By Zoran Antonijevic
Very little has been released on optimization of pharmaceutical portfolios. additionally, so much of released literature is coming from the industrial facet, the place likelihood of technical luck (PoS) is handled as mounted, and never due to improvement method or layout. during this ebook there's a robust specialize in impression of research layout on PoS and finally at the price of portfolio. layout recommendations which are mentioned in several chapters are dose-selection innovations, adaptive layout and enrichment. a few improvement techniques which are mentioned are indication sequencing, optimum variety of courses and optimum choice criteria.
This publication comprises chapters written through authors with very vast backgrounds together with monetary, scientific, statistical, selection sciences, advertisement and regulatory. Many authors have lengthy held government positions and feature been concerned with determination making at a product or at a portfolio point. As such, it truly is anticipated that this booklet will allure a truly huge viewers, together with determination makers in pharmaceutical R&D, advertisement and fiscal departments. The meant viewers additionally contains portfolio planners and executives, statisticians, determination scientists and clinicians.
Early chapters describe ways to portfolio optimization from tremendous Pharma and enterprise Capital standpoints. they've got more advantageous concentrate on funds and techniques. Later chapters current chosen statistical and determination research equipment for optimizing drug improvement courses and portfolios. a few methodological chapters are technical; in spite of the fact that, with a couple of exceptions they require a comparatively easy wisdom of information via a reader.
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Little or no has been released on optimization of pharmaceutical portfolios. furthermore, such a lot of released literature is coming from the economic part, the place chance of technical good fortune (PoS) is handled as mounted, and never as a result of improvement process or layout. during this publication there's a powerful specialize in impression of analysis layout on PoS and eventually at the price of portfolio.
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Additional resources for Optimization of Pharmaceutical R&D Programs and Portfolios: Design and Investment Strategy
The inherent probability of success for any given molecule is unknown (Fig. 2). Furthermore, even if the molecule is actually effective, clinical trials may not demonstrate it as such. The probability of success of a molecule is therefore determined by its efficacy relative to the standard of care or placebo, and the power of the trial relative to the efficacy observed in the trial’s sample patient population. The product’s inherent efficacy is the ultimate unknown in the R & D process so researchers design trials and sample patient populations with the goal of demonstrating the product’s effectiveness and safety (Sidebar 1).
Well understood drugs, with a strong track record of historic sales, for example, should be expected to sell well when positive data is generated in the pediatric setting. An increase in the PoS for registration 2 Clinical Aspects of Pharmaceutical Portfolio Management 31 should also be expected for products with extended release formulations or 505(b)2 applications. The converse is also true. For example, some drugs that work in some settings may not work well in adjunct but apparently similar indications (at least from a therapeutic class standpoint), for example a schizophrenia drug moving into manic depressive disease.
This de-risking process, however, can destroy value in other ways. To increase confidence in the asset before committing significant capital to a long and costly trial, companies typically run multiple earlier studies which extends the overall development timeline, increases costs and reduces the net value of the program. 1). In addition to the inherent complexities and pitfalls of drug development, inflexible corporate processes and infrastructure further hinder pharma companies’ ability to deliver value from their R & D pipelines.
Optimization of Pharmaceutical R&D Programs and Portfolios: Design and Investment Strategy by Zoran Antonijevic