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Conference Agenda

Day 1 timings:
Start: 8:50am – End: 5:45pm

Day 2 timings:
Start 9:00am – End 3:45pm


Day 1

07:30 - 08:50
REGISTRATION, EXHIBITION & WELCOME COFFEE

Chair: Parexel Michelle Hoiseth Corporate Vice President Parexel

08:50 - 09:00
Setting the scene: Drive innovation and healthcare transformation in the current political and regulatory environment

More information coming soon...

Otsuka John Bardi Vice President Public Affairs and Digital Medicine Business Development Otsuka

09:00 - 09:40
Panel: Navigating chaos? Thrive in the changing healthcare and reimbursement landscape
  • Sidestep the hurdles associated with rising healthcare costs by entering risk-sharing agreements through partnership with key stakeholders
  • Hear assessment on the potential outcomes of Obamacare and where US health insurance is headed
  • Understand the legislative and political barriers already pausing the implementation of the 21st Century Cures Act and what timelines may be resultant

Otsuka John Bardi Vice President Public Affairs and Digital Medicine Business Development Otsuka

CSL Behring Debbie Drane SVP Commercial Development CSL Behring

UCB Joseph Dye Head of HEOR, Neurology US UCB

09:40 - 10:10
Real-World Evidence for Real World Impact: The bridge from evidence to access
  • Know what it takes to be successful in todays “Age of Value and Affordability”
  • Design studies that deliver compelling real-world evidence that move Access Pathway decision makers
  • Invest in global real-world data generation that will support the product throughout the lifecycle
  • Learn how to use real world evidence to change the conversation and behavior of payers

ZS Ed Schoonveld Principal, Value & Access ZS

ZS Aaron Mitchell Principal, R&D Excellence ZS

10:10 - 10:40
Meet evidence generation needs by making the most of the full external environment with targeted collaboration
  • See how AstraZeneca is paving the way in stakeholder partnerships to meet evidence needs through multiple case examples
  • Focus efforts based on an understanding of different external stakeholder needs
  • Overcome privacy and data challenges inhibiting the potential benefits of external collaboration

AstraZeneca Sandy Leonard VP Medical Evidence and Observational Research AstraZeneca

10:40 - 11:05
EXHIBITION & NETWORKING COFFEE BREAK
11:05 - 11:45
Panel: Have clarity in your value demonstration approach with understanding of payer decision making preferences and needs
  • Plan your access strategy around the knowledge of evidence requirements from the growing myriad of assessment mechanisms
  • Define the parameters of value which can be related to specific subpopulations, personalising your value proposition
  • Optimize your use of RWE in the value equation to fill data gaps and complete the patient picture

Amgen Peter Juhn VP, Global Head of Value-based Partnerships Amgen

FDA Nneka C. Onwudiwe PRO/PE Regulatory Review Officer US Government

Aetna Edmund Pezalla Former VP, National Medical Director, Pharmaceutical Policy and Strategy Aetna

11:45 - 12:15
Establish real-world value in the eyes of payers and other key stakeholders
  • What is the meaning of value and how is this interpreted by different stakeholders?
  • Harmonization is key: work together with payers to tailor value propositions to their needs
  • Envisage how Teva’s HEOR function works alongside Medical Affairs to generate robust RWE data

Teva Karthik Ramakrishnan Senior Manager, GHEOR Teva

WORKSHOP BREAKOUT (Pharma only – Lunch starts for all others)
12:15 - 1:15
The role of digital technology in RWD programs
  • Explore the use of technology to facilitate patient data capture across observational, pragmatic and commercial programs
  • Understand how this approach enables the capture of high quality, regulatory compliant datasets built for analysis and mining in a real-world setting
  • Discuss how, where applicable, technology can support enhanced patient engagement and improved health outcomes

ERT Gavin Birchnall Senior Solutions Consultant ERT

How to build and architect your Connected Health Cloud
  • Learn what industry analysts define the Connected Health Cloud as, and why they are referencing Connected Health Clouds as a signal that Healthcare IT is leaving “the Dark Ages”
  • Participate in hands-on learning experience on how to build and architect your connected health cloud
  • Learn best practices for connecting disparate data sources including EHR/EMR, IoT/Wearable, and Internal systems to create more actionable insights
  • Assess the state of connected health today with the commonalities and differences between participants and how we can achieve a common path forward

