Keynote Information


Two Keynote Sessions – Tuesday and Wednesday

  • RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES
  • MOVING TOWARD TRIALS OF THE FUTURE
 

Tuesday, January 24, 2017


OPENING PLENARY KEYNOTES
RE-THINKING THE DESIGN AND PLANNING OF OUR STUDIES

7:30 am Registration and Morning Coffee

8:20 Organizer's Welcome
Micah Lieberman

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)


8:25 Chairperson’s Introduction: Reimagining the Patient Experience

Bonnie BresciaBonnie Brescia, Founding Principal, BBK Worldwide


8:30 Understanding the Value of Communication and Collaboration between Industry-Sites-Patients in the Clinical Research Enterprise: SCOPE’s Role in Making the Connection
Christine Pierre

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

Increased collaboration has been the drum beat of clinical research for at least a decade. Over the next three days, many of the sessions will talk about advances in collaboration and engagement that have been made possible through new initiatives, improved processes, patient-centric design, and new technology. As we look at the needs for collaboration that remain unfulfilled, what is working today can serve as a model for how to go forward.

8:40 Co-Presentation: Bringing Design Thinking into Clinical Trials
Katherine Vandebelt

Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company
Jodi_Smith-Gick

Jodi Smith-Gick, Senior Advisor, Product Demand and Supply,, Eli Lilly and Company

This presentation will consider how we can re-evaluate our current approach to the planning and management of our studies. Bringing Design Thinking into clinical trials seems abstract, but embracing new design and planning approaches for clinical trials, de-constructing our current protocol development process, better integrating the customer-patient into our planning, and moving beyond process improvement, all fall under this concept. We will share a story from two perspectives that offers a view into our journey.

9:05 INTERACTIVE PANEL: Re-Thinking the Design & Planning Approaches for Clinical Trials

Realizing the potential to transform clinical trials begins with a reimagined clinical trial protocol. Yet clinical trial protocols grow increasingly complex, and protocol amendments continue to impact study timelines and budgets. Join a discussion into how study design and planning can be approached in novel ways, and how organizations are adapting today to leverage this new future.

  • Learn how to leverage a range of new data, from real world data to investigator performance data and beyond
  • Capture and apply patient insights to drive feasibility, optimization and meaningful endpoints
  • Employ ‘design thinking’ methods to ensure the needs of the participant, investigator and coordinator are considered and realized

Moderator:

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


Panelists:

Murray AbramsonMurray Abramson, M.D., Vice President, Global Clinical Operations, Biogen

Bardia AkbariBardia Akbari, Pharm.D., Vice President, Product Global Development, Oncology, Genentech, Inc.
Robert DiCicco

Robert DiCicco, Pharm.D., Vice President, Clinical Innovation and Digital Platforms, GlaxoSmithKline
Christine Pierre

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

Katherine Vandebelt, Senior Director, Clinical Innovation, Eli Lilly and Company


9:45 Grand Opening Coffee Break in the Exhibit Hall

10:45 Join Your Conference Track

Wednesday, January 25, 2017


AFTERNOON PLENARY KEYNOTES
MOVING TOWARD TRIALS OF THE FUTURE

1:30 pm Organizer's Welcome
Micah Lieberman

Micah Lieberman, Executive Director, Conferences, Cambridge Healthtech Institute (CHI)


1:35 Plenary Keynote Chairperson's Opening Remarks

Christine Phillips, Senior Director, Site & Patient Access, INC Research


CLN Best Practices1:40 Clinical Informatics News Best Practices Awards

Allison ProffittAllison Proffitt, Editorial Director, Bio-IT World & Clinical Informatics News

Clinical Informatics News is proud to present its Second Annual Clinical Informatics News Best Practices Awards. This awards program seeks to recognize outstanding examples of applied strategic innovation, partnerships, deployments, and collaborations that manifestly improve the clinical trial process.

1:50 Crawl. Walk. Run… Is This Really the Best Way to Innovate?
Jeremy Sohn

Jeremy Sohn, Vice President, Head of Digital Business Development & Licensing, Novartis

The pharma industry is one of the most innovative industries in the world, yet we have struggled to accelerate meaningful change in the ways we run our clinical trials. Why isn’t the future now? It is certainly not for a lack of trying or investment, including both successes and failures. We can continue to repeat the past or is it time for us to begin to challenge some of the core principles that have guided us: Should we really crawl…walk…and then run? Should innovation teams exist outside of our mainstream operations or should they be fully integrated? Should we wait for regulatory agencies to get comfortable with technology or should we directly engage agencies to help us solve our collective challenges? Should we innovate independently or should we partner together to accelerate change? Are “innovation” and “transformation” even the right words to use to describe our teams’ objectives? In a world where technology changes every 18 months, where product development cycles are getting shorter and shorter, where agile development models allow us to respond in real-time to the needs of our consumers, the time may be right for us to at least question these norms. I know we as an industry can and want to do better.

2:10 Move Digital Health Innovation from PowerPoint to Action
John Reites

John Reites, Chief Product Officer & Partner, THREAD

As leaders of innovation in our companies, we can see the future benefits of digital health as we strive to change the way research is conducted. As we look ahead, however, we still have many barriers to overcome in bringing the promises of digital health into our daily work. This session will explore strategies to move digital health approaches forward including why we must make the change, review of case studies on remote patient research and accelerator execution models.

2:20 INTERACTIVE PANEL: Moving Towards Trials of the Future

As our industry adjusts to an array of new digital health innovations, consumer trends in connected data and pressure to extensively pilot novel approaches, our teams require a new way of thinking and planning. This session will explore how biopharmaceutical companies are moving these solutions forward to change the way research is conducted and change cultures in their organizations to drive adoption. This panel discussion will include review of the following;

  • Innovation initiatives underway today / What initiatives are you engaged with today to move towards trials of the future?
  • Balance with innovation development between in-house, external partners, consortiums and startup company resources / How do we strike a balance between moving these initiatives forward in the expanded ecosystem of digital health and clinical research partners?
  • Innovation models and accelerators / What innovation execution models are you using and/or seeing are most successful to date?
  • Tools to overcome internal challenges / Do you have any tools or processes to share that are helping you move innovation forward in your companies?
  • Key Performance Indicators (KPIs) needed to drive change / What KPIs are required and/or needed in the future to move to trials of the future?

Moderator:

John ReitesJohn Reites, Chief Product Officer & Partner, THREAD



Panelists:

Michelle CrouthamelMichelle Crouthamel, Lead, Clinical Innovation & Digital Platforms Unit, GlaxoSmithKline
  

Lucia SoaresLucia Soares, Vice President, Healthcare Technology Strategy, Johnson & Johnson

Jeremy SohnJeremy Sohn, Vice President, Head of Digital Business Development & Licensing, Novartis


3:00 Refreshment Break in the Exhibit Hall (Last Chance for Viewing)

4:00 Join Your Conference Track


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