The drug: research, development and application in therapy

Authors

Ettore Novellino, Univeristy of Naples Federico II; Luciano Maria Fuccella, The Society for Applied Pharmacological Science; Domenico Barone, University of Turin; Vincenzo Iadevaia, University of Naples Federico II; Roberto Colonna, University of Naples Federico II; Giacomo Capone, The Italian Medicines Agency (AIFA); Silvia Cammarata, The Italian Medicines Agency (AIFA); Antonella Piscitelli, University of Naples Federico II; Enrica Menditto, Univeristy of Naples Federico II; Valentina Orlando, University of Naples Federico II; Veronica Russo, University of Naples Federico II; Daria Putignano, University of Naples Federico II; Paolo Vinci, MEIER University of Milan; Francesca Guerriero, University of Naples Federico II; Ilenia Bocchi, Bayer SpA; Valentina Calderazzo, Boehringer Ingelheim Italia; Silvia Romano, Sanofi Italia; Stefano Bonato, Bayer SpA; Francesco De Tomasi, Università Cattolica

Synopsis

Logo_FedOAPress

Publishers: FedOA - Federico II University Press

Series:  Pharmàkon

Pages:  266

Language: Italian

NBN: http://nbn.depositolegale.it/urn:nbn:it:unina-25568

Abstract: “The drug: research, development and application in therapy” is an in-depth study on the Research and Development process that a drug performs from the moment it is designed up to its practical use. When a molecule is considered suitable for a medicine, a long process is activated which has as its goal the creation of a new therapeutic tool and its approval for marketing. A path marked by the strict observance of regulations and laws that have evolved over time in step with scientific and technological progress. A path that however has often been determined also by tragic events following damaging adverse reactions that have triggered processes of revision of the norms and experimental protocols. This book starts with a summary on the history of Western pharmacology, written to allow the reader to understand the circumstances that have been the background to those dynamics through which the Research and Development process has gradually consolidated. An important part of the book is dedicated to some aspects that are crucial in the normative universe in which the drug is placed, such as the advanced therapies and new approaches for clinical research. The authors also focused on the prescriptions of off-label drugs and on the issues of pharmacoutilization and pharmacovigilance, two disciplines that, in a few years, have become increasingly influential in the present and future perspectives, not only of the pharmaceutical sciences but of the entire society.

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Author Biographies

Ettore Novellino, Univeristy of Naples Federico II

He is full professor of Pharmaceutical and Toxicology Chemistry. He was Director of the Pharmacy Department of the University of Naples Federico II and President of the National Conference of Pharmacy Department Managers. In 2004 Novellino founded the “Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione” (CIRFF). His scientific production, which boasts over seven hundred works published in major international journal, focuses, in particular, on computational chemistry applied to drug design and nutraceutical.

Luciano Maria Fuccella, The Society for Applied Pharmacological Science

He is an honorary member of the Società Italiana di Medicina Farmaceutica (SIMeF), professor of the Master on Preclinical and Clinical Development of Drugs, of the University of Milan Bicocca and Fellow of the Faculty of Pharmaceutical Medicine (London). In 2018 he was awarded the prestigious title of "Hero in Pharmaceutical Medicine of IFAPP” (International Federation of Associations of Pharmaceutical Physicians).

Domenico Barone, University of Turin

Biologist, specialized in Pharmacology Applied to Industry, he held various roles in the pharmaceutical industry, from research to preclinical development, from quality control of production to Qualified Person. Since 1996 he has been an Adjunct Professor at the Turin University. He is the author of more than 280 scientific papers.

Vincenzo Iadevaia, University of Naples Federico II

He is a biologist and pharmacist and studies the development of new drugs in the clinic. He is the author of numerous publications of pharmacotherapy and pharmaceutical legislation books, and teaches in several university colleges and pharmacy training courses.

Roberto Colonna, University of Naples Federico II

He is editor, responsible for several scientific journals. He has been focusing on writing pharmaceutical books and manuals since 2014. He has a large number of publications on both Italian and international journals.

Giacomo Capone, The Italian Medicines Agency (AIFA)

He is Scientific Officer at Italian Medicines Agency (AIFA), graduated in Chemistry and Pharmaceutical Technologies with a PhD in Drug Science (Pharmacology). Previously he worked in biomolecular research in Italy and abroad and in clinical research for profit and non-profit clinical trials.

Silvia Cammarata, The Italian Medicines Agency (AIFA)

Hospital pharmacist with a PhD in pharmacology and innovative drugs, member of national and international scientific societies, member of the Committee for Training and Research of SIFO. She is currently working as a senior scientific officer at the Italian Medicines Agency. She gained experience on projects with focus on international cooperation, global health and pediatrics.

Antonella Piscitelli, University of Naples Federico II

She is achieving the specialization in “Hospital Pharmacy” and she’s doing her research studies at the Interdepartmental Research Center in Pharmacoeconomics and Pharmacoutilisation (CIRFF). Her research interests concern the realization of studies of Pharmacoutilisation aimed at monitoring the prescriptions, the definition and validation of a report, the evaluation of appropriateness of the use of drugs, development and validation of indicators of quality of care.

