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22 - 24 October, 2018 | Hallam Conference Centre, United Kingdom

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

9:50 am - 10:20 am Stakeholder Relationship Management

Nadia Bodkin - Senior Executive Vice President, MaxifyLife
  • 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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Nadia Bodkin

Senior Executive Vice President
MaxifyLife

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

  • 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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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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Nadia Bodkin

Senior Executive Vice President
MaxifyLife

11:45 am - 12:25 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


12:25 pm - 12:40 pm Real World Data Round Tables

Tom Watson - Executive Vice President, Early Access Programs, Bionical
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Tom Watson

Executive Vice President, Early Access Programs
Bionical

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

1:40 pm - 2:40 pm Transforming Expanded Access to Maximize Support and Study (TEAMSS): A Plan to Create a National Network for Expanded/ Early Access in the United States

Kevin Weatherwax - Managing Director, Michigan Medicine
- Development of a national network that will demonstrate successful multisite integration of Expanded/Early Access programs
- Develop a network for cohort-based Expanded/Early Access programs
- Create a database to standardize Expanded/Early Access data reporting and develop a body of real-world data
- Dissemination of Expanded/Early Access best practices
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Kevin Weatherwax

Managing Director
Michigan Medicine

2:45 pm - 3:25 pm Dilemmas in Early Access, from the Perspective of Smaller Enterprises

Hartwig Gajek - Managing Director, Hesyra-Medical GmbH
  • Create successful global regulatory strategies for early access programmes with the resources of an SME
  • Analyse the differences in national requirements
  • Discover how your peers are complying on a global scale
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Hartwig Gajek

Managing Director
Hesyra-Medical GmbH

3:20 pm - 4:00 pm Ethical Crossroads: Expanded Access, Patient Advocacy and the #SaveJosh Social Media Campaign

Kenneth Moch - President & CEO, Cognition Therapeutics
- Perspectives and learning experiences from the CEO at the center of the 2014 social media campaign for pre-approval access to
Chimerix’s investigational antiviral drug
- Discussion of the ethical dilemmas surrounding expanded access
- Application of these lessons to future EAPs, and advice for companies looking to be well prepared
- Implications from US Right to Try Legislation
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Kenneth Moch

President & CEO
Cognition Therapeutics

4:10 pm - 4:40 pm Chairman’s Closing Remarks