07:00 AM - 07:45 AM
EDT
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Breakfast
Location: Grand Assembly
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07:00 AM - 05:00 PM
EDT
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Antigen Testing Available
Location: Grand Salon A
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08:00 AM - 12:00 PM
EDT
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Keynote Sessions
Location: Royal Palm Ballroom
Speaker(s): Amy Abernethy, Verily; Vlad Coric, Biohaven; Michelle Keefe, Syneos Health; Najat Khan, The Janssen Pharmaceutical Companies of Johnson & Johnson; Candace Saldarini, Otsuka; Reed Tuckson, Tuckson Health Connections, LLC; Brent Vaughan, Cognito Therapeutics
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10:45 AM - 10:55 AM
EDT
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Innovation Showcase: Flatiron Health
Location: Royal Palm Ballroom
Speaker(s): Hugh Levaux, Flatiron Health
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10:55 AM - 11:05 AM
EDT
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Innovation Showcase: VersaTrial
Location: Royal Palm Ballroom
Speaker(s): Mike Wenger, VersaTrial
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11:05 AM - 11:15 AM
EDT
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Innovation Showcase: Cumulus Neuroscience
Location: Royal Palm Ballroom
Speaker(s): Aman Bhatti, Cumulus Neuroscience
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11:15 AM - 11:25 AM
EDT
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Innovation Showcase: ALCEDIAG
Location: Royal Palm Ballroom
Speaker(s): Marianne Morini, ALCEDIAG
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11:25 AM - 11:35 AM
EDT
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Innovation Showcase: Pluto Health
Location: Royal Palm Ballroom
Speaker(s): Joy Bhosai MD MPH, Pluto Health
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12:00 PM
EDT
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Boxed Lunches
Please pick up your boxed lunch and proceed to your breakout room.
Location: Grand Assembly
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12:00 PM - 12:15 PM
EDT
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New Solutions: Empatica
Location: Estate III
Speaker(s): Marisa Cruz, Empatica
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12:00 PM - 12:50 PM
EDT
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Spotlight Session: AI at the Point of Care - Faster Trials, Expanded Market Access
AI is a leapfrog technology in the field of healthcare that is already improving how we detect, monitor and treat diseases, from stroke to heart disease, at the point of care in thousands of hospitals. Now AI-powered care coordination is increasingly being used in the clinical trials to identify eligible and more diverse candidates, connect and research teams, and speed up enrollment. Post-launch, AI-powered care coordination is expanding market access by detecting disease in more patients and connecting the right patients to the right providers.
Join this session as a panel of experts discusses use cases and benefits as well as potential pitfalls of using AI at the point of care throughout clinical development and commercialization.
Location: Addison East
Speaker(s): Wendy Elliott, Marcus Neuroscience Institute, Baptist South; Ryan Kennedy, Oracle; Chris Mansi, Viz.ai; Meri Scott, Eli Lilly and Company; Mason Tenaglia, BioReinsurance Group
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12:00 PM - 12:50 PM
EDT
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Spotlight Session: Connecting People, Data, and Technology to Make a Substantial, Lasting, and Measurable Impact on Patient and Site Burden
The pharma industry’s increasing focus on alleviating patient and site burden in clinical trials stems from the effect complexity, hence burden, has on study success. But it’s a hard goal to achieve – for a single study, let alone at scale across an entire portfolio of trials. Stakeholders from different facets of the clinical trial industry – patient, site, sponsor, and data/tech/service providers – will come together to discuss what patient and site burden means to them; how it is addressed in clinical trial planning and execution today; what meaningful improvement looks like and what is required to achieve this; and how we can connect people, data, and technology to make significant, sustainable improvements for all.
Location: Estate II
Speaker(s): Lauren Briggs, Citeline (formerly Informa Pharma Intelligence); Christina Fawcett, GSK; Felicia Irvin, Centricity Research; Joseph Kim, ProofPilot; Ted Trafford, Probity Medical Research
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12:00 PM - 12:50 PM
EDT
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Spotlight Session: Innovation in At-Home Specimen Collection
Given the rise of trials at-home, what are the smart ways emerging to ensure reliable specimens can be collected, tracked and analyzed?