CloudMine Steve Wray CEO CloudMine

1:15 - 2:30
EXHIBITION & NETWORKING LUNCH
2:30 - 3:00
Move forward with confidence: The latest in FDA philosophy toward the value of RWE
  • Discover the latest updates on how the FDA approaches the use of RWE in their decision-making process
  • See how the 21st Century Cures Act is driving the use the of RWE throughout product development
  • Learn from examples of successful use of RWE to support safety and efficacy claims
  • Explore how approvals within the efficacy paradigm using RWE are stepping closer through rare diseases

FDA Jonathan Jarow Senior Medical Advisor FDA

3:00 - 3:30
Impact of 21C Cures Act on Expanded Access in the US
  • Explore the evolution of pre-approval Expanded Access in the United States as a result of the 21st Century Cures Act of 2016
  • Understand the policy implications for the generation of real-world data prior to approval
  • What does the future look like for the United States and rest of world with respect to these programs?

inVentiv Health Sean Kennedy Principal inVentiv Health

3:30 - 4:00
From evidence to execution: optimize market access through internal structure
  • Equip market access functions to correctly identify and meet the differentiating needs of regional stakeholders
  • Maximize collaboration between international, country and regional market access functions to break silos, increasing internal spread of knowledge
  • Identify the roles in building robust payer value propositions and ensure continues flow of evidence creation to support commercialization post launch

Merck KGaA Ana Cespedes SVP & Project Lead, Core competencies for the future of Merck KGaA Healthcare business, Global Marketing & Strategy Merck KGaA

4:00 - 4:15
Explore innovative new uses of big data in insurance, leading to a more preventive-care focused methodology

More information coming soon...

Company_Name Cheng Zhang Vice President, Life Sciences Business Development Clover Health

4:15 - 4:45
EXHIBITION & NETWORKING COFFEE BREAK
4:45 - 5:15
Value based healthcare and the future of reimbursement
  • Visualise how the marketplace is evolving and the need for value demonstration in reimbursement decisions
  • Establish the key principles needed for the transition to value based healthcare
  • Hear how Amgen have successfully implemented value based contracts and lead the way in further value based activities

Amgen Peter Juhn VP, Global Head of Value-based Partnerships Amgen

5:15 - 5:45
Real-World Evidence redefined: Quantifying value in the digital era of medicine
  • Understand how to bolster your value-demonstration by capturing patient behavior outside brick and mortar walls
  • Hear how consumer devices and wearables are being used to quantify health outcomes in connected patients across the US
  • Discover novel applications of digital biomarkers, critical in the move towards value-based care

Evidation Health Deborah Kilpatrick CEO Evidation Health

5:45 - 7:30
EXHIBITION & NETWORKING DRINKS RECEPTION

Day 2

08:00 - 09:00
REGISTRATION, EXHIBITION & WELCOME COFFEE
RWE
Market Access

Chair: ZS Aaron Mitchell Principal, R&D Excellence ZS

Chair: ZS Ed Schoonveld Principal, Value & Access ZS

09:00 - 09:30
Increase and accelerate RWD utilisation by colleagues throughout the organisation
  • Give your R&D colleagues the edge with linked genomic and EHR data analysis, streamlining development
  • Synthesise and communicate large data sets more quickly and efficiently with next generation analytic capabilities
  • Optimise clinical trial design with more targeted patient recruitment

Pfizer Margaret McDonald Senior Director, Real World Data and Analytics, Global Health and Value Pfizer

The value story: demonstrating value early in the drug lifecycle
  • Understand the importance of demonstrating value of treatment and why the discussion needs to move past pricing
  • Prepare for early launch success by answering the questions associated with value earlier in the development stage
  • Envision how CSL Behring demonstrated the value of high cost rare disease treatment with greater emphasis on patient value

CSL Behring Debbie Drane SVP Commercial Development CSL Behring

09:30 - 10:00
Align on patient outcomes: Understand how market dynamics can facilitate real-world data solutions in research
  • Identify actions that can be taken today to leverage RWD while larger, structural changes take root
  • Become more agile in the complex regulatory environment to ensure RWD strategy remains relevant to review requirements
  • Explore patient ownership of their healthcare data to move our industry forward in its use of RWD

