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DPHARM 2021 Agenda DAY ONE - Tuesday, September 28th ZEITGEIST TALK 9:30 am 7:45 am Data Science as the Backbone in Getting the Registration, Coffee/Tea JnJ Vaccine to Market in Record Time Sponsored by MMG As R&D continues to embrace true data science, we learn in this Zeitgeist talk how it made all the difference in developing a COVID vaccine in record time and how it will change drug development planning and operations. 8:25 am DPHARM Welcome Najat Khan, PhD Chief Data Science Officer and Global Jamie Macdonald Head, Janssen R&D Strategy and CEO, Parexel Operations, Johnson and Johnson PATIENT KEYNOTE 9:50 am 8:30 am Verily Project Baseline: Collaborating to Invent a Better Future for Patients DPHARM 2021 Patient Keynote Presentation Amy Abernethy, MD, PhD Stacy Hurt, MHA, MBA President, Clinical Research Platforms, Verily Life Caregiver and Advocate and Patient Sciences Keynote Speaker 10:05 am - 10:50 am LEADERSHIP TALK DPHARM Exhibit Rooms Grand Opening 9:00 am • Ask the Patients @ Learnings from the Leadership of the DPHARM* Collaboration that Delivered a COVID Vaccine • Exhibits featuring in Record Time an array of patient- Managing roughly 47,000 patients through a COVID centered technologies & services vaccine clinical trial in less than six weeks required • Networking enormous cooperation, speed, new thinking and • DPHARM swag determination. The DPHARM audience will hear first- • Refreshments will be served at the outdoor pavilion hand about the leadership, process and lessons from this extraordinary collaboration. *Ask the Patients @DPHARM Rob Goodwin, MBA DPHARM is proud to support Vice President, Operations Center of this opportunity for attendees ASK THE Excellence, Global Product Development, to meet and speak with Pfizer patients who’ve experienced PATIENT a clinical trial. Steve Cutler, PhD, MBA DPHARM Foundation Treasure Hunt is a CEO, ICON plc program offered to attendees and speakers during the breaks. It is an enjoyable way to meet fellow attendees and the DPHARM exhibitors. All who participate enter into a chance to win a $500 donation to a patient/disease foundation of their choice and two tickets to any Broadway show! 1 www.DPHARMconference.com DPHARM 2021 Agenda Track 1: Track 2: Track 3: Patient-Centered Solutions New Frontiers in Digital The Future of Clinical Trials Technology Track Chair Track Chair Track Chair Jessica Scott, MD, JD Doug Schantz Mark Travers, PhD, MBA Head of R&D Patient Engagement Vice President, Clinical Operations, VP, Head of GCTO Regions, Office, Takeda Pharmaceuticals Alexion Pharmaceuticals Monitoring Excellence, Global Operations and eTMF, Merck & Co. 10:55 am 10:55 am 10:55 am Integrating Patient-Centricity into Access to All: Bringing Clinical Trials Next Gen Solutions: Driving Protocol COVID-19 Clinical Research to Every Patient in Need Compliance in a Decentralized and • Strategies to find, enroll and equip The virtual-first clinical trial model, with a Hybrid Trial Environment COVID-19 positive (+) patients to care team that comes to the patient, is Last year’s events prompted an incredible remotely participate in treatment making it safer, more comfortable, and more response from the industry as sponsors, research convenient for patients to participate in and CROs and sites found innovative ways to • Lessons on how to reduce on-site benefit from clinical research. By making best keep trials on track. With the increasingly visits and protect vulnerable patient use of virtual tools and proven methods, it is decentralized nature of clinical trials, a populations, including for patients possible to design and manage clinical trials shift towards digitization, interoperability enrolled in vaccine research in a way that goes beyond what is expected and data intelligence will help to drive trial • Modalities for post-pandemic research for both sponsors and patients. This session efficiency and protocol compliance. as new variants emerge and long-term addresses how operational excellence, follow-up is needed making the best use of virtual tools and an Kyle Cunningham in-house care team have enabled them to Niklas Morton build Lightship and provide greater access to Chief Product Officer, Greenphire Senior VP, PPD® Digital, PPD clinical trials for all patients. David MacMurchy Chief Executive Officer, Lightship Sam Eells Co-Founder & Chief Design Officer, Lightship 11:05 am 11:05 am 11:05 am Thinking Further: Are we truly How Connecting Data and Analytics is Best Practices for Global DCT listening to patients, or just giving Driving Intelligent Actions Adoption lip service? Getting near real-time insights through Thread will share perspectives and best Are current industry insight practices analytics is streamlining processes and practices