FAES Farma | Spain
Author Profile
Scopus
🌱 Early Academic Pursuits
Dr. Inmaculada Gilaberte’s academic journey is rooted in a commitment to excellence and medical advancement. She initially pursued education in clinical research, equipping herself with in-depth knowledge and skills in therapeutic areas such as neuroscience and immunology. Her academic foundation was further strengthened by certifications, including a lecturer certification from the Spanish Quality Register Agency (ANECA), and advanced leadership programs from institutions like Stanford and MIT. These formative experiences shaped her growth mindset, laying the groundwork for a career dedicated to precision, patient-centered care, and effective team collaboration.
💼 Professional Endeavors
Throughout her career, Dr. Gilaberte has held prominent roles in major pharmaceutical companies such as FAES FARMA, Takeda, TiGenix, Roche, and Lilly, with positions spanning from Clinical Research Physician to Director of Clinical Research. She has led various departments, managed global teams, and directed clinical trials across multiple therapeutic areas, including gastroenterology, immunology, cardiology, and pain management. Her strategic guidance has driven several landmark projects forward, including the advancement of microbiome and cell therapies from preclinical to first-in-human trials, demonstrating her expertise in transforming innovative therapies into viable treatment options.
🧬 Contributions and Research Focus
Dr. Gilaberte has made notable contributions to clinical research, particularly in stem cell therapy, immunology, and neuroscience. Her pioneering work on Darvadstrocel, an allogeneic adipose-derived mesenchymal stem cell therapy, led to significant strides in treating perianal fistulas and positioned her as a leader in regenerative medicine. She has been instrumental in launching global clinical trials, developing target product profiles (TPP), and submitting regulatory applications for FDA and EMA approvals. With a robust publication record, including 66 papers indexed in PubMed, she continues to contribute to scientific literature, sharing her findings and advancing the field of biomedicine.
🏆 Accolades and Recognition
Dr. Gilaberte’s excellence has been recognized through numerous awards across her roles in clinical development and leadership. Her achievements include multiple awards for her work in the clinical progression of innovative therapies and successful drug submissions to global regulatory bodies. She has received recognition for her strategic contributions to the Darvadstrocel trials and for advancing neuroscience programs in Alzheimer’s disease. Her leadership has earned her high regard in the industry, with acknowledgments from institutions and colleagues alike.
🌍 Impact and Influence
Dr. Gilaberte’s impact extends beyond her immediate professional roles. Her contributions to clinical science have enhanced treatment options for patients with complex diseases, and her leadership has shaped clinical strategies in multinational pharmaceutical companies. She has also promoted effective collaboration across global, cross-functional teams, fostering a diverse and inclusive work environment that prioritizes patient needs. Her initiatives in regulatory compliance, risk management, and data integration have set new standards for clinical operations, solidifying her influence as a thought leader in her field.
📜 Legacy and Future Contributions
Looking ahead, Dr. Gilaberte’s legacy is one of commitment to advancing patient care through innovation, collaboration, and strategic foresight. Her future endeavors are poised to make an enduring impact, with ongoing research and leadership contributions that will shape the future of clinical development. Her philanthropic work, such as building a nursery in Uganda, highlights her dedication to global well-being beyond her professional achievements. Dr. Gilaberte continues to inspire the next generation of clinical researchers, ensuring that her legacy of precision, empathy, and patient-first innovation will endure.
Publications
📄 Efficacy and Safety of Weekly Calcifediol Formulations (75 and 100 µg) in Subjects with Vitamin D Deficiency: A Phase II/III Randomised Trial
- Authors: Esteban Jódar-Gimeno, Jose Luis Pérez-Castrillón, Ján Nociar, Michal Lojka, Dimitar Nikolov, Fernando Cereto-Castro, Snežana Novković, Umberto Tarantino, Nadia Mehsen-Cetre, Paula Arranz, Cristina Martínez Ostalé, Aintzane García-Bea, Inmaculada Gilaberte
- Journal: Nutrients
- Year: 2024
📄 Comparative inhibition by oral bilastine, parenteral dexchlorpheniramine, and a new bilastine parenteral (i.v. and i.m.) formulation of histamine-induced wheal and flare response: A randomised phase I trial
- Authors: Coimbra, J., Puntes, M., Molina, P., Arranz, P., Sánchez, C.
- Journal: European Journal of Pharmaceutical Sciences
- Year: 2024
📄 Bioequivalence and Safety of Bilastine 20 mg Orodispersible Tablets and Conventional Tablets: A Randomized, Single-Dose, Two-Period Crossover Study in Healthy Volunteers Under Fasting Conditions
- Authors: Román, M., Ochoa, D., Martin, S., Arranz, P., Sánchez, C.
- Journal: Drugs in R and D
- Year: 2024
📄 Disease Burden, Treatment Patterns, and Economic Impact of Rectovaginal Fistulas in Patients with Crohn’s Disease: Findings from a Retrospective, Observational, Longitudinal Study Based on US Claims Databases
- Authors: Karki, C., Latremouille-Viau, D., Gilaberte, I., Romdhani, H., Lightner, A.L.
- Journal: PharmacoEconomics
- Year: 2023
📄 Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn’s Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial
- Authors: Garcia-Olmo, D., Gilaberte, I., Binek, M., Spinelli, A., Panés, J.
- Journal: Diseases of the Colon and Rectum
- Year: 2022