Event Sponsors
Featured Speakers
Amir Lahav
Digital Healthcare Innovation, Head of R&D Strategy
MITSUBISHI TANABE PHARMA AMERICA
Amy Apostoleris
Global Head, Digital Clinical Trials Solutions
MEDOCITY
Amy Leitman
Patient Advocate
NTM INFORMATION AND RESEARCH
Angel Soubhie
Head Clinical Trial Scientists - Medical Director
BAYER
Antonieta Sosa
Director, Clinical Innovation
Janssen
Archana Sah
Vice President, Head of Clinical Development Operations
Tizona Therapeutics
Barney Morris
Patient Advocate
Craig Lipset
Founder
CLINICAL INNOVATION PARTNERS
Daniella Hensley
Director, Global Clinical Operations
JANSSEN
Dave Bjork
Patient Advocate, CEO
Research Evangelist
Deborah Collyar
Patient Advocate, CEO
Patient Advocates In Research (PAIR)
Dimitri Talantov
Sr. Director Medical Affairs Clinical Trial Innovation
JANSSEN
Elizabeth George
Clinical Trial Diversity Leader, former Director Clinical Trial Diversity
GSK
Gary Friedman
Director, Immunology and Autoimmunity
PFIZER
Gordon Cummins
Vice President, Real World Evidence
Science37
Jane Myles
Director, Decentralized Trials Implementation
COVANCE by LABCORP
Jen Horonjeff
Patient Advocate, Founder and CEO
SAVVY COOPERTIVE
Jeremy Price
Director, Clinical Operations Strategic Partnerships
PFIZER
John Reites
CEO
THREAD
Karlin Schroeder
Associate Vice President, Community Engagement
PARKINSON’S FOUNDATION
Lise Sylvest Helledi
Senior Project Manager, Clinical Development
NOVO NORDISK
Maggie Sweeney
Associate Director, Quality Oversight of Clinical Programs
VERTEX PHARMACEUTICALS
Maimah Karmo
Patient Advocate, CEO
TIGERLILY FOUNDATION
Michelle Luo
Head of Global Evidence & Outcomes
TAKEDA
Michelle Shogren
Senior Director of Innovation, Pharma R&D Clinical Operations
BAYER PHARMACEUTICALS
Musaddiq Khan
Vice President, DCT Solutions
MEDABLE
Nancy Li
Global Category Lead - Central & Core Labs
BAYER
Natalia Muhlemann
Vice President, Strategic Consulting
Cytel
Noolie Gregory
VP, Operations Management, Decentralized Solutions Team
SYNEOS HEALTH
Peter Schaeffer
Projects, Clinical Platforms and Sciences Third Party Resourcing Analytics Director
GLAXOSMITHKLINE
Ray Doresy
Director
UNIVERSITY OF ROCHESTER CENTER for HEALTH AND TECHNOLOGY
Robin Marcus
Head of DCT Market Development, DCT Center of Excellence
COVANCE by LABCORP
Rosamund Round
Vice President, Patient Innovation Center and Decentralized Clinical Trials
PAREXEL
Stephen Lutsch
Director, Head of Revolutionize Clinical Trials
LEO PHARMA
Vinod Das
Associate Director for Pharmacovigilance
BAYER
Wendy Wu
Director, Clinical Development
JAZZ PHARMACEUTICALS
Event Schedule
ALL TIMES ARE IN EASTERN STANDARD TIME
If this pandemic has taught us anything it’s that the future is now – and decentralized clinical trials are here to stay. Deep dive into where we are headed and how to maintain data quality and integrity, through clinical operations best practices and technology.
- Current Operational and Regulatory landscape
- Strategies to overcome perceived DCT adoption barriers
- Best practices for defining and using metrics to drive DCT adoption and success
- Novel methods in clinical trial optimization
- Rethink decentralized trials across all studies
Explore remote collection of Glycaemic and Behaviometric data among patients with Type 2 diabetes Mellitus. Hear about the challenges and future prospective of the study,
- Explore study design and data collection via e-devices
- Operational considerations
- Discuss the patient perspective
The ideal clinical trial is increasingly inclusive, transparent and diverse. Does that have to mean it’s more expensive too? A properly-refined decentralized trial approach can help you achieve both ideals. In this presentation, John Reites, CEO, THREAD provides global insights and guidance on improving participant inclusion, while also mapping out how to reduce costs.
- Analyze how decentralized trials can make your studies more inclusive
- Recognize how more inclusive studies can yield reduced trial costs
- Gauge realistic cost reductions through decentralized global studies as compared to site-based studies
Speaker:
The sponsor can document protocol deviations using its standard processes, or use alternative documentation approaches. What sort of infrastructure is needed to support decentralized trials?
- Develop a concrete plan and update your SOPs or guidelines
- Focus on what working practices are today and how are they differ from a year ago
- Introduce permanent procedures to capture documentation
Delivery of mobile clinical services (e.g. mobile nursing, home biologic sample collections, training on equipment use and protocol compliance) depends on smooth coordination between the sponsor, CRO, sites, central lab, and the mobile clinicians. The old paradigm of using paper for source data collection comes with many inherent problems; switching to a fully-digital workflow addresses these issues while also improving study efficiency and promoting tighter connections between the stakeholders.
