3rd Virtual Clinical Trials

November 16-17, 2020

Philadelphia, PA

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's Attending?

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

OPENING REMARKS

9:15 AM - 9:45 AM

KEYNOTE: What Does the Coronavirus Pandemic Mean for the Future of Patient-Centric Clinical Trials?

9:45 AM - 10:30 AM

PANEL: STRENGTHENING THE IMPLEMENTATION OF VIRTUAL CLINICAL TRIALS

As we move through 2020, the industry will continue to incorporate digital health technologies into clinical study design. Leveraging technologies can improve recruitment, retention and give patients a choice of participating from home or site. Creating a more patient-friendly system is a process the industry is still attempting to solve. This session will discuss opportunities for improvements to virtual studies and examine how organizations are beginning to execute virtual designs.

  • Discuss how the industry is combining conventional strategies with virtual trials
  • Discuss when it can be more cost-effective to run a virtual clinical trial
  • Restructuring internal processes in order to implement a virtual trial
  • Investigate the digital health tools that can be utilized to move a virtual trial forward

10:30 AM - 11:00 AM

PANEL: THE PATIENT PERSPECTIVE; WHAT CAN INDUSTRY DO BETTER

Creating an experience that is less burdensome for patients is a top priority for the industry. Virtual trials can improve convenience for participants giving them broader options. This session will dive into a patient's experience with a virtual clinical trial, let’s discuss the burdens participants are still facing.

  • Explore the ease of using apps and devices in everyday life
  • Examine why the patient perspective is important in virtual trial design
  • Discuss what being monitored continuously is like through the patient perspective
  • What does data privacy mean to pharma vs. patients? Lack of provider engagement

11:00 AM - 11:15 AM

BREAK

11:15 AM - 11:45 AM

PANEL: DETERMINING IF VIRTUAL METHODS ARE A SUITABLE OPTION

Virtual clinical trials are not appropriate for every kind of clinical study. If a study requires complicated health measurements that require a trip to a clinic, a virtual study may not be a good option. How do you determine a good option for a virtual study and what companies are pushing forward with virtual trials? Explore trial selection and discover the best options for virtual studies.

  • Explore trial selection and discover the best options for virtual studies
  • Discover trials where capturing accurate and timely data through devices has been successful
  • Discuss patient needs and how much face-to-face interaction in necessary
  • Discuss new study designs (such as basket trials, adaptive trials, etc) and if they are amenable to virtual

11:45 AM - 12:30 PM

Improving “Virtually” Any Trial: How to Optimize Trial Design in Patient-Centric Models

12:30 PM - 1:00 PM

BREAK

1:00 PM - 1:30 PM

Being at the Forefront and Bringing Clinical Trials into the 21st Century

1:30 PM - 2:00 PM

The Benefits of a Platform Approach to Virtualizing Clinical Trials

2:00 PM - 2:30 PM

Q&A and Closing Remarks

Tuesday

November 17th, 2020 | Day 2

9:00 AM - 9:10 AM

OPENING REMARKS

9:10 AM - 9:30 AM

DISCUSS THE PROCESSES OF EVALUATING NEW WEARABLE SENSORS AND MOBILE TECHNOLOGY FOR DATA GENERATION IN VIRTUAL TRIALS

Implementing new methods and technologies isn’t as easy as it sounds, new methods also bring new challenges. This talk will review successful case studies for evaluating new procedures and help bridge the gaps between conventional and virtual trials.

  • Review how companies are preparing to explore new digital solutions
  • Recognize strengths across different models and learn how teams are building their capabilities to align with new methods
  • Developing digital health strategy for using sensor technology in virtual trials
  • Understanding the value of incentivized strategies for patient engagement when using wearables and healthcare apps

9:30 AM - 10:00 AM

PANEL: STRENGTHENING THE IMPLEMENTATION OF VIRTUAL CLINICAL TRIALS

When faced with tight regulation and balancing the adoption of new technology with patients’ best interests, it can be nerve-racking to push forward with virtual trial designs. This session will explore some of the big challenges that arise when considering new technology in clinical studies and how to overcome challenges to ensure the desired outcome.

  • Address concerns over data accuracy
  • Ensuring technology required works as it should
  • Discuss how organizations are being too conservative with their approach to virtual trials
  • Examine social and cultural barriers

10:00 AM - 10:45 AM

PANEL: THE PATIENT PERSPECTIVE; WHAT CAN INDUSTRY DO BETTER

10:45 AM - 11:00 AM

BREAK

11:00 AM - 11:30 AM

ASSESSING PATIENT PARTICIPATION BURDEN BASED ON PROTOCOL DESIGN
CHARACTERISTICS

  • Tufts CSDD studies have shown that complex protocols have a higher number of procedures associated with supplementary secondary, tertiary, and exploratory endpoints.
  • The results of the 2018 pilot study showed statistically significant associations observed between a composite measure of patient burden and protocol-specific design and performance measures, most notably study visits above the tolerable mean and the study conduct duration from first patient first visit to last patient last visit.
  • The study results also suggest a new and viable approach to optimize protocol design and improve patient engagement.

11:30 AM - 12:00 PM

NEW PROCESSES AND INFRASTRUCTURE REQUIRE NEW SKILLS

  • Discuss the organizational shift that sponsors need to make to support virtual clinical trials
  • Becoming more knowledgeable on how virtual trials are conducted and what data is most important to collect
  • Training employees on new topics and technologies
  • What skills sets must employees have?

12:00 PM - 12:30 PM

BREAK

12:30 PM - 1:00 PM

CASE STUDY: Optimal CNS Trial Design for Virtual Studies

1:00 PM - 1:30 PM

NAVIGATING THE LEGAL AND REGULATORY CONSIDERATIONS OF A DECENTRAILIZED TRIAL

1:30 PM - 2:00 PM

Recognizing Decentralized Trials as the New Normal

2:00 PM - 2:30 PM

Open Q&A and Closing Remarks

FEATURED SPEAKERS

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Oscar Segurado

ASC Therapeutics

Chief Medical Officer

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Judy Hsiung

Arena Pharmaceuticals

Vice President Safety & Pharmacovigilance

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Israel Gutierrez

Geron Corporation

Vice President, Pharmacovigilance and Drug Safety

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Joan A. Chambers

The Center for Information & Study on Clinical Research Participation (CISCRP)

Senior Director, Marketing & Outreach

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Michael Forstner

PrimeVigilance

Senior Vice President and Head of Pharmacoepidemiology and Risk Management

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Sheila Bose

SB Lifesciences Consulting, Inc

President

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Christine Von Raesfeld

More Than Lupus

Patient Advocate and Board Member

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Angela Ramirez Holmes

Cal Rare

Founder/President

CONFERENCE REGISTRATION

ATTENDEE PRICING

Super Early Bird

$1,596


Before 9/18/20

Early Bird

$1,796


Before 10/16/20

Standard

$1,996


Before Event

On-Site

$2,196


At Event

Live Stream

$796


Before 9/18/20

Live Stream

$896


Anytime

Register 2 Attendees, Get 1 Complimentary Registration!*

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

SPONSORED BY

Scarritt Group - Official Media Partner

OFFICIAL LIVESTREAM PROVIDER

MEDIA PARTNERS

PM360 - Media Partner

PREMIER MEDIA PARTNER


SPONSOR THIS EVENT

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