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The industry changing agenda

07:30 - 09:00
REGISTRATION, EXHIBITION & WELCOME COFFEE
09:00 - 09:05
Chairman opening remarks

eyeforpharma Paul Simms Chairman eyeforpharma

09:05 - 09:45
Panel: The future of pharma requires a value shift
  • Change starts within: how to move towards investing in value beyond short-term wins
  • Why pharma must take the lead to build bridges across the healthcare ecosystem
  • How pharma can help stakeholders align to reduce costs and improve patient value

Moderator: Aetion Scott Musial Head of Client Delivery Aetion

Boehringer Ingelheim Anjan Chatterjee VP, Global Head RWE - COE, Epidemiology and Big Data Boehringer Ingelheim

GSK Martin Marciniak VP, US Medical Affairs, Customer Engagement, Value, Evidence and Outcomes GSK

EMD Serono Zhen Su SVP, Chief Medical Officer, North America EMD Serono

09:45 - 10:05
Advance the use of RWE – an industry progress health check and next steps
  • Inventories 2018 state of RWE uses in clinical research
  • Examine operational hurdles for bleeding-edge applications of RWD in RWE research paradigms
  • Explore innovations that can support resolution of unsolved challenges (such as patient consent management, adherence to privacy/data storage regulation, interoperability, data sharing incentives, statistical approaches, etc.) that aligns with current regulatory and healthcare delivery landscape
  • Discuss essential RWD enablers that delivery teams must master in order to successfully innovate

PAREXEL Camie Britton Senior Director PAREXEL

10:05 - 10:25
Create convergence in patient centricity and real-world data in clinical development
  • Understand the benefits of RWE reapplication in your clinical trials for improved patient identification and recruitment
  • Develop marketing tools through-out development to help your access colleagues provide evidence on specific patient populations
  • Re-approach patient engagement to suit the new needs in the era of big data

Pfizer Christopher Boone Vice President, Head of Real World Data and Analytics Center of Excellence Pfizer

10:25 - 11:05
EXHIBITION & NETWORKING COFFEE BREAK
11:05 - 11:25
FDA real-world evidence vision and policy
  • Implementation of the 21st Century Cures Act
  • FDA real-world demonstration projects – Exploring the future

FDA Khair ElZarrad Deputy Director, Office of Medical Policy FDA

11:25 - 12:05
Panel: Use data, analytics, and services to assess and monitor the value of healthcare products
  • Establishing transparency in data sources and methods used to determine product value
  • Fostering trust between payer/manufacturers as partners in contracting
  • Building a scalable approach to value-based contracting for long-term benefits

IBM Watson Health Denise Meade Director of Product Management IBM Watson Health

Further panellists TBC

12:05 - 12:25
Prove the value of digital medicine – the case of Abilify MyCite
  • Learn how to overcome challenges commercializing digital technologies
  • Understand payer needs for creating long-term, outcomes-based agreements for digital products
  • The next steps in scaling digital products to revolutionize healthcare delivery and understanding

Otsuka John Bardi VP Public Affairs & Digital Health Business Development Otsuka

12:25 - 1:25
Interactive Workshop

SAS Hosted by SAS

1:25 - 2:25
EXHIBITION & NETWORKING LUNCH BREAK
2:25 - 3:05
Panel: Communicate and contract for value in an evolving legal landscape
  • Discuss recent FDA final guidance on use of Health Economic Information
  • Update on the status of existing and new safe harbors impacting value based contracting
  • Understand compliant use of dynamic data modeling and RWE when working with payers and providers
  • Best practices in contracting for use of digital health platforms and data when designing value-based offers

