Laboratory medicine aggressively employs new technology to enhance clinical decision-making, disease monitoring, and patient safety. The potential for innovation to transform healthcare systems and laboratory medicine is enormous, and it has the potential to equip healthcare professionals with the information and tools they need to enhance the quality of care offered to more patients with the same or fewer resources. Because of recent advancements, data and AI have become increasingly powerful tools.

Data science and AI are already changing how we live as people and how our businesses, markets, and governments operate. Artificial intelligence (AI) comprises a wide variety of approaches to replicating human cognition, ranging from problem-solving and learning to computers mixed with complex mathematical models. AI has the potential to significantly improve patient quality and safety of care by transforming current diagnostic and disease prevention and control methods, making it one of the most promising fields of application for big data and AI.

As the access to massive amounts of data becomes more readily available, the promises and expectations of the big data and AI sectors are rising exponentially. Compared to other medical fields, laboratory medicine has been among the most technologically sophisticated. Since their debuts, automation, electronic result transmission, and electronic reporting have all achieved significant acceptance.

Furthermore, medical laboratories have extensive databases containing test results and quality control outcomes, and often feature advanced quality management systems. As a result, it should be no surprise that laboratory medicine is a model sector for medical innovation in the digital era. On the other hand, cutting-edge data science advances like AI and ML have yet to reach many fields of laboratory medicine.  Regardless, the time has come. Researchers now have access to three critical components for enhancing laboratory medicine: learning and training algorithms, computing power to run those algorithms, and vast amounts of data.

Recent COVID-19 outbreaks are thought to have contributed to this spread. Even if its worldwide spread has had terrible public health consequences, the pandemic may be a driving force for technological innovation and artificial intelligence. Because of the growing demand for high-quality care and the diminishing availability of resources, healthcare practitioners must embrace the concept of adaptability to a changing technological environment and overall current practices.

Following the global incident, the European Commission published the Expert Panel on Effective Ways of Investing in Health’s Opinion on how to structure resilient health and social services. The advisory presents a framework for health-system resilience testing. It underlines the components and conditions for capacity building to strengthen health-system resilience, as well as to address the healthcare needs of vulnerable patients during times of crisis. Among the many themes discussed were the necessity of data, data integration, and artificial intelligence in countering unanticipated outbreaks.

Several reports have been published about the successful implementation of AI-based solutions for COVID-19, such as AI-based outbreak monitoring apps, AI-based diagnostic Chabots, AI-based assessment of scholarly publications, AI-based triage utilising text analytics for evaluating probable patients, AI-powered prognosis prediction tools utilising radiology CT scans; and so on.

Today, there are several examples of evidence for treating non-communicable chronic diseases such as cancer or cardiovascular difficulties, as well as the added advantage of big data and AI. Artificial intelligence technologies are designed to increase patient safety, treatment quality, and the speed with which clinicians can treat their patients. There is no question that big data and AI can help with decision-making by improving diagnostic and predictive capabilities. In cancer and cardiovascular medicine fields, artificial intelligence (AI) has shown considerable promise in extracting deep phenotypic information from imaging, laboratory, and other medical device data.

AI provides benefits in various domains, including discovering novel genotypes and phenotypes in existing chronic diseases, improving patient treatment quality, and facilitating cost-effectiveness via reduced readmission and mortality rates. The application of AI-based technology may predict the success or failure of clinical research and the unintended effects of polypharmacy combinations.

Furthermore, “digital twins” and other AI-powered technologies may aid clinical teams in planning clinical trials by connecting eligible patients to relevant studies, enabling clinicians to forecast how a certain illness or treatment would affect patients. Big Data and AI are clear facilitators of personalised medicine via early risk prediction, prevention, and therapeutic action. Laboratory and biological data will be very useful to artificial intelligence systems.

Big data and artificial intelligence have a critical therapeutic impact. They also have the ability to make laboratories more sustainable and efficient by reducing waste, simplifying operations, and allowing for more rational ordering of lab tests. With the value and benefits of big data and AI becoming more palpable, it is more critical than ever to incorporate the technologies into day-to-day operations properly.

There are still numerous challenges to overcome, such as the need to build data ecosystems and architectures that will feed and shape AI, merge and reap the benefits of the upcoming “European Data Space”, include healthcare staff in external validation and demonstrate the generalisation of AI technologies, integrate digital and AI-related material into existing training and education programmes for medical professionals, and create a strong political and legislative framework.

Experts in laboratory medicine and clinical laboratories will play critical roles in this transition, with responsibilities including, at a minimum, the provision of standardised and organised data, advise on the type of data to be used, the integration of multidisciplinary teams for the validation of AI-derived instruments, and the use of these devices to maximise healthcare quality, lab procedures, and outcomes.

The application of data science, big data, and AI in its various applications, from protection and testing to early diagnosis and illness management, may radically improve the healthcare experience for patients at every stage of the continuum. The successful and secure integration of big data and AI technologies, as well as staff training and patient education, will depend largely on diagnostics and clinical laboratory specialists’ skills. International healthcare systems stand to benefit greatly from the careful use of big data and AI technologies.

References available on request.

Abdulaziz M Aljohani is the Operations Administrator, Laboratory Services at Prince Mohammed bin Abdulaziz Hospital in Riyadh, and Najah Almutairi, Medical Technologist I, Pathology & Laboratory Department, Prince Mohammed Bin Abdulaziz Hospital — MNG-HA in Medina.

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This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Looking at industrial development eras in the history of humanity, the world experienced four industrial revolutions starting with the industry 1.0 revolution by the end of the 18th century where we saw the use of water and steam-powered mechanical production facilities. It was the era of power generation, mechanical production, and railroads driven by the advancements in engineering sciences.

The beginning of the 20th century introduced the use of electrical power, which enabled work-sharing mass production and the advent of the assembly line paved the road for the industry revolution 2.0. With 100 years of electronics, production improvements and information technology leaps, automated production became the norm and computers became predominant in shaping industry revolution 3.0.