PAREXEL Michelle Hoiseth Corporate Vice President PAREXEL

Risk-sharing in the US and its impact on access negotiations
  • Gain insights from MCOs, IDNs, and PBMs on how payers execute value-based contracts, the impact of data in shaping agreements and the effect of provider risk-sharing
  • Overcome the barriers associated with more innovative value-based care models and ensure you address providers as well as payers
  • Successfully negotiate and design value-based contracts in today’s market and further explore areas of opportunity as the industry transitions to value based care delivery

Huron Consulting Kenneth Beers Managing Director Huron Consulting

10:00 - 10:30
Bridge the divide between how Pharma and the FDA view RWE in regulatory decision-making
  • Build stakeholder consensus on how to define RWE in both the premarketing and post-marketing setting
  • Maximize marketplace opportunities by developing a market access strategy built around the product’s lifecycle
  • Improve value communication and promotional activities by adopting a RWE based communication strategy that is supported by a regulatory framework
  • Reduce legal and regulatory uncertainty by substantiating medical product claims and propositions on FDA led guidance

FDA Nneka Onwudiwe PRO/PE Regulatory Review Officer US Government

Maximizing Access: Transitioning your organization towards addressing stakeholder value
  • Fully aligning internal teams to understand and align around the components of product value that will address the value needs of the evolving stakeholder set

Bayer Reg Waldeck Market Access Strategy Leader Bayer

10:30 - 11:00
EXHIBITION & NETWORKING COFFEE BREAK
11:00 - 11:30
Measure comparative effectiveness in a real-world setting with pragmatic clinical trials
  • See how Sanofi’s Toujeo pragmatic study is determining the efficacy and outcomes of the diabetes treatment in broad real-world populations
  • Understand how the study design allows the analysis of patient vs. physician reported outcomes accuracy
  • Explore how the study creates a more complete effectiveness picture by incorporating the wider treatment support program
  • Meet the growing range of stakeholder data requirements with a multi-layer methodological approach

Sanofi Riccardo Perfetti Senior Medical Officer, VP Global Medical Affairs, Diabetes Division Sanofi

Demonstrating value earlier in the development process
  • Hasten reimbursement by bringing products to market with a robust value proposition
  • Align internal teams to ensure evidence is generated earlier in the drug’s development for early reimbursement and successful launch
  • Establish continued collection of RWE to further address payer needs and accurately prove value to patient populations

Aetna Edmund Pezalla Former VP, National Medical Director, Pharmaceutical Policy and Strategy Aetna

11:30 - 12:15
Panel: The future of pragmatic trials in the United States
  • Balance your RPT approach by finding the right balance between the technical and business challenges to reduce operational risk
  • Learn how collaboration and communication throughout the build-up and operational process with the complete stakeholder ecosystem involved is key for success
  • What will the impact of the 21st Century Cures act be on the adoption of pragmatic trials

Sanofi Riccardo Perfetti Senior Medical Officer, VP Global Medical Affairs, Diabetes Division Sanofi

FDA Jonathan Jarow Senior Medical Advisor FDA

Janssen Jack Sheehan RWE Pragmatic Trial Team Lead Janssen

Panel: Indication pricing - a fresh take on an old problem
  • Establish the benefits indication pricing holds for patients, payors, providers and pharma
  • Highlight the value your product delivers to specific patient subpopulations and develop a pricing strategy that reflects true effectiveness
  • Continue to gain reimbursement for innovator and specialty drugs while strengthening payor relationships by removing unnecessary spending
  • Better understand how indication pricing agreements are established and ensure you can move to a value-based pricing system in the future

ICER Bill Dreitlein Director of Pharmaceutical Policy ICER

Independent Blue Cross Michael Mittelman New Product Development & Capability Manager Independent Blue Cross

Bayer Reg Waldeck Market Access Strategy Leader Bayer

12:15 - 12:45
Transform clinical trial design with RWE to accelerate development timelines
  • Explore how Flatiron Health’s collaborative project with the National Cancer Institute (NCI) is using EHR data to inform study planning
  • Identify specific patient populations and sample sizes to create a more targeted evidence generation process
  • See how the successful application of RWD will modernise the R&D paradigm

