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Executive Sponsors

CRF Health
goBalto
ICON plc
INC Research
Medidata
Oracle Health Sciences
Quintiles

Associate Sponsors

Ai Cure
DrugDev
ePharmaSolutions
Greenphire
iCTRS
MedPoint Digital
MMG
Patient Profiles
Target Health
Trial Reach
Veeva Systems

Supporting Sponsor

PAREXEL International

Soapbox Sponsors

Comprehend Systems
CureLauncher
HealthCarePoint
ImageIQ
Phlexglobal Ltd.
Xhale

Exhibitors

AMC Health
C3i
Chiltern
Clinical Ink
ERT
Langland
MobileSmith
PCM Trials
PHT Corporation
RX Solutions
Sanguine BioSciences
Taigle
Transperfect Life Sciences
Trifecta

Media Partners

Big3Bio

Agenda

  • 8:00 am

  • Breakfast & Registration

  • 8:45 am

  • Co-Chairs’ Welcome Remarks

    Innovation and Disruptive Innovation: Challenges and Overcoming Them – Who is Disrupting the Pharma Industry?

    Opening Remarks

     

     

     

     

     

    Jeffrey Kasher, PhD
    VP, Clinical Innovation & Implementation, Eli Lilly

    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances, Janssen

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

    Komathi Stem
    Senior Director, Product Development, Innovation Lead, Genentech

  • 9:00 am

  • Imagine Running Clinical Trials Together: What Would this Look Like?

    Imagine having the same protocol, same database, same investigators and same statistical analysis plan. We agree on the primary end points and we don’t have to agree on all the secondary end points. What truths would this reveal? This session will also feature highlights on the Lung-MAP study.

    Jeff Allen, PhD
    Executive Director, Friends of Cancer Research

    Lynn Marks, MD
    SVP, Projects, Clinical Platforms & Sciences, GSK

    Santiago Arroyo, MD
    VP, CMO & Head of Clinical Research for Pharma Therapeutics, Pfizer Worldwide R&D

  • 9:30 am

  • Mobile Health 2.0: The Rise of Digiceuticals

    The first wave of mobile health brought the platform capabilities of mobile health-oriented data collection to the consumer space. The next iteration will validate mobile data analytics, creating a “digital biome” where data collected from the patient’s pocket constitute digital biomarkers of disease. A patient-centric philosophy which creates an engaging and inviting environment for the user combined with back-end data gathering can create an ecosystem where both patient and investigator benefit. Apps which are inherently useful to the user and driven by analytics validated in rigorous trial settings may garner uptake and reimbursement not unlike traditional pharmaceutics. This is Mobile Health 2.0, and the rise of Digiceuticals.

    Heather Bell
    VP Program Management, IT/Operations, AstraZeneca

  • 10:00 am

  • The Salford Lung Study

    The Salford Lung Study is the world’s first phase III pRCT in asthma and chronic obstructive pulmonary disease (COPD), which aims to randomize over 7,000 patients. In this session, Dr Collier shares the journey of the hurdles in overcoming the enormous effort and resources required to establish this comparative effectiveness study of a pre-licence intervention. GlaxoSmithKline initiated this innovative study to evaluate with as little intervention from the clinical trial team how its once-daily ICS/LABA Breo Ellipta impacts health outcomes versus existing treatments. More specifically:

    • The vision
    • Trial design
    • Electronic health records
    • Challenges
    • Progress

    Sue Collier, PhD
    Head of Medical Operations for the Salford Lung Study, Global Respiratory Medical Franchise, GSK

  • 10:30 am

  • Networking Break & Soapbox Presentations

    Soapbox Presenter

    Ramita Tandon, inVentiv Health presenting on the DPharm Soapbox

     

     

     

     

     

     

     

     

    Presenting companies:

    • Phlexglobal
    • CureLauncher
    • HealthCarePoint
    • Xhale
    • ImageIQ
    • Comprehend Systems
  • 11:15 am

  • A Mobile Registry for Rheumatic Heart Disease in Africa – Can the Technology Disrupt How We Run Clinical Trials in the Developed World?

    Novartis is launching a mobile disease registry for rheumatic heart disease, screening 10,000 patients over a six month period. Find out what the low cost high impact way they set up a mobile disease registry, and how they are now exploring opportunities to use this same platform to run / disrupt “normal” studies as well.

