Pre-Conference Program, Monday, September 24, 2018 – 8:00 am – 5:45 pm

Mobile in Clinical Trials Full Day Conference

2018 Agenda

  • 7:45 am

  • Registration & Coffee

    Registration Hosted by:

    Badge and Material Collection

    Tea/Coffee

  • 8:30 am

  • DPharm’s Got Talent Patient Survivor Opening Performance

    Caly Bevier is a teen cancer survivor, singer, America’s Got Talent quarter finalist and Golden Buzzer winner. Caly opens DPharm 2018 with a performance for the audience and tells her incredible story, from being diagnosed with late stage ovarian cancer at 16 to how she made it to the global stage in a matter of months.

    AGT Caly Bevier
    Caly Bevier
    Patient Advocate and Performer

  • 9:00 am

  • Co-Chairs’ Welcome


    Andreas Koester, MD, PhD
    VP and Global Head, Janssen Clinical Innovation, Janssen


    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer

  • 9:15 am

  • Global Keynote: Estonia, the Digital Republic: Where Patients Own Their Data

    An Insight into our Possible Future Faster than You Think

    “E-Estonia is the most ambitious project in technological statecraft today, for it includes all members of the government, and alters citizens’ daily lives.” – The New Yorker

    Estonia is now a digital republic and considered to currently be the most advanced digital society in the world with a virtual government, blockchained and secure. Our keynote guest from Estonia, Indrek Õnnik, tells us how Estonia became the fastest country in the world to go digital. Its 1.3 million citizens pay with their mobile phones, have their health records stored in the digital cloud, and file their annual tax return online in five minutes. We will learn how Estonian citizens have come to own their personal health records, how doctors have to get their permission to use these records, and how patients choose their own medications digitally. We will also learn about their challenges, policies and, of course, their vision for digital clinical trials.


    Indrek Õnnik

    Program Manager, E-Estonia Showroom, a partner of the Estonian Government

  • 9:55 am

  • Networking Break

    Grand Opening of the Networking and Exhibit Room:

    • Meet the exhibitors
    • Coffee/tea & breakfast
    • Ask the Patients
    • Meet the keynotes
    • Partnering Tables
    • Technology demos
    • Chocolates by Boston’s oldest chocolatier
    • Patient-centric teachers with therapy dogs
    • DPharm Treasure Hunt
    • Join a Site-less Trial

  • 10:45 am

  • A View on the Software-enabled Clinical Trial Tech Universe – Where the Tide is Rising

    In this interactive audience session, digital rights advocate and researcher, Andy Coravos, presents her latest map of the software-enabled clinical trial technology universe and gives an overview of today’s ecosystem, what’s new and when we can expect a paradigm shift in clinical trials. She will poll the audience on what we still need, what we want our ecosystem to innovate most, and for what reason.

    Andrea Andy Coravos
    Andy Coravos

    Co-founder & CEO / Former Fellow, Computational Health Informatics, Elektra LabsBoston Children’s Hospital

    Meet the Following Companies from Andy’s Software-Enabled Clinical Trials
    Landscape Map at DPharm:
     
    • Transparency Life Sciences
    • WIRB Copernicus
    • goBalto
    • ERT
    • Trifecta
    • IQVIA
    • TrialX
    • mProve
    • Langland
    • Trialspark
    • Deep 6 AI
    • Parexel
    • CluePoints
    • Greenphire
    • Bracket
    • Target Health
    • PhysIQ
    • Forte Research
    • THREAD
    • PRA
    • Medable
  • 11:00 am

  • Track Choices of a Wide Variety of Technologies and Services with Innovations to Advance Clinical Research

    • Track One: Where Are They Now?

      This track highlights companies who have shared their innovation at a previous DPharm conference, but have exciting advances to report on.

      Moderated by:

      Chandra Ramanathan
      Chandra Ramanathan, PhD, MBA

      Head, East Coast Innovation Center, Bayer, US

    • 11:05 am

      More Collaboration with Investigative Sites: Less Technology Overload Delivers Transparency and Efficiencies

      Purpose-built study startup technology is at the forefront of an effort to create more collaboration with investigative sites, helping sponsors and CROs accelerate the sharing of feedback with sites by validating performance through data-driven transparency into study milestones and by enabling stakeholders to communicate with their site-based partners in a timely fashion. Get the latest updates on how this gets done.

      Jae_Chung
      Jae Chung, MBA

      President and Founder, goBalto

      with


      Malcolm Horsley
      Senior Director Site Intelligence and Activation, PPD
    • 11:20 am

      How to Run a Modern Day Clinical Trial Where We can Minimize the Burden to the Patient

      • How to minimize the use of paper starting with informed consent?
      • How do we maximize the paperless clinical trials without being totally paperless?
      • How can we minimize patient visits and get the data over the web?


      Jules Mitchel, PhD

      President, Target Health

    • 11:30 am

      Achieving System-Wide Efficiencies by Inverting the Focus from a Single Trial to the Site

      Imagine a world where we don’t have to talk about source data verification, transcription errors, or data entry lag times. Where we can use clinical data immediately to evaluate and adjust. Sound like a pipe dream the industry has been talking about for years? It’s closer than you think.

      The research industry has the right technology in place and regulatory support for a transformation of data flow in clinical research. So, why are we still waiting? When electronic systems for clinical research were new, people mimicked paper processes in digital format. Since then, the industry has matured and become more sophisticated in its approach to electronic data. We are now poised to transform research through interoperability and streamlined data exchange.

      Past initiatives have focused on data flow from sites to sponsors. But now, imagine a truly bi-directional flow of digital clinical information from protocols, study schedules and forms, to regulatory documents, participant statuses, lab results, and subject data.

