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2020 Agenda

  • 8:30 am

  • Opening Remarks & Welcome

    Valerie Bowling New
    Valerie Bowling

    Executive Director, DPharm


    Tammy Guld

    Janssen Clinical Innovation, Global Team Lead, Janssen

  • 8:45 am

  • The Immortal Life of Henrietta Lacks

    The international success of Rebecca Skloot’s New York Times bestseller, The Immortal Life of Henrietta Lacks, has left people keenly interested in the Lacks family and Henrietta’s legacy. Members of the Lacks family have enthralled audiences across the country by talking about their mother, grandmother, and great-grandmother, Henrietta Lacks, and her transcendentally important contributions to science. What has it meant for decades after the fact—that Henrietta’s cells were being used in laboratories around the world, bought and sold by the billions? They put a personal face on such issues as the dark history of medical experimentation on African-Americans, the birth of bioethics, and the legal battles over informed consent. We are honored to welcome the Lacks family to talk about Henrietta Lacks, complicated questions about whether we control the stuff we’re made of, and whether we should share in the profits and discuss, transparency, inclusivity and diversity.

    Lacks-Family

    Members of the Henrietta Lacks Family

     

    Hosted with:
    Craig Lipset
    Craig Lipset, MBA

    Advisor and Founder, Clinical Innovation Partners

  • 9:15 am

  • A Vision for Clinical Trials in 2030 – Top 5 Countdown

    These two speakers bring together vision, leadership and passion for doing everything we can to get therapeutics to patients faster. Together they will present a vision for clinical trials 2030.

    Donna Cryer
    Donna Cryer, JD

    President and CEO, Global Liver Institute

    Pamela Tenaerts
    Pamela Tenaerts, MD, MBA

    Executive Director, CTTI

  • 9:45 am

  • Modernizing Clinical Trials Keynote: Q&A with FDA

    We are honored to welcome Dr Amy Abernethy to do a keynote FDA Q&A on such topics as:

    • FDA culture, especially post Covid-19
    • Decentralized trials
    • Managing digital across different review divisions
    • Collection of real world data
    • Working with FDA in collaboration towards the modernization of clinical trials
    • What’s holding back industry?

    Amy Abernethy
    Amy Abernethy, MD, PhD

    Principal Deputy Commissioner, FDA

    Hosted with:

    Tammy Guld
    Janssen Clinical Innovation, Global Team Lead, Janssen

  • 10:30 am

  • Break

  • 10:45 am

  • Keynote Guest Fireside Chat on Incentives for Innovation

    Stephen Dubner is a journalist, most famous for co-authoring Freakonomics: A Rogue Economist Explores the Hidden Side of Everything. This book has been challenging conventional economic thinking for over 15 years now. Stephen will share his interesting view on incentives that reward innovation and more.

    Stephen Dubner
    Stephen Dubner

    Co-Author, Freakonomics

    Hosted with:
    Craig Lipset
    Craig Lipset, MBA
    Advisor and Founder, Clinical Innovation Partners

  • 11:30 am

  • Innovative Sources & Solutions 3 Track Choices:

    We have seen a really nice evolution in companies that are enabling many new capabilities that can radically improve and disrupt the future of clinical trials and the patient experience.  The companies listed below have been invited to present on what they are specifically solving to advance clinical trials, increase efficiencies and reduce the burden to patients and investigators.  Attendees are free to choose among the following presenting companies.

    • Track 1: Where are They Now?

      Moderated by:

      Mark Travers
      Mark Travers, PhD, MBA

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

      Presenting Companies:

      Oracle Health Sciences

      BBK

      Greenphire

      Saama

      Complion

      Trials.ai

      ClinEdge

    • Track 2: Innovative Digital Solutions

      Moderated by:

      Judith Reece
      Judith Reece, PhD, MBA

      VP, Digital Development, GSK

      Presenting Companies:

      Intersystems

      Clinical Ink

      Parexel

      Clinical Pipe/Protocol First

       

    • Track 3: Innovative Patient Solutions

      Moderated by:

      Jessica Scott
      Jessica Scott, MD, JD

      Head of R&D Patient Engagement Office, Takeda

      Presenting Companies:

      Quest Diagnostics

      Elligo

      Science 37

      Clincierge

      Inato

      THREAD Research

       

  • 12:50 pm

  • Lunch Break

  • 1:30 pm
    - 2:40 pm

  • Pharma Innovation 2020 Reporting from the Trenches

    This is a great opportunity to hear from several different pharma companies reporting on a specific example of innovation applied to advance clinical trials within the last 12 months.  Each session addresses the milestones, challenges and problems with adoption.  Attendees are free to choose among the following presenting companies.