The advancement milestones in medicine started to appear on the horizon in the 1960s when the hidden secrets of human DNA data began to reveal useful information in understanding the human genome and causes of diseases at the cellular levels. This led to fast jumps in advancing diseases and syndromes’ diagnostic testing, predictions of infections, as well as advanced treatment regimes.

Trilogy matrix of healthcare

The acceleration of digital technology and discoveries of the human genome project in 2000, it became evident that six characters 0, 1, A, T, C, and G are rebooting medicine and health in modern medicine today to enhance the quality of life. Personally, I strongly believe that human DNA discoveries, combined with Information Technology (IT) and quality are forming the new “Trilogy Matrix” for the upcoming generations, where diseases, cancers, and syndromes could be prevented — not just predicted — and the quality of human life would be much better with efficient and cost-effective treatments.

Big data, artificial intelligence, robotics, three digital printing, internet of things (IOT), social media, virtual reality, and simulation are the new tools shaping the 4.0 industry revolution. Today, cyber-physical systems are being implemented to monitor, analyse and automate all kinds of businesses, not just industrial facilities, and quality has always been the mirror of good indusial outcomes. It accompanied all manufacturing industrial revolutions without obvious exposure, until after the second world war when Dr. Edward Deming and other quality gurus started to put the framework of quality as a science and put its applications and statistical tools in action to monitor and improve processes and their efficiencies and effectiveness. They started to identify customers and classify them into external, internal, and other stakeholders. They provided approaches to measure their satisfaction, expectations, and feedback.

Rise of quality protocols

Quality control (QC) standards started to become dominant between the ‘50s and ‘60s to ensure consistency, focusing on output and based on inspectorate responsibility then matured to quality assurance (QA) between the mid-60s to mid-70s. Quality Assurance works through a system for the purpose of efficiency using a feed-forward mechanism, unlike QC which used a feedback mechanism. In Quality Assurance, each business unit carries the responsibility for it.

The concept of Quality Management was introduced between the mid-80s to 90s when corporate leadership started to recognise quality as a management style to improve business outcomes and increase market shares. In the mid-90s, Total Quality Management (TQM) was introduced as an ultimate, mature approach because it works through people with the purpose of effective results.

The focus of an organisation that adopts the TQM approach is on the outcome with special attention to corporate social responsibility. In TQM laboratories, everybody is responsible for the quality. A TQM company depends on a mutual relationship mechanism with its customers which is a much better proactive approach than being reactive and awaiting feedback after the products or services have been delivered.

The TQM model has been recognised by many organisations such as the European Foundation for Quality Management (EFQM) as a roadmap for organisational excellence, which each corporate vision aims to achieve and excel. With the advancement of industrial revolution 4.0 based on digital acceleration and quality maturity to improve the human quality of life, the international community of quality professionals claimed the start of quality 4.0 aiming to take all healthcare worldwide including clinical laboratories to a much higher paradigm. Quality 4.0 is not really a story about technology. It is about how that technology improves culture, collaboration, competency, agility, empathy, sustainability, and leadership.

We should shed the light on different laboratory accreditations models which are obtained to ensure that the laboratory is implementing a set of requirements or standards to ensure laboratory workflow from pre-analytical, analytical, and post-analytical are correctly and appropriately followed to ensure laboratory results are useful for proper diagnosis and follow ups.

In 2006, I wrote an article in Medlab magazine highlighting the importance to build laboratories based on quality, not just accreditations. Accreditation is just a destination while quality is a journey where every member of the laboratory shall join, contribute, and enjoy. From many lessons over the years, we have learned that creating healing and safe environment of care is way beyond compliance and accreditation. It is important for any leadership to understand that everyone in the organisation has a role to make quality happen not just the quality officer, champion, or department. Sharing knowledge, people engagement, and patient involvement in care planning are critical factors not only in achieving excellence but in creating a “just culture” for safety and quality.

Clinical laboratories worldwide have the right recipe in their foundation to get the biggest advantage of shaping the future of health and quality of life as a national index of social and economic well-being using 4.0 industrial revolutionary tools and a 4.0 quality approach.

Dr. Nashat Nafouri is the Medical and Quality Director, Futurelab Medical Laboratories; Chair, Healthcare Interest Group; Executive Officer, Saudi Quality Council. 

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This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

 

 

As the health and medical tourism sectors began to emerge from the trauma of the COVID pandemic at the beginning of 2022, global travel slowly started to gain momentum and the demand for cross border healthcare services increased gradually. Current trends have materialised, changing the delivery of services and the competitive landscape. Innovation, fresh strategies, novel approaches to enhancing the patient journey, as well as exploring new markets mark the way forward.

Travel chaos: patient safety and risk management

Once the borders reopened to travel, airlines, airports, and supporting services were called on to meet the exploding demand, which was an enormous task. Airlines have done their best to deliver but the reopening process has been extremely challenging. The year 2022 saw record numbers of cancelled and delayed flights, lost and undelivered baggage, shortages of pilots and flight attendants, limited wheelchair services, and other disruptions in travel services. Airline services are not expected to reach pre-2020 capacity until 2025.

Related: eBook: Navigating the healthcare market: Saudi Arabia edition

These gaps in services and uncertainty of reaching destinations on time created headaches for international patient departments and facilitators who are trying to assure patient safety and reduce risks, both clinical and nonclinical. Patients may be at greater medical risk if stranded at airports due to cancellations, missed flights, or substantial delays.

Anticipating problems, offering pre-travel solutions, and extra attention are all required now and for the next two or three years.

In 2022, the world saw the impact of climate change in the number of extraordinary weather events including extreme flooding, droughts, hurricanes and fires — some of which have occurred in places that never experienced these types of situations. Risk management responses may include evacuation, relocation, or cancellation of medical procedures. New risks to staff have surfaced as violence against healthcare workers has risen globally, during a period of staffing shortages.

These external societal challenges require a re-examination of the patient experience, for all patients, domestic and international. The patient journeys should be updated and remapped for at least four aspects of the patient journey: clinical; logistical; technological; and emotional/ psychological. The journey map for accompanying guests also should be updated to ensure their best possible experience.

