Mathieu Albasser, PhD

Therapeutic Area: Respiratory, Pain, Vitamins.

Trials (US): Healthy volunteers and patients: Real-World Evidence, Bioequivalence, Visualization Study.

• Clinical lead for the design, execution, and analysis of clinical trials to evaluate the safety, efficacy, and performance of new products.
• Provide clinical strategy expertise for Global and Business Unit projects.
• Point of contact between the clinical study team and R&D stakeholders.
• Clinical expert for Health Authorities and Notified Bodies interactions (FDA, Health Canada, BfArM, MHRA).

Therapeutic Area: Respiratory.

Trials (UK, France, Italy, Sweden, Russia): Patients: Real World Evidence, Patient-Reported Outcome.

• Clinical lead and strategic partner for innovation projects and clinical trials, ensuring alignment with internal standards and external regulatory requirements
• Cross-functional collaboration with R&D, Regulatory Affairs, Medical Affairs, and Marketing teams to ensure clinical insights are integrated into product strategy.
• Clinical expert and coordinator of label harmonization for GSK and Novartis.

Therapeutic Area: Respiratory

Trials (US): Patients: Sampling study.

• Coordinate and oversee the development and execution of clinical trial protocols, reports, and disclosures/publications to ensure scientific robustness.
• Key contributor to the Project R&D teams.
• Interface on behalf of GSK with external parties, including key experts and HCPs.
• Responsible for conducting clinical due diligence for external opportunities.
• Support regulatory activities (e.g., FDA positioning, 510(k) applications, and audit).
• Coordinate the update of clinical evaluation reports for 10 medical devices in respiratory.

Therapeutic Area: Oncology, Neurodegeneration.

Trials (US, UK):

• Healthy subjects: Relative Bioavailability, Bioequivalence, Food Effect, DDI.
• Patients: C14.

Responsibilities

• Planned and executed studies in compliance with protocols, ethics, and regulatory requirements.
• Managed timelines and budgets.
• Led study team meetings.
• Coordinated protocol writing and participated in Protocol Review Committees.
• Liaised with Clinical Trial Material representatives for labeling and delivery to investigator sites.
• Coordinated and approved study documents, including monitoring plans, informed consent forms, and data management documents (snapshot plan, data flow, eCRF).
• Ensured that study deliverables were met according to targets.
• Communicated study-level requirements to vendors, ensuring protocol adherence and oversight.
• Led the implementation of the Trial Level Safety Review Plan and the completion of the Clinical Study Report.
• Ensured timely submission of documents to ethics and regulatory bodies upon study completion.

Therapeutic Areas: Neuroscience, Pain, Endocrine, Diabetes.

Trials (UK, US, Singapore, Japan): First Human Dose, SAD, MAD.

Responsibilities

• Lead data consultant and coordinator for clinical pharmacology data across multiple studies and compounds.
• Ensured timely delivery of data management outputs in compliance with GCP and regulatory standards.
• Reviewed study protocols to align data acquisition and database design with protocol objectives.
• Provided direction to study teams, ensuring adherence to Lilly and CDISC standards.
• Acted as a domain expert in Electronic Data Capture (eDC) systems (RAVE, eCRF).
• Administered SAS Drug Development (SDD) requests, including study builds and account access; provided SDD training.
• Collaborated with the Sourcing group to evaluate vendor risk and oversight processes.
• Supported global medical quality in the FDA inspection readiness project, including 100% source data verification for key patients and all adverse events in submission compounds.

• Expertise in in vivo pharmacology, neurodegeneration, and psychiatry.
• Principal investigator of new assays to support CNS drug discovery projects in accordance with Good Laboratory Practices.
• Compiled reports for review committees and management.
• Core member of the pharmacology and neurodegenerative teams in drug development.
• Key contributor to the Lilly Centre for Cognitive Neuroscience: a consortium of academic and industrial scientists.

• Led and managed highly challenging research projects simultaneously.
• Mentored and coordinated research assistants and students
• Maintained and sought scientific collaborations with internal and external partners
• Published data in high-quality peer-reviewed journals

• Expertise in neuroscience, behavior, immunohistochemistry, microscopy, image analysis, and neuroanatomy.
• Planned, developed, analyzed, and validated in vivo studies to support the thesis/research project.
• Communicated scientific findings efficiently to various audiences.

• Set up a new assay to support schizophrenia projects.
• Conducted statistical analysis, and presented the project report and data.