Real-World Evidence in Rare Diseases: Accelerating Market Access
Real-World Evidence in Rare Diseases: Accelerating Market Access

Course Description

This unique training focuses on leveraging patient-centric Real-World Evidence (RWE) to accelerate the patient and market access of innovative and potentially transformative Orphan Medicinal Products (OMPs). Delegates will address the challenge of early market access based on fewer and less mature data, with the creation of an Early Value Proposition and a Patient-Centric Evidence Generation Plan that comprehensively support value demonstration, product positioning, and that meet stakeholders’ requirements.
  • Opportunities and Challenges in Orphan Medicinal Products (OMPs)
  • Rare Patient Empowerment & Involvement
  • Real-World Evidence (RWE) Throughout the Value Chain
  • Real-World Case Examples
  • Early Value Proposition and Evidence Generation Planning
  • Next-Generation OMP Market Access Strategies
  • Why are market access opportunities and challenges for OMPs different from other drugs?
  • How to collaborate with patients & caregivers in rare conditions to generate patient-meaningful outcomes?
  • Leveraging applications of RWE for pricing and access success and throughout the lifecycle
  • To mitigate payer uncertainty by addressing the challenge of early market access with accelerated approvals and fewer clinical data
  • How to develop a next-generation market access strategy with a life-cycle full spectrum evidence generation plan that maximizes product value from launch to loss of exclusivity?
  • To differentiate and succeed in the increasingly competitive rare disease space with a ‘fast to patient’ approach

Real-World Evidence in Rare Diseases: Accelerating Market Access

26 - 27 Septeber 2022, Live Online Training
€1.650,00
David Schwicker

David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. Founder of ORPHA Strategy Consulting, and former Vice President with PAREXEL International in the United States. David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access of ATMPs.

Training dates will be announced soon. In meantime, feel free to request an agenda.

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Course Description

This unique training focuses on leveraging patient-centric Real-World Evidence (RWE) to accelerate the patient and market access of innovative and potentially transformative Orphan Medicinal Products (OMPs). Delegates will address the challenge of early market access based on fewer and less mature data, with the creation of an Early Value Proposition and a Patient-Centric Evidence Generation Plan that comprehensively support value demonstration, product positioning, and that meet stakeholders’ requirements.
  • Opportunities and Challenges in Orphan Medicinal Products (OMPs)
  • Rare Patient Empowerment & Involvement
  • Real-World Evidence (RWE) Throughout the Value Chain
  • Real-World Case Examples
  • Early Value Proposition and Evidence Generation Planning
  • Next-Generation OMP Market Access Strategies
  • Why are market access opportunities and challenges for OMPs different from other drugs?
  • How to collaborate with patients & caregivers in rare conditions to generate patient-meaningful outcomes?
  • Leveraging applications of RWE for pricing and access success and throughout the lifecycle
  • To mitigate payer uncertainty by addressing the challenge of early market access with accelerated approvals and fewer clinical data
  • How to develop a next-generation market access strategy with a life-cycle full spectrum evidence generation plan that maximizes product value from launch to loss of exclusivity?
  • To differentiate and succeed in the increasingly competitive rare disease space with a ‘fast to patient’ approach

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

Real-World Evidence in Rare Diseases: Accelerating Market Access

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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