February 1-2 , 2017

San Francisco

 

Day One
Wednesday February 1, 2017

Day Two
Thursday February 2, 2017

08:50
Chairman’s Opening Remarks

Synopsis

Key Takeaways & Lessons Learned from Day One

Clinical Trial Monitoring in Real Time: mHealth & Wearable Devices

09:00
mHealth & Wearables – Collecting Clinical Outcome Data Remotely

  • Elena Izmailova, PhD Senior Director of Devices & Novel Data Streams, Data Science Institute, Takeda Pharmaceuticals Inc.

Synopsis

  • Exploring wearable technologies and their applications in drug development
  • Consumer and medical grade devices – fit-for-purpose principle
  • Overview of existing regulations for wearables
  • Addressing the challenges and potential solutions of deploying wearable devices in the clinic

09:30
Sensational Sensors & Wonderful Wearables – Uncovering the Promise of Multivariate, Continuous, Individual Data in Clinical R&D

  • Nina Mian Head of Biomedical Informatics, Advanced Analytics Center, AstraZeneca

Synopsis

  • Developing capabilities to manage, integrate and analyze data collected from wearables – a Case-Study on the efforts at AstraZeneca Advanced
  • Analytics Center to derive meaning and value for the clinical pipeline and patients
  • Understanding the areas of opportunity, challenges, and successes we gleaned from our experience to-date
  • Diving into the detail of defining novel digital disease biomarkers, phenotypes and endotypes
  • Realizing value in clinical trials, and how we may forge a path to novel outcome measures

10:00
Morning Refreshments & Networking

10:45
Panel Discussion: One Step Further on Clinical Trial Outcome Monitoring – Key Benefits & Challenges Around mHealth & Wearables

  • Elena Izmailova, PhD Senior Director of Devices & Novel Data Streams, Data Science Institute, Takeda Pharmaceuticals Inc.
  • Nina Mian Head of Biomedical Informatics, Advanced Analytics Center, AstraZeneca

Synopsis

  • Unravelling the possibilities behind remote real-time data acquisition during clinical trials
  • Proof of concept – is the technology and/or the industry ready to embrace this new approach?
  • Are regulation standards in the way or working the way towards clinical trial monitoring with wearable devices?
  • Return on investment – understanding if the results driven from wearables compensate implementation and maintenance costs
  • Patient compliance and device wearability – how to find the right balance between technical accuracy and reliability and patient comfort

11:30
Can Data Collection & Reporting from Wearable Devices Cloud, Supplement or Replace Standard Measures in Clinical Trial Reporting? – A Regulatory Perspective

  • Todd Townsend, PhD. Commissioner’s Fellow, United States Food and Drug Administration (FDA)

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-Center crossing) clinical research – Approval and implementation considerations for wearable devices

12:00
Lunch & Networking

13:00
Interactive Round Table Discussions & Feedback Panel Session

  • Ankit Lodha Analytics Operations Lead in Clinical Systems & Analytical Reporting (CSAR), Amgen
  • Todd Townsend, PhD. Commissioner’s Fellow, United States Food and Drug Administration (FDA)
  • Abhik Bhattacharya, PhD. Senior Director & Global Head of Analytics, Astellas US LLC.
  • Rajneesh Patil Senior Director, Clinical Development, Quintiles

Synopsis

These moderated, interactive roundtable discussions give you the chance to spend time in facilitated debate and exchange on the issues most concerning you.

Sessions are ‘off the record’ and give you the chance to share best practice and discuss practical solutions with peers from across the industry facing the same challenges you face every day.

  • Advanced Analytics in Clinical R&D – Ankit Lodha
  • Regulation and Guidance for the Future of Data in Clinical Innovation: Wearables, RWE and Adaptive Trials – Todd Townsend
  • Real World Data in Clinical Trials – Abhik Bhattacharya
  • CDM in Clinical Research – Centralized Monitoring, Analytics & Risk Based Monitoring – Rajneesh Patil

15:00
Afternoon Refreshments & Networking

Real World Data in Clinical Research

15:30
Real World Data (RWD) Sources – the Health Data Revolution in Clinical Research

Synopsis

  • Real World Data – How to leverage RWD sources in the drug development phase and throughout the life to support internal strategy and decision making
  • Using EHRs– addressing the current challenges of data quality and granularity & unfolding the new possibilities
  • Using RWD to optimize clinical trial design and execution

16:00
Assessing Clinical Trial Operational Feasibility – the Role of Data Analysis Before Trial Start up

Synopsis

  • Designing clinical trials – data analysis for decision making in the operational context
  • Selecting where to operate the trial – which country, which site?
  • Assessment factors – discussing start-up time, site performance, etc.
  • Developing the algorithms to analyze design data
  • Exploring potential new applications of RWD in feasibility assessments

16:30
Chairman’s Closing Remarks

16:45
Close of Conference Day Two & End of Conference