      When transformation begins at the sites, we gain efficiencies and enable standardization for all stakeholders, ultimately changing the clinical research landscape for the better. Join Shree Kalluri as he shares his vision for Digital Research Through Connected Technology.

      Learning Objectives:

      • To question how research is currently conducted
      • Highlight the pivotal role that sites can play in clinical research efficiency
      • To understand how one streamlined system between all stakeholders can improve quality, reduce timelines and improve clinical research overall

      Shree Kalluri
      Shree Kalluri

      Founder, President, CEO & Chief Customer Officer, Forte Research

       

      11:40 am

      Leveraging Technology to Ensure Perpetual Inspection Readiness

      Trifecta Clinical will share how they partnered with a Top-10 Pharma company to centralize and automate ALL training documentation by leveraging multiple integrated technology solutions (web, mobile, eTMF, etc.).


      Rick Ward
      VP Commercial Operations, Trifecta
       
       
      11:50 am

      Building Patient Communities beyond the Clinical Trial

      In this session, learn how Be the Partner’s customers build a strategic patient and alumni community beyond trials and, how the patient relationship management platform works in 26 countries and the impact on patient engagement.


      Thomas Klein

      CEO, Be the Partner

       

      12:00 pm

      A Patient-centric Approach to Driving Products to Market Faster

      More specifically, hear how Elligo is:

      • Bringing research opportunities to new patients, enrolling studies faster and enabling patients to participate through their own trusted physicians
      • Streamlining the entire research processes, including patient identification using advanced healthcare analytics and eSource documentation using standards-based technology for data to flow smoothly from site to submission
      • Encouraging better communication with patients and offering research as a care option through our network of Research Ready™ physician study sites and experienced clinical networks in various therapeutic areas


      Jacylyn Bodmer, MBA

      Chief Innovation Officer, Elligo Health Research

       

      12:05 pm

      Showcasing AI Analysis of Images (CT scans) During Study Conduct

      • Address the challenges of adopting AI algorithms
      • How to progressively control the risk/benefit
      • Proof-of-Concept data demo


      Timothy Corbett-Clark, PhD

      Chief Technology Officer, Cmed Group

       

      12:10 pm

      Innovation towards Mainstream – One year later

      • Challenges and successes with early adopters
      • Real-time visibility from sites to life sciences

      Eric Gildenhuys
      VP, Business Development, Deep 6 AI
    • Track Two: Innovative Sources and Solutions

      This track features companies, who are new to presenting at DPharm and have interesting technologies and services to help with clinical trial management, consent, matching, acceleration and recruitment.

      Moderated by:


      Craig Lipset, MBA

      Head of Clinical Innovation, Pfizer

    • 11:05 am

      Accelerating Clinical Research by Mining and Leveraging Electronic Health Records Data

      We’ve all heard the statistics. Half of all clinical trials miss their timelines. Eleven percent of trial sites don’t enroll a single patient. It can cost $2-3 billion dollars to bring a new drug to market. This is an incredibly challenging area that is ripe for new ideas and approaches. Optum is now ready to launch a solution that will significantly change the way clinical research is done. It’s called the Digital Research Network and its goal is to combine EHR data (80+ million lives), leading-edge cloud-based technology, study design expertise and our existing relationships with research-ready provider groups in a way that only Optum can. The result will be an entirely new way to conduct clinical research that will shorten time to market and reduce the overall cost of clinical research.


      Cynthia Senerchia, RN, MS, RAC

      VP, Quality and Regulatory Compliance, Optum

    • 11:20 am

      Innovations in Patient-Centric Services; Home Visits

      As a truly patient-centric solution, homecare services in support of clinical trials results in greater patient participation, shorter development timelines and higher patient, site and sponsor satisfaction. Find out how this gets done.


      Gail Adinamis

      Founder and CEO, GlobalCare Clinical Trials

    • 11:30 am

      Evolving Virtual Clinical Trials into Community Based Trials

      In this session, Dr Graham Wylie, CEO of MRN demonstrates how, in order to become mainstream, virtual trial technology needs to be broken into its different types and integrated with Home Healthcare and traditional site visits, all of which need to be considered part of the unifying concept of community based trials.


      Graham Wylie, MB BS

      CEO, MRN Medical Research Network

       

      11:40 am

      Destroy Clinical Data Silos

      We all know that speed to insight is the key to the operational success of running a study, a country, a region, or a large portfolio of studies. Add to that the complexity of multiple people working on a study or portfolio with divergent needs and different focus on KPIs and risks. This problem is further exacerbated by all the different systems and data warehouses. It’s one fine siloed mess.
      The latest technology advances have enabled a platform-based approach to solve these complex problems in a data source agnostic manner. In this session, we demonstrate how you can:

      • Improve data processing, standardization, and creation of analytics-ready datasets
      • Introduce machine learning capabilities to improve predictions of risks
      • Enhance the user experience through the use of a conversational experience
      • Create executive summaries embedded with relevant persona-based insights
      • Spend less time wrangling your data and get better operational outcomes like rapid start-up, improved risk management, and incredible efficiency


      Amit Gulwadi

      SVP, Clinical Innovations, Saama Technologies

       

      11:50 am

      Disruptive Technologies are Being Built with the Intention of Influencing Quality, Speed and COSTS for Sponsors, but do they?

      • Does advancement in technology contradict your current outsourcing providers business model?
      • Risk-Based Monitoring: How can it NOT save you money?
      • Does Risk-Based Monitoring by itself lead to change or can you use it as a cornerstone to affect structural advances?