    • Track 1:
      Flexible/ Decentralized Clinical Trials

      Moderated by:
      Monique Adams
      Monique Adams, PhD

      Director, Clinical Innovation Lead, Janssen

      BMS – Adapting a Long Term Follow Up Oncology Study into the Decentralized Clinical Trial Model
      This presentation will demonstrate how to adapt the decentralized model for oncology patients. Key takeaways include:

      • Explore opportunities for decentralized trials in oncology
      • Understand the nuances for oncology patients compared to other TA patients

      Hassan Kadhim
      Hassan Kadhim

      Director, Head of Clinical Trial Business Capabilities, Global Development Operations, Bristol-Myers Squibb


       

      EMD Serono: Flexible Trials are the New Normal
      In this session, Dr Garcia shares the lessons learned from understanding, embracing and implementing solutions to meet patients’ needs where patients are in clinical trials. Dr Garcia also shares his experience in working with study teams to get them on board with vital changes to support flexible clinical trials.
      Rodrigo Garcia
      Rodrigo Garcia, MD

      Head of Clinical Innovation, EMD Serono


       

      Sanofi – Decentralization of Clinical Trials
      For the past 12 months Sanofi has been working on a pivotal trial design that includes remote visits. Sanofi is now bringing much of that insight into their plans to ‘pandemic-proof’ protocols for upcoming trials. In this session, you will hear an update and lessons learned.
      Laura Kling
      Laura Kling

      Director, Digital Innovation, Sanofi


       

      Janssen – How to Scale-Up Direct-to-Patient Trials in a Large Pharma Company
      Elise Felicione
      Elise Felicione

      Senior Director Global Development, Janssen


       

      Eli Lilly Case Study

      Nicole Sheetz, PharmD

      Director, Clinical Systems & Supply Planning (CSSP), Clinical Design, Delivery & Analytics (CDDA), Eli Lilly and Company

    • Track 2:
      New Partnerships and Collaborations

      Moderated by:
      Chandra Ramanathan
      Chandra Ramanathan, MBA, PhD

      Global Head, Pharma R&D Open Innovation, Bayer Healthcare

      Novartis – Partnering Effectively with the Digital Ecosystem: A Guide for Big Pharma
      Novartis Biome has been on a journey for the past two years to find new and effective ways to partner with the entire digital ecosystem (big and small). This session covers:

      • Identifying critical differences when working with a tech (large or small) company
      • Cultural change is key to ensuring engagements are fruitful and lead to long lasting partnerships
      • Differences between a vendor and a partner
      • Getting to a fruitful and mutually beneficial relationship between big pharma companies and startup health tech companies

      Robin Roberts
      Robin Roberts

      Co-founder, Managing Director, Global Head of Strategy, Novartis Biome


       

      Takeda – The Wisdom of Crowds and Unusual Partners as Enablers of Pharma Innovation
      Magdalena Schoeneich
      Magdalena Schoeneich

      Head Center for Scientific Leadership & Innovation, Takeda


       

      UCB Case Study
      Shelly Barnes
      Shelly Barnes

      Global Clinical Innovations Lead, UCB

    • Track 3:
      Advances in Data Driven Efforts

      Moderated by:
      Yusuf Ghadiali
      Yusuf Ghadiali

      Senior Director, Global Clinical Operations, Biogen

      Johnson & Johnson Case Study: The Collaboration that Built the Data-driven Platform to Benefit Patients
      This case study tells the story about the collaboration that was formed to build a data-driven platform that:

      • Enables data source in one place
      • Identifies burden scores for sites and patients
      • Gets to the primary endpoint
      • Improves streamline work-study team and patient experience
      • Holds teams accountable

      Monica Teall
      Monica Teall

      Associate Director, Janssen

      Miruna Sasu
      Miruna Sasu

      Clinical Operations and Data Science, J&J


       

      Roche on their Progress in Pushing the Boundaries in Digital Biomarkers 
      Roche has been busy pushing the boundaries to advance their Digital Biomarker research portfolio. In particular, they have made substantial progress with their Parkinson’s, Multiple Sclerosis, Huntington’s, Autism and other Digital programs. In this session, attendees get an update on their progress and the impact.

