Author: Zoran Antonijevic
Publisher: Springer
ISBN: 3319090755
Category : Business & Economics
Languages : en
Pages : 204
Book Description
Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.
Optimization of Pharmaceutical R&D Programs and Portfolios
Author: Zoran Antonijevic
Publisher: Springer
ISBN: 3319090755
Category : Business & Economics
Languages : en
Pages : 204
Book Description
Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.
Publisher: Springer
ISBN: 3319090755
Category : Business & Economics
Languages : en
Pages : 204
Book Description
Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.
Optimization of Pharmaceutical R&D Programs and Portfolios
Author: Zoran Antonijevic
Publisher: Springer
ISBN: 9783319343129
Category : Business & Economics
Languages : en
Pages : 0
Book Description
Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.
Publisher: Springer
ISBN: 9783319343129
Category : Business & Economics
Languages : en
Pages : 0
Book Description
Very little has been published on optimization of pharmaceutical portfolios. Moreover, most of published literature is coming from the commercial side, where probability of technical success (PoS) is treated as fixed, and not as a consequence of development strategy or design. In this book there is a strong focus on impact of study design on PoS and ultimately on the value of portfolio. Design options that are discussed in different chapters are dose-selection strategies, adaptive design and enrichment. Some development strategies that are discussed are indication sequencing, optimal number of programs and optimal decision criteria. This book includes chapters written by authors with very broad backgrounds including financial, clinical, statistical, decision sciences, commercial and regulatory. Many authors have long held executive positions and have been involved with decision making at a product or at a portfolio level. As such, it is expected that this book will attract a very broad audience, including decision makers in pharmaceutical R&D, commercial and financial departments. The intended audience also includes portfolio planners and managers, statisticians, decision scientists and clinicians. Early chapters describe approaches to portfolio optimization from big Pharma and Venture Capital standpoints. They have stronger focus on finances and processes. Later chapters present selected statistical and decision analysis methods for optimizing drug development programs and portfolios. Some methodological chapters are technical; however, with a few exceptions they require a relatively basic knowledge of statistics by a reader.
Bayesian Methods in Pharmaceutical Research
Author: Emmanuel Lesaffre
Publisher: CRC Press
ISBN: 1351718665
Category : Medical
Languages : en
Pages : 583
Book Description
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.
Publisher: CRC Press
ISBN: 1351718665
Category : Medical
Languages : en
Pages : 583
Book Description
Since the early 2000s, there has been increasing interest within the pharmaceutical industry in the application of Bayesian methods at various stages of the research, development, manufacturing, and health economic evaluation of new health care interventions. In 2010, the first Applied Bayesian Biostatistics conference was held, with the primary objective to stimulate the practical implementation of Bayesian statistics, and to promote the added-value for accelerating the discovery and the delivery of new cures to patients. This book is a synthesis of the conferences and debates, providing an overview of Bayesian methods applied to nearly all stages of research and development, from early discovery to portfolio management. It highlights the value associated with sharing a vision with the regulatory authorities, academia, and pharmaceutical industry, with a view to setting up a common strategy for the appropriate use of Bayesian statistics for the benefit of patients. The book covers: Theory, methods, applications, and computing Bayesian biostatistics for clinical innovative designs Adding value with Real World Evidence Opportunities for rare, orphan diseases, and pediatric development Applied Bayesian biostatistics in manufacturing Decision making and Portfolio management Regulatory perspective and public health policies Statisticians and data scientists involved in the research, development, and approval of new cures will be inspired by the possible applications of Bayesian methods covered in the book. The methods, applications, and computational guidance will enable the reader to apply Bayesian methods in their own pharmaceutical research.
Handbook on Project Management and Scheduling Vol. 2
Author: Christoph Schwindt
Publisher: Springer
ISBN: 3319059157
Category : Business & Economics
Languages : en
Pages : 768
Book Description
Due to the increasing importance of product differentiation and collapsing product life cycles, a growing number of value-adding activities in the industry and service sector are organized in projects. Projects come in many forms, often taking considerable time and consuming a large amount of resources. The management and scheduling of projects represents a challenging task and project performance may have a considerable impact on an organization's competitiveness. This handbook presents state-of-the-art approaches to project management and scheduling. More than sixty contributions written by leading experts in the field provide an authoritative survey of recent developments. The book serves as a comprehensive reference, both, for researchers and project management professionals. The handbook consists of two volumes. Volume 1 is devoted to single-modal and multi-modal project scheduling. Volume 2 presents multi-project problems, project scheduling under uncertainty and vagueness, managerial approaches and a separate part on applications, case studies and information systems.
