Blog search results for Tag: pharma

Health & Wellbeing

Each year, the World Health Organisation celebrates World Heath Day, an international health awareness day which aims to draw attention particular health challenges across the world. The theme for 2019 is universal health coverage for everyone, everywhere.

world health day globe

In honour of World Health Day, held on 7 April 2019 annually, we have collated the five most innovative healthcare projects we have featured on SCI’s website over the past year. 


New cardiac MRI scan improves diagnostic accuracy

beating heart gif

Originally posted by medschoolgeek

Using 2D imaging techniques to diagnose problems with the heart can be challenging due to the constant movement of the cardiac system. Currently, when a patient undergoes a cardiac MRI scan they have to hold their breath while the scan takes snapshots in time with their heartbeat.

Still images are difficult to obtain with this traditional technique as a beating heart and blood flow can blur the picture. This method becomes trickier if the individual has existing breathing problems or an irregular heartbeat.


3D cell aggregates could improve accuracy of drug screening

 3d cell

An innovative new screening method using cell aggregates shaped like spheres may lead to the discovery of smarter cancer drugs, a team from the Scripps Research Institute, California, US, has reported.

The 3D aggregates, called spheroids, can be used to obtain data from potentially thousands of compounds using high throughput screening (HTS). HTS can quickly identify active compounds and genes in a specific biomolecular pathway using robotics and data processing.


Antibiotic combinations could slow resistance

 antibiotics

Several thousand antibiotic combinations have been found to be more effective in treating bacterial infections than first thought.

Antibiotic combination therapies are usually avoided when treating bacterial infections, with scientists believing combinations are likely to reduce the efficacy of the drugs used. Now, a group at UCLA, USA, have identified over 8,000 antibiotic combinations that work more effectively than predicted.


Mechanism that delays and repairs cancerous DNA damage discovered

 microscope

Researchers at the University of Copenhagen, Denmark, have identified a mechanism that prevents natural DNA errors in our cells. These errors can lead to permanent damage to our genetic code and potentially diseases such as cancer.

Mutations occurring in human DNA can lead to fatal diseases like cancer. It is well documented that DNA-damaging processes, such as smoking tobacco or being exposed to high levels of ultraviolet (UV) light through sunburn, can lead to increased risk of developing certain forms of cancer.


Alzheimer’s drugs made from Welsh daffodils

flowers gif

Originally posted by naturegifs

Treatments for Alzheimer’s disease can be expensive to produce, but by using novel cultivation of daffodils one small Welsh company has managed to find a cost-effective production method of one pharmaceutical drug, galanthamine.

Alzheimer’s disease is a neurodegenerative disease with a range of symptoms, including language problems, memory loss, disorientation and mood swings. Despite this, the cause of Alzheimer’s is very understood. The Alzheimer’s disease drug market is currently worth an estimated US$8bn.


Sustainability & Environment

Scientists studying DNA in soil samples from Svalbard in the High Arctic have discovered a surprisingly large number of clinically-important antibiotic resistance genes. In total, 131 antimicrobial resistance genes were identified, while five out of eight sites had abundant multidrug resistance genes.

 The Svalbard Islands

The Svalbard Islands are in Northern Norway.

The finding is all the more unexpected as the team was seeking a virgin environment to try and establish what a background level of antimicrobial resistance in soil bacteria looks like. 

 soil bacteria

Scientists found genes important to antimicrobial resistance in soil bacteria.

‘We took 40 samples to give us an idea of what the baseline of resistance might look like in nature, but we were surprised by how different the sites were from each other,’ says lead scientist David Graham at Newcastle University. Areas with high wildlife or human impact had greatest diversity of resistance DNA in the soil.

The results show that antibiotic resistance genes are accumulating even in the most remote locations. Included in a number of samples was a multidrug resistant gene called New Dehli strain, first isolated in India.

