September 18-19, 2019
Boston, MA

                             Join us at the 7th Annual Summit

AboutConference Day 2

Day Two

Thursday 19th September 2019

8:20 am Chair’s Opening Remarks

Rethinking Real World Evidence Strategy

8:30 am ‘IMPACCT’ Panel Discussion: Value Generation, Real World Evidence & Life Cycle Management – Distilling Strategy for Innovation

Synopsis

• In what stages of the drug life cycle does RWE have greatest impact?
• Establishing the right evidence generation plan that meets clinical, regulatory and commercial needs of a product:
• How to?
• Does it differ between big and small pharma?
• What’s the ROI vs. value generation?
• Driving internal collaboration for value-based evidence generation

9:15 am Can Pharma Save $1 Billion Through the Strategic Use of RWE?

  • Melvin Olson Global Head, RWD Strategy & Innovation, Novartis

Synopsis

• Reviewing current evidence needs and trends
• Introducing a framework for integrated evidence generation
• Revisiting IMSHealth (now IQVIA) claims that Pharma can save $1 billion through real-world evidence

9:45 am RWE: Retrospective & Prospective Solutions To Support Advancement in Patient Care

  • Stella Safo Chief Clinical Transformation Officer, Premier Inc.

Synopsis

  • Exploring the role of RWD to provide the evidence for gaps in current treatment and clinical trial patient identification
  • Discussing the role of a strong partnership with member hospitals in developing and testing solutions to identified gaps
  • Putting it all together with a case study: Partnership of Life Science companies, Providers of Care, and Premier in Solution Development

10:15 am Morning Refreshments & Networking

10:45 am The Role of RWE in a Comprehensive Product Evidence Generation Plan

Synopsis

  • Key questions across the product lifecycle that can be addressed through RWE
  • Creating the necessary synergies across the organization to fully leverage the strengths of RWE
  • Deriving critical insights from RWD to facilitate successful drug development and commercialization

11:15 am RWE Across the LifeCycle – Strategy Before Tactical Solutions

  • Marla Curran Executive Director, Head of Biometrics & Medical Writing, Paratek Pharmaceuticals

Synopsis

• Synthesizing information and alignment: key data gaps, SWOT, functionspecific needs
• Discussing big pharma vs. small pharma
• Strategic planning framework: Challenges > Resolutions > Tactical Plan
• Exploring stakeholder engagement and prioritization
• The strength of evidence spectrum and optimizing trial/study designs

11:45 am Getting to High-Quality Real-world Data & Its Applications Across RWE

Synopsis

  • Getting the data that matters
  • Making it research grade
  • Using it in impactful ways across the product lifecycle

12:15 pm Lunch & Networking

1:15 pm Making Choices in Evidence Development: Using Local Insights to Drive a Truly Global Evidence Base

  • Michael Lees Head of Value, Evidence & Portfolio Strategy , Takeda

Synopsis

• Generating a comprehensive evidence base for new medicines by using RCT and RWE in an integrated way
• Establishing trade-offs needed between competing needs of different country decision makers, when developing a truly global evidence base
• Effectively managing these trade-offs where strong local input, internal and external to the developer of the medicine, is provided early and systematically into the evidence team

1:45 pm Use of Real World Data Outside of Traditional Comparative Effectiveness Research

  • Ravi Iyer Director, Global HEOR , Teva Pharmaceuticals

Synopsis

• Using RWD in early phase of life-cycle development
• Presenting a case study in the use of real world data to support payer discussions
• Exploring opportunities and challenges associated with use of RWD in early phase of asset development and payer discussions

2:15 pm Mastermind Session: Supporting & Enhancing Product Life Cycle with Innovative Evidence Strategies

Synopsis

This session facilitates in-depth discussions among participants in an informal environment. After splitting into groups, participants will discuss key challenges and opportunities regarding the current RWE landscape in regards to its utilization across product life-cycle to drive innovation and more patient-facing outcomes.

3:00 pm Afternoon Refreshments & Networking

Driving Commercial Success & Supporting the Bringing of New Therapeutic Options to Market

3:30 pm Evidence Planning: Leveraging Innovation for Impact

  • Sandy Leonard Former VP, Medical Evidence & Observational Research , AstraZeneca

Synopsis

• Understanding evidence needs early in the product lifecycle
• Identifying opportunities to invest in innovative evidence to address gaps
• Leveraging evidence with key medical and payer audiences

4:00 pm What Does it Take to Substantiate a Million-Dollar Price Tag in Gene Therapy?

Synopsis

• Exploring the challenges with gene therapy market access
• Discussing how evidence requirements are more rigorous in gene therapy
• Establishing a very different business model for gene therapies

4:30 pm ‘IMPACCT’ Panel Discussion: Looking Outwards – Demonstrating Product Value & Improved Care Delivery with Real World Evidence

  • Frank Zhang VP, Head of Market Access, uniQure
  • Mandeep Kaur VP, Head of North America Medical Affairs, Immunology, Sanofi
  • Sandy Leonard Former VP, Medical Evidence & Observational Research , AstraZeneca

Synopsis

• Developing a suitable evidence framework to demonstrate product value and differentiation
• Addressing external stakeholders’ (payors, providers and patients) concerns as they increasingly seek to understand the effects of new products in the real-world setting
• Supporting decision-makers and payors with evidence that is better tailored to help them determine reimbursement policies and insurance coverage for new therapeutic options

5:15 pm Chair’s Closing Remarks