2021 Agenda


  • *All session times are in Eastern Time.


  • 8:00 am

  • DPHARM platform opens along with the ability to network with fellow attendees with Meeting Mojo

    Graciously hosted by  MMG

  • 8:25 am

  • DPHARM Welcome


    Jamie Macdonald
    CEO, Parexel


  • Patient Keynote

  • 8:30 am

  • DPHARM 2021 Patient Keynote Presentation

    Karlin Schroeder new
    Stacy Hurt, MHA, MBA

    Patient Keynote Speaker
    Advocate, Caregiver, Consultant


  • Leadership Talk

  • 9:00 am

  • Learnings from the Leadership of the Collaboration that Delivered a COVID Vaccine in Record Time

    Managing roughly 47,000 patients through a COVID vaccine clinical trial in less than six weeks required enormous cooperation, speed, new thinking and determination. The DPHARM audience will hear first-hand about the leadership, process and lessons from this extraordinary collaboration.

    Karlin Schroeder new
    Rob Goodwin, MBA

    Vice President, Operations Center of Excellence, Global Product Development, Pfizer


    Steve Cutler, PhD, MBA

    CEO, ICON plc


  • Zeitgeist Talk

  • 9:30 am

  • Data Science as the Backbone in Getting the JnJ Vaccine to Market in Record Time

    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.

    Amy Abernethy
    Najat Khan, PhD

    Chief Data Science Officer and Global Head, Janssen R&D Strategy and Operations, Johnson and Johnson

     

  • 9:50 am

  • Verily Project Baseline: Collaborating to Invent a Better Future for Patients

    Amy Abernethy
    Amy Abernethy, MD, PhD
    President, Clinical Research Platforms, Verily Life Sciences

     

  • 10:35 am
    - 10:50 am

  • DPHARM Morning Break

  • 10:45 am

  • DPHARM Announcements

  • 10:50 am

  • Patient-Centered Innovative Sources and Solutions for the Future of Clinical Trials

    The companies listed below will present on what they are specifically solving to advance clinical trials, enable R&D digital transformation, increase efficiencies, and or to reduce the burden to patients and investigators. 

    • Track 1

      Patient-Centered Solutions

       

      Track Chair:


      Jessica Scott, MD, JD

      Head of R&D Patient Engagement Office, Takeda Pharmaceuticals


      10:55 am

      Integrating Patient-Centricity into COVID-19 Clinical Research

      • Strategies to find, enroll and equip COVID-19 positive (+) patients to remotely participate in treatment research
      •  Lessons on how to reduce on-site visits and protect vulnerable patient populations, including for patients enrolled in vaccine research
      • Modalities for post-pandemic research as new variants emerge and long-term follow-up is needed


      Niklas Morton

      Senior VP, PPD® Digital, PPD

       

       

       

       


      11:05 am

      Thinking Further: Are We Truly Listening to Patients, or Just Giving Lip Service?

      Are current industry insight practices actually fostering ongoing engagement with clinical trial participants, or are they simply checklists of things we feel we should include in our patient recruitment and retention planning? This session will examine current industry practices and explore what we can learn from our colleagues in commercial to ensure we better serve the patients and communities we hope to support.


      Sarah McKeown-Cannon

      Director, Strategic Relationships, Langland


      11:15 am

      Leverage New Patient Survey to Make Your Studies More Diverse & Inclusive

      The August 2021 Patient Voices survey results will be unveiled, providing insight into tools and tactics to make studies more diverse and inclusive. Learn the benefits of an engagement solution center for enrollment success.


      Alexia Medici

      Account Executive, BBK Worldwide


      Danielle Frate

      Creative Director for Strategic Services, BBK Worldwide

       


      11:25 am

      The Real ROI of a Patient Portal

      How Can a Patient Portal Meaningfully Benefit Trial Sponsors and Patients Alike? 

      In this session, attendees will learn through a live demo how a patient portal works, how it builds trust and provides meaningful patient insights. 


      Thomas Klein

      Founder and CEO, Be The Partner

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       


      11:35 am

      Is the Patient Voice Being Lost with Advancing Technologies?

      This session will address what technology will work post the COVID era. Questions will be answered like are we considering patient technology literacy when trying to engage the patient and how does the patient voice influence this? How is the patient perspective continuing to influence new technologies?


      Kelly Franchetti, RN,CCRN,CEN

      Senior Vice President, Global Head Patient Insights & Strategy, YPrime

       

       

       

       

       

       

       

       

       

       

       

       

       

       


      11:45 am

      Three Key Learnings to Create Vastly Better Patient Experiences in DCTs

      The Innovation that comes from being at the center of key relationships has had a tremendous impact on how a patient can experience a decentralized clinical trial. In this session, our presenter goes through three key learnings in customizing a patient’s experience and how to avoid alienation in a DCT. More specifically: 

      1. Understanding how patient perspectives have changed and insights into accommodating them through engagement
      2. Building an investigator network that allows you to select an investigator who will be a trusted match for a patient  
      3. Utilizing diagnostic data to identify patients directly who may benefit from a clinical trial and the impact on enrollment

      Earl Seltzer
      Senior Director, Feasibility and Site Selection, Labcorp

       


      11:55 pm

      Bringing Phlebotomy Services to Where the Patients Are

      In this session, learn how Portamedic brings phlebotomy and home-based medical services to where the patients are. These kind of portable services help to enable decentralized clinical trials.

      Craig Vaughan
      Vice President, Sales, Portamedic


      12:00 pm

      Track 1 Concludes

    • Track 2

      New Frontiers in Digital Technology

       

      Track Chair:


      Doug Schantz

      Vice President, Clinical Operations, Alexion Pharmaceuticals


      10:55 am

      Access to All: Bringing Clinical Trials to Every Patient in Need

      The virtual-first clinical trial model, with a care team that comes to the patient, is making it safer, more comfortable, and more convenient for patients to participate in and benefit from clinical research. By making best use of virtual tools and proven methods, it is possible to design and manage clinical trials in a way that goes beyond what is expected for both sponsors and patients. This session addresses how operational excellence, making the best use of virtual tools and an in-house care team have enabled them to build Lightship and provide greater access to clinical trials for all patients.


      David MacMurchy

      Chief Executive Officer, Lightship


      11:05 am

      How Connecting Data and Analytics is Driving Intelligent Actions

      Getting near real-time insights through analytics is streamlining processes and driving faster actions across clinical development, especially with the use of more digital solutions.


