2016 Agenda

  • 8:00 am

  • Registration & Breakfast in the Exhibit Rooms

  • 8:30 am

  • Patient Keynote: Seize the Limitations to Unlock Creativity

    DPharm 2016 kicks off with Phil Hansen, a remarkable artist who embraced an unexpected limitation that unlocked unimaginable and relentless innovation. You will leave this session determined to identify what you need to unlock.

    philhansen_draw

     

    Phil Hansen
    Artist, Author, Innovator

  • 9:10 am

  • Setting the Stage

    Valerie Bowling New


    Valerie Bowling
    Executive Director, DPharm

    with

    Co-Chairs:
    Andreas Koester B&W1

    Andreas Koester, MD, PhD
    VP, Innovation R&D Operations, Janssen

     

    Craig Lipset_bw1

    Craig Lipset, MBA
    Head of Clinical Innovation, R&D, Pfizer, Inc

     

    Kathy_Rouan_bw


    Kathy Rouan, PhD

    SVP, Projects, Clinical Platforms and Sciences (PCPS)GSK

  • 9:25 am

  • Moonshot 2020 & Open Source Clinical Research: How Clinical Research is Going to be Radically Different

    DPharm’s 1st Keynote is back! Moonshot’s director, Greg Simon, first graced the DPharm stage in 2011 in Philadelphia, where he challenged us in patient engagement. In this keynote, Greg addresses open source clinical research and what this means for the future of medical research. Do we need to create new business models to accommodate the future of data transparency? Are we faced with a future of competing with less IP? Plus, an update on the Cancer Moonshot.

    Greg_Simon_bw


    Greg Simon, JD
    Executive Director, White House Cancer Task Force

  • 9:55 am

  • Patient Engagement Fundamental Transformation Like You’ve Never Seen Before: The Ochsner Health System Example

    Ochsner has long been on the forefront of using mobile technology in care delivery. At Ochsner, providers use iPhone, iPad, Apple Watch and apps from Epic to fully engage patients in their care with the goal of smarter, shorter hospital stays. With the technology they are embracing, Ochsner is also monitoring patients outside the hospital and patients with chronic disease. They are the first health system to integrate Epic with Apple’s HealthKit to provide better coverage driving improved economic and outcomes data. In this disruptive session, you will see how this example can apply new possibilities for clinical trials. Following the presentation, Dr Milani will be joined by Dr Jeffrey Kasher of Patients Can’t Wait to discuss:

    • Leadership, culture and change management
    • How engaging patients improved health care
    • Wearables/sensors + clinically relevant data + EHRs =?
    • How to use the EHR in clinical research
    • Bumps in the road
    • Advice on how to rapidly integrate new technologies in the clinical research ecosystem for improved patient engagement
    • Connectivity between wearable devices to patients in a hospital setting, what can pharma learn?

    Richard_Milani_bw


    Richard Milani, MD
    Chief Clinical Transformation Officer, Ochsner Health System

    with

    Jeff_Kasher_bw


    Jeffrey Kasher, PhD
    Founder, Patients Can’t Wait

  • 10:20 am

  • Networking Break in Exhibit Rooms

    DPharm-AskThePatient_banner

  • 10:50 am

  • Choice of Two Sessions

    • A. How the Largest Single Payer Health Care System in the Country is Disrupting Clinical Trials

      What does the VA health system do so well to overcome the technical, regulatory and ethical barriers that prevent making clinical trials from being more successful? In this session, Dr Louis Fiore addresses:

      • How the Point of Care Project dramatically reduced clinical trial costs
      • Training clinicians and engaging patients
      • Getting everyone to buy into a new paradigm including the patients/veterans
      • Million Veteran Project status and impact
      • Bringing clinical trials to patients
      • Going from designing clinical trials for drug approvals to designing clinical trials to help patients

      louisfiore_bw
      Louis Fiore, MD, MPH

      Executive Director, Massachusetts Veterans Epidemiology Research and Information Center, VA

    • B. The "Uberization" of Clinical Trials

      John Brownstein_bw
      John Brownstein, PhD

      Chief Innovation Officer, Boston Children’s Hospital

  • 11:20 am

  • Choice of Two Sessions

    • A. What Happens When Innovative Leaders Participate in a Clinical Trial Simulation Project?

