2nd Annual

Virtual Clinical Trials

Event 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.

Featured Speakers

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Josh Rose

VP & Global Head
IQVIA Virtual Trials

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Craig Lipset

Founder
Clinical Innovation Partners

Top 5 Reasons to Watch

  1. Discuss how the industry is combining conventional strategies with virtual trials
  2. Explore trial selection and discover the best options for virtual studies
  3. Restructuring internal processes to implement a virtual trial
  4. Understanding the benefits of going virtual across all stakeholders
  5. Discuss how to improve equity in access and participation through virtual clinical trials

Attendee Profile

This conference is designed for life science professionals responsible for:

  • Virtual Trials
  • Remote Monitoring
  • Clinical Innovation
  • Patient Experience
  • Patient Recruitment
  • Trial Design Innovation
  • Clinical Projects
  • Clinical Operations
  • R&D
  • Clinical Supply Chain
  • Clinical Scientific Affairs
  • Outsourcing
  • Clinical Regulatory Affairs
  • Clinical Data Management
  • Clinical Safety
  • Medical Advisors

LIVE Stream Day 1


9:00 AM - 9:15 AM

OPENING REMARKS

Craig Lipset - Founder
Clinical Innovation Partners

Karen Beyers - Director, Clinical Project Scientists
Johnson & Johnson

9:15 AM - 9:45 AM

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

Josh Rose - VP & Global Head
IQVIA Virtual 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

Moderator:
Josh Rose - VP & Global Head
IQVIA Virtual Trials

Panelists:
Kelly McKee - Head, Patient Recruitment and Patient-Centric Innovations
Vertex Pharmaceuticals

Reginald Hooks - Head of Clinical Operations
ONCOLYTICS BIOTECH

Hassan Kadhim - Head of Clinical Trials Business Capabilities
BRISTOL-MYERS SQUIBB

TJ Sharpe - Patient Advocate
TJSHARPE.COM

John Reites - President
THREAD

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

Moderator:
Craig Lipset - Founder
Clinical Innovation Partners

Panelists:
Christoph Hornik, MD - Associate Professor of Pediatrics, Chief, Division of Quantitative Sciences
Duke Clinical Research Institute

Shelley Barnes - Patient Experience and Implementation Lead
UCB

Jen Horonjeff - Founder & CEO
SAVVY COOPERATIVE

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

Moderator:
Craig Lipset - Founder
Clinical Innovation Partners

Panelists:
Alka Shaunik, MD - Senior Medical Director, Global Medical Affairs
Sanofi

Jim Kremidas - Executive Director
Association of Clinical Research Professionals

Penny Randall - VP & Head, Central Nervous System (CNS) Center of Excellence
IQVIA

Alicia Staley - Member, Patient Advocate Board
CANCER UNIVERSITY

11:45 AM - 12:30 PM

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

Bola Oyegunwa - Head of Hybrid and Virtual Trials
COVANCE

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

Kirsten Engelhardt  - Associate Director, Applied Innovation & Process Improvement
OTSUKA

1:30 PM - 2:00 PM

The Benefits of a Platform Approach to Virtualizing Clinical Trials

Anthony Costello - Senior Vice President
MEDIDATA

2:00 PM - 2:30 PM

Q&A and Closing Remarks

Craig Lipset - Founder
CLINICAL INNOVATION PARTNERS

Karen Beyers - Director, Clinical Project Scientists
JOHNSON & JOHNSON


LIVE Stream 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

Amir Lahav - Individual Digital Medicine Consultant
Former Head of Digital Innovation for Rare Diseases, Pfizer
Executive Director and Head of Digital Medicine, Karyopharm
Therapeutics Healthcare Intelligence Consultant, Mitsubishi Tanabe Pharma America

9:30 AM - 10:00 AM

THE BIG CHALLENGES WHEN CONSIDERING A VIRTUAL CLINICAL TRIAL

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

Wendi Lau - Vice President, Operational Improvement & Reporting Excellence
Astellas Pharma

10:00 AM - 10:45 AM

PANEL – MISTAKES TO AVOID WHEN COLLECTING DATA THROUGH DIGITAL HEALTH TECHNOLOGIES

Moderator:

Amir Lahav - Individual Digital Medicine Consultant
Former Head of Digital Innovation for Rare Diseases, Pfizer
Executive Director and Head of Digital Medicine, Karyopharm
Therapeutics Healthcare Intelligence Consultant, Mitsubishi Tanabe Pharma America

Panelists:
Karen Beyers - Director, Clinical Project Scientists
Johnson & Johnson

Glynn Dennis Jr., Sr. Director, Data Science
AstraZeneca

Jacob LaPorte, PhD - Co-Founder & Global Head of The Novartis Biome, Chief Digital Office
Novartis Pharmaceutical Corporation

Nagaraja Srivatsan - Senior Vice President and Chief Digital Officer, Research and Development Solutions
IQVIA

Sarah Krug - Executive Director
CANCER 101

10:45 AM - 11:00 PM

BREAK

11:00 PM - 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.