      Christian Gossens
      Christian Gossens, PhD, MBA

      Global Area Head Digital Biomarkers, pRED Informatics, Roche Pharmaceutical Research and Early Development


       

      Takeda’s Collaboration with Be the Partner to Innovate for Patients
      This session highlights a patient portal case study.

      Thomas Klein
      Thomas Klein

      Founder and CEO, Be the Partner

      Jessica Scott
      Jessica Scott, MD, JD

      Head of R&D Patient Engagement Office, Takeda

  • 2:40 pm

  • Break

  • 2:55 pm

  • DPharm Idol Disrupt

    Now in its 9th year, DPharm Idol Disrupt is a live show 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 the DPharm Idol Disrupt 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 and Tasso. Who will be the DPharm Idol Disrupt 2020 winner?

    2019 Winner: Tasso, Where are They Now?

    Ben Casavant
    Ben Casavant

    PhD, Co-Founder and CEO, Tasso

    DPharm Idol Disrupt Judges:

    Esther Dyson
    Esther Dyson

    Executive Founder, Way to Wellville

    Cindy Geoghegan
    Cindy Geoghegan

    Patient Advocate

    Yusuf Ghadiali
    Yusuf Ghadiali

    Senior Director, Global Clinical Operations, Biogen

    Hassan Kadhim
    Hassan Kadhim

    Director, Head of Clinical Trial Business Capabilities, Bristol-Myers Squibb

    Joseph Kim
    Joe Kim, MBA

    Senior Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & Company

    Ülo Palm
    Ülo Palm, MD, PhD

    Former SVP, Head, Digital Science, Allergan

    Chandra Ramanathan
    Chandra Ramanathan, MBA, PhD

    Global Head, Pharma R&D Open Innovation, Bayer Healthcare

    Douglas Schantz
    Douglas Schantz

    VP, Clinical Operations, Alexion

    Jessica Scott
    Jessica Scott, MD

    Head of R&D Patient Engagement Office, Takeda Pharmaceuticals

    Mark Travers
    Mark Travers, PhD, MBA

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

  • 4:30 pm
    - 5:30 pm

  • Partnering and Group Networking Meetings

    Day One Concludes

  • 7:00 pm
    - 8:00 pm

  • Group Networking Meetings

2020 Agenda

  • 9:00 am

  • Opening Remarks & Announcement of the 2020 DPharm Idol Disrupt Winner

    Valerie Bowling New
    Valerie Bowling

    Executive Director, DPharm


    Tammy Guld

    Janssen Clinical Innovation, Global Team Lead, Janssen


  • R&D Leadership Fireside Keynote Chat

  • 9:15 am

  • How Regeneron Disrupted Themselves to Adapt to A Massive Shift for COVID-19 without Sacrificing the Rest of their Portfolio

    David Weinreich
    David Weinreich, MD, MBA

    SVP, Head, Global Clinical Development, Regeneron Pharmaceuticals

  • 9:45 am

  • Fostering Innovation and Service: Lessons from a Veteran Disney Executive

    We are honored to welcome Marty Yudkovitz, a veteran Disney executive with more than 30 years of experience. In this fireside chat, we discuss with Marty how Disney approaches innovation and service. In doing so, we explore the realities of building support for innovative projects, overcoming obstacles and getting executive buy-in. We also talk about how Disney maintains excellence in the end-user experience at the parks and what we can take away from this to apply to patients’ experiences.