      Liss Easy

      VP, Clinical Technology Offerings, IQVIA

       

       

       

       

       

       

       


      11:15 am

      Leveraging a Connected Technology Ecosystem to Expedite Study Startup and Reduce Burden on Sites, Study Teams, and Participants

      An overabundance of systems can result in inefficiency, reduction in data quality, and poor participant experience. This session will outline a path forward for an integrated technology ecosystem to centralize research workflows, streamline processes, and conduct a more participant-centric trial.


      Aidan Gannon

      Director of Client Services, Advarra

       

       

       


      11:25 am

      How a Global Connected Health Platform is Driving Patient Adherence, Patient Outcomes and Physician Loyalty

      Pharma companies face multiple challenges when developing digital solutions, from diversity of patient expectations, to meeting regulatory and compliance standards, which vary by country / region.

      Learn how ICON is applying its connected health platform to support commercial use cases that drive patient adherence and outcomes, as well as physician loyalty.  Digital solutions can be key to establishing a differentiated brand strategy that focuses on patient, caregiver and physician experience. The real world data generated from these solutions may be used to support additional regulatory discussions.   Learn how ICON can help Pharma companies shift from siloed disconnected touchpoints  to continuous ongoing relationships with patients, caregivers and providers, through implementation of global DTx Solutions.


      Louisa Roberts

      VP Corporate Development and Partnerships, ICON plc


      11:35 am

      Using AI/ML & RWD to Revolutionize Clinical Study Recruitment for Rare and Specialty Diseases

      Clinical studies investigating rare and specialty conditions pose unique challenges for life sciences companies with more than 90% failing to meet patient recruitment goals. The traditional clinical study playbook designed for high prevalence and highly diagnosed diseases is simply not applicable. This session will offer an alternative approach that applies artificial intelligence and machine learning against real world data to uncover medically eligible undiagnosed patients and their healthcare ecosystems, optimize site and investigator selection and improve clinical study recruitment efforts for low prevalence, low diagnosed conditions. Attendees will learn firsthand how this revolutionary approach can help their clinical study recruitment through specific use cases from leading biotechnology and pharmaceutical brands.


      John Seaner

      Chief Marketing Officer, IPM.ai, a part of Real Chemistry


      11:45 am

      Building a Digital Site Footprint for the Future of Patient-First Clinical Trials

      You will learn how pharmaceutical sponsors are building digital site footprints to support the patient-first clinical trials of tomorrow, today. Real-world examples will be shared of how a global digital network of sites powered COVID vaccine trials on a global level and kept 10,000 study sites operational.


      Blake Adams

      VP of Marketing, Florence Health

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       


      11:55 am

      Developing A Unified Approach To Support The Creation Of New Digital Endpoints

      Identifying the right sensors in support of hybrid or virtual trials is only the beginning.  The ability to distill meaningful clinical insights from massive amounts of data requires a dynamic approach to data ingestion and analysis that will ultimately have the desired impact on the development of new digital endpoints.  This session points out key considerations for developing a comprehensive data strategy to support the creation of new digital endpoints that impact safety monitoring, disease progression, and more effective treatments.


      Ben Schlatka

      VP, Digital Biomarker Solutions, Medidata

       

       

       

       

       

       

       

       

       

       

       

       


      12:05 pm

      The Digital Transformation Enabler You Might Be Missing

      Modernizing and digitizing clinical development is a strategic imperative. The elluminate Clinical Data Cloud is a foundational component of digital trials that delivers faster insights from data acquisition through analytics. Attendees will hear how this works, the end user experiences it creates and how it accelerates decentralized and digital trials.


      Sheila Rocchio

      Chief Marketing Officer, eClinical Solutions


      12:15 pm

      Collaborating on Digital Endpoints with Open-Source Algorithms

      Wearables and digital technologies in general have a potential to dramatically improve clinical trials, so why aren’t more trials using them? Learn how Shimmer is using collaboration and open-source algorithms to offer a path to widespread endpoint development.


      Geoffrey Gill

      President, Shimmer Americas, Shimmer Research


      12:20 pm

      Track 2 Concludes

    • Track 3

      The Future of Clinical Trials

       

      Track Chair:

      Mark Travers
      Mark Travers, PhD, MBA

      VP, Head of GCTO Regions, Monitoring Excellence, Global Operations and eTMF, Merck & Co.


      10:55 am

      Next Gen Solutions: Driving Protocol Compliance in a Decentralized and Hybrid Trial Environment

      Last year’s events prompted an incredible response from the industry as sponsors, CROs and sites found innovative ways to keep trials on track. With the increasingly decentralized nature of clinical trials, a shift towards digitization, interoperability and data intelligence will help to drive trial efficiency and protocol compliance.


      Kyle Cunningham

      Chief Product Officer, Greenphire

       

       

       

       

       

       

       


      11:05 am

      Best Practices for Global DCT Adoption

      Thread will share perspectives and best practices focused on scaled adoption of decentralized clinical trial approaches. Topics include:

      • Global implementation
      • How to move beyond pilots
      • The convergence of DCT technology and real-world data
      • The use of analytics to prove out the value proposition of DCT
      • The importance of working closely with research ambassador teams, participants & sites to enable change management.


      John Reites

      CEO, THREAD


      11:15 am

      Top 5 Things I Wish I Knew About Virtual Investigator Training Before COVID
      Investigator training is a necessity in clinical trial execution. So, how can this be done without burdening the sites with hours of training content requirements? This session will include practical and actionable steps you can take to ensure site personnel are optimally prepared and to avoid significant risks to quality and compliance. Highlights will include variation in Clinical Trial Training Delivery, how OnDemand & Virtual Training are becoming the new standard and Perpetual Inspection Readiness in a single source.


      Amanda Steenbergen

      Sr. Director – Global Clinical Training, WCG Clinical


      11:25 am

      Managing Clinical Trial Complexity: The Future is Collaborative

      The future of drug development is taking shape in an open architecture approach to accommodate new models ranging from traditional site-based studies to patient-centric virtual trials. Preparing for this future, the biopharma industry should look to extend patient-centric innovation and explore established working practices from other sectors where suppliers and partners are an integral part of the R & D value chain.

      This session will address operational frameworks that seamlessly harness a broad ecosystem of partners, suppliers, and stakeholders to successfully implement clinical trials, generate efficiencies, and establish much-needed standardization across end-to-end processes.


      Sy Pretorius

      President, Clinical Development & Chief Medical Officer, Parexel

       

       

       

       

       

       

       

       


      11:35 am

      The Consumerization of Clinical Trials

      In 2020 Decentralized Clinical Trials (DCT’s) went from edge case to main case, ushering in a new era of clinical trials. This era is democratizing access to clinical trials by removing the barriers posed by time, travel, and more. Medable has led the movement to decentralize clinical trials with over 150 DCT’s to date. Expanding access by modernizing the clinical trial experience is leading to the consumerization of clinical trials. Keys to modernizing:

      • Choice: choose how to participate: in the clinic or at home
      • Convenience: access anytime, anywhere with 24/7/365 support 
      • Confidence: rest assured knowing data is fully secure
      • Collaboration: give participants a voice

      This session shares insights and examples that highlight how the consumerization of trials will democratize and modernize clinical development.