Newcastle University find antibiotic resistant genes in Arctic. Video: Newcastle University

Some sites had levels of antimicrobial resistance 10 times greater than others, particularly those with elevated levels of phosphorus, a nutrient usually scarce in Arctic soils. 

‘There was much greater resistance diversity in sites with strong signatures of faecal matter,’ says Graham, indicating that migratory birds most likely brought the antimicrobial resistance genes, depositing them via their guano.


Health & Wellbeing

 alzheimers

Almost half of world’s adults aged 85 and over have Alzheimer’s Disease.

The amyloid-B precursor protein (APP) plays a key role in the development of the amyloid plaques that are the hallmark of Alzheimer’s disease. Now, researchers claim to have identified thousands of genetic variants of the APP gene that codes for the protein in the brains of patients with the most common form of Alzheimer’s disease, known as late-onset or sporadic AD (SAD). 

The study reveals for the first time how this genetic variation occurs – by a mechanism involving the enzyme reverse transcriptase, the same type of enzyme used by HIV to infect cells.

 plaques in the brain

APP forms plaques in the brain, as shown above in a light micrograph.

Our findings provide a scientific rationale for immediate clinical evaluations of HIV antiretroviral therapies in people with AD,’ says Jerold Chun, senior VP of Neuroscience Drug Discovery at Sanford Burnham Prebys Medical Discovery Unit (SBP), an idea that the researchers say is supported by the relative absence of proven AD in ageing HIV patients on antiretroviral medication.

The APP gene variants were created by reverse transcription, the researchers note, when RNA acts as a template to form complementary DNA sequences that are then reinserted back into the original genome.

Discovery of possible Alzheimer’s treatment. Video: Sanford Burnham Prebys Medical Discovery Institute

This process of gene recombination – which occurs each time cells divide to make new ones – has not previously been reported in nerve cells (neurons) in the brain but could also help to explain the complexity and diverse functions of our brain cells.


Health & Wellbeing

Microscopic membranous vesicles floating outside of cells were first discovered 50 years ago; 30 years later, a subset of these was coined exosomes. At the time, these membrane bubbles were believed to be nothing more than a cellular waste disposal mechanism. But within the past decade, extracellular vesicles – and exosomes in particular – have piqued scientists’ interests, resulting in a research boom.

In 2006, there were just 115 publications referencing exosomes; by 2015, this number had mushroomed to 1010. Today, a PubMed search brings up more than 7500 publications. Consulting firm Grand View Research estimates that the global exosome market could reach $2.28bn by 2030.

 cancer cells

Advancements in exosome research could lead to breakthroughs in prostate cancer treatment. 

The interest in exosomes has been driven by the new finding that exosomes are more than just a waste disposal system – they are also a means of communication between cells and have the ability to carry cargos such as proteins and mRNA, suggesting there could be potential medical applications. 

‘Currently, research into exosomes and other extracellular vesicles is very strong,’ says Jason Webber, Prostate Cancer UK research fellow in the Division of Cancer and Genetics at Cardiff University. ‘I think this field of research will continue to grow and I believe we’ll also see greater clinical application of exosomes and a drive towards research exploring the therapeutic potential of exosomes.’

Exosomes in Cancer Research. Video: Thermo Fisher Scientific

Exosomes are best described as extracellular vescles – essentially membrane sacs – formed by the inward budding of the membrane of intracellular compartments known as multivesicular bodies (MVBs) or multivesicular endosomes (MVEs). They are released from cells when MVBs fuse with the cell’s plasma membrane, releasing its contents outside the cell. These vesicles, made of a phospholipid bilayer and ranging between 40nm and 150nm in diameter, are found in all biological fluids including blood, urine, saliva, bile, semen and breast milk.


Health & Wellbeing

Biopharmaceuticals are sourced from living organisms.

Researchers at Massachusetts Institute of Technology (MIT), US, have developed a portable drug manufacturing system that can make several different biopharmaceuticals to be used in precision medicine or to treat outbreaks in developing countries.