      Daniel Perlman
      Dan Perlman

      CEO, Transformative Pharmaceutical Solutions (TPS)

       

      12:00 pm

      It’s All About the Visit: the Reinvention of Patient Follow-Up in Clinical Trials

      Resolving the ubiquitous problem of lost, late and missing data in clinical trials is onerous, expensive and often too little too late. In this session, see how:

      • Focusing on study visit efficiencies for trial teams and experiences for patients may solve broader challenges including enrollment, time to review and time to approval
      • New distributed models of clinical trials are dramatically changing the landscape of patient accessibility and speed of enrollment while and producing high quality data and real world evidence.


      Jodi Akin

      Founder and CEO, Hawthorne Effect

       

      12:05 pm

      Translational Pharmaceutics®: Integration of Real-time Adaptive Manufacturing and Clinical Research

      This talk will explains the benefits of Translational Pharmaceutics, a unique approach which integrates real-time adaptive manufacturing and clinical research. The presentation will illustrate how, by breaking down the CDMO and CRO silos within our industry and integrating horizontally, we can significantly accelerate early drug development timelines and reduce R&D expenditure.


      Kieran Crowley, PhD

      Executive Director and Head, Drug Development Solutions, Quotient Sciences

  • 12:15 pm

  • Keynote: Regenerative Medicine Maverick

    Regenerative Medicine as a Disrupter in Clinical Trials

    Dr Atala, a renowned key opinion leader on the topic of regenerative medicine, brings to the DPharm audience for the first time a fascinating presentation on how it’s possible to reduce the number of patients needed in clinical trials with the advancement of regenerative medicine, and how regenerative medicine can improve accuracy and speed up the clinical trial process.


    Anthony Atala, MD

    Director, Wake Forest Institute for Regenerative Medicine
    W. H. Boyce Professor and Chair of Urology, Wake Forest University

  • 12:45 pm

  • Lunch and Networking

  • 1:55 pm

  • Co-Creating the Industry’s Scalable Solution for EHR-Enabled eSource to Disrupt Clinical Trials

    The potential for eSource has been discussed for years, but realizing its promise has been difficult. While most health data today can be captured within electronic health records, the diversity of systems across medical centers and around the world coupled with a lack of health data interoperability has limited our ability to source clinical trial data from existing electronic systems across thousands of investigator sites supporting trials globally.

    Rob Goodwin and Amy Nordo share an exciting new collaboration – including industry and academia, as well as health authorities and leading technologists – positioned to break through the barriers to allow the power and the promise of eSource across companies and medical centers.


    Rob Goodwin

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


    Amy Nordo

    Program Director, Duke Center for Healthcare Informatics

  • 2:25 pm

  • Pharma Innovation 2018 Reporting from the Trenches

    This section of DPharm highlights several pharmaceutical companies in order to report 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.

  • 2:30 pm

    • Track A

      Innovation in Clinical Trial Operations and Patient Data Access

      Moderated by:


      Andreas Koester, MD, PhD
      VP and Global Head, Janssen Clinical Innovation, Janssen

      Allergan: New Approach to Optimizing Clinical Systems – a Paradigm Shift

      Allergan walks through its new approach to running clinical trials with a strategic perspective, including the role of innovation and practical implementation.

      Presenting Companies:

      PAREXEL
      Nick Darwall-Smith

      VP Technology, Clinical Research Services, PAREXEL


      Joseph Fleming

      Associate VP, R&D IT, Allergan


      Sarah Luijpers

      AVP and Head of Business Operations, Allergan

       

      3:00 pm

      AstraZeneca: Incorporating External Innovation in Clinical Trial Transformation

      Kim will share how working with smaller and non-traditional vendors has helped to catalyze innovation as part of a major transformation program in the late stage development organization. New companies may not have the scale or expertise of established players, but their entrepreneurialism, fresh perspective and (often) technology savvy are critical components of digital transformation – especially in areas of longer term change, where initial pilots are as much about developing new capability as they are about immediate ROI.


      Kim Smyth, MBA

      Technology Innovation Director, AstraZeneca

       

      3:15 pm

      How Roivant an Emerging BioPharma is Innovating Drug Development

      Key discussion points:

      • Keys to unlocking innovation – incentives and recruiting
      • Innovation as a driver of execution, evolution and disruption (and providing room for all three)
      • Distributed yet coordinated development – Digital Innovation in Clinical Development
      • Building disruptive businesses – sharing innovative technology with the industry
      • Building disruptive businesses – designing business processes around technological innovation

      Dan Rothman
      Dan Rothman

      Chief Information Officer, Roivant Sciences

       

      3:30 pm

      Alexa, How Do I Prevent a Migraine Today?

      The Amgen xLab is focused on transforming the patient experience in clinical trials by partnering with patients and leveraging digital health technology. Amgen is engaging with patients and testing a variety of capabilities to deliver a modern clinical trial experience. In this session, Matthew will talk about a roadmap for the future on the patient experience and digital health. Learn about their efforts to a holistic approach at re-designing the clinical trial model starting and ending with patients.


      Matthew Bryant, MBA

      Head xlab, Clinical Technology & Experience Lab, Amgen

       

      3:45 pm

      Janssen: Patient Data Access in Clinical Trials – from Concept to Implementation

      The healthcare industry is transitioning into patient-centered care models and patients want to be empowered with their own health data. Janssen Clinical Innovation (JCI) has developed the Janssen Global Trial Community through which they aspire to empower patients by giving them access to their data, study information, feedback and new research opportunities, thereby fostering engagement and creating a long-term partnership built on transparency, trust and awareness. In this model of accelerating innovation through collaboration, they address:

      • Global implementation of data access through the Janssen Global Trial Community
      • Challenges, stakeholder acceptance and business value
      • Collaboration with stakeholders (including customers) and competitors: how a consortium creates new opportunities and greater value by increasing speed of innovation, adoption and responsiveness to customers.