Publisher: Springer
ISBN: 3319059157
Category : Business & Economics
Languages : en
Pages : 768
Book Description
Due to the increasing importance of product differentiation and collapsing product life cycles, a growing number of value-adding activities in the industry and service sector are organized in projects. Projects come in many forms, often taking considerable time and consuming a large amount of resources. The management and scheduling of projects represents a challenging task and project performance may have a considerable impact on an organization's competitiveness. This handbook presents state-of-the-art approaches to project management and scheduling. More than sixty contributions written by leading experts in the field provide an authoritative survey of recent developments. The book serves as a comprehensive reference, both, for researchers and project management professionals. The handbook consists of two volumes. Volume 1 is devoted to single-modal and multi-modal project scheduling. Volume 2 presents multi-project problems, project scheduling under uncertainty and vagueness, managerial approaches and a separate part on applications, case studies and information systems.
29th European Symposium on Computer Aided Chemical Engineering
Author: Anton A. Kiss
Publisher: Elsevier
ISBN: 0128186356
Category : Technology & Engineering
Languages : en
Pages : 1886
Book Description
The 29th European Symposium on Computer Aided Process Engineering, contains the papers presented at the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event held in Eindhoven, The Netherlands, from June 16-19, 2019. It is a valuable resource for chemical engineers, chemical process engineers, researchers in industry and academia, students, and consultants for chemical industries. - Presents findings and discussions from the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event
Publisher: Elsevier
ISBN: 0128186356
Category : Technology & Engineering
Languages : en
Pages : 1886
Book Description
The 29th European Symposium on Computer Aided Process Engineering, contains the papers presented at the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event held in Eindhoven, The Netherlands, from June 16-19, 2019. It is a valuable resource for chemical engineers, chemical process engineers, researchers in industry and academia, students, and consultants for chemical industries. - Presents findings and discussions from the 29th European Symposium of Computer Aided Process Engineering (ESCAPE) event
Platform Trial Designs in Drug Development
Author: Zoran Antonijevic
Publisher: CRC Press
ISBN: 1351683934
Category : Mathematics
Languages : en
Pages : 323
Book Description
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.
Publisher: CRC Press
ISBN: 1351683934
Category : Mathematics
Languages : en
Pages : 323
Book Description
Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient’s rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry’s key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive’s perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.
Portfolio Decision Analysis
Author: Ahti Salo
Publisher: Springer Science & Business Media
ISBN: 1441999434
Category : Business & Economics
Languages : en
Pages : 410
Book Description
Portfolio Decision Analysis: Improved Methods for Resource Allocation provides an extensive, up-to-date coverage of decision analytic methods which help firms and public organizations allocate resources to 'lumpy' investment opportunities while explicitly recognizing relevant financial and non-financial evaluation criteria and the presence of alternative investment opportunities. In particular, it discusses the evolution of these methods, presents new methodological advances and illustrates their use across several application domains. The book offers a many-faceted treatment of portfolio decision analysis (PDA). Among other things, it (i) synthesizes the state-of-play in PDA, (ii) describes novel methodologies, (iii) fosters the deployment of these methodologies, and (iv) contributes to the strengthening of research on PDA. Portfolio problems are widely regarded as the single most important application context of decision analysis, and, with its extensive and unique coverage of these problems, this book is a much-needed addition to the literature. The book also presents innovative treatments of new methodological approaches and their uses in applications. The intended audience consists of practitioners and researchers who wish to gain a good understanding of portfolio decision analysis and insights into how PDA methods can be leveraged in different application contexts. The book can also be employed in courses at the post-graduate level.
Publisher: Springer Science & Business Media
ISBN: 1441999434
Category : Business & Economics
Languages : en
Pages : 410
Book Description
Portfolio Decision Analysis: Improved Methods for Resource Allocation provides an extensive, up-to-date coverage of decision analytic methods which help firms and public organizations allocate resources to 'lumpy' investment opportunities while explicitly recognizing relevant financial and non-financial evaluation criteria and the presence of alternative investment opportunities. In particular, it discusses the evolution of these methods, presents new methodological advances and illustrates their use across several application domains. The book offers a many-faceted treatment of portfolio decision analysis (PDA). Among other things, it (i) synthesizes the state-of-play in PDA, (ii) describes novel methodologies, (iii) fosters the deployment of these methodologies, and (iv) contributes to the strengthening of research on PDA. Portfolio problems are widely regarded as the single most important application context of decision analysis, and, with its extensive and unique coverage of these problems, this book is a much-needed addition to the literature. The book also presents innovative treatments of new methodological approaches and their uses in applications. The intended audience consists of practitioners and researchers who wish to gain a good understanding of portfolio decision analysis and insights into how PDA methods can be leveraged in different application contexts. The book can also be employed in courses at the post-graduate level.
