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NEW FOR 2025: Networking tables throughout the day at Seamark at the Encore Boston Harbor. A dedicated space for connection and conversation throughout the day. Reserved for Regular and Premium participants.

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SUMMIT 2021

Agenda

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MONDAY

NOV 8

  • 06:00 AM - 06:00 PM EDT

ANTIGEN TESTING AVAILABLE

Please pre-book your antigen test here http://www.careaccess.com/boston

  • 07:00 PM EDT

BREAKFAST

  • 08:00 PM - 12:00 PM EDT

KEYNOTE SESSION

Speakers

  • Glen de Vries, CoFounder, Medidata, a Dassault Systèmes Company ( Featured Speaker )
  • Amy Abernethy, President, Clinical Studies Platforms, Verily ( Featured Speaker )
  • Antony Loebel, President and CEO, Sunovion Pharmaceuticals Inc. ( Featured Speaker )
  • Christian Angermayer, CEO & Founder, ATAI Life Sciences ( Featured Speaker )
  • Florian Brand, Chief Executive Officer, ATAI Life Sciences ( Featured Speaker )
  • Srinivas Rao, Co-Founder & Chief Scientific Officer, ATAI Life Sciences ( Featured Speaker )
  • Michelle Longmire, CEO, Medable ( Featured Speaker )
  • David Coman, Chief Executive Officer, Science 37 ( Featured Speaker )
  • John Reites, CEO, THREAD ( Featured Speaker )
  • Kabir Nath, President, North America Pharmaeuticals, Otsuka Pharmaceuticals ( Featured Speaker )
  • Najat Khan, Chief Data Science Officer and Global Head of R&D Strategy and Operations, Janssen, Janssen ( Featured Speaker )
  • 11:00 AM EDT

INNOVATION SHOWCASE PRESENTATION BY RIPPLE SCIENCE

Speakers

  • Peter Falzon, CEO, Ripple Science ( Presenting Company Speaker )
  • 11:00 AM EDT

INNOVATION SHOWCASE PRESENTATION BY CURAVIT

Speakers

  • Joel Morse, CEO & Co-founder, Curavit Clinical Research ( Presenting Company Speaker )
  • 11:00 AM EDT

INNOVATION SHOWCASE PRESENTATION BY HUMANFIRST

Speakers

  • Andrea Coravos, Co-Founder & CEO, HumanFirst, Inc. ( Presenting Company Speaker )
  • 11:00 AM EDT

INNOVATION SHOWCASE PRESENTATION BY CEREBRAL

Speakers

  • David Mou, Chief Medical Officer, Cerebral ( Presenting Company Speaker )
  • 11:00 AM - 12:00 PM EDT

Innovation Showcase Presentations

  • 12:00 PM EDT

LUNCHES

  • 01:00 PM - 01:15 PM EDT

NEW SOLUTIONS PRESENTATION: DATACUBED – TRANSFORMING THE PATIENT EXPERIENCE IN THE DIGITAL AGE

Speakers

  • Kyle Hogan, Chief Strategy and Marketing Officer, Datacubed Health ( Company Presenter )
  • 01:00 PM - 01:50 PM EDT

SPOTLIGHT SESSION: OPPORTUNITIES AND CHALLENGES OF COLLECTION WEARABLE DATA IN DECENTRALIZED CLINICAL TRIALS

Technology-enabled decentralized and hybrid clinical trial designs offer a multitude of benefits for patients and sponsors alike. Wearables provide a means to collect continuous, objective data from the comfort and safety of the patients’ home. This reduced dependence on site visits, combined with the passive nature of wearable devices, lowers the trial burden for patients. Furthermore, these tools provide high precision, real-world data, enhancing the clinical meaningfulness of outcome measures in alignment with regulators’ emphasis on patient-centered drug development. Despite the promise of DCTs, there are still hurdles that must be overcome in order to fully realize these benefits. Operational challenges, including technology deployment, compliance monitoring, and data collection and transfer, must be fully understood and addressed before the study begins. Additionally, trial sponsors may not be comfortable replacing traditional endpoints with wearable-enabled digital endpoints. During this Spotlight Session, a panel of experts will explore the opportunities these technology-enabled DCTs offer, the inherent challenges of this type of study design, and real-world strategic approaches for success.

