2014 Archived Content

Keynote Information

Tuesday, February 4, 2014 | 8:00 – 9:45 am


Opening Plenary Keynotes and Panel:
Keeping the Patient in Mind

Jamie HeywoodWhat Does a Trial Mean in the Era of Real-Time Measurement? 

Jamie Heywood, Co-Founder and Chairman, PatientsLikeMe

Our understanding of disease is being rapidly redefined by new genomic and observational insights to the point that the indication we study today may not exist tomorrow. How much longer will the model “one study, one condition, one claim” serve a changing market? Beyond the regulator, is our scientific method providing the patient, the physician, and the payer the personalized and actionable data they need? In the end it’s all about getting the right drug to the right patient. We need to master patient-centered, real-time measurement today to serve the needs of the patient and health system of tomorrow.

Christine PierreThe Silent Partners and Their Role in Clinical Research: Improving Trial Design and Management by Understanding the Real “Customer” 

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

Developing a medical treatment and trying to escort it through a trial and onto the market is a complex production involving many players. Ultimately the stars of this production and complex process are the subject volunteers. However, we are all cast members in this production. We each operate from a set of assumptions on how best to design and run these trials from our own perspective. As the protocols become more complex, as competition for investigators and volunteers becomes more fierce, as regulatory hurdles are raised, as the size of trials both in size and geography grows, and as the burden on the subjects increases, are we actors in the broader research community losing sight of the end game and of each of our key roles in the overall production?

PANEL: Perspective from a Cast of Characters Needed for Any Successful Study Execution

Are we sometimes losing touch with our “customer,” the research subjects themselves? It is important to understand how your decisions ultimately impact research volunteers and thereby the reality of study timelines and budgets. Whether you are in protocol writing, drug development, study start-up, feasibility, recruitment, monitoring, compliance, data analysis, or supply chain it is equally as important to take the lessons you’ll learn back into the office and ensure that moving forward you and your studies are designed for success among the other players in your production.

Thursday, February 6, 2014 | 8:00 – 9:40 am



Jeffrey KasherAccelerating Clinical Research through Collaboration 

Jeffrey Kasher, Ph.D., Vice President, Global Clinical Trial: Materials, Implementation and Transformation, Eli Lilly & Co.; TransCelerate Operations Committee Member

TransCelerate is developing shared-industry research and development solutions to simplify and accelerate the delivery of innovative products to patients. It is a pre-competitive model and its vision is to improve the health of people around the world by accelerating and simplifying the research and development of innovative new medicines. What have we done? Why is it working? Where are we going?

Craig LipsetData across the Clinical Research Continuum: How Data is the Common Denominator 

Craig Lipset, Head, Clinical Innovation, Worldwide Research & Development, Pfizer

The SCOPE Summit features multiple tracks covering a range of issues on clinical trial planning and management. A common thread across these topics is data – how to get it, how to make it available, how to use it to make better decisions. Across much of the clinical research continuum, and we are all in the data business.

PANEL: The Discipline of Innovation in Clinical Research

As an industry and as a community made up of researchers and patients we have a shared goal and interest in improving the development of new medicines. Beyond the current scientific, operational and financial challenges
we have to start thinking about improved models and how to build innovation into the clinical research enterprise. Topics to be discussed include:

  • Innovation beyond the buzz – moving from ideas to execution
  • Supporting innovation in a pragmatic clinical research organization
  • Delivering the portfolio today while ensuring a sustainable R&D model for tomorrow
  • Can we innovate even if we cannot forecast an ROI

Craig LipsetCraig Lipset, Head, Clinical Innovation, Worldwide Research & Development, Pfizer

Jeffrey KasherJeffrey Kasher, Ph.D., Vice President, Global Clinical Trial: Materials, Implementation and Transformation, Eli Lilly & Co.; TransCelerate Operations Committee Member

BrunoGagnonBruno Gagnon, Vice President, Clinical Operations, BioMarin Pharmaceutical, Inc.

Andrew LeeAndrew Lee, Senior Vice President & Head, Global Clinical Operations, Genzyme Corp., a Sanofi Co.


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