Yaritza Peña - Research Analyst, Tufts CSDD
Tufts University School of Medicine

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?

Jim Kremidas - Executive Director
Association of Clinical Research Professionals

12:00 PM - 12:30 PM

BREAK

12:30 PM - 1:00 PM

CASE STUDY: Optimal CNS Trial Design for Virtual Studies

Chris Reist - Medical Director, Psychiatry and Behavioral Sciences
Science 37

1:00 PM - 1:30 PM

NAVIGATING THE LEGAL AND REGULATORY CONSIDERATIONS OF A DECENTRAILIZED TRIAL

Monica Chmielewski/Kyle Faget
Foley & Lardner, LLP

1:30 PM - 2:00 PM

Recognizing Decentralized Trials as the New Normal

Michelle Longmire - Co-Founder and CEO
MEDABLE

2:00 PM - 2:30 PM

Open Q&A and Closing Remarks

Craig Lipset - Founder
CLINICAL INNOVATION PARTNERS

Karen Beyers - Director, Clinical Project Scientists
JOHNSON & JOHNSON


TWO DAYS OF EDUCATION AND OPPORTUNITY

DON'T MISS IT

WATCH NOW

2020 Speaker Faculty


Josh Rose

Josh Rose

VP & Global Head
IQVIA Virtual Trials

Craig Lipset

Craig Lipset

Founder
Clinical Innovation Partners

Kyle Faget

Kyle Faget

Special Counsel
Foley & Lardner, LLP

Monica Chmielewski

Monica Chmielewski

Attorney
Foley & Lardner, LLP

Shelly Barnes

Shelly Barnes

Global Clinical Innovations
UCB Biosciences

Yaritza Peña

Yaritza Peña

Research Analyst, Tufts CSDD
Tufts University School of Medicine

Wendi Lau

Wendi Lau

Vice President, Operational Improvement & Reporting Excellence
Astellas Pharma

Kelly (Johnston) McKee

Kelly (Johnston) McKee

Head, Patient Recruitment
Vertex Pharmaceuticals

Jim Kremidas

Jim Kremidas

Executive Director
Association of Clinical Research Professionals

Karen Beyers

Karen Beyers

Director, Clinical Project Scientists
Johnson & Johnson

Alka Shaunik

Alka Shaunik

Senior Medical Director, Global Medical Affairs
Sanofi

Bola Oyegunwa

Bola Oyegunwa

Vice President and Head of Virtual Trials
Covance

Chris Reist

Chris Reist

Medical Director, Psychiatry and Behavioral Science
Science 37
Professor Emeritus, Department of Psychiatry and Human Behavior School of Medicine
University of California- Irvine
Research Psychiatrist
Long Beach VA Healthcare System

Amir Lahav

Amir Lahav

Individual Digital Medicine Consultant
Former Head of Digital Innovation for Rare Diseases
Pfizer
Executive Director and Head of Digital Medicine
Karyopharm
Therapeutics Healthcare Intelligence Consultant
Mitsubishi Tanabe Pharma America

Christoph Paul Vincent Hornik

Christoph Paul Vincent Hornik

Associate Professor of Pediatrics, Chief, Division of Quantitative Sciences
Duke Clinical Research Institute

Nagaraja Srivatsan

Nagaraja Srivatsan

Senior Vice President and Chief Digital Officer, Research and Development Solutions
IQVIA

Kirsten Engelhardt

Kirsten Engelhardt

Associate Director, Applied Innovation & Process Improvement
Otsuka Pharmaceutical Companies (U.S.)

Penny Randall

Penny Randall

VP & Head, Central Nervous System (CNS) Center of Excellence
IQVIA

Glynn Dennis Jr.

Glynn Dennis Jr.

Sr. Director, Data Science
AstraZeneca

Jacob LaPorte

Jacob LaPorte

Co-Founder & Global Head of The Novartis Biome, Chief Digital Office
Novartis Pharmaceutical Corporation

Reginald Hooks

Reginald Hooks

Associate Director, Clinical Operations
Oncolytics Biotech

Jen Horonjeff

Jen Horonjeff

Founder & CEO
SAVVY COOPERATIVE

TJ Sharpe

TJ Sharpe

Patient Advocate
TJSHARPE.COM

Anthony Costello

Anthony Costello

Senior Vice President of Mobile Health
Medidata

John Reites

John Reites

President
THREAD

Sarah Krug

Sarah Krug

Executive Director
CANCER 101

Michelle Longmire

Michelle Longmire

Co-Founder and CEO
Medable

 

CONFERENCE PRICING


VIRTUAL LIVE STREAM

$896

Interested in registering groups of 10 or more? Contact us directly for pricing.

PLATINUM SPONSOR

EVENT SPONSORS

SPONSOR THIS EVENT

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


MEDIA PARTNERS

PM360

PREMIER MEDIA PARTNER