Many competitors completed updating their patient journeys as well as the patient safety, risk management, and evacuation plan review. But what updates need to be done at our hospital or clinic?

Telehealth and telemedicine: health and medical travellers want more

Consumer acceptance, use of telehealth and telemedicine visits, and consultations skyrocketed during the past two years. More people than ever have access to health data through mobile phones and wearables. Healthcare providers lagged in integrating this data into preventive care and monitoring of medical conditions.

Medical travel is the perfect opportunity to utilise this readily available information that can be reliably reported to the home physician as well as the travel team to coordinate care. During these days of stressful travel, medical conditions can be monitored to ensure the patient’s fitness to travel throughout the journey, as well as to manage risk when the data supports an intervention from minor to major.

The healthcare providers who embrace the technology and incorporate it into the clinical care and patient journey will have a competitive advantage while meeting the demands of consumers.

Changing global landscapes: new competitors and shifting markets

Prior to the pandemic, the Gulf countries and China were the major sources of patients travelling for health and medical care. The flow of patients from those regions has substantially changed due in part to investment in infrastructure and political influences. The shift ranges from sending patients abroad to treating their own citizens internally as well as serving international patients. It may take years or decades for the full impact to be felt but the trend has started. The time to prepare is now.

The biggest player to emerge onto the international medical tourism scene in the past three years is Saudi Arabia. The Kingdom is investing billions of dollars in both domestic infrastructure and posturing to become a major destination for international patients. Money is no obstacle.

According to the International Trade Administration’s Saudi Arabia Country Investment Guide, “Under Vision 2030, the Saudi Arabian Government plans to invest over US$65 billion to develop the country’s healthcare infrastructure. In addition, it aims to increase private sector contribution from 40 per cent to 65 per cent by 2030, targeting the privatisation of 290 hospitals and 2,300 primary health centres”. The logical consequences of this investment are better and more options for treatment in country with less government support for treatment abroad.

In addition to Saudi Arabia, the UAE, Egypt, Jordan, and Tunisia, among others, have plans to expand their share of the health and medical travel markets. Their success will dramatically reduce the number of patients leaving the region for healthcare services.

Like Saudi Arabia, China’s role in crossborder healthcare services will treat more of its citizens domestically by investing in healthcare infrastructure. Its plans to build more hospitals have been disrupted by the impact of the pandemic and the country’s zero-COVID policy which has all but closed the borders. The country has demonstrated that not only can it build hospitals quickly but also graduate enough well-trained doctors and nurses to staff them.

Healthy China 2030 is a blueprint for revamping and upgrading the entire Chinese healthcare system to improve quality and access to services for its citizens. There are equally ambitious plans to promote China as a medical tourism destination. The tip of the iceberg is the South China province of Hainan. It is targeting 500,000 medical travellers by 2025.

Innovate, plan, and grow

The change in health and medical travel sectors from 2019 to 2022 is substantial. The travel sector, as well as the environment present patient safety and risk management challenges. Consumers want technology to be incorporated into their care, but providers are slow to offer what they are demanding. New competitors with huge budgets are moving into the global marketplace, changing the pre-COVID dynamics.

To remain competitive, healthcare providers must innovate, rethink old strategies, and plan for the future.

References available on request.

Elizabeth Ziemba, JD, MPH, is the President of Medical Tourism Training, and Regional Director for Temos serving the US, LATAM, and the Caribbean. She is a pioneer in the fields of wellness, health, and medical travel.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Back to Management

According to the World Health Organization, worldwide obesity has nearly tripled since 1975, while in 2016, more than 1.9 billion adults were overweight, and over 650 million were obese. World Obesity Day marks an occasion to revisit the urgency of tackling this urgency and the need to create awareness of the issue. We explore what obesity is, how to measure it, and its social and health ramifications.

Obesity is defined as abnormal or excessive fat accumulation that may impair health. It is usually an outcome of an energy imbalance between calories consumed and spent by an individual.

How to measure obesity?

Body mass index (BMI) is an indicator of obesity. It is a simple index of weight-for-height that can be calculated and used to classify overweight and obesity in adults. It is defined as a person's weight in kilograms divided by the square of his height in meters (kg/m2). A BMI greater than or equal to 25 qualifies as obesity.

What is the impact of obesity on society?

Obesity as a social stigma

Socially, obesity is commonly stigmatised. People who are obese are often subject to discrimination and prejudice.This often leads to social isolation, lower self-esteem, and depression among obese individuals. As a society, it is crucial to raise awareness that obesity is a disease and not a personal failure. Therefore, it's essential to support people in their efforts to manage and prevent obesity.

Obesity as a health concern

While being overweight may seem like a cosmetic concern on the surface, it also has several health ramifications beyond. Obesity often leads to comorbidities like diabetes and heart disease. Statistics from the WHO reveals that obesity is one of the leading causes of preventable death worldwide. In fact, most of the world's population lives in countries where overweight and obesity kills more people than underweight.

Surprisingly, childhood obesity is also a major concern. Around 39 million children under the age of five were overweight or obese in 2020. It has been seen that childhood obesity leads to several health issues, such as high blood pressure, diabetes, and asthma, from a tender age. Therefore, it is crucial to promote healthy eating habits and physical activity from an early age to prevent childhood obesity.

How is the Middle East attempting to tackle obesity?

Obesity is a significant concern in the Gulf region, and governments are proactively taking measures to reverse the trend. Data suggests that about 70 per cent of Saudis, especially children and youth, who account for at least 50 per cent of the population, are obese or overweight.

In that vein, the Saudi government is taking proactive steps to tackle the obesity epidemic. The Saudi national strategy for diet and physical activity up to 2025 targets:

• Lowering the rate of overweight and obesity to 40 per cent.
• Lowering the rate of people with low physical activity to 20 per cent.
• Increasing vegetable and fruit consumption (5 units/day) from 8.4 per cent to 20 per cent among males and from 4.5 per cent to 20 per cent among females.
• To stabilise the prevalence rate of hyperlipidaemia at 19.3 per cent.
• To stabilise the prevalence rate of diabetes mellitus at 18 per cent.