      Instead of patients, innovative leaders from outside of pharma agreed to be part of a clinical trial simulation at Bellevue hospital. In this session, Joanne Choi brings us through the experience and shares feedback from the participants on what they would do differently.

      joanne-choi_bw
      Joanne Choi, MPH

      Administrative Director, NYU Simulation Center

       

    • B. The Digitization of Clinical Trials: Progress

      Kaveeta_bw
      Kaveeta Vasisht, MD, PharmD

      Medical Officer, Office of Medical Policy, CDER, FDA

  • 11:45 am

  • Disrupting Clinical Operations from the CRO Perspective

    What are CROs doing to disrupt clinical operations? How are CROs distinguishing themselves to move clinical research forward? What is new on the horizon that CROs can offer to support innovation in clinical trials?

    Moderators:
    Jeff_Kasher_bw


    Jeffrey Kasher, PhD
    Founder, Patients Can’t Wait

    Kathy_Rouan_bw

     

    Kathy Rouan, PhD
    SVP, Projects, Clinical Platforms and Sciences (PCPS), GSK

    Panelists:

    Solomon Babani_bw2

     

    Solomon Babani
    VP, Business Development, BioPharma Solutions, Covance

    AdrianMcKemey-BW

     

    Adrian McKemey, PhD
    SVP and Managing Director, Advisory ServicesQuintiles

    Ira_Spector_bw


    Ira Spector, PhD, MBA

    EVP, Analytics and ConsultingICON

  • 12:25 pm

  • The Hero’s Journey – A Memorial to Participants in Research, Inspiring Everyone

    Over 2 million people finish their participation in research every year, yet there’s not a shred of evidence of their contribution and bravery…until now. Come get inspired by Lilly’s crowdsourced art project and learn that innovation is not just about unlocking technology, data and process, but also about unlocking the human spirit.

    Joe Kim_bw1


    Joseph Kim, MBA
    Senior Advisor, Clinical InnovationEli Lilly & Company

    Kelly McKee_bw
    Kelly McKee
    Advisor, Clinical InnovationEli Lilly & Company

  • 12:35 pm

  • Lunch Break

  • 1:30 pm

  • From the Race Garage to Clinical Research

    McLaren is known for its work in delivering winning performance through innovation across businesses, not least those within the life science industry. It pioneered the data-gathering technology used today across Formula 1 by all racing teams, which helps in the analysis of a race car’s performance. Over a race weekend, the McLaren team performs over 140,000 simulations on data from up to 400 sensors located on each car, enabling engineers and strategists to make real-time, in-race decisions. We are pleased to welcome McLaren Applied Technologies Chief Medical Officer, Adam Hill, to tell us how they have taken what they do from the race garage into clinical research and more. Joining Dr Hill is Dr Tomasz Sablinski, Founder, Transparency Life Sciences, in a fireside chat.

    Adam Hill_bw


    Adam Hill, MD
    Chief Medical Officer, McLaren Applied Technologies

    with

    Tomasz Sablinski BW

     

    Tomasz Sablinski, MD, PhD
    Founder, Transparency Life Sciences

  • 2:00 pm

  • Innovation in Problem Solving in Two Tracks

    What all presentations have in common on both tracks is the focus on innovation by partnering companies to solve problems in clinical trials. Each presenter will state the problem or challenge, followed by innovative solutions their company is capable of providing. Track A presenters will also share their progress since last speaking at DPharm.

    • Track A: Where Are They Now?

      Moderated by:
      Stephanie_Petrone_bw

       

       

      Stephanie Petrone
      Executive Director, Medical Operations, Novartis Oncology

      Presenting Companies:
      goBalto
      CRO case study on improvements in operational process efficiency and insights through study startup with goBalto technology.
      Jae Chung, MBA, Founder and President
      with
      Marie KeeganVP & Global Function Head, Study Start Up, ICON plc

      AiCure
      Why is clinical validation of adherence technology so important in today’s life science industry?
      Adam Hanina, MBA
      , CEO

      Greenphire
      Three years ago Greenphire presented at DPharm, highlighting the ClinCard solution for improving patient engagement. This year we’ll hear how a global pharma company has taken this “Disruptive Innovation” beyond piloting to broader adoption and institutionalizing it as a best-practice for supporting patients in their clinical trials.
      Rick Ward, VP Business Development
      with
      Deborah Howe, Associate Director, Vendor Alliance Lead, Clinical Trial Planning & Operations, R&D, Bristol-Myers Squibb

