Maria Dominguez

As Consultant and Head of DMPK I am responsible for: • Lead DMPK activities within cross functional project teams and guide study design, execution, and data interpretation. • Design nonclinical DMPK packages to support candidate selection, IND/CTA filings, and clinical development. • Provide scientific oversight of all in vitro and in vivo ADME studies and integrate findings with safety and efficacy data. • Manage and oversee CRO relationships, including selection, contracting, monitoring, and data review. • Author and review DMPK sections of regulatory submissions and act as a SME in health authority interactions. • Keep the DMPK function aligned with emerging science and regulatory expectations; promote innovation and improved predictive tools. • Build and develop a high performing DMPK team through coaching, mentoring, and performance management.

-Lead the preclinical strategy and execution for drug discovery and development programs. -Provide expert guidance and scientific oversight on DMPK and safety assessments based on clinical development plans. -Develop and implement DMPK and toxicology screening strategies to support discovery portfolios. -Oversee preclinical studies conducted at multiple external CROs. -Ensure all preclinical studies comply with regulatory guidelines, SOPs, and ICH requirements. -Manage preclinical development budgets and perform contingency planning. -Provide line management and mentoring for DMPK and toxicology project representatives. -Collaborate with Discovery and Development teams to address preclinical issues and optimize strategies. -Review and/or author DMPK and toxicology sections of regulatory documents (e.g., pre‑IND, IND, IB). -Represent the company in meetings with regulatory agencies.

As Head of the DMPK department I am responsible for: - Management of all DMPK Research Activities, leading a team of 8 scientists and a budget of €1.5M. - Provide functional and strategic leadership in DMPK to a number of Discovery projects (from early exploratory to candidate selection). - Define the DMPK strategies in New Chemical Entities and Repositioning of existing molecules in the core research area of Dermatology. - Management of external projects outsourced to Contract Research Organisations. - Support to Business Development in the scientific evaluation of in-licensing opportunities.

As DMPK project leader of inhaled and oral programs I am responsible for: -In vitro and in vivo ADME assays critical in the screening cascade. -Prediction of toxicity and potential for drug interactions. -Analysis of pharmacokinetic parameters from pre-clinical species using specialized software (i.e. -WinNolin Phoenix) and elaboration of PK/PD relationships. -Prediction of pharmacokinetic parameters and efficacious dose in humans using available in vitro and in vivo data using PK and PBPK software packages such as Phoenix and GastroPlus. Main responsibilities as DMPK representative in Discovery programs include: -Ensure intelligent study design to provide the required information in an efficient and effective manner. -Set up new methodology according to program needs. -Prepare presentations and advise project teams and senior management on resolving DMPK issues. -Collaborate in the evaluation of the ADME package from external programs as licencing-in opportunities. Experience in oral, inhaled and topical programs.

DMPK representative for one CNS discovery program. -Taking part in all the steps involved in the discovery of a new Drug Candidate from Feasibility, Hit to Lead and Lead Optimisation phases and candidate nomination. -Responsible for the evaluation and discussion of results with Biology and Chemistry project leaders. Design and perform experiments to investigate the in vitro and in vivo parameters of new molecules: -In vitro studies to elucidate the ADME properties of new compounds such as metabolic stability, permeability, plasma protein binding, covalent binding and CYP inhibition and induction. -In vivo studies including animal pharmacokinetics, tissue distribution and excretion studies using radio isotopes.

- Bioanalyst responsible for method development, validation and analysis of samples from pre-clinical and clinical studies. - Development and validation of sample extraction methodologies for the analysis of plasma and urine samples, such as protein precipitation and solid phase extraction. - Development of quantitative methods of HPLC-MS/MS.

-Mass spectrometer operator responsible for the analysis of samples from clinical studies using HPLC/MS-MS. -Extensive knowledge in the use of PE Sciex mass spectrometers. -Work carried out under GLP guidance and other relevant regulatory standards.