9:00am – 10:00am (ET)
Embrace the stakeholder: why collaboration is the key for clinical innovation
Lionel Bascles Global Head, Clinical Sciences & Operation Sanofi
Rachel Edwards Exec Director Global Development Operations Amgen
Mo Ali VP Digital Analytics and Performance GSK
Kendal Whitlock Metasite Strategic Engagement Lead Boehringer Ingelheim
Moderator:: Marie Lamont President and Chief Operating Officer Inteliquet
10:00am – 10:15am (ET)
Calling all clinical innovators: your new marketplace for novel collaboration and partnership
Kai Langel Director, R&D Operations Innovation Janssen Clinical Innovation
10:15am – 10:30am (ET)
In partnership with:
Enable patient-centric clinical research with The Decentralized Clinical Trial Operating System: A requisite, technology-first system.
David Coman Chief Executive Officer Science 37
10:30am – 10:45am (ET)
Fireside chat: The Digital Responsibility
Cindy Hoots Chief Digital Officer & CIO AstraZeneca
Jessica Federer Managing Director Huma
10:45am – 11:00am (ET)
Live Q&A
11:00am – 11:10am (ET)
BREAK (10 Minutes)
11:10am – 12:00pm (ET)
In partnership with:
Trial decentralisation in practice
Craig Lipset Advisor and Founder Clinical Innovation Partners
Munther Baara VP Product Strategy and innovation EDETEK
Grace Cordovano, PhD, BCPA Board-Certified Patient Advocate & Founder Enlightening Results
Sam Hariry Global Head, Clinical Innovation Novartis
Moderator: Kent Thoelke EVP & Chief Scientific Officer PRA Health Sciences
12:00pm – 12:15pm (ET)
Grow your post COVID DCT capabilities
Rachel Soon Innovation Project Manager Novartis
12:15pm – 12:30pm (ET)
In partnership with:
Bringing clinical trials home: How virtual research can reduce patient burden & improve outcomes
Dr. Terry Plasse Medical Director RedHill Biopharma
Matty Culbreth-Notaro SVP Global Operations ObvioHealth
12:30pm – 12:45pm (ET)
From patient visits to patient study tasks
John Zibert CEO Studies and me
12:45pm – 1:00pm (ET)
Live Q&A
9:00am – 9:15am (ET)
Navigate the complexities of direct to patient shipping
Catharina Östberg Head Clinical Operations Sweden GSK
9:15am – 9:30am (ET)
In partnership with:
Best Practices to Scale Your Global Hybrid Decentralized Studies
John Reites CEO THREAD
9:30am – 9:45am (ET)
New Strategies to Balance Protocol Complexity, Customization and Executional Feasibility
Ken Getz Director and Professor Tufts University School of Medicine
9:45am – 10:00am (ET)
Live Q&A
10:00am – 10:15am (ET)
How to align diverse data sources to drive trial diversity
Irfan Khan CEO Circuit Clinical
10:15am – 10:30am (ET)
In partnership with:
14. Longitudinal Patient Insights - Linking Clinical Trial and Real World Data to Create an End-to-End Patient Record
Arnaub Chatterjee Senior Vice President - Product, Acorn AI Medidata, a Dassault Systèmes company
10:30am – 10:45am (ET)
Advanced Analytical Approaches to Enrollment Forecasting and Screening Impacts during the Pandemic
Rohit Nambisan President Lokavant
10:45am – 11:00am (ET)
Live Q&A
11:00am – 11:10am (ET)
Break (10 Minutes)
11:10am – 12:00pm (ET)
In partnership with:
Panel: Employ cross-platform data standardisation to drive novel endpoints
John Zibert CEO Studies and me
Ralph A. DeMasi, Ph.D. VP, Head of Biostatistics and Data Management ViiV Healthcare
Haider Alleg Global Head Of Digital Excellence Ferring
Mimi Huizinga VP and Head, US Oncology Medical Novartis
Chair: Todd Johnson, MPH, MBA Principal Consultant, Organizational Solutions Halloran Consulting
12:00pm – 12:15pm (ET)
Direct from the FDA: guidance on diversity, implementation and RWD integration
Dr. Amy Abernethy CIO FDA
12:15pm – 12:30pm (ET)
Extended FDA Q&A
Dr. Amy Abernethy CIO FDA
9:00am – 10:00am (ET)
Identify, recruit and retain diverse patient populations with a patient-driven digital transformation strategy
Jen Horonjeff Founder Savvy Cooperative
Anne Marie L. Inglis, PhD Senior Director, Clinical Operations Mallinckrodt Pharmaceuticals
Satasuk "Joy" Bhosai, MD MPH Founder Pluto Health Entrepreneur-in-Residence Duke
Charlotte Jones-Burton, MD, MS VP of Clinical Development, Nephrology Otsuka Pharmaceutical
Rosamund Round Vice President, Patient Innovation Center Parexel
10:00am – 10:15am (ET)
Fireside Chat: A Call for the Democratization of Clinical Trials
Charlotte Jones-Burton, MD, MS VP of Clinical Development, Nephrology Otsuka Pharmaceutical
10:15am – 10:30am (ET)
Putting patients first in COVID-19 research: Improving the experience and health outcomes for study participants
Niklas Morton Senior Vice President, PPD® Digital PPD
10:30am – 10:45am (ET)
Case Study: Employ TransCelerate’s Modernizing Clinical Trial Conduct Initiative to reduce conduct burdens
Melissa Suprin Head of Quality Risk Management Pfizer
10:45am – 11:00am (ET)
Live Q&A
11:00am – 11:15am (ET)
Ensure patient centricity drives digital development
Jessica Federer Managing Director Huma
11:15am – 11:30am (ET)
Generate new insights with digital health platforms to put patients at the center and drive clinical innovation
Amy Apostoleris, MAT, MBA Global Head, Digital Clinical Trials Solutions Medocity Inc
11:30am – 11:45am (ET)
Fireside chat International Vaccines and the USA
Jessica Federer Managing Director Huma
Céline Gounder Infectious Disease Specialist, Former member Biden-Harris Transition COVID Advisory Board and CEO Just Human Productions
11:45am – 12:00pm (ET)
Sanofi case study: Building digital clinical assessments to measure what matters most
Andrew Pearlmutter Digital Innovation Leader – Sanofi North American Digital Innovation Hub Sanofi
12:00pm – 12:30pm (ET)
Live Q&A
Roundtable · Date & Time (TBC)
Digital Resilience: How can we keep our clinical data safe?
