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Agenda

Navigate Country-Specific Regulations and Reimbursement Models ● Optimise Stakeholder Collaboration ● Utilise Real-World Data Collection

May 21-22, 2019
  • Amsterdam, The Netherlands

Agenda

Want more agenda details? Download the brochure.

DAY ONE | Tuesday, 21 May 2019

7:45

Registration and Welcome Refreshments

8:15

Co-Chairs’ Welcome and Opening Remarks

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

Optimise the Value of
Managed Access Programmes

8:30

Revolutionise Managed Access Programmes for Better Patient Centricity

David Haerry
Partner
The Patvocates Network

Navigate Global and Country-Specific
Regulations and Reimbursement Models

9:00

LANDSCAPE OVERVIEW
European and National Authority Regulations —
A Snapshot of Where Industry is Now and Where Industry Needs to Go

Paul Aliu
Global Head Medical Governance, Chief Medical Office
Novartis

9:30

Ensure Continuous Access to Treatment and Maximize Reimbursement Potential

Becky Thompson
Real World Evidence Solutions
Parexel

10:15

Networking and Refreshment Break

10:45

CASE STUDY
IMI ADAPT-SMART Project —
Capture Value from Critical Findings and Strategic Learnings

Solange Rohou
Senior Director, Regulatory Affairs and Policy, EU, AstraZeneca;
Deputy Project Lead, IMI ADAPT SMART

11:15

Compassionate Use Program (CUP) — Analysis & Recommendations,
de-risking When Carrying Out Compassionate Use Programmes (CUP)

Maryna Kolochavina
Director, Client Engagement Solutions, Real World and Late Phase
Syneos Health

12:15

Explore Alternative Pathways for Breakthrough Therapies to
Streamline Patient Access

Bettina Ryll
Founder, Melanoma Patient Network Europe;
former Chair, ESMO Patient Advocacy Working Group

David Haerry
Partner
The Patvocates Network

12:45

Networking Luncheon

Improve Stakeholder Collaboration for
Expedited Patient Access

13:45

Streamline Expanded Access to Optimise the Patient Journey

Dennis Akkaya
Corporate Development
myTomorrows

14:30

MULTI-STAKEHOLDER PANEL
Enhance Collaboration Amongst Patient Advocacy Groups,
Payers and Manufacturers

Moderator:

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Panelists:

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

Bettina Ryll
Founder, Melanoma Patient Network Europe; Former Chair
ESMO Patient Advocacy Working Group

Michael Mittelman
Chairman
American Living Organ Donor Fund;
Ambassador
Patient-Centered Outcomes Research Institute (PCORI)

David Haerry
Partner
The Patvocates Network

15:15

The Road to Global Access to Medicine For Everyone—Streamline Patient Access to Cross-Border Approved Treatments

Sjaak Vink
Founder and CEO
TheSocialMedwork

15:45

Networking and Refreshment Break

16:15

CHOOSE BETWEEN TWO IN-CONFERENCE BREAKOUTS (A or B)

A Real-World Data — Supporting Product Effectiveness, Safety and Value Strategies and Seamlessly Integrate
Best Practices

I. Collaborate with Patients and Physicians to Drive RWD

II. Explore How RWD Can Support Pricing and Reimbursement Negotiations with Stakeholders in Different Countries

Neil Watson
Global Business Development
Clinigen Group

Marco Adey
Global Business Development
Clinigen Group

Will Rogers
RWD Business Lead
Clinigen Group

 
B From Clinical to Commercial — Accelerating Access to Orphan Drugs for
Rare Diseases

I. Clinical and Regulatory Policy and Pathways

II. Market Access, Pricing and Reimbursement for Rare Diseases

David Schwicker
Principal
ORPHA Strategy Consulting

Michael Mittelman
Co-founder, VP Strategic Partnerships
American Living Organ Donor Fund;
Ambassador
Patient-Centered Outcomes Research Institute (PCORI)

17:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO | Wednesday, 22 May 2019

8:00

Welcome Refreshments

8:30

Conference Co-Chairs’ Review of Day One

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

8:45

Cross-Collaboration with Local Partners to Run an
Expanded Access Programme

Dimitri Dimitriou, MSc, FRSC, FRSB
Chief Executive Officer
ImmuPharma plc

9:30

Create a Company Strategy for Expanded/Managed Access

Ramona Reichenbach
Global Medical Governance Lead
Novartis Pharma AG

10:00

Operationalise a Successful Managed Access Programme

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

10:45

Networking and Refreshment Break

11:15

Using Data from EA Programmes for Regulatory Approvals: Analysis of EMA and FDA over the years

Tobias Polak
Data Scientist
myTomorrows

12:00

CALL TO ACTION
Paving the Path Forward — Critical Next Steps for Access

Conclude the programme by summarising possible actions that can be taken in order to encourage progress. Collaborate to review key action steps discussed over the past day and a half to further accelerate patient access to treatment.