Biopharmaceuticals are drugs made up of proteins such as antibodies and hormones, and are produced in bioreactors using bacteria, yeast or mammalian cells. They must be purified before use, so the process has dozens of steps and it can therefore take weeks or months to produce a batch.

The Challenges in Manufacturing Biologics. Video: Amgen  

Due to the complex nature of the process and its time restrictions, biopharmaceuticals are usually produced at large factories dedicated to a single drug – often one that can treat a wide range of patients.

To help supply smaller, more specific groups of patients with drugs, a group of researchers at MIT have developed a system that can be easily configured to produce three different pharmaceuticals – human growth factor, interferon alpha 2b and granulocyte colony-stimulating factor – all of a comparable quality to commercially available counterparts.

 old man with walking stick

Biopharmaceuticals can treat autoimmune diseases, such as arthritis. Image: Pixabay

‘Traditional biomanufacturing relies on unique processes for each new molecule that is produced,’ said J Christopher Love, a Chemical Engineering Professor at MIT’s Koch Institute for Integrative Cancer Research. ‘We’ve demonstrated a single hardware configuration that can produce different recombinant proteins in a fully automated, hands-free manner.’


Careers

 

Interested in the pharmaceutical industry and research community? Take a look at this short video to see how we bring science and business together. 

Health & Wellbeing

The US Food and Drug Administration (FDA) has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9 – AstraZeneca’s drug for the treatment of adults with hyperkalaemia.

A serious condition, hyperkalaemia is characterised by elevated potassium levels in the blood and can lead to cardiac arrest and death. It is associated with cardiovascular, renal, and metabolic diseases – the risk of hyperkalaemia increases significantly for patients with chronic kidney disease, and those who take common medications for heart failure, such as renin-angiotensin-aldosterone system (RAAS) inhibitors, which can increase potassium in the blood.

To help prevent the recurrence of hyperkalaemia, RAAS-inhibitor therapy is often modified or discontinued, which can compromise its effectiveness and increase the risk of death.

The announcement comes two months after the European Commission granted marketing authorisation for Lokelma in the EU.

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the fields of oncology, cardiovascular, renal and metabolism, and respiratory.

Health & Wellbeing

An innovative new screening method using cell aggregates shaped like spheres may lead to the discovery of smarter cancer drugs, a team from the Scripps Research Institute, California, US, has reported.  

The 3D aggregates, called spheroids, can be used to obtain data from potentially thousands of compounds using high throughput screening (HTS). HTS can quickly identify active compounds and genes in a specific biomolecular pathway using robotics and data processing.

 A spheroid under a confocal microscope

A spheroid under a confocal microscope. Image: Kota et al./The Scripps Research Institute  

The spheroids – 100 to 600 microns thick in diameter – spread in a similar way to cancer cells in the body and are therefore more effective in identifying potential cancer drugs, the team hypothesises.

For this study, the team focused on KRAS – a gene belonging to the RAS family. It is estimated these genes account for one-third of all cancers.

 Robots handle assays in a HTS system

Robots handle assays in a HTS system. Image: NIH/Flickr

DOI: 10.1038/s41388-018-0257-5


Health & Wellbeing

Around 700,000 people worldwide die every year from bacteria that have developed resistance to antibiotics. In the UK alone, that figure is at least 12,000 – more deaths than from breast cancer. And those numbers look set to rise even higher.

‘It’s not just the fact that resistance is increasing – that’s inevitable,’ says Nick Brown, Director of advocacy group, Antibiotic Action. ‘The issue is more the rate of increase in resistance, which appears to be accelerating.’

The Infectious Diseases Society of America recently reported resistance to drugs within six months of antibiotics coming onto the market, and in some cases, even before the drug goes on the market. Many bacterial strains are increasingly displaying resistance to combinations of commonly used and last-resort antibiotics.

 antibiotics

Of 33 antibiotics in development targeting priority pathogens, just nine belong to five new antibiotic classes. Image: Public Domain Pictures

‘The end of the antibiotic era isn’t on the horizon just yet,’ Brown says. ‘But we can see it wouldn’t take much to get that way.’

