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2019 Agenda

  • 7:45 am

  • Registration & Coffee/Tea hosted by:


  • 🔑 Patient Advocate Keynote

  • 8:30 am

  • Patient Advocate Opening Presentation

    Fewer than 1% of the women who audition for the famed Radio City Rockettes make the roster and ironically, fewer than 5% of women under 40 get breast cancer. Our patient advocate keynote, Alyssa Epstein has experienced both. This veteran professional dancer will share her patient story, what mattered to her most as a patient and what it took to get back on stage.


    Alyssa Epstein
    Patient Advocate, Radio City Rockette and Inspiration

  • 9:00 am

  • Co-Chairs' Opening


    Tammy Guld
    Janssen Clinical Innovation, Global Team Lead, Johnson & Johnson


  • 🔑 Keynote

  • 9:05 am

  • Modernizing Clinical Trials, Frameworks and Priorities

    Scott Gottlieb
    Scott Gottlieb, MD

    23rd Commissioner of the FDA

  • 9:45 am

  • Keynote: Collaborating to Transform R&D

    rod mackenzie
    Rod MacKenzie, PhD

    EVP, Chief Development Officer, Pfizer, Inc

    with

    Benjamine Liu
    Benjamine Liu, DPhil

    CEO and Founder, TrialSpark

  • 10:05 am

  • Grand Opening of the DPharm Networking & Exhibits Café

    • Breakfast
    • Partnering Tables
    • Meet the Exhibitors
    • Networking
     

     


  • Disruptive Restoration Cornerstone Speaker

  • 10:45 am

  • Good, Better…Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines

    Merck is walking the walk in disrupting how to restore best practices for people, product and productivity. With a clear vision on output, their remarkable team mapped a plan to an enterprise to change operational delivery. In this R&D Leadership session hear the story on how they are delivering what they promise:

    • How to plan upfront once and do it properly
    • Getting the basics right and what do you need to disrupt to get there
    • Significant changes on greatly improving monitoring
    • The use of iPad technology to monetize CRA visits
    • How monitoring reports got reduced from 8 to 2
    • Building a stable workforce with strong employee engagement
    • Behavior, structure, systems and tools
    • Scaling it

    Mark Travers
    Mark Travers, PhD, MBA

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

  • 11:10 am

  • Actions to Embrace and Support Innovation for the Benefit of Patients

    Shwen Gwee
    Shwen Gwee, PhD

    Co- Founder, Novartis Biome, and General Manager, Head of Open Innovation, Novartis


  • 🔑 Guest Keynote

  • 11:20 am

  • The World’s 50 Most Innovative Companies 2019

    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 the Deputy Editor of Fast Company to tell us about:

    • Defining InnovationFast company 2019 magazine cover
    • The process for selecting companies as the World’s 50 Most Innovative
    • Interesting examples of Fast Companies top 50 most innovative companies
    • Common elements in the identified 50 companies? Any major themes?
    • Thoughts based on the top 50 list over the years on what the key enablers are of sustaining innovation over a longer period of time
    • Established companies that have either re-invented themselves or surprised Fast Company with something innovative for their customers
    • Favorites to highlight and biggest surprises
    • Thoughts on which companies can change the world and why?
    • Advice for pharma R&D developers

    David Lidsky
    David Lidsky, JD

    Deputy Editor, Fast Company

    with

    Shwen Gwee
    Shwen Gwee, PhD

    Co- Founder, Novartis Biome, and General Manager, Head of Open Innovation, Novartis

  • 11:45 am

  • Innovative Sources & Solutions

    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 A – Innovative Digital Solutions

      Moderator:

      Nikhil Kavimandan
      Nikhil Kavimandan, PhD

      Director of Innovation & Strategy, Global Development Operations, Novartis

      Presenting Companies:

      11:50 am – 12:05 pm

      Oracle Health Sciences

      Learning to Fish in an Industry Filled with Data Lakes

      Jae_Chung
      Jae Chung, MBA

      VP, Product Management/Strategy


      H
      elen Yeardley, PhD
      SVP, Global Head of Feasibility, Site ID and Study Start-up, Clinical Research Service, ICON plc


      12:05 – 12:15 pm

      Clinical Ink

      The Move From EDC to eSource: Overcoming the Industry’s Data Crisis

      Ed Seguine
      Ed Seguine, MBA

      CEO


      12:15 – 12:25 pm

      4G Clinical

      Using Natural Language Processing (NLP) to Accelerate Protocol Amendments in IRT to Days: Follow the Science without Technology Limitations

      Neta Bendelac
      Neta Bendelac

      Senior Director, Strategy


      Washington Alves

      Senior Director, CMC Operations, Gemini Therapeutics


      12:25 – 12:30 pm

      snapIoT

      Bridging Socio-Economic Barriers in Important Maternal Health Research

      Edward Triebell
      Edward Triebell

      VP Sales, Marketing, and Business Development


      12:30 – 12:35 pm

      Complion

      Why Respecting Site Agency is the Key to Site Success


      Rick Arlow, MD, PhD

      Founder and CEO


      12:35 – 12:40 pm

      Science 37

      Virtual Trials: A Peak Under the Hood

      Jonathan Cotliar
      Jonathan Cotliar, MD

      CMO


      12:40 – 12:45 pm

      UBC

      Accelerating from Site-based to Real World Data-driven Clinical Development

      Paul Bloom
      Paul Bloom

      Sr. Director, Software Engineering


      12:45 – 12:50 pm

      IBM Watson Health

      Observed Best Practices for Patient-Reported Outcomes

      Walker Bradham
      Walker Bradham

      Offering Manager – IBM Clinical Development Platform

      Danielle Chow
      Danielle Chow

      Life Sciences Portfolio Manager for Watson Health


      12:50 – 12:55 pm

      Improving Patient Recruitment: Returning Genetic Results

      Shantanu Kaushikkar
      Shantanu Kaushikkar, MBA

      Director Product Marketing, Genotyping, Thermo Fisher Scientific

    • Track B – Innovative Patient Solutions

      Moderator:

