Skip navigation

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
Research/Patient Advocate and Consultant

10:15

Networking and Refreshment Break

10:45

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 Business

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

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

11:45

CASE STUDY Asthma App Trial Studies — Finding 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

12:10

Networking Luncheon

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A or B)

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

1:30

Track Chairperson’s Opening Remarks

Duncan Emerton, PhD
Director, Pharma Consulting
Informa Intelligence

1:35

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

 
Track B: Putting the Patient First — UtilizingFeedback

1:30

Track Chairperson’s Opening Remarks

Kevonna Hayes
Senior Program Coordinator
The Greater Gift

1:35

FDA PERSPECTIVE FDA Perspective on Patient Engagement

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

1:55

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

MODERATOR:

Duncan Emerton, PhD
Director, Pharma Consulting
Informa 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 & Research Lead,
Digital Medicine (DiMe) Society

Raj Pallapothu
mHealth Global Business Lead
Bayer Pharmaceuticals

Mary E. Dixon
CEO/President
Innovenn Inc.

MarlaJan Wexler, BSN, RN, CPN
CPN & CEO; Nurse, Patient
Luck Fupus

 

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:

Julia Farides-Mitchell, MA
Senior Manager,
Account and Project Management
Center for Information & Study on
Clinical Research Participation (CISCRP)

Madeline Geday
Director, Global Patient Innovation
and Engagement,
Global Clinical Trial Operations
Merck and Co., Inc.

Dr. Ted Search
CEO
Skipta

Laura Russell, MS
Senior Manager, 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

Challenges with Digital and Wearable Technologies and Platforms in the New Wave of Clinical (Virtual) Trials

Raj Pallapothu
mHealth Global Business Lead
Bayer Pharmaceuticals

3:45

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

 
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

MODERATOR:

Kevonna Hayes
Senior Program Coordinator
The Greater Gift

PANELISTS:

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

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

Cassandra Smith
Diversity and Inclusion in Clinical Trials Lead
Janssen Research & Development

Fabian Sandoval, MD
CEO & Research Director
Emerson Clinical Research Institute, Inc.

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 A Technology-Based, Patient-Focused Transformative System of Accelerated Research (SOAR™)

Jacylyn Bodmer
Chief Innovation Officer
Elligo Health Research

Rebecca Kush, PhD
Chief Scientific Officer
Elligo Health Research

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

Continental Breakfast

8:30

Chairperson’s Review of Day One

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

8:45

FDA PERSPECTIVE Decentralized Clinical Trials 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
Jones Day

10:15

What Would You Ask An 8 Million Member Patient Advisory Board? —
Case Studies of Tech-Enabled Patient Insights at Scale

Shawn Tedman, MBA
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

LEAD FACILITATORS:

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

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

Cassandra Smith
Diversity and Inclusion in Clinical Trials Lead
Janssen Research & Development

MarlaJan Wexler, BSN, RN, CPN
CPN & CEO; Nurse, Patient
Luck Fupus

3:00

Close of Conference

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
Research/Patient Advocate and Consultant

10:15

Networking and Refreshment Break

10:45

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 Business

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

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

11:45

CASE STUDY Asthma App Trial Studies — Finding 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

12:10

Networking Luncheon

CHOOSE BETWEEN TWO TRACKS OF CONTENT (A or B)

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

1:30

Track Chairperson’s Opening Remarks

Duncan Emerton, PhD
Director, Pharma Consulting
Informa Intelligence

1:35

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

 
Track B: Putting the Patient First — UtilizingFeedback

1:30

Track Chairperson’s Opening Remarks

Kevonna Hayes
Senior Program Coordinator
The Greater Gift

1:35

FDA PERSPECTIVE FDA Perspective on Patient Engagement

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

1:55

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

MODERATOR:

Duncan Emerton, PhD
Director, Pharma Consulting
Informa 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 & Research Lead,
Digital Medicine (DiMe) Society

Raj Pallapothu
mHealth Global Business Lead
Bayer Pharmaceuticals

Mary E. Dixon
CEO/President
Innovenn Inc.

MarlaJan Wexler, BSN, RN, CPN
CPN & CEO; Nurse, Patient
Luck Fupus

 

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:

Julia Farides-Mitchell, MA
Senior Manager,
Account and Project Management
Center for Information & Study on
Clinical Research Participation (CISCRP)

Madeline Geday
Director, Global Patient Innovation
and Engagement,
Global Clinical Trial Operations
Merck and Co., Inc.

Dr. Ted Search
CEO
Skipta

Laura Russell, MS
Senior Manager, 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

Challenges with Digital and Wearable Technologies and Platforms in the New Wave of Clinical (Virtual) Trials

Raj Pallapothu
mHealth Global Business Lead
Bayer Pharmaceuticals

3:45

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

 
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

MODERATOR:

Kevonna Hayes
Senior Program Coordinator
The Greater Gift

PANELISTS:

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

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

Cassandra Smith
Diversity and Inclusion in Clinical Trials Lead
Janssen Research & Development

Fabian Sandoval, MD
CEO & Research Director
Emerson Clinical Research Institute, Inc.

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 A Technology-Based, Patient-Focused Transformative System of Accelerated Research (SOAR™)

Jacylyn Bodmer
Chief Innovation Officer
Elligo Health Research

Rebecca Kush, PhD
Chief Scientific Officer
Elligo Health Research

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

Continental Breakfast

8:30

Chairperson’s Review of Day One

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

8:45

FDA PERSPECTIVE Decentralized Clinical Trials 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
Jones Day

10:15

What Would You Ask An 8 Million Member Patient Advisory Board? —
Case Studies of Tech-Enabled Patient Insights at Scale

Shawn Tedman, MBA
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

LEAD FACILITATORS:

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

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

Cassandra Smith
Diversity and Inclusion in Clinical Trials Lead
Janssen Research & Development

MarlaJan Wexler, BSN, RN, CPN
CPN & CEO; Nurse, Patient
Luck Fupus

3:00

Close of Conference