The UAE is also taking measures. The country launched the National Programme for Happiness and Wellbeing, which aims to promote healthy living and reduce nutrition-related lifestyle diseases, including diabetes and obesity.

With the growing awareness, and governments, individuals, and the health sector working together towards defeating this epidemic, we can expect a reversal in suboptimal lifestyle trends and a healthier obesity-free world in the years to come.

< Back to Clinical

The term Patient Blood Management (PBM) was first used in 2005 by Professor James Isbister, an Australian haematologist, who realised that the focus of transfusion medicine should be changed from blood products to the patients. Countries around the world are facing challenges in maintaining the supply of safe blood and blood products and also their appropriate use.

The World Health Organisation (WHO) published a policy brief on the urgent need to implement patient blood management in all member state countries with the aim to create awareness about the global disease burden of iron deficiency, anaemia, blood loss, and bleeding disorders; as well as to create a sense of urgency for healthcare authority and all staff working in blood transfusion chain on implementing patient blood management.

Anaemia in the general population affects an estimated 1.95 to 2.36 billion individuals worldwide, with the highest prevalence in low- and lower middle-income countries (LICs and LMICs), Iron deficiency anaemia (IDA) alone affects an estimated 1.24 to 1.46 billion people. Twice that number may suffer iron deficiency without anaemia or other micronutrient deficiencies that can lead to anaemia.

Large multicentric observational studies and randomised controlled trials demonstrated that patient blood management significantly improves morbidity, mortality, and the average length of hospital stay while reducing the overall cost of care. The expected improvements in outcomes and cost savings as well as more efficient use of (blood) resources were identified as the core drivers. The need for changing work practice and for collaboration and communication and the lack of experience with patient blood management is rated as the most important barriers due to a lack of awareness among both patients and healthcare professionals.

Patient blood management implementation requires a change in culture and behaviour, structural adjustments in health services delivery and redirection of scarce resources, active working hospital transfusion committee. Studies have shown that implementation of PBM programme can lead to reductions in length of stay, the incidence of infection, and re-admission rates for postoperative complications in patients not receiving a transfusion.

Patient blood management is considered an essential part of patient management in developed countries. The programme stresses the implementation of an evidence‐based multidisciplinary approach to optimising the care of patients who might need a transfusion. It should review patient blood management and utilisation practices in a prospective, concurrent, and/or retrospective manner aiming for improving patient outcome.

The programme will be responsible for, but not limited to, oversight and monitoring of:

• Physician blood ordering.
• Preoperative optimisation of coagulation.
• Preoperative anaemia management and autologous donation.
• Intraoperative patient blood management techniques.
• Techniques to reduce blood loss.
• Use of medications to decrease blood loss.
• Postoperative strategies and patient outcomes.
• Routine venipuncture and blood loss.
• Massive transfusion.
• Blood utilisation.

The programme should develop educational materials for hospital staff (healthcare professionals) and patients. The educational programme includes:

• Clinical guidelines, risks and benefits of blood transfusion.
• Anaemia diagnosis and management.
• Massive transfusion protocol and bleeding management.
• Review the alternatives to blood transfusion.
• It also involves methods for improving blood use such as:
• Evidence-based transfusion thresholds.
• Choosing wisely campaign for red blood cell transfusion.
• Pre-operative anaemia management for elective surgery (e.g. oral or intravenous iron, or erythropoietin).
• Antifibrinolytics to reduce blood loss (e.g. aminocaproic acid or tranexamic acid).
• Intra-operative autologous transfusion (cell salvage).
• Anaesthetic management (e.g. autologous normovolemic, haemodilution, controlled hypotension and normothermia).   
• Surgical method (e.g. newer cautery methods topical haemostatic and sealants).
• Reduce phlebotomy blood loss (e.g. use microcontainers and reduce unnecessary laboratory tests).
• Point of care testing (e.g. thromboelasography).

The five main beneficiary groups of patient blood management

• Individuals living with anaemia or at risk of developing anaemia, including individuals with isolated iron deficiency, and those with bleeding or blood loss;
• Healthcare professionals including general practitioners, family doctors and nurses, speciality consultants, surgeons and hospital-based clinicians;
• Healthcare institutions and hospitals;
• Health insurers and insurance organisations;
• Health authorities at the federal and jurisdictional levels, including public healthcare
• Systems in general.

Conclusion

Patient blood management is not anti-transfusion, it is more than this. It can be considered personalised therapy or a PBM plan for specific patients at specific times with the active participation of the patient. The introduction and implementation of Patient Blood Management programme in all hospitals will contribute a lot to patient safety and quality of blood transfusion services provided to our customers in developing countries.

References available on request.

Salwa Hindawi, MSc, FRCPath, CTM is the Chief Scientific Officer of Saudi Society of Transfusion Medicine, and Professor of Haematology and Transfusion Medicine at King Abdulaziz University, Jeddah, Saudi Arabia.

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

 

Immunotherapy is an area of cancer research that has attracted much attention in recent decades, and this has allowed it to gradually become part of the established arsenal for treating patients. As promising as cancer immunotherapy seems, it remains a fact that such treatments can be incredibly costly. With hefty price tags often hovering over US$150,000 per patient for treatment. 

Nearly half of the 20 million people diagnosed with cancer in 2020 succumbed to the deadly illness, according to the International Agency for Research on Cancer. Moreover, the number of people suffering from the medical condition is expected to expand further to reach 25 million by 2030 and 30 million by 2040.  

It is particularly striking that some regions are more affected by the disease than others. Asia has the world’s largest share of people diagnosed with cancer, understandably due to its huge population. Nonetheless, cancer is also on its relentless march in the rest of the world. 