      Tyler Pugsley

      Vice President of Life Sciences, Medable

       

       

       


      11:45 am

      RWD use in Clinical trials- Deep Learning to Find Elusive Patient Populations

      Deep learning capabilities on federated RWD sets is enabling identification and enrollment of elusive patient populations into clinical trials. This presentation will provide real world examples, showing how the use of digital targeting and the mining of electronic health records can help find hard-to-recruit patient populations – from diverse cohorts to rare disease.


      Susan Dallabrida, PhD

      Vice President of Clinical Science and Innovation, ObvioHealth

       

       

       

       

       

       

       

       

       

       

       

       

       

       

       


      11:55 pm

      Reporting Masterclass: How Predictive Analytics Can Power the Health of Your Studies

      How eCOA/ePRO reporting standards are evolving, with emerging solutions focused on innovations like interactive dashboards and predictive analytics to drive greater insight into the overall health of a study. A deep-dive into metrics on participant engagement and instrument compliance rates, sites, sponsors and CROs can intervene early to get participants and studies back on track.


      Kyle Hogan

      Executive Vice President, Strategy, Datacubed Health


      12:00 pm

      The Enduring Impact of COVID on Clinical Trials

      The discussion will address key eRegulatory and eISF challenges moving forward and the renewed importance of Inspection and Audit Readiness.  Challenges discussed include the benefits of purpose-built technology to address Inspection and Audit Readiness, the proper use of workflows to manage accurate documentation, and how eRegulatory solutions support remote SDV.


      Keith Martinek

      VP Customer Experience, Complion


      12:05 pm

      Next-Generation Technologies for Remote Blood Collection

      For decentralized clinical trials to be widely adopted, reliable and convenient remote blood collection methods are needed. This session will discuss innovations in the field of decentralized blood testing for clinical trials that will unlock a broad shift to these technologies.

      Ben Casavant
      Ben Casavant, PhD
      CEO and Co-Founder, Tasso, Inc.


      12:10 pm

      Track 3 Concludes

  • 12:30 pm

  • Lunch & Networking

  • 1:10 pm

  • DPHARM Announcements

  • 1:20 pm

  •  

    Pharma Reporting from the Trenches

    A Festival of Accomplishments in Innovation that Supports New Thinking in Patient-Centered Clinical Trials

    DPHARM attendees get to hear from several different pharma companies reporting on a specific example of innovation applied to advance clinical trials from this past year.  They cover advances in DCTs, digital enabled trials, the role of patient experience data, examples of collaborations that got innovation done and much more. Each session addresses the why, milestones, challenges and problems with adoption.


  • Session Descriptions

    Track 1

    COVID: Lessons Learned and What will Stick 

    Track Chair:

    Cindy Geoghegan
    Cindy Geoghegan

    Patient Advocate

    1:20 pm – 1:50 pm

    How Regeneron Got an FDA Approved Therapy for COVID in Record Time: Lessons Learned

    • Driving greater efficiencies in a pandemic
    • A fresh look at solving problems
    • Prioritizing priorities

    Monique Adams
    Bari Kowal

    Senior Vice President, Head Development Operations & Portfolio Management, Regeneron

    with

    Craig Lipset
    Craig Lipset
    Advisor and Founder, Clinical Innovation Partners


    1:50 pm – 2:20 pm

    Recruitment at Warp Speed: Lessons from a Moderna COVID-19 Vaccine Study

    As the race to develop a COVID-19 vaccine has demonstrated, study sponsors do not have to sacrifice other priorities, such as quality or diversity, in a tradeoff for speed. This was especially true for Moderna’s high-profile Operation Warp Speed trial. In fact, thanks to an innovative, industry-first approach to patient recruitment, this study reached its diversity enrollment goal 50% faster than the next-quickest Operation Warp Speed trial.This session will share learnings from Moderna’s recruitment effort, tracking the recruitment process from pre-screenings to referrals to randomizations and how this can effectively be applied to other studies and disease areas.


    Mike Wenger

    VP, Patient Engagement, Citeline Connect, Pharma Intelligence


    Diane Montross
    Sr Director, Patient Recruitment and Retention, Moderna 


    2:20 pm – 3:00 pm

    The Role of RWD in the Development of Remdesivir

    Gilead joins us to share how they designed, developed and obtained Emergency Use Authorization and Full Approval for Remdesivir for the treatment of COVID-19 in record time.

    Key topics:

    • How they built new capabilities at an extremely accelerated pace to design and execute the remdesivir trials
    • The role of Real World Data (RWD) in remdesivir trials to understand the natural history of the disease, to inform study design and conduct, and support real world effectiveness
    • Managing compassionate use programs and communicating with regulators at the peak of the global pandemic
    • Lessons learned and the impact on other therapeutic areas


    Matthew Bryant, MBA

    Head of Technology & Innovation Global Development and Clinical Operations, Gilead Sciences


    Anand Chokkalingam, PhD 

    Senior Director, Clinical Research, Gilead Sciences

    with 

    Hassan Kadhim
    Hassan Kadim 

    Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS


    Track 2

    Disrupting the Potential of Sites / Digital Endpoints

    Track Chair:

    Ülo Palm
    Sarah Krüg

    CEO, Cancer101

    1:20 pm – 2:20 pm

    Merck Reporting on Site Monitoring, Performance and Database Lock

    Merck’s  proprietary Site Monitoring and Reporting Tool (SMART) is an iOS Apple iPad technology that enables “monitoring and deviation management” before, during and after COVID-19. In this session, Merck talks about how they got SMART.

    Merck developed a real-time “scorecard” for sites called Site Health Check, which allows them to see how they are performing in absolute and relative terms compared to other sites. Merck will address how this really helped in COVID-19.

    Merck has engaged in project RESTART to help sites and to lock databases (~300 locked in 2020 and none missed in 2020 and 2021).  Merck shares with the DPHARM audience how this worked.


