MAY 19-20, 2020

PLATINUMSPONSOR

Speaker Snapshot

Discuss how the industry iscombining conventionalstrategies with virtual trials

Restructuring internal processes to implement a virtual trial

Understanding the benefits ofgoing virtual across allstakeholders

Explore trial selection anddiscover the best options forvirtual studies

Discuss how to improve equity inaccess and participation throughvirtual clinical trials

Learning Objectives

Conference Chair

Explore the Shift to Decentralized Clinical Trials and Navigatethe Broad Spectrum of Models Available in 2020

Virtual Clinical TrialsConference

2nd Annual

Sheraton Philadelphia University City Hotel

Kelly McKee, Head,Patient Recruitmentand Patient-CentricInnovations, Vertex

Pharmaceuticals

Josh Rose, VP, IQVIAR&D Solutions

Strategyand Global Head,IQVIA Virtual Trials

Wendi Lau, VicePresident,

OperationalImprovement &

Reporting Excellence,Astellas Pharma

Shelly Barnes, PatientExperience andImplementation

Lead, UCB

Kyle Faget, SpecialCounsel, Foley &

Lardner, LLP

Alka Shaunik, MD,Senior MedicalDirector, GlobalMedical Affairs,

Sanofi

Amir Lahav,HealthcareIntelligenceConsultant,

Mitsubishi TanabePharma America

Jim Kremidas,Executive Director atAssociation of Clinical

ResearchProfessionals

Craig Lipset, Founder, ClinicalInnovation

Partners

With growing pricing demands, increased regulatory scrutiny,patent expirations, and generic competition, it’s crucial thatR&D departments are able to utilize digital technologies toensure high-quality clinical trials. The industry is excitedabout virtual clinical trials, but the adoption curve is still light.As your organization prepares to apply novel technologies toclinical trials, whether they are fully-virtual or hybrid, it’simportant to take into consideration how operationalactivities will perform when the trial is conducted virtually asopposed 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 asuccessful outcome. Join us to examine how the industry isnavigating different models of remote trials and gain bestpractices for preparing or improving internal infrastructure tosupport a decentralized study.

Why Attend? Who Should Attend

VenueSheraton PhiladelphiaUniversity City Hotel3549 Chestnut St.Philadelphia,PA 19104

215-387-8000

dmclernan@sheruniv.com

Virtual TrialsDecentralized TrialsRemote MonitoringClinical InnovationPatient ExperiencePatient RecruitmentTrial Design InnovationClinical ProjectsClinical OperationsR&D Clinical Supply ChainClinical Scientific AffairsOutsourcing Clinical Regulatory AffairsClinical Data ManagementClinical SafetyMedical Advisors

Virtual Clinical TrialsConference

2nd Annual

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

DETERMINING IF VIRTUAL METHODS ARE ASUITABLE OPTION

1:45

Moderator: Craig Lipset, Founder, ClinicalInnovation Partners

Panelists:Alka Shaunik, MD, Senior Medical Director, GlobalMedical Affairs, Sanofi

Additional panelists TBD

Virtual clinical trials are not appropriate for every kind ofclinical study. If a study requires complicated healthmeasurements that require a trip to a clinic, a virtual studymay not be a good option. How do you determine a goodoption for a virtual study and what companies are pushingforward with virtual trials? Explore trial selection anddiscover the best options for virtual studies.

AGENDA DAY ONETUESDAY, MAY 19

Discuss how the industry is combining conventionalstrategies with virtual trialsDiscuss when it can be more cost-effective to run avirtual clinical trial    Restructuring internal processes in order to implementa virtual trialInvestigate the digital health tools that can be utilized tomove a virtual trial forward

STRENGTHENING THE IMPLEMENTATION OFVIRTUAL CLINICAL TRIALS

10:00

As we move through 2020, the industry will continue toincorporate digital health technologies into clinical studydesign. Leveraging technologies can improve recruitment,retention and give patients a choice of participating fromhome or site. Creating a more patient-friendly system is aprocess the industry is still attempting to solve.  Thissession will discuss opportunities for improvements tovirtual studies and examine how organizations arebeginning to execute virtual designs.