    Joris Van Dam, PhD
    Strategic Project Leader, Pharmaceutical Development, Novartis

  • 11:30 am

  • Gamification

    Video Games as Next-generation Clinical Trial Tools: How Engagement + Science are Enabling at-Home Cognitive Metrics

    How can clinical trials be transformed with a platform that combines gaming and science? Our speaker will provide specific examples in running a trial with Pfizer in Alzheimer’s disease. A demo video showing actual clinical data (in the form of action video game play) from an ongoing pediatric clinical study will also be featured.

    Eddie Martucci, PhD
    Founder & VP, Research and Development, Akili Interactive Labs

    Planning a Randomized Controlled Trial for a Serious Game to Help Children with ADHD

    Executing a randomized controlled trial for a serious game to help children with ADHD requires careful planning with a number of partners. The impact of the game was tested in a clinical trial and our speaker takes you through:

    • The journey
    • The game
    • Clinical and commercial trial results

    Annik Willems
    Manager Health Information Sciences, Janssen

  • 12:00 noon

  • Where are They a Year Later?

    Led by:

    Komathi Stem
    Senior Director, Product Development, Innovation Lead, Genentech

    DrugDev
    Ibraheem Mahmood
    President & CEO

    Quintiles
    Mark Vermette
    VP, Infosario IT Customer Engagement

    Target Health Inc
    Jules Mitchel, PhD, MBA
    President

    TrialReach
    Pablo Gravier
    CEO

    Walgreen Company
    Howard Golub MD, PhD
    VP, Clinical Research

  • 12:40 pm

  • Luncheon

  • 1:45 pm

  • Meet Oz

    The FDA knows both industry and the National Institute of Health have to change the way they conduct clinical trials and seek alternative methods for finding patients. Find out how biomedical informaticist, physician, and i2b2 founder Dr Isaac Kohane is leading efforts to bring down the costs of clinical trials 10 times.

    Issac Kohane, MD, PhD
    Chair Informatics Program, Boston Children’s Hospital


  • Follow up Q&A – Enabling Patients to Donate Data. How Can this Change R&D?

    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances, Janssen

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

  • 2:05 pm

  • An Interview Series of Disruptive Thinkers hosted by Craig Lipset, Pfizer

    Interview Series

    Craig Lipset, Pfizer with Krishna Yashwant, Google Ventures

    Our co-chair Craig Lipset, MBA, Head of Clinical Innovation, Research & Development, Pfizer Inc., interviews the following disruptive thinkers:

     

    Katherine Wilson
    Director, Digital Health Solutions, PATH
    Putting Digital Innovation into Motion for Global Impact
    PATH is an international nonprofit organization that transforms global health through innovation. Their approach blends the entrepreneurial spirit of business, the scientific expertise of a research institution, and the passion and on-the-ground experience of an international NGO. How is the Director of Digital Health Solutions at PATH leading her team to bridge the gap between those who understand health and people who understand IT? What is their progress so far and how is PATH looking at running clinical trials cost effectively in the developing world?

     

    Zen Chu, MBA
    Faculty Director and Entreprepreneur-In-Residence, MIT
    Digital Healthcare Transformation in China: Lessons Learned for Clinical Trials
    On the pulse of digital healthcare transformation in China, MIT Hackathon leader, Zen Chu updates us on:

    • MHealth in China: what’s happening
    • Reaching doctors via mHealth in China
    • Engaged patients in China today
    • Brand vs generic Trust in China
    • The next wave of consumer health growth in China

     

    Sachin Jain, MD, MBA
    CMIO, Merck Research Laboratories
    Demystifying “big data” for clinical research
    Some of the realities of how diverse data is used today, and where future growth and innovation is most promising. What are some of the interesting ways EMR and real world data can be used to enhance study design and planning? Thoughts on true disruption in clinical trials. What are the challenges of building something new in something old? It is not just the what, it’s the how.

     

    James Streeter
    Senior Director Life Sciences Product Strategy, Oracle
    Oracle Update on Biomarker Data for Clinical Trials
    Oracle shares their progress on biomarker data for clinical trials where less data is needed and can be shared from other trials. The impact on trial design, patient recruitment and length of trial time is also discussed.

     

    Mark Lim, PhD
    Medical Research Innovation Associate Director, FasterCures
    5-Minute Review on Consortia-pedia
    Mark Lim, PhD, author of the Consortia-pedia project, shares highlights on understanding the breadth and scope of a wide range of consortia and what they are doing to advance R&D. The Consortia-pedia project is to better understand the breadth and scope of approaches that a wide range of consortia have adopted to bring together non-traditional partners with a shared R&D goal. Mark will also address challenges that some consortia are facing as well as opportunities to further collaboration.