    Andrew Onikepe
    Director, Monitoring Excellence – North America, Global Clinical Trial Operations (GCTO), Merck


    Merle Schneider

    Director, Monitoring Excellence Innovation, Merck 


    Katherine Taylor, MBA
    Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck 


    2:20 pm – 2:50 pm

    How Sanofi is Unlocking Sites’ Potential and Supercharging their Ability to Manage Enrollment
    Sanofi is investing in innovation to support sites to supercharge their ability to manage enrollment. They are joined by the CEO of Reify Health to address how to:

    • introduce new technology and processes to a team
    • evolve past manual processes
    • leverage data-driven insights to manage enrollment strategies and site performance proactively

    Laura Kling
    Laura Kling
    Director, Digital Innovation, Sanofi

    Monique Adams
    Ralph Passarella

    CEO and co-founder, Reify Health


    2:50 pm – 3:10 pm

    Federated Learning Collaborations

    In this session, Janssen will share two novel ML/AI approaches applied in the clinical setting and future outlook of data driven health transformation which will generate value for patients, investigators and the scientific community. Key discussion points include:

    • How patient data can contribute to the accomplishment of the learning organization
    • Connecting institutional silos in order to advance patient-focused healthcare, across the spectrum of disease prevention, early diagnosis, targeted treatments and restoring health and well-being

    Martine Lewi
    Tine Lewi
    Scientific Director, Clinical Innovation, Janssen Research & Development


    Track 3

    Transforming R&D & Creating More Meds of Value 

    Track Chair:

    Barry Nelson
    Patient Advocate

    1:20 pm – 1:50 pm

    How Patient Experience Data will Help Create More Medicines of Value to Patients

    This session will demonstrate the link between ​patient ​experience data in regulatory submissions and innovation. The 21st Century Cures Act mandates that ​FDA make public the Patient Experience Data (PED) considered in the approval of a drug application.We have an opportunity to enhance regulatory decision-making that reflects patient perspectives to ensure we bring more medicines of value to patients in the market.

    Monique Adams
    Jessica Scott, MD, JD

    Head of R&D Patient Engagement Office, Takeda Pharmaceuticals


    Wendy Sanhai, PhD, MBA 
    Specialist Leader, Federal Strategy and Operations, Deloitte Consulting LLP

     


    1:50 pm – 2:20 pm

    GSK’s Protocol Design Lab: Disrupting Protocol Developments and Operational Delivery Using Cutting Edge Data Analytics and Technology

    GSK shares how the implementation of their Protocol Design Lab (PDL) has disrupted their approach to protocol development through the use of cutting-edge data analytics and technology. The PDL is designed to optimize protocol designs and develop more patient-centric protocols that translate into improved enrollment cycle times and a reduction in overall protocol amendments. Find out how the GSK PDL Lab is helping unlock more value to patients and drive acceleration.

    Monique Adams
    Tracy Vanderslice

    VP & Head, Pharma Global Clinical Operations, GSK

    Monique Adams
    Ryan Tomlinson, PhD

    Head, Protocol Design & Delivery, Global Clinical Operations, Development – R&D, GSK


    2:20 pm – 2:50 pm

    Boehringer Ingelheim on Lessons from Managing Decentralized Clinical Trials in a Pandemic

    Boehringer Ingelheim and Science 37 have been in a collaboration since 2019 to allow patients to participate in clinical trials remotely. During the pandemic remote access reached new heights and in this session, our speakers share the lessons learned to better serve patients including:

    • What to know about developing an investigator ‘metasite’ network
    • Developing a decentralized clinical trial network (during a pandemic) isn’t what you may think
    • Patients ask simply for “a glass of water…not a firehose of information” about clinical trials

    Monique Adams
    Kendal Whitlock

    Metasite Strategic Engagement Lead, Boehringer Ingelheim


    Chris Reist, MD, MBA

    Medical Director, Psychiatry and Behavioral Science, Science 37


    2:50 pm – 3:10 pm

    Innovation in Action – Building and Testing a Novel Digital Endpoint in Parkinson’s Disease

    Sanofi is on a mission to bring innovative Parkinson’s Disease therapies to patients faster. One piece of the puzzle? A way to measure disease state accurately, objectively, and from the patient’s home. Enter the PD-FIDI, or Parkinson’s Disease Functional Impacts Digital Instrument. Join Sanofi and the Koneksa Health team as they discuss how they collaborated to design a minimum viable product (MVP), engage regulators, patients, and HCPs, and advance a full program of validation research – including technical, usability, and clinical validation studies. In this presentation, we discuss insights and collaboration lessons learned at each stage of the PD-FIDI’s R&D life cycle. We also highlight next steps and open questions for our industry to address as we move closer to adopting digital trial endpoints in PD and beyond.


    Andrew Pearlmutter
    Associate Director, Digital, Sanofi


    Chris Benko
    CEO, Koneksa Health

    Track 4

    Janssen on, DE&I Collaborations, DCTs & Medicine Adherence 

    Track Chair:


    Maimah Karmo
    Founder/CEO, Tigerlily Foundation


    1:20 pm – 1:50 pm

    Bringing Trials to Where the Patients Are

    Monique Adams
    Monique Adams, PhD

    Director, Clinical Innovation Lead, Janssen

    Monique Adams
    Owen Garrick, MD

    VP, Conduct, Clinical Trial Services, CVS Health


    1:50 pm – 2:55 pm

    Part 1:

    Advancing  Multi-disciplinary Approaches to Enhancing   Equitable Access to Clinical Trials

    Janssen is advancing multi-disciplinary approaches to enhancing equitable access to clinical trials. They are bringing cutting-edge science, creative approaches, new collaborations and disruptive technologies together to create more diverse and equitable clinical trials. Janssen assembled a panel of leaders to share their multidisciplinary approaches designed to ensure their trials are more diverse, inclusive and equitable. This will follow with a specific case study from Janssen’s VP, Immunodermatology Disease Area Stronghold Leader and Q&A.

    Moderated by:


    Cassandra Smith, MBA
    Director, Diversity & Inclusion Clinical Trials, Janssen

    with

    Monique Adams
    Monique Adams, PhD

    Director, Clinical Innovation Lead, Janssen


    Beth Mahon, JD

    Global Feasibility TA Head, Oncology, Janssen


    Maura Snyder
    Global Head, Clinical Trial Engagement, Janssen


    Greg Tuyteleers
    Global Operations Head MAO, Janssen

    Part 2:

    Case Study: Deployment of Diversity, Equity, and Inclusion Methodology in Janssen Immunology

    This session will take a deep dive into how Janssen’s methodology has been applied in actual studies


    Lloyd Miller, MD, PhD
    VP, Immunodermatology Disease Area Stronghold Leader, Janssen


    2:55 pm – 3:10 pm

    Innovation in Medication Adherence and Patient Outcomes in Resource-limiting Settings 

    Janssen Clinical Innovation and Johnson & Johnson’s Global Public Health R&D team have partnered with the Infectious Disease Institute in Uganda to explore innovative, digital adherence technologies – tailored to the unique needs of MDR-TB patients – that could potentially serve as a substitute for the human resource-heavy DOT model in resource-limited settings to maintain or even improve patient outcomes.