Failure to tackle antibiotic-resistant superbugs could result in 10m deaths a year by 2050, according to the UK government-commissioned Review on Antimicrobial Resistance. The UN and G20 have both made political commitments to combat the problem. Nevertheless, time is running out.

‘This is an urgent and rapidly rising global health problem,’ says Ghada Zoubiane, science lead for the Wellcome Trusts’ drug-resistant infections team. ‘We need greater investment in developing new ways to treat and protect people from these deadly infections and we need better understanding of how resistance spreads.’

 

What causes antibiotic resistance? Video: TED-Ed

Despite calls for increased R&D, no new classes of antibiotics have been approved since the early 1980s, apart from the approval of linezolid in 2000, and the last new class to treat Gram-negative bacteria was discovered in 1962, Zoubiane says.

Big pharma withdrew en masse from the antibiotic space in the 1990s, due to the low returns on the high level of investment required in antibiotic R&D. Recognising the urgency of the problem, however, in January 2016 more than 90 pharma and biotech companies committed to enhancing antibiotic discovery.

The move has been accompanied by more research into understanding resistance mechanisms, as well as a shift to more outside-of-the-box thinking about alternative treatments.

 microscope

In 2016, over $500m was invested into research into antibiotic resistance. Image: PxHere

In February 2017, the World Health Organization (WHO) published its list of 12 antibiotic-resistant ‘priority pathogens’ that pose the greatest threat to human health. Most notable are the Gram-negative bacteria, which possess an additional outer cell membrane and are harder to treat with antibiotics than Gram-positive bacteria.

‘These bacteria have been assessed as the most critical priority for antibiotic R&D, as strains are emerging worldwide that cannot be treated with any of the antibiotics currently on the market,’ WHO says.

bacteria gif

Originally posted by amnhnyc

Despite the increased commitment to R&D, however, a WHO report in September 2017 lamented the ‘serious lack of new antibiotics under development’. Among the 33 new chemical entity antibiotics in development targeting priority pathogens, just nine belong to five new antibiotic classes.

There are 16 products, both antibiotics and biologics, with activity against one or more Gram-positive priority pathogens – although mostly targeting methicillin-resistant Staphylococcus aureus (MRSA) – including two new antibiotic classes.

Meanwhile, ‘the situation is worse for Gram-negative bacterial infections’, says WHO. Of ten products in Phase 1 trials, ‘almost all the agents are modifications of existing antibiotic classes […] active only against specific pathogens or a limited subset of resistant strains’.

The 2016 Lister Memorial Lecture: Dame Sally Davies on Global antiiotic resistance. Video: SCI

WHO warns that ‘more investment is needed in basic science, drug discovery and clinical development, especially for the critical priority Gram-negative carbapenem-resistant pathogens P. aeruginosaA. baumannii, and Enterobacteriaceae.’

‘We need to find a strategy not to overcome resistance, but to be able to live with and manage it,’ Brown reflects. ‘I’m more optimistic than some. It’s important to remember that before antibiotics were discovered, the human race didn’t die out.’


Antimicrobial drug discovery

 bacteria pertri dish

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Health & Wellbeing

Tweaking the chemical structure of the antibiotic vancomycin may offer a new route to tackle the burgeoning problem of antibiotic-resistant bacteria, researchers in Australia have discovered.

Vancomycin has been used since the late 1950s to treat life-threatening infections caused by Gram-positive bacteria, including methicillin-resistant S. aureus (MRSA). The antibiotic works by binding to a precursor of the cell wall component, peptidoglycan, Lipid II, thus inhibiting bacterial growth.

Lipid II is present in both Gram-positive and Gram-negative bacteria. However, in Gram-negative bacteria it is protected by an outer membrane. In Gram-positive bacteria, Lipid II is embedded in the cell membrane but part of the molecule – a pentapeptide component – sticks out, which is what vancomycin binds to.

