Mastering Quality By Design

Biography 

With a degree in Chemistry and Pharmaceutical Technologies from the University of Pavia (Italy) in 1999, Mirka boasts a rich career in formulation development. From Pfizer Ltd (Sittingbourne, UK) to GSK (Verona, Italy), Aptuit, and Kedrion Biopharma, she has excelled in oral dosage forms and plasma-derived intravenous product development. Currently, as a key member of Evotec Verona Scientific Direction, Mirka provides invaluable technical-scientific input and consultancy to Pharmaceutical Development & Manufacturing.

Biography

Zadeo brings over two decades of expertise in chemical development from his tenure at GSK and Aptuit. With a Chemistry degree from the University of Milan, Zadeo's career spans route scouting, development, scale-up, and technology transfer for commercial manufacturing. He has authored numerous scientific papers, including on Quality by Design, and spearheaded the implementation of API Oligonucleotides manufacture capability at Evotec.

Biography 

Denise, at Evotec Verona since 2016, holds an MS in Bio-demographic statistics from the University of Bologna (2012) and a second-level master's in advanced biostatistics for clinical research from the University of Padova (2022). With prior experience as a programmer and statistician in diverse fields, Denise now spearheads the Biostatistics team within Evotec's Pharmacometrics department. Her team offers vital statistical support across various drug discovery and development stages, with a focus on preclinical toxicology, safety studies, in-vitro biology, bioanalysis assay development, and Chemistry, Manufacturing, and Controls (CMC).

Biography

Francesco, a chemistry graduate from the University of Padova (Italy) in 1991, embarked on his career at Glaxo in Verona in 1992. Initially part of the Chemical Development Department, he honed his expertise in lab-scale chemistry and scale-up challenges. Later, as a member of the Lab Automation Team since 1997, Francesco developed and utilized automated systems for multiple and parallel reactions, enabling rapid optimization and deeper understanding of chemical processes. His profound knowledge of Quality by Design (QbD) principles and statistical tools, including principal component analysis (PCA), multivariate analysis (MVA), and experimental designs (DoE), seamlessly integrates with automated workstations for solvent/reagent screenings and process optimization. Currently, at Evotec Verona’s API Development and Manufacturing Department, Francesco oversees chemical projects from conception to pilot plant technology transfer, ensuring a smooth progression from route definition to reaction optimization.

Biography

Simone, a graduate of the 5-year program in Chemistry and Pharmaceutical Technologies at the University of Padova (Italy) in 2013, pursued a PhD in Molecular Science in 2017, with several scientific publications to his credit. Following a year of consultancy in the pharmaceutical sector, Simone joined Evotec in Verona. Initially focusing on compliance, he transitioned into a Quality Assurance (QA) specialist role over the past five years. Simone excels in managing client audits, internal audits, regulatory audits, KPIs, and cross-risk assessments within a global team.

Biography

Dorly holds a degree in Chemistry and Pharmaceutical Technologies from the University of Pavia (Italy) and a PhD in Pharmaceutical Sciences from the University of Milan. With a career spanning Pharmacia-Upjohn, Vectorpharma, Pharmatec, Merck-Serono, Eurand, Novo-Nordisk, and now Evotec, Maria has excelled in formulation development. Her expertise includes modified release formulations for subcutaneous administration, microparticles and nanoparticles for oral and subcutaneous delivery of peptides and small proteins, and development of new oral formulations of GLP1 analogues. Maria has contributed significantly to the field through her patents, research papers, and presentations at international pharmaceutical conferences.