    Marty
    Marty Yudkovitz, JD

    Former Head of Strategic Business Innovation, Disney

    Hosted with:
    Monique Adams
    Monique Adams, PhD

    Director, Clinical Innovation Lead, Janssen

  • 10:15 am

  • Fireside Keynote: Highlights of the 50 Most Innovative Companies

    Fast Company magazine publishes an annual innovation report ranking businesses making the most profound impact on both industry and culture demonstrating a range of ways to succeed in a competitive world. In particular, they rank the top 50 companies and we are delighted to welcome back for the 2nd year in a row, the Deputy Editor of Fast Company to tell us about the highlights.

    David Lidsky
    David Lidsky

    Deputy Editor, Fast Company

    Hosted with:
    Shwen Gwee
    Shwen Gwee

    VP and Head of Global Digital Strategy, Bristol Myers Squibb


    Jennifer Wulff

    Pfizer Strategic Partnerships-Clinical Operations and Global Product Development, Pfizer

  • 10:45 am

  • Break

  • 11:00 am

  • Today Show @ DPharm

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

    Presenting Companies:

    1. Microsoft
    2. Parexel
    3. IQVIA
  • 11:45 am

  • Reshaping Clinical Trials in a Covid-19 World

    Jessica Scott
    Jessica Scott, MD, JD

    Head of R&D Patient Engagement Office, Takeda

    with

    Donna Schwarz
    Donna Schwarz

    Founder, Schwarz Consultants

  • 12:15 pm

  • Lunch

  • 1:30 pm

  • Break Out Choices

    • Track A: Way Beyond eSource: Progressing Clinical Research through e-Source from the Pharma, Patients, Academia & Regulatory Perspectives

      Moderated by:
      Amy Cramer
      Amy Cramer

      Global Product Development Strategic Partnerships, Pfizer 

      DPharm welcomes a distinguished group of experts representing pharma, academia and a regulatory agency to provide fresh insights and real world examples that will go way beyond eSource.

      1:30 pm

      Evaluating Patient Claims as Real World Evidence
      The 21st Century Cures Act requires the US FDA to develop a Real-World Evidence (RWE) program to fill knowledge gaps in the use of Real-World Data (RWD) to generate RWE of product effectiveness.  Patient claims frequently are used to identify follow-up period events in RWE studies. However, endpoint measurement differences between patient claims and the EHR may be significant. This presentation from Eric Eisenstein will highlight results from an antiplatelet trial simulation.  Results will demonstrate differences between patient claims and EHR endpoint estimates, measurement errors and sample size requirements.

      Eric Eisenstein
      Eric Eisenstein

      Associate Professor in Medicine, Duke Clinical Research Institute


       

      Perspective on the Evolving Role of Regulators
      The Danish Medicines Agency (DKMA) has established a data and analytics center (DAC) that is unique in the world. DAC is using a secure supercomputer shared between academia, the health sector and national agencies to pull in registry data that exists in the country (covering entire lifespan). They are able to access anonymized medical records of their citizens in real-time and apply analytics and machine learning to better understand the effect of treatments. They are also able to provide scientific advice to the industry in leveraging analytics using AI and ML based on real-world data. This presentation will highlight a step-wide approach to e-source in regulatory agencies with examples from DKMA DAC.

      Jesper Kjaer
      Jesper Kjaer

      Head of Data Analytics, The Danish Medicines Agency


       

      It’s Time to Stop Talking and Start Doing
      eSource is more than re-use of EHR data. In this presentation, Rob Goodwin will:

      • review the integration of all eSource modalities as defined by TransCelerate
      • highlight lessons learned from Pfizer’s eSource program
      • speak to the goals, scope and current state of Vulcan, a HL7 FHIR accelerator dedicated to Translational and Clinical Research and convened by the US FDA, NLM, NIH, CTSA Sites, Patient Representative, TransCelerate Biopharma, Society for Clinical data management, and Standards Organizations.  Vulcan encourages all interested parties to join.