The researchers at the University of Queensland’s Institute for Molecular Biology (IMB), led by director of superbug solutions Matt Cooper, reasoned that if they could increase the ability of vancomycin to bind to the bacterial membrane, this would make it more difficult for bacteria to develop resistance to it.

‘Our strategy was to add components to vancomycin so that the new derivatives – which we call “vancapticins” – could target more widely the membrane surface,’ explains Mark Blaskovich, senior research chemist at IMB. ‘By providing two binding sites – the membrane surface and the membrane-embedded Lipid II - this allows binding to resistant strains in which the Lipid II has mutated to reduce interactions with vancomycin.’ 

In addition, the researchers say that the vancapticins have been designed to take advantage of compositional differences between mammalian and bacteria cell membranes – ie bacterial cells have a greater negative charge. The vancapticins have greater selectivity for bacterial cells over mammalian cells, potentially reducing off-target effects and giving a better safety profile. A series of structure–activity studies showed that some of the vancapticins were more than 100 times more active than vancomycin.

 MRSA

Hospital-Associated Methicillin-resistant Staphylococcus aureus (MRSA) Bacteria. Image: NIAID

This membrane-targeting strategy, the researchers say, has the potential to ‘revitalise’ antibiotics that have lost their effectiveness against recalcitrant bacteria as well as enhance the activity of other intravenous-administered drugs that target membrane associated receptors.

John Mann, emeritus professor of chemistry at Queen’s University Belfast, UK, comments: ‘Bacteria have developed numerous strategies to modify the binding, uptake and expulsion of antibiotics, and thus develop resistance. So, it is especially exciting to see the development of these new vancomycin derivatives that enhance the membrane binding properties of the antibiotic, thus enhancing its efficacy and beating the bacteria at their own game.’

Health & Wellbeing

A new drug developed by Eli Lilly to combat the symptoms of psoriatic arthritis (PsA) – including severe joint pain and swelling – has been approved for market by the European Commission.

Ixekizumab, or Taltz®, can be used to treat patients with PsA who have not responded to, or are intolerant to, traditional anti-rheumatic drug therapies, such as methotrexate, which act to treat the underlying cause of arthritis to slow disease progression, rather than the symptoms.

PsA is caused by a fault in a person’s immune system, when the body sends out signals for inflammation even when damage has not occurred., causing swollen, stiff, and painful joints. It is a chronic and progressive disease with no known cure.

Health & Wellbeing

Vaccines are much debated these days, but before starting a discussion about them, let’s see how a vaccine is defined.

The World Health Organisation defines a vaccine as: 

‘a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins. The agent stimulates the body’s immune system to recognize the agent as foreign, destroy it, and “remember” it, so that the immune system can more easily recognize and destroy any of these microorganisms that it later encounters.’

We put in our bodies something that looks like or has a tiny part of the ‘microbe’ that produces the disease so that our body can produce the right agents to fight it in case we actually contract the real illness.

A vaccine is comprised of an active ingredient and other added ingredients. Like any other drug, the active ingredient is the key component that triggers the immune response. Beside this, the added ingredients have different roles, such as improving the immune response, or acting as a preservative, stabiliser, or suspending fluid.

These added ingredients are the ones that are sometimes contested due to their toxicity. But when speaking about toxicity, there is a very important point to make. Everything is toxic.

It all comes down to the dose you eat, drink, or otherwise insert into your body. An important indicator of toxicity is LD50 (lethal dose 50), which is the dose at which 50% of individuals die. Sodium chloride, also known as table salt, has a LD50 of 12,400mg/kg (868g of salt for a 70kg individual) for humans. The lower the LD50 indicator is, the more toxic a compound is.

saltbae gif

Originally posted by gifsme

Table salt can also be toxic. 