Women in Industrial and Systems Engineering
Author: Alice E. Smith
Publisher: Springer Nature
ISBN: 3030118665
Category : Technology & Engineering
Languages : en
Pages : 599
Book Description
This book presents a diversity of innovative and impactful research in the field of industrial and systems engineering (ISE) led by women investigators. After a Foreword by Margaret L. Brandeau, an eminent woman scholar in the field, the book is divided into the following sections: Analytics, Education, Health, Logistics, and Production. Also included is a comprehensive biography on the historic luminary of industrial engineering, Lillian Moeller Gilbreth. Each chapter presents an opportunity to learn about the impact of the field of industrial and systems engineering and women’s important contributions to it. Topics range from big data analysis, to improving cancer treatment, to sustainability in product design, to teamwork in engineering education. A total of 24 topics touch on many of the challenges facing the world today and these solutions by women researchers are valuable for their technical innovation and excellence and their non-traditional perspective. Found within each author’s biography are their motivations for entering the field and how they view their contributions, providing inspiration and guidance to those entering industrial engineering.
Publisher: Springer Nature
ISBN: 3030118665
Category : Technology & Engineering
Languages : en
Pages : 599
Book Description
This book presents a diversity of innovative and impactful research in the field of industrial and systems engineering (ISE) led by women investigators. After a Foreword by Margaret L. Brandeau, an eminent woman scholar in the field, the book is divided into the following sections: Analytics, Education, Health, Logistics, and Production. Also included is a comprehensive biography on the historic luminary of industrial engineering, Lillian Moeller Gilbreth. Each chapter presents an opportunity to learn about the impact of the field of industrial and systems engineering and women’s important contributions to it. Topics range from big data analysis, to improving cancer treatment, to sustainability in product design, to teamwork in engineering education. A total of 24 topics touch on many of the challenges facing the world today and these solutions by women researchers are valuable for their technical innovation and excellence and their non-traditional perspective. Found within each author’s biography are their motivations for entering the field and how they view their contributions, providing inspiration and guidance to those entering industrial engineering.
Portfolio, Program, and Project Management in the Pharmaceutical and Biotechnology Industries
Author: Pete Harpum
Publisher: John Wiley & Sons
ISBN: 0470888962
Category : Science
Languages : en
Pages : 352
Book Description
This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.
Publisher: John Wiley & Sons
ISBN: 0470888962
Category : Science
Languages : en
Pages : 352
Book Description
This book describes the way that pharmaceutical projects and programs are currently managed, and offers views from many highly experienced practitioners from within the industry on future directions for drug program management. The book integrates portfolio, program, and project management processes as fundamental for effective and efficient drug product development. Contributing expert authors provide their view of how the projectization approach can be taken forward by the drug industry over the coming years.
Enterprise Project Portfolio Management
Author: Dr. Richard Bayney
Publisher: J. Ross Publishing
ISBN: 1604270608
Category : Computers
Languages : en
Pages : 305
Book Description
This unique guide and professional reference presents a structured framework for practitioners and students of project, program, and portfolio management to enhance their strategic and analytic capabilities in the evolving discipline of project portfolio management (PPM). It provides a practical, step-by-step approach to building competencies in categorizing, evaluating, optimizing, prioritizing, and managing an IT, pharmaceutical, biotech or other complex R&D-oriented portfolio of investments.
Publisher: J. Ross Publishing
ISBN: 1604270608
Category : Computers
Languages : en
Pages : 305
Book Description
This unique guide and professional reference presents a structured framework for practitioners and students of project, program, and portfolio management to enhance their strategic and analytic capabilities in the evolving discipline of project portfolio management (PPM). It provides a practical, step-by-step approach to building competencies in categorizing, evaluating, optimizing, prioritizing, and managing an IT, pharmaceutical, biotech or other complex R&D-oriented portfolio of investments.