    Jason LaRoche
    Associate Director, Janssen Clinical Innovation, Janssen

  • 3:00 pm

  • DPHARM Afternoon Break

     

    Networking
    • Networking
    • Meet the exhibiting companies featuring an array of patient-centered technologies & services

     

  • 3:15 pm

  • DPHARM IDOL DISRUPT

    Now in its 11th year, DPharm Idol Disrupt is a live pitch feast featuring a select group of innovators who present what they believe is a disruptive technology or service that could be a changing force for clinical trials. Each of the pre-approved presenting companies gives a quick-fire session followed by questions from a group of distinguished judges.

     

    The questions from the judges provide great examples of how to assess technologies/services for their disruptive quality, especially for the benefit of patients. Past DPharm Idol Disrupt winners include Medidata, Spaulding Clinical, ePharma Solutions, Science 37, Florence Healthcare, PhysIQ, Medable, Tasso and King-Devick. Who will be the DPharm Idol Disrupt 2021 winner?

    DPHARM Idol will kick off with the 2020 winner

    Monique Adams
    Steve Devick

    Chairman and CEO, King-Devick

    Presenting companies to date:

    Lifelink Systems


    Justin Mardjuki
    Vice President, Product Marketing

    Biofourmis


    Jaydev Thakkar
    COO

    Curebase


    Tom Lemberg
    Founder & CEO

    Pro-Ficiency


    David Hadden
    President & Founder


    Michael Raymer
    Co-Founder 

    Unlearn.ai


    Charles Fisher
    Founder & CEO

    Greenphire


    Catherine Click
    Director, Investigator Grants Payments

     

     

    DPharm Idol Disrupt Judges:


    Deirdre BeVard

    R&D Strategic Operations,  CSL Behring

    Esther Dyson
    Esther Dyson

    Executive Founder, Way to Wellville

    Cindy Geoghegan
    Cindy Geoghegan

    Patient Advocate


    Jen Horonjeff, PhD

    Founder and CEO, Savvy Cooperative

    Yusuf Ghadiali
    Adama Ibrahim, eMBA

    Director, Digital Solutions, Global Drug Development, Novartis

    Ülo Palm
    Sarah Krüg

    CEO, Cancer101

    Chandra Ramanathan
    Doug Schantz

    Vice President, Clinical Operations, Alexion Pharmaceuticals

    Mark Travers
    Mark Travers, PhD, MBA

    VP, Head of GCTO Regions, Monitoring Excellence, Global Operations and eTMF, Merck & Co.

     

     

  • 5:00 pm

  • A choice of DPHARM virtual face-to-face round table discussions will be announced shortly. Attendees are free to choose any of the round tables and they conclude at 5:40 pm.

    How Testing the Delivery of an Intervention with Patients Prevented Failure and Made All the Difference in the Success of the Medication Delivery Experience 

    This session focuses on how collaborating with patients can minimize clinical trial support gaps and prevented go-to-market failure. This session is led by patients with AZ.


    Jen Horonjeff, PhD
    CEO, Savvy Cooperative


    Scott Saunders
    Product Discovery Lead, AstraZeneca


    Dominic Quagliozzi
    Patient Advocate


    The Engagement Room Concept: How a Patient Portal Can Motivate and Connect Patients During a Clinical Trial

    What can we do to support patient enrollment? How can we increase engagement during this process and once patients are actually enrolled in a trial? Join Thomas Klein (CEO, Be the Partner) and Matt Walz (CEO, Trialbee) for this exciting roundtable discussion which tackles these key questions and others by presenting the novel, “Engagement Room” concept.


    Thomas Klein
    CEO, Be the Partner


    Matt Walz
    CEO, Trialbee

    Additional Roundtable Topics TBD

  • 5:40 pm

  • Day One Concludes

2021 Agenda


  • *All session times are in Eastern Time.


  • 8:00 am

  • DPHARM platform opens along with the ability to network with fellow attendees with Meeting Mojo

    Graciously hosted by.  MMG

  • 8:30 am

  • DPHARM Idol Disrupt 2021 Winner Announcement


  • Keynote

  • 8:40 am

  • Unpacking Unconscious Bias and its Link to Innovation

    Dr Lisa Coleman is the first special assistant to Harvard’s president and its first chief diversity officer and now the inaugural SVP, global inclusion and strategic innovation and chief diversity officer at New York University. Dr Coleman joins us at DPHARM for the first time to unpack what is truly meant by unconscious bias. She will address how bias massively impacts an organization’s ability to innovate effectively. Dr Coleman will draw connections and provide practical advice on how we can understand our own unconscious bias and take action to be more effective change makers for greater innovation. 

    David Weinreich
    Lisa Coleman, PhD

    SVP, Global Inclusion and Strategic Innovation and Chief Diversity Officer, New York University

     


  • R&D Industry Veteran

  • 9:05 am

  • The Impact of Innovation on Drug Development Operations: How We Become Agile to Remain Viable in a Post-Covid World

    Why did it take more than 20 years for EDC to become widely adopted? Why has the adoption of e-consent stagnated? Innovations supporting clinical trial operations follow a relatively similar, protracted and inefficient process. In this truly thought-provoking session, industry veteran Ken Getz will assess the typical innovation process in clinical development and identify opportunities to optimize the process. He will next discuss how we can modify the process to accommodate a variety of solutions that will be needed in a post-covid world. More specifically:

    • What it means to be an agile organization
    • How we can create cultural and operational alignment
    • Implications for infrastructure, collaboration effectiveness and workforce training
    • Comparisons with examples of the innovation process in other industries

    Marty
    Kenneth Getz, MBA

    Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine/ Founder and Board Chair, CISCRP

     

  • 9:30 am

  • Nurses and Clinical Coordinators POV on What Innovation is Needed for Remote Clinical Trials

    For the first time, nurses and navigators take center stage at DPHARM to give us practical insight from their point of view on what innovation is needed in clinical trials. Since the pandemic, nurses and navigators have had to rapidly adapt to support patient needs remotely and even figure out ways to ship clinical trials supplies. This session raises the voice of nurses and navigators to find out how we can do a better job in creating value for them and to get feedback on identifying new opportunities.