Moderator: Covington Rujul Desai Of Counsel Covington

AbbVie Brad Patrick Division Counsel AbbVie

Covington Michael Labson Partner Covington

Further panellist TBC

3:05 - 3:25
Presentation TBC

Evidation Health Evidation Health

3:25 - 3:45
Create a Multi-stakeholder and Integrated Blueprint for VBC: A Medical Affairs Perspective
  • Collaboratively define VBC driven endpoints with payers and strategize the burden of evidence
  • Integrate provider perspectives to drive VBC adoptions and support for evidence generation
  • Set patient at the center of VBC strategy and generate a payer-patient value chain

Acer Therapeutics Usman Iqbal Vice President, Medical Affairs Acer Therapeutics

3:45 - 4:15
EXHIBITION & NETWORKING COFFEE BREAK
4:15 - 4:35
Are Employers the new gatekeepers to access?
  • Essential briefing on how employers view the changing access landscape
  • How do employers view value and where do they differ from payers?
  • Can pharma contract directly with employers? Is this the next frontier for value-based contracting?

National Alliance of Healthcare Purchaser Coalitions Michael Thompson President & CEO National Alliance of Healthcare Purchaser Coalitions

4:35 - 4:55
Find synergy between Product Development and Commercialization - the Biopharmaceutical Acceleration Model
  • Explore why and how historically product development has largely been disengaged from commercialization
  • See the emerging need for both clinical and real-world evidence to inform stakeholder decisions on product use and reimbursement
  • Meet clinical, regulatory and commercial needs with using the Biopharmaceutical Acceleration Model approach for comprehensive evidence development

Syneos Health Rob Chipperfield Executive Director, Client Engagement Syneos Health

4:55 - 5:35
Panel: The Roadmap to Scale VBC
  • What lessons can we learn from failure of previous attempts at VBC?
  • Case Study: How Aetna and Merck created their VBC for Januvia
  • Create incentives to align partners and scale the adoption of VBC

Moderator: National Pharmaceutical Council Dan Leonard President National Pharmaceutical Council

Aetna Harry Vargo Director of Value Based Contracting and Manufacturer Trade Relations Aetna

Merck David Hartenbaum Executive Director, Account Management Merck

5:35
EXHIBITION & NETWORKING DRINKS RECEPTION

Day 2

08:00 - 09:15
REGISTRATION, EXHIBITION & WELCOME COFFEE
09:15 - 10:00
Strategic Collaborations with hospital & provider systems, IDNs and ACOs to bring value-based care to patients
  • Investigate success factors for meaningful pharma provider systems engagement
  • Explore opportunities for implementation of VBC programs using population health
  • Discuss unique advantages of direct-to-system collaborations over traditional payer engagements
  • Learn how to leverage real-world evidence programs and risk-based contracting

Moderator: Pharmvivo Ulrich Neumann Founder Pharmvivo

Astellas Americas Shontelle Dodson SVP and Head, Medical Affairs Astellas Americas

Pfizer Oncology Gergana Zlateva VP, Payer Insights and Access Pfizer Oncology

Sunovion Pharmaceutical Matt Portch Vice President, Managed Markets Sunovion Pharmaceutical

Regional Cancer Care Associates Terrill Jordan President & CEO Regional Cancer Care Associates

10:00 - 10:20
Pairing Real-World Data with treatment guidelines to identify and access underserved patient populations
  • Learn by example how you can use real-world data to find treatment-eligible patients at a local level to maximize your treated-patient conversion rates within the addressable population
  • Claims and EHR analysis linked to treatment guidelines and established standards of care to identify and size eligible patient populations
  • Identification of major patient “drop-out” points to understand where to focus your commercial activity
  • How variability in regional care delivery and patient disease burden impacts treatment pull-through opportunity

drg Adrienne Lovink Partner, Consulting DRG

10:20 - 10:40
Presentation TBC
10:40 - 11:00
EXHIBITION & NETWORKING COFFEE BREAK
11:00 - 11:45
Panel: Build a robust American data ecosystem
  • Build trust in RWE amongst regulators and payers by aligning data standards with competitors
  • Work directly with IDNs and providers to fix gaps and align efforts towards a unified data capture strategy and breaking data silos
  • Use technology to generate and enhance research grade data

