3rd Virtual Clinical Trials

November 16-17, 2020

Online Livestream

What To Expect

The coronavirus pandemic has changed the world forever.  A year ago, virtual clinical trials were a high-interest curiosity; now, they are essential to your pipeline.  With the entire drug industry forced into a crash-course on virtual trials, and the uptake curve dangerously light, the early adopters are set for a massive advantage.  The time to begin to catch up is now… if you can.

Switching to virtual trials requires more than just running standard methods in front of a webcam.  Your entire clinical approach must be reconceptualized in order to get the most benefit from a virtual approach.  That’s why you cannot afford to miss the 3rd Virtual Clinical Trials conference – the industry’s leading, longest-lasting conference on this subject, offering you exclusive insights our speaking faculty hasn’t shared anywhere else!

Hilton East Brunswick

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3 Tower Center Blvd.
East Brunswick, NJ 08816

(732) 828-2000

Hotel Website

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.

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

Why Attend?

  • Flag the most important successes in post-COVID clinical trial modifications
  • Compare and contrast different models of remote trials
  • Visualize new clinical research and patient interaction methods that garner the most benefits from an online platform
  • Evaluate your clinical infrastructure’s readiness to go virtual
  • Maintain patient centricity and patient input in all clinical trial methods

Who Should Attend?

You will benefit from attending this event if you are a professional in the pharmaceutical, biotech, or medical device sectors, with responsibility in the following areas:

  • Clinical Trials
  • Clinical Research
  • Clinical Operations
  • Clinical Supply Chain
  • Clinical Regulatory Affairs
  • Decentralized Trials
  • Remote Monitoring
  • Mobile
  • Wearables
  • Technology
  • Clinical Innovation
  • Patient Recruitment
  • Patient Experience
  • Medical Advisors

Monday

November 16th, 2020 | Day 1

9:00 AM - 9:15 AM

Chairperson’s Opening Remarks

Craig Lipset - Founder
CLINICAL INNOVATION PARTNERS

9:15 AM - 10:00 AM

Guide Technology Providers to Confront their “Unknown Unknowns”

  • Communicate the level of validation needed in order to make claims on data
  • Upgrade due diligence around the technologies that clinical trial teams must have in place
  • Bridge gaps in levels of inherent knowledge

Lesley Schofield - Director of Clinical Trial Operations, U S Medical Affairs
NOVARTIS

Claus Torp Jensen - Chief Digital Officer and Chief Technology Officer
MEMORIAL SLOAN KETTERING CANCER CENTER

10:00 AM - 10:45 AM

Global Considerations for Hybrid Decentralized Studies

  • Explore select differences in launching hybrid decentralized studies in Europe, Asia Pacific and South America
  • Discuss flexible approaches for eConsent, telehealth, eCOA sensors and home health
  • Review lessons learned to date with global DCT expansion

John Reites - President
THREAD

10:45 AM - 11:00 AM

BREAK

11:00 AM - 11:45 AM

PANEL: Emphasize and Maintain Patient Centricity

  • Reduce the need for site visits through at-home monitoring
  • Gather and reliably archive patient feedback on drug formulation and delivery
  • Turn a challenging time into new opportunity, with trial structures that more easily fit into patients’ routines

Alka Shaunik - Global Therapy Area Head, Cardiovascular & Metabolism, Medical Affairs
CSL BEHRING

Vanessa Gertsen - Head, Recruitment Strategy, Clinical Trial Engagement & Enrollment
BRISTOL-MYERS SQUIBB

Jen Horonjeff - Patient Advocate, Ceo and Founder
SAVVY COOPERATIVE

11:45 AM - 12:30 PM

Navigating the Complexity of the Adoption of Virtual Trials

  • Explore the potential of remote models
  • Recognize and adapt to burdens and complexities of multiple stakeholders
  • Evaluate vendor capabilities to move beyond virtual sites and take on both CRO and site capabilities

Emily Kunka - Digital Transformation Project Lead
UCB

Michelle Luo - Head, Global Evidence & Outcomes
TAKEDA

12:30 PM - 1:00 PM

Lunch

1:00 PM - 1:45 PM

Regulatory Considerations for Virtual Clinical Trials

  • Understand the regulatory guidance available and consider the implications to the regulatory strategy for products that use these novel approaches in clinical trials.
  • Utilize novel approaches to clinical trials within a context of COVID-19
  • Explore the US FDA guidance documents published related to COVID-19 pandemic and provide regulatory insights as to moving forward in our ‘new normal’ of clinical trial development.