    Moderated by:

    David Lidsky
    Bert Hartog, PhD

    R&D Operations Senior Director, Janssen Clinical Innovation at Johnson & Johnson


    Cameron Sze, RN
    Clinical Trials Nurse, Dana Farber Cancer Institute


    Jennifer Hedglin, RN

    Clinical Research Nurse, Phase I, Targeted and Immunotherapy Combination Trial, Dana Farber Cancer Institute


    Juli Madzsar, RN

    Clinical Trials Nurse, Neurology, Memorial Sloan Kettering Cancer Center


    Shea Overcash
    Former Clinical Research Coordinator, Senior Manager, Quality Assurance, Javara

  • 10:05 am

  • Lessons Learned from Powering Solidarity, the World’s Largest Adaptive Covid-19 Trial

    To combat the largest pandemic in recent history and generate sufficient evidence of the efficacy and safety of potential treatments, the World Health Organization (WHO) needed to mount an equally massive clinical trial, while at the same time addressing varying challenges and complexity of bringing together 2,145 investigators at 553 sites in over 30 countries.  In this presentation learn how to leverage emerging technology and incorporate these same practices in your clinical development and DCT strategy.

    David Lidsky
    Derk Arts, MD, PhD

    Founder and CEO, Castor

  • 10:20 am

  • DPHARM Morning Break

  • 11:00 am

  • Today Show @DPharm


    This section of DPHARM highlights guest speakers in an interview format on innovation in clinical research, especially as it relates to modernizing patient-centered clinical trials.

    Hosted by:
    Michelle Shogren
    Michelle Shogren
    Senior Director of Innovation, Pharma R&D Clinical Operations, Bayer

     

    Presenters Include:

    Five Pathways to Successfully Scale Decentralized Clinical Trials 


    Peyton Howell
    Chief Commercial Officer, Parexel

    Applying AI to Select the Best Sites while Maximizing Patient Diversity & Inclusion


    Lucas Glass
    Vice President of Artificial Intelligence, IQVIA

    Raising the Voice of Sites in Clinical Trials


    Bryan Spielman, MBA
    Chief Growth Officer, Advarra

    How Lab Data Insights can Assist you in the Design and Execution of your Decentralized Trials


    Parag More
    Executive Director, Healthcare Analytics Solutions, QUEST Diagnostics

     

  • 12:05 pm

  • Track Choices A, B & C


  • Track A

    12:05 – 12:40 pm

    Lessons from the Banking Industry on Embracing Digital Transformation to Provide Vastly Better End User Experiences

    We bring Citi’s Managing Director of Global Head of Digital Channels to the DPHARM audience to tell us about the lessons learned in how the banking industry accomplished a digital transformation to better serve clients. Industry veteran, Craig Lipset will moderate and help draw out insights that can benefit R&D operations as we continue to embark on our own digital transformation to achieve greater efficiencies in clinical trial operations that benefit patients.

    Michelle Shogren
    Mayank Mishra
    Managing Director, Global Head of Digital Channels, CITI

    with

    Michelle Shogren
    Craig Lipset
    Advisor and Founder, Clinical Innovation Partners


    Track B

    12:05 – 12:40 pm

    Preparing for the ​Intersection Between R&D and Consumerism​ to Support Patient Convenience and Regulatory ​Expectations

    As we continue to transform digitally with the rise of consumerism, drug development needs to prepare to support new innovations that preserve patient convenience and meet regulatory requirements. This panel will discuss their views on what we can expect and what to think about to prepare for in R&D with the rise of consumerism in a digital world.

    Moderated by:

    Michelle Shogren
    Adama Ibrahim, eMBA
    Director, Digital Solutions, Global Drug Development, Novartis

    Panelists:

    Michelle Shogren
    Ray Dorsey, MD, MBA
    David M. Levy Professor of Neurology and Director of the Center for Health + Technology, University of Rochester Medical Center

    Marty
    Ken Getz, MBA
    Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine/ Founder and Board Chair, CISCRP


    Elizabeth Desrosiers
    Executive Director, Head, Clinical Sciences and Study Management, Infectious Diseases and Vaccines, Merck


    Ian Wallace
    Senior Expert, Engineering Connected Health, Novartis


    Track C

    12:05 – 12:40 pm

    The RECOVERY Trial: Lessons from an International COVID Platform Study with 40K+ Participants Across 181 Active Sites

    Marty
    Martin Landray, PhD

    Professor of Medicine and Epidemiology, Oxford University

  • 12:40 pm

  • Lunch & Networking

  • 1:20 pm

  • DPHARM Announcements

  • 1:25 pm

  • DPHARM Afternoon Digital/DCT and CRAACO Track Choices


  • Session Descriptions

    Track A

    Digital Transformation / Data Science / AI

    Track Chair:

    Mohammed Ali
    Mohammed Ali
    VP, Digital Analytics and Performance, GSK

    1:30 pm
    Digital Transformation in Clinical Research and New Systems of Care Around Technology  

    In the first part of Dr Steinhubl’s session, he will discuss his thoughts on digital transformation in clinical research and new systems of care around technology. 

    1:45 pm
    The Promise of Wearables and Predictive Analytics for Addressing Unmet Needs in Immuno-Oncology

    In the second part of Dr Steinhubl’s session he will provide a specific example to the promise of wearables in predictive analytics for improved patient care in the immuno-oncology space. Immunotherapies in cancer care such as CAR-T represent a step change opportunity in improving clinical outcomes. Despite their promise, these treatments do carry risk of adverse events, especially Cytokine Release Syndrome (CRS), which have important implications for treatment expansion. Medical grade wearable biosensors, multiparametric vital sign analysis, and near real time clinical event notification have the potential to transform how these therapies can be safely delivered in a way that removes constraints for clinical development and commercialization. This session will focus on how physIQ’s work in detecting early decompensation related to COVID infection and inflammation related to vaccine reactogenicity is laying the foundation for a turn-key solution for CAR-T/immunotherapy safety monitoring.

    Marty
    Steve Steinhubl, MD
    Chief Medical Officer, PhysIQ


    2:00 pm – 2:20 pm
    How Takeda is Striving for 30% Remote Clinical Trials Globally

    Dr Datta shares with the DPHARM audience how Takeda is fundamentally re-imagining how they do clinical development to include 30% of their clinical trials to be remote globally. Key topics covered include:

    • Silver Linings program
    • Takeda’s approach to bringing the trial to the patient
    • Leveraging where remote trials make sense
    • Considerations for design and operations
    • Remote devices

    Marty
    Shoibal Datta
    Head, R&D Digital Strategy Group, Data Sciences Institute, Takeda Pharmaceuticals


    2:20 pm – 2:30 pm
    Data Linking in Patient-Focused Research 

    The focus of this talk is on expanding research with data linking to understand the patient journey beyond the trial site. Use cases are featured to include retrospective sub-cohort analysis, long-term surveillance monitoring, operational insights for site selection and patient recruitment.


