Virtual Clinical Trials

in Drug Development

Register Now View Agenda

May 22-23, 2019 | Philadelphia, PA

The Inn at Penn, a Hilton Hotel

Conference Overview

With growing pricing demands, increased regulatory scrutiny, patent expirations, and generic competition, it’s crucial that R&D departments are able to utilize digital technologies to ensure high-quality clinical trials. The industry is excited about virtual clinical trials, but the adoption curve is still light. As your organization prepares to apply novel technologies to clinical trials, whether they are fully-virtual or hybrid, it’s important to take into consideration how operational activities will perform when the trial is conducted virtually as opposed to a standard brick-and-mortar model.

Conceptualizing virtual trials not simply as a standard study, but as a way of doing things differently, is essential to a successful outcome. Join us to examine how the industry is navigating different models of remote trials and gain best practices for preparing or improving internal infrastructure to support a remote study.

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  • Keep pace with industry trends and discuss fully-virtual clinical trials, hybrid trials, and location-flexible trials
  • Discuss why the industry needs to reshape its infrastructure to make virtual trials a reality 
  • Learn from the industry’s brightest on how to distribute drugs, capture endpoints, and deal with regulators
  • Discover new approaches to prepare your team for the transition from a brick-and-mortar trial to a virtual trial
  • Talk to patients about what it's like to be enrolled in a virtual trial

EVENT VENUE

The Inn at Penn, a Hilton Hotel

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3600 Sansom Street
Philadelphia, PA 19104

215-222-0200
Hotel Website

Featured Speakers

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Craig Lipset

Head of Clinical Innovation
Pfizer

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Jeff Kingsley

Chief Executive Officer
IACT Health 

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Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice
Deloitte

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Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

About the Chairperson

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Dr. Matthew T. Roe has been a faculty member at Duke University School of Medine and the Duke Clinical Research Institute (DCRI) since 1999. As a senior investigator at the DCRI, he has been the principal investigator for numerous phase II-IV cardiovascular clinical trials and is currently a co-principal investigator for the ADAPTABLE trial—the first large-scale pragmatic trials being conducted in the PCORnet network. He has also served in leadership roles for several observational registries focusing upon the treatment and outcomes of patients with cardiovascular disease and has served as the Director of the DCRI Clinical Research Fellowship since 2010.

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Wednesday, May 22nd, 2019 | Day 1

 

8:00 - 9:00

Registration and Breakfast

9:00 - 9:15

Chairperson’s Opening Remarks

Matthew Roe, Professor of Medicine
Duke University Medical Center and Duke Clinical Research Institute

9:15 - 10:00

Ten Years of Virtual Trials: The Remote Trial Journey from Novelty Toward Mainstream

Craig Lipset, Head of Clinical Innovation
Pfizer

10:00 - 10:45

Let’s Talk About Options; Fully-Virtual Clinical Trial, Hybrid Trial, Location-Flexible Trials

Hassan Kadhim, MBA, Director, Head of Clinical Trial Business Capabilities
Bristol Myers Squibb 

10:45 - 11:00

Networking and Refreshment Break 

11:00 - 12:15

Panel: Preparing Your Team for the Transition from Brick-and-Mortar to Virtual Clinical Trials and Building Partnerships to Work in Parallel

Moderator: 

Jeffrey Zucker, MS, SVP Global Clinical Operations, Site Management & Trial Optimization
Worldwide Clinical Trials

Panelists: 

Jeff Kingsley, DO, MBA, CPI, FACRP, Chief Executive Officer
IACT Health 

Jane Fang, R&D Information Head for Clinical Biologics
AstraZeneca 

Jonathan Cotliar, MD, Chief Medical Officer
Science37

12:15 - 1:15

Networking Lunch

1:15 - 2:30

Roundtable Sessions:

Roundtable One: Direct-to-Patient Shipping

Michelle Smith, Product Delivery, Advisor, Technical Center of Excellence
Eli Lilly and Company

Roundtable Two: Change Management

Holly Merrill, Senior Director, Training and Education
Science37

Roundtable Three: Regulatory Challenges 

Monica R. Chmielewski, Attorney
Foley & Lardner, LLP

Kyle Y. Faget, Special Counsel
Foley & Lardner, LLP

2:30 - 3:00

Improving Clinical Trials Efficiencies Through Technology

Lance Hill, Chief Executive Officer
Within3

3:00 - 3:15

Networking and Refreshment Break

3:15 - 4:00

Re-Structuring and Designing Internal Processes for Virtual Trials & Working with Technology Companies

Karen Beyers, Senior Director, MAF Clinical Operations
Johnson & Johnson

4:00 - 4:45

Wearable Devices and Surveillance Technology as Major Drivers for Data Generation in Virtual Trials

Amir Lahav, Sc.D., Digital Medicine and Clinical Innovation Lead, Rare Diseases
Pfizer

4:45 - 5:00

Day One Closing Remarks


Thursday, May 23rd, 2019 | Day 2

 

8:00 - 9:00

Networking and Breakfast

9:00 - 9:15

Chairperson’s Recap of Day One

Matthew Roe, Professor of Medicine
Duke University Medical Center and Duke Clinical Research Institute

9:15 - 10:00

Discuss How Organization Are Managing the Complexities of Virtual Trials

Dawn Anderson, Managing Director, Life Sciences Strategy and Operations, R&D Practice
Deloitte

10:00 - 11:00

Panel: Working Together to Improve Patient Engagement Initiatives: Are Virtual Clinical Trials Taking Patient Centricity to the Next Level?

