AGENDA DAY 1

Evidence and Pharma Pricing & Market Access USA Day 1

ACCESS + EVIDENCE = VALUE

Jonathan Jarrow
09:00

Keynote Address: Evidence Generation in the Electronic Era - Leveraging Real World Data

  • Learn how the FDA utilizes real world data in regulatory decision-making
  • Current barriers to full implementation of a learning healthcare system
  • Regulatory hurdles to development of real world evidence 
Panel discussion
Sachin Palod
10:00

Value Frameworks and their influence on Payers

  • What are the top value frameworks accepted by payers and how you can benefit from them
  • Discussing the growing desire of payers to accept new value frameworks and how you should adapt to these
  • Capturing the patient experience in the value framework
10:20

Speed Networking

"The musical chairs like phenomenon to get you introduced to the maximum number of people in the shortest time possible"
10:40

Networking Coffee Break

DATA GENERATION

PAYER PARTNERSHIPS

EVIDENCE
11:20

FIRESIDE CHAT: Future tools and technologies for evidence generation

  • A widely cited study for the National Institute of Standards & Technology (NIST) reports that inadequate testing methods and tools annually cost the U.S. economy between $22.2 and $59.5 billion, with roughly half of these costs borne by software developers in the form of extra testing software users in the form of failure avoidance and mitigation efforts
  • How to implement new tools: Demonstrating ethics, value and enabling it to connect databases
  • Ensuring the required standard of evidence is met
  • Exploring data mining, signal detection, patient portals, N of 1 studies, insilico methodologies
PRICING & MARKET ACCESS
11:20

PANEL: Transparency across the drug supply chain- how can we get costs out in the open?

  • Pharmaceuticals originate in manufacturing sites; are transferred to wholesale distributors; stocked at retail, mail-order, and other types of pharmacies; subject to price negotiations and processed through quality and utilization management screens by pharmacy benefit management companies (PBMs); dispensed by pharmacies; and ultimately delivered to and taken by patients
  • How to deliver the best value to patients and those that are exposed to vulnerability from high prices
  • What each player does and the role that it plays in the flow of pharmaceuticals from manufacturer to patient
  • How cash flow works between the manufacturer and the patient
  • What would be the impact of greater transparency?
EVIDENCE
11:40

Pragmatic EHR trials? So close, yet so far…

  • Deciding whether and how to use EHRs as a source of data in clinical investigations
  • Is there enough EHR data to formulate real results?
  • Overcoming data fragmentation within companies; is there a better way of standardizing across platforms
EVIDENCE
12:00

Where is the guidance? Overhauling EMR Data Standards

  • Ensuring the quality and the integrity of EHR data that are collected and used as Electronic source data in clinical investigations
  • Using EHRs that are interoperable with electronic systems supporting clinical investigations
  • FDA draft guidance on EMR standards and their implications
PRICING & MARKET ACCESS
12:00

Does Canada do it better - Payer partnerships and HTA in Canada – biosimilar market access

  • Assess how payer partnerships narrow the network and patient assignments
  • Improve patient outcomes and engagement through payer partnerships
  • Decrease healthcare costs while remaining innovative by aligning payers with community partners
  • Biosimilar examples
EVIDENCE
12:20

Sponsorship Available

PRICING & MARKET ACCESS
12:20

Sponsorship Available

round tables
12:40

ROUND TABLES

1) US payer introduction to the structures and processes

  • Jennifer L. Bragg, Partner
    , FDA regulatory and litigation attorney

2) Statistical methodologies- learning new meta analysis techniques

  • Andy Gunn, Global Head Evidence Generation
    , UCB BioPharmaceuticals Inc

3) Policy framework- Patient data and evidence management

  • Amy Niles, Vice President, External Affairs, Patient Access Network Foundation
  • Leena Patel, President and CEO
    , PAN Foundation

4) Economic Evaluation of Vaccines- Providing value through the prevention of disease

  • David Davidovic, Former Vice President & Global Head, Commercial Services
    , Roche & Genentech

5) Value Frameworks - What is the future?