Flatiron Health Ken Carson Senior Medical Director Flatiron Health

Where there’s smoke, there’s… Original research exploring the US payer perspective on current outcomes-based contracting activity
  • Understand the payer reported experience with negotiations, and their level of satisfaction
  • See the prevalence of different types of innovative contracts, and which kinds payers anticipate growth in over the next three years
  • Understand the health conditions which are prioritized by payers for the future innovative and OBC initiatives
  • Know the factors payers think drive interest for innovative or OBC initiatives, and which factors create the largest barriers

MME Dave Evans Partner MME

12:45 - 2:00
EXHIBITION & NETWORKING LUNCH BREAK
2:00 - 2:45
Panel: Overcome data quality issues to successfully meet evidence needs through the latest digital health technologies
  • Leverage the latest analytical innovations to turn raw prospective data into valued insight, discovering previously unmet needs
  • See how real-time collection of data will move healthcare further into the preventive landscape
  • More than just a novel idea: Explore examples of the latest tools being developed and implanted to overcome data standards issues creating true RWD

UnitedHealthcare Vidya Raman-Tangella SVP, Head Innovation Center of Excellence UnitedHealthcare

Otsuka Holly Krasa Senior Director, Health Outcomes Otsuka

MeaningCloud Eduardo Valencia Linguist and Data Analytics Manager MeaningCloud

Janssen Sean McElligott Global Market Access Lead Dermatology Janssen

2:45 - 3:15
Not all data is created equal: leveraging evidence from alternative sources
  • Kickstart your data generation by effectively analyzing external prospective and retrospective data sets
  • Create robust evidence by identifying the right question while understanding the limitations of the data
  • Save time and money through analysis of virtual head-to-head RCTs
  • Take the next step – innovative ways to process and clean unstructured data and social listening

Janssen Sean McElligott Director, Global Market Access Lead Dermatology Janssen

3:15 - 3:45
Innovative Pricing & Reimbursement Agreements in Oncology
  • Establish the need for innovative access agreements and highlight the opportunities for improved access
  • Sidestep hurdles associated with innovative access agreements in oncology, from a US and non-US viewpoint
  • Explore the future of combination therapies and identify effective pricing and reimbursement strategies

Pfizer Gergana Zlateva VP Market Access Oncology Pfizer

3:45
END – COFFEE TO STAY OR GO

Day 1

07:30 - 08:50
REGISTRATION, EXHIBITION & WELCOME COFFEE

Chair: Parexel Michelle Hoiseth Corporate Vice President Parexel

08:50 - 09:00
Setting the scene: Drive innovation and healthcare transformation in the current political and regulatory environment

More information coming soon...

Otsuka John Bardi Vice President Public Affairs and Digital Medicine Business Development Otsuka

09:00 - 09:40
Panel: Navigating chaos? Thrive in the changing healthcare and reimbursement landscape
  • Sidestep the hurdles associated with rising healthcare costs by entering risk-sharing agreements through partnership with key stakeholders
  • Hear assessment on the potential outcomes of Obamacare and where US health insurance is headed
  • Understand the legislative and political barriers already pausing the implementation of the 21st Century Cures Act and what timelines may be resultant

Otsuka John Bardi Vice President Public Affairs and Digital Medicine Business Development Otsuka

CSL Behring Debbie Drane SVP Commercial Development CSL Behring

UCB Joseph Dye Head of HEOR, Neurology US UCB

09:40 - 10:10
Real-World Evidence for Real World Impact: The bridge from evidence to access
  • Know what it takes to be successful in todays “Age of Value and Affordability”
  • Design studies that deliver compelling real-world evidence that move Access Pathway decision makers
  • Invest in global real-world data generation that will support the product throughout the lifecycle
  • Learn how to use real world evidence to change the conversation and behavior of payers

ZS Ed Schoonveld Principal, Value & Access ZS

ZS Aaron Mitchell Principal, R&D Excellence ZS

10:10 - 10:40
Meet evidence generation needs by making the most of the full external environment with targeted collaboration
  • See how AstraZeneca is paving the way in stakeholder partnerships to meet evidence needs through multiple case examples
  • Focus efforts based on an understanding of different external stakeholder needs
  • Overcome privacy and data challenges inhibiting the potential benefits of external collaboration

AstraZeneca Sandy Leonard VP Medical Evidence and Observational Research AstraZeneca

