2nd Annual

Virtual Clinical Trials

May 19-20, 2020

Via Online Live Stream

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

Vice President of R&D
IQVIA

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Craig Lipset

Founder
Clinical Innovation Partners

Top 5 Reasons to Attend

  1. Learn best practices to cultivate multi-stakeholder professional relationships and build internal cross-functional teams to improve rare disease patient outcomes through collaboration
  2. Discuss competitive advantages created with strategic partnerships between pharmaceutical companies and university medical centers
  3. Gain insights into best practices for FDA approval; OR into FDA regulations regarding biosimilars and Gene therapy for rare
  4. Explore new developments in translational medicine, HERO in rare, drug pipelines for biosimilars/gene therapies/T-cell therapies, real world evidence for the FDA, off-label uses for orphan drugs
  5. Learn about digital tools for the benefit-risk optimization of medicines

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

Tuesday, May 19th, 2020 | 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

SESSION TBD

Josh Rose - VP, IQVIA R&D Solutions Strategy and 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, IQVIA R&D Solutions Strategy and Global Head
IQVIA Virtual Trials

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

Additional panelists TBD

10:30 AM - 11:15 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

Additional panelists TBD

11:15 AM - 12:00 PM

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

12:00 PM - 12:30 PM

LUNCH BREAK/NETWORKING

12:30 PM - 1:00 PM

IMPROVING ‘VIRTUALLY’ ANY TRIAL: HOW TO OPTIMIZE TRIAL DESIGN IN PATIENT CENTRIC MODELS

Dr. Bola Oyegunwa - Head of Hybrid and Virtual Trials
Covance

1:00 PM - 1:30 PM

MOVING INTO THE VIRTUAL TRIAL SPACE AND TAKING FULL ADVANTAGE OF TECHNOLOGY IN A GLOBAL SETTING

Novo Nordisk is conducting clinical trials in > 50 countries with different regulations and digital adoption levels. This poses a challenge in terms of entering the virtual trial space globally.

  • Discuss how Novo Nordisk is working on transforming conventional trial conduct into a more modern effective and patient centric way of trial conduct
  • Learn to take advantage of the fast-technological development and digitalization of clinical processes

Lise Sylvest Helledi, Ph.D., EMBA - Project Lead, Virtual Clinical Study Collaboration
Novo Nordisk

4:30 PM - 5:00 PM

 

5:00 PM

END OF SESSIONS DAY ONE

Craig Lipset – Founder
Clinical Innovation Partners

Karen Beyers - Director, Clinical Project Scientists
Johnson & Johnson

5:00 PM - 6:00 PM

IQVIA HOSTED COCKTAIL RECEPTION

IQVIA invites you to join us for a cocktail reception following the conference. Join your peers and make connections with the speaking faculty. We’ll provide an open bar with appetizers from 5:00 - 6:00. We hope you’ll be able to join us for this fun networking opportunity at this year’s Virtual Clinical Trials Conference.


Wednesday, May 20th, 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

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

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 - 11:00 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
Healthcare Intelligence Consultant, Mitsubishi Tanabe Pharma America
Digital Medicine & Innovation Lead, Karyopharm Therapeutics

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

IQVIA

11:00 AM - 11:30 PM

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 PM - 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

LUNCH BREAK/NETWORKING

12:30 PM - 1:00 PM

Science 37

Jonathan Cotliar - Chief Medical Officer
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

Closing remarks and open-ended questions


TWO DAYS OF EDUCATION AND OPPORTUNITY

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2020 Speaker Faculty


Josh Rose

Josh Rose

Vice President of R&D
IQVIA

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

Patient Experience and Implementation Lead
UCB

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

Amir Lahav

Amir Lahav

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

Alka Shaunik

Alka Shaunik

Senior Medical Director, Global Medical Affairs
Sanofi

Bola Oyegunwa

Bola Oyegunwa

Vice President and Head of Virtual Trials
Covance

Kelly Johnson

Kelly Johnson

Head, Patient Recruitment and Patient-Centric Innovations
Vertex Pharmaceuticals

Karen Beyers

Karen Beyers

Director, Clinical Project Scientists
Johnson & Johnson

Lise Sylvest Helledi

Lise Sylvest Helledi

EMBA, Insulin & Devices, Trial Operations
Novo Nordisk A/S

Glynn Dennis Jr.

Glynn Dennis Jr.

Sr. Director, Data Science
AstraZeneca

Kirsten Engelhardt

Kirsten Engelhardt

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

Christoph Paul Vincent Hornik

Christoph Paul Vincent Hornik

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

Hassan Kadhim

Hassan Kadhim

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

Jacob LaPorte

Jacob LaPorte

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

Jonathan Cotliar

Jonathan Cotliar

Chief Medical Officer
Science 37

 
 
 

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$896

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EVENT SPONSORS

SPONSOR THIS EVENT

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


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