Marie-Agnes Cassar

Responsible for the management of nonclinical aspects (pharmacology, pharmacokinetics and toxicology) and clinical pharmacology (drug-drug interaction) for small molecules, biologics, medical devices and combination products Gap analyses and interactions with US and EU regulatory agencies, nonclinical regulatory documentation preparation Nonclinical regulatory strategy Due diligence Early clinical development Involvement in Safety Review Committee as toxicologist in FIH studies

-Expertise in oncology products (small and large molecules) -Scientific and technical expertise regarding preclinical safety profile of compounds in development -Selection of the best candidates for early projects -Toxicology representative in project teams as well as with regulatory authorities -Interface with CROs (studies monitoring, budgets, timelines, study plans, reports...) -Preparation of scientific/technical dossier for regulatory purposes (Briefing package, IND, CTA, IMPD, CTD, DSUR…) -Responses to Health/regulatory Authorities questions -Gap analyses & Due diligence evaluation

-Non-clinical manager with the responsibility of the tox studies performed in-house and outsourced safety studies (toxicology, reprotox, genotox, safety pharmacology, alternative in vitro) -Management of a team of scientists (Study Directors and Study Monitors, MSc. DVM, Ph.D.) -Representative of the non clinical department in project teams to lead the strategy for preclinical safety evaluation (proposition of non clinical strategic plans to support clinical trials) of drug candidates, -Preparation of non-clinical documentation (Investigator’s Brochure, IND, CTA, IMPD, CTD), -Responsible of budget and timelines for non-clinical programme, -Consultation with Regulatory Agencies (FDA, EMA, PMDA), -Expertise in Rx (small molecules). Knowledge in large molecules (non clinical prerequisites), cosmetics, OTC, nutraceuticals, medical devices and combination products.

Full responsibility in data evaluation, study plan and report preparation according to regulatory guidelines and GLP regulations. General toxicology studies (particular interest for nonrodent studies) Ethical expertise (MDS Ethical Committee since 2003, President of Animal Ethical Committee from November 2005 to April 2006) Implementation of dog and minipig neonatal studies in 2005.

Teacher: chemistry, biochemistry, physiology and pathophysiology (lectures and tutorials) to 1st and 2nd year Biological Engineering students (192 hours of lectures/tutorials). Post doctoral position, Laboratoire de Pharmacologie, Faculté de Médecine de Nancy, France (Subject: PPAR, chondrocyte, inflammation and synovial fibroblasts).

Teacher (192 hours of lectures and tutorials in 1999; 64 hours in 1998 and 81 hours in 1997) Ph.D. (3 years) at Laboratoire de Pharmacologie, Faculté de Médecine, Nancy, France (Subject: fluoroquinolone-induced toxicity in articular cartilage and Achilles tendon in rodents).

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