Cancer burden worldwide (2020–2040) 

Source: International Agency for Research on Cancer, Julius Baer 

Given that cancer is one of the major public health challenges of the 21st century, it does not come as a surprise that scientists and academics have been intensifying their research into different types of cancer treatment in recent decades. Not only does research aim to improve patient outcomes, but it also creates national wealth through homegrown innovations in the field of oncology.  

However, bibliometrics lay bare a significant discrepancy in research activities across countries. Larger nations, such as China and the US, and wealthy ones, such as Japan and South Korea, and a few affluent European countries like Italy, Germany and the UK, account for the majority of cancer-related publications. 

CANCER RESEARCH OUTPUT BY COUNTRY (2020) 

 

Source: Scimago Journal and Country Rank, Julius Baer; note: H index is a metric used to evaluate the cumulative impact of an author’s scholarly output and performance. 

 

The promise of cancer immunotherapy  

By stimulating the natural defenses of our immune system, which comprises a network of biological processes that protect the body against infections, tumour cells lurking in a patient’s body can be more easily located and eliminated. However, immunotherapy is not yet effective for all types of cancer patients living with the disease. As Johns Hopkins School of Medicine revealed, around 15 per cent of patients achieve durable results from the therapy. 

Damien Ng is a Next Generation Research Analyst at Julius Baer

While some people with melanoma, bladder, and lung cancers are likely to respond to the treatment, those with breast and pancreatic cancers rarely do so. Nonetheless, the still-low patient outcomes have not put a dent into the ever-growing body of scientific research into the various types of immunotherapies – such as vaccines, monoclonal antibodies, checkpoint inhibitors, cytokines, and chimeric antigen receptor (CAR) T-cell therapies.  

Research output in the field of immunotherapy (1960–2021) 

 

 Source: US National Library of Medicine, Julius Baer 

In the case of inoculation, two types of immunotherapy vaccines have been approved by the US Food and Drug Administration for the purpose of preventing cancer. One protects against the human papillomavirus (HPV), which is a sexually transmitted disease that can lead to cancers relating to the cervix, genitalia, and the back of the throat.  

Another type of vaccine protects individuals from hepatitis B. Chronic hepatitis B infection may lead to more serious illnesses, such as the scarring of the liver caused by long-term liver damage (also known as cirrhosis) and liver cancer. Although vaccines such as these two are at the vanguard of effective cancer immunotherapies, further research and development are still required before such vaccines become a potent preventive strategy against other types of cancer. 

Investment conclusion  

Although immunotherapy works for a handful of cancers at present, it offers great hope in the treatment of certain cancers associated with the skin, lungs, kidneys and bladders. After all, cancer immunotherapy has begun to yield clinical dividends after years of setbacks. 

While the high costs associated with immunotherapy may restraint industry growth since many patients may be compelled to forego the expensive treatments as a result of inadequate insurance coverage or personal savings, harnessing the power of the individual’s immune system to fight against tumour cells gives rise to the hope for a revolutionary shift in the way cancer care is delivered. Put differently, the growing availability of immunotherapy – with or without other forms of treatment like chemotherapy and surgery – will offer a better chance of survival and recovery for many cancer patients. 

The global oncology industry remains largely characterised by large pharmaceutical companies, and the cancer immunotherapy sector, which broadly comprises pure-play firms with much lower market capitalisation (under US$2 billion), plus privately held biotech companies. In the US alone, oncology is estimated to be worth over US$500 billion by 2040, which is higher than many other therapeutic areas like cardiovascular diseases and dermatology.  

From an investor’s perspective, we see the greater risk associated with smaller firms due to a smaller drug portfolio that has greater likelihood of failure than the larger players. In other words, the reward may be extremely high, but the risk is as well – especially in the case of single-company investments.  

Hence, we recommend investing in oncology overall. We believe that over time this area will expand its footprint in immunotherapy to offer the most holistic and personalised cancer treatments possible. 

  

Damien Ng is a Next Generation Research Analyst at Julius Baer. 

 

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

Back to Management

Emergency transfusion support is an essential element of modern healthcare. Life-threatening anaemia and haemorrhage require timely red cell transfusion. Haematological support is also essential to reduce the risk of critical bleeding due to haemostatic failure. The context of this article is the organisational and clinical management of major haemorrhage which may require both. Major haemorrhage is a clinical emergency that rapidly results in morbidity and mortality.

Common causes include obstetric emergencies, gastrointestinal bleeding, major surgery, and trauma. Mortality is high unless actively managed with early haemorrhage control and resuscitation, especially in trauma. Recent conflicts have driven a paradigm shift in the use of blood and raised expectations in the wider healthcare community. In this short article, we consider recent developments and innovations in emergency transfusion and the challenges for the transfusion community.

Lessons from military healthcare, including the response to Mass Casualty Events (MCEs), have influenced civilian trauma practice, registries, and transfusion emergency preparedness. The principles are also applied, with modification, to other causes of life-threatening haemorrhage.

Table 1 lists examples of clinical and organisational innovation. Clinical guidance emphasises the recognition of the patient at risk of shock, early haemorrhage control, the use of tranexamic acid, and balanced blood-based resuscitation. This approach has improved survival. The emphasis on early intervention in trauma has stimulated an interest in pre-hospital haemorrhage control and transfusion.

Table 1. Examples of development and innovations in emergency transfusion

• Re-organisation of trauma systems and registries
• Damage control resuscitation with haemorrhage control and early use of transfusion
• Use of Major Haemorrhage Protocols and tranexamic acid
• Pre-hospital transfusion with improved cold chain management
• Non-medical authorisation for transfusion and wider scope of practice
• Component research and development
• Transfusion support to emergency and disaster planning
• Development in hemovigilance systems
• Application of human factors science
• International collaboration and multi-centre trials

Successful pre-hospital transfusion programmes have driven developments in cold chain and stock management. In addition, the challenge for the simple, speedy safe delivery of blood has driven a renewed interest in both group O whole blood and universal dried plasma. In turn, the simplification of the transfusion process enables the non-medical authorisation of blood transfusion.

