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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 - 10:15 am Exploring Regulatory Disparity: A Comparative Assessment of the Belgian and Dutch Approach to Early Access Programmes

  • Analyse the lack of consistency in terminology and processes for Early Access Programs in Europe
  • Explore the regulations of the Netherlands and Belgium, as an example the diverse regulatory landscape
  • Discuss effects and approach to regional disparity 
Paul Lacante, Medical Director Benelux at Bristol-Myers Squibb

Paul Lacante

Medical Director Benelux
Bristol-Myers Squibb

10:15 am - 10:50 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)

10:50 am - 11:20 am Networking Break

11:20 am - 11:55 am Understanding the FDA Approach to Expanded Access and Project Facilitate

  • Deep-dive into the new FDA pilot project ‘Facilitate’, analysing how the project will influence your Early Access Programme and relationship with the regulator
  • Help push the Industry Forward: Understand responsibilities under U.S. expanded access rules, transparency, and how to communicate with patients about access programmes 
  • Explore the social and political influences that are currently directing US legislation, spotlighting the ‘Right-to-Try’ Movement and what we might expect of future policy and regulations
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 
Ramona Reichenbach, Global Medical Governance Lead – Managed Access Programs (MAPs) at Novartis

Ramona Reichenbach

Global Medical Governance Lead – Managed Access Programs (MAPs)
Novartis

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)

1:40 pm - 2:40 pm Networking Lunch

1:40 pm - 2:15 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

2:15 pm - 2:50 pm Building a Case for Reimbursement and Engaging with Payers

  • Gain insight into the uncertainty surrounding the critical factors that influence reimbursement decisions on orphan drugs
  • Explore how Early Access Programmes can be used as a mechanism for managing risk while enabling potentially beneficial drugs and the impact this has on reimbursement
  • Understand the variation in reimbursement strategies from payers across Europe

2:50 pm - 3:20 pm Networking Break

3:20 pm - 3:55 pm Collaborating with Patients and Patient Advocacy Groups in the Social Media Age

  • Analyse how increasingly educated and empowered patients and patient advocacy groups use of the internet and social media has lead to their growing acceptance as key stakeholders in the regulatory process
  • Develop an effective ‘reactive communication’ strategy to  prepare for requests of information through the channels of Physicians, Managed Access Programme Providers and social media
  • Understand the necessity  for Pharma companies to balance requests for treatment with the need to protect patient safety and continuing the drug development process, as the number Named Patient Requests grows

3:55 pm - 4:40 pm Troubleshooting Clinic

Bring your unsolvable challenges and unanswered questions to the forefront of the industry in a Q&A with our Expert Speaker Faculty

4:40 pm - 5:00 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