FIERCEBIOTECH PRESENTS:

VIRTUAL CLINICAL TRIALS — ONLINE

NOW AVAILABLE ON-DEMAND

WATCH NOW Group

 

Following the success of ExL’s Virtual Clinical Trial conference 2019, we wanted to continue the conversation and invite our community to discuss decentralized clinical trials in an online forum.

This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

NOW AVAILABLE ON-DEMAND

WATCH NOW Group

AGENDA

WEDNESDAY, APRIL 22

10:00AM-10:15AM
CONFERENCE CHAIRS’ OPENING REMARKS

Now Available On-Demand | 10:15AM-10:45AM
WHAT IS COVID-19 TEACHING US ABOUT OPTIMAL CLINICAL TRIAL CONDUCT RIGHT NOW?

  • Clinical Trial Conduct has been evolving slowly despite the pressures of increasing cost, duration and competition for patients. 

  • Progress is being made in virtualizing components of clinical trials to deal with these changes. 

  • Wars and Disasters drive a rapid need to evolve in order to survive, not only for individuals but also for businesses. 

  • COVID-19 is having a profound impact on clinical trial conduct as companies respond to multiple problems. 

  • How can virtualization help us deal with the usual challenges and mitigate the effects of the next global pandemic? 


Craig

Chairperson

Craig Lipset,

Former Head of Clinical Innovation,

Pfizer

Rob

Rob Scott, M.D.

Chief Medical Officer, Head of Development

AbbVie

Costello

Anthony Costello

Senior Vice President of Mobile Health

Medidata

Medidata

Sponsored By

Medidata

Now Available On-Demand |10:45AM-11:30AM
Decentralized Clinical Trials (DCT) in the Time of COVID-19 and Beyond

  • Advances in and increased adoption of decentralized clinical trials (DCT) pre-COVID-19

  • Impact of the COVID-19 pandemic on ongoing, traditional clinical trials

  • Mitigating the impact of COVID-19 through decentralized clinical trials (DCT)

  • Post-COVID-19 – is DCT the new normal?

Sy

Sy Pretorius

Executive Vice-President, Chief Medical & Scientific Officer

Parexel

Parexel

Sponsored By

Parexel

 

11:30AM-11:45AM
NETWORKING BREAK

Now Available On-Demand |11:45AM-12:45PM
MULTI-STAKEHOLDER PERSPECTIVE ON VIRTUAL CLINICAL TRIALS

  • Who are the stakeholders in virtual clinical trials? 

  • What is the stakeholder perspective on the challenges and opportunities? 

  • How to leverage an understanding of stakeholders to change the current clinical trial paradigm?

Jennifer

Moderator:

Jennifer Goldsack, MChem, MA, MBA

Executive Director

Digital Medicine Society (DiMe)

Mohammed Ali

Panelist:

Mohammed Ali

Global Head Digital Development, Global Clinical Operations

Boehringer Ingelheim 

Adama Ibrahim

Panelist:

Adama Ibrahim, EMBA 

Associate Director, Performance Operational Capabilities, Global Clinical Operations

Biogen 

Alka

Panelist:

Alka Shaunik, M.D., 

Senior Medical Director, Global Medical Affairs

Sanofi 

Now Available On-Demand |12:45PM-1:30PM
Kickoff in a crisis: Lessons from launching the first fully virtual trial during a pandemic

  • Two years in the making: careful planning and stakeholder alignment

  • Macro environment to make changes to standard protocol design

  • Setting up and launching virtual trial in a complex disease during a cautious time

  • Early lessons and learnings

Licholai

Greg Licholai, MD,

Chief Medical Information Officer, 

PRA Health Sciences 

PRA

Sponsored By 

PRA Health Sciences 

1:30PM–1:45PM
CONFERENCE CHAIRS' CLOSING REMARKS

 

AGENDA

THURSDAY, APRIL 23

 

10:00AM-10:15AM
Conference Chairs' Opening Remarks

Now Available On-Demand |10:15AM-10:45AM
Learn Legal Concepts, Issues, and Solutions for Use in Decentralized Clinical Trials, including:

  • Telehealth license requirements and scope of practice

  • The use of digital health tools in DCTs

  • New changes in state and federal laws and regulations due to COVID-19

Cox

Chairperson

Edward Cox, 

Digital Medicine Thought Leader and Founder

Dthera

Brad

Brad Davidsen

Counsel, Clinical R&D

AbbVie 

Now Available On-Demand |10:45AM-11:30AM
Accelerating Clinical Trials and Processes with Emerging Technologies; Thinking Beyond Document Management

  • Where new technologies -- big data, cloud, AI -- fit in the clinical software space

  • Why some applications just are not right for document management

  • How to evaluate the new generation of clinical content and quality business applications

  • Tying the impact and benefits of new technology to clinical goals and metrics

Ken

Ken Lownie

Head of North American Operations,

Agatha INC. 

Agatha

Sponsored By 

Agatha

 

11:30AM-11:45AM
Networking Break

Now Available On-Demand |11:45AM-12:45PM
Panel Discussion: Leveraging Technology to Drive Direct-to-Patient Trial Designs

  • What technologies enable a fully decentralized model?

  • Dive into the many ways’ companies can improve patient engagement to enhance retention while maintaining a focus on emerging technology

  • How to harmonize data access across the clinical trial system in near real time

  • Understand the impact of patient-facing technologies as a benefit to all clinical trial stakeholders

Kristen

Panelist:

Kirsten Engelhardt, MBA, PMP 

Associate Director, Applied Innovation & Process Improvement

Otsuka Pharmaceutical Companies (U.S.) 

Peter

Panelist:

Peter Schaeffer

Projects, Clinical Platforms and Sciences TPR Analytics Director

GlaxoSmithKline

Now Available On-Demand |12:45PM-1:15PM
Maintaining Data Consistency: Traditional to Virtual Trial Continuum

  • What to look for when partnering with a digital solutions vendor

  • How to budget for virtual tech with a lean budget

  • Who to turn to for vendor oversight and quality management

Kerensa

Kerensa Saljoopi, 

Senior Director, Clinical Operations, 

Emalex Biosciences

1:00PM-1:15PM
Conference Chairs' Closing Remarks

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