The best-known recent developments in emergency transfusion are Major Haemorrhage Protocols (MHPs). These are site-specific protocols that outline the processes, people, blood components, and adjuncts required to treat a bleeding patient. The treatment algorithms pre-specify the order and ratios of blood, components, or products used to treat bleeding in different clinical contexts. Common to all is patient safety which demands secure safe sampling and testing for blood type before transfusion. Clinical response directs initial blood-based resuscitation rather than haematological testing.

However, subsequent treatment is ‘goal-directed’ and tailored using Near-patient testing and laboratory support. Activation of an MHP should trigger a timely well-rehearsed response; whereas over-activation is resource-intensive and may lead to blood wastage. It is a difficult call to make. Emergency transfusion is stressful for both clinical and laboratory staff. Sourcing and preparing components take time, when the clinician sees the patient in front of them and demands blood, the laboratory is often busy supporting other patients.

The advent of MHPs and pre-hospital transfusion challenges both hospitals and blood providers. The innovations may drive blood demand including a greater proportion of ‘universal’ components such as group O red cells and group AB plasma. These components are often in short supply. Treating a single critically ill patient with haemorrhage may rapidly drain local blood stock. Multiple casualties magnify the need for blood and often trigger a surge in donors. Careful and coordinated management of both emergency transfusion demand and supply is essential.

Managing demand requires agreed protocols and clinical commitment using the principles of Patient Blood Management (PBM). PBM interventions include reducing blood loss, timely access to surgery, optimising physiology, and tolerating lower transfusion targets. If transfusion must be prioritised, pre-prepared blood shortage plans support fair distribution of blood. The challenge for blood providers is to meet both immediate and future demand, especially following Major Incidents or MCEs.

Transfusion support for major incidents requires organisational preparation and working in partnership to be successful. Public engagement partnership includes public first aid programmes to “stop the bleeding” and high-readiness blood donor panels. Organisational developments for the transfusion teams include the application of transfusion triage.

The concept of clinical triage is well established in the context of multiple casualties. By analogy, transfusion triage prioritises blood allocation, sample handling and laboratory work-streams as well as donor selection. The purpose of triage is to ensure fair and appropriate allocation of resources by ensuring blood grouping and transfusion for those in most need.

Over-categorisation uses scarce resources and limits the availability of others. We have found that providing emergency blood and advice in the Emergency Department and a focus on human factors improves blood ordering and sample handling. The International Society for Blood Transfusion and others have also highlighted the value of Transfusion Practitioners in emergencies.

We all have a responsibility to meet the challenge of emergency transfusion, whether we are dealing with a critically ill individual or multiple casualties. Guidance is valuable. Humanitarian organisations provide the overarching framework for disaster planning for healthcare. More recently, the Council of Europe and WHO has advised on the continuity of blood supplies during emergencies. The advice reminds us of the importance of a national approach to policy and planning. However, a local level commitment is essential for timely response, organisational resilience, and data collection. The outcome data fed back to planners and hemovigilance systems should drive further service improvement, development, and research.

Emergency transfusion is transforming. It is an exciting topic that has stimulated an enormous international academic effort. The challenge is translating this research into locally sensitive practice that balances timely transfusion with safety and sufficiency.

Dr. Heidi Doughty, Dr Philos, FRCP, FRCPath, is a Consultant in Transfusion Medicine. She will be speaking at the Blood Transfusion Medicine conference at Medlab Middle East 2023.

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This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

The acronyms in Clinical Immunology are gradually increasing because of the identification of novel immune disorders and the expansion of our understanding of immunopathogenesis. The term primary immunodeficiency (PID) is now being superseded by an inborn error of immunity (IEI).

This change is partly driven by the recognition that such disorders may not only involve impaired immune response to infection, but also autoimmunity, lymphocytic infiltration, and malignancy. Indeed, the terms primary immune dysregulatory disorder (PIRD) and monogenic immune dysregulation diseases (MIDD) have been recently coined and encapsulate the subset of IEI, which involve loss of normal inflammatory control and immune tolerance mechanisms, predominantly characterised by autoimmunity. The rate of discoveries in IEI research is truly astounding, with the number of IEI’s increasing from 191 in 2011 to 485 in 2022 according to the International Union of Immunological Societies (IUIS) classification.

The evolution of the IUIS classification over recent years has also recognised the importance of immune dysregulation. Defining the responsible genetic variant(s) can result in practical clinical benefit for the patient, which may include:

• A more accurate clinical diagnosis
• More specific advice regarding prognosis
• Opportunity for tailored therapies for certain IEI’s
• Consideration for haematopoietic stem cell transplantation for certain IEI’s
• Genetic counselling for the family: siblings and future family planning

Advances in clinical care and research in IEI disorders have been facilitated by multi-centre national and international collaborations — increasing the number of patients with specific rare disorders enables the elucidation of clinical and immunological features, genetic diagnosis, response to therapy, and prognosis. For example, the Middle East and North African (MENA) IEI registry recently published a report based on MIDD patients from 11 MENA countries, and this international group published guidelines for IEI diagnosis and management to improve care of patients within the region.

In the UK, the National Institute of Healthcare and Research Bioresource undertook a whole genome sequencing (WGS) study of sporadic PID patients. A range of disparate causative molecular defects were identified e.g. in NFKB1 (nuclear factor B subunit 1), and TACI/TNFRSF13B (transmembrane activator and CAML interactor).

However, in many PID patients, the search for a molecular diagnosis has not yet been fruitful despite the use of clinical gene panels and WGS. It is also recognised that different variants (gain or loss of function, mono-allelic, bi-allelic and exon splicing) affecting the same gene can produce different clinical presentations.

One of the best examples illustrating the value of genetic diagnosis impacting therapeutic options was the discovery by Dr. Bernice Lo in her previous laboratory at the National Institute of Health in the USA and Dr. Michael Jordan at Cincinnati Children’s Hospital Medical Center. When LRBA deficiency was first described, the function of LRBA was not really known and so how LRBA deficiency caused an immunodysregulatory disorder was unclear.

