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Agenda

Navigate Global and Country-Specific Regulations and Reimbursement Models for Early and Expedited Access

May 16-17, 2018
  • Amsterdam, The Netherlands

Agenda

Want more agenda details? Download the brochure.

DAY ONE | Wednesday, 16 May, 2018

7:30

Registration and Continental Breakfast

8:30

Co-Chairs’ Welcome and Opening Remarks

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

Michael Zaiac
Head of Medical Affairs Haematology/Oncology EMEA
Celgene

8:45

Nomenclature Clarification —
What do All the Different Terminologies Mean?

Alison Bateman-House
Assistant Professor, Division of Medical Ethics
NYU School of Medicine

Global and Country-Specific Regulations

9:15

Overview of the Regulatory Framework of Expanded Access in the U.S.

Richard Klein
Former Patient Liaison Program Director
FDA

10:00

Networking and Refreshment Break

10:30

Navigate Regulatory and Policy Updates in Europe

Pedro Franco
Director, Europe for Global Regulatory and Scientific Policy, Merck Serono;
formerly with EMA

11:15

COUNTRY-SPECIFIC CASE STUDY Examine Compassionate Use in Switzerland

Carole-Anne Baud, MLaw
PhD Candidate
University of Geneva

11:45

GLOBAL THINK TANK Brainstorm Challenges and Troubleshoot Solutions for Global Managed Access Programmes

Moderator:

Brian J. Fisher
Vice President, Operations and Corporate Partnerships
The Sturge-Weber Foundation

Panelists:

Patrick Hopkinson
Executive Director, WWHEOR Markets
Bristol-Myers Squibb Pharmaceuticals

Stephan Toutain
Former Chief Commercial Officer
Interleukin Genetics

12:30

Networking Luncheon

Optimise Patient Access through Education
and Resources for all Stakeholders

13:45

PATIENT ADVOCACY SPOTLIGHT Advocacy through the Entire Process —
Patient Voice in Research, Legislation and Accelerated Pathways

Conversation Contributors:

Brian J. Fisher,
Vice President, Operations and Corporate Partnerships
The Sturge-Weber Foundation

Jennifer Mcnary
Board Member, Beauhawks Foundation;
Manager, JMcNary Consulting

14:30

CASE STUDY Joint Presentation on Transforming Pre-Approval Access

I. CompAC — Lessons Learned and Next Steps

II. Ethical Considerations for Running an Early Access Programme

Alison Bateman-House
Assistant Professor, Division of Medical Ethics
NYU School of Medicine

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

15:15

Networking and Refreshment Break

15:45

Developing an Internal Procedure for Managed Access at Novartis

Samantha Nunes Radimerski, PhD
Medical Governance Lead, Managed Access Programs,
Global Drug Development – Chief Medical Office,
Novartis Pharma AG

16:30

PARTNERSHIP PAVILION Partner with Key Stakeholders to Overcome Roadblocks to Optimise Patient Access

Conversation Contributors:

Edith P. Mitchell, MD, FACP, FCPP
Clinical Professor, Medicine and Medical Oncology,
Associate Director, Kimmel Cancer Center
Thomas Jefferson University

Brian J. Fisher
Vice President, Operations and Corporate Partnerships
The Sturge-Weber Foundation

Jennifer Mcnary
Board Member, Beauhawks Foundation;
Manager, JMcNary Consulting

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

Alison Bateman-House
Assistant Professor, Division of Medical Ethics
NYU School of Medicine

17:15

Close of Day One

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

DAY TWO | Thursday, 17 May, 2018

8:00

Continental Breakfast

8:30

Conference Co-Chairs’ Review of Day One

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

Michael Zaiac
Head of Medical Affairs Haematology/Oncology EMEA
Celgene

Leading Frameworks for Accelerated Pathways

8:45

Access Programmes for Next Generation Treatments —
Future of Gene Therapy

Jim Thomson
Gene Therapy Global Launch Manager, Rare Diseases,
GSK

9:30

PROGRAMME SPOTLIGHT Inside Look at a Successful Managed Access Programme

Michael Zaiac
Head of Medical Affairs Haematology/Oncology EMEA
Celgene

10:15

Networking and Refreshment Break

10:45

Industry Paradox —
The Earlier the Access, the Harder the Reimbursement

Omar Ali
Visiting Lecturer, Value Based Pricing, University of Portsmouth;
Former Adviser, NICE

11:30

Evaluate Country-Specific Reimbursement Models —
UK, Germany, France, Italy and Switzerland

Conversation Contributors:

Omar Ali
Visiting Lecturer, Value Based Pricing, University of Portsmouth;
Former Adviser, NICE

Carole-Anne Baud, MLaw
PhD Candidate
University of Geneva

12:15

Networking Luncheon

13:30

Changing Incentives —
Real World Data Generation within Early Access Programmes

Tom Watson
Executive Director
TW Consulting Group LLC

14:15

THERAPEUTIC-SPECIFIC TABLE TALKS Shine Light on Company-Specific Strategies

Omar Ali
Visiting Lecturer, Value Based Pricing, University of Portsmouth;
Former Adviser, NICE

15:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE | Wednesday, 16 May, 2018

7:30

Registration and Continental Breakfast

8:30

Co-Chairs’ Welcome and Opening Remarks

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

Michael Zaiac
Head of Medical Affairs Haematology/Oncology EMEA
Celgene

8:45

Nomenclature Clarification —
What do All the Different Terminologies Mean?