Conversation Contributors:

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

Solange Rohou
Senior Director, Regulatory Affairs and Policy, EU, AstraZeneca;
Deputy Project Lead, IMI ADAPT SMART

12:45

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE | Tuesday, 21 May 2019

7:45

Registration and Welcome Refreshments

8:15

Co-Chairs’ Welcome and Opening Remarks

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

Optimise the Value of
Managed Access Programmes

8:30

Revolutionise Managed Access Programmes for Better Patient Centricity

David Haerry
Partner
The Patvocates Network

Navigate Global and Country-Specific
Regulations and Reimbursement Models

9:00

LANDSCAPE OVERVIEW
European and National Authority Regulations —
A Snapshot of Where Industry is Now and Where Industry Needs to Go

Paul Aliu
Global Head Medical Governance, Chief Medical Office
Novartis

9:30

Ensure Continuous Access to Treatment and Maximize Reimbursement Potential

Becky Thompson
Real World Evidence Solutions
Parexel

10:15

Networking and Refreshment Break

10:45

CASE STUDY
IMI ADAPT-SMART Project —
Capture Value from Critical Findings and Strategic Learnings

Solange Rohou
Senior Director, Regulatory Affairs and Policy, EU, AstraZeneca;
Deputy Project Lead, IMI ADAPT SMART

11:15

Compassionate Use Program (CUP) — Analysis & Recommendations,
de-risking When Carrying Out Compassionate Use Programmes (CUP)

Maryna Kolochavina
Director, Client Engagement Solutions, Real World and Late Phase
Syneos Health

12:15

Explore Alternative Pathways for Breakthrough Therapies to
Streamline Patient Access

Bettina Ryll
Founder, Melanoma Patient Network Europe;
former Chair, ESMO Patient Advocacy Working Group

David Haerry
Partner
The Patvocates Network

12:45

Networking Luncheon

Improve Stakeholder Collaboration for
Expedited Patient Access

13:45

Streamline Expanded Access to Optimise the Patient Journey

Dennis Akkaya
Corporate Development
myTomorrows

14:30

MULTI-STAKEHOLDER PANEL
Enhance Collaboration Amongst Patient Advocacy Groups,
Payers and Manufacturers

Moderator:

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Panelists:

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

Bettina Ryll
Founder, Melanoma Patient Network Europe; Former Chair
ESMO Patient Advocacy Working Group

Michael Mittelman
Chairman
American Living Organ Donor Fund;
Ambassador
Patient-Centered Outcomes Research Institute (PCORI)

David Haerry
Partner
The Patvocates Network

15:15

The Road to Global Access to Medicine For Everyone—Streamline Patient Access to Cross-Border Approved Treatments

Sjaak Vink
Founder and CEO
TheSocialMedwork

15:45

Networking and Refreshment Break

16:15

CHOOSE BETWEEN TWO IN-CONFERENCE BREAKOUTS (A or B)

A Real-World Data — Supporting Product Effectiveness, Safety and Value Strategies and Seamlessly Integrate
Best Practices

I. Collaborate with Patients and Physicians to Drive RWD

II. Explore How RWD Can Support Pricing and Reimbursement Negotiations with Stakeholders in Different Countries

Neil Watson
Global Business Development
Clinigen Group

Marco Adey
Global Business Development
Clinigen Group

Will Rogers
RWD Business Lead
Clinigen Group

 
B From Clinical to Commercial — Accelerating Access to Orphan Drugs for
Rare Diseases

I. Clinical and Regulatory Policy and Pathways

II. Market Access, Pricing and Reimbursement for Rare Diseases

David Schwicker
Principal
ORPHA Strategy Consulting

Michael Mittelman
Co-founder, VP Strategic Partnerships
American Living Organ Donor Fund;
Ambassador
Patient-Centered Outcomes Research Institute (PCORI)

17:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO | Wednesday, 22 May 2019

8:00

Welcome Refreshments

8:30

Conference Co-Chairs’ Review of Day One

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

8:45

Cross-Collaboration with Local Partners to Run an
Expanded Access Programme

Dimitri Dimitriou, MSc, FRSC, FRSB
Chief Executive Officer
ImmuPharma plc

9:30

Create a Company Strategy for Expanded/Managed Access

Ramona Reichenbach
Global Medical Governance Lead
Novartis Pharma AG

10:00

Operationalise a Successful Managed Access Programme

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

10:45

Networking and Refreshment Break

11:15

Using Data from EA Programmes for Regulatory Approvals: Analysis of EMA and FDA over the years

Tobias Polak
Data Scientist
myTomorrows

12:00

CALL TO ACTION
Paving the Path Forward — Critical Next Steps for Access

Conclude the programme by summarising possible actions that can be taken in order to encourage progress. Collaborate to review key action steps discussed over the past day and a half to further accelerate patient access to treatment.

Conversation Contributors:

Beverly Harrison
Head of Patient Support, Office of the Chief Medical Officer
Johnson & Johnson

Greg Tuyteleers
Senior Director, Global Operations Lead,
Managed Access, Medical Affairs Operations
Johnson & Johnson

Solange Rohou
Senior Director, Regulatory Affairs and Policy, EU, AstraZeneca;
Deputy Project Lead, IMI ADAPT SMART

12:45

Close of Conference