Massimo Cella Email & Phone Number

Lombardy, Italy

Parma, Emilia-Romagna, It

Parma, Emilia-Romagna, It

I lead clinical pharmacology science for the assigned Clinical Development Programmes, incorporating quality pharmacokinetic and pharmacodynamic analysis, utilizing internal and literature data.I contribute to the development and application of clinical trial methodologies across projects in order to devise and optimize future studies.I work with other members of the pre-clinical and clinical development matrix to steer clinical pharmacology study science and integrate appropriate PK/PD modeling and simulation strategies across a defined therapeutic area.I am responsible to keep abreast of developments in the field of clinical pharmacology and PK/PD to ensure colleagues are kept up-to-date with relevant information.

Parma, Emilia-Romagna, It

Acting as a core Member of the Product Project Team and as the Leader of the Extended Clinical Team, I deliver the Clinical Development Plan in accordance with the Target Product Profile and the Product Development Plan.I am accountable for the clinical program to product registration and corporate lifecycle management on a world-wide basis.I represent the product clinical expertise inside and outside the company.

New York, New York, Us

I serve as the Clinical Pharmacology Lead on multidisciplinary development teams and provide clinical pharmacology expertise and leadership to a project. I work closely with clinicians and statisticians to create clinical development plans that include assessments of a drug's efficacy, safety, and commercial viability. In collaboration with other quantitative clinical and nonclinical disciplines, I integrate PK-PD knowledge from preclinical experiments, clinical results, and meta-analyses of the literature to inform target validation, human administration, phase 2 study design and analysis in the pain management area.

Brentford, Middlesex, Gb

I am responsible for the PKPD modelling activities of PharmaCog's Working Package 7 (Quantitative Pharmacology). The focus of my research is on translational models, Alzheimer's Disease progression models and Clinical Trial Simulations.PharmaCog is a project funded by Innovative Medicine Initiative about prediction of cognitiveproperties of new drug candidates for neurodegenerative diseases in early clinical development.

“Does size matters? Bridging and dose selection in paediatric trials” investigates the use of pharmacokinetic (PK) modelling to support dosing recommendation in children during drug development. The thesis addresses the methodological issues of pharmacokinetic bridging and its implementation in paediatric clinical trials.

Regulatory affairs, in particular for the elaboration and drawing up of orphan drug designations anddrug registration dossiers.

Doctor Of Philosophy - Phd, Clinical Pharmacology

Master Of Science, Pharmaceutical Chemistry And Technology

Maturita' Scientifica