       


      Sandra Freeman

      Associate Director, Global Clinical Operations, Johnson & Johnson

       

      Presenting Companies:

      11:50 am – 12:05 pm

      PA Consulting

      Clinical Trial 2030: Pragmatic Predictions for the Next Evolution of Trials and What We Can Do Now to Prepare


      Kelsey Jakee

      Life Sciences Expert


       

      12:05 – 12:15 pm

      BBK Worldwide

      The Myth: New Technology Inherently Equals Improved Outcomes


      Aaron Fleishman

      Director of Market Development

      Matt Kibby new
      Matt Kibby

      Principal, President


       

      12:15 – 12:25 pm

      ClinEdge

      The ROI of Providing Patient Travel Options: Exploring Cost Savings & Benefits for Sponsors & CROs


      Al Peters

      VP, Patient Travel Services


       

      12:25 – 12:35 pm

      Greenphire

      From Rideshare to Reservations: Improving the Patient Experience through Travel Innovation

      Kyle Cunningham
      Kyle Cunningham

      Chief Product Officer


       

      12:35 – 12:45 pm

      Clincierge

      Improving Clinical Trial Performance through Effective Management of The Patient Journey

      Scott Gray
      Scott Gray

      CEO


       

      12:45 – 12:55 pm

      Inteliquet

      Increasing Patient Recruitment to Trials: Innovation in Predictive Analytics and Digitization Brings Clinical Trials into Clinical Care

      Debra Kientop
      Debra Kientop, MBA

      VP, Life Sciences


       

      12:55 – 1:05 pm

      AiCure

      AI-Based Digital Endpoints of Clinical Functioning: Increasing Sensitivity and Validity in Evaluating Clinical Efficacy

      Isaac Galatzer-Levy
      Isaac Galatzer-Levy, PhD

      VP Clinical and Computational Neuroscience

    • Track C – Where Are They Now?

      Moderator:

      Ülo Palm
      Ülo Palm, MD, PhD

      SVP and Head, Digital Science, Allergan

       

       

       

      Presenting Companies:

      11:50 am – 12:00 pm

      Elligo Health Research

      True Electronic Source: Why Elligo’s Approach Attains Real Source Data Collection in our Healthcare-Enabling Research Organization


      Jacylyn Bodmer, MBA

      Chief Information & Technology Officer


       

      12:00 – 12:10 pm

      MRN

      Successful Integration of In-Home Visits with Mobile Technology


      Graham Wylie, MBBS

      CEO


       

      12:10 – 12:20 pm

      Edetek

      EDETEK’s CONFORM™ Clinical Informatics Platform is Revolutionizing How Clinical Data is Being Ingested (from patient monitoring devices, EDCs, Labs, EHRs, Iot, etc.), Standardized, Transformed, Validated, Blinded, and Mapped to Create Near Real Time Access to Decision Makers on Trial Executions

      Mark Gee
      Mark Gee

      Sr. Director Business Development


       

      12:20 – 12:30 pm

      GlobalCare Clinical Trials

      Decentralized/Hybrid Trials – Patient-Centric Services Facilitate Recruitment, Compliance and Retention


      Gail Adinamis

      CEO


       

      12:30 – 12:40 pm

      Quest Diagnostics

      Case study: Impact of Lab Data on Phase 3 Study Planning, Site Selection and Recruitment

      David Freeman
      GM, Information Ventures


       

      12:40p – 12:45 pm

      Clinical Pipe

      First Year into Live Connection of EHR-to-EDC Clinical Pipe Application: Site Buy-in, Sponsor/CRO Adoption, Challenges and Solutions

      Hugh Levaux
      Hugh Levaux, PhD

      Founder and CEO


       

      12:45 – 12:50 pm

      Hawthorne Effect

      Case Study


      Jodi Akin

      Founder and CEO

  • 12:50 pm

  • Lunch & Networking

    DPharm 2018 lunch

  • 2:00 pm

  • Pharma Innovation 2019 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 and details to come shortly:

    • Track A

      Moderator:


      Tammy Guld
      Janssen Clinical Innovation, Global Team Lead, Johnson & Johnson

       

      Presenting Companies:

      2:05 – 2:20 pm

      The Evolution of Using Real World Data to Create Trial Readiness Cohorts

      Martine Lewi
      Martine Lewi, PhD, MBA

      Janssen Clinical Innovation, Scientific Director, Johnson & Johnson


       

      2:20 – 2:35 pm

      Re-Thinking Clinical Development – Using Historical Data to Transform Clinical Trials

      Aaron Mann
      Aaron Mann

      Global Program Lead, Industry Collaborations Data Sharing Initiatives, Genentech, a member of the Roche Group