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      Caroline Feys, MBA

      Clinical Innovation Leader, Janssen

      (The topic of Patient Data Access and Ownership will extend into day two, Sept 26.)

       

    • Track B

      All Things in Digital Innovation in Clinical Trials

      Moderated by:


      Ryan Jones

      Cofounder and CEO, Florence Healthcare

      Moving the Digital Needle: Lessons from Designing a Digital, Fully Remote, Interventional Clinical Trial

      Digital health (DH) technologies provide opportunities for designing and conducting remote clinical trials, which may be an effective way to improve patient access to and experience with clinical research trials. However, there can be challenges within the design and operational conduct of remote clinical trials that incorporate DH technologies compared to clinical trials designed and conducted in a traditional, in-clinic setting. During protocol development for an exploratory, fully remote, interventional trial embedded within a Phase IV clinical trial, a number of challenges were encountered for which actionable and sustainable solutions (both digital and non-digital) were required. This presentation will provide a perspective on key considerations related to DH technology integration with a focus on patient centricity for protocol development, operational conduct and data integrity.

      Presenting Companies:


      Hassan Kadhim, MSc

      Senior Associate Director, Head, IT Clinical Trial Planning & Management, Boehringer Ingelheim Pharmaceuticals, Inc


      Sharon Attick, MS, MBA

      Director, Site Management; Clinical Operations, Study Management & Conduct, Boehringer Ingelheim Pharmaceuticals, Inc

       

      2:45 pm

      BMS: Increasing Clinical Trial Awareness, Participation and Engagement through Study Connect, a BMS Digital Platform

      BMS developed Study Connect as a comprehensive clinical trial resource for patients, caregivers, parents and healthcare professionals to learn about and find clinical trials, and connect with others. Study Connect provides an experience that empowers patients, provides transparency, and supports patients and caregivers during their clinical trial experience. In this session, they review the key features of their innovation, as well as how they are supporting their ultimate goal in educating, connecting and engaging the clinical trial community.

      Carolyn Brehm
      Carolyn Brehm

      BMS Study Connect Business Lead, Global Clinical Operations, Bristol-Myers Squibb

       

      3:00 pm

      Sanofi: The Implementation of a Digital Strategy to Change the Way Clinical Trials are Done

      At Sanofi, the Digital Strategy team and the Operations team collaborated on implementing a digital strategy to change how clinical trials are done to reduce patient burden. Through their collaborations and work with online recruitment and wearables, this group has shifted its thinking to support the patient of the future. In this session, learn how they created a culture to shift the thinking and the enormous impact it’s had already on their trials.

      Moderator:


      Victoria Huang

      Digital Catalyst Initiative Leader, Sanofi

      Panelists:


      Walter Cannizzo

      Trial Operations Team Leader, Director, Sanofi


      Kim Hawkins

      CSO Project Leader Head, Sanofi


      Christina Koutoudis

      Domain Head, Mobile and Social, Clinical Digital (ITS), Sanofi


      Amy Zwanziger

      Head of Digital Catalyst, Sanofi

       

      3:30 pm

      Bayer: Virtual Assistants for Sites and Patients in Clinical Trials

      Bayer shares how they use virtual assistants and chatbots to support study teams, research sites and patients. Learn how they are doing this and what you should consider.

      Michelle Shogren
      Michelle Shogren

      Head of Innovation, Portfolio & Operations, Bayer

       

      3:45 pm

      Roche: How Digital Biomarker Innovation is Modernizing Clinical Endpoints

      Roche provides an update on the company’s progress in how they are collecting data with sensor technology and turning it into a clinically meaningful endpoint with multiple indications, including Parkinson’s disease and Multiple Sclerosis. Session takeaways include:

      • Understand what Digital Biomarker innovation means for the future of clinical development and potentially personalized healthcare.
      • Be inspired to use mobile sensors technology in the context of clinical trials and beyond.
      • Develop a detailed understanding of the underlying complexity to run such efforts and be able to plan for it.
      • Understand how regulators are looking at these novel approaches.


      Christian Gossens, PhD, MBA

      Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED)

       

  • 4:00 pm

  • Afternoon Networking Session

    • Meet the exhibitors
    • Ice-cream
    • Ask the Patients
    • Meet the keynotes
    • Partnering Tables
    • Technology demos
    • Coffee/tea & chocolates by Boston’s oldest chocolatier
    • Patient-centric teachers with therapy dogs
    • DPharm Treasure Hunt
    • Join a Site-less Trial
  • 4:30 pm

  • DPharm Idol 2018

    Now in its 7th year, DPharm Idol is a live show featuring a select group of innovators, who present what they believe is a disruptive service or technology that could be a changing force for clinical trials. Each company delivers a quick-fire session followed by questions from the DPharm Idol judges. The questions from the judges provide great examples of how to assess technology/services to benefit drug development. Past DPharm Idol winners include Medidata, Spaulding Clinical Research, ePharma Solutions, Science37, Florence Healthcare and PhysIQ. Who will be the DPharm Idol 2018 winner?

