Optimization of Pharmaceutical R&D Programs and Portfolios

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.

Addresses the impact of study design on maximizing the output at the portfolio level in the pharmaceutical industry Examines portfolio optimization comprehensively by integrating input from multiple stakeholders Provides an integrated approach that considers value proposition earlier in the clinical development process by incorporating marketing, commercial and medical affairs perspectives Includes supplementary material: sn.pub/extras

Auteur

Zoran Antonijevic is a Senior Director at Cytel Consulting with responsibility for strategic advice at trial, program, or portfolio level. His research areas include: adaptive design, pharmaceutical portfolio optimization, and decision-making within clinical drug development process. Zoran has 20 years of experience in drug development. His prior experience includes positions at Harvard School of Public Health, GlaxoSmithKline, and Quintiles Innovation where his primary responsibility was to develop designs and approaches that maximize probability of success for programs and/or maximize product's value. He also has extensive experience with performing due-diligence, and as a member of product portfolio executive teams. Externally, Zoran is the chair of DIA Adaptive Design Scientific Working Group.

Contenu
Need 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.