Biography

Senior Scientific Project Leader with over 20 years' experience in the pharmaceutical industry. Strong experience in Pre-Clinical Drug Development mainly from candidate selection up to market drug approval. Accountable for the scientific management of drug development integrated projects defined as multi- departmental and potentially multi-sites work packages including CMC and Pre-clinical functions, leading overall scientific strategy development and facilitating technical problems solving and solutions implementation.

Extensive knowledge and background in the design and execution of Pre-clinical studies (as well as in the interpretation of generated data), tailored to needs of each development phase depending on the specific indication accordingly to regulatory (ICH and FDA) requirements. Experience in review of and contributions to regulatory submissions of Investigator's Brochure, IND, CTD, IMPD and registration dossiers to support NDA/MAA drug submission.

Biography

Prior to joining Aptuit in April 2017, Federico was principal scientist and formulation lead at Novartis Global Development in Switzerland. He previously held different roles with increasing responsibility at Novartis Pharma and Chiesi Farmaceutici.

Federico has more than 12 years’ experience in the pharmaceutical industry, acquired within pharma companies at global level and he combines a solid knowledge of drug product development, especially on inhalation products, with project leadership skills.

He has been a member and leader of several formulation and validation projects that led to market product launches.

Accountable for the scientific management of drug development integrated projects defined as multi- departmental and potentially multi-sites work packages including CMC and Pre-clinical functions, leading overall scientific strategy development and facilitating technical problems solving and solutions implementation.