     

    Donald Jones
    Chief Digital Officer, Scripps Translational Science Institute
    How Can We Marry a Digital Solution with our Drugs to Allow Us to Understand Outcomes and the Ability to Manage Regulatory and Reimbursement Demands?

  • 3:00 pm

  • Networking Break

    Networking 1

  • 3:30 pm

  • Digital Engagement: The Impact on Advancing R&D

    Dr. Vicki Seyfert-Margolis, CEO of My Own Med, Inc. and former Senior Advisor of Science Innovation and Policy to the FDA’s Commissioner’s Office, launched a customizable digital platform and mobile health app that captures between-visit patient health data. The aim is to better educate patients and caregivers, as well as to provide payers and health systems with new analytical tools for understanding patients’ needs. This session addresses the critical nature of user experiences in digital health tools for the long-term engagement of patients. Vicki also addresses what a social network represents for managing one’s health and ultimately how this can advance R&D.

    Vicki Seyfert-Margolis, MD
    CEO, MyOwnMed

  • 3:50 pm

  • How a Patient Helped Define a New Clinical Endpoint in Narcolepsy

    Diagnosed with narcolepsy with cataplexy in 2007, award-winning author and founder of Project Sleep, Julie Flygare, shares her story on how she helped define a clinical endpoint with the FDA and what this can mean for the future of the drug developed.

    Julie Flygare
    Founder, Project Sleep

  • 4:05 pm

  • A Collaborative IT Eco System to make Clinical Innovation Happen: A Leadership View on Getting it Right

    Led by:

    Martin Leach
    VP, R&D IT, Biogen Idec

    with

    Robert Boland
    External Innovation, R&D IT, Janssen

    Adrian McKemey, PhD
    SVP & Managing Director, The Consulting Group at Quintiles

  • 4:40 pm

  • 3rd Annual DPharm Idol: Quick Fire Disruptive Technology Presentations in an “American Idol” Format

    American Idol - Adrian McKemey

    Adrian McKemey, Quintiles at DPharm Idol

    This section of the program features eight short, but impactful presentations by technology disruptive developers and services. A panel of judges asks questions and challenge our presenters to tell us how their technologies and services are advancing clinical development. 
At the conclusion of the session, an award is given to the most disruptive presenter.

    Last year, Medidata and Spaulding Clinical won the DPharm “Idol” award – Disruptor the Year – for a novel study evaluating the impact of mobile cloud-based technology and patent engagement on improving health outcomes in the diabetes community. To kick off DPharm Idol, Medidata’s President, Glen de Vries will update this study – which is in the field – and talk about the challenges and rewards of being a technology disruptor.

    DPharm Idol Winners Randy Spaulding and Glen de Vries

    DPharm Idol Winners Randy Spaulding, Spaulding Clinical and Glen de Vries, Medidata

     

    Click here to see the winner’s presentation.

    The 2014 line up:

    MMG

    ePharma Solutions

    MedPoint Digital

    Patient Profiles

    Veeva Systems

    iCTRS

    AiCure

    The Judges:
    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances, Janssen

    Paulo Moreira
    VP, GCO, Head of External Innovation, EMD Serono

    Linda Morgan
    Research Advocate & Patients Advisory Council Member, Parkinson’s Disease Foundation

    John Orloff, MD
    Global Head of R&D, Baxter BioSciences

    Ulo Palm, MD, PhD, MBA
    SVP, Drug Development & Research Operations, Forest Labs

    Komathi Stem
    Senior Director, Product Development, Innovation Lead, Genentech

  • 5:45 pm

  • Networking Reception

    Sponsored by:

    INC Research logo

Agenda

  • 8:00 am

  • Breakfast

  • 8:45 am

  • Co-Chairs’ Welcome Remarks

    Jeffrey Kasher, PhD
    VP, Clinical Innovation & Implementation, Eli Lilly

    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances, Janssen

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

    Komathi Stem
    Senior Director, Product Development, Innovation Lead, Genentech

  • 9:00 am

  • Keynote: 21st Century Cures Update & Q&A with Rep. Diana DeGette (D-CO)

    21st Century Cures is a new initiative that aims to accelerate the pace of cures and medical breakthroughs in the United States. Rep. Diana DeGette (D-CO) and House Energy and Commerce Committee Chairman Fred Upton (R-MI) are leading this initiative.

    “The 21st Century Cures initiative is a rare effort in Congress where there are no preconceptions about what we are going to do before we do it.” said Rep. DeGette. “I am excited that this initiative will take a big picture look at our health care system in this country: the research, approval process, and how we get it to clinical application to make it more affective for patients and keep our preeminence in the world as the leader in biomedical research.”

