Main Conference Day 1

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

8:50 AM - 8:55 AM Welcome from Pharma IQ

8:55 AM - 9:00 AM Chairman’s Opening Remarks

9:00 AM - 9:45 AM Creating a Strategy for Successful Early Access Programs

Manuel Quaresma, Senior Global Medical Advisor, Boehringer Ingelheim
  • “Starting from scratch” – considering your programme parameters
  • Examine key implementation criteria and how it will shape your programme
  • Create programme protocol and devise an effective stakeholder treatment agreements


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Manuel Quaresma

Senior Global Medical Advisor
Boehringer Ingelheim

9:45 AM - 10:30 AM Ethical Considerations of Running an Early Access Programme

Alison Bateman-House, Assistant Professor – Division of Medical Ethics, NYU
  • Understand the importance transparency plays in running an Early or Managed Access Programme
  • Assess ethical considerations that arise from a variety of EAP pathways to choose which one best suits your company
  • Gain clarity on the fairness of EAP patient and drug distribution

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Alison Bateman-House

Assistant Professor – Division of Medical Ethics
NYU

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

11:00 AM - 11:45 AM CompAc - Lessons Learned and Next Steps

Beverly Harrison, Head, Patient Support , Johnson and Johnson
  • Gain an understanding of how NYU and J&J developed an industry tool to maximise ethical distribution of patient treatment, and look ahead to possible European application
  • Analyse CompAc as a best practice model to address ethical considerations
  • Capitalise on the lessons learned by J&J and look ahead to the next steps for CompAc development

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Beverly Harrison

Head, Patient Support
Johnson and Johnson

11:45 AM - 12:30 PM Understanding the Role of Patient Advocacy Groups within Early Access Programmes

Lindsay Weaver, CEO, CLIMB Vee Mapunde, Associate Consumer Lead, National Cancer Research Institute (NCRI)
  • Uncover the advantages of partnering with patient groups to support your Early Access Programme
  • Realise the importance of considering the patient treatment plan when examining the cost/benefit ratio of EMAPs
  • Create an effective channel of communication for patient, physician and supplier
  • Discover new ways to successfully manage patient and caregiver interactions in difficult times

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Lindsay Weaver

CEO
CLIMB
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Vee Mapunde

Associate Consumer Lead
National Cancer Research Institute (NCRI)

12:30 PM - 1:30 PM Networking Lunch

1:30 PM - 2:15 PM Controlling the Uncontrollable – Managing the Influence of External Environmental Factors

Anne B. Cropp, Chief Scientific Officer, Early Access Care
  • Understand the importance of establishing and maintaining your own company policy in the social media age
  • Identify key risk mitigation strategies for EAPs
  • Address and react effectively to setbacks in an environment controlled by external factors

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Anne B. Cropp

Chief Scientific Officer
Early Access Care

2:15 PM - 3:00 PM Defining Access – Considering the Role of the Patient, Physician and Pharmaceutical Industry in EMAPs

Richard Evans, Founder, NexGen Healthcare Communications
  • Finding a definition of Access that incorporates the role of all EMAPs
  • Discuss how to manage the role of all three stakeholders
  • “The Elephant in the Room” – understand complications and risks you could face when managing these stakeholder relationships

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Richard Evans

Founder
NexGen Healthcare Communications

3:00 PM - 3:45 PM Afternoon Tea and Networking

  • Define consent in the pharmaceutical space
  • Examine the requirements of ‘informed’ consent, and discuss the most effective ways to achieve this
  • Address the importance of active consent for ongoing patient treatment

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Dr Kieran Doran

Senior Legal Practitioner and Healthcare Ethics Lecturer
University College Cork

4:30 PM - 5:15 PM Right to Try Act and its Implications for Patients, Physicians and Pharmaceutical/Biotech Companies

Richard Evans, Founder, NexGen Healthcare Communications Dr Kieran Doran, Senior Legal Practitioner and Healthcare Ethics Lecturer, University College Cork
  • Discuss the shift towards patient-centric treatment models
  • Debate how early is too early for patient treatment to be ethical?
  • Identify the risks the Right to Try law poses to novel drug development

Richard Evans

Founder
NexGen Healthcare Communications

Dr Kieran Doran

Senior Legal Practitioner and Healthcare Ethics Lecturer
University College Cork

5:15 PM - 5:30 PM Chairman's Closing Remarks and End of Day One