      MedPoint Digital
      The mission of MedPoint Digital is to empower the paperless study site, and to do that we’ve created a new technology, the Study eSafe. This platform is built for and controlled by study sites, serving as the paperless solution for every trial they conduct.
      Bill Cooney, MBA, President and CEO

      Target Health
      FDA cleared a product where eSource (Target e*CTR®) was used in the pivotal trial. Last year. Target Health told you about two development programs that used Target Health eSource solution, Target e*CTR (eClinical Trial Record) fully integrated with Target e*CRF (EDC). This talk will cover the results to date.
      Jules Mitchel, PhD, MBA, President

      Trial Reach
      Introducing the Evolution of TrialReach
      Pablo Graiver, Co-founder and CEO

    • Track B: Innovative Sources & Solutions

      Moderated by:
      Joe Kim_bw1

       

       

      Joseph Kim, MBA
      Senior Advisor, Clinical Development Innovation, Eli Lilly & Company

      Presenting Companies:
      Covance
      Covance sits in a unique position to facilitate partnering between biotech and pharma companies. Take the opportunity to hear about their secure, online platform for connecting biopharma companies interested in co-development or licensing drug assets or programs.
      Solomon BabaniVP, Business Development, BioPharma Solutions

      Nimblify
      Nimblify demonstrates increasing protocol quality and compliance through site-supporting technology. Instead of each site manually recreating the protocol calendar in their CTMS from scratch risking variation in interpretation, the Protocol Calendar Exchange provides 1 sponsor-approved version that can be downloaded into each site’s CTMS.
      Shree Kalluri, Founder and CEO
      Laura HiltyVP, Product Management & Operations, Nimblify

      SynteractHCR
      Hear a discussion about recruitment challenges, solutions to maximize recruitment and the results.
      Cheryl Johnson, Project Director

      Lyft
      Hear how transportation is disrupting clinical trials.
      Omar Nagji, Account Executive

      Hexoskin
      Learn about wearable sensors for long-term remote monitoring in clinical trials.
      Pierre-Alexandre FournierCEO & Co-founder

      AMC Health
      Telehealth eVisits can bridge the distance between the clinical research site and the home to reduce the burden of in-person visits, and to increase the type and amount of data collected. AMC Health will review individual cases to see how a broad range of study protocols have benefited from this first wave of telehealth-enabled studies.
      Michael O’Brien, President, Clinical Trials Division

      TrialX
      Launch a study website in minutes with “Trialspace”
      Sharib Khan, MD, MA, MPH, Co-founder and CEO

      Bracket
      Bracket will discuss how algorithms and intelligently designed systems can improve the way clinicians evaluate patients and their symptoms in clinical trials.
      Adam Butler, SVP, Strategic Development and Corporate Marketing

  • 3:30 pm

  • Networking Break in the Exhibit Rooms

    DPharm-AskThePatient_banner

  • 4:00 pm

  • On-Demand Trial Data Access for Patients: Results from a Demonstration Project Embedded in a Phase III Clinical Trial

    Discover how Janssen enabled patients to get on-demand access to their data during the trial in order to promote transparency, engagement and retention. Megan McBride of Janssen shares how legal and privacy concerns were addressed and give a first-hand account of patient and investigator reactions.

    Megan_McBride_bw


    Megan McBride, MPH
    Associate Director, R&D Operations Innovation, Janssen

  • 4:15 pm

  • Going Beyond Data Return and Making it a Reality

    Thomas_Klein_bw


    Thomas Klein
    CEO, Be the Partner


  • Big Changes in Patient Learning & Communication

  • 4:30 pm

  • Re-Designing Medical Data: Turning Patient-Reported-Experience into Better Information

    ThomasGoetz_bw


    Thomas Goetz
    Former Executive Editor / Co-founder & CEO, Wired / Iodine

  • 4:50 pm

  • Prescription to Learn: Patient Cliff Notes

    Sarah_Krug_bw
    Sarah Krüg

    CEO / President, Cancer 101 / Society of Participatory Medicine

  • 5:05 pm

  • DPharm Idol 2016

    DPharm Idol is the concluding section of day one where a select group of companies present what they believe to be a disruptive service or technology that could be a force in clinical trials. Each company provides a quick fire session followed by questions from the DPharm Idol judges. Who will be the DPharm Idol winner of 2016?

