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Author: Zoran Antonijevic
Publisher: Springer
ISBN: 3319090755
Category : Business & Economics
Languages : en
Pages : 204
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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.
Author: Zoran Antonijevic
Publisher: Springer
ISBN: 3319090755
Category : Business & Economics
Languages : en
Pages : 204
Get Book Here
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.
Author: Ravi Badwe
Publisher:
ISBN:
Category :
Languages : en
Pages : 99
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Book Description
Pharmaceutical R&D involves significant uncertainty, including high attrition rate and long time for a project to progress from a target identification phase to commercial launch. Despite this uncertainty, senior leaders must make decisions about R&D portfolio, the impact of which may not be observable for many years. Hence the purpose of this thesis is to understand the current state of Pharmaceutical R&D portfolio management and identify the gaps in R&D portfolio management research. The literature survey revealed that though there are many qualitative and quantitative approaches for the portfolio management of projects in the development phase (i.e. from pre-clinical to phase 3.), the topic of portfolio management in the drug discovery phase (i.e. target validation to lead optimization) have not been well covered in the literature. Hence the problem statement of this thesis is to develop a portfolio management approach for drug discovery. Portfolio management in pharmaceutical drug discovery space is not only a mathematics problem but also a representation problem in terms of activities, resources, decisions, dependencies, and uncertainties. There is something about the nature of the scope of early research in pharma which makes it different from downstream phases and respective parallels in other sectors. Improved representation can lead to improved prediction in drug discovery phase. Hence as the first step, structured survey was conducted to listen to insights from an experienced professional in the drug discovery domain at NIBR (Novartis Institute of Biomedical Research) to build the required understanding about discovery phase. The survey results helped in identification of the biology, chemistry, medical, marketing, and strategy factors generally taken into consideration during drug discovery project prioritization. Resource allocation is not considered during project prioritization - even though resource allocation determines the cycle-time that in turn influences the probability of project to reach pre-clinical phase. Proposed semi-quantitative portfolio management approach, which is based on the survey results, incorporates three key aspects of drug discovery project - scope feasibility (science), desirability (market and strategy), and time feasibility (resource allocation and cycle time). Proposed criterion based model for computing scope feasibility and desirability can be uniformly and transparently applied to all the projects across different disease areas and requires discussion between concerned teams to generate required scores. Also, proposed resource allocation model will enable portfolio management teams to generate multiple scenarios (trade spaces) on scope feasibility, time feasibility, and desirability dimensions. Based on the thresholds, which can be calculated from past data, portfolio team and management in conjunction with other teams such as disease area representatives, chemistry team, marketing etc. can decide the best scenario. The future work needs to focus on validating the proposed portfolio management approaches and models with the real data from past projects in the drug discovery phase in order to enable to organization-wide implementation.
Author: Min Ding
Publisher: Springer Science & Business Media
ISBN: 1461478014
Category : Medical
Languages : en
Pages : 763
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Book Description
The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.
Author: Mitchell N. Cayen
Publisher: John Wiley & Sons
ISBN: 1118035208
Category : Medical
Languages : en
Pages : 507
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Book Description
The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 107
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Book Description
Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.
