, PhD
Co-Founder, Managing Director of
BIOME - The Digital Innovation Lab;
VP, Global Head of Digital Development
Novartis

Christine Manta
Research Project Manager
Elektra Labs

 

1:55

PANEL DISCUSSION Challenges and Innovative Solutions to Put the Patient First in Trials

MODERATOR:

Sheila Bose
Patient Advocate & Life Science Consultant
(Specializing in Rare Disease)

PANELISTS:

Rachel Weitzner, MPH
Research Associate
Center for Information & Study on Clinical Research Participation (CISCRP)

Trisha Devlin
Director,
Patient Advocacy & Engagement
Dermira

MarlaJan Wexler, BSN, RN, CPN
Patient and Survivor, CEO/Founder,
Luck Fupus, LLC;
Registered Nurse,
The Children’s Hospital of Philadelphia

Dr. Ted Search
CEO
Skipta

Shawn Tedman
Director, Clinical Trials Business
23andMe

2:45

Networking and Refreshment Break

Track A: Transformative Technology and Applications for Clinical Trials — Digital Health, Monitoring
and Analysis

3:15

CASE STUDY Asthma App Trial Studies — Findings from the HealthKit Data Analysis

Yvonne (Yu-Feng) Chan, MD, PhD, FACEP
Director, Center for Digital Health;
Associate Professor, Genetics &
Genomic Sciences; Associate Professor, Emergency Medicine
Icahn School of Medicine at Mount Sinai

3:45

CASE STUDY Digital Health Landscape — Partnership with the VA

Dr. Joe Ronzio, DHSc, CPHIMS
Deputy Chief Technology Officer
Department of Veterans Affairs (invited)

 
Track B: Putting the Patient First — Expanding Diversity in
Clinical Trials

3:15

PANEL DISCUSSION Global Diversity and Quality in Clinical Trials — How to Achieve it and Not Break the Bank

PANELISTS:

Cassandra Smith
Associate Director,
Diversity and Inclusion, Clinical Trials
Janssen

Nancy Meyerson-Hess
Chief Compliance & Regulatory Officer
eMQT Emerging Markets Quality Trials

Anne Marie Inglis, PhD
Senior Director, US Clinical Operations
GlaxoSmithKline

Track A: Transformative Technology and Applications for Clinical Trials

4:15

State of the Industry Report — Analysis of The Avoca Group’s Survey of Emerging Technology and Data Sources in Clinical Trials

Dennis Salotti, MS, MBA, CCRA
Chief Operating Officer
The Avoca Group

 
Track B: Putting the Patient First —
Rare Disease Perspective

4:15

Best Practices in Rare Disease Patient Engagement, Roadmap and Governance NORD Workstream Project Update

Rob Metz
Senior Vice President External Affairs
Horizon Pharma

Track A: Transformative Technology and Applications for Clinical Trials — Sponsored Presentation

4:45

CASE STUDY Closing the Gap of Recruitment and Engagement with Patients and Physicians

Speaker TBA
Elligo Health Research

 
Track B: Putting the Patient First — Sponsored Presentation

4:45

Sponsored Presentation Available

Contact John Egan at [email protected] for more information.

5:15

Close of Day One

Networking, Wine and
Cheese Reception
Immediately Following the Conclusion of Day One

DAY TWO FRIDAY, AUGUST 9, 2019

8:00

Registration and Continental Breakfast

8:30

Chairperson’s Opening Remarks

Darren Cowan
Area Head, Americas Global Site & Study Operations,
Clinical Development & Operations, GP
Pfizer Inc

8:45

FDA PERSPECTIVE Clinical Trial Innovation and the Current Regulatory Landscape

Isaac Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Policy Development
FDA-CDER

9:15

PANEL DISCUSSION Global Highlights —
Gain an Update on Local and Global Regulations Impacting Your Clinical Trials

Isaac Rodriguez-Chavez, PhD, MHSc, MSc
FDA Officer, Clinical Research Methodology,
Regulatory Compliance and Policy Development
FDA-CDER

Bradley Davidsen
Counsel, Clinical R&D
AbbVie

Chris Markus
King & Spalding

Maureen Bennett
Co-Life Sciences Leader, Health Care & Life Sciences Practice Group
Jones Day

10:15

Session Reserved for 23andMe

Shawn Tedman
Director, Clinical Trials Business
23andMe

10:45

Networking Refreshment Break in the Exhibit Hall

11:15

Behavioral Analysis and Precision Medicine —
The Need for Innovative Trial Design Models

Michelle Everill
Senior Director, Head of Global Feasibility
Janssen

12:00

Networking Luncheon

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A or C)

Track A: Transformative Technology and Applications for Clinical Trials — What’s so Great About Blockchain and AI?

12:55

Chairperson's Remarks

 
Track C: Clinical Trial Brainstorm Pods — Creative Solutions to Your Biggest Pain Points

12:55

Chairperson's Remarks

Heidi Floyd
Patient and Advocate

1:00

SPONSORED PRESENTATION Redefining Pharmaceutical Research Objectives to Deliver Precision Medicine through Launching AI Enhanced Medical Software Products

Mary E. Dixon
CEO/President
Innovenn Inc.

Linda McCormick
Director Global Medical Affairs,
Renal and Oncology
Otsuka Pharmaceutical Company

1:30

Blockchain for Clinical Trials —
The Who, the What, the How

Frank Leu
CEO
Novapeutics

2:15

This Track ends, please move to another Track.

 

1:00

Breakout Groups on Key Pain Points

MODERATOR:

Heidi Floyd
Patient and Advocate

PANELISTS:

Renee Leverty, BSN, MA
Program Lead CDRI
Stakeholder Engagement
Duke Clinical Research Institute

Han Phan, MD
Pediatric Advisory Committee, FDA;
Clinician Consultant and Guest Researcher, CDC

3:00

Close of Conference