    In this session, Rep. Diana DeGette provides an update on the initiative and takes Q&A from our audience.

    Rep. Diana DeGette (D-CO)
    Energy and Commerce Committee Member

  • 9:30 am

  • Social Media Revolution in Clinical Trials: When?

    If you want information seeking patients to find you, you must by definition, be social. The truth of the matter is that patients don’t see research and treatment as two different things. They all just want to feel better. When they know about research, they position it as treatment in their minds. In this session, Josepf Haslam, called the Godfather of Social Media, teams up with Joseph Kim, Senior Advisor, Clinical Development Innovation, Eli Lilly to address current social media and the new eco system for clinical trials.

    Josepf Haslam
    Managing Director of SEO & Social Media, EducationDynamics

    with

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

    Joe KIm

    Joseph Kim, Shire presenting at DPharm 2013

  • 10:00 am

  • Design Thinking for Clinical Trials

    This session is focused on design thinking and how this leads to new ideas and amazing changes. It takes the mystery out of innovation by embedding it into a process. It involves five critical steps:

    • Empathizing with the user
    • Define the problem from a user perspective
    • Ideate
    • Prototype
    • Test

    Led by:
    Komathi Stem
    Senior Director, Product Development, Innovation Lead, Genentech

    with

    Joling Mew
    Senior Development Excellence Leader, Global Product Development, Genentech

    Komathi Stem and Valerie Bowling

    DPharm Co-Chair Komathi Stem, Genetech with Valerie Bowling, Director, DPharm

     

  • 10:30 am

  • How Can the Healthcare Startup Model Improve Our Clinical Trials?

    How can we bring a healthcare start up culture to pharma to help us be more innovative? What does the risk-taking, entrepreneurial environment look like beyond patient engagement? If a large, regulated hospital system can implement entrepreneurial risk-taking approaches, then pharma should also be able to. How are hospitals making data collection fun and patient-friendly, with new approaches and technologies that could be leveraged for clinical trials to accelerate timelines, etc.?

    Sterling Lanier
    Co-Founder & CEO, Tonic Health

    with

    Abbe Steel
    Founder & CEO, HealthiVibe

  • 10:50 am

  • Networking Break

  • 11:20 am

  • Keynote Interview: Once Upon a Time, 3D Printing, Crowdsourcing & Open Innovation Came Together to Create a Medical Device That Enabled 200 People

    Richard Van As

    Just a South African guy with an Idea

     

    Richard Van As
    Founder, Robohand

  • 11:50 am

  • Emerging & Enabling Technology Series

    Led by:
    Jeffrey Kasher, PhD
    VP, Clinical Innovation & Implementation, Eli Lilly

    Faster Than the Speed of Sites: How the Cloud is Accelerating Study Startup
    Advanced, cloud-based collaboration platforms allow sponsors, CROs, and sites to dramatically reduce study startup timelines, eliminate bottlenecks, and reduce costs. This session addresses the how.

    Carol Aliyar
    SVP, Study Start-Up, INC Research

    Jae Chung
    Founder & President, GoBalto

    Barry Milton
    Director, Project & Regulatory Management, Novartis

     

    Disrupting Trial Patient Compensation
    This session addresses how to disrupt:

    • The standard practice of sponsors allocating funds for patient payments in site budgets
    • The standard practice of sites processing countless paper check requests
    • The standard patient experience of waiting weeks to receive paper checks, and often incurring check-cashing fees

    Deborah Howe
    Associate Director of Vendor Management, Global Recruitment & Analytics, Bristol-Myers Squibb

    Stuart Horowitz, MBA, PhD
    President, Institutions & Institutional Services, WIRB-Copernicus Group

    Christine Pierre
    President, Society for Clinical Research Sites (SCRS)

    Rick Ward
    Senior Director, Business Development, Greenphire

     

    The Impact of Innovation on Clinical Partnerships
    Steve Cutler
    COO, ICON

  • 12:45 pm

  • Luncheon

  • 2:00 pm

  • The SIGNATURE Clinical Trial Program: Disrupting Clinical Trials, and Making Them Better

    SIGNATURE is a new kind of clinical trial developed by US Novartis Oncology. Looking at all the common challenges of enrolling cancer clinical trials, we found a way to overcome them. Using adaptive statistical design, a simple protocol, and standard documents, we developed a rapid study startup model that allows the patient to stay where they are, locally, and still have a chance to participate in innovative research. We bring “the protocol to the patient”. Any qualified Oncology Research Physician can participate, they simply contact our call center.  If the patient pre-qualifies, the site is open in ~4 weeks. The study is designed to quickly find where a drug is working and move on from cancers that show no effect. Faster, easier, and more cost-effective, we are getting to proof of concept more rapidly and accelerating the research process. We aren’t just thinking, we’re doing.