Location: Estate I
Speaker(s): Erwin Berthier, Tasso Inc; Stacy Hurt, Independent; Craig Lipset, Decentralized Trials & Research Alliance; Joy Somogyi, ixlayer; Shawn Tedman, ixlayer
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12:00 PM - 12:50 PM
EDT
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Spotlight Session: The Next Evolution of Study Delivery: Shifting the Paradigm to Bringing Trials Into the Community
The traditional dedicated clinical trial site approach has been the gold standard for a long time; however, there is a growing need to evolve how and where studies are conducted. Patients have become more mobile, more digitally enabled, and more discriminating about when to engage with clinical trials. At the same time, many are excluded from research. Delivery models for clinical trials have progressed, including a greater reliance on decentralized/hybrid trials (DCTs) and conducting studies in community settings, to improve the focus on patient access and to increase patient participation. The changing landscape allows for better patient optionality, giving them choices of where to participate: retail clinical site, home, virtual, or traditional site. This needed shift expands the clinical trial model to accelerate enrollment of diverse patient populations and embraces a faster and more effective study delivery. During this Signature Session, a panel of senior leaders will explore these innovations and how they lead to increased access, health equity, and engagement.
Location: Grand Ballroom D
Speaker(s): Najat Khan, The Janssen Pharmaceutical Companies of Johnson & Johnson; Michelle Longmire, Medable; Jamie Macdonald, Parexel; Kyu Rhee, CVS Health; Josh Rose, CVS Health
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12:00 PM - 01:50 PM
EDT
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Spotlight Session: A 360º View of Diversity in Clinical Trials
Join Medidata and Circuit Clinical to learn more about the diversity of diversity in clinical research. We’ve got an all-star line-up of guests to speak to the value of data and benchmarking of diversity as well as site, patient, and sponsor perspectives. In this friendly and provoking session, Kelly and Dana will focus on improving access, awareness, and inclusion across the value chain. Adding to the talk show experience, top ten lists, thank you notes, and mean tweets will be shared. This is a can’t miss session of CNS!
Location: Addison West
Speaker(s): Aman Bhatti, Cumulus Neuroscience; Dana Edwards, Circuit Clinical; Christina Fawcett, GSK; Hassan Kadhim, Bristol Myers Squibb; Kelly McKee, Medidata, a Dassault Systèmes company; Kemi Olugemo, Laronde; Daniel Perez, Worldwide Clinical Trials; Josh Rose, CVS Health; Del Smith, Acclinate; Alicia Staley, Medidata, a Dassault Systèmes company; Christine Von Raesfeld, People With Empathy
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12:00 PM - 02:30 PM
EDT
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Neuroscience Spotlight
Location: Royal Palm Ballroom
Speaker(s): Scott Braunstein, Marinus Pharmaceuticals; Murali Doraiswamy, Duke University School of Medicine; Mike Egan, Merck & Co.; Joshua Gordon, National Institute of Mental Health; Terence Kelly, Perception Neuroscience; Harry Tracy, NI Research
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12:15 PM - 12:30 PM
EDT
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New Solutions: Evernorth
Location: Estate III
Speaker(s): Ria Westergaard, Evernorth
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12:30 PM - 12:45 PM
EDT
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New Solutions: Mural Health
Location: Estate III
Speaker(s): Samuel Whitaker, Mural Health
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12:45 PM - 01:00 PM
EDT
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New Solutions: Datacubed
Location: Estate III
Speaker(s): Kyle Hogan, Datacubed Health; Natasha Massias, Datacubed Health
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01:00 PM - 01:15 PM
EDT
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New Solutions: Pro-ficiency
Location: Estate III
Speaker(s): David Hadden, Pro-ficiency
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01:00 PM - 01:50 PM
EDT
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Spotlight Session: A Prescription for Clinical Trials: Setting Up DCT for Long-Term Success
Decentralized clinical trials (DCT) experienced a significant upsurge during the pandemic. The adoption of this important clinical trial system of capabilities is decelerating with the market partially returning to the ways of working before Pandemic-era restrictions necessitated widescale adoption of DCT techniques. There are several reasons for this slowdown, including the following:
- And vs Or: Many experts, including those at Cognizant, posited from the beginning that in the long term, DCT would represent one suite of arrows in the full quiver of clinical capabilities, versus supplanting the entire academic center based system of clinical trials
- Existing Infrastructure: Sponsors have made significant, multi-decades long investments in the traditional, pre-DCT systems, and this prior infrastructure represents an inertial mass that simply cannot be abandoned for the build phase of DCT
- In the fullness of time: The pandemic was too short to produce DCT stickiness. Many DCT-based improvements, including the emergence of DCT platforms, have not had sufficient time in market to overcome risk perceptions related to capacity and robustness of solutions `
Confident in the transformational impact of the DCT model, market-leading firms continue to invest in helping our industry reach an equilibrium where DCT constitutes 30-50% of overall studies. In this panel discussion, we will explore the following topics:
Critical capabilities required in the DCT model
- Lessons learned from the DCT experiments to date
- DCT platform providers who are emerging as market leaders
- What else must we do to bring about the promise of DCT?