       

      2:35 – 2:50 pm 

      The Novartis Biome: Helping the Digital Health Ecosystem Truly Impact Drug Development

      Robin Roberts
      Robin Roberts

      Co-Founder, Novartis Biome, Head of Strategy & Innovation, Novartis


       

      2:50 – 3:20 pm 

      Myth Busting with Merck and Bayer

      Robin Roberts
      Laura Galuchie

      TransCelerate Program Lead, Merck

      Robin Roberts
      Michelle Shogren

      Director of Innovation, Pharma R&D Clinical Operations, Bayer

    • Track B

      Moderator:


      Joseph Kim, MBA
      Sr Advisor, Clinical Operations and Digital Registry, Digital Health Office Translational Technology & Innovation, Eli Lilly

      Presenting Companies:

      2:05 – 2:20 pm

      The PD-FIDI: Developing a Digital Endpoint for Parkinson’s Disease

      Laura Kling
      Laura Kling

      Director, Digital Innovation, Sanofi


       

      2:20 – 2:35 pm

      Pfizer: The Validation Study – ePRO and Scrolling 

      Elan Josielewski
      Elan Josielewski

      VP of Patient Centered Science, ICON Commercialisation & Outcomes, ICON

      Sachin Karnik
      Sachin Karnik

      Director of New Clinical Paradigm, Pfizer


       

      2:35 – 2:50 pm 

      Digital Recruitment and Analog Issues: Goals, Metrics and Challenges in Evaluating Recruitment Tactics

      Sarah Luijpers
      Sarah Luijpers

      Associate VP, Drug Development Operations, Business Operations, Allergan


       

      2:50 – 3:05 pm

      Structured Data and Corporate Structure: How a Centralized Data Platform Within a Decentralized Organization Unlocks Value

      Daniel Rothman
      Daniel Rothman

      Chief Information Officer, Roivant Sciences


       

      3:05 – 3:20 pm

      Clinical Research as a Care Option into Direct to Patient Trials Leveraging Mobile Technologies

      Kent Thoelke
      Kent Thoelke
      EVP, Chief Scientific Officer, PRA Health Sciences

      with

      John Whang
      John Whang, MD

      IET Head, Cardiovascular and Metabolism, Johnson & Johnson

    • Track C

      Moderator:

      Paulo Moreira
      Paulo Moreira
      Global Head of Clinical Operations, Agenus

       

       

      Presenting Companies:

      2:05 – 2:20 pm

      How Bayer Leveraged the Patient Voice in the Re-design of their Clinical Trial Finder

      Michelle Shogren
      Michelle Shogren

      Director of Innovation, Pharma R&D Clinical Operations, Bayer


       

      2:20 – 2:35 pm

      Eli Lilly: Tracing Patient Recruitment Effectiveness


      Nicole Sheetz, PharmD

      Advisor, Clinical Design, Delivery & Analytics, Eli Lilly & Company


       

      2:35 – 3:05 pm 

      Don’t Clinical Trial Participants Have a Right to their Data and Results?  What is PDAI Doing About it?

      Moderator:


      Jessica Scott, MD

      Head of R&D Patient Engagement Office, Takeda Pharmaceuticals

      Panelists:

      David Leventhal
      David Leventhal, MBA

      Senior Director, Clinical Trial Experience, Pfizer 


      Sara Loud, MBA

      Operations and Repository Director, Accelerated Cure Project (ACP) for MS


      Megan McBride, MPH

      Associate Director, Janssen Clinical Innovation, Janssen


       

      3:05 – 3:20 pm

      Partnering with Patients: Retention and Engagement through Patient Data Return


      Dana Edwards

      Sr. Director, Go-to-market strategy, Design and Delivery Innovation, IQVIA

      with
      April Lewis
      April Lewis

      Sr. Director R&D Clinical Technology, GSK
  • 3:30 pm

  • Afternoon Break in the DPharm Networking & Exhibits Café hosted by:

    • Refreshments including chocolates by Boston’s oldest chocolatier and ice cream. 
    • Partnering Tables
    • Meet the Exhibitors
    • Networking

  • Zeitgeist Talk Choices

    • 4:00 pm

      Choice A

      Tech-Enabled Direct-to-Patient Return of Trial Results

      23andMe and CISCRP are collaborating with industry stakeholders to enable: 

      • Return of trial results directly to patients
      • Conduct end-to-end patient voice engagement throughout the medicine development life cycle
      • Provide more dynamic and in-depth conversation with patients that is bigger than their participation in one trial
      • Enable two-way feedback with patients to improve planning for clinical studies 
      • Empowering the patient to take control of their health – and access novel therapies through clinical trials

      In this session, hear more about how these organizations are innovating in this space and impacts on the future of drug development with the patient at the center and the patient’s voice throughout.

      Shawn Tedman
      Shawn Tedman, MBA

      Director, Clinical Trials Business, 23andMe

      with

      Getz_Ken-2018
      Ken Getz, MBA

      Director of Sponsored Research, Tufts CSDD and Founder, CISCRP

      Paulo Moreira
      Paulo Moreira

      Global Head of Clinical Operations, Agenus

    • 4:00 pm

      Choice B

      The Use of AI and Big Data to Increase Reproducibility and Greater Accuracy in Drug Development

      Arjun Manrai
      Arjun (Raj) Manrai, PhD
      Assistant Professor, Harvard Medical School and Faculty Member, Computational Health  Informatics Program (CHIP), Boston Children’s Hospital


      4:20pm

      How Digital Twins will Revolutionize Clinical Trials

      Charles Fisher
      Charles Fisher, PhD

      Founder and CEO, Unlearn.AI

  • 4:30 pm

  • DPharm Idol 2019

    Now in its 8th year, DPharm Idol 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 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 winners include Medidata, Spaulding Clinical, ePharma Solutions, Science 37, Florence Healthcare, physIQ and Medable.