Speakers

  • Craig Lipset, Co-Chair, Decentralized Trials & Research Alliance ( Featured Speaker )
  • John Reites, CEO, THREAD ( Featured Speaker )
  • Keith Wenzel, Senior Director, Scientific Data Organization, Parexel ( Featured Speaker )
  • Jeremy Wyatt, CEO, ActiGraph ( Featured Speaker )
  • 01:00 PM - 01:50 PM EDT

SPOTLIGHT SESSION: SWIPE RIGHT TO LINK RWD TO CLINICAL TRIAL DATA

The current gaps between clinical trial and real world data (RWD) make it hard to fully draw the insights necessary to understand long term outcomes and therapeutic efficacy – resulting in suboptimal data, costly delays or additional follow-up visits which increase the burden to sites, patients and sponsors alike. Access to compelling and relevant evidence is crucial to drug development, safety monitoring and better patient outcomes. Join this session to hear Arnaub Chatterjee, SVP Acorn AI Product and Ecosystem and Kelly McKee, VP of Patient Recruitment and Registries discuss how Medidata Link combined with myMedidata accelerates insights within & beyond the clinical trial using a high tech and high touch approach.

Speakers

  • Arnaub Chatterjee, Senior Vice President, Product (Acorn AI), Medidata, a Dassault Systèmes Company ( Featured Speaker )
  • Hassan Kadhim, Global Head, Clinical Trials Business Capabilities, Clinical Innovation and Industry Collaborations, Bristol-Myers Squibb ( Featured Speaker )
  • Kelly McKee, Vice President, Patient Recruitment and Registries, Medidata, a Dassault Systèmes Company ( Featured Speaker )
  • 01:00 PM - 01:50 PM EDT

Spotlight Session: Achieving Diversity in Clinical Trials: Overcoming Industry Challenges to Develop Actionable Plans for Implementation

In November 2020, the FDA released a guidance to expand diversity in clinical trial populations. This guidance outlines the need to expand the percentage of non-white participants to provide accurate representation of the population in the data sets. The guidance addresses eligibility criteria, enrollment practices and trial designs to achieve this outcome. The radical collision of COVID simultaneously with the MeToo, BIPOC and immigration movements is the ideal time to address diversity, equity and inclusion to include communities of color in the clinical trial lifecycle. Understanding socioeconomic, cultural and geographical differences while acknowledging discrimination is the first step in regaining trust in the pharmaceutical industry by minority populations. Only then will patients of color consider clinical trials as a healthcare option to address the pathology of illnesses in minority ethnicities, leading to more effective treatments for targeted demographics. This panel will explore the path of mistrust, potential solutions on the road to recovery, capitalizing on the COVID momentum and how each stakeholder can contribute to this global call to action.

Speakers

  • Shishuka Malhotra, Founder and CEO, Neurobehavioral Clinical Research INC ( Session Chair )
  • Alexandria Wise, SVP, Psychiatry, Syneos Health ( Session Chair )
  • Zach Mitchell, Director of Business Operations, iResearch Atlanta ( Featured Speaker )
  • Stacey Versavel, Senior Director- Early Phase & Scientific Operations, Cerevel Therapeutics (Featured Speaker )
  • Simone Whitmore, Clinical Site Investigator, iResearch Atlanta ( Featured Speaker )
  • Charles Wilcox, Ph.D., CEO, Praxis Research Consulting ( Featured Speaker )
  • 01:00 PM - 01:50 PM EDT

Spotlight Session: Implementing Digital Biomarkers in Clinical Development

The COVID-19 pandemic has highlighted an acute need to develop and validate digital biomarkers to support clinical trials. These tools may include repositioning a wearable device from healthcare delivery to clinical research, changing its context of use, or developing a new measure to collect data from patients’ homes instead of hospital visits. What should clinical teams consider when selecting devices for biomarker-based mobile measures? What validation experiments need to be designed and completed before these tools can be deployed in interventional studies? Which aspects of device selection and validation can be done, via pre-competitive consortia collaboration efforts, and which should be kept internally? We will discuss key aspects of implementing digital biomarkers in drug development with experts from a pre-competitive consortium and throughout the industry.  

