Regulatory in Thoughts from the Centre
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By Dr Maria João Cruz, PhD, Assistant Manager, UK Centre for Health Solutions, and Sonal Shah, Senior Manager, US Center for Health Solutions
This week we launched Seeds of change: Measuring the return from pharmaceutical innovation 2020, the 11th report in our series on biopharmaceutical (biopharma) R&D. Since 2010, we have provided insights into the state of biopharma R&D by tracking the returns that leading global biopharma companies might expect to achieve from their late-stage pipelines. While the past few years has seen an increase in breakthrough advances in science and technology, the growing complexity of development and longer cycle times have reduced the average internal rate of return (IRR) for the cohort of companies covered by our research and placed mounting pressures on the industry. In addition, over the past 16 months, the search for treatments and vaccines against the COVID-19 virus have galvanised innovation at an unprecedented pace and scale. At the same time, many non-COVID-19 clinical trials have been delayed or even halted. This week’s blog explores our 2020 report findings and how companies can realise a productive future for drug development.
By Karen Taylor, Director, Deloitte Centre for Health Solutions
Over the last few weeks of 2020 we published a series of ten predictions on what the future of healthcare and life sciences looks like in 2025. Each prediction follows the same format, including a number of ‘portraits’ imagining the experience of individuals and organisations in 2025, the evidence today that enables us to predict tomorrow and the common constraints that need to be overcome to realise the prediction. We also considered how the COVID-19 pandemic has affected each prediction. Subsequently, we brought all of the predictions together in one report: The future unmasked: Predicting the future of healthcare and life sciences in 2025 and launched a podcast with senior leaders from our life sciences and healthcare practice discussing how the predictions affect their parts of the industry. I have used this first blog of 2021 to examine the cross cutting constraints that need to be overcome to realise our view of the future.
By Maria João Cruz, PhD, Research Analyst, Centre for Health Solutions
Clinical trials provide the necessary evidence to prove safety and efficacy of new treatments and medical products. Given that the responses to a specific medication may differ among population subgroups depending on factors such as age, sex, genetic profile and ethnicity, clinical trials need to reflect the demographic diversity of the population that a pharma product is intended to serve.1,2 Last August the Centre published a blog on the importance of inclusion and diversity in clinical trials and why it should be a research priority. At the time, we highlighted the initiatives being launched by regulatory bodies to improve diversity in clinical research but noted that, while there have been some improvements, pharma companies were still struggling to enrol participants from diverse demographic groups, particularly women, racial and ethnic minorities, and the elderly.3
By Sarah Thomas, managing director, Deloitte Center for Health Solutions, Deloitte Services LP, and Greg Szwartz, managing director, Life Sciences data science practice lead, Deloitte Consulting LLP
This week we are sharing a blog written by our US colleagues, Sarah Thomas, the managing director of Deloitte’s US Center for Health Solutions, and Greg Szwartz, who leads the life sciences data science practice for Deloitte Consulting LLP. The focus of their blog is on ‘vaccine hesitancy’ and the finding from surveys that show that 25 to 50 per cent of Americans have said they would be hesitant to get a COVID-19 vaccination due to concerns about safety and the unprecedented speed of development. In the UK, a survey by Ipsos MORI and King’s College London found that 53 per cent of respondents said they would certainly or very likely get a vaccine against COVID-19, and 16 per cent that they are unlikely to, or definitely will not, get the vaccine.1 We believe that the strategies and tactics identified in the US blog to help improve understanding of behaviours and increase uptake of inoculations are relevant to the UK and indeed to most countries.
How COVID-19 has accelerated the development of vaccines and medicinal therapies: lessons for the future of regulation
By Malka Fraiman and Paulien Nuyts
The COVID-19 pandemic has had a profound impact on countries across the world and, in the absence of any known therapies, galvanized a global race to find safe and effective treatments and vaccines. Regulators have responded swiftly to help expedite drug development and approval. This blog focuses on two of the geographies most affected by COVID-19, Europe and the United States of America (US), and specifically the response of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). It considers the challenges and opportunities that arise from the changes in the regulatory landscape and the implications for the future of medicines regulation.
By Paul van Geffen and Eleonora Lena, Deloitte Risk Advisory
The COVID-19 pandemic has disrupted everyone’s daily lives and touched every industry across the world. While many countries had influenza and other pandemic preparedness plans in place prior to COVID-19, no one was fully prepared for the speed and indiscriminate spread of the disease. Indeed, in many countries the demand for appropriate medical devices and equipment quickly outstripped supply, leading to critical shortages, particularly of ventilators and personal protective equipment (PPE). Consequently, traditional and novel medical equipment manufacturers have pivoted many of their activities to meet this demand. At the same time, international and national regulators have had to adapt their approach to granting market approval. These changes have implications for the future of medical device regulation.
By Karen Taylor, Director, and Maria João Cruz, Research Analyst, Centre for Health Solutions
According to the World Health Organization (WHO), rapid testing of patients who meet the suspected case definition for COVID-19 is a priority for determining the clinical management and policy response to control the outbreak.1 Diagnostic testing for COVID-19 is critical to track the spread of this novel virus, understand its epidemiology, inform health managers of each case, and suppress transmission.2 Currently, different countries have implemented different testing strategies, depending on the availability of diagnostics kits and reagents, and on the capacity and capability of the healthcare system. However, there has been a global call to increase the speed and capacity for testing to help isolate cases and flatten the peak. This week’s blog explores the importance of testing, what tests can be done and which are already available.
By Karen Taylor, Director, Centre for Health Solutions
Our previous reports have highlighted the increasing number of innovations that have led to life-saving and life-enhancing clinical treatments and how, over the past 30 or so years, healthcare has moved from treating infectious or communicable diseases to managing a ‘tidal wave’ of complex age and behaviour related, non-communicable, diseases.1 This transition was made possible by the development and widespread use of vaccines and antibiotics which dramatically reduced the prevalence and improved outcomes for most infectious diseases. Today, this scenario has been turned on its head as people across the world face the unrelenting human and economic impact from a novel, infectious, coronavirus SARS-CoV-2 (named COVID-19 disease). On 11th March the World Health Organisation (WHO) declared COVID-19 a pandemic, and the biopharma industry is now in a race to develop both preventive and therapeutic interventions.
By Dr Francesca Properzi, PhD. Research Manager, and Maria João Cruz, Research Analyst, Centre for Health Solutions
This week we launched the third report in our series on the impact of artificial intelligence (AI) across the biopharma value chain. This latest report, Intelligent clinical trials: Transforming through AI-enabled engagement, explores how AI, in particular machine learning and natural language processing, can reduce clinical trial cycle times while reducing the costs and improving the productivity and outcomes of clinical development. In this blog, we highlight the main takeaways from our report.
By Mark Green, Director Board Advisory
The NHS Long Term Plan (LTP) and the development of STPs, ICSs, ICPs and now PCNs (see Figure 1), not only makes for a mouthful of acronyms, but also raises the prospect of a governance headache. While the LTP requires every NHS organisation and their local partners to become part of a geographically-based ICS by April 2021, and recognises that it’s possible to implement the necessary changes without primary legislation, it also acknowledges that legislative change could make implementation easier and faster.1 However, there are currently limited signs of any primary legislation being introduced in the short to medium term to support and guide the shift in health and care policy.