Aluminium salts are used in many vaccines as adjuvants. This means that they help by stimulating the immune response and by a slow release of the active ingredient.

The most used salts are aluminium hydroxide, aluminium phosphate and potassium aluminium sulphate. Data about these compounds are freely accessible by searching for their material safety data sheets (MSDS) on the big chemical suppliers’ websites. The 11th section of an MSDS file is the toxicological information section, which contains the LD50 value, carcinogenicity information, and others.

 aluminium phosphate MSDS

Section 11 of the aluminium phosphate MSDS Sigma-Aldrich

None of the salts above are reported as carcinogenic, and the LD50 of aluminium phosphate is more than 5,000mg/kg for mice. The total quantity of the aluminium in a vaccine is less 1mg (0.001g), which is a very low quantity. In the normal European diet the amount of aluminium we intake from food varies between 3–10mg a day.

Vaccine composition lists also include compounds and products used in the manufacturing process – even though at the end of manufacture they are present only in trace amounts, if at all.

One of the chemicals on this list that scares people is formaldehyde, which is indeed carcinogenic with and LD50 of 42mg/kg for mice. Nevertheless, the quantity present in a vaccine dose is less 0.1 mg. One 200g pear contains 12mg of formaldehyde. We should always remember ‘the dose makes the poison’, as compound interest illustrates below.

 chemicals in food

The does makes the poison – ‘toxic’ chemicals in food. Compound Interest

Vaccination is a personal decision. Nevertheless, it should be based on information from multiple verified sources. Easily accessible and clear information can be found on the Vaccine Knowledge Project website designed by the Vaccine Research Group from the University of Oxford.

 

Health & Wellbeing

The US is in the midst of a healthcare epidemic. Tens of thousands of people are dying each year from opioid drugs, including overdoses from prescription painkillers such as OxiContin (oxycodone) and the illicit street drug heroin, and each year the numbers rise.

The opioid epidemic is currently killing almost twice as many people as shootings or motor vehicle accidents, with overdoses quadrupling since 1999. According to Gary Franklin, medical director of the Washington State Department of Labour and Industries and a professor of health at the University of Washington, the opioid epidemic is ‘the worst man-made epidemic in modern medical history in the US’.

 Montgomery Ohio

Montgomery, Ohio, is at the centre of the epidemic, with the most opioid-related deaths per capita this year. Image: Wikimedia Commons

Incredibly, an influx of synthetic opioids is making the problem worse. Fentanyl, a licensed drug to treat severe pain, is increasingly turning up on the street as illicit fentanyl, often mixed with heroin. According to the NCHS, fentanyl and synthetic opioids are blamed for 20,145 of the 64,070 overdose deaths in 2016. Heroin contributed to 15,446 deaths, while prescription opioids caused 14,427.


Potent opioid

Fentanyl (C22H28N20), a lipophilic phenylpiperidine opioid agonist, is generally formulated as a transdermal patch, lollipop and dissolving tablet. Like the opioids derived from opium poppies, such as morphine, fentanyl binds to opioid receptors in the brain and other organs of the body, specifically the mu-receptor.

 opium poppy

Heroin and other opioids come from the opium poppy.  Image: Max Pixel

Such binding mimics the effects of endogenous opiates (endorphins), creating an analgesic effect, as well as a sense of well-being when the chemical binds to receptors in the rewards region in the brain. Drowsiness and respiratory depression are other effects, which can lead to death from an overdose.


Rise of illicit fentanyl

The opioid epidemic can be traced back to the 1990s when pharmaceutical companies began producing a new range of opioid painkillers, including oxycodone, touting them as less prone to abuse. In addition, prescribing rules were relaxed, while advocates championed the right to freedom from pain. Soon, opioids were being prescribed at alarming rates and increasing numbers of patients were becoming hooked.

 

Why is there an opioid crisis? Video: SciShow

Franklin, who was the first person to report in 2006 on the growing death rate from prescribed opioids, says: ‘OxyContin is only a few atoms different to heroin – I call it pharmaceutical heroin.’