 

Enrica Menditto, Univeristy of Naples Federico II

She is assistant professor, at the Department of Pharmacy, University of Naples, Federico II. Research activities are related to economic evaluations of health programs and observational studies in a ‘real-world’ setting by using health-related administrative databases (i.e. pharmaceutical, and hospital discharge records) and clinical data.

Valentina Orlando, University of Naples Federico II

She is Assistant Professor, Department of Pharmacy, University of Naples, Federico II. She is doing research at “Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione” (CIRFF), dealing with outcome research and assessment of the impact of health policies in real clinical practice.

Veronica Russo, University of Naples Federico II

She specialized in “Hospital Pharmacy” and PhD student in Pharmaceutical Sciences. She’s doing her research at the “Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione” (CIRFF) of Naples. Her research interests concern the realization of studies of Pharmacoutilisation aimed at monitoring the prescriptions, identifying the determinants of the use of drugs at the local and hospital level. She has a large number of publications on international journals.

Daria Putignano, University of Naples Federico II

She is a researcher at the Laboratory for Maternal Infant Health of the “Mario Negri” Institute of Pharmacological Research in Milan. Her scientific interests concern the systematic review of drug use during pregnancy, lactation and developmental age. She is author and co-author of publications in national and international scientific journals.

Paolo Vinci, MEIER University of Milan

Founder of “Avv. Paolo Vinci & Associati” Law Firm, Paolo Vinci is a lawyer specialising in the field of professional liability and major injuries, in both civil and criminal matters. Paolo Vinci is author of several publications, lecturer and speaker at important national and international conferences, as well as university professor, previously at Bicocca University and currently at Meier University, where he holds the position of Director of the Road and Medical Malpractice Victims Department.

 

Francesca Guerriero, University of Naples Federico II

Post-graduate student in hospital pharmacy, she is doing research at “Centro Interdipartimentale di Ricerca in Farmacoeconomia e Farmacoutilizzazione” (CIRFF), dealing with pharmaceutical prescriptions and outcome research.

Ilenia Bocchi, Bayer SpA

Pharmacovigilance Country Head deputy (PVCH deputy) in the Pharmacovigilance team of Bayer SpA. Graduated in Medical Biotechnologies with a II level Master in Pharmacovigilance, she is working in Drug Safety area since more than 10 years and she has gained experience in several pharma-industries. Active member and coordinator of the Pharmacovigilance Working Group of the Italian Society of Pharmaceutical Medicine (SIMeF).

Valentina Calderazzo, Boehringer Ingelheim Italia

Head of Pharmacovigilance of the Boehringer Ingelheim Italia SpA Pharmaceutical Company. Graduated in Pharmacy, with a II level Master's Degree in Pharmacovigilance, she coordinates the Pharmacovigilance department of the German pharmaceutical company and monitors the local pharmacovigilance requirements related to all authorized and developing portfolio products. She collaborates with Farmindustria (Pharmacovigilance Working Group), is an active member of the Italian Society of Pharmaceutical Medicine (SIMeF) and collaborates with various associations. Her activities and scientific interests focus on raising awareness of the concept of risk-benefit ratio and continuous monitoring of medicines for patient safety.

Silvia Romano, Sanofi Italia

Vaccine Safety Officer (VSO), Responsible for Sanofi Pasteur Vaccines, at the Pharmacovigilance and Safety Department of Sanofi SpA. With a Master Degree in Pharmaceutical Chemistry and Technology, a PhD and Post-Doctorate in Pharmacology and a II level Master Course in Drug Regulatory Affairs, she gained significant experience in Pharmacovigilance and Regulatory Affairs in different pharma companies. Active member of the Pharmacovigilance Working Group of the Italian Society of Pharmaceutical Medicine (SIMeF).

Stefano Bonato, Bayer SpA

Pharmacovigilance Country Head (PVCH) in Bayer S.p.A. since 1993 with previous experience in the pharmaceutical industry since 1990, after 6 years of hospital ward and specialization in Gastroenterology. Alongside that responsibility, he has also gained experience as Medical Adviser, Regulatory Affairs Country Head (ethical drugs) and Compliance Manager. For almost thirty years, an active member of the Pharmacovigilance Working Group of the Italian Society of Pharmaceutical Medicine (SIMeF) and co-founder of the Italian branch of the International Society of Pharmacovigilance (ISoP). He combines his job, teaching in numerous university Masters and collaborates with some professional training companies

Francesco De Tomasi, Università Cattolica

MD, worked in Hospital, Pneumology Department, and then in Pharmaceutical Industry, as Research Clinical Director in 2 Multinational Companies for studies in Italy and Europe. Was President of SSFA (Scientific Society of Applied Research, now SIMeF – Italian Society of Pharmaceutical Medicine- ); Actually retired, is in the Committee of II° level Master “Preclinical and clinical drug development : Scientific Regulatory and Ethical aspects”, at the Catholic University of Rome.

 

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Published

November 26, 2019

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Details about this monograph

ISBN-13 (15)

978-88-6887-065-2

Publication date (01)

2019-11-26

doi

10.6093/978-88-6887-065-2