  • Christine Verini, Chief Business Development Officer, CancerCare
6) Biosimilars - Market Access
  • Jennifer Voelker, HEOR fellow, Janssen
  • Biosimilars - Market Access
  • Jennifer Voelker

    Jennifer Voelker, Post-doctoral HEOR fellow, Jansen

  • Policy framework- Patient data and evidence management
  • Leena Patel

    Leena Patel, President and CEO, Patient Access Network Foundation

  • The Journey to Building a Comprehensive Precision Oncology Program at an Academic Medical Center
  • Bat-ami Katzman Gordon

    Bat-ami Katzman Gordon, Project manager of Precision Medicine at the Sylvester Comprehensive Cancer Center, University of Miami

  • US payer introduction to the structures and processes
  • Jennifer Bragg

    Jennifer Bragg, Partner, Skadden Arps Slate Meagher & Flom LLP

  • Value Frameworks - What is the future
  • 13:20

    Lunch

    VALUE & AFFORDABILITY

    VALUE GENERATION IN IMMUNO ONCOLOGY

    EVIDENCE
    14:40

    Digital technologies for value based healthcare

    • The future of healthcare will be almost entirely digital, driven by new and existing generations of consumers who are more mobile, technologically sophisticated and want more control over their own healthcare decisions
    • How to demonstrate value and develop awareness & empowerment across the whole drug development process
    • The regulatory, economic and other challenges the new digital landscape presents
    PRICING & MARKET ACCESS
    14:40

    Value in cancer care- how to cope with rising R&D costs and requirements for value demonstration

    • Value of new cancer therapies based on clinical benefit
    • Achieving high-quality, high-value care for all patients with cancer
    • Improvements in patient symptoms or quality of life in the context of cost
    EVIDENCE
    15:00

    Taking a step beyond clinical trial information- why is this essential?

    • How to improve the quality of risk-sharing agreements between manufacturers and payers that are based on outcomes
    PRICING & MARKET ACCESS
    15:00

    PANEL: Accelerated Approval and Expensive Drugs — A Challenging Combination

    • Despite the uncertain evidence of clinical benefit, drugs receiving accelerated approval enter the market as FDA-approved products. Insurers must decide whether and how to pay for them
    • How do insurers decide whether to pay for these drugs in light of little evidence?
    • Ensuring that confirmatory trials conducted after receiving accelerated approval are performed in a timely fashion and are designed optimally to limit the period of uncertainty about true clinical effect
    EVIDENCE
    15:20

    Brazil focus: Market access and value generation

    • Analyze what stakeholders in Brazilian healthcare can bring to the table to create business opportunities and provide value at the same time
    • Challenges can only be met together: Discover how helping partners keeps you one step ahead of future health trends
    • Find out how creating long-lasting relationships helps pinpoint business opportunities where there are common goals
    EVIDENCE
    15:40

    Sponsorship Available

    PRICING & MARKET ACCESS
    15:40

    Sponsorship Available

    PRECISION MEDICINE AND BIOMARKERS

    COMMERCIALIZATION

    EVIDENCE
    16:00

    PANEL: The impact of precision medicine and biomarkers on drug pricing structures

    • Understanding how biomarkers will have an increasing role to play in drug pricing 
    • What impact will precision medicine have on the overall cost of healthcare
    • Do we have the necessary evidence to put a price on precision medicine?
    Karen Keeley, Consultant, R.A.R.E. Science
    Rachel Anhorn, Director, Payer Policy and Health Outcomes, Foundation Medicine Inc
    PRICING & MARKET ACCESS
    16:00

    Value and Impact of early collaboration between commercial and development

    • The importance and benefits of early and ongoing communications and collaboration
    • How can such collaboration be appropriate in the current regulatory environment?
    • How this collaboration is essential for patient centricity
    PRICING & MARKET ACCESS
    16:20

    Is this the start of a revulsion revolution?! Are patient centered outcomes changing the equation of value?

    • Healthcare is no longer a disease-centric process. Modern healthcare is patient-centric, where patients (and their families) are active participants in care
    • Defining end points through patient involvement and the advantages that this
    • How accelerating patient-centered CER improves value
    EVIDENCE
    16:40

    Sponsorship Available

    PRICING & MARKET ACCESS
    16:40

    Sponsorship Available

    CROSSFUNCTIONAL VALUE

    17:00

    Networking Coffee Break

    17:20

    Sponsored keynote address

    Elise Berliner, Ph.D.
    17:40

    Show me real evidence - Evaluating strength of evidence in systematic reviews

    • Reports of study design issues that lead to low strength of evidence and how to mitigate your chances of pitfalls.
    • Working with patient registries and generating strong data to empower the value equation
    • Making information valid and reliable for patient and policy decision making 
    18:00

    Closing Remarks

    Evening Networking Drinks Reception

    last published: 26/Jul/17 16:05 GMT