Dr. Lo and colleagues discovered that in the absence of LRBA in patient T cells, CTLA-4 was degraded by lysosomes, indicating that LRBA plays a role in preventing CTLA-4 from lysosomal degradation. They showed that LRBA helps to maintain a pool of CTLA-4 inside the cells that allow for the rapid mobilization of CTLA-4 to the cell surface for its function. Since CTLA-4 is a crucial and potent inhibitory molecule for regulating immune responses, deficiency of CTLA-4 could explain the immunodysregulatory disease characteristic of LRBA deficiency.

Several LRBA-deficient patients had organ involvement that was refractory to various immunosuppressive drugs. However, treatment with abatacept, a chimeric CTLA-4 and Ig Fc fusion protein drug, was found to be a highly effective therapy for LRBA-deficient patients. Since the immune dysregulation in LRBA deficiency is due to insufficiency of CTLA-4 protein, replacement of CTLA-4 through treatment with abatacept functions as a targeted or precision therapy. This finding illustrated the importance of unravelling the molecular etiology of IEI for the implementation of precision medicine.

The use of a broadening range of immunomodulatory medications, including biologic drugs, in autoimmune disease or malignancy is leading to an epidemic of secondary immunodeficiency (SID). The best example is the development of clinically significant secondary antibody deficiency in a subset of patients treated with B-cell targeting therapies (BCTT), with some patients requiring immunoglobulin replacement. The numbers of SID patients are much higher than the number of patients with antibody deficiency related to PID.

To complicate matters further, it now emerges that the boundaries between PID and SID can be blurred. For example, BCTT use in children with autoimmune disease, especially for autoimmune cytopenia, can lead to hypogammaglobulinemia. In a subset of these children, clinical gene panels and/or WGS have identified underlying IEIs that account for both the autoimmune manifestations and the antibody deficiency.

In a landmark Italian study of children with autoimmune hemolytic anaemia, immune thrombocytopenia, or Evan’s syndrome treated with BCTT, the identified IEIs have involved variants in the following genes: ADA2 (adenosine deaminase 2), ARTEMIS, NFKB1, PIK3CD (phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit delta), and TACI.

In summary, the improved classification of immunodeficiency disorders, supported by advances in genetic diagnosis, has enabled Immunology to enter a golden age of discovery. Already, there are early examples of translation into patient care, illustrating the potential for the application of precision medicine to benefit our patients.

References available on request.

 

Prof. Mohammed Yousuf Karim, MD FRCP FRCPath, is the Clinical Professor in Immunopathology, College of Medicine at Qatar University, and Division Chief, Haematology/Immunology/Transfusion at Sidra Medicine. Dr. Bernice Lo, PhD, is the Principal Investigator, Research Branch, Sidra Medicine, and Adjunct Assistant Professor, College of Health and Life Sciences at Hamad Bin Khalifa University. Both are based in Doha, Qatar.

 

 

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

 Laboratory

The acronyms in Clinical Immunology are gradually increasing because of the identification of novel immune disorders and the expansion of our understanding of immunopathogenesis. The term primary immunodeficiency (PID) is now being superseded by an inborn error of immunity (IEI).

This change is partly driven by the recognition that such disorders may not only involve impaired immune response to infection, but also autoimmunity, lymphocytic infiltration, and malignancy. Indeed, the terms primary immune dysregulatory disorder (PIRD) and monogenic immune dysregulation diseases (MIDD) have been recently coined and encapsulate the subset of IEI, which involve loss of normal inflammatory control and immune tolerance mechanisms, predominantly characterised by autoimmunity. The rate of discoveries in IEI research is truly astounding, with the number of IEI’s increasing from 191 in 2011 to 485 in 2022 according to the International Union of Immunological Societies (IUIS) classification.

The evolution of the IUIS classification over recent years has also recognised the importance of immune dysregulation. Defining the responsible genetic variant(s) can result in practical clinical benefit for the patient, which may include:

• A more accurate clinical diagnosis
• More specific advice regarding prognosis
• Opportunity for tailored therapies for certain IEI’s
• Consideration for haematopoietic stem cell transplantation for certain IEI’s
• Genetic counselling for the family: siblings and future family planning

Advances in clinical care and research in IEI disorders have been facilitated by multi-centre national and international collaborations — increasing the number of patients with specific rare disorders enables the elucidation of clinical and immunological features, genetic diagnosis, response to therapy, and prognosis. For example, the Middle East and North African (MENA) IEI registry recently published a report based on MIDD patients from 11 MENA countries, and this international group published guidelines for IEI diagnosis and management to improve care of patients within the region.

In the UK, the National Institute of Healthcare and Research Bioresource undertook a whole genome sequencing (WGS) study of sporadic PID patients. A range of disparate causative molecular defects were identified e.g. in NFKB1 (nuclear factor B subunit 1), and TACI/TNFRSF13B (transmembrane activator and CAML interactor).

However, in many PID patients, the search for a molecular diagnosis has not yet been fruitful despite the use of clinical gene panels and WGS. It is also recognised that different variants (gain or loss of function, mono-allelic, bi-allelic and exon splicing) affecting the same gene can produce different clinical presentations.

One of the best examples illustrating the value of genetic diagnosis impacting therapeutic options was the discovery by Dr. Bernice Lo in her previous laboratory at the National Institute of Health in the USA and Dr. Michael Jordan at Cincinnati Children’s Hospital Medical Center. When LRBA deficiency was first described, the function of LRBA was not really known and so how LRBA deficiency caused an immunodysregulatory disorder was unclear.

Dr. Lo and colleagues discovered that in the absence of LRBA in patient T cells, CTLA-4 was degraded by lysosomes, indicating that LRBA plays a role in preventing CTLA-4 from lysosomal degradation. They showed that LRBA helps to maintain a pool of CTLA-4 inside the cells that allow for the rapid mobilization of CTLA-4 to the cell surface for its function. Since CTLA-4 is a crucial and potent inhibitory molecule for regulating immune responses, deficiency of CTLA-4 could explain the immunodysregulatory disease characteristic of LRBA deficiency.