A crackdown on prescribing was inevitable. But then, with a shortage of prescription opioids, addicts turned to illicit – and cheaper – heroin. According to Franklin, 60% of heroin users became addicted via a prescribed opioid. ‘You don’t have to take these drugs for very long before it’s very hard to get off,’ he says: ‘Just days to weeks.’ Heroin use soared and with it increased tolerance, leading users to seek out more potent highs. By 2013, there were almost 2m Americans struggling with an opioid-use disorder.


Drugs to fight drugs

 public health emergency

President Trump declared the opioid crisis a public health emergency in October. Image: Pixabay 

Attention is finally being given to the epidemic. US president Donald Trump recently declared a public health emergency, although no new funds will be assigned to deal with the crisis.

There is particular interest around research into a vaccine against fentanyl. Developed by Kim Janda at The Scripps Research Institute, California, US, the vaccine, which has only been tested in rodents, can protect against six different fentanyl analogues, even at lethal doses. ‘What we see with the epidemic, is the need to find alternatives that can work in conjunction with what is used right now,’ he says.

This vaccine could treat heroin addiction. Video: Seeker

The vaccine works by taking advantage of the body’s immune system to block fentanyl from reaching the brain. Its magic ingredient is a molecule that mimics fentanyl’s core structure, meaning the vaccine trains the immune system to recognise the drug and produce antibodies in its presence. These antibodies bind to fentanyl when someone takes the drug, which stops it from reaching the brain and creating the ‘high’.

 

Health & Wellbeing

Often, the pharmaceutical industry is characterised as the ‘bad guy’ of equality in healthcare. This is particularly evident in the United States, with cases such as Martin Shkreli, whose company Turing Pharmaceuticals infamously increased its leading HIV and malaria drug by over 50 times its value overnight, and a lack of regulation in advertising. The latter is accused of influencing prescriptions of certain brands based on consumer demand, which could lead to unnecessary treatment and addiction.

With stories like these dominating the media, it is no wonder the public if often found to harbour a negative view towards ‘Big Pharma’. However, the actions and motives of this industry are rarely fully understood. Here are five facts about pharmaceutical manufacturing you might not know:


1. Out of 5,000-10,000 compounds tested at the pre-clinical stages, only one drug will make it to market

The drug discovery and development process explained. Video: Novartis

This may seem like slim odds, but there are many stages that come before drug approval to make sure the most effective and reliable product can be used to treat patients.

There are four major phases: discovery and development; pre-clinical research,  including mandatory animal testing; clinical research on people/patients to ensure safety; and review, where all submitted evidence is analysed by the appropriate body in hopes of approval.


2. If discovered today, aspirin might not pass current FDA or EMA rules

 older drugs

Some older drugs on the market would not get approval due to safety issues. Image: Public Domain Pictures

Problems with side effects – aspirin is known to cause painful gastrointestinal problems with daily use – mean that some older drugs that remain available might not have gained approval for widespread use today. Both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) run programmes that monitor adverse side effects in users to keep consumers up-to-date.

Tighter regulation and increased competition mean that the medicines we take today are arguably more effective and safer than ever.


3. The average cost of drug development has increased by a factor of 15 in 40 years

money gif

Originally posted by blisteredblue

Back in the 1970s, the cost to produce a drug from discovery to market was $179 million. Today, drug companies shell out $2.6 billion for the same process – a 1,352% increase! Even considering inflation rates, this number is significantly higher.

With the average length of time needed to develop a drug now 12 years, time is an obvious reason for the high costs. However, the difficulty of finding suitable candidates at the discovery stage is also to blame. Pre-clinical stages can be resource-intensive and time-consuming, making pharmaceutical companies look towards other methods, such as the use of big data.