    Who will be the DPharm Idol 2019 winner?


    Presenting Companies:

    TrialScout


    Irfan Khan, MD
    , CEO


    xCures


    Mika Newton
    , CEO


    Shimmer Research

    Geoff Gill
    Geoff Gill
    , President


    Intelligencia

    Vangelis Vergetis
    Vangelis Vergetis, PhD
    , Co-Founder


    Trials.ai

    Kim Walpole
    Kim Walpole
    , Founder and CEO


    Tasso

    Ben Casavant
    Ben Casavant, PhD
    , Co-Founder and CEO


    DPharm Idol Winner 2018, Medable, on Disrupting the Clinical Trial Business Model by Connecting the Clinical Trial Ecosystem

    Michelle Longmire, MD
    Co-founder and CEO, Medable


    DPharm Idol MC:


    Valerie Bowling

    Executive Director, DPharm

    DPharm Idol Judges:


    Sandra Freeman
    Associate Director, Global Clinical Operations, Johnson & Johnson


    Cindy Geoghegan

    Cancer Veteran and Patient Advocate


    Hassan Kadhim

    Director, Head of Clinical Trial Business Capabilities, BMS

    Ülo Palm
    Ülo Palm, MD, PhD

    SVP and Head, Digital Science, Allergan

    Douglas Schantz
    Douglas Schantz

    Executive Director, Development Operations, AstraZeneca


    Jessica Scott, MD, JD

    Head of R&D Patient Engagement, Takeda Pharmaceuticals

    Mark Travers
    Mark Travers, PhD, MBA

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

  • 5:45 pm

  • DPharm Annual Networking Reception & Partnering

2019 Agenda

  • 8:00 am

  • Morning Coffee and Partnering

  • 8:30 am

  • Co-Chair Opening & DPharm Idol Winner Announcement


    Tammy Guld

    Janssen Clinical Innovation, Global Team Lead, Johnson & Johnson


  • Zeitgeist Speaker on Big Data & AI for Drug Development

  • 8:40 am

  • The Collective Struggle to Evolve a Drug Development Organization’s Data and Analytics Culture and Capabilities

    Perhaps one of the most inquisitive CDOs in R&D, Milind Kamkolkar joins DPharm for the first time to address:

    • The theory of going digital in drug development?
    • Identifying hype from reality
    • What is the problem we are trying to solve?
    • Taking a big, complex organization and evolving it to be digitally modern
    • Given the distance between data and decision making, how can we accelerate this from R&D to commercial?
    • What is the intended use of the data?
    • The social and ethical use of the data
    • Priorities, structure, culture and next steps

    Milind-Kamkolkar
    Milind Kamkolkar

    Chief Data Officer, Cellarity


  • 🔑Healthgrades Keynote

  • 9:05 am

  • Healthgrades Founder Kerry Hicks on Transparency and the Future of Patient Expectations

    “Everyone likes progress and no one likes change.” Kerry Hicks

    Kerry Hicks is the founder of Healthgrades, which put the power of transparency into millions of patients’ hands on provider visit experiences. In this fireside chat, we will begin with his vision for Healthgrades, what it was like to build it, early fears, and unintended consequences. We will discuss Kerry’s three top principals: 1. Transparency 2. Accountability and 3. Empowerment. Our conversation will also cover the intersection between patient experience, technology and clinical research. Finally, we will get Kerry’s insights on why you must consider transparency with everything you build going forward, the customer/patient experience, key changes in clinical research and who may come along to disrupt us.

    Kerry Hicks
    Kerry Hicks, MBA

    Founder, Healthgrades

    with


    Craig Lipset, MBA

    Former Head of Clinical Innovation, Pfizer


  • Guest Design Speaker

  • 9:25 am

  • Starbucks: Innovation for the End User Experience

    Starbuck’s guest speaker, Robert Mercer sits down with Eli Lilly’s Joe Kim to discuss an-out-of industry example from one of the best companies to cherish the end user experience. We will hear how Starbucks approaches innovation and in particular how they designed their mobile experience with the customer in mind. More specifically:

    • Barriers and executive buy-in
    • Rolling out the mobile experience
    • Balancing the scale of new solutions across stores around the globe with the need to maintain existing operations and delivery
    • How Starbucks engages with customers to learn and develop innovative new solutions

    Robert Mercer
    Robert Mercer

    Design Director, Global Digital Products, Starbucks

    with


    Joseph Kim, MBA

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

  • 9:45 am

  • Today Show @DPharm

    Host:

    Michelle Shogren
    Michelle Shogren
    Director of Innovation, Pharma R&D Clinical Operations, Bayer

    Guest Companies:

    IQVIA

    Parexel
    Sy Pretorius
    Sy Pretorius, MBChB, MBA
    Chief Medical and Scientific Officer