Several LRBA-deficient patients had organ involvement that was refractory to various immunosuppressive drugs. However, treatment with abatacept, a chimeric CTLA-4 and Ig Fc fusion protein drug, was found to be a highly effective therapy for LRBA-deficient patients. Since the immune dysregulation in LRBA deficiency is due to insufficiency of CTLA-4 protein, replacement of CTLA-4 through treatment with abatacept functions as a targeted or precision therapy. This finding illustrated the importance of unravelling the molecular etiology of IEI for the implementation of precision medicine.

The use of a broadening range of immunomodulatory medications, including biologic drugs, in autoimmune disease or malignancy is leading to an epidemic of secondary immunodeficiency (SID). The best example is the development of clinically significant secondary antibody deficiency in a subset of patients treated with B-cell targeting therapies (BCTT), with some patients requiring immunoglobulin replacement. The numbers of SID patients are much higher than the number of patients with antibody deficiency related to PID.

To complicate matters further, it now emerges that the boundaries between PID and SID can be blurred. For example, BCTT use in children with autoimmune disease, especially for autoimmune cytopenia, can lead to hypogammaglobulinemia. In a subset of these children, clinical gene panels and/or WGS have identified underlying IEIs that account for both the autoimmune manifestations and the antibody deficiency.

In a landmark Italian study of children with autoimmune hemolytic anaemia, immune thrombocytopenia, or Evan’s syndrome treated with BCTT, the identified IEIs have involved variants in the following genes: ADA2 (adenosine deaminase 2), ARTEMIS, NFKB1, PIK3CD (phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit delta), and TACI.

In summary, the improved classification of immunodeficiency disorders, supported by advances in genetic diagnosis, has enabled Immunology to enter a golden age of discovery. Already, there are early examples of translation into patient care, illustrating the potential for the application of precision medicine to benefit our patients.

References available on request.

 

Prof. Mohammed Yousuf Karim, MD FRCP FRCPath, is the Clinical Professor in Immunopathology, College of Medicine at Qatar University, and Division Chief, Haematology/Immunology/Transfusion at Sidra Medicine. Dr. Bernice Lo, PhD, is the Principal Investigator, Research Branch, Sidra Medicine, and Adjunct Assistant Professor, College of Health and Life Sciences at Hamad Bin Khalifa University. Both are based in Doha, Qatar.

 

 

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

 Laboratory

There is a progressive move towards value-based healthcare and the optimisation of healthcare budgets and spending in the Middle East and Africa as well as globally. This poses significant challenges to the healthcare ecosystem.  

Although health technology assessment (HTA) is mature and well-established in the pharmaceutical field, it is still expanding in the field of medical technology. Given this, Mecomed embarked on a study to explore the differences between HTA for pharmaceuticals and medical technologies. 

The study consisted of a literature review as well as interviews with several industry stakeholders, policymakers, HTA agencies in the Kingdom of Saudi Arabia, UAE, Egypt and global experts. The industry respondents, with an average of 22 years of experience, were very knowledgeable in healthcare: 78 per cent have graduate and post-graduate qualifications in health economics or related subjects.   

Throughout this study, core themes emerged highlighting the unique elements of HTA for medical devices. One such theme includes the difference in evidence generation. Often, comparative effectiveness evidence is lacking for medical devices at launch compared to the typical phase three evidence gathered in clinical trials of pharmaceuticals. Furthermore, randomised controlled trials are not conducted for many medical devices. This poses the question: what evidence could support claims of efficacy, safety, and quality? This has been debated extensively in other regions of the world. One solution includes a flexible approach towards evidence generation using real-world data (RWD).  

Another important difference is the learning curve effect observed in many medical devices where there is a device-operator interaction. Commonly, the operator (healthcare professional) becomes more proficient in performing procedures over time. For example, theatre time for robotic surgery would initially be longer as the operator builds experience, however, over time, with improved proficiency, theatre time would be shorter than that of conventional surgery. The question then arises of how one should approach this learning curve effect when performing economic modelling. One solution is to follow a lifecycle approach by considering the economic impact at different stages in the device’s lifecycle. 

Incremental innovation is yet another important difference that needs to be considered. Not all innovations in medical devices are breakthrough innovations. Many are incremental innovations or small enhancements. This makes the product lifecycle very short compared to pharmaceuticals. Often these incremental innovations cannot be directly attributed to health outcomes as they might be of benefit to the operator. Given the high rate of innovation in medical devices, it is not feasible to do an HTA submission for each incremental innovation. 

 

Some other important differences include the dynamic pricing mechanisms seen in devices (capital investment, rental, lease, etc.) and the organisational impact of implementing some medical devices in a facility (staff, space, etc.). 

Overall, the study showed that there is a significant evidence base supporting the challenges faced in performing HTA for medical devices. It is imperative to work towards addressing the potential risk that HTA could create, giving an additional hurdle in ensuring access to innovation to patients in need and ensuring that HTA is the tool for enabling rewarding real-world innovation. Capacity building and advancing the HTA knowledge base for devices should start early, at all stakeholder levels. This will pave the way for constructive partnerships between HTA agencies and industry.   

Evidence from the study further highlights that one of the key attributes of successful, mature HTA agencies is their bias toward transparency, inclusiveness, communication, and procedural justice. This should be the aim of all HTA agencies. 

Collaboration at a regional and global level with more mature HTA agencies is needed to ensure that the adopted processes and policies are not only scientifically robust but also consider individual health system realities.  

The study confirmed that the devices industry is diverse and faces unique challenges related to HTA implementation and that significant opportunities exist for collaboration between different stakeholders. One of the early imperatives will be to invest in the education of stakeholders to ensure the adoption of HTA policies and processes that support population health outcomes. 

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Dr. Tienie Stander is the Managing Director of VI Research FZ LLC and Dr. Inna Nadelwais is the Executive Director of MECOMED. 

 

This article appears in the latest issue of Omnia Health Magazine. Read the full issue online today.

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