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The Economist Intelligence Unit. The Innovation Imperative: The Future of Drug Development Part II: Barriers, Enablers and Calls to Action.The Economist. 2018. Compare the four major techniques discussed in the article according to the four design-criteria feasibility, viability, desirability, and conducive to life. The techniques are adaptive trial designs; patient-centric trials; precision medicine trials; and real-world trials. Be sure to define each criterion and how you would measure them. Include trial efficiency (viable), likelihood to launch (viable, feasible, humanly desirable), and formulary or market access approval (feasible) within the design criteria
A report by The Economist Intelligence Unit The Innovation Imperative: The Future of Drug Development Part II: Barriers, Enablers and Calls to Action Commissioned by The world leader in global business intelligence The Economist Intelligence Unit (The EIU) is the research and analysis division of The Economist Group, the sister company to The Economist newspaper. Created in 1946, we have over 70 years’ experience in helping businesses, financial firms and governments to understand how the world is changing and how that creates opportunities to be seized and risks to be managed. Given that many of the issues facing the world have an international ( if not global) dimension, The EIU is ideally positioned to be commentator, interpreter and forecaster on the phenomenon of globalisation as it gathers pace and impact. 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Through a distinctive blend of interactive conferences, specially designed events, C-suite discussions, member briefings, and high-calibre research, The Economist Corporate Network delivers a range of macro (global, regional, national, and territorial) as well as industry-focused analysis on prevailing conditions and forecast trends. http://www.eiu.com/consumer http://www.eiu.com/healthcare http://www.eiu.com/healthcare http://www.eiu.com/publicpolicy http://www.eiu.com/publicpolicy THE INNOVATION IMPERATIVE: THE FUTURE OF DRUG DEVELOPMENT PART II: BARRIERS, ENABLERS AND CALLS TO ACTION © The Economist Intelligence Unit Limited 20181 Foreword 2 Impetus for the research program 3 Innovations prove impactful but face adoption barriers 6 The data are vast, new—and fragmented 7 The workforce is not large enough or adequately trained 8 Payers and patients have negative perceptions of pharma’s approach to innovation 8 Cultural barriers surround drug development and innovation 9 The known unknowns—understanding the true barriers today and in the future 11 Overcoming challenges by enabling future innovations 12 Advanced data and analytics 14 Workforce readiness 15 Collaborative partnerships 17 Early regulator, payer and patient engagement 18 Conclusions and calls to action 23 Appendix 25 Methodology for qualitative analysis 25 References 28 Contents THE INNOVATION IMPERATIVE: THE FUTURE OF DRUG DEVELOPMENT PART II: BARRIERS, ENABLERS AND CALLS TO ACTION © The Economist Intelligence Unit Limited 20182 Foreword Part II of The Innovation Imperative: The Future of Drug Development is a call to action. Together with the deep and insightful findings presented in Part I, it lays out a blueprint for reversing one of the most talked-about and worrying trends in healthcare: the unsustainable path of drug development. Encouragingly, it provides evidence that, by and large, the tools required to significantly improve all key performance indicators in this industry already exist, and can be leveraged by eliminating inertia and focusing on the right set of powerful enablers for success. As part of our organization’s heritage, The Economist Intelligence Unit (EIU) has a long history of questioning the status quo through a holistic understanding of the world, fact-driven analysis and thought-provoking conclusions. In the health arena this translates into reinforcing the much-hyped but still not fully implemented shift towards value across the continuum of care, as this is the most logical and in all likelihood, the only way to achieve a sustainable system in the future. Much of our work on this topic over the past decade has sought to educate and guide participants by breaking down issues to their core and building them back up through a combination of real evidence and pragmatic application. While many (including the EIU) have devoted attention to assessing the demonstrated impact of specific health policies and interventions, little work has been done on how to transform an inefficient drug development system. This is a critical component of the value equation, as the flow to market of timely, safe and accessible new drugs that improve patient outcomes is necessary to combat growing societal health challenges. In this sense, discovering avenues for greater productivity in drug development will in turn help to facilitate a process that is crucial in keeping pace with the promise of medical science. I was struck by a number