Moderator: Josh Rose, VP, IQVIA R&D Solutions Strategy andGlobal Head, IQVIA Virtual Trials

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

Additional panelists TBD

REGISTRATION & BREAKFAST8:00CHAIRPERSONS OPENING REMARKS9:00Craig Lipset, Founder, Clinical InnovationPartners

NETWORKING BREAK11:00

TBD

KEYNOTE: TBD9:15

Josh Rose, VP, IQVIA R&D Solutions Strategy andGlobal Head, IQVIA Virtual Trials

TBD

Discover how virtual clinical trials help bridge theunderserved communitiesUsing data to better understand patient populationsHow to best relieve patients of trial burdens to retainparticipantsDiscuss how to improve equity in access andparticipation through virtual clinical trials

RECRUITMENT FOR CLINICAL TRIALS &EXPANDING ACCESS

1:00

Shelly Barnes, Patient Experience andImplementation Lead, UCB

Explore the ease of using apps and devices in everydaylifeExamine why the patient perspective is important invirtual trial design Discuss what being monitored continuously is likethrough the patient perspective What does data privacy mean to pharma vs. patients?Lack of provider engagement

THE PATIENT PERSPECTIVE; WHAT CANINDUSTRY DO BETTER?

11:15

Patient Panel

Creating an experience that is less burdensome forpatients is a top priority for the industry. Virtual trials canimprove convenience for participants giving them broaderoptions. This session will dive into a patient's experiencewith a virtual clinical trial, let’s discuss the burdensparticipants are still facing.

NETWORKING LUNCH12:00

PANEL

PANEL

AGENDA DAY ONETUESDAY, MAY 19

 Examine the challenges and potential solutions toissues surrounding the collection of remote data frompatients Discuss how to ensure the integrity and accuracy ofelectronic records from remote measurementsLearn how investigators should evolve to trainpersonnel on new processes unique to virtual clinicaltrials    Ensure that participants are accurately familiarized onhow their data will be shared

LET’S TALK ABOUT POLICY – DISCUSS HOW THEFDA IS APPROACHING THE SHIFT TODECENTRALIZED CLINICAL TRIALS

3:15

FDA Representative Invited

Applying current regulations to new conditions willvary based on the disease area, the type of investigationaldrug, and the types of trial activities that are decentralized.Policies and regulations will need to consider the integrityof the data that digital technologies produce in a virtualsetting. This session will explore the areas of interest forregulators when thinking about policy considerations forvirtual clinical trials.

IQVIA HOSTED COCKTAIL RECEPTION

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

5:00

IQVIA invites you to join us for a cocktailreception following the conference. Join your

peers and make connections with the speakingfaculty. We’ll provide an open bar with appetizersfrom 5:00 - 6:00. We hope you’ll be able to join usfor this fun networking opportunity at this year’s

Virtual Clinical Trials Conference.

Review how companies are preparing to explore newdigital solutionsRecognize strengths across different models and learnhow teams are building their capabilities to align withnew methodsDeveloping digital health strategy for using sensortechnology in virtual trialsUnderstanding the value of incentivized strategies forpatient engagement when using wearables andhealthcare apps

DISCUSS THE PROCESSES OF EVALUATING NEWWEARABLE SENSORS AND MOBILE TECHNOLOGYFOR DATA GENERATION IN VIRTUAL TRIALS

4:30

Amir Lahav, Healthcare Intelligence Consultant,Mitsubishi Tanabe Pharma America

Implementing new methods and technologies isn’t as easyas it sounds, new methods also bring new challenges. Thistalk will review successful case studies for evaluating newprocedures and help bridge the gaps betweenconventional and virtual trials.Examine if virtual, hybrid, siteless or conventional trials

are the best option for your study  Learn about outsourcing vs. in house management ofvirtual trials Understand how to ease into virtual methods with amore flexible or hybrid approach

WHICH MODEL IS RIGHT FOR YOU? DISCOVERTHE BROAD VARIETY OF SOLUTIONS

2:45

When it comes to virtual trials, one size does not fit all.Because every trial is unique, it’s important to determinethe right model for the study. This session will examine thebroad variety of options available for exploring.

