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Conference Agenda

Day 1

Section 1:
Plenary Keynotes – Become a real-world oracle
08:30 - 09:00
Setting the scene: Drive innovation and healthcare transformation in the current political and regulatory environment

More information coming soon...

Otsuka John Bardi VP Government Affairs, Advocacy & Digital Medicines Business Development Otsuka

08:30 - 09:00
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 VP Government Affairs, Advocacy & Digital Medicines Business Development Otsuka

CSL Behring Debbie Drane SVP Commercial Development CSL Behring

UCB Bruce Lavin Global Head of External Engagement and Policy UCB

Industry speaker TBA – see website

08:30 - 09:00
ZS – Presentation

More information coming soon...

ZS Ed Schoonveld Principal, Value & Access ZS

ZS Aaron Mitchell Principal, R&D Excellence ZS

08:30 - 09:00
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

08:30 - 09:00
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

Novo Nordisk Stanislav Glezer Former VP Medical Affairs Novo Nordisk

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

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

Payer speaker TBA - see website

08:30 - 09:00
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

EMD Serono Ana Cespedes SVP, Global Head of Market Access and Pricing EMD Serono

08:00 - 08:30
LUNCH BREAK
Section 2:
Stakeholders hold the answers
08:30 - 09:00
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

08:30 - 09:00
Real-world payers – meet payer demands in a RWE driven environment
  • Understand how best to tailor your value demonstration based on the RWE that payers want to see
  • Reduce risk with improved real-world study design, with incorporation of payer requirements from the outset, early collaboration and partnership
  • Explore innovative new uses of big data in insurance, leading to a more preventive-care focused methodology

Company_Name Vivek Garipalli CEO Clover Health

Further speakers TBA – see website

08:30 - 09:00
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 Riad Dirani VP, Global Health Economics and Outcomes Research Teva

08:30 - 09:00
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

08:30 - 09:00
Evidation Health - Presentation

More information coming soon...

Evidation Health Deborah Kilpatrick CEO Evidation Health

08:30 - 09:00
The continued evolution of EBM: From Experience, to Evidence, and now Empiric Based Medicine
  • Utilise RWD to make near real-time decisions in the treatment process
  • Personalise treatments based on the real-world outcomes of targeted population analysis
  • An inevitable change to the practise of medicine: how do you get drugs to market in a system always basing decisions on the past?

Astellas Thomas Abbott Global Head, Real World Informatics Capabilities and Alliances Astellas

Day 2

08:30 - 09:00
Section 3.1:
The next steps in the real-world data application
Section 4.1:
Driving market access with a focus on value
08:30 - 09:00
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

08:30 - 09:00
INC Research – Presentation

More information coming soon.

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 Ken Booth Managing Director Huron Consulting

Pope Woodhead Andrew Hobbs Managing Director Pope Woodhead

08:30 - 09:00
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

Maximize access with a shift towards value, not the brand
  • Distinguish your product from competitors using reliable data which backs up your value proposition
  • Fully align internal teams to communicate product value and overcome hurdles in the reimbursement process
  • Identify unmet needs of patient populations to tailor product offering, ensuring better outcomes and better access

Bayer Reg Waldeck Market Access Strategy Leader Bayer

08:30 - 09:00
Measuring 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

08:30 - 09:00
Section 4.2:
Become value centric through pricing innovations
08:30 - 09:00
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

RAND Soeren Mattke Senior Scientist RAND

Bayer Reg Waldeck Market Access Strategy Leader Bayer

08:30 - 09:00
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

Overcome difficulties measuring performance in value based pricing
  • Integrate patient value into the business model as a basis for sustainable industry partnership with healthcare system and payers
  • Define target patient population and simple yet conclusive outcomes measures which are agreed by relevant stakeholders
  • Build data collection systems to monitor value through measuring patient and healthcare system outcomes
  • Identify and mitigate the risk of value based agreements

Novo Nordisk Stanislav Glezer Former VP Medical Affairs Novo Nordisk

08:30 - 09:00
Section 5.0:
Closing keynotes
08:30 - 09:00
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

08:30 - 09:00
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

UCB Andy Gunn Global Head of Evidence Generation Strategy UCB

Otsuka John Bardi VP Government Affairs, Advocacy & Digital Medicines Business Development Otsuka

MeaningCloud Eduardo Tirapu Linguist and Data Analytics Manager MeaningCloud

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

08:00 - 08:30
END

Day 1

Section 1:
Plenary Keynotes – Become a real-world oracle
08:30 - 09:00
Setting the scene: Drive innovation and healthcare transformation in the current political and regulatory environment

More information coming soon...