10:40 - 11:05
EXHIBITION & NETWORKING COFFEE BREAK
11:05 - 11:45
Panel: Have clarity in your value demonstration approach with understanding of payer decision making preferences and needs
  • Plan your access strategy around the knowledge of evidence requirements from the growing myriad of assessment mechanisms
  • Define the parameters of value which can be related to specific subpopulations, personalising your value proposition
  • Optimize your use of RWE in the value equation to fill data gaps and complete the patient picture

Amgen Peter Juhn VP, Global Head of Value-based Partnerships Amgen

FDA Nneka C. Onwudiwe PRO/PE Regulatory Review Officer US Government

Aetna Edmund Pezalla Former VP, National Medical Director, Pharmaceutical Policy and Strategy Aetna

11:45 - 12:15
Establish real-world value in the eyes of payers and other key stakeholders
  • What is the meaning of value and how is this interpreted by different stakeholders?
  • Harmonization is key: work together with payers to tailor value propositions to their needs
  • Envisage how Teva’s HEOR function works alongside Medical Affairs to generate robust RWE data

Teva Karthik Ramakrishnan Senior Manager, GHEOR Teva

WORKSHOP BREAKOUT (Pharma only – Lunch starts for all others)
12:15 - 1:15
The role of digital technology in RWD programs
  • Explore the use of technology to facilitate patient data capture across observational, pragmatic and commercial programs
  • Understand how this approach enables the capture of high quality, regulatory compliant datasets built for analysis and mining in a real-world setting
  • Discuss how, where applicable, technology can support enhanced patient engagement and improved health outcomes

ERT Gavin Birchnall Senior Solutions Consultant ERT

How to build and architect your Connected Health Cloud
  • Learn what industry analysts define the Connected Health Cloud as, and why they are referencing Connected Health Clouds as a signal that Healthcare IT is leaving “the Dark Ages”
  • Participate in hands-on learning experience on how to build and architect your connected health cloud
  • Learn best practices for connecting disparate data sources including EHR/EMR, IoT/Wearable, and Internal systems to create more actionable insights
  • Assess the state of connected health today with the commonalities and differences between participants and how we can achieve a common path forward

CloudMine Steve Wray CEO CloudMine

1:15 - 2:30
EXHIBITION & NETWORKING LUNCH
2:30 - 3:00
Move forward with confidence: The latest in FDA philosophy toward the value of RWE
  • Discover the latest updates on how the FDA approaches the use of RWE in their decision-making process
  • See how the 21st Century Cures Act is driving the use the of RWE throughout product development
  • Learn from examples of successful use of RWE to support safety and efficacy claims
  • Explore how approvals within the efficacy paradigm using RWE are stepping closer through rare diseases

FDA Jonathan Jarow Senior Medical Advisor FDA

3:00 - 3:30
Impact of 21C Cures Act on Expanded Access in the US
  • Explore the evolution of pre-approval Expanded Access in the United States as a result of the 21st Century Cures Act of 2016
  • Understand the policy implications for the generation of real-world data prior to approval
  • What does the future look like for the United States and rest of world with respect to these programs?

inVentiv Health Sean Kennedy Principal inVentiv Health

3:30 - 4:00
From evidence to execution: optimize market access through internal structure
  • Equip market access functions to correctly identify and meet the differentiating needs of regional stakeholders
  • Maximize collaboration between international, country and regional market access functions to break silos, increasing internal spread of knowledge
  • Identify the roles in building robust payer value propositions and ensure continues flow of evidence creation to support commercialization post launch

Merck KGaA Ana Cespedes SVP & Project Lead, Core competencies for the future of Merck KGaA Healthcare business, Global Marketing & Strategy Merck KGaA

4:00 - 4:15
Explore innovative new uses of big data in insurance, leading to a more preventive-care focused methodology

More information coming soon...