focused on scaled adoption of actually fostering ongoing engagement driving faster actions across clinical decentralized clinical trial approaches. with clinical trial participants, or are they development, especially with the use of more Topics include: simply checklists of things we feel we digital solutions. • Global implementation should include in our patient recruitment • How to move beyond pilots and retention planning? This session • The convergence of DCT technology and will examine current industry practices Liss Easy real-world data and explore what we can learn from our • The use of analytics to prove out the colleagues in commercial to ensure we VP, Clinical Technology Offerings, IQVIA value proposition of DCT better serve the patients and communities • The importance of working closely with we hope to support. research ambassador teams, participants & sites to enable change management. Sarah McKeown-Cannon Director, Strategic Relationships, John Reites Langland CEO, THREAD 2 www.DPHARMconference.com DPHARM 2021 Agenda Track 1: Track 2: Track 3: 11:15 am 11:15 am 11:15 am New Patient Survey Results on Leveraging a Connected Technology Site Training in Clinical Trials: Tools to Make Your Decentralized Ecosystem to Expedite Study Startup Preparedness without Site Burden Clinical Trials More Inclusive and Reduce Burden on Sites, Study Investigator training is a necessity in Get the latest survey findings that inform Teams, and Participants clinical trial execution. So, how can this innovative ways to engage a more diverse An overabundance of systems can result be done without burdening the sites with audience and drive inclusion as well as in inefficiency, reduction in data quality, and hours of training content requirements? strategies that engage patients where poor participant experience. This session This session will include practical and they are. will outline a path forward for an integrated actionable steps you can take to ensure technology ecosystem to centralize research site personnel are optimally prepared and to avoid significant risks to quality Alexia Medici workflows, streamline processes, and conduct a more participant-centric trial. and compliance. Highlights will include Account Executive, BBK Worldwide variation in Clinical Trial Training Delivery, how OnDemand & Virtual Training are Danielle Frate Aidan Gannon becoming the new standard and Perpetual Creative Director for Strategic Director of Client Services, Advarra Inspection Readiness in a single source. Services, BBK Worldwide Brian Schilb Sr Director, Training Solutions, WCG Clinical 11:25 am 11:25 am 11:25 am The Real ROI of a Patient Portal How a Global Connected Health How Flipping the Traditional Site How Can a Patient Portal Meaningfully Platform is Driving Patient Selection Model Brings Clinical Trials Benefit Trial Sponsors and Patients Alike? Adherence, Patient Outcomes and to the Patient Physician Loyalty In this session, attendees will learn Today, 70% of clinical trials are conducted through a live demo how a patient portal Pharma companies face multiple challenges by just 5% of the world’s sites, leading to works, how it builds trust and provides when developing digital solutions, from decreased patient access and increased meaningful patient insights. diversity of patient expectations, to meeting competition. This session addresses regulatory and compliance standards, which how flipping the site selection model and vary by country / region. partnering with a broader range of sites Thomas Klein leads to more accessible, inclusive, and Founder and CEO, Be The Partner Learn how ICON is applying its connected health platform to support commercial use effective clinical trials. Attendees will learn: cases that drive patient adherence and outcomes, as well as physician loyalty. • Innovative approaches to gauging early Digital solutions can be key to establishing a site interest and finding the best sites for differentiated brand strategy that focuses on each trial patient, caregiver and physician experience. • Approaches to partnering with a broader The real world data generated from these range of community-based sites solutions may be used to support additional • Insights from community site leaders who regulatory discussions. Learn how ICON successfully partnered with large, global can help Pharma companies shift from siloed sponsors to enroll underserved patients disconnected touchpoints to continuous ongoing relationships with patients, caregivers and providers, through implementation of Liz Beatty global DTx Solutions. Chief Strategy Officer, Inato Louisa Roberts VP Corporate Development and Partnerships, ICON plc 3 www.DPHARMconference.com DPHARM 2021 Agenda Track 1: Track 2: Track 3: 11:35 am 11:35 am 11:35 am Creating a RWD Ecosystem