Agenda - SDE Virtual

Shobhit Shrotriya
Life Sciences R&D Operations,Accenture
SCDM India Steering Committee Chairperson

Craig Lipset
Founder, Clinical Innovation Partners LLC
Former Head of Clinical Innovation, Pfizer

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development.  He is the founder of Clinical Innovation Partners, bringing vision and driving action at the intersection of research, digital solutions, and patient engagement.  Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and the founding management teams for two successful startup ventures.

He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science.  Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University.

Craig has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who’s Who in eHealth.

Kent Thoelke
EVP and Chief Scientific Officer
PRA Health Sciences

Kent Thoelke, is the Chief Scientific Officer and Executive Vice President of PRA Health Sciences, a Global Contract Research Organization.  With 30 years of experience in the drug development industry, he has oversight of Medical Affairs, Scientific Affairs, and Pharmacovigilance/Patient Safety.  Mr. Thoelke is also responsible for all aspects of Digital Health at PRA Health Sciences which includes, Mobile Health/Telehealth, Connected Health/Remote Patient Monitoring, EHR integration/eSource technologies, Patient Experience, and Virtual Clinical Trial Services.  Mr. Thoelke is responsible for the strategic vision regarding the deployment of Clinical Research as a Care Option utilizing Virtual/Decentralized Trials, and Connected/Mobile health as a means of ensuring patient care an business continuity during the COVID19 pandemic and how these solutions will translate into the “new normal” for the drug development paradigm moving forward.

Michael Tucker
Senior mHealth Product Specialist
Medidata Solutions

Michael is a member of Medidata’s Mobile Health team and is a subject matter expert in electronic informed consent and virtual trials. Over the last decade, Michael has worked collaboratively with sponsors, CROs, regulators, ethics committees and researchers around the world to pioneer the use of electronic informed consent and virtual trials. His 30-year career in medical research includes 8 years with the US government conducting and supporting surgical research and 22 years working in the commercial sector to provide technology solutions that improve and support preclinical and clinical research. Michael has been a participant in two clinical trials, bringing a unique perspective to the use of clinical technologies.

Reimagining Clinical Research – Enhancing the ‘Patient Centricity’ through Decentralized Clinical Trials

The world post Covid-19 will be different and continue to evolve in a dynamic fashion. Changes to the way clinical research is conducted today is certainly imminent. As one can imagine, the innovations in clinical research would happen now more than ever. During this panel discussion, we will discuss how decentralized clinical trials (DCTs) offer a more patient-centric approach with fewer visits to the clinic, thereby reducing the burden on investigator, patient and health caregiver. During this changing time, the critical imperatives of DCTs would be to focus on patient safety, ensure data quality and maintain research continuity seamlessly.

Key themes:

• Decentralized Clinical Trials – the approach, challenges and proposed risk mitigation strategies
• Guidelines for enabling remote patient enrollment, patient screening, consent and data capture processes
• Patient engagement through use of technology – ePRO, wearable devices, video calls, etc.
• Data Capture and Data Integration from varied data sources – EDC, ePRO, eCOA, Wearables, EMR, EHR, etc.

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Virtual Trial Technologies to improve patient enrollment, retention, and engagement.

Medidata is continuously monitoring the global impact of COVID-19 on clinical trials. Medidata’s analysis shows the decline in new patients entering clinical trials and actively recruiting studies demonstrate the growing significance of the pandemic’s impact on cities, regions, and countries, with increasingly tighter laws and guidelines restricting movement by anyone outside of the home. Inaccessible sites mean that alternative, remote approaches to study conduct, compliance, patient safety and data quality are needed. The more trials can be safely “virtualised,” the more likely they will be able to successfully proceed.

Enrolment of patients in trials will decrease further apparent as the COVID-19 situation lingers. It is now important for sponsors and investigators to explore the virtualisation of clinical trials. Technology is the only way to address the disruption and challenges clinical trial industry facing posed by COVID-19 such as participation of subject, visits, remote consent and remote monitoring.

“In this session, Aparajeeta will present how technology can help sponsors, CRO partners and clinical investigators to virtualise their trials. Moreover, she will address patient’s participation in clinical trials, and sites to oversight remotely” The session would also cover demonstration of the benefits of technology to virtualise trials using Medidata solutions.”

Technologies that improve site, Sponsor and CRO execution of studies, and how can they address global challenges, like COVID-19

Sites, sponsors and CROs face a myriad of challenges when executing studies including increased trial complexity, patient engagement and aggressive timelines. Covid-19 has magnified many traditional challenges whilst intensely accelerating the need for trial virtualisation.

This interactive session will explore how technologies can enable sites, sponsors and CROs to execute trials with greater speed and agility.

– How can technology reduce manual processes and empower teams to work more efficiently?
– How can system configurability simplify change management and minimise validation effort?
– What does virtualisation mean to sites, and how can technology improve site engagement, satisfaction and performance?

This session will include participant breakout discussions and interactive exercises to engage the audience.

Mayank Anand
Head Global Data Management Service Delivery for Global Clinical Operations, Bristol Myers Squibb (BMS)
Member, Board of Trustees SCDM

Shobhit Shrotriya
Life Sciences R&D Operations,Accenture
SCDM India Steering Committee Chairperson