Marc Twagirumukiza

In my role as a Professor in Clinical Pharmacology & Therapeutics, my focus is primarily research, with an emphasis on addressing poverty-related diseases, infectious diseases, and neglected diseases in low and middle-income countries

My work encompassed strategic thinking and design of research projects and the leading the implementation of large epidemiological projects at national, regional and international level

Key Responsibilities:

• Collaborative Research Programs: Currently promoter of more than 3 large funding including EU HORIZON / EDCTP3 projects
• Secured funding and grants to support research initiatives, demonstrating strong leadership and project management skills
• Coaching, Leadership and Mentorship: Supervised MSc/PhDs students in clinical pharmacology and therapeutics
• Academic teaching
• Global Health Impact: Focused on addressing health data gap through real-time data gathering by developing affordable, scalable, and deliverable healthcare solutions for low and middle-income countries (VLIR UOS Flemish Project in Uganda and Rwanda)

In my role as Associate Director in Vaccine R&D Clinical Sciences, I am responsible for conducting Phase I-IV Clinical Development activities within a program or group of related programs within the context of the GSK process in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and GSK standard operating procedures (SOP).
Key Achievements and Expertise:

• Successfully leading the Clinical Development activities for the assigned RSV studies and authored clinical study related documents, ensuring data consistency across other studies. Results: The Vaccine is now on market.
• Leading the Independent Data Monitoring Committees (IDMC) activities, which reached so far all milestones.
• Project Team Leadership: driving and aligning activities of a matrix team of more than 30 staff.
• Regulatory Expertise: Contributed to preparing the clinical portions of regulatory submissions and the registration process, including the development of clinical sections of regulatory files (including the EU CTR –CTRIS, FDA, PMDA, MHRA and the rest of the world).
• Commercial and Business Development Support: Provided and continuing to provide the strategic medical support to Marketing and Business Development teams, contributing to the successful commercialization and lifecycle management of products (am involved into the RSV LCM program).
• Environmental and Scientific Vigilance: Proactively collected and reviewed scientific information related to company projects, ensuring up-to-date knowledge of the competitive landscape and enhancing the strategic direction of projects

Working in Internal Medicine Business Unit for the International Developed Markets (IDM) at Pfizer Biopharmaceuticals Group (BeLux): Covering 6 marketed compounds

Key responsibilities for this medical affairs role:

• Provided medical input for the reimbursement dossier in a matrix collaboration with market access and regulatory teams -with primary responsibility of ensuring consistency of the data across different studies/project but also between Randomized Clinical trials (RCTs) and real world data (RWD) studies
• Achieved strategic partnerships development with key stakeholders both externally and internally
• Engaging KOLs at local level (Belgium & Luxembourg), European level and Global level (Including US and Asia/Japan)
• Delivered medical and scientific advice from gathered evidences from published works to support internally and externally to ensure that the interests of both the patient/customer and Pfizer are safeguarded in a competitive landscape
• Led the RWD project gathering data on asset products use in Belgium hospitals with partnership with the RWD data partner company working on re-use of EHRs
• Managed 15 medical representatives (field forces) and 2 MSLs.

Part of Janssen Clinical Innovation (JCI), a dedicated team working in disruptive innovations optimizing the clinical trials process, feasibility and outcomes in 3 areas: trial design services, sites selection/study placement process and innovative tools for patient’s recruitment

• Covered cross-therapeutic areas including infectious diseases, oncology and the global public health
• Gained experience in matrix working environment, interacting daily with Global Clinical Development Operations teams, Safety teams, Study clinical teams, and sites PIs
• Leveraged the Real World Data (RWD)/Real world evidence (RWE) technologies to support the study level adverse events reporting
• Mainly using TriNetX, Clinerion, IQVIA suite, and former InSite Platforms but also the NLP based tools and others.

Achieved completion of 2 PoC studies with new indications for the company leading compound-immunology

My role as a medical lead focused on:

• Pre-trial activities: Trial design, Trial protocol synopsis development, registration process, protocol development and review, Investigator’s Brochures, CRFs, protocol related questions from IECs/IRBs)
• During-trial activities (global monitoring both scientific and management, interact with investigators/sites)
• Post-trial activities (review of adverse events including SAEs, AESIs, trial results reporting)
• Providing medical input in development of PSUR, DSUR, and other safety data templates
• Support to Medical Affairs team with medical differentiating strategies, market landscape analysis (compounds in the same indication) and key medical message
• Gained experience in communication skills, presentation and in delivering messages to big, heterogeneous audience during different investigator meetings.

Working as medical expert/advisor of the “advanced clinical application” group.

• Led the SALUS European Collaborative FP7 project- with AGFA Healthcare as a partner
• SALUS project aims at building an interoperability platform and a dedicated toolkit to enable secondary use of electronic health records (EHR) data for post marketing drug surveillance, through medical data harmonization through OMOP CDM mappings
• An important component of this toolkit is a drug-related adverse events (AE) reporting system designed to facilitate and accelerate the reporting process using automatic pre-population mechanisms.

Project Manager (including budget, staff and scientific) for a multicenter EU funded project: “Accessing Medicines in Africa and South Asia (AMASA) EU FP-7 Project”.

Website: https://cordis.europa.eu/project/rcn/94190/factsheet/en

• The main aim of the project was to investigate through data gathering how the interplay of patent regimes, pharmaceutical regulation, availability of drug production facilities, health care infrastructure and service provision, and engagement by foreign donors influence appropriate, affordable access to medicines in South Asia and Sub-Saharan Africa
• We mapped patterns of production, distribution, supply and consumption of medicines within seven health care areas – HIV/AIDS, Malaria, Reproductive Health, Tuberculosis control, Mental Health, Pain Management and Diabetes
• We also investigated the strategies and influence of selected Indian producers who are active as exporters, partners in joint ventures, or as direct producers in the selected South Asian and African countries.

Investigator (FIH, Phase 1-2a studies) in hospital based clinical pharmacology unit, All therapeutic areas.
Https://www.crig.ugent.be/en/drug
My role included operational management of clinical trial and medical tasks (perform investigations, medical monitoring of health volunteers, safety/clinical/efficacy listings review, ad-hoc interactions with sponsors physicians, AEs/SAEs reporting)

Working as a clinical practitioner physician (internal medicine). Also involved in hospital activities and academic bed-side teaching to medical students in training.

This experience provides a solid foundation in clinical care, research, and health system management, making you well-versed in the complexities of internal medicine and patient care in a tertiary healthcare setting.