of insights arising from our research. While it was not a shock to see that key innovations have a positive impact on improving drug development, it was a revelation to find such a consistent effect across multiple success metrics, geographies and therapeutic areas. It was also immensely valuable to quantify this impact for the first time, as simply assuming it to be true does not act as an impetus for measurable change. At the same time, I was encouraged to see so much recognition by experts around the importance of not just understanding the science of data analytics, but of actively seeking to create a collaborative ecosystem in which data and knowledge could readily flow among the people who want to build upon the learnings of others. It is also clear that the path forward is not a linear one, or simply a matter of institutionalizing the innovations studied. As this report lays out in detail, there are building blocks that require attention and investment in order to support the innovations to come as well as the ones we have in our toolkit today. And while high-profile topics like big data and collaborative partnerships garner much attention (with good reason), we should not lose sight of less hyped but equally critical issues like the necessity of providing the workforce with the skills needed to adapt to whatever may come in the future. In the end, our hope is that this research incites not just educated dialogue among stakeholders but, more importantly, collective action with a common purpose: to foster a dynamically innovative and ultimately sustainable approach to developing future drugs that will have a positive impact on patients. David Humphreys, Head of Health Policy & Clinical Evidence Practice, EIU Healthcare THE INNOVATION IMPERATIVE: THE FUTURE OF DRUG DEVELOPMENT PART II: BARRIERS, ENABLERS AND CALLS TO ACTION © The Economist Intelligence Unit Limited 20183 Impetus for the research program While innovations across many industries are driving better returns and greater efficiency at lower costs, this is not the case with pharmaceutical drug development. In fact, the research and development (R&D) process has become more expensive over time, exacerbated by the end of the blockbuster drug era, the patent cliff, and increasingly complex trials and regulatory and payer approvals processes.1,2 This process, known as Eroom’s Law (the observation that drug discovery is becoming slower and more costly over time), represents the major challenge facing drug companies in today’s development landscape. The urgency around the adoption of innovation in drug development cannot be overstated in an industry with a failure rate that can be as high as 90%, in which the average time to market for a new drug has hovered around 12 years for the past three decades and where the R&D costs of developing a drug more than doubled between 2003 and 2016.3,4,5,6 At the same time, the R&D pipeline is obviously a significant expense for pharmaceutical companies (especially given that overall investment in development picked up in 2017).53 Still, despite the imperative for innovation that this predicament presents, productivity has stagnated or fallen.53 So far, the pharmaceutical industry has been slow to react to new innovations in drug development, particularly in comprehensively assessing the impact of new approaches. This has left it without the necessary evidence to prove the effectiveness of drug development innovations to both industry insiders and other stakeholders—notably regulators, payers and patients. Healthcare systems and patients face the consequences of this uneven performance. The ramifications include higher drug costs and longer times to market—and the access issues arising from these factors. Aging populations, the rising prevalence of chronic diseases and healthcare budgets Source: EIU calculations based on Mestre-Ferrandiz J et al and DiMasi JA et al. 7, 8 Figure 1: Projecting future R&D costs per drug (Eroom's law) 0 5,000,000,000 10,000,000,000 15,000,000,000 20,000,000,000 2,5000,000,000 204320342025201620112003 88% 70% 100% 100% 100% THE INNOVATION IMPERATIVE: THE FUTURE OF DRUG DEVELOPMENT PART II: BARRIERS, ENABLERS AND CALLS TO ACTION © The Economist Intelligence Unit Limited 20184 that outstrip inflation all increase the financial burdens of healthcare on governments and families. Ultimately, the costs to society of little or no progress in drug development productivity are both human and economic. The worrying trends on cost, time to market and patient impact suggest that overcoming entrenched risk aversion and leaning into the opportunities that innovation offers is imperative. With this in mind, PAREXEL commissioned The Economist Intelligence Unit (EIU) to evaluate the dynamics of innovation in drug development and gain an understanding of current perspectives among industry stakeholders. The result was a study that examined measurable innovations in drug development and identified the underlying factors that both hold these innovations back today and will