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Regulation and reimbursement of gene and cell-based therapies

Regulation and reimbursement of gene and cell-based therapies

Discipline: Health Technology Assessment Startdatum: In consultation
YearOfStudy: Research master Taal: Dutch, English
Niveau: Master Locatie: In consultation
Looptijd: 6+ months Contact: R.M.T.tenham-2@umcutrecht.nl

Are you a pro-active, independent, and inventive student with an interest in regulation and reimbursement of innovative medicines? We offer several research internships investigating the drug life cycle of gene and cell-based therapies (GCT). GCTs are highly innovative medicines creating new opportunities to treat indications with high unmet medical need, of which many were thought to remain untreatable. Their scientific and clinical novelty combined with high prices cause challenges amongst regulatory authorities and health technology assessment (HTA) bodies responsible with their assessment.

Objective

Our research focusses on drug development evidence generation to inform and steer drug development from a developer, regulator as well as HTA-perspective. We can host multiple students simultaneously throughout the academic year.

Examples of outstanding research projects are:

  • Institutional readiness of regulatory authorities
  • Impact of new guidelines on development of gene and cell-based therapies
  • Role of regulator-imposed post approval studies for development of gene and cell-based therapies
  • Factors influencing (non-)approval of gene and cell-based therapies in Europe
  • Evidence underlying HTA-decisions of gene and cell-based therapies

Methods

Thematic Content Analysis, Qualitative Data Analysis

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