In recent years there has been increased attention to the area of abuse liability by regulatory agencies. Abuse liability may represent a risk to the development portfolio, may lead to project delay or termination and may limit patients’ access to medicines because of the increased complexity in physician prescription process. Therefore, the absence of abuse potential and of scheduling of a drug by regulatory authorities will represent a major commercial advantage as well as a significant benefit for public health.
This informative webinar will focus on the drivers for testing and the type of drugs candidates likely to need abuse liability assessment, in light of the regulatory requirements for liability testing globally, as outlined by FDA, ICH, EMA recent guidelines. Further, practical and pragmatic approaches to preclinical assessment of liability testing of novel CNS-active candidates will be presented, and the translation of these predicative tests (from early in-vitro screens to in-vivo behavioural studies on dependence/withdrawal, self-administration) debated. Finally, the best implementation strategies and the ideal timing of testing will be thoroughly analysed.
Maria Pilla, PhD, Head, Nervous System and Electrophysiology Safety Pharmacology, Preclinical Biosciences, Aptuit Center for Drug Discovery & Development, Verona – Italy
Maria Pilla is Head of the Nervous System and Electrophysiology Safety Lab, within the Safety Assessment Department at the Aptuit Center for Drug Discovery & Design in Verona, Italy. Starting with a degree in Pharmaceutical Chemistry and Technology from the University of Padova, she obtained her PhD degree at the Department of Experimental Psychology, University of Cambridge, after completing a thesis entitled: “The psychopharmacology of drug-seeking behaviour”, under the supervision of Prof. Barry Everitt. In 2002 she joined GSK S.p.A., Verona, Italy, as a senior scientist in the Drug Dependence Department. In this role she led and was part of projects for the identification of potential novel targets for the treatment of drug dependence, up to candidate selection of molecules for first time in human.
She has a successful track record in performing behavioural assays (pharmacodynamic and disease) in multiple preclinical species with relevance for multiple disease areas. She has been involved in the organisation and co-ordination of critical experiments across several disciplines. Over the past few years Maria has complemented the scientific expertise with interaction with Regulatory Agencies in the field of Abuse liability to support submissions.
Maria is a fully trained Study Director. She is the author of peer reviewed papers in highly acknowledged scientific journals, and she also acts as a reviewer for some journals.Message Presenter
Who Should Attend?
- Program and project leaders
- Head of labs
- Preclinical CNS scientists
- Regulatory specialists
Aptuit LLC provides the most complete set of integrated early discovery to mid-phase drug development services in the Pharmaceutical industry including Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Pharmaceutical Sciences and Aptuit INDiGO® (a fixed-cost program that accelerates drug development). Fully integrated drug discovery & development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains five global facilities with approximately 700 employees in Europe and the United States. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.