Moderator: OM1 Rich Gliklich CEO OM1

Boehringer Ingelheim Anjan Chatterjee VP, Global Head RWE - COE, Epidemiology and Big Data Boehringer Ingelheim

Vertex Pharmaceuticals Denise Globe VP, Head Global Real World Evidence Center of Excellence Vertex Pharmaceuticals

Celgene Patrick Loerch Senior Director, Data Sciences (Information, Knowledge Utilization - iKU), Celgene

Janssen Sean McElligott Director, Market Access, Scientific and External Strategy Janssen

11:45 - 12:05
Presentation TBC

mark_logic MarkLogic

12:05 - 12:55
ROUNDTABLE DEBATES
  1. It’s a trust issue: discuss strategies for pharma and payer to achieve greater levels of partnership and decrease perceptions of data bias
  2. Europe’s GDPR tremor: is a shift in US privacy regulation around the corner? Discuss the impact new EU regulations are already having and how they might alter the US system
  3. Real-time patient insights: explore how to overcome issues with data quality and trust from the new era of digital devices
  4. Predict outcomes: learn how to work with payers to model patient populations
  5. Social media as a source of RWE: discuss how emerging technologies such as Natural Language Processing (NLP) are being used to find new patient insights
  6. The use of RWE in clinical trials: debate how to best incorporate big data insights into the development process, keeping high data relevance and quality
  7. Agree on outcomes: discuss experience and best practices on effective communication with payers and agreeing on desired outcomes
  8. The pragmatic solution: explore different approaches to defining the right question for pragmatic studies
  9. One standard to rule them all: learn about developments in data standardization techniques and discuss whether a standardized model is the best approach to harmonizing data silos
  10. Put your house in order first: discuss difficulties and different approaches on how best to place internal RWE expertise for the most effective knowledge dissemination
  11. Real-world patients: how can pharma engage with patients regarding ownership and data use?
  12. Learning healthcare systems: harmonized HEOR - but how feasible are these systems and what’s a realistic timeframe for their development?

American Living Organ Donor Fund Michael Mittelman Executive Director American Living Organ Donor Fund

Cutaneous Lymphoma Foundation Susan Thornton CEO Cutaneous Lymphoma Foundation

GSK Rafael Alfonso Senior Director, Value Evidence and Outcomes, Scientific Lead – Americas, GSK

Bayer Stephanie Chen Market Access Bayer

DRG Keshia Maughn Director, Data Science Methodology DRG

12:55 - 1:55
EXHIBITION & NETWORKING LUNCH BREAK
1:55 - 2:15
Case study: Accelerate clinical development leveraging real-world data
  • Inform phase 3 trial design by enabling clinical colleagues to define endpoints and inclusion criteria more accurately
  • See how Lilly adapted traditional FDA submission standards to incorporate new levels of patient/population understanding from RWE sources

Eli Lilly Diana Stefani-Hunyady Global Senior Director, IL-23 Medical Affairs Launch Lead Eli Lilly

2:15 - 2:35
Accelerate therapeutic development with blockchain technology – the case for a drug development meritocracy
  • Discuss the impact of blockchain on data ownership and the breaking down of data silos
  • Explore use case examples of blockchain technology in patient registries and genomic matching
  • Build industry trust in blockchain through the reputation systems: KYC – Know Your Customer, Collaborator, Clinician

Mitsubishi Bryan Hill Medical Science Director Mitsubishi

2:35 - 2:55
Presentation TBC
2:55 - 3:15
Case Study: How Discover Diabetes is setting new standards for global epidemiology
  • The story behind AstraZeneca's platform to enrol patients from >35 countries in a global study of diabetes treatment and outcomes
  • Identification of the drivers of diabetes care across the world
  • How to pull through best practices for multi-country real-world studies

