Clàudia Resa Parés, PhD

- Coordinate and execute cross-functional projects across R&D, CMC, preclinical, clinical, and regulatory teams, ensuring timelines, budget compliance and alignment with international partners (EU & India). - Execute and oversee the nonclinical toxicology program, ensuring IND/CTA-enabling safety data are generated, interpreted, and integrated into regulatory submissions. - Present scientific data, project progress, and strategic findings to senior management, stakeholders, and external audiences, including investor-facing communications. - Lead preparation, review, and consolidate regulatory documentation (Scientific Advice, PIP, ODD), ensuring completeness, consistency, and strategic decision support. - Monitor project progress, identify execution gaps or delays, and implement corrective actions to maintain timelines and regulatory readiness. - Streamline documentation workflows and milestone tracking, enhancing efficiency and ensuring accurate, on-time regulatory submissions. - Serve as operational interface across R&D, Quality, CMC, and clinical teams, maintaining data integrity and defend project progress and strategic plans in front of investors and stakeholders. - Contribute to early-phase clinical study protocols, including clinical pharmacology strategy and dose rationale. Expertise: Drug development (CMC, preclinical and clinical development), blood–brain barrier (BBB), CNS diseases, oncology, rare diseases, medical writing, project management, regulatory affairs, and medical affairs.

- Led formulation and preclinical development activities to generate and analyze pharmacology and efficacy data supporting translational and early clinical programs. - Authored and edited scientific reports, manuscripts, and technical documentation to support regulatory submissions and key clinical development milestones. - Analyzed complex preclinical pharmacology datasets to ensure scientific rigor, data integrity, and clarity in evidence summaries. - Coordinated cross-functional collaborations with clinicians, researchers, and external partners to advance preclinical assets toward clinical application. - Developed and characterized patient-derived tumor models, integrating molecular and biological datasets to inform biomarker-driven and mechanism-of-action strategies. Expertise: Adult and pediatric oncology | CNS tumors | Blood–brain barrier (BBB) biology | Ocular DDS | Drug delivery systems | Cytotoxic agents | Nanomedicine | Translational medicine | Medical affairs | Project management PhD Research Translational research focused on overcoming the blood–brain barrier (BBB) to treat pediatric high-grade gliomas. Designed and led the preclinical development program of G2B-002, a novel DDS encapsulating SN-38 in micelles functionalized with the BBB-shuttle peptide MiniAp4. Key Achievements - Designed and physicochemically characterized a BBB-penetrating nanomedicine platform. - Conducted pharmacokinetic and biodistribution studies in plasma, cerebrospinal fluid, and brain tissue. -Demonstrated effective BBB penetration and delivery of pharmacologically active drug to brain parenchyma. -Achieved significant antitumor efficacy in orthotopic xenograft models of diffuse midline glioma. - Generated preclinical data packages supporting clinical translation in high unmet-need pediatric indications. - Secured patent protection (WO/2023/186822). - Contributed scientific documentation supporting Orphan Drug Designation submissions to EMA and FDA.

Focused on translational research in the Pediatric Cancer Treatment Research Group, led by Dr. Ángel M. Carcabosso. - Translational research using animal models established from patient-derived samples (PDX). - Study, characterization, and evaluation in vitro and in vivo new therapies for the treatment of pediatric solid tumors (Ewing sarcoma, rhabdomyosarcoma, neuroblastoma, DIPG, glioblastoma). - Identification of biomarkers of response to anti-tumor drugs.

During this period, in the Pediatric Cancer Treatment laboratory led by Dr. Ángel Montero Carcaboso, I conducted: My Bachelor’s thesis: Identification of biomarkers of response to irinotecan in pediatric sarcoma xenografts. My Master’s thesis: Identification of biomarkers of response to Abraxane in pediatric sarcoma xenografts. Additionally, I participated in other projects such as establishing patient-derived animal models and personalized medicine studies.

El Máster me ha proporcionado una formación exhaustiva en dos áreas clave de la industria farmacéutica. Por un lado, en Garantía de Calidad, enfocándome en el diseño y desarrollo de sistemas que abarcan desde la fabricación hasta la liberación de medicamentos, asegurando el cumplimiento de las normativas vigentes. Por otro lado, en Registros y Asuntos Regulatorios, adquiriendo los conocimientos necesarios sobre los requisitos técnicos para la autorización de comercialización de productos farmacéuticos, garantizando su conformidad con las normativas sanitarias y facilitando su llegada al mercado en el menor tiempo posible