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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.
By Karen Taylor, Director, Centre for Health Solutions
Since the outset of the COVID-19 pandemic debate has been growing about the benefits or otherwise of the general public wearing face masks to help control the spread of the virus. While arguments exist on both sides of the debate, history and culture has played a crucial role in polarising opinions. Nevertheless, all countries have accepted the need for mitigation strategies and importantly, the views of public health advisors and most governments have now converged in favour of wearing masks. While growing numbers of people across the world have begun to wear face masks in public, confusion still remains as to the merits or otherwise of wearing a mask. This week’s blog discusses of the supporting evidence for face masks and, why they have become the new ‘must have’ accessory.
By Samrina Bhatti, MRPharmS, PGDipGPP, Manager, Centre for Health Solutions
The growth of antimicrobial resistance (AMR) is widely acknowledged as an urgent public health challenge, causing at least 700,000 deaths globally every year.1 AMR also presents serious financial threats in healthcare costs and productivity losses.2 Although COVID-19 is caused by the SARS-CoV-2 virus, a growing body of international evidence shows that the global threat of AMR is worsening due to the fact that many patients with COVID-19 symptoms are being prescribed antibiotics partly due to uncertainty about the pathology of the infection; and as a precaution in preventing and treating secondary bacterial infections.3
By Francesca Properzi, PhD, Research Manager, Deloitte Centre for Health Solutions
The COVID-19 pandemic continues to have serious and far reaching consequences for the health and wealth of our population. As countries begin to move into the recovery phase, there is an urgent need to learn the lessons from local, national and international responses. A critical feature of the past four months has been an explosion in the scientific data and literature exploring how and why the pandemic has evolved and what impact is it having. This data suggest the virus is highly discriminatory and that in addition to the underlying health and age of individuals, deprivation and population density are crucial causes of higher mortality rates. What is currently less evident are insights on what we could have done to be better prepared and how we can be better prepared next time? This week’s blog provides ‘my take’ on how improving the immune health of vulnerable populations has a pivotal role to play.
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 Steve Burrill, vice chairman, US Health Care Leader, Deloitte LLP
This week we wanted to share with you one of the insightful blogs from our colleague in the US on the impact that COVID-19 is having on their healthcare system; and which first appeared as a US Center for Health Solutions ‘Health Forward’ blog on 28 May. While the image of empty hospitals, healthcare job losses and funding challenges aren’t things we expect to see in the UK, the description of the reality of the past three months for healthcare staff on the front-line, and how to address the growing backlog of deferred medical services, does resonate. Moreover the main thrust of the blog, on the four key areas of healthcare that COVID-19 is likely to change in the ‘future of health’, is something we do expect to see happening across the UK and Europe and, likewise, we expect this to happen much more quickly than we might previously have predicted.
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.
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 Samrina Bhatti, MRPharmS, PGDipGPP, Manager, Centre for Health Solutions
COVID-19 has been a powerful stimulus in catalysing the use of technology. This has led to digital technologies becoming embedded more than ever in our everyday lives and, importantly, within healthcare roles. As a result, the digitalisation of healthcare practices and the amount of data held within electronic health records is growing exponentially. However, we are still catching up on methods of optimising the use of all of this data and generating actionable insights. As a pharmacist who has worked both locally and nationally, I have seen the positive effects that increased digitalisation can have on prescribing and administration practices.