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

Format:

Book

Contributor:

Schuhmacher, Alexander, editor.

Hinder, Markus, editor.

Gassmann, Oliver, editor.

Language:

English

Subjects (All):

Pharmaceutical industry--Technological innovations.

Pharmaceutical industry.

Physical Description:

1 online resource (542 p.)

Edition:

1st ed.

Place of Publication:

Weinheim, Germany : Wiley, 2016.

Summary:

This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

Contents:

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

Notes:

Description based upon print version of record.

Includes bibliographical references at the end of each chapters and index.

Description based on online resource; title from PDF title page (ebrary, viewed January 22, 2016).

ISBN:

9783527693436

3527693432

9783527693405

3527693408

9783527693412

3527693416

OCLC:

935272885