Translational Project Management & Regulatory Affairs
The aim of the Translational Project Management and Regulatory Affairs Unit is to support and facilitate the translation of SR-Tiget innovative and potentially transformative gene therapies programs towards product development, preclinical and clinical development, registration and market/patient access. For programs funded through industrial partnerships or start-ups, the Unit supports the progression of the alliances, while ensuring SR-Tiget preserves its scientific independence and academic nature.
The Unit offers a customized support to research teams and helps building optimized drug development plans integrated with the regulatory requirements to maximize the most suitable opportunities of regulatory engagement aimed at accelerating their development regardless of how the projects are funded (i.e., internal funds, national/international competitive grants, industrial partnerships, start-ups).
The Translational Project Management & Regulatory Affairs Unit supports SR-Tiget with expertise in the following main areas:
- Project Management applied to pharmaceutical drug development;
- Industrial Alliance Management;
- Global and CMC (Chemistry, Manufacturing and Controls) Regulatory Affairs with in-depth expertise in orphan drugs, Advanced Therapy Medicinal Products (ATMP), pediatrics and patient access (including cross-border)
- External CDMO selection, qualification and management for starting materials and drug products.
Translational Project Management activities of the Unit are:
- liaising as primary point of contact with external partners, managing core alliances meetings;
- supervising contracts execution and handle amendments with external CDMOs;
- tracking project milestones, mapping criticalities and elaborate/coordinate resolution plans;
- maintaining overall projects overview by specific development phase (i.e., CMC, preclinical, clinical, registration, market & patient access) and liaise internally with the relevant stakeholders within the 2 partner-organisations;
- managing publications plans regulated by licensed products; manage biological materials chain of custody responsibilities and accompanying quality and technical agreements necessary to accomplish the requirements of the complex and highly regulated supply chain to deliver ATMP in clinics;
- managing patient treatment scheduling.
Specifically, with regards to the Regulatory Affairs activities include:
- support in defining the most suitable regulatory strategy for each gene therapy drug under development.
- support in managing and obtaining the most appropriate regulatory designations/opportunities needed for the specific project progression;
- global and CMC regulatory advise for the development plan, identification and selection of external CDMO (i.e., quality and compliance suitability of the services offered, quality and suitability of starting and raw materials to be used during the clinical manufacturing process by development phase, etc);
- support in defining and implementing the most appropriate early access strategy (i.e. 648 law, 326 law, etc);
- support cross-border patient access across the different legal frameworks.