Pharma 2020: Virtual R&D Which Path Will You Take?

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Pharma 2020: Virtual R&D Which Path Will You Take? Pharmaceuticals & Life sciences Pharma 2020: Virtual R&D Which path will you take? Pharma 2020: Virtual R&D 1 TableTable ofof contentscontents Innovation essentials 1 Getting to know ourselves 4 Making research more predictive 6 Expediting development 9 Collaborating to bring treatments to the market 15 Imperatives for change 18 Acknowledgements 19 References 20 Contacts 21 Pharma 2020: Virtual R&D – Which path will you take? is the second in a series of papers published by PricewaterhouseCoopers exploring the future of the pharmaceutical industry. Published in June 2007, Pharma 2020: The vision – Which path will you take? highlighted a number of issues that will have a major bearing on the industry over the next 13 years and outlined the changes we believe will best help pharmaceutical companies realise the potential the future holds to enhance the value they provide to shareholders and society alike. This paper explores the opportunities to improve the R&D process. It proposes new technologies will enable the adoption of virtual R&D; and by operating in a more connected world, the industry in collaboration with researchers, governments, healthcare payers and providers, can address the changing needs of society more effectively. Innovation essentials Pharma is at a pivotal point in Seven major trends reshaping the pharmaceutical marketplace its evolution. As we* indicated The pharmaceutical marketplace is changing dramatically, with huge ramifications in “Pharma 2020: The vision” by for the industry as a whole. We have identified seven major socio-economic trends. PricewaterhouseCoopers, published in June 20071, the social, demographic The burden of chronic disease is clinical advances render previously fatal and economic milieu in which the soaring. The prevalence of chronic diseases chronic. The self-medication industry operates is undergoing huge diseases like diabetes is growing sector is also increasing as more changes (see sidebar, Seven major everywhere. As greater longevity forces prescription products are switched to trends reshaping the pharmaceutical many countries to lift the retirement age, over-the-counter status. The needs marketplace). These challenges have more people will still be working at the of patients are changing accordingly. been compounded by the dearth of point at which these diseases start. The Where treatment is migrating from the good new compounds in its pipeline. social and economic value of treatments doctor to ancillary care or self-care, for chronic diseases will rise accordingly, patients will require more comprehensive but Pharma will have to reduce its information. Where treatment is prices and rely on volume sales of such migrating from the hospital to the products because many countries will primary-care sector, patients will require otherwise be unable to afford them. new services such as home delivery. Healthcare policy-makers and payers The markets of the developing world, are increasingly mandating what where demand for medicines is likely doctors can prescribe. As treatment to grow most rapidly over the next 12 protocols replace individual prescribing years, are highly varied. Developing decisions, Pharma’s target audience countries have very different clinical is also becoming more consolidated and economic characteristics, and more powerful, with profound healthcare systems and attitudes implications for its sales and marketing towards the protection of intellectual model. The industry will have to work property. Any company that wants to much harder for its dollars, collaborate serve these markets successfully will with healthcare payers and providers, therefore have to devise strategies that and improve patient compliance. are tailored to their individual needs. Pay-for-performance is on the rise. Many governments are beginning A growing number of healthcare payers to focus on prevention rather than are measuring the pharmacoeconomic treatment, although they are not yet performance of different medicines. investing very much in pre-emptive Widespread adoption of electronic measures. This change of emphasis medical records will give them the will enable Pharma to enter the realm outcomes data they need to determine of health management. But if it is to best medical practice, eschew do so, it will have to rebuild its image, products that are more expensive since healthcare professionals and or less effective than comparable patients will not trust the industry to therapies and pay for treatments provide such services unless they are based on the outcomes they deliver. sure it has their best interests at heart. So Pharma will have to prove that its The regulators are becoming more medicines really work, provide value for risk-averse. The leading national and money and are better than alternative multinational agencies have become forms of intervention. much more cautious about approving The boundaries between different truly innovative medicines, in the wake * PricewaterhouseCoopers refers to the network forms of healthcare are blurring. The of the problems with Vioxx. of member firms of PricewaterhouseCoopers primary-care sector is expanding as International Limited, each of which is a separate and independent legal entity. Pharma 2020: Virtual R&D 1 Table of contents Pharma’s traditional strategy of Figure 1: The decline in R&D productivity placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well 50,000 60 for shareholders for many years. s 45,000 al However, its productivity in the lab 50 40,000 is now plummeting, as it switches pprov 35,000 A 40 its attention from diseases that are A 30,000 relatively common and easy to treat to 25,000 30 those that are much more complex or 20,000 20 unusual. In 2007, the US Food and Drug 15,000 Administration (FDA) approved only 19 10,000 10 No. of NME, BL new molecular entities and biologics – a R&D Spending (US$ Millions) 5,000 smaller number than at any time since 0 0 2 1983 (see Figure 1) . 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Moreover, the patents on many of the medicines the industry launched in R&D Spending NME and New Biologics Approved (BLA) the glory days of the 1990s will expire NME: over the next few years, leaving Big New chemical or biological prescription therapeutic: excludes vaccines, Pharma very exposed. US research firm antigens and combination therapies which do not include at least one new constituents Sanford C. Bernstein estimates that generic erosion will knock between 2% and 40% off the revenues of the top Source: FDA CDER, PhRMA and PricewaterhouseCoopers analysis 10 companies between now and 2015 Note: Data on R&D spending for non-PhRMA companies are not included here. (see Figure 2). Worse still, it calculates that only four of the 10 have pipelines containing products sufficiently valuable to offset these losses.3 2 PricewaterhouseCoopers Figure 2: The impact of generic erosion on Big Pharma’s revenues “Base Revenue Estimates” (US$ Millions) Company 2008 2015 % Change Novartis $40,529 $45,714 13% Schering-Plough $20,595 $20,216 (2%) Wyeth $22,367 $20,537 (8%) GlaxoSmithKline $22,858 $20,294 (11%) sanofi-aventis $43,177 $36,186 (16%) Merck & Co $29,724 $24,428 (18%) Bristol-Myers Squibb $21,603 $16,364 (24%) Eli Lilly $20,275 $15,286 (25%) Pfizer $48,639 $34,075 (30%) AstraZeneca $31,522 $18,878 (40%) Source: Bernstein estimates and analysis Note: These figures show each company’s “base revenues” from products that are already on the market. They exclude any future pipeline contributions This “innovation deficit” has enormous We believe that, if the industry is to strategic implications for the industry become more innovative and cut its as a whole. Many pharmaceutical R&D costs, four features will be vital: companies need to decide what they • A comprehensive understanding of want to concentrate on doing and how the human body works at the identify the core competencies they will molecular level require, a process which may involve exiting from some parts of research and • A much better grasp of the development (R&D). But even those that pathophysiology of disease (by regard research and development as a which we mean the functional core element of their business will have changes associated with, or arising to make fundamental alterations in the from, disease or injury) way they work. They may, for example, • Greater use of new technologies to have to focus more heavily on speciality “virtualise” the research process and therapies, since most of the diseases accelerate clinical development; and for which there are currently no effective medications or cures are not amenable • Greater collaboration between the to mass-market treatments, as well as industry, academia, the regulators, reducing the time and costs involved governments and healthcare in researching and developing such providers. medicines to ensure that society can We shall discuss some of the changes afford them. we consider necessary in more detail in the following pages. Pharma 2020: Virtual R&D 3 Getting to know ourselves At present, when pharmaceutical predictive models and generate further Virtual vermin companies start investigating biological knowledge. The American Diabetes Association targets, they may know relatively little Bioinformatics experts aim to create a and US biopharmaceutical company about how those targets are involved complete mathematical model of the Entelos have developed a diabetic in the diseases they want to treat. The molecular and cellular components of the virtual mouse that is being used to information they possess usually comes human body – a “virtual” man – which study cures for Type 1 diabetes. from academic literature and patents, can be used to simulate the physiological Researchers can simulate the effect and is often based on animal studies, effects of interacting with specific targets, of new medicines, including different which may not be relevant to the way in identify which targets have a bearing on dosing levels and dosing regimens, which a disease progresses in humans.
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