Claudia Zuany Amorim FROMOND

Provide strategic and hands-on support to biotech and investment groups in the areas of pharmacology, translational science, and early drug development. Services include: • Advising on preclinical strategy and IND/CTA-enabling activities for immuno-oncology, oncology and immune-inflammation programs • Reviewing and contributing to regulatory documentation (e.g., IMPD, IB, pharmacology and PK sections) • Supporting biomarker strategy and clinical trial design for FIH and PoC studies • Evaluating scientific and technical assets for investors and business development teams • Offering due diligence and risk assessment for therapeutic programs in early development

• Led the translational and biomarker strategy for a first-in-human Phase I trial of a CAR T-cell therapy in acute myeloid leukemia (AML), with a focus on mechanistic biomarkers, target engagement, and early indicators of response and resistance. • Designed and implemented a fit-for-purpose biomarker plan integrating NGS, PCR, FISH, flow cytometry, cytokine profiling, and multiplex IHC analysis to monitor pharmacodynamic effects, T-cell persistence, and immune modulation in patients. • Collaborated cross-functionally with clinical development, regulatory, CMC, and external CROs to align biomarker operations with clinical timelines and regulatory expectations. • Developed a strategy for reverse translational insights, leveraging patient samples to inform next-generation CAR designs and resistance mechanisms. • Contributed to the clinical protocol, investigator brochure (IB), and biomarker sections of the regulatory submission package for IND/CTA filing. • Led IND-enabling pharmacology and translational strategy for an ADC program, including biomarker identification, patient selection and nonclinical safety packages (DRF, GLP-tox studies). • Ensured tight integration between discovery research and clinical development, coordinating internal and external teams to streamline program progression. • Due to Advesya's recent Series A funding challenges that led to workforce reductions, my position was unfortunately impacted.

• Led the translational strategy for the discovery and clinical development of immuno-oncology and immune-inflammation programs, with a focus on patient selection, target engagement, pharmacodynamic markers, and predictive biomarkers of drug response. Applied omics- and transcriptomics-based approaches, including NGS, RNAseq, Nanostring, Olink, multiplex IHC, and ctDNA, to enable data-driven decision-making and optimize clinical development. • Oversaw the design, implementation, and interpretation of integrated PK/PD studies, supporting drug development from preclinical to early clinical phases. Ensured data robustness and scientific rigor in advancing therapeutic candidates to IND/CTA submission. • Directed the development and execution of nonclinical safety strategies (DRF, GLP-tox, TCR), ensuring seamless transitions from discovery to first-in-human clinical trials. Authored and updated regulatory sections (Pharmacology, PK, Toxicology) for documents including IMPD, IND, and IB. • Managed cross-functional collaborations with the Discovery team, CMO, Clinical Operations, CMC, and Regulatory Affairs. Led a team of 3 members and supervised outsourcing of studies to CROs and academic collaborators, maintaining high standards of operational efficiency and scientific oversight.

- In charge of the Pharmacology Department, leading an innovative R&D project portfolio based on monovalent and multivalent nanobodies - Led the pre-clinical functions accountable for target identification/validation, in vivo efficacy, target engagement and PK/PD studies and biomarker strategy setting and execution for both immune-oncology and immune-inflammation project clusters. - Reported in to the CSO and member of the Senior R&D leadership team that oversees strategic and operational activities for all non-clinical R&D activities, as well as a member of key senior management level decision-making committees, representing Pharmacology functions in both pre-clinical and clinical programmes. - Accountable for the Department budget, resource deployment to meet project goals and timelines and staff development.

- Reported to the CSO and member of the Research Leadership Team. - Accountable for the Department budget, staff development, initiation and maintenance of collaborations. Line management for 26 staff, of which 6 have PhDs - In charge of drug discovery project progress and prioritization to align with revisions of company goals, while still maintaining staff focus and motivation - Responsible for research project presentations to Investors, Board of Directors and Pharmaceutical Companies