    ERT

    Andrea Valente
    EVP and Chief Development Officer

  • 10:30 am

  • Morning Networking in the DPharm Café

    • Breakfast
    • Partnering Tables
    • Meet the Exhibitors
    • Networking
     
  • 11:10 am

  • 3 Break Out Choices

    Track A:
    EHR eSource, Security,
    RWD & the Rise 
    of Voice Tech
    Track B:
    MAPs, Virtual Trials, Patient/
    Investigator Comm & Protocol Toolkit
    Track C:
    Big Data, AI & Machine Learning

  • Track A: EHR eSource, Security, RWD & the Rise of Voice Tech

  • 11:15 am
    - 11:35 am

  • Operationalizing EHR eSource – Ruthless Separation of Hype from Reality

    DPharm welcomes one of the most credible voices in e-source, Dr Meredith Zozus for the first time to this event. Dr Zozus will begin briefly with why e-source can be truly disruptive to clinical studies from overall cost reduction, the ability to cut down on clinical data monitoring, reducing errors on data collection, site burden to the enormous decrease in manual labor. Joining DPharm for the first time as well is Pfizer’s Michele Cherry who is working with Dr Zozus on operationalizing esource at Pfizer. Together, they will show the DPharm audience how esource works and talk about what is required to implement it on a multicenter clinical study. Expect ruthless separation of hype from reality and discussion around the following questions:

    • What makes a study a good or bad candidate for EHR esource and why?
    • How much of the data is really available in the EHR?
    • How does operationalizing esource change site selection and start up time-lines?
    • How to reengineer start up times around esource?
    • How to make ends meet from a regulatory perspective to operational perspective?
    • What are the unknowns and pitfalls?
    • Is the technology ready? Are the sites ready? Is my organization ready?
    • How to prompt discussions in your organization about when to jump on the adoption curve?
    • How do we gain experience with EHR esource and de-risk it for my company?

    Meredith Zozus
    Meredith Zozus, PhD

    Associate Professor and Vice Chair for Academic Programs, University of Arkansas for Medical Sciences’ College of Medicine—Department of Biomedical Informatics

    with

    Michele Cherry
    Michele Cherry

    Senior Manager, Client Partner, Pfizer


  • Track A: EHR eSource, Security, RWD & the Rise of Voice Tech

  • 11:35 am
    - 12:00 pm

  • #WeHeartHackers: Why this is Vital to Clinical Trial Data Security

    Biohacking Village founder Janine Medina will cover a topic that we don’t always think about, but when you get exposed to it, you’re so glad as it makes you think deeper about clinical trial innovation, safety and privacy for patients, especially in this digital era. Janine is joined by former entrepreneur-in-residence at the FDA, Andrea Coravos where they discuss:

    • What is hacking? And why is it important for your clinical trial?
    • White Hat vs Black Hat
    • Security Bill of Materials for Connected Medical Devices / Wearables
    • Digital tools in trials and their vulnerabilities
    • Conventional trials and their vulnerabilities
    • What unexpected things can we learn from hackers when they look at the existing clinical trial process (the less scary things)
    • Coordinated disclosure
    • FDA’s CyberMed Safety (Expert) Analysis Board (CYMSAB)
    • #WeHeartHackers, and FDA-led initiative around cybersecurity research
    • BHV at DEF CON

    Janine Medina
    Nina Alli

    Executive Director, Biohacking Village

    with

    Andy Coravos
    Andy Coravos

    CEO and Co-Founder, Elektra Labs


  • Track A: EHR eSource, Security, RWD & the Rise of Voice Tech

  • 12:00 pm
    - 12:20 pm

  • Using Real World Data to Plan Eligibility Criteria and Enhance Recruitment

    Sponsors are increasingly using real world data (RWD) to pressure-test assumptions and explore the impact of different eligibility criteria on trial feasibility before the protocol is finalized. In this session from the Clinical Trials Transformation Initiative (CTTI), learn about:

    • Practical models and operational guidance for using RWD to facilitate RCT planning and execution
    • Enhancing recruitment and eligibility through new approaches enabled by RWD
    • Actionable tools and case studies that support the appropriate use of RWD sources in clinical trial planning

    At a time when limited best practices exist, CTTI’s multi-stakeholder work provides a much needed framework for using RWD to enhance the quality and efficiency of clinical trials moving innovation forward.


    CAPT Dianne Paraoan, USPHS

    Associate Director for Regulatory Affairs, Office of Medical Policy, Center for Drug Evaluation and Research, FDA


    Jack Sheehan, RPh, MBA, PhD

    Director, Real-World Value and Evidence, Neuroscience, Janssen Scientific Affairs


  • Track A: EHR eSource, Security, RWD & the Rise of Voice Tech

  • 12:20 pm
    - 12:40 pm

  • The Future Outlook on Voice Technologies and Their Possible Impact on Clinical Trials


    Sara Holoubek, MBA

    CEO, Luminary Labs


  • Track A: EHR eSource, Security, RWD & the Rise of Voice Tech

  • 12:40 pm
    - 12:50 pm

  • Case Study with 83bar

    Kate Hermans
    Kate Hermans

    Chief Business Officer – Pharma, 83bar


  • Track A: EHR eSource, Security, RWD & the Rise of Voice Tech

  • 12:50 pm
    - 1:00 pm

  • Case Study with Microsoft

    Paul Slater
    Paul Slater

    Co-Founder, Clinical Research Innovation Hub, Microsoft Corporation


  • Track B: MAPs, Virtual Trials, Patient/ Investigator Comm & Protocol Toolkit

  • 11:15 am
    - 11:35 am

  • Master Protocols as the Future of Clinical Research: Patient-Centric R&D and Transformational Efficiencies

    We know patients, regulators, investigators and drug developers have a common interest in bringing safe and effective therapies quickly to patients needing them, yet the familiar clinical trial process contains built-in inefficiencies leading to delays, redundancies, and escalating costs. Master Protocols enable drug developers to answer questions more quickly, and patients participating in clinical trials to have the best opportunity to access promising therapies while contributing to the scientific understanding of their condition thereby allowing the field to progress as rapidly as possible.