Location: Addison East
Speaker(s): Bryan Hill, Cognizant; Avi Kulkarni, Cognizant; Craig Lipset, Decentralized Trials & Research Alliance; Sanskriti Thakur, Medable
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01:00 PM - 01:50 PM
EDT
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Spotlight Session: Leverage AI Driven NLP to Optimise Real World Data, Accelerate Clinical Trials and Deliver Precision Medicine
This session, led by Mark Messenbaugh (Advisor, Akrivia Health), sets out to discuss how real-world data can be leveraged for optimising clinical trials and precision neuroscience. Precision Neuroscience combines detailed clinical phenotyping, genomic sequencing, biobanking for ‘omics, and digital health to gain unique clinical and molecular insights into mental health and dementias. We will delve into how real-world data and evidence can support the development of drugs from target product profiles, clinical trial acceleration, and finally to provide the invaluable evidence needed for approval, to deliver these vital drugs to the caregivers and patients who need them most. *Join Akrivia Health, an Oxford-based company dedicated to the advancement of drug discovery and development for mental health and dementias, through real-world data, advanced AI driven NLP, and partnerships with mental health care providers to positively impact patient lives.
Location: Estate II
Speaker(s): Mark Messenbaugh, Akrivia Health; David Newton, Akrivia Health; Sian Ratcliffe, Biogen; Gayle Wittenberg, Janssen Research & Development
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01:00 PM - 01:50 PM
EDT
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Spotlight Session: Making Digital Measures Fit-For-Purpose in Alzheimer’s Trials
Digital tools offer novel insights into Alzheimer’s disease with the opportunity to measure, and by extension manage, what matters most to patients. However, to realise the benefits of digital measurement, understanding how to engage patients with these tools is key. Attendants to this session on Making digital measures fit-for-purpose in Alzheimer’s trials will learn:
-Development and validation frameworks for digital measures in clinical trials
-Feasibility and useability of digital measures with older adults
-Principles and process recommendations for digital measures in Alzheimer’s trials
Location: Estate I
Speaker(s): Francesca Cormack, Cambridge Cognition; Aaron Koenig, Sage Therapeutics
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01:00 PM - 01:50 PM
EDT
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Spotlight Session: Powering Digital Biomarkers with Integrated Analytics Platforms
The evolution of digital health technologies and biomarkers in clinical trials will depend on ensuring the highest standards of data collection, transmission, security, quality, and analysis. Scalable clinical analytics platforms built within core engineering frameworks are the only way to ensure the integrity, repeatability, and value of data standards and insights. In this session, with groundbreaking NIH-funded neurology research and the WATCH-PD study as examples, we will lead an interactive discussion about how high-dimensional data sources--which allow patients to be monitored more precisely, objectively, and with higher frequency--and resulting development of digital biomarkers necessitate a new paradigm of engineering-forward analytics solutions.