AstraZeneca Eric Wittbrodt Director, Epidemiology AstraZeneca

3:15
Coffee available to stay or go
07:30 - 09:00
REGISTRATION, EXHIBITION & WELCOME COFFEE
09:00 - 09:05
Chairman opening remarks

eyeforpharma Paul Simms Chairman eyeforpharma

09:05 - 09:45
Panel: The future of pharma requires a value shift
  • Change starts within: how to move towards investing in value beyond short-term wins
  • Why pharma must take the lead to build bridges across the healthcare ecosystem
  • How pharma can help stakeholders align to reduce costs and improve patient value

Moderator: Aetion Scott Musial Head of Client Delivery Aetion

Boehringer Ingelheim Anjan Chatterjee VP, Global Head RWE - COE, Epidemiology and Big Data Boehringer Ingelheim

GSK Martin Marciniak VP, US Medical Affairs, Customer Engagement, Value, Evidence and Outcomes GSK

EMD Serono Zhen Su SVP, Chief Medical Officer, North America EMD Serono

09:45 - 10:05
Advance the use of RWE – an industry progress health check and next steps
  • Inventories 2018 state of RWE uses in clinical research
  • Examine operational hurdles for bleeding-edge applications of RWD in RWE research paradigms
  • Explore innovations that can support resolution of unsolved challenges (such as patient consent management, adherence to privacy/data storage regulation, interoperability, data sharing incentives, statistical approaches, etc.) that aligns with current regulatory and healthcare delivery landscape
  • Discuss essential RWD enablers that delivery teams must master in order to successfully innovate

PAREXEL Camie Britton Senior Director PAREXEL

10:05 - 10:25
Create convergence in patient centricity and real-world data in clinical development
  • Understand the benefits of RWE reapplication in your clinical trials for improved patient identification and recruitment
  • Develop marketing tools through-out development to help your access colleagues provide evidence on specific patient populations
  • Re-approach patient engagement to suit the new needs in the era of big data

Pfizer Christopher Boone Vice President, Head of Real World Data and Analytics Center of Excellence Pfizer

10:25 - 11:05
EXHIBITION & NETWORKING COFFEE BREAK
11:05 - 11:25
FDA real-world evidence vision and policy
  • Implementation of the 21st Century Cures Act
  • FDA real-world demonstration projects – Exploring the future

FDA Khair ElZarrad Deputy Director, Office of Medical Policy FDA

11:25 - 12:05
Panel: Use data, analytics, and services to assess and monitor the value of healthcare products
  • Establishing transparency in data sources and methods used to determine product value
  • Fostering trust between payer/manufacturers as partners in contracting
  • Building a scalable approach to value-based contracting for long-term benefits

IBM Watson Health Denise Meade Director of Product Management IBM Watson Health

Further panellists TBC

12:05 - 12:25
Prove the value of digital medicine – the case of Abilify MyCite
  • Learn how to overcome challenges commercializing digital technologies
  • Understand payer needs for creating long-term, outcomes-based agreements for digital products
  • The next steps in scaling digital products to revolutionize healthcare delivery and understanding

Otsuka John Bardi VP Public Affairs & Digital Health Business Development Otsuka

12:25 - 1:25
Interactive Workshop

SAS Hosted by SAS

1:25 - 2:25
EXHIBITION & NETWORKING LUNCH BREAK
2:25 - 3:05
Panel: Communicate and contract for value in an evolving legal landscape
  • Discuss recent FDA final guidance on use of Health Economic Information
  • Update on the status of existing and new safe harbors impacting value based contracting
  • Understand compliant use of dynamic data modeling and RWE when working with payers and providers
  • Best practices in contracting for use of digital health platforms and data when designing value-based offers

Moderator: Covington Rujul Desai Of Counsel Covington

AbbVie Brad Patrick Division Counsel AbbVie

Covington Michael Labson Partner Covington

Further panellist TBC

3:05 - 3:25
Presentation TBC

Evidation Health Evidation Health

3:25 - 3:45
Create a Multi-stakeholder and Integrated Blueprint for VBC: A Medical Affairs Perspective
  • Collaboratively define VBC driven endpoints with payers and strategize the burden of evidence
  • Integrate provider perspectives to drive VBC adoptions and support for evidence generation
  • Set patient at the center of VBC strategy and generate a payer-patient value chain