Speakers

  • Elena Izmailova, Chief Scientific Officer, Koneksa ( Featured Speaker )
  • Derek Buhl, Scientific Director, Takeda Pharmaceuticals ( Featured Speaker )
  • Aaron Kithcart, Association Medical Director, Regeneron Pharmaceuticals (Featured Speaker )
  • James Donohue, Senior Manager, Patient Innovation, Regeneron Pharmaceuticals ( Featured Speaker )
  • Diane Stephenson, Executive Director, Critical Path for Parkinson’s Consortium, Executive Director, Critical Path for Parkinson’s Consortium ( Featured Speaker )
  • 01:00 PM - 01:50 PM EDT

Spotlight Session: The Patients are Waiting – Reducing 10 Years of Development to Less Than 10 Months

How the use of Risk Based-Quality Management (RBQM) and Centralized Monitoring Enabled Pfizer’s Covid-19 Vaccine Development in record time. Understand how and why RBQM principles and centralized monitoring were applied to the Pfizer Covid-19 vaccine program. Review key take-aways to inform future RBQM & Centralized Monitoring best practice. How the RBQM-focused approach can and will be replicated across the portfolio.

Speakers

  • Stephen Young, Chief Operations Officer, Cluepoints ( Featured Speaker )
  • Lynne Cesario, Senior Director, Global Risk Based Monitoring Lead, Pfizer ( Featured Speaker )
  • 01:00 PM - 03:00 PM EDT

Spotlight Session: Extrapolation of Efficacy and Use of Synthetic Control Arms in CNS Pediatric Trials

A discussion of recent FDA guidances of the use of extrapolation in lieu of short-term efficacy pediatric studies in some CNS pediatric indications such as pediatric epilepsy and adolescent schizophrenia. Methodology of PK exposure matching between adult and pediatric data within the indication to establish pediatric dosing, therefore support the extrapolation of short-term efficacy in pediatric patients and the US sNDA submission with extrapolation for CNS pediatric indications. The potential use of synthetic control arms could reduce number of trial participants in clinical trials and limit the number of pediatric patients randomized in placebo arms.

Speakers

  • Eva Kohegyi MD, Executive Director, GCD-CNS, Otsuka Pharmaceuticals ( Session Chair )
  • Yuko Hirata, Medical Director, Avanir Pharmaceuticals ( Featured Speaker )
  • Shailly Mehrotra, Associate Scientific Director, Takeda Pharmaceuticals ( Featured Speaker )
  • Yanlin Wang, Sr. Scientist, Otsuka Pharmaceuticals ( Featured Speaker )
  • Shuvayu Sen, Vice President and Head, Value and Real World Evidence, Otsuka Pharmaceuticals ( Featured Speaker )
  • Sarah Atkinson, MD, Principal Investigator, Evolution Research Group ( Featured Speaker )
  • Xiaofeng Wang, Otsuka Pharmaceuticals ( Featured Speaker )
  • Caroline Ward, Director, Global Clinical Development, Otsuka Pharmaceuticals ( Featured Speaker )
  • Argie Zoubroulis, Manager, Global Regulatory Affairs, Otsuka Pharmaceuticals ( Featured Speaker )
  • 01:00 PM - 03:00 PM EDT