Federal and State regulation of technology and the usethereof for the provision of patient servicesPI Licensure Establishment of patient relationsPermitted modalities/technologyStandards of practiceUse of technology with patients/PI oversight Patient Consent and Data Considerations Consent requirements/electronic delivery Data capture – use of technology for sameHIPAA and 21 CFR Part 11 consideration

NAVIGATING THE LEGAL AND REGULATORYCONSIDERATIONS OF A DECENTRAILIZED TRIAL

3:45

Monica Chmielewski, Attorney, Foley & Lardner, LLPKyle Faget, Special Counsel, Foley & Lardner, LLP

CLOSING REMARKSCraig Lipset, Director Former Head of ClinicalInnovation, Global Product Development, Pfizer

5:00

END OF SESSIONS DAY ONE

THANK YOU TOOUR SPONSORS

COCKTAIL RECEPTION CONCLUDES6:00

|

NETWORKING BREAK2:30

NETWORKING & BREAKFAST8:00

Examine case studies and discuss mistakes that couldhave been avoided Working through technical difficulties with the userinterfaceDiscuss the risk of sharing sensitive health informationonlineLearning the skillsets required to capture and utilizedata Developing digital health strategy for using wearabletechnology in virtual trials

MISTAKES TO AVOID WHEN COLLECTING DATATHROUGH DIGITAL HEALTH TECHNOLOGIES

10:00

Moderator:Craig Lipset, Founder, Clinical InnovationPartners

Panelists:Amir Lahav, Healthcare Intelligence Consultant,Mitsubishi Tanabe Pharma America

Additional panelists TBD

CLOSING REMARKSCraig Lipset, Founder, Clinical InnovationPartners

3:00

CHAIRPERSON’S RECAP OF DAY ONECraig Lipset, Founder, Clinical InnovationPartners

9:00

NETWORKING BREAK11:00

NETWORKING LUNCH12:00

AGENDA DAY TWOTUESDAY, MAY 20

Address concerns over data accuracyEnsuring technology required works as it should Discuss how organizations are being too conservativewith their approach to virtual trialsExamine social and cultural barriers

THE BIG CHALLENGES WHEN CONSIDERING AVIRTUAL CLINICAL TRIAL

9:15

Wendi Lau, Vice President, OperationalImprovement & Reporting Excellence, AstellasPharma

When faced with tight regulation and balancing theadoption of new technology with patients’ best interests, itcan be nerve-racking to push forward with virtual trialdesigns. This session will explore some of the bigchallenges that arise when considering new technology inclinical studies and how to overcome challenges to ensurethe desired outcome.

TBD

Examine Participation Burden11:15

Yaritza Peña, Research Analyst, Tufts CSDD, TuftsUniversity School of Medicine

TBD

Discuss how organizations are effectively using AI tooptimize trial design and performanceExamine how technology is transforming clinical researchIdentify key challenges when implementing AI into trialdesignConsider whether decisions can be based on RWDanalyzed by AI

WHAT ROLE DOES AI PLAY INVIRTUAL CLINICAL TRIALS?

1:45

SPEAKERTBD

Will artificial intelligence help streamline the virtual clinicaltrial process? AI-based models are helping with trial design,patient recruitment, increasing cybersecurity, remotemonitoring, EHR processing and more. This session willexplore possible applications for AI in decentralized trialsand how AI is already changing the clinical landscape in2020.

Discuss the organizational shift that sponsors need tomake to support virtual clinical trials Becoming more knowledgeable on how virtual trials areconducted and what data is most important to collectTraining employees on new topics and technologies What skills sets must employees have?

NEW PROCESSES AND INFRASTRUCTUREREQUIRE NEW SKILLS

2:15

SPEAKERTBD

PANEL

TBD

ACRP PRESENTATION1:00

Jim Kremidas, Executive Director at Association ofClinical Research Professionals

TBD

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Explore the Shift to Decentralized Clinical Trials andNavigate the Broad Spectrum of Models Available in2020

Virtual Clinical TrialsConference

2nd Annual

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