    Approved Presenting Companies:

    Edetek


    Peter Smilansky

    SVP of Product Strategy

    Medable


    Michelle Longmire, MD

    Co-founder and CEO

    Quest Diagnostics


    David Freeman, MBA

    General Manager, Information Venture

    WCG Clinical


    Steven Beales

    SVP IT and Market Owner, Safety Solutions

    Clinical Pipe


    Amit Shah

    Founder, Chief Technology Officer

    BioSensics


    Joseph Gwin, PhD

    VP of R&D

     

    Opening Presentation with DPharm Idol 2017 Winner PhysIQ:
    Continuous Physiological Data from Wearable Biosensors Enable a New Frontier of Quantifying Safety and Efficacy of Pharmacotherapies
    This session will address:

    • How advanced physiology analytics are characterizing physiology in a real world environment
    • How pharmaceutical companies are leveraging this insight to advance impact of clinical trials
    • The relationship between patient reported and biosensor-based data sets

    Chris Economos
    Chris Economos, MBA

    VP of Business Development, PhysIQ

    joined by


    Georgia Mitsi, PhD, MBA

    Sr. Director, Search & Evaluation, Digital Healthcare, Sunovion Pharmaceuticals

    DPharm Idol Anchor:

    Valerie Bowling
    Executive Director, DPharm

    DPharm Idol Judges:

    Esther Dyson
    Esther Dyson

    Executive Founder, Way to Wellville


    Sandra Freeman

    Associate Director, Global Clinical Operations, Johnson and Johnson

    cindy geoghegan
    Cindy Geoghegan

    Patient Advocate


    Rob Goodwin

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


    Christian Gossens, PhD, MBA

    Global Head Early Development Workflows, pRED, Informatics, Roche Pharmaceutical Research and Early Development (pRED)


    Hassan Kadhim, MSc
    Senior Associate Director, Head, IT Clinical Trial Planning & Management, Boehringer Ingelheim Pharmaceuticals, Inc


    Joseph Kim, MBA

    Sr Advisor, Patient Experience and Design Innovation Design Hub Foundations, Eli Lilly and Company

    Jacob LaPorte
    Jacob LaPorte, PhD

    Head of Digital Development, Novartis

    Chandra Ramanathan
    Chandra Ramanathan, PhD, MBA

    Head, East Coast Innovation Center, Bayer, US

    Dan Rothman
    Dan Rothman

    Chief Information Officer, Roivant Sciences


    John Varaklis

    Head of Global Clinical Operations, Roche Pharmaceutical Research and Early Development (pRED)

  • 6:00 pm

  • Networking Reception

2018 Agenda

  • 8:00 am

  • Opening Networking

    • Breakfast
    • Partnering Tables
    • Meet the Exhibitors
    • Networking
  • 8:30 am

  • Co-Chairs’ Fireside Chat with VIP Guest Esther Dyson and Announcement of the 2018 DPharm Idol Winner


    Andreas Koester, MD, PhD

    VP, Innovation, R&D Operations, Janssen


    Craig Lipset, MBA

    Head of Clinical Innovation, Pfizer

    VIP Guest:

    Esther Dyson
    Esther Dyson

    Executive FounderWay to Wellville

    SaveSave

  • 8:45 am

  • Keynote: How to Innovate like Amazon in the Drug Development Industry with a View to Modernizing Clinical Trials

    When Amazon announced that it’s creating a new healthcare company with Berkshire Hathaway and JPMorgan Chase, the move signaled how the company is stepping into the healthcare industry. However, Amazon Web Services (AWS) has been working directly with the healthcare and life science industries for quite some time. Life Science Director, Mark Johnston, shares how AWS thinks about innovation, in particular for the life science industry, including clinical trials. More specifically:

    • How AWS looks at problems and transforms processes through new technologies
    • How to think about going faster to be more effective in solving problems without the worries of infrastructure
    • How to imagine what to do next if you were un-trapped by historical baggage and perceived limitations
    • Opportunities to consider
    • Examples

    Mark Johnston
    Mark Johnston

    Director of Global Business Development for Health Care, Life Sciences and Agricultural Technology, Amazon Web Services

    SaveSave

  • 9:25 am

  • Bringing Blockchain to Life: Digitizing Clinical Supply Chain End-to-End for Clinical Trials

    We are pleased to welcome to the DPharm stage for the first time Michael Ku, who will speak about some of Pfizer’s earliest work making blockchain ‘real’, as well as some of their forward-leaning work digitizing supply chain for clinical trials.


    Michael Ku, PharmD, MBA

    VP, Clinical Supply Chain, Pfizer

    SaveSave

  • 9:45 am

  • The Today Show @DPharm


    Ülo Palm, MD, PhD

    SVP, Global Drug Development Operations, Allergan

    Allergan and Trialspark Case Study on Scaling More Efficient Clinical Trials 

    Benjamin Liu
    Benjamin Liu, DPhil

    Co-founder and CEO, Trialspark

    SaveSave

  • 10:00 am

  • Getting to the Next Norm: How Today’s Technology Advances are Becoming Tomorrow’s Research Realities

    Voice assistant technology and artificial intelligence (AI), including machine learning, will become the norm in the very near future, so companies must prepare now. In this interview, we discuss some of these trends and their implications with Andrea Valente, EVP & Chief Development Officer, ERT.

    • What’s needed to enable successful data collection, analysis and submission using these new technologies?
    • Which technologies will have the biggest impact for pharma in the next 5 years?
    • What opportunities are presented to trial sponsors and their CRO partners?
    • Where should companies invest – and when – to keep pace with the rate and pace of change?
    • What data and privacy considerations should be accommodated?


    Andrea Valente

    EVP and Chief Development Officer, ERT

  • 10:15 am

  • The 23andMe Approach to Clinical Trial Recruitment


    Laura Russell

    Business Development and Alliance Manager23andMe

  • 10:30 am

  • Morning Networking Session

    • Meet the exhibitors
    • Coffee/tea & breakfast
    • Ask the Patients
    • Meet the keynotes
    • Partnering Tables
    • Technology demos
    • Chocolates by Boston’s oldest chocolatier
    • Patient-centric teachers with therapy dogs
    • DPharm Treasure Hunt
    • Join a Site-less Trial
  • 11:10 am

  • Flipping the Paradigm of Clinical Research with The All Of Us Research Program

    All Of Us is a US Precision Medicine program from the NIH that aims to enroll a million Americans and follow them for 10 years, during which time participants will contribute biological, environmental, and lifestyle data.  One-third of participants will participate virtually (not via a research site).  The cohort will mirror the projected 2040 census: <50% non-Hispanic white.  All one million will be direct partners throughout.