      Rob Goodwin
      Rob Goodwin

      VP and Head, Pfizer Global Product Development Operations Center of Excellence

      with

      Amy Cramer
      Amy Cramer

      Global Product Development Strategic Partnerships, Pfizer


       

      2:30 pm

      The Future of Clinical Research is Now
      Pfizer, EDETEK, and PatientLink are excited to reveal a new approach to clinical research that enables real-time, 360-degree patient engagement and data sharing between patients, sites and researchers to improve clinical research and data return through eSource. More specifically they address:

      • How the fluid flow of compliant and permissioned data before, during, and after clinical research permits sites and sponsors a more real-time view of data, enables proactive decision making, transparency, and potentially helps retain both sites and patients
      • Highlight the strengths and benefits of using HL7 FHIR interoperability standards now and in the future (which will impact patients, sites, researchers, payers, sponsors and health systems)


      Munther Baara

      Vice President Of Product Strategy and Innovation, EDETEK, Inc.


      Debi Willis

      CEO / Founder, PatientLink


      2:50 pm

      How ‘Transformative eSource and EHR2EDC’ Solutions are Enabling the Growing Convergence between Care and Research: Where are We Now?
      There is a growing convergence between care and research, enabled through ‘transformative eSource and EHR2EDC’ solutions. This trend has an impact on the global healthcare research setting, with breakthrough initiatives both in North America and Europe. Today, we can leverage mature technologies in Natural Language Processing and Machine Learning / Artificial Intelligence which allows us to take major steps in creating connected, augmented real-world data.

      The presentation will start from the challenges we have to overcome in order to go “way beyond eSource”. Next, it will highlight benefits for patients, investigators, regulatory agencies and the life sciences R&D companies from these breakthrough innovations, bringing care and research closer together.

      Martine Lewi
      Martine Lewi

      Scientific Director, Clinical Innovation, Janssen

    • Track B: Data, AI and Machine Learning

      Moderated by:


      Joseph Kim

      Senior Advisor, Clinical Operations & Digital Registry, Digital Health Office, Translational Technology  & Innovation, Eli Lilly  & Co

      1:35 pm

      Fireside Chat: Creating a Data Driven Culture that Can Absorb AI/ML Capabilities
      Vipin Gopal
      Vipin Gopal

      Chief Data & Analytics Officer, Eli Lilly


      1:50 pm

      Conversational AI: How Voice Technology is used in Clinical Studies
      This multi-stakeholder panel will share how voice technology has been used in a research study to efficiently provide patient input and improve patient experiences in clinical research and trials. Key talking points include:

      • How did we get there?
      • What did we learn?
      • What do the patients tell us?
      • How did nurses respond?
      • How did the physicians think about it?

      Moderator:
      Bert Hartog
      Bert Hartog, PhD

      Senior Director, Janssen Clinical Innovation, Janssen R&D Global Development, Janssen-Pharmaceutica NV

      Panelists:
      Daniel H Solomon
      Daniel H Solomon, MD, MPH
      Associate Physician & Chief, Section of Clinical Sciences, Division of Rheumatology, Brigham and Women’s Hospital

      Emma Richard
      Emma Richard

      Manager, Data Science Insights, Janssen


      Nathan Treloar
      President and Co-Founder, Orbita


       

      2:15 pm

      IQVIA Case Study


      2:30 pm

      Panel: How AI/Machine Learning is being Utilized to Accelerate Clinical Trial Design and Development
      This panel addresses how AI/Machine learning is now being utilized beyond the discovery phase in clinical development. Key areas include advancements in AI/ML for the following applications:

      • Trial design and execution
      • Patient identification and trial matching
      • Patient recruitment and enrollment
      • Optimizing protocols (ie: inclusion/exclusion criteria)
      • Site selection
      • FDA approval

      Moderator:
      Prasanna Rao
      Prasanna Rao

      Head, AI and Data Science, Data Monitoring and Management, GPD, Pfizer

      Panelists:

      Vipin Gopal
      Vipin Gopal

      Chief Data & Analytics Officer, Eli Lilly


      Alex Aronov

      Senior Director & Head of Data Science, Data Strategy & Solutions, Vertex Pharmaceuticals

      Judith Reece
      Judith Reece, PhD, MBA

      VP, Digital Development, GSK

      John Reynders
      John Reynders

      Vice President, Data Sciences, Genomics, and Bioinformatics (DGB), Alexion Pharmaceuticals


      3:00 pm

      Parexel and Lokavant Discuss their Strategic Partnership to Study Feasibility and Medical Monitoring with the Use of Advance AI Driven Platform


      Jamie Macdonald
      CEO, Parexel


      Rohit Nambisan
      President, Lokavant, Inc.


