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22 - 24 October, 2018 | London, UK

Agenda Day 2

8:30 am - 9:00 am Morning Registration and Coffee

9:00 am - 9:10 am Chairman’s Opening Remarks

9:10 am - 9:50 am International Keynote: The US Patient Perspective on Expanded Access

Andra Stratton - President & Co-Founder, Professional Patient Advocate & Rare Leader Lipodystrophy United
  • Incorporate the patient advocacy perspective to develop a review process and formalised procedure on expanded access
  • Recognise actionable steps to optimising patient access
  • Discuss working with patient groups to help demystify pre-approval access and create community-specific resources
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Andra Stratton

President & Co-Founder, Professional Patient Advocate & Rare Leader
Lipodystrophy United

  • Discuss how to optimise relationships with caregivers, clinicians and healthcare providers
  • Explore ways to work effectively with patient advocacy groups
  • Get to grips with patient centricity and understand how it can benefit pharma manufacturers
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Anne Bruns

Rare Disease Advocate and Board Member
Rare & Undiagnosed Network RUN

10:30 am - 11:00 am Morning Coffee Break

11:00 am - 11:40 am Local Perspectives: The EU Patient Perspective on Expanded Access

Thomas Smith - Rare Disease Advocate, Parliamentarian and Committee Member European Health Parliament
  • Learn best practice on collaboration between manufacturer and patient from a EU perspective
  • Optimise your working relationships with key European stakeholders such as policy makers, NGOs, and the media
  • Understand the decision making process behind European policies
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Thomas Smith

Rare Disease Advocate, Parliamentarian and Committee Member
European Health Parliament

  • Soliciting input - the rare disease patient advocates perspective on the process of accessing treatment in EMAPs
  • Understand the tools/recourses and practices to best promote awareness/education with patients
  • Discover the key challenges faced by patients seeking early access and suggested ways for medicines manufacturers to help overcoming these
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Anne Bruns

Rare Disease Advocate and Board Member
Rare & Undiagnosed Network RUN

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Thomas Smith

Rare Disease Advocate, Parliamentarian and Committee Member
European Health Parliament

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Andra Stratton

President & Co-Founder, Professional Patient Advocate & Rare Leader
Lipodystrophy United

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Shannon Burkoth

Rare Disease & Narcolepsy Advocate, Program Mentor
Rare Advocacy Movement (RAM)

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Simon Stones

Trustee and Patient Leader
Fibromyalgia Action UK

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Nadia Bodkin

Senior Executive Vice President
MaxifyLife

12:40 pm - 1:40 pm Networking Lunch Break

1:40 pm - 2:20 pm RWE Acquisition – Collaboration and Investment from Healthcare Providers

Ramona Reichenbach - Global Medical Governance Lead – Global Governance Office Novartis Pharma AG
  • Formulate standards for RWD collected on patient health status and/or the delivery of healthcare
  • Develop the expertise needed to design and implement RWE studies
  • Engage in pre-competitive collaborations to define best practices
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Ramona Reichenbach

Global Medical Governance Lead – Global Governance Office
Novartis Pharma AG

2:20 pm - 3:00 pm Adding Value by Utilising RWD from Managed Access Programmes in Conjunction with Clinical Trial Data

Tom Watson - Executive Vice President, Early Access Programs Bionical
  • Create greater precision and clarity as to the safety and efficacy profile of new products
  • Improve the amount and quality of information available to patients and physicians, leading to more informed decision-making about new products
  • Demonstrate benefit: examination of real-world use of products may accelerate the rate at which products prove their value to patients, providers and payers, supporting reimbursement with real-world evidence
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Tom Watson

Executive Vice President, Early Access Programs
Bionical


3:00 pm - 3:30 pm Afternoon Coffee Break

3:30 pm - 4:10 pm Managing the Whole Process of Running Early and Manages Access Programmes

Kenneth Moch - President & CEO Cognition Therapeutics
  • Define operational excellence criteria and understand supply logistics from a manufacturers point of view
  • Manage collaboration with patients, patient advocacy groups and caregivers
  • Implement end-to-end operational excellence strategies
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Kenneth Moch

President & CEO
Cognition Therapeutics

  • Discuss the requirements for policy harmonisation globally and terminology education across
  • Define strategy for implementing data capture protocols and making use of RWD by also taking into account the Patient and Clinician input
  • Discuss the most efficient path to manufacturer and patient collaboration
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Samantha Nunes Radimerski

PhD, Medical Governance Lead, Managed Access Programs, Chief Medical Office
Novartis Pharma AG

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Pedro Franco

Director Europe, Global Regulatory & Scientific Policy (GRASP)
Merck Serono

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Ramona Reichenbach

Global Medical Governance Lead – Global Governance Office
Novartis Pharma AG

4:50 pm - 5:00 pm Chairman’s Closing Remarks