    Stephanie Petrone
    Executive Director, Clinical Operations, Novartis Oncology US CD&MA

  • 2:20 pm

  • Mount Sinai Hospital on Reducing Geographic Barriers to Cancer Clinical Trial Participation: Learning from the Telemedicine Intensivist Model?

    The cancer clinical trials enterprise is slow, expensive, and inefficient. Our group has previously shown that approximately 20% of initiated cancer clinical trials are not completed at all, with poor accrual as the main culprit. We have also shown that cancer clinical trials are geographically inaccessible to a large proportion of the United States population. As trials focus on identifying smaller and smaller subsets of patients with tumors harboring specific molecular characteristics, the problem of geographic inaccessibility is likely to become even more apparent and new models of trial conduct will be needed. To address geographic barriers to critical care specialists in community hospitals, models have emerged allowing an “expert” critical care physician, through telemedicine and tele monitoring, to work with local clinicians to optimize patient care and minimize costly, burdensome, and often unnecessary, patient transfers. Dr Galsky shares his initiative with a pilot study to determine the feasibility of such a model in the conduct of a cancer clinical trial. Joining Dr Galsky, Dr Ray Dorsey, John Holland and Marc Foster will present additional case studies and discuss challenges of telemedicine neurology and gastroenterology trials, and conduct a live demonstration video visit.

    Matthew Galsky, MD
    Associate Professor of Medicine, Director, Genitourinary Medical Oncology, Associate Medical Director, Cancer Clinical Trials Office, Tisch Cancer Center, Icahn School of Medicine at Mount Sinai

    with

    Ray Dorsey, MD, MBA
    Professor of Neurology and Co-Director of the Center for Human Experimental Therapeutics, University of Rochester Medical Center

    Marc Foster, MBA
    Co-Founder and Chief Operating Officer, Transparency Life Sciences

    John Holland
    SVP, Research and Business Development, AMC Health, New York

  • 2:50 pm

  • Progress….

    Strengthening the Clinical Trial Ecosystem through Collaboration: Putting the Investigator in Investigator Databank

    Janssen announced investigatordatabank.org, a global collaboration between Janssen, Lilly, Merck, Pfizer and Novartis (with more companies to come) to share investigator information with one another that each company has on file. Investigator Databank aims to reduce administrative burden for investigators and to increase visibility of qualified investigators to research sponsors. Metrics, investigator responses and databank feasibility and site selection: Where are they now?

    Mohammed Ali
    gpM, Global Clinical Operations, Novartis

    Jeffrey Ramsey
    Consultant, Clinical Development Innovation, Eli Lilly

    Match Update
    The Patients 2 Consortium effort between Lilly, Pfizer and Novartis is focused on enabling patients and those who serve patients to easily pre-screen patients to clinical studies, including using their electronic medical record such as a Blue Button+ document.  Through consistent, structured clinical trial eligibility criteria made available through an open API technical platform, so-called “matching services” can be enabled to streamline patient engagement and potential clinical trial participation.

    The update will include:

    • What is “P2T” or Match project
    • Where are we today and what is current focus and activity including end-user collaborations
    • What types of end-user collaborations are in place, what have we learned, and anticipated benefits to end-users
    • What are the key learnings we have had in the consortium that have helped move this project forward

    Thomas Krohn, RPh, MBA
    Director, Lilly Open Innovation, Eli Lilly

  • 3:30 pm

  • Dirty Laundry Stand-Up

    Stand-up professionals share ideas that failed. They are willing to expose their dirty laundry so we can reap the benefits of the lessons learned. Come hear these five minute stories. We welcome our audience to share their dirty laundry secrets with all of us too. An award for best learning from failure will be presented. “It is fine to celebrate success, but it is more important to heed the lessons of failure.” – Bill Gates.

    Led by:
    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances, Janssen

    Andreas Koester in Session

    Dr Andreas Koester, co-chair

     

     

     

     

     

     

     

    Point-of-Care Labs
    Jeffrey Kasher, PhD
    VP, Clinical Innovation & Implementation, Eli Lilly

    Recruitment
    Ulo Palm, MD, PhD, MBA
    SVP, Drug Development & Research Operations, Forest Laboratories

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

     

    Interested in sharing your dirty laundry on the stage, please email us at Jennifer@tcfllc.org.

  • 4:30 pm

  • Conference Concludes