Author: Benjamin Thomas Burley
Publisher:
ISBN:
Category :
Languages : en
Pages : 67
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Book Description
Pharmaceutical drug development is exhibiting a consistent trend of increased R&D investment required per successful therapy brought to market. Simultaneously, cultural and political sentiment is increasingly putting downward pricing pressure on new therapies. In this difficult environment it is clear increases in efficiency, as far upstream in this development process as possible, are critical. One aspect of efficiency in this industry is the accuracy with which drugs in early development are valued; this valuation is performed in consideration of multiplied criteria with significant ambiguity and extensive uncertainty, and typically in the context of multiple drugs in the development pipeline. This thesis develops an approach to this drug portfolio valuation process that is intended to reduce human bias in the decision process, and increase the consistency of multi-criteria consideration. This valuation model for drugs in early development considers monetary and utility values in conjunction with a rules based expert system to estimate the value of a portfolio of drugs. This model takes categorical and continuous inputs about drugs in development and maps this to value to the relevant company or investment group. Specifically, the model utilizes scorings for individual drugs along many criteria and a formal representation of the relevant company’s structure and strategic goals as input. Applying value functions that use non-linear relationships between input capability and the resulting value to the company, an amalgamated utility value is estimated for the drug portfolio in the context of a given company and / or investment strategy. This value mapping allows for the inclusion of expert knowledge and judgement to a systematic and consistent assessment of multiple criteria. The outputs of the system allow for visual and quantitative comparisons of potential groups of drugs for development. The model produces an amalgamated utility valuation for the portfolios under consideration, with the capability to analyze a set of portfolios with multiple strategic scenarios, and produces visual comparisons of these multiple scenarios. In addition, the model estimates an adjusted net present value for the portfolios with weighted input from the various assessment criteria. Initial results from this modelling are not predictive at this stage, but illustrate the capability of this model to reduce decision bias and improve the capacity for consideration of many relevant criteria.
Author: Ahti Salo
Publisher: Springer Science & Business Media
ISBN: 1441999434
Category : Business & Economics
Languages : en
Pages : 410
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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.
Author: Richard O. Michaud
Publisher: Oxford University Press
ISBN: 0199715793
Category : Business & Economics
Languages : en
Pages : 145
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Book Description
In spite of theoretical benefits, Markowitz mean-variance (MV) optimized portfolios often fail to meet practical investment goals of marketability, usability, and performance, prompting many investors to seek simpler alternatives. Financial experts Richard and Robert Michaud demonstrate that the limitations of MV optimization are not the result of conceptual flaws in Markowitz theory but unrealistic representation of investment information. What is missing is a realistic treatment of estimation error in the optimization and rebalancing process. The text provides a non-technical review of classical Markowitz optimization and traditional objections. The authors demonstrate that in practice the single most important limitation of MV optimization is oversensitivity to estimation error. Portfolio optimization requires a modern statistical perspective. Efficient Asset Management, Second Edition uses Monte Carlo resampling to address information uncertainty and define Resampled Efficiency (RE) technology. RE optimized portfolios represent a new definition of portfolio optimality that is more investment intuitive, robust, and provably investment effective. RE rebalancing provides the first rigorous portfolio trading, monitoring, and asset importance rules, avoiding widespread ad hoc methods in current practice. The Second Edition resolves several open issues and misunderstandings that have emerged since the original edition. The new edition includes new proofs of effectiveness, substantial revisions of statistical estimation, extensive discussion of long-short optimization, and new tools for dealing with estimation error in applications and enhancing computational efficiency. RE optimization is shown to be a Bayesian-based generalization and enhancement of Markowitz's solution. RE technology corrects many current practices that may adversely impact the investment value of trillions of dollars under current asset management. RE optimization technology may also be useful in other financial optimizations and more generally in multivariate estimation contexts of information uncertainty with Bayesian linear constraints. Michaud and Michaud's new book includes numerous additional proposals to enhance investment value including Stein and Bayesian methods for improved input estimation, the use of portfolio priors, and an economic perspective for asset-liability optimization. Applications include investment policy, asset allocation, and equity portfolio optimization. A simple global asset allocation problem illustrates portfolio optimization techniques. A final chapter includes practical advice for avoiding simple portfolio design errors. With its important implications for investment practice, Efficient Asset Management 's highly intuitive yet rigorous approach to defining optimal portfolios will appeal to investment management executives, consultants, brokers, and anyone seeking to stay abreast of current investment technology. Through practical examples and illustrations, Michaud and Michaud update the practice of optimization for modern investment management.
Author: Tannista Banerjee
Publisher:
ISBN:
Category :
Languages : en
Pages : 44
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Book Description
Author: Dr. Richard Bayney
Publisher: J. Ross Publishing
ISBN: 1604270608
Category : Computers
Languages : en
Pages : 305
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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.