Location: Grand Ballroom D
Speaker(s): David Anderson, PhD, Clinical ink; Matthew Rizzo, University of Nebraska Medical Center
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01:30 PM - 01:45 PM
EDT
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New Solutions: PCM Trials
Location: Estate III
Speaker(s): Ellen Weiss, PCM Trials
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02:00 PM - 02:15 PM
EDT
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New Solutions: ZS
Location: Estate III
Speaker(s): Emily Goldsher-Diamond, ZS Associates; April Lewis, ZS Associates
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02:00 PM - 02:50 PM
EDT
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Spotlight Session: Digital Clinical Trials - Creating a Vision for the Future
The shift to decentralized trials has highlighted the need for better data management and direct digital connections that link sponsors, sites, and patients. Success with patient-centered digital clinical trials also hinges on engaging patients in various ways and managing huge volumes—and new forms—of data.
Join us as we explore the industry-wide move toward end-to-end digital trials for a seamless flow of information across patients, sites, and sponsors to create a connected trial ecosystem. We’ll discuss the key challenges of decentralized trials, how the industry can advance toward a digital and connected future, and the critical need for a strong data foundation.
Location: Estate II
Speaker(s): Andrew Moniz, Syneos Health; Jim Reilly, Veeva Systems; Lauren Sunshine, Bristol Myers Squibb; Richard Young, Veeva Systems
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02:00 PM - 02:50 PM
EDT
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Spotlight Session: Digital Phenotyping in Rare Disease: Using Real-world Data to Accelerate the Cycle from Research to Care
Location: Estate I
Speaker(s): Zeenia Framroze, Smart Omix by Sharecare; Franscesca Rinaldo, Smart Omix by Sharecare
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02:00 PM - 02:50 PM
EDT
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Spotlight Session: Partnering to Accelerate Clinical Development with AI
Clinical trials are becoming increasingly decentralized, customized, and built on precise predictions of clinical trial outcomes, which will lessen the resource burden on participants. Artificial Intelligence (AI) is at the forefront of this transformation by making clinical trials safer, more effective, and above all, patient-centric. Hear from a panel of industry leaders to discuss how pharma can partner with companies to implement innovative AI and how pharma is developing AI internally. The collective goal is to accelerate the clinical development process with AI, making trials significantly more efficient within an acceptable regulatory framework.
Location: Grand Ballroom D
Speaker(s): Bryan J. Hansen, Janssen Research & Development; Alex Morozov, Stealth; Luis Olmos, Unlearn.AI; Venkat Sethuraman, Bristol Myers Squibb
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02:00 PM - 02:50 PM
EDT
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Spotlight Session: Psychedelics Forum
Location: Addison East
Speaker(s): Rolando Gutierrez-Esteinou, atai Life Sciences; Amir Inamdar, Cybin Corp.; Rishi Kakar, Segal Trials; Dan Karlin, MindMed
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02:00 PM - 02:50 PM
EDT
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Spotlight Session: The Next Chapter for Digital Therapeutics
Location: Addison West
Speaker(s): Edward Cox, Pfizer; Marty Culjat, EVERSANA; Melinda Decker, MAJ Global Consulting; Aaron Gani, BehaVR, Inc.
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02:15 PM - 02:30 PM
EDT
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New Solutions: Clinical Research IO
Location: Estate III
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02:30 PM - 02:45 PM
EDT
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New Solutions: OM1
Location: Estate III
Speaker(s): Carl Marci, OM1, Inc.
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03:30 PM - 05:00 PM
EDT
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One to One Networking
Location: Royal Palm Ballroom
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05:00 PM - 07:00 PM
EDT
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Special Evening Event & Exhibits & Posters
View the ICNS abstract supplement here.
Location: Grand E-J
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07:00 PM - 08:00 PM
EDT
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Chairman's Reception
Everyone with a red star on their badge is welcome!
Location: Addison Ballroom
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08:00 PM - 09:30 PM
EDT
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Hosted Reception: Lightship
All are welcome!
Location: Estate Ballroom
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09:00 PM
EDT
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Betty Woodaman Fundraiser
All are welcome!
Location: Cloister Building, 5th Floor, Suite 536
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09:00 PM
EDT
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Pink Socks Meet Up
All are welcome!
Location: Palm Court
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