September 18-19, 2019
Boston, MA

                             Join us at the 7th Annual Summit

AboutConference Day 1

Day One

Wednesday 18th September 2019

8:15 am Chair’s Opening Remarks

8:30 am ‘IMPACCT’ Panel Discussion: Advancing the Generation & Utilization of Real World Evidence to Drive Patient-Centricity & Better Outcomes

  • Javier Jimenez VP & Global Head of RWE & Clinical Outcomes, Sanofi
  • Kara Dennis SVP & General Manager, Life Sciences, Clarify Health Solutions
  • Melvin Olson Global Head, RWD Strategy & Innovation, Novartis
  • Michael Lees Head of Value, Evidence & Portfolio Strategy , Takeda

Synopsis

• Focusing on patient-centered drug development – what is the role of RWE?
• Defining and establishing clinically meaningful evidence to support R&D
• How to bring RWE-enhanced drug development one step forward?
• Where does the biggest opportunity for next steps in this space lie?
• Discussing the current regulatory climate in RWE
• Analyzing the rise of AI and Machine Learning capabilities and its impact in RWE-driven patient-centric clinical innovation and outcomes

Supporting Clinical R&D with Real-World Evidence

9:15 am Advancing the Use of Advanced Analytics in Real World Evidence

Synopsis

• More information coming soon

9:45 am Session Reserved for Deloitte

Synopsis

• More information coming soon

10:15 am Speed Networking Session

10:45 am Morning Refreshments

11:15 am Using Real World Data to Augment the Cardiovascular Drug Development Process

  • Keith Friend Global Medical Director, Cardiovascular, Bristol-Myers Squibb

Synopsis

• Exploring the use of RWD in early development
• Using RWD in full development
• Discussing how to support registration, launch and market access activities with real-world data

11:45 am Using NLP to Improve Identification of Patients of Interest & Safety Events

  • Dongmu Zhang Director & Head of Epidemiology Data Analytics, AbbVie

Synopsis

  • Discussing EHR data vs. claims data
  • Exploring the use of NLP to identify and segment patients of interest
  • Developing NLP-based algorithm in safety events identification

12:15 pm Patient Perspective of Disease Burden & Prevailing Unmet Need in Serious Mental Illness Treatment Landscape

Synopsis

• Overviewing of study types to collect patient perspective data
• Choosing appropriate instruments with study objectives in mind
• Exploring examples of qualitative and quantitative patient perspective research to highlight disease burden & unmet need

12:45 pm Lunch & Networking

1:45 pm Real World Evidence to Support Regulatory Submissions

Synopsis

• Exploring the FDA’s RWE framework
• When and how can RWE best augment RCTs?
• Discussing the FDA’s demonstration projects

Tackling Implementation & Data Challenges

2:15 pm Lesson Learned from The Development & Implementation of an Integrated Data & Evidence Strategy at AbbVie

Synopsis

• Developing and implementing an original data and evidence strategy from first principles – delving into the experience at AbbVie, a new large cap biopharmaceutical company
• Exploring the continuous implementation process over the last five years – identifying several key learnings that have led to modifications and additions to the ongoing roll out
• Focusing on some of those key learnings and their impact on implementation of the data and evidence strategy at AbbVie

2:45 pm Biopharmaceutical Acceleration Model for Product Development & Commercialization

Synopsis

  • Discussion how, historically, product development has largely been disengaged from commercialization.
  • Exploring how, in the current environment, health system stakeholders demand both clinical and real-world evidence to inform decisions regarding product use and reimbursement
  • Describing (and illustrating with a case study) the benefits of a Biopharmaceutical Acceleration Model approach to product development and commercialization, involving comprehensive evidence development to meet clinical, regulatory, and commercial needs

3:15 pm Afternoon Refreshments & Networking

3:45 pm Advanced Analytics in Clinical & Observational Research

  • David Anstatt Executive Director, Observational Research & Data Sciences, Bristol-Myers Squibb

Synopsis

• The Data Story: evolving and expanding to meet research demands (social media, genomics as RWD, unstructured to structured, data provenance, sensors, privacy, PRO, study metadata)
• The Methods Story: exploring the advances in research, grounded in FDA/EMA guidelines (boost techniques, NLP, prediction, optimization)
• The Impact Story: working across the development and commercialization process (discovery and development predictive analytics, study optimization, patient journey/treatment analytics, regulatory use of RWD)
• Exploring Social Media Data in Pharmacovigilance

4:15 pm Evolving Real World Evidence Strategy Across Lifecycle – Improving Evidence for Patient Care

Synopsis

• Identifying gaps is easy, addressing them requires a deep understanding of data sources available, including strengths, limitations, and accessibility
• Generating relevant RWE requires understanding of key audience needs, their understanding of RWE, and credible methods and data sources
• Successful RWE programs reflect cross-functional expertise and collaboration across internal and external stakeholders with disciplined approach to evidence generation

4:45 pm What’s Driving Real World Data Utilization from Early to Late Phase Development

  • CJ Hameed Senior Director, Real World Data & Analytics, Chief Digital Office, Pfizer

Synopsis

  • Reviewing the current landscape, identify gaps and opportunities for RWD utilizing in drug development
  • Discussing RWE Methodologies, Data management for RWD Assets and advance analytics
  • How to effectively engage the stakeholders in RWD use and evidence generation and where to go next?

5:15 pm Chair’s Closing Remarks