EATRIS offers a multitude of expert services to our members, including Regulatory advice. Here is feedback from EATRIS member Bellvitge Biomedical Research Institute (IDIBELL) from a recent service provided by one of EATRIS experts in Regulatory Science, Nadina Grosios.
IDIBELL is currently developing the “Heptammune” project, an innovative biological drug aimed at reprogramming the immune system to tackle hyperinflammation and immune dysregulation in autoimmune diseases, with a particular focus on inflammatory bowel disease. The project is led by Dr. Josep Maria Aran and supported by IDIBELL’s Business Development and Innovation Area. To accelerate the preclinical development and regulatory planning for Heptammune, IDIBELL sought support from EATRIS. EATRIS engaged regulatory expert Nadina Grosios, leveraging her extensive experience in drug development and regulatory affairs, to provide strategic guidance and planning for the project.
Scope of Consultancy Services Provided by Nadina Grosios
- Strategic Retreat:
IDIBELL organised and led a full-day, in-person strategic meeting with the entire project team to facilitate key decision-making. Nadina participation was key for the success of the event and the definition of strategic decisions. - Program Planning:
Developed a detailed timeline (chronogram) for the Heptammune program, outlining key activities and milestones leading up to the submission of a Clinical Trial Application (CTA). - Comprehensive Development Plan:
Delivered a development plan for Heptammune, covering the overall strategy up to the First-in-Human (FIH) clinical trial, including clinical and regulatory pathways and business case development for Heptammune. The development plan for the Heptammune project was comprehensive and structured, encompassing all critical aspects necessary for the successful advancement of the drug candidate. It began by clearly outlining the project objectives and the underlying scientific hypothesis, followed by an analysis of the clinical context and the competitive landscape. The plan detailed the target product profile (TPP) and addressed product quality considerations through CMC (Chemistry, Manufacturing, and Controls) strategies. Furthermore, it laid out the clinical and regulatory development strategies, provided a thorough timeline with budget estimates and a risk management plan. - Expert Meeting Participation:
- Accompanied the team in meetings with clinical key opinion leaders to draft the Phase I First-in-Human clinical trial protocol.
- Participated in and facilitated discussions with CMC, DMPK, and preclinical experts to define optimal strategies and prioritize experimental assays, ensuring alignment with available resources.
- Investor Relations Support:
Provided advice and strategic input for interactions with potential investors.
- Support on competitive call preparation: In addition to these core elements, the consultancy services included assisting the team in preparing a successful application for a highly competitive local funding call from a foundation of a private Spanish bank, which resulted in securing non-dilutive funding of €0.5 million to support the project’s development.
Conclusion
Nadina Grosios’s consultancy has been instrumental in shaping the regulatory and development strategy for the Heptammune project, supporting IDIBELL in advancing towards clinical development with a clear, actionable roadmap and enhanced readiness for regulatory and investment milestones.