      3:20 pm

      PhysIQ Case Study
      Matt Pipke new
      Matt Pipke, JD

      CTO and Co-Founder, PhysIQ


      3:35 pm

      Alexion Case Study on Applying Analytics and Machine Learning to Understand Site Performance 
      Hear how Alexion is applying analytics and machine learning to analyze clinical trial site performance and create a prioritized list for trial sponsors. Algorithms in this multidimensional space are able to pick up on signals and propose sites that would be far better than others in terms of starting up trials. Factors considered relate to:

      • Availability of patients
      • Availability of trained physicians in a given indication
      • Physician experience
      • Clinical trial site experience in a given indication
      • Previous metrics on how sites perform in clinical trials and issues that have been flagged with FDA

      Amit-Gulwadi new
      Amit Gulwadi

      Vice President, Head of Transformation, Alexion Pharmaceuticals

    • Track C: Digital Endpoints

      Moderated by:
      Carrie Northcott
      Carrie Northcott, PhD

      Director, Early Clinical Development (ECD) Digital Medicine and Translational Imaging, Pfizer, Inc.

      1:30 pm

      PfIRe it Up! Using the PfIRe Lab to Develop Digital Endpoints
      Pfizer built an Innovation Research Lab (PfiRe) to evaluate wearable devices before deploying them into clinical studies.  In this session, you’ll hear about the innovative way they test these devices to determine which are fit-for-purpose, a critical step in developing a novel digital endpoint, and how they develop their own algorithms to use in clinical trials.  Pfizer will also share insights from the STRYDE study, which was developed in the PfiRe lab.

      David Caouette new
      David Caouette

      Executive Director, Early Clinical Development, Pfizer

      Mar Santamaria
      Mar Santamaria

      Director, Early Clinical Development, Pfizer


       

      Sanofi Case Study: Remote Spirometry in COPD: Foundations for Wearables in Clinical Trials
      Sanofi conducted a trial to validate at-home spirometry using a Bluetooth connected device with a companion app to track to time the user and to track the reading, with a goal to collect data for validation.  This presentation will focus on the process, approach and lessons learned in comparing in-clinic spirometery readings to the home device where patients were enrolled in a couple of different drug trials in COPD.  More specifically:

      • A look back on lessons learned from two years of testing at-home spirometers in COPD patients
      • The remaining hurdles to clear so we can translate wearables data collection into value for patients, providers, and pharma

      Nikita Bakhru
      Nikita Bakhru

      Digital Initiative Leader, Sanofi


       

      The Pitfalls of Validating Novel Digital Endpoints:  What You Need to Know
      Developing and validating Digital outcomes for use in a real world setting is fraught with complications not typically observed in a controlled setting as a clinic or lab.  This presentation  will cover examples of failed validations as well as computational means for controlling confounders.  It will also highlight collaborative bench-marking efforts to better inform validity of outcomes in different settings.

      Larsson Omberg new
      Larsson Omberg

      VP Systems Biology, Sage Bionetworks


       

      SMART Markers: A New Framework for Capturing Patient-Generated Digital Endpoints
      Computational Health Informatics Program at Boston Children’s’ Hospital leveraged the newly regulated SMART on FHIR (Fast Health Interoperability Resources) API to build a software framework– SMART Markers, to capture patient-generated health data, including patient-reported outcomes, and their seamless electronic submission to the health system.  Learn how app innovators can use SMART Markers to create their own custom version of practitioner and patient apps and readily leverage an interoperable PGHD functionality out of the box for research or care, at scale- without having to reinvent the wheel.

      Raheel Sayeed
      Raheel Sayeed

      Chief Fellow in Pediatrics, Boston Children’s Hospital and Harvard Medical School

  • 4:00 pm
    - 5:00 pm

  • Partnering and Group Networking

  • 5:00 pm

  • DPharm Concludes