    In this collaborative session representing both the patient and drug developer perspectives, learn what it takes to make MAPs a reality – the opportunities, challenges, why it’s disruptive and how all stakeholders can contribute.

    Abby Bronson
    Abby Bronson

    SVP of Research Strategy, Parent Project Muscular Dystrophy

    Daniel Millar
    Daniel Millar, MBA

    Senior Director, Strategic Business Transformation Quantitative Sciences, Janssen Research & Development


  • Track B: MAPs, Virtual Trials, Patient/ Investigator Comm & Protocol Toolkit

  • 11:35 am
    - 11:50 am

  • Case Study: The ADAPTABLE Trial and Shared Learnings from a Virtual Trial

    The ADAPTABLE trial is the largest virtual trial ever run on the Medidata platform. Learn about the rationale around the decision to run the trial as a virtual trial, the impact on patient enrollment, engagement and retention as well as the incorporation of patients to inform the design of the trial and the tools used in the conduct of the study.

    Michael Tucker
    Michael Tucker

    Senior Product Solutions Specialist, Mobile Health, Medidata

    with

    Holly Robertson
    Holly Robertson, PhD

    Project Leader, Global MegaTrials, Duke Clinical Research Institute


  • Track B: MAPs, Virtual Trials, Patient/ Investigator Comm & Protocol Toolkit

  • 11:50 am
    - 12:20 pm

  • Direct-to-Patient Clinical Trials Next Milestones and Actions to Get There

    We have called direct-to-patient trials, virtual trials, flexible trials, siteless trials, remote trials, decentralized trials and more. Many of us have done pieces of these types of trials, but as an industry, this is still not the norm by a long shot. In this discussion, we report on our progress, identify what’s missing to close the gaps and next steps and call to actions.

    Led by:


    Craig Lipset, MBA

    Former Head of Clinical Innovation, Pfizer

    with

    Adama Ibrahim
    Adama Ibrahim, EMBA

    Associate Director, Performance Operational Capabilities, Global Clinical Operations, 
    Biogen


    Jacob LaPorte, PhD

    Co-founder & VP, Global Head of Novartis Biome, Novartis

    Kelly McKee
    Kelly McKee

    Head, Patient Recruitment, Vertex Pharmaceuticals


    Jules Mitchel, PhD

    President, Target Health


  • Track B: MAPs, Virtual Trials, Patient/ Investigator Comm & Protocol Toolkit

  • 12:20 pm
    - 12:40 pm

  • Enhancing Clinical Trial Communications between Patients and Investigators

    As an industry, we must prioritize building rapport with the patients who have instilled their trust and made a commitment to help researchers learn more about a disease and improve healthcare in the future. It’s equally important for healthcare professionals to feel that they have the support they need to build strong relationships with patients in the clinical trial setting. The more clinical trial sponsors do to show empathy and personalize the interaction with patients, healthcare professionals and site staff, the better trials will be. This presentation is a call to action for the audience to invest in high quality conversations between site staff and patients/ study participants.

    • Understanding patient interest and motivation
    • Deepening the connection between patients and site staff
    • Empowering Patients

     The goal is for patients to feel more engaged with the trial, and to equip site staff with tools to drive patient-centered conversations.

    Suzann Johnson
    Suzann Johnson

    Associate Director Investigator Patient Engagement, CIE, Janssen


  • Track B: MAPs, Virtual Trials, Patient/ Investigator Comm & Protocol Toolkit

  • 12:40 pm
    - 1:00 pm

  • The Launch of the Patient Protocol Engagement Toolkit (P-PET)

    The #1 way to make clinical trials patient-centric is to ask patients what they want.

    We know that patients are empowered by knowledge of their diseases and understanding how drugs are developed and they want to take an active role in the drug development process. While sponsors recognize the importance of partnering with patients to create better experiences for clinical study participants, caregivers, and families, they do not always have the tools for engaging patients in study design and measuring patients’ experiences during a clinical study.

    For the first time attendees will preview the Patient Protocol Engagement Toolkit (P-PET). It entails a User and Resource Guide and templates that help teams consider necessary details when engaging patients during protocol development. Patient feedback during protocol development may help identify ways to improve patient experience and reduce patient burden.

    The audience will also preview the recently made public Study Participant Feedback Questionnaire (SPFQ) toolkit. It includes the three questionnaires and a User Guide to help study teams consider necessary details to include the questionnaires into the study trial design. Collecting real-time feedback from clinical study patients may help identify burden/impact and inform the steps to take to make the current or future studies less burdensome to patients. These tools support innovation for the benefit of patients and drug development.