    Individual pharma companies are never going to create cohorts like this, so the importance of this open source frame work that drug developers can tap into will be highly beneficial in serving the patient of the future.

    Learning objectives:

    • About All Of Us – context, objectives, progress to date, and what’s to come
    • What we’ve learned so far
    • How might pharmaceutical companies become involved in the years ahead?

    Elise Felicione
    Elise Felicione, MPH, MBA

    Scientific Collaborator, Scripps Translational Science Institute, Sr. Director, Janssen Research & Development

  • 11:25 am

  • A Collaborative Approach on How to Run a Successful Digital Trial

    It is now feasible to collect data from a wide range of sensors and devices to capture critical physiological data. Using machine learning, this biometric data can be combined with patient diaries and environmental factors to generate new insights, signals and even digital biomarkers that could be used to remotely monitor patients. However the implementation of digital technologies and the continuous capture of clinical data outside of the traditional site require new thinking with respect to trial design. In order to run a successful digital trial, new approaches are required in order to address several critical areas such as patient burden, compliance and engagement, device selection and logistics, privacy and security and regulatory issues and data management, analysis and insights.

    In this talk, you will hear an example from a recent POC designed to assess the feasibility of capturing biometric, environmental and diary data that could be used to generate a digital biomarker to monitor respiratory patients in non-clinical settings with COPD subjects. COPD was selected as a disease area that is complex with multiple physiological and environmental factors that can effect and are impacted by the disease progress. Using this POC as an example the presenters discuss what is required to operationalize a digital study.


    Chen Admati

    Head of Intel® Pharma Analytics Platform, Intel

    and

    Marie McCarthy
    Marie McCarthy, MBA

    Senior Director Product Innovation, ICON

  • 11:40 am

  • Two Track Choices

    • Track 1

      The Democratization of Patient Data Ownership: Returning Results

      Moderator:


      Craig Lipset, MBA

      Head of Clinical Innovation, Pfizer

      We anticipate a future with secure patient data ownership, where patients are empowered to provide permissions. In this series of talks on patients ‘donating’ data, patient data ownership, data rights, and why this is a disruptive force in advancing clinical trials, we address the need to ensure we have the appropriate systems, security, and ability to withstand a Facebook/Cambridge Analytica scenario.

      We welcome to the DPharm stage for the first time this coordinated series of talks with special guests, hosted by Co-Chair, Craig Lipset.

      SaveSave

    • 11:45 am

      #1 Patient and Provider Perspective on Patient Data Access, Control, Ownership & Non-Health Data


      Harlan Krumholz, MD

      Harold H. Hines, Jr. Professor of Medicine, Yale and Founder, Hugo


      Bray Patrick-Lake, MFS

      Director of Stakeholder Engagement, Duke Clinical Research Institute

      SaveSave

    • 12:05 pm

      #2 Technology and Policy Supports for Patients to Access and Control their Data

      Addressing a widespread uptake of data standards enhancing patient access to their data and the emergence of data control as a leading bipartisan issue


      Mark Scrimshire

      Entrepreneur in Residence, NewWave, on assignment as Medicare Blue Button 2.0 Innovator, CMS

      SaveSave

    • 12:20 pm

      #3 Clinical Trials and the Life Science Industry’s Crucial Role: the Patient Data Access Initiative


      Mike DePalma

      Founder, President and COO,
      Hu-manity.co


      Jessica Scott, MD, JD

      Director Med Advocacy and Policy, Global Medical Governance, GSK

    • 12:40 pm

      #4 An Emerging Ecosystem of Entrepreneurs Making Patient Data Ownership a Reality

      In this section, we discuss:

      • Enabling access and use of data
      • Permissions and sharing


      Mike DePalma

      Founder, President and COO,
      Hu-manity.co


      Harlan Krumholz, MD

      Harold H. Hines, Jr. Professor of Medicine, Yale and Founder, Hugo

    • Track 2

      Artificial Intelligence / Machine Learning to Advance Clinical Trials

      Moderator:


      Jane Rhodes, PhD

      Executive Director, Business Development and Strategic Alliances, FORMA Therapeutics, Inc.

    • 11:45 am

      MIT and Johns Hopkins Collaboration: Applying Machine Learning to Calculate Clinical Trial Complexity and Predict Odds of Success

      MIT and Johns Hopkins formed a collaboration to look at the difficulties in clinical trials and to come up with a model to predict the failure/success of the trial. Together they developed data-driven models (machine learning) to predict the failure/success of trials entering Phase I-IV. In this session, you will hear about both the collaboration and the model.


      Felipe Feijoo, PhD

      Postdoctoral Researcher, Provosts’ Diversity Fellowship Recipient, Johns Hopkins University

    • 12:05 pm

      Harvard Medical School: The Use of AI and Big Data to Increase Reproducibility and Greater Accuracy in Drug Development


      Arjun (Raj) Manrai, PhD

      Assistant Professor, Harvard Medical School

      SaveSave

    • 12:30 pm

      Trusting AI and Machine Learning at Scale for Global Clinical Trials

      Machine learning algorithms are changing the way clinical trial feasibility has been conducted historically. However, the challenges to the adoption of machine learning at scale are robust. This presentation talks about those challenges and how we are overcoming them through the case study of our investigator/study recommender system.


      Lucas Glass

      Sr. Director Data ScienceIQVIA

    • 12:40 pm

      Novartis: Are Healthbots the Future of Healthcare Engagement?