Company_Name Cheng Zhang Vice President, Life Sciences Business Development Clover Health

4:15 - 4:45
EXHIBITION & NETWORKING COFFEE BREAK
4:45 - 5:15
Value based healthcare and the future of reimbursement
  • Visualise how the marketplace is evolving and the need for value demonstration in reimbursement decisions
  • Establish the key principles needed for the transition to value based healthcare
  • Hear how Amgen have successfully implemented value based contracts and lead the way in further value based activities

Amgen Peter Juhn VP, Global Head of Value-based Partnerships Amgen

5:15 - 5:45
Real-World Evidence redefined: Quantifying value in the digital era of medicine
  • Understand how to bolster your value-demonstration by capturing patient behavior outside brick and mortar walls
  • Hear how consumer devices and wearables are being used to quantify health outcomes in connected patients across the US
  • Discover novel applications of digital biomarkers, critical in the move towards value-based care

Evidation Health Deborah Kilpatrick CEO Evidation Health

5:45 - 7:30
EXHIBITION & NETWORKING DRINKS RECEPTION

Day 2

08:00 - 09:00
REGISTRATION, EXHIBITION & WELCOME COFFEE
RWE
Market Access

Chair: ZS Aaron Mitchell Principal, R&D Excellence ZS

Chair: ZS Ed Schoonveld Principal, Value & Access ZS

09:00 - 09:30
Increase and accelerate RWD utilisation by colleagues throughout the organisation
  • Give your R&D colleagues the edge with linked genomic and EHR data analysis, streamlining development
  • Synthesise and communicate large data sets more quickly and efficiently with next generation analytic capabilities
  • Optimise clinical trial design with more targeted patient recruitment

Pfizer Margaret McDonald Senior Director, Real World Data and Analytics, Global Health and Value Pfizer

The value story: demonstrating value early in the drug lifecycle
  • Understand the importance of demonstrating value of treatment and why the discussion needs to move past pricing
  • Prepare for early launch success by answering the questions associated with value earlier in the development stage
  • Envision how CSL Behring demonstrated the value of high cost rare disease treatment with greater emphasis on patient value

CSL Behring Debbie Drane SVP Commercial Development CSL Behring

09:30 - 10:00
Align on patient outcomes: Understand how market dynamics can facilitate real-world data solutions in research
  • Identify actions that can be taken today to leverage RWD while larger, structural changes take root
  • Become more agile in the complex regulatory environment to ensure RWD strategy remains relevant to review requirements
  • Explore patient ownership of their healthcare data to move our industry forward in its use of RWD

PAREXEL Michelle Hoiseth Corporate Vice President PAREXEL

Risk-sharing in the US and its impact on access negotiations
  • Gain insights from MCOs, IDNs, and PBMs on how payers execute value-based contracts, the impact of data in shaping agreements and the effect of provider risk-sharing
  • Overcome the barriers associated with more innovative value-based care models and ensure you address providers as well as payers
  • Successfully negotiate and design value-based contracts in today’s market and further explore areas of opportunity as the industry transitions to value based care delivery

Huron Consulting Kenneth Beers Managing Director Huron Consulting

10:00 - 10:30
Bridge the divide between how Pharma and the FDA view RWE in regulatory decision-making
  • Build stakeholder consensus on how to define RWE in both the premarketing and post-marketing setting
  • Maximize marketplace opportunities by developing a market access strategy built around the product’s lifecycle
  • Improve value communication and promotional activities by adopting a RWE based communication strategy that is supported by a regulatory framework
  • Reduce legal and regulatory uncertainty by substantiating medical product claims and propositions on FDA led guidance

FDA Nneka Onwudiwe PRO/PE Regulatory Review Officer US Government

Maximizing Access: Transitioning your organization towards addressing stakeholder value
  • Fully aligning internal teams to understand and align around the components of product value that will address the value needs of the evolving stakeholder set

Bayer Reg Waldeck Market Access Strategy Leader Bayer

10:30 - 11:00
EXHIBITION & NETWORKING COFFEE BREAK
11:00 - 11:30
Measure comparative effectiveness in a real-world setting with pragmatic clinical trials
  • See how Sanofi’s Toujeo pragmatic study is determining the efficacy and outcomes of the diabetes treatment in broad real-world populations
  • Understand how the study design allows the analysis of patient vs. physician reported outcomes accuracy
  • Explore how the study creates a more complete effectiveness picture by incorporating the wider treatment support program
  • Meet the growing range of stakeholder data requirements with a multi-layer methodological approach

Sanofi Riccardo Perfetti Senior Medical Officer, VP Global Medical Affairs, Diabetes Division Sanofi

