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Dr Romina Oxborough
Director, Clinigen Consulting

Harnessing Early Access Programs for Real-World Evidence & Insights


Ever-increasing pressures being placed on healthcare budgets means that only those treatments offering the greatest value in routine clinical practice will be reimbursed, yet evidence of a product’s effectiveness – or value – will truly only come once reimbursement has been achieved and the product used in everyday practice. The challenge for pharma, therefore, is to seek ways in which to maximise the evidence available to support the value demonstration for their product ahead of pricing and reimbursement negotiations.

Whether you’re in a clinical, medical, patient-focused or commercial role, there has never been a greater appetite – or more pressing need – for real-world evidence and insights that can be exploited for internal decision making and also to support local submissions.

This webinar will discuss the unique opportunity to capture real-world data on products used in the pre-approval setting, explore the nature of the data that can be collected and describe how such data can be used to generate additional evidence and insights ahead of launch.

Don’t miss the chance to learn more about how and why RWD collection is increasingly being incorporated within Early Access Programs and the value this can bring to your organisation. Register here to join our free webinar.

Presented by

Dr Romina Oxborough,

Director, Clinigen Consulting

Romina has a wealth of experience in the managed access/early access field having advised biopharmaceutical companies on policy, strategy and operationalization of programs to provide ethical, fair and compliant supply for many years. She has extensive experience in Drug Safety and Medical Information having been responsible for those functions before her present position.  Romina currently heads an international team of consultants and data experts. In addition to providing consultancy services, her team supports the strategy and implementation of Real World Evidence generation during the lifecycle of their Client’s assets. Romina holds a PhD and an MBA and has co-authored over 20 international peer-reviewed publications and several conference abstracts and presentations.


Lucia von Bredow,

Patient Advocacy Manager

Lucia has substantial experience of devising patient engagement strategies in the area of access to medicines, and has a background as a commercial lawyer in the healthcare and life sciences field. She has worked across a variety of therapeutic areas on both sides of the table – advising industry, but also representing a number of patient advocacy groups throughout the R&D pipeline. She comes to Clinigen from a medical research charity, where she was Head of Stakeholder Relations in the Medical Directorate.  She thus has vast experience of representing the patient interest in a global context, and has an insider view of the challenges and opportunities patient advocacy presents. In addition to holding an LLB in Law, a Postgraduate Diploma in Legal Practice (Law School), and with experience as a qualified Solicitor, Lucia also has a Masters of Law in European and International Business Law (an LLM focussing on Intellectual Property in R&D), and a postgraduate qualification in Bioethics (medical ethics and data sharing). 

Learning objectives
  • Awareness of the role that Managed Access Programs play in the development of a new therapeutic
  • Understand the unique opportunity that exists to collect product-related RWD pre-launch
  • Explore the utility of RWD collected as part of a Managed Access Program
  • Head of Medical Affairs
  • Chief Medical Officer
  • Head of Clinical Development
  • Directors
  • Head of Safety
  • Head of Regulatory
  • Chief Compliance Officer
  • Medical Director
  • Head of Investigator Initiated Studies
  • Head of Investigator Sponsored Studies
  • Head of Clinical Trial Supply
  • Head of Strategic Sourcing
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