Robert Hannigan Chairman BlueVoyant International
Dr. Amy Williams Director of Proactive Services BlueVoyant
Roundtable · Date & Time (TBC)
Patient Activation and Behavioural Science to raise Patient Engagement in Clinical Trials
Ying Jiang SVP of Customer Engagement Hū Clinical Solutions
Roundtable · Date & Time (TBC)
Break down barriers to data standardisation and flow
Stephanie Lee Chief Business Officer Lokavant.
Roundtable · Date & Time (TBC)
Leverage and manage the online narrative before during and after a clinical trial
Julia Walsh CEO Brand Medicine International
Roundtable · Date & Time (TBC)
Work with patient groups to identify patient needs
Vicky DiBiaso Global Head Patient Informed Development & Health Value Translation Sanofi
Roundtable · Date & Time (TBC)
Implement patient experience in post-pandemic early phase R&D
Carole Scrafton Patient Advocate Fibroflutters
Dr. Oleksandr Gorbenko, MD, PhD, BCMAS Global Patient Centricity Director Ipsen
Roundtable · Date & Time (TBC)
Role of Decentralized Clinical Trials and Clinical Research as a Care Option to Modernize Trial Design and Enhance Patient Experience
Isaac Rodriguez-Chavez SVP Scientific and Clinical Affairs, Global Center of Excellence for DCTs PRA Health Sciences
Louisa Roberts VP Corporate Development and Partnerships PRA Health Sciences
Workshop · Thursday 8th April · 10:00am (GMT)
Welcome to the content cloud: One secure platform for Clinical collaboration and remote site monitoring
Due to Covid-19, life sciences organisations are pressured to accelerate collaboration across their clinical researchers, clinicians, sponsors, and external alliances like CROs and Labs. Traditional in-person clinical site workflows, like document verifications or clinical site monitoring digital are challenged without an easy way to share and collaborate on clinical site documents, analyse it, and then drive it through the value chain quickly.
Join Manu Vohra, Managing Director, Life Sciences, Katherine Davidson, Large Enterprise Account Executive, Marco Rohr, Large Enterprise Account Executive, Jan Husemeier, Large Enterprise Account Executive, Box to discuss:
Accelerate clinical R&D processes across the value chain, maintain GxP compliance and reduce your overall IT footprint. Designed with content at the center, Box is the content cloud: one secure platform for managing your clinical and patient records in the cloud.
Workshop · Tuesday 13th April · 9:00am (ET) / 2:00pm (GMT)
Protecting the crown jewels from cyber threats.
Discuss the challenges, ideas and practical solutions for protecting the Life Sciences sector amidst the escalating cyber threat landscape.
They will kick off the discussion and share their experiences and perspectives on keeping data safe.
Join Abel Archundia, MD Life Sciences, Istari, & Advisor to BlueVoyant, formerly the Global Pharma CIO and Digital Transformation at Bayer, Robert Hannigan CMG a cybersecurity specialist and International Chairman, BlueVoyant and Dr. Amy Williams, Director of Proactive Services, BlueVoyant as they explore the following questions:
Workshop · Tuesday 13th April 11:00am (ET) / 4:00pm (GMT)
Wearables and Remote Monitoring in Clinical Trials: Patient and Human Factors
With hybrid and decentralized clinical trials becoming the new normal, the use of sensor-based wearables, monitoring devices and clinical trial apps intended to regularly collect PRO and experience data are critically important to the success of the trial. Choosing, testing, modifying, and then validating devices and solutions for trials can be complex, yet it needs to be done quickly and effectively. The answers and validation are often, "outside the building" with the patients, caregivers, and investigators who will use these devices and tools. This will be a highly engaging conversation about the real-world concerns and factors about preparing for success.
Join Todd Greenwood PH.D, Director of Client Solutions, Medullan, Vasundhara Sridharan, Principle user experience researcher, Medullan and Adriano Garcez, Director, Digital Health Strategy & Implementation, Medullan as they discuss:
Workshop · Thursday 15th April 11:00am (ET) / 4:00pm (GMT)
Crisis as a Catalyst: Clinical Trial Decentralization Perspectives on Patient, Clinical Sites and Sponsors
Join Matthew McCarty, Integrated Customer Solutions, ERT, Elisa Cascade, EVP, eCOA, ERT and Matt Johnson, Vice President, Wearables & Digital Biomarkers, ERT as they discuss the key learning objectives: