Post-Conference Workshop Day
9:00 am - 11:00 am Patient Perspective: Maximising Patient Engagement Across the Time-Line of an Early Access Programme
Patients are at the heart of every Early Access Programme. With growing influence in the development of regulatory guidelines, now is the time to engage your patients in the evolution of your Early Access Programme.
Explore the benefits of patient-centricity across the timeline of an Early Access Programme, deep-diving into the opportunities that arise by bringing the voice of the patient to the development of future programmes, with respect to commercialisation and market access strategies.
- Improve your understanding of how patient engagement helps shape market access as part of your commercialization strategy
- Highlight the benefits of working collaboratively with patients at the preparatory stages of your Early Access Programme, with the view to maximize patient uptake
- Analyse the positive business implications of patient engagement beyond your Early Access Programme and the clinical trial by cooperating on close-out planning
- Explore the work of PCORI within the industry and analyse the growing influence of Patient Advocacy groups and patients on regulatory change
Michael MittelmanChairman, American Living Organ Donor Fund, Ambassador and Rare Disease Patient,
Patient-Center Outcomes Research Institute (PCORI)
Dr. Amy PricePatient Editor Research and Evaluation & CEO
The BMJ & Empower2Go
Ataxia and Me
11:30 am - 3:00 pm Mapping the Operational Challenges Encountered During a Complete Early Access programme, From Early Planning to Close Out
Delivering an Early Access Programme is a complex challenge, where too often the unforeseen regulatory or operational obstacles can inhibit a patient’s access to treatment. From the creation of company-wide criteria for processes and governance structures for assessing Named Patient Requests, to understanding key performance indicators, each milestone can become daunting.
Overcome the principle challenges faced from early planning to close out of an Early Access Programme by utilising the tips and tricks of Janssen, the only company world-wide to entirely centralise their Early Access Programmes, to ensure you maintain regulatory compliance throughout the timeline of an Early Access Programme.
- Assess the different operational support models and criteria to assess the model that will best fit the needs of your company
- Understand the criteria for successful management and execution of Managed Access programs
- Define the roles of various stakeholders involved across the timeline of a Managed Access Programme
- Address the operational challenges in the execution of Managed Access Programmes and consider potential mitigations
- Re-imagine the tools you are using to support the execution of Managed Access Programmes by engaging in a technology demonstration of a Software-as-a-Service platform for end-to-end management of a Managed Access Programme
Gregory TuyteleersGlobal Operations Lead - Managed Access
Torunn ThingstadClinical Operations lead for Managed Access