Spotlight Session: Neuroscience

Speakers

  • Stephen Brannan, Chief Medical Officer (CMO), Karuna Therapeutics ( Session Chair )
  • Harry Tracy, President, NI Research ( Featured Speaker )
  • Antony Loebel, President and CEO, Sunovion Pharmaceuticals Inc. ( Featured Speaker )
  • Bill Martin, Global Head of Neuroscience, Janssen R&D (J&J), Janssen ( Featured Speaker )
  • Michael Gold, Vice President, AbbVie ( Featured Speaker )
  • Steve Paul, CEO, Karuna Therapeutics ( Featured Speaker )
  • Vikas Mohan Sharma, Global Head of Medicine CNS, Retinopathies & Emerging Areas, Boehringer Ingelheim Pharma Inc. ( Featured Speaker )
  • Amit Etkin, CEO, Alto Neuroscience ( Featured Speaker )
  • Murali Doraiswamy, Professor, Duke University School of Medicine ( Featured Speaker )
  • 01:20 PM - 01:35 PM EDT

New Solutions Presentation: – Cambridge Cognition – Cognitive Assessments and Enhancing Contextual Insight Into Passive Physiological Measures

Speakers

  • Nathan Cashdollar, Director of Digital Neuroscience, Cambridge Cognition ( Company Presenter )
  • 01:40 PM - 01:55 PM EDT

New Solutions Presentations: Empatica – Crossing the FDA Finish Line with Your Digital Biomarker Design: Empatica Presents Your How-to Guide

Speakers

  • Chelsea Trengrove, Director of Business Development , Empatica ( Company Presenter )
  • 02:00PM - 02:15 PM EDT

New Solutions Presentation: – Intelligencia.Ai – AI to Assess, Understand and Reduce the Risk of Drug Development

Our mission at Intelligencia is bringing new therapies to patients faster through data science. We combine exceptional data with the computational power of AI to quantify and improve clinical success and to enhance sourcing of external innovation. Our customers – large pharmaceutical companies, and biotechs ranging from multi-billion large-cap to emerging preclinical – use Intelligencia’s platform to (i) assess the probability of technical and regulatory success (PTRS) of their development programs and minimize any risks, (ii) optimize trial design and evaluate additional indications for a clinical asset, (iii) evaluate the relative attractiveness external assets, and (iv) predict likely future areas of scientific innovation. Our team is made up of industry veterans, data scientists, bioinformaticians, software engineers, biologists, and drug developers.

Speakers

  • Vangelis Vergetis, CEO/Cofounder, intelligencia ( Company Presenter )
  • 02:00PM - 02:50 PM EDT

Spotlight Session: The Seven Essentials of Clinical Development: How to Avoid Shooting Yourself in the Foot

In our many decades of combined experience in clinical medicine, academic research, regulatory affairs, and development of drugs and medical applications of information technology, we have had the privilege of being involved with dozens of drug and device trials and clinical development programs. Many were successful but too many failed, even when a drug or device likely had a favorable effect on disease outcome. In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors – none of which can be mitigated by novel or “cutting edge” study designs – consistently emerge as essential components of success and failure. Although all are largely within control of the developers, many are often inadequately considered or overlooked. Our goal is to remind us of the details and importance of these essentials so that effective therapies have a greater likelihood of reaching patients in need.

Speakers

  • John Greist, Chief Medical Officer, Meret Solutions, LLC ( Featured Speaker )
  • Thomas Laughren, Director, Laughren Psychopharm Consulting, LLC ( Featured Speaker )
  • Jack Modell, Chief Medical Officer, Rho, Inc ( Featured Speaker )
  • 02:00PM - 02:50 PM EDT

Spotlight Session: The Role of Continuous Remote Biosensors in Decentralized Trials

Decentralized trials represent patient-centric trial delivery models and are transforming the way we think about clinical development. Allowing patients to remain at home, however, requires innovative solutions in terms of data collection and maximizing clinical insight. Continuous remote biosensors provide data streams that not only support decentralized models, but also generate physiological insight that transforms safety monitoring, study endpoints and trial operations. This panel will explore where we are and where we’re going, with respect to optimizing decentralized trial models by using wearable sensors and advanced analytics.