    Michelle Hoiseth
    Chief Data Officer, Senior Vice President, Parexel


    2:30 pm – 2:40 pm
    Using Advanced Clinical Monitoring in Decentralized Trials to Deliver High Risk Therapy in the Outpatient Setting

    With the increasing patient demand for care at home, organizations are being pushed to explore how they can minimize or eliminate on-label hospital stays required with certain high-risk therapies and deliver more care at home. Through the use of biosensors, patient reported data, and clinical alarming, organizations can gain hospital-level insight into patient health at home – both during and after the clinical trials – allowing them to safely expand utilization of high risk therapies into the outpatient setting. Learn how Current Health has supported both hybrid and fully decentralized clinical trials to accomplish this, enabling safer, more patient-centered care experiences.

    Adam Wolfberg
    Chief Medical Officer, Current Health


    2:40 pm – 2:50 pm
    Lessons Learned from Deploying Decentralized Trials: How Configurable Data Platforms Can Support Any Trial Design and Meet Stakeholder Needs

    COVID-19 forced sites and sponsors to pivot, resulting in the increased adoption of decentralized clinical trial models. Trends within the industry show DCTs are here to stay: adoption of this model has highlighted valuable lessons around the technology that supports DCTs and other clinical trial models. In this session, Clinical Ink CEO Ed Seguine will discuss the significance of flexible data platforms on DCT outcomes and how a configurable data platform design is key to supporting sites, patients, and sponsors in a post-COVID world.

    Ed Seguine

    Ed Seguine, MBA 
    CEO, Clinical Ink


    2:50 pm – 3:05 pm
    Accelerating Digital Biomarker Innovation through Open-Source Collaboration

    Digital Biomarkers represent a paradigm shift, challenging the scientific community to re-imagine how drugs are evaluated and disease progression is studied. However, despite their potential, the proprietary nature of many digital biomarker algorithms renders them inaccessible to the scientific community. Learn how industry-wide collaboration is advancing the adoption of Digital Biomarkers. In the spirit of innovation, researchers can leverage open-source platforms to move beyond traditional measures of disease progression — unlocking the power to measure patients’ response to treatment at scale and the potential to impact medicine beyond clinical trials.


    Ed Ikeguchi, MD 
    CEO, AiCure


     3:05 pm – 3:20 pm
    Mobility as an Endpoint: Leveraging Meaningful Change in Patient Quality of Life 

    Mobility impairment is associated with greater mortality, morbidity, cognitive decline, and dementia, making it a major health care priority and central to physical, mental, and social well-being. Capturing specific mobility endpoints that are both sensitive to change and meaningful to patient quality of life is challenging. Advancements in wearable technologies provide new opportunities to objectively quantify patient functional mobility by obtaining precision motion data in clinical and real-world settings. Increased adoption of wearables in clinical trials will uncover insights that leverage the assessment of meaningful change in patient quality of life across a broad range of therapeutic areas/indications. The Mobilise-D initiative is a prime example of this effort, in which digital mobility outcomes (DMO’s) are being established and validated – in people with Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and in recovery from proximal femoral fractures to generate regulatory-acceptable endpoint measures for use in clinical trials, real world assessment of mobility, and improved patient treatment.


    Kristen Sowalsky, PhD
    Director, Clinical Science and Consulting – Wearables and Digital Biomarkers, ERT


    3:20 pm – 3:30 pm
    Patient Centricity by Design – Improving Patient Engagement While Reducing Burden With Fit-for-purpose Technology

    In this session, learn how IQVIA is accelerating the time from patient interest to first office visit using assisted scheduling for study enablement.


    Ann Dokus
    Director of Technology, Global Patient & Site Services, IQVIA


    3:30 pm – 3:45 pm
    Next Generation Technologies to Enable Smarter Approaches to Clinical Research 

    Analytics, automation, AI, and other technologies continue to transform the way sponsors and CROs conduct clinical research. Saama joins us to share how the next evolution of intelligent technology and their capabilities will accelerate clinical trial operations and ensure smarter clinical outcomes.


    Jonathan Burr
    Senior Vice President, Clinical Platform Strategy, SAAMA


     3:45 pm – 3:55 pm
    How a Composable Digital Platform can Improve Study Outcomes, Generate Patient Insights and Support their Disease Journey Post Approval

    • How to capture objective patient experiences with smarter digital interactions and greater engagement
    • How to seamlessly connect all stakeholders in clinical development and patient care via a single end-to-end ecosystem
    • How to apply AI/ML to capture real-world data, generate real-time insights and provide proactive guidance with one platform
    • Demonstrating the importance of high patient satisfaction and engagement in improving study metrics and outcomes


    Amy Apostoleris
    Global Head, Digital Clinical Trials Solutions, Medocity


    3:55 pm – 4:15 pm
    Biogen Case Study: Decentralized Clinical Trial Strategy and Making it Stick Post COVID

    Biogen joins us to share their approach to decentralized clinical trials (DCT), how they increased awareness of the possibilities and benefits of DCTs, and strategies to make those approaches stick post-COVID. Key Topics Include:

    • Initiating DCTs and where we started
    • Promoting what we are doing currently to dispel myths and engage stakeholders
    • Implementing how we will transition to a future of clinical trials that combines the optimal use of technology with customer-focused innovation

    Moderated by:

    Yusuf Ghadiali

    Yusuf Ghadiali
    Executive Director, Head of Clinical Trial Business Operations, Global Clinical Operations and Planning, Daiichi Sankyo, Inc.

    with


    Danielle Horton
    Associate Director, Performance Operational Capabilities, Biogen


    4:15 pm – 4:35 pm
    Key Trends in Digital Transformation and How Amazon Approaches Innovation

    Richard Halkett, Director, Worldwide Digital Innovation at Amazon Web Services joins DPHARM to share his journey in understanding the process and complexity of innovation; how it does and does not work and how this led to his role at Amazon Web Services. Mr Halkett will share how AWS creates conditions to support and sustain innovation and provide his perspective on digital trends he is seeing that may impact patients. Key talking points:
    • AWS Environment for Innovation
    • Key Digital Trends
    • Impact on Clinical Development

    Marty
    Richard Halkett
    Managing Director, Digital Innovation, Amazon AWS

    with

    Michelle Shogren
    Craig Lipset

    Advisor and Founder, Clinical Innovation Partners


    Track B

     

    CRAACO Clinical Research as a Care Option / How to Reduce the Gaps to Integrate Care & Research

    Track Chair:


    Deirdre BeVard

    R&D Strategic Operations,  CSL Behring

    1:30 pm – 1:45 pm

    Progress in Integrating Clinical Research within the Healthcare  Ecosystem

    The industry has seen some strides over the last year to make research accessible to a wider and more diverse patient population. Yet, R&D is still far behind in truly accessing the patients who would benefit from clinical trials, and the physicians, sites and participants the industry needs to complete quality studies.