Moderator: 

Jeffrey Zucker, MS, SVP Global Clinical Operations, Site Management & Trial Optimization
Worldwide Clinical Trials

Panelists:

MarlaJan Wexler, BSN, RN, CPN, Creator/Author Luck Fupus, LLC
Patient Leader

Kelly Conway, Cofounder/Patient Advocate 
International Foundation for Autoimmune Arthritis

Terri Ellsworth, Director of Professional Relations, Patient Advocacy
Accreditation Council for Medical Affairs (ACMA)

11:00 - 11:15

Networking and Refreshment Break 

11:15 - 12:00

Virtual Visits: The Hybrid Approach That Is Moving Studies from Clinic to Home Faster

John Reites, Chief Product Officer & Partner
THREAD

12:00 - 1:00

Networking Lunch

1:00 - 2:00

Panel:  Navigating the Legal, Regulatory and Ethical Considerations of a Virtual Trial

Legal & Regulatory Considerations: 

Ross Friedberg, General Counsel & Chief Privacy Officer
Doctor on Demand

Kyle Y. Faget, Special Counsel
Foley & Lardner, LLP

Monica R. Chmielewski, Attorney
Foley & Lardner, LLP

Ethical Considerations: 

Kayla Kostelecky, JD, MA, PhD Candidate
Saint Louis University

2:00 - 2:15

Networking and Refreshment Break

2:15 - 3:00

Discovering What Tools and Devices are Best for Your Specific Needs

Michael Song, Pharmaceutical Device and Digital Health
MedImmune

3:00 - 3:30

Key Takeaways and Next Steps: Q&A and the Way Ahead

MarlaJan Wexler, BSN, RN, CPN, Creator/Author Luck Fupus, LLC
Patient Leader

Ross Friedberg, General Counsel & Chief Privacy Officer
Doctor on Demand

John Reites, Chief Product Officer & Partner
THREAD

3:30 - 3:45

Chairperson’s Closing Remarks

Matthew Roe, Professor of Medicine
Duke University Medical Center and Duke Clinical Research Institute


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TWO DAYS OF EDUCATION AND NETWORKING

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Speaker Faculty


Dawn Anderson

Dawn Anderson

Managing Director, Life Sciences Strategy and Operations, R&D Practice
Deloitte

Craig Lipset

Craig Lipset

Head of Clinical Innovation
Pfizer Inc.

Kyle Faget

Kyle Faget

Special Counsel
Foley & Lardner, LLP

Jeff Kingsley

Jeff Kingsley

CEO
IACT Health

Ross Friedberg

Ross Friedberg

General Counsel & Chief Privacy Officer
Doctor on Demand

Monica Chmielewski

Monica Chmielewski

Attorney
Foley & Lardner, LLP

Lance Hill

Lance Hill

Chief Executive Officer
Within3

Michael Song

Michael Song

Senior Manager, Drug Delivery and Device Development
MedImmune

Jane Fang

Jane Fang

Director, R&D Information Head for Clinical Biologics
AstraZeneca

Hassan Kadhim

Hassan Kadhim

Director, Head of Clinical Trial Business Capabilities
Bristol-Myers Squibb

Kayla Kostelecky

Kayla Kostelecky

PhD Candidate, Health Care Ethics
Saint Louis University

Terri Ellsworth

Terri Ellsworth

Director of Professional Relations, Patient Advocacy
Accreditation Council for Medical Affairs (ACMA)

MarlaJan Wexler

MarlaJan Wexler

Patient Advocacy & Education

Jonathan Cotliar

Jonathan Cotliar

Chief Medical Officer
Science37

Kelly Conway

Kelly Conway

Patient

John Reites

John Reites

Chief Product Officer & Partner
THREAD

Michelle Smith

Michelle Smith

Product Delivery, Advisor, Technical Center of Excellence
Eli Lilly and Company

Holly Merrill

Holly Merrill

Senior Director, Training & Education
Science 37

Jeffrey Zucker

Jeffrey Zucker

SVP Global Clinical Operations, Site Management & Trial Optimization
Worldwide Clinical Trials

Karen Beyers

Karen Beyers

Senior Director, MAF Clinical Operations
Johnson & Johnson

Amir Lahav

Amir Lahav

Digital Medicine and Clinical Innovation Lead
Pfizer

 
 
 

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