Katherine Tsokas - Regulatory Head of Regenerative Medicine & Advanced Therapy, Interim Global Regulatory Affairs Neuroscience Head
JANSSEN

1:45 PM - 2:30 PM

Presentation by MEDIDATA

2:30 PM - 2:45 PM

Networking Break

2:45 PM - 3:30 PM

PANEL: Strengthen the Implementation of Virtual Clinical Trials

  • Review how the industry combines conventional strategies with virtual trials
  • Restructure internal processes as needed for implementation
  • Investigate the most cost-effective applications and outcomes
  • Analyze how digital health tools can move trials forward
  • Ensure the data integrity and subjects' safety monitoring in the virtual clinical trials implementation

Elizabeth Stoner - Senior Clinical Advisor
ALLOVIR

Nancy Sacco - VP, Clinical Development
MEITHEAL SPECIALTY PHARMA

Safwan Kezbor - Medical Director, Clinical Development
SHIONOGI

3:30 PM - 4:15 PM

Prep for Realtime Troubleshooting and Worst-Case Scenarios

Tuesday

November 17th, 2020 | Day 2

9:00 AM - 9:15 AM

Chairperson’s Recap of Day One

Craig Lipset - Founder
CLINICAL INNOVATION PARTNERS

9:15 AM - 10:00 AM

PANEL: What Does Long-Term Commitment to Decentralized Trials Look Like?

  • Explore areas requiring change in order to drive sustaining adoption in the organization
  • Discuss specific examples spanning processes, vendor selection, training and protocol authoring
  • Share experiences managing organizational change to recognize pitfalls and drivers of success

Moderator:
Craig Lipset - Founder 
CLINICAL INNOVATION PARTNERS

Hassan Kadhim - Director, Global Head of Clinical Trial Business Capabilities and Clinical Innovation
BRISTOL MYERS SQUIBB

Mike Collins - Senior VP, Clinical Operations & Data Sciences
AKEBIA THERAPEUTICS

10:00 AM - 10:45 AM

Explore the Viability of “Hybrid” Trial Designs

Presentation by COVANCE

10:45 AM - 11:00 AM

BREAK

11:00 AM - 11:45 AM

Ensure Participant Adherence and Compliance in Virtual Trials

  • Outline how the proper technology choices can help or hinder you
  • Compare and contrast technical platform options
  • Focus on the clinical trial without commercial consideration

Michael Song - Senior Manager, Head of Device Functionality, Safety, and Digital Connectivity
ASTRAZENECA 

Bibhudatta Mishra - Senior Clinical Trial Scientist
JOHNS HOPKINS MEDICINE

11:45 AM - 12:30 PM

Make Breakthroughs with Virtual Clinical Investigator Meetings

  • Evaluate the benefits of virtual meetings in terms of cost and convenience
  • Compare different methods for gathering information through “breakouts
  • Review new outreach options for CRAs and training
  • Clarify in advance the needs for tech support

Nina Renner-Thomas - Clinical Project Lead, Manager, Clinical Operations
SANOFI

12:30 PM - 1:00 PM

Lunch

1:00 PM - 1:45 PM

Artificial Intelligence and Machine Learning in Virtual Trials: Separate Potential from Best Practice

  • Explore the most up-to-date options for large-scale data analysis for virtual trials
  • Address common mistakes and misperceptions
  • Clarify what is realistically possible for digital health and bioinformatics in a remote setting

Shameer Khader - Senior Director, Data Science, Digital Health, and Bioinformatics
ASTRAZENECA

1:45 PM - 2:30 PM

Risk-Based Monitoring and Site Management Applications

  • Determine the most important indicators of site quality
  • Plan creative collaboration and flexible strategies
  • Find the fastest techniques for site quality maximization
  • Recognize how behavior influences team results

