識見

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Blockbuster status has long been the heultimate goal of drug development, defined as a sales potential of more than $1bn. The economics of drug development, and in fact of the entire biopharma industry, very much rely on these few gems that provide the returns to compensate for the long development pathway and often several billion dollars of investment per new molecular entity.

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申し訳ありません、このコンテンツはただ今　アメリカ英語　のみです。

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Medicine Maker, January 2017
It seems likely that 2016 will go down as one of the most eventful years in modern
history, but what did the pharma industry make of it? Here, we quiz a number of past
contributors to The Medicine Maker for their opinions on 2016 – and ask them what
priorities and resolutions the industry should focus on for 2017

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While CAR-Ts have already demonstrated convincing efficacy in a specific setting, the jury is still out on whether they are a ‘game-changer’ for oncology as a whole and can justify current valuations and investor interest.

In Vivo – Biopharma R&D, December 2015

Has biopharma R&D productivity increased since last year’s analysis? (See “Value-Based Pharma R&D Productivity: Is There A Sweet Spot?” — IN VIVO, June 2014.) Who are the new entries into the elite top-five group, and who has dropped out? Is the acceleration in innovation, indicated by the increased number of breakthrough designations and FDA approvals, a direct result of improving R&D productivity in our sample of the 30 largest biopharmas?

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IN VIVO, October 2014

The superior R&D and growth performance of companies like Celgene, Gilead, or Biogen can be attributed to a number of factors such as the size of the R&D budget, a high degree of portfolio focus, a good mixture of internal and external innovation sourcing, but most importantly a strong culture, leadership, and the ability to attract the right people.

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pharmind Pharm. Ind. 76, Nr.9 2014

Drug development inarguably is a risky business, especially for biotech companies pursuing novel approaches, and having only a small portfolio further aggravates overall risk of failure at a corporate level. Being able to carry out a standardised, fact-based evaluation of development candidates becomes a crucial factor for decision-making in many contexts e. g. internal portfolio investments, fund-raising, deciding on a project strategy or preparing for out-licensing.

IN VIVO, January 2014

The restructuring of pharmaceutical R&D organizations has failed to address fundamental issues that afflict R&D across several industries. Most of this shortfall can be attributed to a dearth of effective leadership within the C-suites of the drug industry.

European Biopharmaceutical Review, January 2014

Payers worldwide are under increasing pressure to reign in continuously rising healthcare costs. In this article, we will discuss a methodology that pragmatically integrates payer needs into R&D decision-making, and highlights a project’s future sales-at-risk within various payer scenarios. This then allows for the cost-benefit evaluation of various options which can mitigate this risk. Furthermore, the methodology can be used to answer important practical questions such as; what is the estimated maximum sales value of a particular patient segment in the seven major markets? How would this change upon introducing a value-based pricing system into a particular market? This article follows on from part one of the series which outlines the drivers of a payer dominated world.

European Biopharmaceutical Review, October 2013

Across the globe it has become essential for payers to gain control over dramatically rising healthcare costs. This trend, in combination with three other key drivers, is resulting in the decline of the ‘free-pricing’ of pharmaceuticals and the rise of value-based pricing, particularly in the European Union (EU). In this article we discuss each of these factors and highlight how recent developments suggest that value-based pricing is coming to the US, the world’s largest pharmaceutical market. Part two of the series focuses on a practical methodology for integrating payer needs into R&D decision making.

International Pharmaceutical Industry, Vol 5. Issue 4 (Winter 2013)

Applying adaptive licensing strategies can significantly increase the value of R&D projects. Although regulatory frameworks do not include adaptive pathways yet, some strategies already work within the existing regulations and regulators encourage pilot schemes. Thus, a new opportunity to optimise R&D portfolio value has arisen.

European Biopharmaceutical Review, April 2012

Situated somewhere between classic academic research and the biotech industries, translational research institutions require portfolio management that is pragmatic, flexible, and holistic enough to reconcile high project heterogeneity, plus is able to ensure adequate funding and prioritisation of the most promising translational research areas and projects.

Journal of Commercial Biotechnology, Vol 17. Nr 1 (January 2011)

Comprehensive, metric-based portfolio management yields well-known benefits such as increased transparency and the potential for greater objectivity in decision-making. However, the research and development (R&D)-driven characteristics of the pharma and biotech space call for further refinement of general techniques now in use. Because of the years-long timeline for the R&D of products and treatments, and because of similar horizons for testing and for securing regulatory approval, the growth, stability, and even survival of companies in this space are especially sensitive to the quality of portfolio management. In this article, we (1) briefly describe the history of portfolio management and the uneven results of its application in the R&D-centric pharma and biotech space; (2) identify eight factors which can limit the impact and quality of portfolio management in the space; (3) document a four-step process for portfolio management that directly addresses these factors; and (4) document the results of the implementation of this process in the post-merger period at Merck Serono S.A.- Geneva.

European Biopharmaceutical Review, January 2011

Proof-of-concept (PoC) has become a widely used phrase in the biopharmaceutical space. Some pharma companies have gone as far as embedding the principle at the organisational level by dividing their structures into a pre-PoC part (discovery and early development) and a post-PoC part (full development). GlaxoSmithKline, Bayer Schering, Merck Serono and Roche are examples of companies that have implemented organisational variants of this approach. The goal of these re-structuring efforts was to realise more effective decision-making that would be better aligned with the nature of the R&D process and governance than the traditional division of the operating model into discovery and clinical development.