Otsuka John Bardi VP Government Affairs, Advocacy & Digital Medicines Business Development Otsuka

08:30 - 09:00
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 VP Government Affairs, Advocacy & Digital Medicines Business Development Otsuka

CSL Behring Debbie Drane SVP Commercial Development CSL Behring

UCB Bruce Lavin Global Head of External Engagement and Policy UCB

Industry speaker TBA – see website

08:30 - 09:00
ZS – Presentation

More information coming soon...

ZS Ed Schoonveld Principal, Value & Access ZS

ZS Aaron Mitchell Principal, R&D Excellence ZS

08:30 - 09:00
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

08:30 - 09:00
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

Novo Nordisk Stanislav Glezer Former VP Medical Affairs Novo Nordisk

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

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

Payer speaker TBA - see website

08:30 - 09:00
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

EMD Serono Ana Cespedes SVP, Global Head of Market Access and Pricing EMD Serono

08:00 - 08:30
LUNCH BREAK
Section 2:
Stakeholders hold the answers
08:30 - 09:00
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

08:30 - 09:00
Real-world payers – meet payer demands in a RWE driven environment
  • Understand how best to tailor your value demonstration based on the RWE that payers want to see
  • Reduce risk with improved real-world study design, with incorporation of payer requirements from the outset, early collaboration and partnership
  • Explore innovative new uses of big data in insurance, leading to a more preventive-care focused methodology

Company_Name Vivek Garipalli CEO Clover Health

Further speakers TBA – see website

08:30 - 09:00
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 Riad Dirani VP, Global Health Economics and Outcomes Research Teva

08:30 - 09:00
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

08:30 - 09:00
Evidation Health - Presentation

More information coming soon...

Evidation Health Deborah Kilpatrick CEO Evidation Health

08:30 - 09:00
The continued evolution of EBM: From Experience, to Evidence, and now Empiric Based Medicine
  • Utilise RWD to make near real-time decisions in the treatment process
  • Personalise treatments based on the real-world outcomes of targeted population analysis
  • An inevitable change to the practise of medicine: how do you get drugs to market in a system always basing decisions on the past?

Astellas Thomas Abbott Global Head, Real World Informatics Capabilities and Alliances Astellas

Day 2

08:30 - 09:00
Section 3.1:
The next steps in the real-world data application
Section 4.1:
Driving market access with a focus on value
08:30 - 09:00
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

08:30 - 09:00
INC Research – Presentation

More information coming soon.

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 Ken Booth Managing Director Huron Consulting

Pope Woodhead Andrew Hobbs Managing Director Pope Woodhead

08:30 - 09:00
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

Maximize access with a shift towards value, not the brand
  • Distinguish your product from competitors using reliable data which backs up your value proposition
  • Fully align internal teams to communicate product value and overcome hurdles in the reimbursement process
  • Identify unmet needs of patient populations to tailor product offering, ensuring better outcomes and better access

Bayer Reg Waldeck Market Access Strategy Leader Bayer

08:30 - 09:00
Measuring 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

08:30 - 09:00
Section 4.2:
Become value centric through pricing innovations
08:30 - 09:00
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

RAND Soeren Mattke Senior Scientist RAND

Bayer Reg Waldeck Market Access Strategy Leader Bayer

08:30 - 09:00
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

Overcome difficulties measuring performance in value based pricing
  • Integrate patient value into the business model as a basis for sustainable industry partnership with healthcare system and payers
  • Define target patient population and simple yet conclusive outcomes measures which are agreed by relevant stakeholders
  • Build data collection systems to monitor value through measuring patient and healthcare system outcomes
  • Identify and mitigate the risk of value based agreements

Novo Nordisk Stanislav Glezer Former VP Medical Affairs Novo Nordisk

08:30 - 09:00
Section 5.0:
Closing keynotes
08:30 - 09:00
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

08:30 - 09:00
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

UCB Andy Gunn Global Head of Evidence Generation Strategy UCB

Otsuka John Bardi VP Government Affairs, Advocacy & Digital Medicines Business Development Otsuka

MeaningCloud Eduardo Tirapu Linguist and Data Analytics Manager MeaningCloud

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

08:00 - 08:30
END

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