    Science 37, our 2015 DPharm Idol of the year winner, will tell us where they are a year later and kick off 2016 DPharm Idol.

    Noah Craft_bw_2016


    Noah Craft
    Co-founder and CEO, Science 37

     

    Presenting Companies:
    Optimal Strategix Group (OSG)
    Giri IyerEVP & GM, Analytics

    Florence Health
    Ryan Jones, MBA, CEO

    N of One
    Jennifer Levin Carter MD, MPHFounder and Chief Medical Officer

    Health Verity
    Andrew Goldberg,
     Co-founder and COO

    4G Clinical
    Ed Tourtellotte
    Founder and CTO

    TriNetX
    Gadi Lachman, CEO

     

    DPharm Idol Judges

    Laura_Galuchie_bw2

     

    Laura Galuchie
    Head, Clinical Performance, Analysis & InnovationMerck Research Laboratories 
    Julian_Jenkins_bw
    Julian Jenkins, PhD

    VP, Innovation Performance & Technology, GSK

    Andreas-Koester-2_bw
    Andreas Koester, MD, PhD
    VP, Innovation R&D Operations, Janssen

    Sarah_Krug_bw
    Sarah Krüg

    CEO, Cancer 101 and President, Society of Participatory Medicine

    Stephanie_Petrone_bw
    Stephanie Petrone

    Executive Director, Medical Operations, Novartis Oncology

    Chandra_Ramanathan_bw
    Chandra Ramanathan, PhD, MBA

    VP and Head, East Coast Innovation Center, Bayer HealthCare

    Jane_Rhodes_bw
    Jane Rhodes, MBA, PhD

    Senior Director of New Initiatives, Biogen Idec

    Darshan_Shah_bw
    Darshan Shah

    Director Global Products, Global Medicines Director, AstraZeneca

    Katherine_Vandebelt_bw
    Katherine Vandebelt

    Global Head, Clinical Innovation, Eli Lilly & Company

  • 6:15 pm

  • Reception in Exhibit Rooms

2016 Agenda

  • 8:00 am

  • Morning Networking and Breakfast in Exhibit Rooms

  • 8:30 am

  • Welcome and Announcement of DPharm Idol of the Year

    Co-Chairs:
    Andreas Koester B&W1
    Andreas Koester, MD, PhD

    VP, Innovation R&D Operations, Janssen

    Craig Lipset_bw1
    Craig Lipset, MBA

    Head of Clinical Innovation, R&D, Pfizer Inc

    Kathy_Rouan_bw


    Kathy Rouan, PhD

    SVP, Projects, Clinical Platforms and Sciences (PCPS)GSK

  • 8:45 am

  • Keynote: Does Pharma R&D Have to Start Thinking Like a Service Industry?

    As we face a future of patient-centricity, empowerment and the possibility of open clinical data, how do we succeed in this environment of growing transparency? Might we have to start thinking like service industries whose survival depends on providing exceptional service? In this keynote, Chip Bell, the most prominent author and expert on educating organizations on creating a culture of service, will tell us how to think like a service industry and why it’s worth it for R&D. How will the concept of service make us better at drug development and help us be more disruptive thinkers? How do we make this a reality for ourselves and our organization?

    ChipBellforday2agenda_action
    Chip Bell
    Author and Senior Partner, The Chip Bell Group

  • 9:30 am

  • Pfizer’s "Blue Sky" Approach with IBM to Transform Clinical Research in Parkinson’s Disease

    How did these two large companies put together an entrepreneurial middle ground to use sensor technology to demonstrate efficacy?

    David Caouette_bwDavid Caouette, MBA
    Senior Director, Strategy and Operations Lead, BlueSky and Quantitative Medicine, Pfizer, Inc

    Daniel Karlin_bw2
    Daniel Karlin, MD, MA

    Senior Director, Quantitative Medicine. Clinical Lead, BlueSky, Pfizer, Inc

  • 10:00 am

  • Simulation of an Upcoming Phase 2b Study at a Phase 2a Site with the Phase 2a Investigators, Staff and Some Subjects: Outcome Please?