    In this session, we identify the progress and next steps to align key stakeholders to truly improve the drug development process for all people.


    Jennifer Byrne
    CEO, Javara


    1:45 pm – 2:05 pm

    How Everyday Healthcare Will Revolutionize Research

    • Identifying challenges in leveraging EHR data for research and clinical trials
    • Describing data sharing efforts that help enable clinical research and trials for health systems
    • Assessing opportunities for EHR data to support decentralized and pragmatic clinical research


    Ryan Moog
    Sr. Director, LS Market Strategy & Data Platform, Cerner


    2:05 pm – 2:20 pm

    Leveraging EHR to ID Patients and Accelerate Clinical Trials 

    • Accelerating decentralized clinical trials through effective uses of EHRs/healthcare data
    • Overcoming regulatory, privacy, and human challenges around the use of healthcare data for decentralized clinical trials
    • Realizing the importance of technology to streamline the overall clinical research workflow


    Michael Ibara, PharmD
    Chief Data Officer, Elligo Health Research


    2:20 pm – 2:40 pm

    Harnessing Real-World Data to Address the Future of Research 

    • Using RWE to facilitate regulatory decision-making beyond pharmacovigilance, e.g., breakthrough therapy designation and accelerated approval
    • Developing RWD standards that create RWE that is traceable and reliable (has clinically acceptable endpoints and outcomes, clear data provenance, and high data quality)
    • Expanding the definition of patient-generated RWD to encourage use and explore new avenues for study designs utilizing such data


    Andy Stankus, MBA
    General Manager, Health Division, Kantar Health


    2:40 pm – 3:10 pm

    Scaling CRAACO: Bridging Healthcare Engagement with Clinical Research

    In order to enable CRAACO at scale, we must figure out how to bridge healthcare engagement with clinical research. This presentation will discuss the following topics:

    • Breaking down the realities of the intersection of healthcare engagement with clinical research
    • The process of scaling
    • The role of DCTs to enable CRAACO
    • Latest regulatory developments supporting DCTs enabled by DHTs and expected future developments
    • Addressing the challenge of just in time sites

    Marty
    Isaac Rodriguez-Chavez, PhD
    SVP, Scientific & Clinical Affairs, Head, Global Center of Excellence, DCT Strategy, ICON plc


    Kent Thoelke
    Chief Innovation Officer, ICON plc


    3:10 pm – 3:20 pm

    An Innovative Platform to Amplify CRAACO and Value-Based Care 

    In this session, ObjectiveGI shares how in partnership with physicians, they created a framework that enables more patients to gain access to research opportunities and services. Key topics include:

    • Case studies of successful partnership programs with physicians and health systems
    • Accelerated research program adoption strategies for rural health systems
    • EHR integration and outreach strategies that engage patients
    • Demonstration of software-based optimization tools that integrate with provider workflows, to deliver improved outcomes


    Colleen Hoke 
    President and Chief Executive Officer, Objective Health


    3:20 pm

    Track B Concludes

     

  • 4:35 pm

  • DPharm Concludes

    Save the Date!

    DPHARM 2022, September 13-14 

    Westin Copley Place Boston

2021 Agenda



  • Welcome to this complimentary webinar featuring two examples from two different companies putting forth a specific vision to transform an aspect of clinical trial development. In the first part, you will hear from LEO Pharma on their vision to revolutionize clinical trials and how they are putting their vision into practice. The second half of the webinar is with Eli Lilly in how they formed an incredible collaboration internally to transform the clinical development value chain with AI for the benefit of patients. We are delighted to give you a taste of the 11th annual DPHARM which will be live on September 28-29 virtually.

     


  • 10:30 am – 11:00 am ET

    LEO Pharma Case Study on their Paradigm Shift to Revolutionize Clinical Trials 

    Medicine development companies are at different stages of innovation to create solutions for digitally-enabled clinical trials that allow for mobility, greater efficiencies in data collection, and all with a patient-centric approach. It starts with a vision and commitment from leadership that transcends throughout the R&D organization. LEO Pharma shares how their company made this transition to re-imagine clinical trials in a totally different way and what has resulted thus far.

    • The vision behind putting together a department dedicated to revolutionizing clinical trials and their implementation process
    • What was the culture needed to establish this?
    • What innovation means to them and how to deploy innovation?


    Stephen Lutsch
    Director, Head of Revolutionize Clinical Trials, LEO Pharma


  • 11:00 am – 12:00 am ET

    Transforming the Clinical Development Value Chain with AI for Greater Efficiencies to Ultimately Benefit Patients

    Eli Lilly has been embracing and cultivating an environment that is utilizing AI to advance drug development for clinical trial design, reducing protocol amendments, site selection, predicting timelines, and more. Through their vision, organizational capabilities and demonstrating the value of AI, it is no wonder Eli Lilly is winning awards for their work with AI in drug development. The speakers address from an organizational point of view the transformation and how they just got this done.

    Moderated by:


    Steve Steinhubl, MD
    Chief Medical Officer, PhysIQ

    Participants:

    Monique Adams
    Vipin Gopal, PhD, MBA

    Chief Data & Analytics Officer, Eli Lilly and Company


    Robert Baker, MD

    Deputy Chief Medical Officer, Eli Lilly and Company

    Monique Adams
    Tim Coleman

    VP and Information Officer, Medicines Development Unit, Eli Lilly and Company

     

     

     


     


  • Friday, September 17, 2021

    11:00 am – 11:50 am ET

    Transforming the Clinical Development Value Chain with AI for Greater Efficiencies to Ultimately Benefit Patients

    Eli Lilly has been embracing and cultivating an environment that is utilizing AI to advance drug development for clinical trial design, reducing protocol amendments, site selection, predicting timelines, and more. Through their vision, organizational capabilities and demonstrating the value of AI, it is no wonder Eli Lilly is winning awards for their work with AI in drug development. The speakers address from an organizational point of view the transformation and how they just got this done

    Moderated by:


    Steve Steinhubl, MD
    Chief Medical Officer, PhysIQ

    Participants:

    Monique Adams
    Vipin Gopal, PhD, MBA

    Chief Data & Analytics Officer, Eli Lilly and Company


    Robert Baker, MD

    Deputy Chief Medical Officer, Eli Lilly and Company

    Monique Adams
    Tim Coleman

    VP and Information Officer, Medicines Development Unit, Eli Lilly and Company