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2013 Agenda

Thursday, September 19, 2013

  • 7:45 am

  • Breakfast & Registration

  • 8:30 am

  • Chairs’ Welcome & Opening Address: Avoiding the Trap of Incremental Change

    How can we be disruptive to change the pace of clinical trials to meet patient needs? What kinds of leadership do we want and need to support disruption and innovation?  What is the job description for innovation as a discipline? Our chairs open the 2013 event addressing these questions and more.

    Jeff Kasher, PhD
    VP, Clinical Trial: Materials, Implementation and Transformation, Eli Lilly

    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances,  Janssen, Pharmaceutical Companies of Johnson & Johnson

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

    John Orloff, MD
    SVP, Global Development & CMO, Novartis Pharma AG

  • 8:45 am

  • How Not to Do a Traditional Clinical Trial

    Can we have clinical trials without expensive infrastructure while engaging the patient and generating credible clinical data? In our opening session, Dr Lee shares his story in designing a non-traditional clinical trial to reduce infrastructure, engage patients and generate credible clinical data.

    Andrew Lee, MD
    SVP, Global Clinical Operations, Genzyme

  • 9:15 am

  • Innovation in Alternative Clinical Settings: The Walgreens-Novartis Collaboration

    This session presents an example of innovation in an alternative clinical setting. Our presenters address:

    • How to drive clinical trials more into the community
    • How to make research participation easier for patients and providers
    • The technology to make it possible
    • Overcoming barriers

    Kiran Dole, PharmD
    Clinical Trial Lead, Novartis Institute for BioMedical Research

    John Orloff, MD
    SVP, Global Development & CMO, Novartis Pharma AG

    Gerry Gleeson
    Group VP, Biopharmaceutical Development and Market Access, Walgreens

    Aaron Nelson
    Strategic Projects Leader, Novartis Pharmaceutical Development

    Joris Van Dam, PhD
    Translational Sciences Strategic Project Leader, Novartis Institutes for Biomedical Research

  • 10:00 am

  • Keynote Fireside Chat with Google Ventures

    Dr. Krishna Yeshwant is a physician, programmer, and entrepreneur who has been working with Google Ventures since its inception.  As a physician and life science investor, Dr Yeshwant has a unique perspective on a wide range of new approaches to disrupt drug development. In this fireside keynote chat we will discuss:

    • How attractive for VC investors is the notion of disruptive innovation in drug development?
    • New approaches to using social and mobile technologies
    • How can these new platforms impact drug development?
    • How big data can revolutionize healthcare and in particular the current clinical trial model; what are some of the concerns?

    Krishna Yeshwant, MD, MBA
    General Partner, Google Ventures

  • 10:40 am

  • Networking Break

    Soapbox Presentations

    Featuring five-minute rapid talks on cutting-edge technologies, inventions and ideas.


    • Global Record Systems
    • inVentiv Clincial Trial Recruitment Solutions
    • aiCure
    • 5AM Solutions
    • Medical Research Network
  • 11:15 am

  • Innovation in Regulatory

    Regulatory changes to support innovation is happening and our FDA presenter gives us an update on:

    • Enrichment strategies
    • Adaptive Design
    • Role of simulating clinical trials

    Robert T. O’Neill, PhD
    Director, Office of Biostatistics, OTS, CDER, Food and Drug Administration

  • 11:45 am

  • An Interview with TransCelerate’s CEO on Progress & Disruption

    TransCelerate BioPharma with the support of ten major biopharmaceutical companies has a mission to develop shared industry research and development solutions to simplify and accelerate the delivery of innovative products to patients. Our co-chairs discuss with the CEO of TransCelerate the following:

    • The road map on initiatives and where TranCelerate is going
    • How TransCelerate is supporting and implementing initiatives
    • Cross industry collaborations on sharing data and what does this really mean for pharma, CROs and Sites?
    • What are the shared solutions to kill drugs faster?
    • What’s been disruptive?
    • What is the end game and when is it going to deliver results

    Dalvir Gill, PhD
    CEO, TransCelerate BioPharma Inc.

  • 12:15 pm

  • Patient eConsent Pilot Results

    Paper based consenting is a suboptimal model, resulting in error prone documentation and a non-patient centric delivery of concepts critical to the clinical research process. This session will provide an overview of the business case, rollout and lessons learned from a pilot deployment of multimedia eConsents on the iPAD.

    • Clarify the issues related to paper based consents
    • Learn about the key lynchpins to success
    • Envision the roadmap for the future of this technology and process
    • Get ahead of audit findings
    • How to improve successful adoption by your organization

    Joseph Kim, MBA
    Clinical Operations Director, Shire

  • 12:40 pm

  • Luncheon

  • 2:00 pm

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

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

    Jamie Freedman, MD, PhD, SVP, Global Clinical Development, Medimmune discusses disruptive initiatives on how new technologies are helping informative early Go/No Go decisions in drug development.