    Bert_Hartog_bw
    Bert Hartog, PhD

    Director, R&D Operations Innovation, Janssen

  • 10:20 am

  • Networking Break in the Exhibit Rooms


  • The Today Show @DPharm

    This section of the conference highlights VIP guest speakers with the DPharm co-chairs on the following:

  • 11:00 am

  • Speed of Data Donation and Making Our Data Count for Us: Sync 4 Science

    Using real world/observational data in clinical trials.

    Isaac_Kohane_bwIsaac Kohane, MD, PhD
    Professor and Chair, Department of Biomedical Informatics, Harvard Medical School


  • How to Maintain the Patient Community

    Roni_Zeiger_bw
    Roni Zeiger, MD

    Co-founder, Smart Patients


  • Investors Point of View on Innovative Technologies in Clinical Trials

    Philippe_Chambon_bw
    Philippe Chambon, MD
    Managing Director, New Leaf Ventures

    Jeremy_Sohn_bwJeremy Sohn
    VP, Head of Digital Business Development & Licensing, Novartis
    Formerly Managing Director, MPM Capital

  • 12:10 pm

  • ZEST (The Zika Experiment-Science Team) Open Source Pre-Clinical Research: Releasing Data in Real Time Fireside Chat

    Although there are a few examples of scientific teams sharing genomic data online during disease outbreaks, instant open-data release remains the exception rather than the rule, particularly in clinical research. Inspired by researchers during the Ebola epidemic, who rapidly published genomic-sequencing publicly, Dr David O’Connor has created the ZEST team to help scientists worldwide with the Zika virus. How can open pre-clinical data reshape the idea that academic science is for the public and how can this expedite the process of drug development? We are moving towards an era not restricted by journal pages. What might we fear and where are the risks? How do we manage possible incorrect data and influence on public policy and deals?

    David_O'Connor_bwDavid O’Connor, PhD
    Professor, Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison

    with

    Daniel Karlin_bw2
    Daniel Karlin, MD, MA

    Senior Director, Quantitative Medicine, Clinical Lead, BlueSky, Pfizer

  • 12:35 pm

  • Lunch in the Exhibit Rooms


  • DPharmX

    This section of the program is designed to stimulate new conversations on the following topics:

  • 1:45 pm

  • The David & Goliath Partnership between Big Pharma & Startups

    There are phenomenal opportunities with real value in partnerships between big pharma and startups. We have all observed situations where big pharma has choked these companies unintentionally.

    • How can big pharma partner more successfully with these companies that can provide a unique solution?
    • How can they work differently with startups?
    • What can they do to support and even nurture these small companies to help them grow to help big pharma?
    • How much risk taking do they have to consider to really accelerate the progress they are looking for?
    • Formula 1 in the trucking lane. How Startups can navigate big pharma.

    Moderator:

    Komathi_Stem_bw


    Komathi Stem

    Former Strategic Innovation Leader, Genentech/Roche

    Panelists:

    Katherine_Vandebelt_bw
    Katherine Vandebelt
    Global Head, Clinical Innovation, Eli Lilly & Company

    011fdf8.jpg
    Matthew Amsden

    CEO, Proofpilot

    Abbe Steel B&W


    Abbe Steel, MSc

    CEO, HealthiVibe, LLC

    Adam Hanina_bw


    Adam Hanina, MBA

    CEO, AiCure

  • 2:20 pm

  • Making it Easy for Physicians to be Investigators

    Katherine_Vandebelt_bw
    Katherine Vandebelt

    Global Head, Clinical Innovation, Eli Lilly & Company

  • 2:40 pm

  • How do We Manage Unsupervised Collection of Patient Data Remotely?

    Led by:

    Jeremy_Sohn_bwJeremy Sohn
    VP, Head of Digital Business Development & Licensing, Novartis
    Formerly Managing Director, MPM Capital

  • 3:00 pm

  • Inspiring Innovation & Progress from the UK’s NIHR in Clinical Trials

    The NIHR is leading transformation in clinical trials in the UK. Dr Matt Cooper reports on the following:

    • What happens when the public can easily sign up to be contacted for a clinical trial: Dementia Research Registry
    • Patent & Public involvement and engagement – a national approach
    • Results of the Salford Lung Study and how the UK is gearing up for more real world studies
    • Value-based clinical research – the effect of being a research-active organization

    Matt_Cooper_bwMatt Cooper, PhD
    Business Development & Marketing Director, NIHR Clinical Research Network Coordinating Centre UK

  • 3:30 pm

  • Conference Concludes