Acer Therapeutics Usman Iqbal Vice President, Medical Affairs Acer Therapeutics

3:45 - 4:15
EXHIBITION & NETWORKING COFFEE BREAK
4:15 - 4:35
Are Employers the new gatekeepers to access?
  • Essential briefing on how employers view the changing access landscape
  • How do employers view value and where do they differ from payers?
  • Can pharma contract directly with employers? Is this the next frontier for value-based contracting?

National Alliance of Healthcare Purchaser Coalitions Michael Thompson President & CEO National Alliance of Healthcare Purchaser Coalitions

4:35 - 4:55
Find synergy between Product Development and Commercialization - the Biopharmaceutical Acceleration Model
  • Explore why and how historically product development has largely been disengaged from commercialization
  • See the emerging need for both clinical and real-world evidence to inform stakeholder decisions on product use and reimbursement
  • Meet clinical, regulatory and commercial needs with using the Biopharmaceutical Acceleration Model approach for comprehensive evidence development

Syneos Health Rob Chipperfield Executive Director, Client Engagement Syneos Health

4:55 - 5:35
Panel: The Roadmap to Scale VBC
  • What lessons can we learn from failure of previous attempts at VBC?
  • Case Study: How Aetna and Merck created their VBC for Januvia
  • Create incentives to align partners and scale the adoption of VBC

Moderator: National Pharmaceutical Council Dan Leonard President National Pharmaceutical Council

Aetna Harry Vargo Director of Value Based Contracting and Manufacturer Trade Relations Aetna

Merck David Hartenbaum Executive Director, Account Management Merck

5:35
EXHIBITION & NETWORKING DRINKS RECEPTION

Day 2

08:00 - 09:15
REGISTRATION, EXHIBITION & WELCOME COFFEE
09:15 - 10:00
Strategic Collaborations with hospital & provider systems, IDNs and ACOs to bring value-based care to patients
  • Investigate success factors for meaningful pharma provider systems engagement
  • Explore opportunities for implementation of VBC programs using population health
  • Discuss unique advantages of direct-to-system collaborations over traditional payer engagements
  • Learn how to leverage real-world evidence programs and risk-based contracting

Moderator: Pharmvivo Ulrich Neumann Founder Pharmvivo

Astellas Americas Shontelle Dodson SVP and Head, Medical Affairs Astellas Americas

Pfizer Oncology Gergana Zlateva VP, Payer Insights and Access Pfizer Oncology

Sunovion Pharmaceutical Matt Portch Vice President, Managed Markets Sunovion Pharmaceutical

Regional Cancer Care Associates Terrill Jordan President & CEO Regional Cancer Care Associates

10:00 - 10:20
Pairing Real-World Data with treatment guidelines to identify and access underserved patient populations
  • Learn by example how you can use real-world data to find treatment-eligible patients at a local level to maximize your treated-patient conversion rates within the addressable population
  • Claims and EHR analysis linked to treatment guidelines and established standards of care to identify and size eligible patient populations
  • Identification of major patient “drop-out” points to understand where to focus your commercial activity
  • How variability in regional care delivery and patient disease burden impacts treatment pull-through opportunity

drg Adrienne Lovink Partner, Consulting DRG

10:20 - 10:40
Presentation TBC
10:40 - 11:00
EXHIBITION & NETWORKING COFFEE BREAK
11:00 - 11:45
Panel: Build a robust American data ecosystem
  • Build trust in RWE amongst regulators and payers by aligning data standards with competitors
  • Work directly with IDNs and providers to fix gaps and align efforts towards a unified data capture strategy and breaking data silos
  • Use technology to generate and enhance research grade data