Alison Bateman-House
Assistant Professor, Division of Medical Ethics
NYU School of Medicine

Global and Country-Specific Regulations

9:15

Overview of the Regulatory Framework of Expanded Access in the U.S.

Richard Klein
Former Patient Liaison Program Director
FDA

10:00

Networking and Refreshment Break

10:30

Navigate Regulatory and Policy Updates in Europe

Pedro Franco
Director, Europe for Global Regulatory and Scientific Policy, Merck Serono;
formerly with EMA

11:15

COUNTRY-SPECIFIC CASE STUDY Examine Compassionate Use in Switzerland

Carole-Anne Baud, MLaw
PhD Candidate
University of Geneva

11:45

GLOBAL THINK TANK Brainstorm Challenges and Troubleshoot Solutions for Global Managed Access Programmes

Moderator:

Brian J. Fisher
Vice President, Operations and Corporate Partnerships
The Sturge-Weber Foundation

Panelists:

Patrick Hopkinson
Executive Director, WWHEOR Markets
Bristol-Myers Squibb Pharmaceuticals

Stephan Toutain
Former Chief Commercial Officer
Interleukin Genetics

12:30

Networking Luncheon

Optimise Patient Access through Education
and Resources for all Stakeholders

13:45

PATIENT ADVOCACY SPOTLIGHT Advocacy through the Entire Process —
Patient Voice in Research, Legislation and Accelerated Pathways

Conversation Contributors:

Brian J. Fisher,
Vice President, Operations and Corporate Partnerships
The Sturge-Weber Foundation

Jennifer Mcnary
Board Member, Beauhawks Foundation;
Manager, JMcNary Consulting

14:30

CASE STUDY Joint Presentation on Transforming Pre-Approval Access

I. CompAC — Lessons Learned and Next Steps

II. Ethical Considerations for Running an Early Access Programme

Alison Bateman-House
Assistant Professor, Division of Medical Ethics
NYU School of Medicine

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

15:15

Networking and Refreshment Break

15:45

Developing an Internal Procedure for Managed Access at Novartis

Samantha Nunes Radimerski, PhD
Medical Governance Lead, Managed Access Programs,
Global Drug Development – Chief Medical Office,
Novartis Pharma AG

16:30

PARTNERSHIP PAVILION Partner with Key Stakeholders to Overcome Roadblocks to Optimise Patient Access

Conversation Contributors:

Edith P. Mitchell, MD, FACP, FCPP
Clinical Professor, Medicine and Medical Oncology,
Associate Director, Kimmel Cancer Center
Thomas Jefferson University

Brian J. Fisher
Vice President, Operations and Corporate Partnerships
The Sturge-Weber Foundation

Jennifer Mcnary
Board Member, Beauhawks Foundation;
Manager, JMcNary Consulting

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

Alison Bateman-House
Assistant Professor, Division of Medical Ethics
NYU School of Medicine

17:15

Close of Day One

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

DAY TWO | Thursday, 17 May, 2018

8:00

Continental Breakfast

8:30

Conference Co-Chairs’ Review of Day One

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

Michael Zaiac
Head of Medical Affairs Haematology/Oncology EMEA
Celgene

Leading Frameworks for Accelerated Pathways

8:45

Access Programmes for Next Generation Treatments —
Future of Gene Therapy

Jim Thomson
Gene Therapy Global Launch Manager, Rare Diseases,
GSK

9:30

PROGRAMME SPOTLIGHT Inside Look at a Successful Managed Access Programme

Michael Zaiac
Head of Medical Affairs Haematology/Oncology EMEA
Celgene

10:15

Networking and Refreshment Break

10:45

Industry Paradox —
The Earlier the Access, the Harder the Reimbursement

Omar Ali
Visiting Lecturer, Value Based Pricing, University of Portsmouth;
Former Adviser, NICE

11:30

Evaluate Country-Specific Reimbursement Models —
UK, Germany, France, Italy and Switzerland

Conversation Contributors:

Omar Ali
Visiting Lecturer, Value Based Pricing, University of Portsmouth;
Former Adviser, NICE

Carole-Anne Baud, MLaw
PhD Candidate
University of Geneva

12:15

Networking Luncheon

13:30

Changing Incentives —
Real World Data Generation within Early Access Programmes

Tom Watson
Executive Director
TW Consulting Group LLC

14:15

THERAPEUTIC-SPECIFIC TABLE TALKS Shine Light on Company-Specific Strategies

Omar Ali
Visiting Lecturer, Value Based Pricing, University of Portsmouth;
Former Adviser, NICE

15:00

Close of Conference