      Healthcare, and in particular the biopharma industry, has struggled with patient engagement for a very long time. With our strict regulations, extended timelines for review of materials, and the need for only sharing scripted, pre-approved content, even our most personalized engagements – like human-led call centers – can often sound robotic and impersonal. With the rise of AI, machine learning and new conversational platforms like Facebook Messenger and Alexa, could chat/voice-bots become more engaging and more personalized than humans can ever be in this industry? Is there an opportunity for us to change the current clinical trial experience by utilizing healthbots? More specifically:

      • How can we make bots that are more engaging than humans?
      • Can we leverage what we already have developed (existing content) when developing these new platforms?
      • What are some examples and real-world use case studies in healthcare?
      • How can we leverage healthbots to change the clinical development customer experience?

      Attendees will walk away with an understanding of:

      • Why healthcare is uniquely suited to leveraging chat/voice-bots
      • Real-world examples of existing healthbots and what they are delivering
      • What to consider when planning for your own chat/voice bot


      Shwen Gwee

      General Manager, Digital Accelerator, Novartis

      SaveSave

  • 1:00 pm

  • Lunch

  • 2:00 pm

  • Ready for Launch: CTTI’s Decentralized Clinical Trials (DCT) Recommendations and the Patient of the Future

    The Clinical Trials Transformation Initiative (CTTI), a public private partnership co-founded by Duke University and the U.S. Food and Drug Administration, is proud to unveil its Decentralized Clinical Trials (DCT) recommendations at DPharm 2018. Through implementation of these recommendations, sponsors, CROs, and others can help advance the appropriate use of DCTs and experience the resulting benefits.

    DCTs using telemedicine, mobile and/or local healthcare providers (HCPs) continue to evolve and offer several potential advantages compared to traditional clinical trial sites, including:

    • Faster trial participant recruitment, which can accelerate trial participant access to important medical interventions and reduce costs for sponsors.
    • Improved trial participant retention, which may reduce missing data, shorten clinical trial timelines, and improve data interpretability.
    • A greater amount of control, convenience, and comfort for trial participants by offering at-home or local patient care.
    • Increased diversity of the population enrolled in clinical trials.
    • An opportunity for home administration or home use of the investigational medicinal product (IMP), which may be more representative of real-world administration/use post-approval.

    Join us in this session to change the clinical trial experience to meet the expectations of the patient of the future.

    Led by:


    Penny Randall, MD, MBA

    VP and Therapeutic Head, CNS, IQVIA


    Jeffry Florian

    Clinical Analyst, FDA, CDER, Office of New Drugs

    SaveSave

  • 2:20 pm

  • Real World Evidence of De-Centralized Trials

    In this session, Medidata’s Joe Dustin will de-mystify some of the perceptions of virtualizing clinical research supported by case study examples and experience in this exciting and growing area of our industry to speed new treatments to market and lower patient burden.


    Joe Dustin
    Solution Director, Mobile Healthcare, Medidata

  • Choice of Two Concurrent Programs

    • 2:30 pm- 6:00 pm

      Clinical Research as a Care Option (CRAACO)

       

      Program Welcome

      Jen Byrne
      Jennifer Byrne

      CEO and Board Chair/Founder, Javara/The Greater Gift

      Bringing clinical research as a care option to patients is arguably the greatest change we can collaborate on to give patients the best choices of care and to help make clinical trial options easier for providers to access. Higher rates of clinical trial participation inside a health system produces better patient outcomes, lower cost of care and happier patients. Health systems and patients get access to the latest research and pharma can get access to more patients in need of clinical research options.

      The concept of CRAACO was introduced at DPharm 2014. We have supported this topic each year and are delighted to bring all stakeholders together to identify next steps in supporting this movement to make it more realistic for physicians to offer clinical trials to patients.

      SaveSave

    • 2:30 pm

      Vision for Standardized Access to Clinical Trials

      • Foundational overview with data that supports how research does serve as a means to lower health costs
      • Ethical considerations
      • Payer considerations

      Movements (like buzz surrounding RWE, virtual trials, data aggregation and analysis) that are gaining momentum

      Mary Hennings
      Mary Hennings

      Former VP, Market Planning Innovation & Implementation/ Independent Consultant, BC BS of Massachusetts/ Mary N. Hennings, LLC

      Joseph Ternullo
      Joseph Ternullo, JD, MPH

      Vice Chair, Society for Participatory Medicine

    • 2:55 pm

      What Is the Patient Really Up Against?

      • Identifying barriers
      • How do patients get access to clinical trials?
      • Reimbursement
      • Need for interoperability and “fit for purpose” health data to enable research that benefits patients
      • Awareness of clinical trials

      cindy geoghegan
      Cindy Geoghegan

      Patient Advocate


      Sarah Larson

      Director, Global Clinical Operations, Biogen

    • 3:10 pm

      A Roadmap for How to Integrate Clinical Research as a Care Option

      Changing the Clinical Research Conversation

      Understanding and optimizing the patient experience as the first evaluate clinical research as a care option


      Irfan Khan, MD

      CEO, Circuit Clinical

      3:20 pm

      How to Lower Barriers of Entry for Patients to Participate in Clinical Trials

      • How we are progressing, next steps and call to action
      • Next steps to bring clinical trial awareness


      Kelly McKee

      Head, Patient Recruitment, Rare Diseases, Vertex Pharmaceuticals


      Kent Thoelke

      EVP and CSO, PRA Health Sciences

    • 3:40 pm

      Understanding the Impact of the Right to Try Act

      Access to the newest therapies

      • Access to cutting-edge research
      • Compression of the treatment discovery cycle
      • Reduction in regulatory restraints
      • Localization of research options


      Cynthia Senerchia, RN, MS, RAC

      VP, Quality and Regulatory Compliance, Optum

    • 3:50 pm

      Keynote: Service and Patients

      The patient’s expectations are being quickly changed today by disruptors far beyond the Pharma industry. Chip will show pragmatic ways to change our culture to support service-oriented thinking that benefits patients and investigators. How will the concept of service make us better at drug development and help us become more disruptive thinkers?