    Leonard D’Avolio, PhD, Assoc. Center Director, VA Boston Healthcare System on a trial simplification approach through the example of running randomized diabetes clinical trials at point-of-care with the VA EMR. How can we translate this approach to investigational drugs and in other settings to merge care delivery with clinical research at the point of care?

    Joseph Kvedar, MD, Director, Center for Connected Health on leveraging existing and emerging tools to conduct trials remotely.

    Michael Cantor, MD, Senior Director, Clinical Informatics & Innovation, Pfizer addresses the following questions: What if we could bring together all of the control arm data from our various studies to create a rich and clean database of natural disease progression?  How could this resource be used to better design and plan studies?  What if we could then bring together the control arm data across research sponsors to create a vast new data resource?  Would we still need the same size control arms for future trials?

  • 3:15 pm

  • Networking Break

    Networking Break
    • Meet with Exhibiting Companies
    • One-on-One Meeting Space Available
  • 3:30 pm

  • The 2nd Annual Quick Fire Disruptive Technology Presentations in an “American Idol” Format

    This section of the program features several short, but impactful presentations by technology disruptive developers and services. Two panels of judges will ask 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 will be given to the most disruptive presenter.


    Judging Panel 1

    Craig Lipset, MBA
    Head of Clinical Innovation, Research & Development, Pfizer Inc.

    Todd Pietri, MBA
    Partner, Milestone Venture Partners

    Peter Richardson, BMedSci
    Global Head Clinical & Regulatory Affairs, Alcon Laboratories

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

    Presenting companies:
    Verified Clinical Trials

    Kerri Weingard, ANP
    COO, Verified Clinical Trials

    Mitchell Efros, MD, FACS
    CEO, Verified Clinical Trials


    Pablo Graiver
    CEO, Trialreach


    Fabio Thiers, MD, MSc, PhD
    Founder and CEO, ViS Research


    Rick Ward
    VP of Sales, Greenphire


    Dave Young
    CEO, Trifecta

    Alden Meier
    President, Trifecta


    Adrian McKemey
    SVP, Consulting, Quintiles


    Judging Panel 2

    Deirdre BeVard
    VP, Development Operations, Endo Pharmaceuticals

    Jeff Kasher, PhD
    VP, Clinical Trial: Materials, Implementation and Transformation, Eli Lilly

    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances, Janssen, Pharmaceutical Companies of Johnson & Johnson

    Daphne Zohar
    Founder, Managing Partner, PureTech Ventures

    Presenting companies:
    CRF Health

    Rauha Tulkki-Wilke
    VP Product & Service Management, CRF Health


    Zoran Antonijevic
    Senior Director, Strategic Consulting and Adaptive Implementation, Cytel


    Sean Harrison
    Chief IT Architect, iTrials


    Mika Newton
    VP, Sales & Marketing, Archimedes

    Spaulding Clinical

    Randy Spaulding
    Founder and CEO, Spaulding Clinical Research

    Glen De Vries
    President, Medidata Solutions

  • 6:15 pm

  • Networking Reception

2013 Agenda

Friday, September 20, 2013

  • 8:00 am

  • Breakfast

  • 8:45 am

  • Chairs’ Welcome & Re-Cap

    Jeff Kasher, PhD
    VP Clinical Trial: Materials, Implementation and Transformation, Eli Lilly

    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances,  Janssen, Pharmaceutical Companies of Johnson & Johnson

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

    John Orloff, MD
    SVP, Global Development & CMO, Novartis Pharma AG

  • 9:00 am

  • MIT Hackathon Results on Disrupting Barriers to Clinical Trial Innovation

    The Founder of MIT’s Hacking Medicine program will present the results from our Barriers to Clinical Trials Hackathon, including themes, process, solutions and which ideas gained the most traction as viable solutions and ventures.

    Zen Chu, MBA
    Faculty Director, MIT Hacking Medicine & Entrepreneur-In-Residence, Trust Center for MIT Entrepreneurship


  • 9:45 am

  • VIP Guest Session: The Mobile Banking Revolution in Africa: What can Drug Developers Learn from this Extraordinary Example of Disruption?

    Bernhard Warner is a reporter who writes about disruptive innovation across a multitude of industries for Bloomberg Businessweek and other publications. In this session, Mr Warner will tell us about one of the greatest examples of disruption transforming Africa. Following his insightful story, Dr Andrew Lee, SVP, Global Clinical Operations, Genzyme will join Mr Warner in an open discussion on what we can learn and apply to clinical trials.

