Biotechnology in Thoughts from the Centre
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By Maria João Cruz, PhD, Research Analyst, Centre for Health Solutions, and Jose M. Suárez, Manager, Life Sciences Advisory
The COVID-19 pandemic has claimed over 1.1 million lives and infected over 45 million people worldwide, numbers that continue to increase.1 Alongside its devastating human impact, the pandemic has exerted unrelenting pressure on pharma and healthcare supply chains. COVID-19 has exposed the fragility of our medical supply chains, and highlighted their global inter-dependencies and vulnerability to shock. We have also experienced major challenges in the medical equipment supply chain, including manufacturing, transport and distribution of testing kits, personal protective equipment (PPE), and ventilators. However, these challenges pale in comparison to the huge task ahead of us in getting life-saving COVID-19 vaccines to people around the world, in record time, to halt the spread of this virus. Importantly, this will have to be done while maintaining production, distribution and administration of other life-saving therapies, including the seasonal flu shots, and other essential medicinal products.
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
Wake me up when September ends: my reflections on the search for a treatment for Alzheimer’s disease, in honour of World Alzheimer’s Month
By Dr Francesca Properzi, PhD. Research Manager, Centre for Health Solutions
Since 2012, September has been celebrated as World Alzheimer’s Month, and this year’s theme is 'Let's talk about dementia'. This is clearly much needed, especially as one person is diagnosed with dementia every three seconds.1 As a neuroscientist, I spent more than 10 years leading a research lab dedicated to finding new approaches for diagnosing and treating neurodegenerative diseases at the Italian Institute of Health in Rome. I also had first-hand experience of the disease, as I had originally accepted that position and left my job in London, to take care of my father, who was himself fighting dementia. Those years have shaped me greatly both personally and professionally and, as September coincides with my last month at the Deloitte Centre for Health Solutions, I am delighted to use this blog to provide my reflections on the challenges presented by Alzheimer’s disease and to consider what more needs to be done to expedite progress in identifying treatments and ultimately a cure.
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.
By Maria João Cruz, PhD, Research Analyst, Centre for Health Solutions
In early May, we published a blog about the race for a COVID-19 vaccine.1 At the time, biotech and biopharma companies together with research organisations and academia had commenced the development of some 110 potential vaccines against SARS-CoV-2. Notable features of the race include the unprecedented acceleration in the pace of R&D and the significant scale of collaboration and cooperation between stakeholders across multiple geographies.2 By the end of August, there are 203 vaccine candidates under development. Six have already reached Phase III or II/III clinical trials, the last stage of clinical development before vaccines can obtain regulatory approval (see Figure 1).3,4 This was achieved in only few months, rather than the years it would normally take.5 Importantly, the COVID-19 vaccine developers are using a variety of technologies and techniques, ranging from the tried and tested to completely novel approaches. This blog explores the different approaches being used for obtaining an approved and licenced vaccine.
By Maria João Cruz, PhD, Research Analyst, Centre for Health Solutions, and Alex Grisman, Director, Deloitte
Clinical trials are vital to find out whether a new medicine (or medical device) is safe, effective and better than existing treatments. Essentially, clinical trials serve to accumulate sufficient, robust evidence to assure regulators of the patient benefits from a new medical intervention. The COVID-19 pandemic has overwhelmed medical infrastructures and had a significant disruptive effect on the current clinical trial landscape. A number of our previous blogs have examined the response of biopharma companies in pivoting their research activities to try and develop COVID-19 treatments and vaccines.1,2 This week we take a look at the challenges COVID-19 is presenting to the operation of other clinical trials, including site and participant selection recruitment and retention, and the strategies that biopharma is adopting to mitigate these challenges.
By Mike DeLone, US life sciences leader, Deloitte LLP
I am particularly pleased this week to share with you a blog by Mike DeLone, the national sector leader for Deloitte’s US Life Sciences practice. Mike’s clear articulation of why he is feeling inspired by what he is seeing in the life sciences sector, resonated strongly with me, and I hope will resonate with those reading this blog.
By Greg Reh, Deloitte Global 's Life Sciences & Health Care practice
This week we are delighted to share with you a blog written by Greg Reh who leads the life sciences practice for Deloitte Global. The focus is on partnerships and collaborations which have been a feature of the industry for a number of years — particularly in terms of preventing infections and communicative diseases in underserved parts of the world. However, the COVID-19 pandemic has elevated the importance and viability of collaborations, both inside and outside of the life sciences sector, and has accelerated activity, including increasing dialogue and commitment among key industry stakeholders.
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 Dr Francesca Properzi, PhD. Research Manager, and Maria João Cruz, Research Analyst, Centre for Health Solutions
This week we launched the fourth in our series of reports highlighting the impact of artificial intelligence (AI) across the biopharma value chain. Our report, Intelligent drug supply chain: Creating value from AI, explores the digital transformation of biopharma’s global supply chains and how AI can help improve value and manage risks more effectively. Given the unprecedented challenges as a result of the COVID-19 pandemic, the report also considers the role that AI can play in helping supply chains respond, recover and thrive.