LEADER 04929nam 22006735 450 001 9910298509603321 005 20200918224745.0 010 $a3-319-09075-5 024 7 $a10.1007/978-3-319-09075-7 035 $a(CKB)3710000000261954 035 $a(EBL)1965451 035 $a(OCoLC)893557476 035 $a(SSID)ssj0001372222 035 $a(PQKBManifestationID)11895532 035 $a(PQKBTitleCode)TC0001372222 035 $a(PQKBWorkID)11319446 035 $a(PQKB)10468952 035 $a(DE-He213)978-3-319-09075-7 035 $a(MiAaPQ)EBC1965451 035 $a(PPN)182093476 035 $a(EXLCZ)993710000000261954 100 $a20141010d2015 u| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aOptimization of Pharmaceutical R&D Programs and Portfolios $eDesign and Investment Strategy /$fedited by Zoran Antonijevic 205 $a1st ed. 2015. 210 1$aCham :$cSpringer International Publishing :$cImprint: Springer,$d2015. 215 $a1 online resource (204 p.) 300 $aDescription based upon print version of record. 311 $a3-319-09074-7 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aNeed for Optimal Design of Pharmaceutical Programs and Portfolios in Modern Medical Product Development -- Clinical Aspects of Pharmaceutical Portfolio Management -- Drug Development and the Cost of Capital -- Investment Considerations for Pharmaceutical Product Portfolios -- Challenges of Portfolio Management in Pharmaceutical Development -- Impact of Phase 2b Strategies on Optimization of Drug Development Programs -- Using Decision Analysis to Support the Design of Clinical Trials at a Program Level -- Indication Sequencing for a New Molecular Entity with Multiple Potential Oncology Indications -- Maximizing Return on Investment in Phase II Proof-of-Concept Trials -- Portfolio Optimization of Therapies and Their Predictive Biomarkers -- Dynamically Optimizing Budget Allocation for Phase 3 Drug Development Portfolios Incorporating Uncertainty in the Pipeline. 330 $aVery little has been published on optimization of pharmaceutical portfolios. Moreover, most of the published literature comes from the commercial perspective, 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 the impact of study design on PoS, and ultimately a portfolio?s value. Design options that are discussed are dose-selection strategies, adaptive design, and enrichment. Some development strategies that are examined 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, focusing 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 basic knowledge of statistics by a reader. . 606 $aOperations research 606 $aDecision making 606 $aMathematical optimization 606 $aStatistics  606 $aOperations Research/Decision Theory$3https://scigraph.springernature.com/ontologies/product-market-codes/521000 606 $aOptimization$3https://scigraph.springernature.com/ontologies/product-market-codes/M26008 606 $aStatistics for Life Sciences, Medicine, Health Sciences$3https://scigraph.springernature.com/ontologies/product-market-codes/S17030 615 0$aOperations research. 615 0$aDecision making. 615 0$aMathematical optimization. 615 0$aStatistics . 615 14$aOperations Research/Decision Theory. 615 24$aOptimization. 615 24$aStatistics for Life Sciences, Medicine, Health Sciences. 676 $a330 676 $a519.5 676 $a519.6 676 $a658.40301 702 $aAntonijevic$b Zoran$4edt$4http://id.loc.gov/vocabulary/relators/edt 906 $aBOOK 912 $a9910298509603321 996 $aOptimization of Pharmaceutical R&D Programs and Portfolios$92518793 997 $aUNINA