Ivan Tommasini, Ph.D.

Ivan Tommasini, Ph.D.

Ivan Tommasini, Ph.D.

Principal Consultant

Ivan has extensive Research and Development experience gained within the EU Regulatory Affairs functions of top pharmaceutical and biotechnology companies (Pfizer, Amgen, Gilead, Cambridge Antibody Technology, MedImmune and AstraZeneca). Ivan began his career as a Medicinal Chemist at Pfizer, working on the design and synthesis of small molecule drug candidates against a range of biological targets, where he became a Team Leader. After nearly 6 years of industrial experience in medicinal chemistry, he moved into Regulatory Affairs.

Ivan is experienced in all phases of strategic product development and post-approval activities, for small molecule and biotechnology (mAb) candidates and marketed products, covering a wide range of therapeutic areas including oncology, diabetes, respiratory, inflammation and antivirals. With 20 years in regulatory affairs, he has extensive experience of EU regulatory agency interactions (EMA, EU national), regulations and processes, leadership of complex regulatory programmes and submissions management. He also has strong US and Rest-of-World regulatory experience and awareness.

Having worked in a wide range of therapeutic areas and phases of development, Ivan is able to advise on problem solving, agency interactions, optimal regulatory strategies and mitigations, and their implementation.

Work Experience

Prior to joining Parexel in 2017, he spent a total of 10 years at Cambridge Antibody Technology (CAT), MedImmune Ltd and AstraZeneca as Regulatory Affairs Manager, Associate Director and EU lead (Director) on a range of small and large molecule candidates at all phases (1-3), license submission (MAA) and post-approval. His post-approval experience includes both new and established products, and he has extensive experience of leading regulatory and cross-functional teams in large, complex submissions. 

Education

Dr Tommasini has a degree in Chemistry (B.Sc Hons, 1st Class) and a PhD (Organic Chemistry) in organosilicon synthesis from the University of Glasgow.

We are always available for a conversation.

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