    Bernhard Warner
    Reporter, Columnist, Bloomberg Business Week


    Andrew Lee, MD
    SVP, Global Clinical Operations, Genzyme

  • 10:30 am

  • Executing Disruptive Innovation: What You Need to Know and Do to Have Breakthrough Performance

    Peter J. Valenti III, MBA
    formerly EVP and Global President, Vision Care, Bausch + Lomb

    Jennifer Zimmer
    Partner, Insigniam

  • 11:00 am

  • Networking Break

    Networking Break
    • Meet with Exhibiting Companies
    • One-on-One Meeting Space Available
  • 11:30 am

  • Discovery Channel Interview Series



    John J. Whyte, MD, MPH, Chief Medical Expert & Vice President, Health and Medical Education, Discovery Channel interviews prominent healthcare voices disrupting thought and leadership to advance health care.


    Jeff Carroll, PhD, Patient Advocate, is a prominent scientific researcher in the field of Huntington’s Disease. He is also a public advocate for families affected by the disease, and co-founder of the HD research news platform HD Buzz. His life and work were the subject of a 2011 Gemini award nominated CBC documentary feature. Jeff Carroll is an Assistant Professor of Neuroscience in the Department of Psychology, Western Washington University.

    Anthony Costello, CEO, Mytrus is creating better ways for patients to participate in clinical trials from recruitment through the clinical trial process.

    Jules T. Mitchel, PhD, MBA, President, Target Health and John Orloff, MD, Senior Vice President, Global Development & CMO, Novartis Pharma AG discuss eSourcing and other technologies to bring innovation to life and how we can use fewer patients in clinical trials.

    2012 presenters, Elise Felicione, MPH, Director, Clinical Trial Innovation, Janssen, Pharmaceutical Companies of Johnson & JohnsonJeff Ramsey, Consultant, Clinical Development Innovation, Eli Lilly and Company and Maya Van Horn, Director, Clinical Innovation, Pfizer, Inc. discuss where they are a year later with their Cross-Pharma Pre-Competitive Investigator Databank Project.

  • 12:40 pm

  • Luncheon

  • 1:45 pm

  • Disruptive Case Study on Next Generation Clinical Monitoring

    Eugene Patin
    Head of US Clinical Operations, Novartis

  • 2:10 pm

  • Will the Trial Medication of the Future be as Smart as our Phones?

    Electronic lid bottles that track when the patient  opens them is old news and medication intake tracking via an embedded microchip has moved recently from science-fiction into the realm of clinical research. The question now is, can we move from such individual solutions towards a fully integrated platform that provides everything from automated drug accountability to real-time compliance monitoring and automatic label updates? In this session we will give an outlook on how investigational product will be handled in the future and share the results of a recently completed technical pilot.

    Hilde Vanaken, PhD
    Clinical Trial Innovation Director, Janssen, Pharmaceutical Companies of Johnson & Johnson

  • 2:25 pm

  • The Pfizer Blue Button Project: Engaging Patients by Sharing Electronic Clinical Data

    In 2013 Pfizer will launch the Pfizer Blue Button Project, a first-of-it’s-kind initiative enabling patients who have participated in clinical trials the opportunity to download their individual clinical data.  Using the Blue Button standard launched by the White House, patients will be empowered to use the data to improve their overall health and wellness, from sharing with healthcare providers to powering clinical risk assessments.  In this session Pfizer will share more on why they have launched this initiative, initial learnings, and where the project may go if successful.

    Adam Dole
    Presidential Innovation Fellow, The White House

    Jennifer Wulff
    Director, Clinical Innovation, Pfizer

  • 3:00 pm

  • The Investigator POV: What Disruption is Needed to Achieve Better Relationships

    After DPharm 2012, it was highly requested to hear the voice of the investigator to help us candidly understand what is needed to greatly improve our relationship with them. This interview style session with investigators addresses:

    • What do we have to do to bring investigators back?
    • What are the new ways we can attract investigators?
    • Solutions to every day site challenges
    • Thoughts on protocol writing
    • What would make a great relationship?

    Moderated by:

    Andreas Koester, MD, PhD
    VP, Clinical Trial Innovation & External Alliances,  Janssen, Pharmaceutical Companies of Johnson & Johnson

    Christine Pierre
    President, Society for Clinical Research Sites


    Jeff Kingsley, DO
    Investigator & CEO, SERRG, Inc.

    Michael Koren, MD
    Investigator & Founder, Florida Physicians and Research Associates

    Jeffrey Rosen, MD
    Medical Director, Clinical Research of South Florida

  • 3:45 pm

  • Clinical Trial Visit of the Future: Interactive Session

    This session will simulate a future clinical trial visit using emerging technologies followed by a discussion on opportunities and challenges to include patient access, recruitment and retention. Also discussed will be uses of novel technologies in clinical trials and regulatory/patient safety implications.

    Craig H. Lipset, MBA
    Head of Clinical Innovation, Worldwide Research and Development, Pfizer Inc, United States

    Tomasz Sablinski, MD, PhD
    Founder & CEO, Transparency Life Sciences

    Komathi Stem
    Senior Director, Product Development, Innovation Lead, Genentech, A Member of the Roche Group, United States

  • 4:45 pm

  • Conference Concludes