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05 - 07 November, 2019 | Hilton London Olympia , London, United Kingdom

Conference Day Two

9:30 am - 9:40 am Chairperson's Opening Address

Anne Cropp Pharm.D., Chief Scientific Officer at Early Access Care LLC

Anne Cropp Pharm.D.

Chief Scientific Officer
Early Access Care LLC

9:40 am - 10:20 am Considering the Future of Early Access Programmes

  • Analyse how expanded access to customisable therapies differ to traditional small molecule early access programmes
  • One Chance: Explore the ethics associated with patient selection for therapies that induce an immune response
  • Consider the legal and ethical implications of granting pre-approval to prodromal or early-stage patients who do not meet the criteria for clinical trials, using Alzheimer's Disease as an example
Alison Bateman-House, Co-Chair at NYU Working Group on Compassionate Use and Preapproval Access (CUPA)

Alison Bateman-House

Co-Chair
NYU Working Group on Compassionate Use and Preapproval Access (CUPA)

10:20 am - 11:00 am Early Access to Treatment. More Than Just EAP

Geof Fatzinger, Global Regulatory & Market Access Expert at Caligor Coghlan

Geof Fatzinger

Global Regulatory & Market Access Expert
Caligor Coghlan

11:00 am - 11:30 am Networking Break

11:30 am - 12:10 pm Identifying and Implementing Early Access Programme Regulatory Strategies for Orphan Drugs

Karen Frascello, Director, Global Medical Affairs, Early Access at Alnylam Pharmaceuticals

Karen Frascello

Director, Global Medical Affairs, Early Access
Alnylam Pharmaceuticals

The collection and use of Real World Data divides opinion, not just within the pharmaceutical industry but also between stakeholders. Join us as we demonstrate the diverse perspectives of various stakeholders as we debate the value of Real World Evidence.  
 
The human spectrogram allows all delegates to present their view on this contentious topic by voting with their feet. At the start of the debate, delegates will move to the corner of the room that most aligns with their view on Real World Evidence. We will then conduct  the debate. Following the panel discussion, the delegation will be invited to vote again, allowing us to reflect on how our views have changed.
 
 
Topics of Discussion:
  • Consider the perspective of multiple stakeholders in the collection of real world evidence
  • Understand how this information can be contextulised in a wider clinical trial via the integration of data in a combined study approach
  • Explore how real world evidence affects later submissions for re-imbursement 
Sjaak Vink, CEO at TheSocialMedwork

Sjaak Vink

CEO
TheSocialMedwork

Michael Mittelman, Chairman, American Living Organ Donor Fund, Ambassador and Rare Disease Patient, at Patient-Center Outcomes Research Institute (PCORI)

Michael Mittelman

Chairman, American Living Organ Donor Fund, Ambassador and Rare Disease Patient,
Patient-Center Outcomes Research Institute (PCORI)

Dr. Philipp Schlatter, Community of Practice Leader, Post Trial Access & Drug Supply at Roche

Dr. Philipp Schlatter

Community of Practice Leader, Post Trial Access & Drug Supply
Roche

12:40 pm - 1:40 pm Networking Lunch

Thomas Strong, HTA Adviser - Managed Access (Cancer Drugs Fund) at NICE - National Institute for Health and Care Excellence

Thomas Strong

HTA Adviser - Managed Access (Cancer Drugs Fund)
NICE - National Institute for Health and Care Excellence

Robert Fernley, Programme Manager - Early Access to Medicines Scheme at NHS England

Robert Fernley

Programme Manager - Early Access to Medicines Scheme
NHS England

2:20 pm - 3:00 pm Taking Patient-Centricity Seriously by Creating an Evolved Healthcare Ecosystem for Everyone, Everywhere

  • Deep-dive into the reality of healthcare access around the world
  • Explore how The Social Medwork are streamlining the process and navigating regulations in more than 75 countries
  • What does the future of health access look like? The interconnected ecosystem where all healthcare stakeholders (patients, carers, HCP’s, pharma, health advocates, politicians, policy makers, technologists, etc.) come together
Sjaak Vink, CEO at TheSocialMedwork

Sjaak Vink

CEO
TheSocialMedwork

3:00 pm - 3:20 pm Troubleshooting Quiz!

Check you've remembered the most important lessons from the last 2 days!

3:20 pm - 3:40 pm Chairperson's Closing Address

Anne Cropp Pharm.D., Chief Scientific Officer at Early Access Care LLC

Anne Cropp Pharm.D.

Chief Scientific Officer
Early Access Care LLC