      Chip Bell, PhD

      Keynote Innovative Service Speaker, Author and Senior Partner, The Chip Bell Group

    • 4:35 pm

      How to Move Clinical Research into Communities That Would Truly Benefit from It

      Trying to improve the democratization of clinical trial access and making trials more efficient is a problem that lies in the system and not with communities. More specifically:

      • Educating sites to build confidence and skill sets
      • Democratizing clinical trial access
      • How the issue of reimbursement acts as a barrier and challenging how to solve this
      • Case examples
      • How we make clinical trials a care option for underserved populations and to make real change
      • Growing this movement

      Jonathan Jackson
      Jonathan Jackson, PhD

      Director CARE Research Center, Massachusetts General Hospital

      Katherine Vandebelt
      Katherine Vandebelt

      Chief Ecosystem Officer, Reify Health

    • 5:00 pm

      How Can More Physicians Get Involved in Research and Communicate the Offering of Clinical Trials?

      • How to make it easier for physicians to become investigators
      • Challenges with the physician experience and what are they up against?
      • How to get physicians involved?
      • What is the pathway?
      • How to get physician champions who are well versed in clinical research?
      • What training programs are available for physicians?

      Moderator:

      Jennifer Byrne
      Jennifer Byrne

      CEO and Board Chair / Founder, JavaraThe Greater Gift

      Panelists:

      Bridget Gonzales
      Bridget Gonzales

      Director, Training and Professional Development, ACRP


      Irfan Khan, MD

      CEO, Circuit Clinical

      John Stewart
      John Stewart, MD, MBA

      Professor of Surgery / Associate Director for Clinical Research, University of Illinois College of Medicine / Chicago Cancer Center

    • 5:30 pm

      How Can We Work with Medical Practices to Offer Patients Clinical Trials as a Care Option?

      • Infrastructure and support
      • Incentivizing physicians and care providers
      • What are physicians really up against?
      • How to establish physician champions?
      • How to influence leadership support?
      • How Can a Large Health System Leverage Itself to Do More Research?
        • Reimbursement
        • Data sharing and data security
        • Best practices

      Moderator:

      Jennifer Byrne
      Jennifer Byrne

      CEO and Board Chair / Founder, JavaraThe Greater Gift

      Panelists:

      Judy Hung
      Judy Hung, MD

      Director, Trial Innovation Unit, Division of Clinical Research, Massachusetts General Hospital

      John Stewart
      John Stewart, MD, MBA

      Professor of Surgery / Associate Director for Clinical Research, University of Illinois College of Medicine / Chicago Cancer Center

    • 2:30 pm- 4:35 pm

      How to Create a Service Oriented Culture in Drug Development

       

      Program Welcome


      Bray Patrick-Lake, MFS

      Director of Stakeholder Engagement, Duke Clinical Research Institute

      The commercial side of pharma, if done right, is built around a culture of service. This tends to be the exception not the rule for the R&D side of the business. However, R&D ultimately is serving patients. This section of DPharm begins with a panel of patients, who identify vital areas of patient needs and service improvements. Where can we do better? How does service-oriented thinking change the culture of drug development? Directly after, we here from a select few companies that focus on patient services. This follows with our concluding keynote speaker, Dr Chip Bell who is a prominent author and advisor to organizations on ways to create a culture of service. He will speak to our audience of drug developers about this paradigm shift and ways to become a service anthropologist and innovator.

      The patient’s expectations are being quickly changed today by disruptors far beyond the Pharma industry. Chip will show pragmatic ways to change our culture to support service-oriented thinking that benefits patients and investigators.

      How will the concept of service make us better at drug development and help us become more disruptive thinkers? How do we make this a reality for ourselves and our organization? Attendees from both afternoon programs come together for Chip’s keynote. Q&A with Chip will take place just after his session in room B.

      SaveSave

    • 2:30 pm

      How to Define a Culture of Service and Value from the Patient Perspective 

      This panel have all experienced a clinical trial(s) and will share their insights on how we can better support and serve patients and provide their thoughts on how to create a culture of service.

      More specifically:

      • The price it takes to participate?
      • Transparency
      • Participatory research 
      • Transitioning patients back to standards of care
      • Thoughts on creating a culture of service

      Moderated by:


      Joseph Kim, MBA

      Sr. Advisor, Patient Experience and Design Innovation, Eli Lilly and Company

      Patient Panel:


      Linnea Olson

      Patient Advocate


      Bray Patrick-Lake, MFS

      Director of Stakeholder EngagementDuke Clinical Research Institute


      Alicia Staley

      Patient Advocate

    • 3:30 pm

      Patient Service Session: Value of Providing 1:1 Assistance and Travel Support in Clinical Trials


      Al Peters

      VP of Operations & Finance, ClinEdge

    • 3:50 pm

      Keynote: Service and Patients

      The patient’s expectations are being quickly changed today by disruptors far beyond the Pharma industry. Chip will show pragmatic ways to change our culture to support service-oriented thinking that benefits patients and investigators. How will the concept of service make us better at drug development and help us become more disruptive thinkers?


      Chip Bell, PhD

      Keynote Innovative Service Speaker, Author and Senior Partner, The Chip Bell Group

      (Both programs come together for Chip’s keynote session.)

  • 6:00 pm

  • DPharm 2018 Concludes