Demonstrating value earlier in the development process
  • Hasten reimbursement by bringing products to market with a robust value proposition
  • Align internal teams to ensure evidence is generated earlier in the drug’s development for early reimbursement and successful launch
  • Establish continued collection of RWE to further address payer needs and accurately prove value to patient populations

Aetna Edmund Pezalla Former VP, National Medical Director, Pharmaceutical Policy and Strategy Aetna

11:30 - 12:15
Panel: The future of pragmatic trials in the United States
  • Balance your RPT approach by finding the right balance between the technical and business challenges to reduce operational risk
  • Learn how collaboration and communication throughout the build-up and operational process with the complete stakeholder ecosystem involved is key for success
  • What will the impact of the 21st Century Cures act be on the adoption of pragmatic trials

Sanofi Riccardo Perfetti Senior Medical Officer, VP Global Medical Affairs, Diabetes Division Sanofi

FDA Jonathan Jarow Senior Medical Advisor FDA

Janssen Jack Sheehan RWE Pragmatic Trial Team Lead Janssen

Panel: Indication pricing - a fresh take on an old problem
  • Establish the benefits indication pricing holds for patients, payors, providers and pharma
  • Highlight the value your product delivers to specific patient subpopulations and develop a pricing strategy that reflects true effectiveness
  • Continue to gain reimbursement for innovator and specialty drugs while strengthening payor relationships by removing unnecessary spending
  • Better understand how indication pricing agreements are established and ensure you can move to a value-based pricing system in the future

ICER Bill Dreitlein Director of Pharmaceutical Policy ICER

Independent Blue Cross Michael Mittelman New Product Development & Capability Manager Independent Blue Cross

Bayer Reg Waldeck Market Access Strategy Leader Bayer

12:15 - 12:45
Transform clinical trial design with RWE to accelerate development timelines
  • Explore how Flatiron Health’s collaborative project with the National Cancer Institute (NCI) is using EHR data to inform study planning
  • Identify specific patient populations and sample sizes to create a more targeted evidence generation process
  • See how the successful application of RWD will modernise the R&D paradigm

Flatiron Health Ken Carson Senior Medical Director Flatiron Health

Where there’s smoke, there’s… Original research exploring the US payer perspective on current outcomes-based contracting activity
  • Understand the payer reported experience with negotiations, and their level of satisfaction
  • See the prevalence of different types of innovative contracts, and which kinds payers anticipate growth in over the next three years
  • Understand the health conditions which are prioritized by payers for the future innovative and OBC initiatives
  • Know the factors payers think drive interest for innovative or OBC initiatives, and which factors create the largest barriers

MME Dave Evans Partner MME

12:45 - 2:00
EXHIBITION & NETWORKING LUNCH BREAK
2:00 - 2:45
Panel: Overcome data quality issues to successfully meet evidence needs through the latest digital health technologies
  • Leverage the latest analytical innovations to turn raw prospective data into valued insight, discovering previously unmet needs
  • See how real-time collection of data will move healthcare further into the preventive landscape
  • More than just a novel idea: Explore examples of the latest tools being developed and implanted to overcome data standards issues creating true RWD

UnitedHealthcare Vidya Raman-Tangella SVP, Head Innovation Center of Excellence UnitedHealthcare

Otsuka Holly Krasa Senior Director, Health Outcomes Otsuka

MeaningCloud Eduardo Valencia Linguist and Data Analytics Manager MeaningCloud

Janssen Sean McElligott Global Market Access Lead Dermatology Janssen

2:45 - 3:15
Not all data is created equal: leveraging evidence from alternative sources
  • Kickstart your data generation by effectively analyzing external prospective and retrospective data sets
  • Create robust evidence by identifying the right question while understanding the limitations of the data
  • Save time and money through analysis of virtual head-to-head RCTs
  • Take the next step – innovative ways to process and clean unstructured data and social listening

Janssen Sean McElligott Director, Global Market Access Lead Dermatology Janssen

3:15 - 3:45
Innovative Pricing & Reimbursement Agreements in Oncology
  • Establish the need for innovative access agreements and highlight the opportunities for improved access
  • Sidestep hurdles associated with innovative access agreements in oncology, from a US and non-US viewpoint
  • Explore the future of combination therapies and identify effective pricing and reimbursement strategies

Pfizer Gergana Zlateva VP Market Access Oncology Pfizer

3:45
END – COFFEE TO STAY OR GO

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