Value creation in the pharmaceutical industry : the critical path to innovation / / edited by Alexander Schuhmacher, Markus Hinder and Oliver Gassmann

• Pubblicazione: Weinheim, Germany : , : Wiley, , 2016; ©2016
• Descrizione fisica: 1 online resource (542 p.)
• Disciplina: 338.476151
• Soggetto topico: Pharmaceutical industry - Technological innovations; Pharmaceutical industry
• Persona (resp. second.): SchuhmacherAlexander; HinderMarkus; GassmannOliver
• Note generali: Description based upon print version of record.
• Nota di bibliografia: Includes bibliographical references at the end of each chapters and index.
• Nota di contenuto: Related Titles; Title Page; Copyright; Table of Contents; List of Contributors; Foreword; Chapter 1: Introduction to the Book; Reference; Chapter 2: Global Epidemiological Developments; 2.1 Introduction; 2.2 Model of Epidemiological Transition; 2.3 Global Burden of Diseases; 2.4 Infectious Diseases; 2.5 Noncommunicable Diseases; 2.6 Antimicrobial Resistance; 2.7 Dynamics; References; Chapter 3: The Value of Pharmaceutical Innovation: Concepts and Assessment; 3.1 Introduction; 3.2 Concepts and Definitions of Value; 3.3 Stakeholder's Perspectives on Value ; 3.4 Recent Developments Influencing the Definition and Assessment of Value3.5 Recommendations: Implications for R&D; 3.6 Discussion; 3.7 Conclusion; References; Chapter 4: A Review of the Pharmaceutical R&D Efficiency: Costs, Timelines, and Probabilities; 4.1 Introduction; 4.2 The Historical Perspective; 4.3 The R&D Phase Model; 4.4 The Low R&D Success Rates; 4.5 The Long R&D Time Intervals; 4.6 The High Cost of Pharmaceutical R&D; 4.7 The Reduced R&D Efficiency; 4.8 Can an Increase in R&D Value Compensate the Reduced R&D Efficiency?; References; Chapter 5: Financing Pharmaceutical Innovation ; 5.1 Introduction5.2 Measuring Innovation: Categories of New Drugs; 5.3 Productivity of Pharmaceutical Industry throughout Time; 5.4 Measuring the Cost of Developing New Medicines; 5.5 Funding Drug Development: a Global Endeavor; 5.6 Public and Private Funds: Complementary Finance for Drug Development; 5.7 How Commercial Drug Development Projects Are Financed Today: Big Firms, Small Firms, and Their Cooperation; 5.8 Public Health Economics and Financing Pharmaceutical Innovation; 5.9 Conclusion; Acknowledgment; References; Chapter 6: Challenges and Options for Drug Discovery; 6.1 Introduction ; 6.2 Paradigm Shifts of R&D Organizations6.3 Productivity of Drug Discovery; 6.4 Is There an Innovation Gap in Biomedical Research?; 6.5 Why Did Drug Candidates Fail?; 6.6 Implications from the "Lessons Learnt" for Future Drug Discovery Research; Acknowledgment; References; Chapter 7: Translational Medicine: Enabling the Proof of Concepts; 7.1 Introduction; 7.2 Translational Medicine and Its Role/Value in Early Development; 7.3 Knowledge Generation; 7.4 Types of Data, Experiments, and Tools Needed to Move from Basic Research to Early Clinical Development; 7.5 FIM (Dose Escalation and MTD) ; 7.6 Proof of Concept (PoC)7.7 Summary; References; Chapter 8: Preclinical Safety and Risk Assessment; 8.1 Introduction; 8.2 Test Systems; 8.3 Case Study: hERG Assay; 8.4 The Preclinical "Package" during the Development of an NME; 8.5 Factors Influencing the Preclinical Data Set; 8.6 Translation into Humans: The "Therapeutic Window"; 8.7 Influence of Intended Therapeutic Use on the Risk Assessment (RA); 8.8 Deep Dive Case Study: Safety Assessment of Biological Drug Formats; 8.9 NBE Case Study 1; 8.10 NBE Case Study 2; 8.11 Carcinogenicity Risk Assessment for Marketed Drugs ; 8.12 Treatment Duration
• Titolo autorizzato: Value creation in the pharmaceutical industry
• ISBN: 3-527-69343-2; 3-527-69340-8; 3-527-69341-6
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910817156403321
• Lo trovi qui: Univ. Federico II