June 12-14 2017
The Westin Boston Waterfront, Boston, US
Register before Friday, April 7 to save up to $600!

Day One
June 13, 2017

Day Two
June 14, 2017

08.30
Chairman’s Opening Remarks: Where Are We Now & A Vision for the Future

  • Spyros Papapetropoulos VP & Global Head, Neurodegenerative Diseases, Movement Disorder & Clinical , Research Transformation Teva Pharmaceuticals

Overcoming Cultural Barriers to mHealth Implementation

08.40
Novartis’ Story: Overcoming Cultural Barriers to Achieve Wide Scale Organizational Adoption

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

Synopsis

  • Disrupting preconceptions and conservatism to achieve an organizational ethos that truly supports innovation, where:
    • Failures are milestones to success and risk is accepted as the price of reward
    • Standard operating procedures are continuously challenged and improved upon, raising the bar for every new study
    • Top down leadership and objectives are aligned and reinforced
  • Highlighting Novartis’ journey on this path, along with successes & failures, and lessons learned

09.10
mClinical: Technology and Culture to Make Mobile Tools “Business As Usual” in Development

Synopsis

  • Discuss Pfizer’s approach to making mobile tools from the exception to the norm for development programs
  • Explore the culture shift and leadership engagement required to make an enterprise change
  • Review the anticipated impact of pervasive use of mobile tools in development programs

09.40
Panel Discussion: Innovation, Adoption, Implementation: Infrastructure Needed to Deploy Digital Tools in Clinical Trials

  • Craig Lipset Head of Clinical Innovation , Pfizer
  • Jeremy Sohn Vice President & Head of Digital Business Development & Licensing , Novartis
  • Rob Dicicco VP, Clinical Innovation , GSK

Synopsis

  • Unravelling the possibilities behind remote real-time data acquisition during clinical trials
  • Return on investment – understanding if the results driven from wearables compensate implementation and maintenance costs
  • Exploring risks and risk appetites in experimenting with new technologies and championing change within your organization
  • Addressing partnering strategies with biotech, CRO and tech organisations to enhance the adoption process.
  • Selling the new approaches to internal therapeutic area heads

10.25
Morning Refreshments and Speed Networking

Facilitating the Conduct of Clinical Trials

11.25
Electronic Facilitation of Clinical Trials Using mHealth Technologies to Enhance Patient Engagement and Trial Conduct

  • Matthew T. Roe Professor of Medicine, Division of Cardiology – Faculty Director, Global Outcomes Commerical Megatrials Duke Clinical Research Institute (DCRI)

Synopsis

  • Showcase the lessons learned from the ADAPTABLE trial which is the first, large-scale pragmatic clinical trial being conducted in the United States solely using electronic health record data
  • Discuss options for leveraging mHealth technologies and approaches for trial recruitment
  • Delineate a framework for evaluating clinical trial quality metrics using electronic facilitation and mHealth technologies for trial conduct

11.55
Building in Stakeholder Perspectives To Enhance Trial Design

  • Mohammed Ali Director, R&D Operation Innovation Leader, Janssen Pharmaceuticals

Synopsis

  • Exploring why patient/site feedback is critical for success
  • Redefining the operating model through ecosystem partnerships by integrating the entire value chain from end to end
  • Different approaches for obtaining this feedback and ultimately measuring success

12.25
Lunch & Networking

Wearables, Sensors and the Next Generation of Patient Focused Tools

13.25
Harnessing Big Data & Wearable Technology to Advise Clinical Readouts

  • Jang-Ho Cha Global Head Translational Medicine, Neuroscience Novartis IBR

Synopsis

  • Debating big data vs. objective measures for specific conditions
  • Evaluating wearable devices consumer vs. medical grade; what should we use and when?
  • Understanding the difference between what patients are willing to use and what researchers are looking for

13.55
Spotlight Presentation: Upcoming Wearables for Clinical Trials that are Consumer Friendly and Clinically Validated

Synopsis

  • Exploring how the next-generation wave of wearables will be applied across various phases of clinical trials
  • Answering what is necessary to accelerate the trend towards a “clinical trial in a box” at scale
  • Beyond geolocation and heart rate data – looking towards the next set of sensors to achieve data collection for essential biomarkers and study adherence

14.05
Mobile Health Technologies in Clinical Development: A Patient- Centric Approach

  • Gowri Murthy Principal Scientist, Translational Medicine , Merck & Co, Inc

Synopsis

  • Utilization of mobile health technology to augment clinical data through at-home dosing and sampling
  • Demonstration of dosing adherence devices and trial participant response
  • Integration and reconciliation of data from devices

14.35
Afternoon Refreshments & Dedicating Poster Session

Barriers to Innovation: Regulatory Frameworks for mHealth Applications

15.15
Exploring Opportunities to Address Gaps in the Regulatory Environment for mHealth Technologies

Synopsis

  • Overview of regulatory framework: how mobile health and connected technologies may enhance this framework
  • Historical perspective on compliance, quality control and quality assurance for mHealth generated data
  • Balancing innovation, validation and qualification in a risk: benefit manner to maximize value and avoid unnecessary risk to patients
  • Tips on how best to navigate the regulatory environment
  • Discussion on common miscomprehensions and recurrent themes arising across diverse stakeholders

15.45
Reinventing mHealth Tool Validation

  • Austin Speier Director , Emerging Technologies Precision For Medicine

Synopsis

  • Questioning the current clinical validation cascade and exploring the drive to re-think the current process
  • Regulated research for mobile health and connected technologies
  • Understanding the path forward for clinical trial innovation and how best to navigate the regulatory environment
  • Achieving robust, rich and validated new endpoints through mHealth

16.15
Panel Discussion: Collection & Reporting from Wearable Devices Cloud, in Supplementing or Replacing Standard Measures in Clinical Trial Reporting?

Synopsis

  • Maximizing data collection and analytic capacity to enrich clinical trials – balancing the power of data volume with outcome fidelity and measurement accuracy
  • Identifying, testing and mitigating risk by (theoretically and experimentally) exploring worst case scenarios
  • Ensuring biometric validation and physician sign-off – formalizing the process and preventing data manipulation
  • Understanding fit-for-purpose device accuracy and adequacy for diverse case studies – high level overview
  • Evaluating the reality of challenges of combining (unapproved) devices and drug discovery in (FDA-Centre crossing) clinical research – approval and implementation considerations for wearable devices
  • Is real time data acquisition a necessity? What level of sampling is sufficient?
  • Patient compliance and device wearability – how to find the right balance between technical accuracy and reliability and patient comfort

17.00
Close of Conference Day One