    Michele Teufel
    Michele Teufel

    Patient and Site Engagement Lead, AstraZeneca


  • Track C: Big Data, AI & Machine Learning

  • 11:15 am
    - 11:35 am

  • Is Digital Science, Big Data, Machine Learning, and AI Going to Revolutionize Medical Research and Practice? Implications for Pharmaceutical R&D

    • What is behind the terms “Digital Science, Big Data, Machine Learning, AI”?
    • Examples where these new technologies are shifting paradigms in medicine
    • What are the implications for pharmaceutical R&D? Can we sit it out or do we rapidly need to change?
    • What can AI do in development and what do we want AI to do in development?
    • How to separate hype from real opportunities to create value?
    • Why can’t we successfully implement Digital Science without a Digital Culture? What is a Digital Culture?
    • How is Allergan creating a Digital Culture to drive the success of Digital Science

    Ülo Palm
    Ülo Palm, MD, PhD

    SVP and Head, Digital Science, Allergan


  • Track C: Big Data, AI & Machine Learning

  • 11:35 am
    - 11:45 am

  • AI in Healthcare: Why Augmented Intelligence Is the Path toward Success
    IQVIA


    Elizabeth Milkovits, PhD
    Director, Global Analytics

  • Track C: Big Data, AI & Machine Learning

  • 11:45 am
    - 11:55 am

  • An AI Powered Pragmatic Study: Mendel 3800

    This session will review a study being conducted by Medel.ai including the methodologies around automatic extraction of patient data being executed by Artificial Intelligence (AI).  The result is a pragmatic study being completed at a fraction of cost and a fraction of time as compared with traditional methods. 


    Karim Galil, MD

    CEO, Mendel.ai

    with

    Matthew Michela
    Matthew Michela, MBA

    President and CEO, Life Image, Mendel.ai


  • Track C: Big Data, AI & Machine Learning

  • 11:55 am
    - 12:10 pm

  • All the Insight at a Fraction of the Time and Effort: Using Deep Learning to Generate a Wearable Sensor-based Proxy for VO2max

    There is a long list of “gold standard” clinical assessments that, while accepted by industry and regulators, are far from ideal or practical.  They are either too expensive (polysomnography), too inaccurate (6 minute walk), or too burdensome for patient and trial coordinator (VO2max).  Multivariate data sets from wearable sensors, when coupled with deep-learning artificial intelligence, represent the opportunity to use continuous, real-world physiology data to replicate these assessments using only the data passively collected throughout activities of daily living.  In this presentation physIQ will discuss their latest proprietary deep learning algorithm that they are validating as a potential replacement for VO2max in clinical trials.

    Chris Economos
    Chris Economos, MBA

    Chief Commercial Officer, physIQ


  • Track C: Big Data, AI & Machine Learning

  • 12:10 pm
    - 12:25 pm

  • Managing Site and Study Performance in Clinical Trials with AI

    Amit-Gulwadi new
    Amit Gulwadi

    SVP, Clinical Innovations, Saama


  • Track C: Big Data, AI & Machine Learning

  • 12:25 pm
    - 12:40 pm

  • Janssen Case Study

    Sudhi Rau
    Sudhi Rau
    Business Technology Leader, Janssen Pharmaceuticals R&D, IT, Global Clinical Development Operations & Janssen Clinical Innovation, Janssen

    Laszlo Vasko
    Laszlo Vasko

    Senior Director, R&D IT Clinical, Janssen


  • Track C: Big Data, AI & Machine Learning

  • 12:40 pm
    - 1:00 pm

  • What Needs to be Assembled Among Teams and Infrastructure to Support AI Deployment?

    • What to assemble to truly be a data driven organization?
    • Adoption challenges
    • Barriers
    • Next steps to AI adoption

    Moderated by:

    Michelle Hoiseth
    Michelle Hoiseth

    Chief Data Officer, Parexel

    Panelists:

    Milind-Kamkolkar
    Milind Kamkolkar

    Chief Data Officer, Cellarity

    Ülo Palm
    Ülo Palm, MD, PhD

    SVP and Head, Digital Science, Allergan

  • 1:00 pm

  • Lunch


  • 🔑 R&D Leadership Keynote

  • 2:00 pm

  • KPIs that Support Innovation for Patient-Engagement

    Dr Plump leads Takeda’s global Research & Development organization, where he provides strategic direction and oversight. He specializes in bringing an unwavering focus on patients and a deep commitment to innovation and positive change in the healthcare industry. Dr Plump is joined by his colleague and DPharm veteran, Dr Jessica Scott in a fireside keynote to share the development of KPIs that support innovation for patient-engagement.

