Main Conference Day 2

8:00 AM - 8:50 AM Registration and Networking Coffee - Meet and Greet

8:50 AM - 9:00 AM Chairman's Opening Remarks and Day One Summary

9:00 AM - 9:45 AM Translating the Impact of the 21st Century Cures Act into a European Framework

David Farber, FDA Life Sciences Partner, King & Spalding
  • Clarify the US Pharmaceutical Industry Requirements in light of the 21st Century Cures Act
  • Discuss the role of the 21st Century Cures Act in European Market development and governance
  • Prepare for a move towards ‘Global Compliance’ – discuss the European response to the 21st Century Cures Act

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David Farber

FDA Life Sciences Partner
King & Spalding

9:45 AM - 10:30 AM Regulatory Complexity Within a European Framework

Katalin Kovacs, Regulatory Operation Liaison, Europe, Bristol-Meyers Squibb
  • Examine the European regulatory landscape and assess the challenge of country specific regulations
  • Develop an understanding of the patient implications from country specific regulations
  • Where are we moving? Analyse the challenges taking an European harmonization or country specific direction. i.e. Article 83

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Katalin Kovacs

Regulatory Operation Liaison, Europe
Bristol-Meyers Squibb

10:30 AM - 11:00 AM Morning Coffee and Networking

11:00 AM - 11:45 AM Preparing your Pathway – the Regulatory Landscape and its Role in Programme Development

Lincoln Tsang, Partner, Arnold & Porter Kaye Scholer LLP
  • Understand the U.K regulatory landscape within an EU context
  • Analyse the European regulatory landscape – is it a support or deterrent for R&D
  • Manage the costs of patient access outside of nationally approved framework
  • Identify and mitigate potential European challenges in the light of Brexit

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Lincoln Tsang

Partner
Arnold & Porter Kaye Scholer LLP

11:45 AM - 12:30 PM Changing-up our Perspective – a Look at the Barriers to Innovative Technological Developments

Michael Seres, Founder and CEO, 11Health
  • Hear a case study on barriers to technological innovation and access within the patient device industry
  • Compare the U.K and U.S route to patient and market access for technological innovations
  • Move towards an outcomes based model – identify the changes we need to see now

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Michael Seres

Founder and CEO
11Health

12:30 PM - 1:30 PM Networking Lunch

  • Discuss unexpected difficulties and challenges around named patient request within clinical development
  • Manage parallel market access programmes: challenges from commercialisation while fulfilling named patient requests
  • Discuss key learnings from prior named patient program initialization

1:30 PM - 2:15 PM How to Manage Named Patient Access Requests within a Clinical Trial

Leigh-Anne Blaire, Senior Director - Clinical Operations, Onconova Therapeutics Inc
  • Discuss unexpected difficulties and challenges around named patient request within clinical development
  • Manage parallel market access programmes: challenges from commercialisation while fulfilling named patient requests
  • Discuss key learnings from prior named patient program initialization

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Leigh-Anne Blaire

Senior Director - Clinical Operations
Onconova Therapeutics Inc

2:15 PM - 3:00 PM Managing the Developmental Path of Early Access Programmes

  • Can EAPs be incorporated in the late phase clinical trial, medical affairs and clinical development strategies?
  • Discuss the challenges in addressing needs from patients, clinicians, payers, regulators and industry with EAPs and clinical trials
  • Identify common complications in designing, executing and closing worldwide EAPs

3:00 PM - 3:30 PM Afternoon Tea and Networking

3:30 PM - 4:15 PM Creating a Sustainable EAP to Support your Clinical Development

Alexander Bastian, Head, Global Value, Access, & Pricing, Incyte
  • Examine the fit and impact of an EAP in Clinical Trial Development
  • Discover how to set up a sustainable Early Access Programme through the implementation of guidelines and restrictions
  • Translate your EAP findings into ‘Real World’ Data to support an application for Market Approval

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Alexander Bastian

Head, Global Value, Access, & Pricing
Incyte
  • Identify potential ramifications of closing you EMAP
  • Understand the importance of managing your patient transition
  • Minimise your risk – discuss strategies to manage your external profile and safety profile in the face of programme closure

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Mariangela Demarcus

Associate Director, Managed Access Programs, Ph IV & Medical Strategy
Vertex Pharmaceuticals

5:00 PM - 5:15 PM Chairman's Closing Remarks and End of Main Conference