Moderator: OM1 Rich Gliklich CEO OM1

Boehringer Ingelheim Anjan Chatterjee VP, Global Head RWE - COE, Epidemiology and Big Data Boehringer Ingelheim

Vertex Pharmaceuticals Denise Globe VP, Head Global Real World Evidence Center of Excellence Vertex Pharmaceuticals

Celgene Patrick Loerch Senior Director, Data Sciences (Information, Knowledge Utilization - iKU), Celgene

Janssen Sean McElligott Director, Market Access, Scientific and External Strategy Janssen

11:45 - 12:05
Presentation TBC

mark_logic MarkLogic

12:05 - 12:55
ROUNDTABLE DEBATES
  1. It’s a trust issue: discuss strategies for pharma and payer to achieve greater levels of partnership and decrease perceptions of data bias
  2. Europe’s GDPR tremor: is a shift in US privacy regulation around the corner? Discuss the impact new EU regulations are already having and how they might alter the US system
  3. Real-time patient insights: explore how to overcome issues with data quality and trust from the new era of digital devices
  4. Predict outcomes: learn how to work with payers to model patient populations
  5. Social media as a source of RWE: discuss how emerging technologies such as Natural Language Processing (NLP) are being used to find new patient insights
  6. The use of RWE in clinical trials: debate how to best incorporate big data insights into the development process, keeping high data relevance and quality
  7. Agree on outcomes: discuss experience and best practices on effective communication with payers and agreeing on desired outcomes
  8. The pragmatic solution: explore different approaches to defining the right question for pragmatic studies
  9. One standard to rule them all: learn about developments in data standardization techniques and discuss whether a standardized model is the best approach to harmonizing data silos
  10. Put your house in order first: discuss difficulties and different approaches on how best to place internal RWE expertise for the most effective knowledge dissemination
  11. Real-world patients: how can pharma engage with patients regarding ownership and data use?
  12. Learning healthcare systems: harmonized HEOR - but how feasible are these systems and what’s a realistic timeframe for their development?

American Living Organ Donor Fund Michael Mittelman Executive Director American Living Organ Donor Fund

Cutaneous Lymphoma Foundation Susan Thornton CEO Cutaneous Lymphoma Foundation

GSK Rafael Alfonso Senior Director, Value Evidence and Outcomes, Scientific Lead – Americas, GSK

Bayer Stephanie Chen Market Access Bayer

DRG Keshia Maughn Director, Data Science Methodology DRG

12:55 - 1:55
EXHIBITION & NETWORKING LUNCH BREAK
1:55 - 2:15
Case study: Accelerate clinical development leveraging real-world data
  • Inform phase 3 trial design by enabling clinical colleagues to define endpoints and inclusion criteria more accurately
  • See how Lilly adapted traditional FDA submission standards to incorporate new levels of patient/population understanding from RWE sources

Eli Lilly Diana Stefani-Hunyady Global Senior Director, IL-23 Medical Affairs Launch Lead Eli Lilly

2:15 - 2:35
Accelerate therapeutic development with blockchain technology – the case for a drug development meritocracy
  • Discuss the impact of blockchain on data ownership and the breaking down of data silos
  • Explore use case examples of blockchain technology in patient registries and genomic matching
  • Build industry trust in blockchain through the reputation systems: KYC – Know Your Customer, Collaborator, Clinician

Mitsubishi Bryan Hill Medical Science Director Mitsubishi

2:35 - 2:55
Presentation TBC
2:55 - 3:15
Case Study: How Discover Diabetes is setting new standards for global epidemiology
  • The story behind AstraZeneca's platform to enrol patients from >35 countries in a global study of diabetes treatment and outcomes
  • Identification of the drivers of diabetes care across the world
  • How to pull through best practices for multi-country real-world studies

AstraZeneca Eric Wittbrodt Director, Epidemiology AstraZeneca

3:15
Coffee available to stay or go

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