. Graduated in Medicine (1985) at Milan University

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·Specialized in Biometrics (1988) and Clinical Pharmacology (1992) at Pavia University

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·Master in Pharmacoeconomics (2015) at Pompeu Fabra University

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·IBM Specialization in Applied Artificial Intelligence (2019)

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. Formal training in Data Science (Johns Hopkins University)

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·More than 30 years of experience in Clinical Development, Medical Affairs, Medical-Marketing, and Pharmacovigilance

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·Has worked in multinational and local companies coordinating and managing several development and registration projects, responsible also for the oversight of all clinical and preclinical aspects, of projects in Italy, Europe and the United States.

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. Has participated in and supervised all stages of drug development – from formulation to Phase I-IV and pharmacovigilance

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. Qualified QPPV, has also prepared and overseen more than 250 non-clinical and clinical overviews and summaries.

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. In the last few years, he has extensively worked in the fields of pharmacoeconomics and health technology assessment and in the field of advanced digital technologies applied to drug development and registration.

·Graduated in Pharmaceutical Chemistry and Technology

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·PhD in Drug Chemistry and Specialized in Hospital Pharmacy

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·Research and development of modified-release drugs for topical use at the University of Milan

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·10 years of experience in the preparation and revision of documents in the fields of Medical Writing, Regulatory writing and Marketing writing

•More than 45 years international experience in pharmaceutical industry and consultancies

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•Functional experience in Regulatory Affairs, Pharmacovigilance, Quality, and Manufacturing

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•Exposure to multiple therapeutic areas, pharmaceutical products with different dosage forms, working environments, and business models

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•Successful record of accomplishment in managing within complex matrix organizations, cross-functional team driven work environments on a local and global basis.

More than 35 years of international experience in Pharma and Phamaceutical primary packaging Research and Development, focused on formulation, CMC development, quality and regulatory. Certified Qualified Person.

 

Project and Program Management including Portfolio Analysis and Management, managing partnership and collaborations among companies, organizations and Universities, including IP strategies and Life Cycle Management.

 

Experienced in several therapeutic areas and different working environment (Big Pharma, small and medium size Drug Delivery Systems, CDMO, Glass Packaging and Medical Devices), developing NDA, 505(b)(2), generics and supergenerics.