    Andrew Plump
    Andrew Plump, MD, PhD
    President, Research & Development, Takeda

    with


    Jessica Scott, MD, JD

    Head of R&D Patient Engagement, Takeda

  • 2:30 pm

  • Super Session Choices


      The concluding section at DPharm offers two compelling tracks addressing   upskilling site staff where we are proudly partnering with ACRP and CRAACO, which   focuses on the integration of research and care. Attendees are free to “pick and mix”.
    • Choice #1

      Workforce Innovation: Upskilling Site Staff for 21st C Clinical Trials

      Moderated by:

      Jim Kremidas
      Jim Kremidas

      Executive Director, ACRP

      This section of DPharm addresses one of the elephants in the room. As an industry, we are not doing a good enough job consistently ensuring the skill levels and training of site staff. The results of this is so costly that not even Tufts CSDD have a number on it. In this section, we are going to address head on the source of this problem and where innovation fits in so we can:

      • Understand the inequality of the workforce performance in clinical trials at the site level
      • Establish a definition and alignment on the competencies required for clinical research staff
      • Establish industry standards for validating the qualifications of site staff
      • Define a career path for site staff to enhance retention and quality
      • Improve enrollment, accurate data, operational efficiencies and overall quality in the clinical research ecosystem

      This will get achieved through these sessions:

       

      2:35 pm

      We Have a Problem with Workforce Performance at the Site Level and Here is What We Can Do Now


      Jeff Kingsley, DO, MBA, CPI, FACRP

      CEO, IACT Health


      Chris Pitcherella, MBA

      Director, Clinical Site Management, Pfizer

      David Vulcano
      David Vulcano, MBA

      VP, Clinical Research Compliance and Integrity, HCA Healthcare


       

      3:05 pm

      How to Develop Career Paths and Build the Competency of the Clinical Research Workforce/Individuals via Organizational Level Changes

      Deena Bernstein
      Deena Bernstein

      Leadership Council, SCRS

      Denise Snyder
      Denise Snyder, MS, RD, LDN

      Associate Dean for Clinical Research, Duke University School of Medicine

      Mark Travers
      Mark Travers, PhD, MBA

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


       

      3:50 pm

      Collaborative Efforts for Workforce Efficiency and Productivity that are Disruptive


      Jennifer Byrne

      CEO, Javara

      Beth Harper
      Beth Harper

      Workforce Innovation Officer, ACRP

      Dave Morin
      Dave Morin, MD

      Director of Research, Holston Medical Group

      Denise Snyder
      Denise Snyder, MS, RD, LDN

      Associate Dean for Clinical Research, Duke University School of Medicine


       

       

        Mobile in Clinical Trials

        September 16th in the same venue.

        Reduced rate available for attendees
        who want to register for both programs.

        For details on the Mobile day,
        click here.

    • Choice #2

      CRAACO: Clinical Research as a Care Option

      Five years ago, DPharm featured a session highlighting an example of research offered as a care option within a health system with positive health outcomes. The interest from both health systems and pharma in learning about the details of how to make this happen continues to grow. DPharm is committed to dedicating this section called CRAACO to highlight examples of bringing research closer to patients and patients closer to research.

      2:35 pm

      Understanding the Goals of Care vs Research

      • Goals for care vs goals for research
      • Oversight and governance
      • Is there an ethical burden of breaking down the line between research and care?
      • What is the hesitation behind embracing the blurring of this boundary?
      • In areas like precision medicine, this is already blurring, how to manage?
      • Hurdles stopping large companies from thinking about this– Is it practical? Ethical?

      Murray Abramson
      Murray Abramson, MD, MPH

      VP, Global Clinical Operations, Biogen


      Jennifer Byrne

      CEO, Javara

      Jonathan Jackson
      Jonathan Jackson, PhD

      Director, CARE Research Center, Massachusetts General Hospital

      Douglas Schantz
      Douglas Schantz

      Executive Director, Development Operations, AstraZeneca


       

      2:50 pm

      How a CRAACO Approach Facilitates Diverse Recruitment and Especially Retention to Clinical Trial

      Jonathan Jackson
      Jonathan Jackson, PhD

      Director, CARE Research Center, Massachusetts General Hospital


       

      3:00 pm

      Weighing Your Options in Considering Clinical Research from a Patient Perspective

      • Strategies and ideas to reduce the burden to patients
      • Understanding of clinical care with their physician?
      • Communication, consent and data sharing

      Moderated by:


      Cindy Geoghegan

      Cancer Veteran and Patient Advocate

      Panelists:

      Dave Bjork
      Dave Bjork

      Patient Advocate

      Danya Kaye
      Danya Kaye

      Patient Advocate


       

      3:25 pm

      How Sanford Health Systems Integrated Clinical Care and Clinical Research – Going from 3% of Patients in Clinical Trials to 10% in 8 years: Case Study

      • Creating a system for all providers to work seamlessly
      • Educational programs and continual training across all areas of care and specialties for trial offerings
      • Identifying gaps in trial availability
      • Attracting providers who are interested in clinical research for their patients
      • NCORP site

      Jennifer Weiss
      Director of Clinical Research, Sanford Research


       

      3:55 pm

      Pfizer’s Collaborative Approach with Ocshner Healthcare System to Integrate Clinical Research into Clinical Care

      Tim Joy
      Tim Joy
      Senior Director, Patient Technologies & eSource, Pfizer

      Olivia Sweetnam
      Olivia Sweetnam
      iO Clinical Consultant, Innovation, Ochsner Health System


       

      4:20 pm

      The Need for an Internal Advocate: How Can Clinical Research Professionals bring CRAACO into Clinical Operations?

      In this session, participants will receive an insider’s view of how being an advocate within pharma for patients and sites can benefit clinical trial awareness, participation, and experiences.

      Kelly McKee
      Kelly McKee

      Head, Patient Recruitment, Vertex Pharmaceuticals


       

      4:40 pm

      Building a Site Network with Clinical Research as a Care Option

      Deena Bernstein
      Deena Bernstein

      Leadership Council, SCRS

  • 4:50 pm

  • DPharm Concludes