Daniella Hensley - Director, Global Clinical Operations
JANSSEN

Wendy Wu - Director, Clinical Development
JAZZ PHARMACEUTICALS

2:30 PM - 2:45 PM

Networking Break

2:45 PM - 3:30 PM

Prioritize Diversity and Access Among Virtual Clinical Patients

  • Emphasize to pharma companies the importance of clinical patient diversity – both to accurately represent the broader patient population and to meet calls for urgent social change
  • Devise solutions for unequal access to virtual / online services, technology, and infrastructure for clinical trials
  • Learn from successful outreach and engagement between pharma and patient groups

Lorena Kuri - Head, Diversity Strategy
BRISTOL-MYERS SQUIBB

Maimah Karmo - Patient Advocate, CEO
TIGERLILY FOUNDATION

3:30 PM - 4:15 PM

Evaluate the Potential of Virtual Reality and Augmented Reality Interfaces

FEATURED SPEAKERS

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Mike Collins

AKEBIA THERAPEUTICS

Senior VP, Clinical Operations & Data Sciences

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Vanessa Gertsen

BRISTOL-MYERS SQUIBB

Head, Recruitment Strategy, Clinical Trial Engagement & Enrollment

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Daniella Hensley

JANSSEN

Director, Global Clinical Operations

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Maimah Karmo

TIGERLILY FOUNDATION

Patient Advocate, CEO

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Safwan Kezbor

SHIONOGI

Medical Director, Clinical Development

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Shameer Khader

ASTRAZENECA

Senior Director, Data Science, Digital Health, and Bioinformatics

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Emily Kunka

UCB

Digital Transformation Project Lead

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Lorena Kuri

BRISTOL-MYERS SQUIBB

Head, Diversity Strategy

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Craig Lipset

CLINICAL INNOVATION PARTNERS

Founder

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Bibhudatta Mishra

JOHNS HOPKINS MEDICINE

Senior Clinical Trial Scientist

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John Reites

THREAD

President

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Nina Renner-Thomas

SANOFI

Clinical Project Lead, Manager, Clinical Operations

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Nancy Sacco

MEITHEAL SPECIALTY PHARMA

VP, Clinical Development

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Lesley Schofield

NOVARTIS

Director of Clinical Trial Operations, U S Medical Affairs

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Alka Shaunik

CSL BEHRING

Global Therapy Area Head, Cardiovascular & Metabolism, Medical Affairs

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Michael Song

ASTRAZENECA

Senior Manager, Head of Device Functionality, Safety, and Digital Connectivity

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Elizabeth Stoner

ALLOVIR

Senior Clinical Advisor

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Katherine Tsokas

JANSSEN

Regulatory Head of Regenerative Medicine & Advanced Therapy, Interim Global Regulatory Affairs Neuroscience Head

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Wendy Wu

JAZZ PHARMACEUTICALS

Director, Clinical Development

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Jen Horonjeff

SAVVY COOPERTIVE

Patienet Advocate, Ceo and Founder

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Hassan Kadhim

BRISTOL MYERS SQUIBB

Director, Global Head of Clinical Trial Business Capabilities and Clinical Innovation

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Michelle Luo

TAKEDA

Head, Global Evidence & Outcomes

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Claus Torp Jensen

MEMORIAL SLOAN KETTERING CANCER CENTER

Chief Digital Officer and Chief Technology Officer

CONFERENCE REGISTRATION

LIVESTREAM PRICING

EARLY BIRD

$796


Before 10/7/20

STANDARD

$896


Anytime

Register 2 Attendees, Get 1 Complimentary Registration!*

Interested in registering groups of 7 or more? Contact us directly for pricing.

SPONSORED BY

Scarritt Group - Official Livestream Provider

OFFICIAL LIVESTREAM PROVIDER

MEDIA PARTNERS

PM360 - Media Partner

PREMIER MEDIA PARTNER


SPONSOR THIS EVENT

Contact Amy Chapman at (561) 571-7687achapman@dgeconfs.com