Speakers

  • Robert Bolduc, Sr. Director, Product, Science 37 ( Featured Speaker )
  • Kenneth Mosca, Senior Manager, Digital Health, Janssen ( Featured Speaker )
  • Steve Steinhubl, Chief Medical Officer, physIQ ( Featured Speaker )
  • Alexandria Wise, SVP, Psychiatry, Syneos Health ( Featured Speaker )
  • 02:00PM - 02:50 PM EDT

Spotlight Session: Leveraging AI to Accelerate Clinical Research

Clinical trials are known to be burdened by slow timelines, excessive costs, and high failure rates. The availability of large, rich clinical datasets and the rapid development of artificial intelligence (AI) technologies mean that clinical trials don’t have to remain stuck in the status quo. Hear from thought leaders and subject matter experts about how AI is being leveraged across the entire life cycle of clinical research, from curating real world evidence and expediting clinical trials to informing and influencing regulatory decisions.

Speakers

  • James Boiani, Member of the Firm, Epstein Becker Green ( Featured Speaker )
  • Rich Christie, Chief Medical Officer, AiCure ( Featured Speaker )
  • Charles Fisher, Founder & CEO, Unlearn.AI ( Featured Speaker )
  • Scott Kollins, Chief Medical Officer, Holmusk ( Featured Speaker )
  • 02:00PM - 02:50 PM EDT

Spotlight Session: Advancing Health Equity in Pharma: Leveraging SDoH Data & Analytics

Hear case examples and best practices to leveraging SDoH insights to address health disparities

Speakers

  • Jean Drouin, CEO, Clarify Health ( Featured Speaker )
  • Laurie Myers, Director, Global Health Literacy & Oncology Health Equity, Merck (Featured Speaker)
  • Lorena Kuri, Head, Diversity Strategy Global Clinical Trial, Bristol-Myers Squibb (Featured Speaker)
  • Kenneth Park, SVP & GM of Life Sciences Solutions, Clarify Health (Featured Speaker)
  • 02:00PM - 02:50 PM EDT

Spotlight Session: How Do We Empower Participants and Improve Retention in Clinical Research?

Join us as we share learnings and best practices for leading participant-centric, decentralized studies that leverage the most ubiquitous healthcare resource: the smartphone. Our session will explore challenges impacting the integrity of studies as clinical research and development push toward new heights and market opportunities. With examples from studies on rare and common diseases, we will explore: promising new research methods for collecting continuous, real-word data; applications for digital biomarkers with predictive artificial intelligence (AI) modeling; the design of seamless digital experiences for researchers and participants; how to achieve richer electronic patient-reported outcomes (ePROs) with value-add incentives; ensuring diversity and inclusivity in research recruitment and its long-term impact

Speakers

  • Nirav Shah, Chief Medical Officer, Sharecare ( Featured Speaker )
  • Colin Lake, Head of Digital Care Transformation Neurology, UCB ( Featured Speaker )

 

  • 02:20PM - 02:35 PM EDT

New Solutions Presentation: Advarra – Connecting Sites, Sponsors, and CROs at the Intersection of Safety, Innovation, and Collaboration for the Advancement of CNS Research

With visibility into over 50% of US clinical trials, and more than 50,000 principal investigators (PIs) using Advarra’s solutions, Advarra is uniquely positioned at the intersection of collaboration, innovation, and safety to help sites and sponsors develop CNS therapies and bring these to patients faster.  Join us to learn what this means for you—including how Advarra connects sponsors with sites to accelerate study startup, as well as increase quality data and improve study conduct in this complex therapeutic area.

  • 02:40 PM - 02:55 PM EDT

New Solutions Presentations: Hawthorne Effect – Addressing the Core Challenges with Access in Clinical Trials

Speakers

  • Jodi Akin, CEO, Hawthorne Effect, Inc. ( Company Presenter )
  • 03:30 PM - 05:00 PM EDT

One to One Networking

  • 05:00 PM EDT

Exhibits, Posters, Happy Hour Reception

View the ICNS abstract supplement here.

  • 07:00 PM EDT

Chairman’s Reception

  • 08:00 PM EDT

Hosted Reception: Biohaven

  • 09:00 PM EDT

Hosted Reception: Pink Socks Meetup

See List of 2021 Speakers

Learn More