- PIs are able to easily order and monitor the conduct of mobile clinical visits,
- There can be a transparent view to the services ordered, the status of the orders, all via a unified dashboard
- A unified solution based on an integrative technology platform is essential for providing high touch care which enhances the patient experience
The technologies pioneered for decentralized trials can greatly increase your efficiency and lead to expedited drug development. In particular, deploying share portals can increase patient recruitment, retention, and engagement, which in turn benefits trial accuracy.
• Avoid trial slowdowns by training personnel on systems that cover multiple technologies rather than per each technology
• Create user ability efficiencies to avoid the exclusion of patients who are not tech savvy or who may not possess the needed devices
• Utilize patient software
Why are companies slow to adopt decentralized trials? Review the current situation with the pandemic and see how these trials can lead to more diverse and patient-centered trials.
- Increase patient diversity in trials
- Tackle recruitment and retention in trials head-on
- Explore opportunities to reduce the burden on patients
Vendor management, auditing and scalability are key concerns in an evolving clinical trial landscape. Assessing vendor availability and operational continuity, particularly regarding data collection, patient recruitment, and enrollment, is essential for planning out your safety monitoring procedures.
• Find new ways to develop standards for patient-facing technology
• Retain patients through the right platform and be more patient-centric
• Ensure vendors are both flexible and customizable to the needs of each patient and trial design
ALL TIMES ARE IN EASTERN STANDARD TIME
Decentralized trials may potentially unlock new advantages in quality, recruitment, and retention – but are you set up to bring these processes to operational life? You could access patients that were previously unable to participate in clinical trials, if only you establish and test the best processes.
- Identify what procedures can be implemented at home
- Ease travel burdens for patients and improve engagement of local clinical facilities to conduct activities
- Understand the laws and regulations that allow and don’t allow DCT in various locations
Conceptually, an ideal endpoint should be a valid and applicable measure of how a patient feels, functions or survives and be perceived by end-users of the research as having meaning and value. It is a responsibility of those who design and conduct trials to choose endpoints which will influence decision-making by clinicians and policymakers.
- Discuss the tools that will be used for endpoint measurement
- Cover mobile technologies to collect endpoints in decentralized trials
- Use patient engagement to define meaningful change, select endpoints and develop/select PROs
Decentralized clinical trials can improve safety monitoring and patient follow up. How can we make sure these new efficiencies are available for the patient’s access?
- Importance of communication in the trial
- Design the trial with the language of the protocols
- Ensure not to sacrifice quality along the way
- Explore case studies and key learnings from rapid DCT adoption over the past year
- Share direct feedback from patients and physicians from underrepresented communities on how to enhance DCT access and optimize the trial experience
- Highlight exciting innovations that will facilitate continued evolution of the DCT model
As we look ahead to conducting research in the post-pandemic world, it will be critical for sponsors and CROs to continue incorporating decentralized tools and technologies not just as an emergency stop-gap measure to ensure trial continuity, but also as part of a broader, more patient-centered approach to study design and conduct that can be applied to studies in each stage of development.
- Efficient methods for longer duration, real-world studies such as those for labeling changes, registries, long-term follow up, pharmacovigilance, outcomes research and pharmacoeconomic studies
- Reduce start-up time, accelerate enrollment, and obtain a patient cohort more representative of the target population
- Utilize DCT tools and technologies that can be used alongside other real-world data to create custom-curated longitudinal datasets
The effect of decentralized trials on the patient experience is both positive & negative. How do DCTs help the trial get a clearer picture by seeing the patient in their own environment?
- Provide a personalization approach to enhance participant experience
- Analyze the new variables introduced by multiple patient settings
- Utilize patient advocates properly to enhance your studies
Speakers:
Barney MorrisPatient Advocate- Michelle ShogrenSenior Director of Innovation, Pharma R&D Clinical OperationsBAYER PHARMACEUTICALS
- Peter SchaefferProjects, Clinical Platforms and Sciences Third Party Resourcing Analytics DirectorGLAXOSMITHKLINE
- Amir LahavDigital Healthcare Innovation, Head of R&D StrategyMITSUBISHI TANABE PHARMA AMERICA
- Wendy WuDirector, Clinical DevelopmentJAZZ PHARMACEUTICALS
With the increasing use of telemedicine in clinical practice, training and procedures must be
adapted from a regulatory perspective. Many important steps of trial visits can and have
been transitioned into video conferencing.
- Explore effective strategies to conduct real-time video use of telemedicine for remote clinical trial visits
- Understand how role of digital biomarkers in these studies
- Learn about ongoing decentralized research studies
- Learn how a connected ecosystem model across the clinical development and pharmaceutical product lifecycle can drive efficiency and ensure a patient centric strategy across the clinical and commercial continuum
- Utilize an interoperable end to end digital health platform that utilizes real time patient data in clinical trial design and improves outcomes
- Hear how wearables can be used as objective patient-focused and informative endpoints or as predictive, prognostic or monitoring biomarkers in drug development
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