4. The US accounts for nearly half of pharmaceutical sales

 The Statue of Liberty

The Statue of Liberty. Over 40% of worldwide medicines sales are made by US companies. Image: Wikimedia Commons

The US is the world-leader in pharmaceutical sales, adding $1.2 trillion to the economic output of the US in 2014 and supporting 4.7 million jobs. The country is also home to the top 10 performing pharmaceutical companies, which include Merck, Pfizer, and Johnson & Johnson.

While the EU’s current share is worth 13.5%, this is expected to fall by 2020 with emerging research countries, such as China, projected to edge closer to the US with a share of 25%.


5. Income from blockbuster drugs drives research into rare diseases

 Rare diseases

Rare diseases are less likely to receive investment for pharmaceutical research. Image: Pixabay

Diseases that affect a large proportion of the worldwide population, such as cancer, diabetes, or depression, are able to produce the biggest revenue for pharmaceutical companies due to the sheer volume of demand. But rarer diseases are not forgotten, as research into these illnesses is likely funded by income from widespread use of the aforementioned medicines.

Rare – or ‘orphan’ – diseases are those that affect a small number of the population, or diseases that are more prevalent in the developing world. With the increasing cost of producing a drug, it becomes risky for pharmaceutical companies to create a fairly-priced drug for a small fraction of patients.

However, this seems to be changing. Researchers from Bangor University, UK, found that pharmaceutical companies that market rare disease medicines are five times more profitable than those who do not, and have up to 15% higher market value, which could finally provide a financial incentive for necessary research.

Health & Wellbeing

In recent years, novel innovation in healthcare and pharmaceuticals have hit the headlines with increasing regularity. Each story promises a better quality of life for patients and a product that will ‘revolutionise’ healthcare as we know it. 

However, many of these innovations fail to materialise due to the complexity of the system. Problems with regulation, intellectual property agreements, and manufacturing are just some of the many issues that industry faces when integrating a new product into hospitals and treatment centres.

 Stephen Dorrell

Stephen Dorrell. Image: NHS Confederation@Flickr

So, do we need rethink our expectations of innovation? Speaking at New Scientist Live in September, Stephen Dorrell, Chair of NHS Confederation and a former Health Secretary, said that as an innate characteristic of humans, innovation will not stop. However, we should be more concerned about the difficulty of making good innovation available everywhere and rethinking what we consider the most efficient way of treating patients, he said.

As the most common type of dementia – affecting one in six over the age of 80 – Alzheimer’s disease needs good innovation. With no known cure, current efforts rely heavily on having a care plan once symptoms appear and medications can only slightly improve symptoms for a time as well as slow down the progression of the disease.


Progress in pharmaceuticals 

The Alzheimer’s research community are well versed in the known causes of the disease, with amyloid plaques and tau tangles the most widely accepted causes of the neurodegeneration that leads to Alzheimer’s. As a result, the majority of research and investment in the field is centred around this theory.

Neuro-Bio is a biotechnology start-up that is taking a different approach to making medicines for Alzheimer’s patients. The company is focused on a ‘previously unidentified mechanism’ of the disease that is linked to the development stages of the brain and cell death, and is working on new drug candidates that can stop the peptide involved in this mechanism from functioning improperly in adults.

After a series of setbacks in Alzheimer’s drug development, Prof Margaret Esiri, a neuropathologist at the Nuffield Department of Clinical Sciences, Oxford, said: ‘Neuro-Bio’s approach to the problem of Alzheimer’s disease is novel and scientifically well-founded. It is a good example of the new thinking that is urgently needed in this field’.


Timing it right 

However, with an uncertainty for future success in Alzheimer’s pharmaceuticals, researchers interested in the genetic make-up of neurodegenerative diseases are focusing on how early diagnosis can be beneficial to patients.

 brain matter

Alzheimer’s can cause a significant loss of brain matter (right) compared to a healthy brain (left). Image: National Institutes of Health

According to UCL geneticist John Hardy, a loss in brain matter and amyloid build-up begins 15 to 20 years before symptoms start to appear, highlighting the need for preventative measures. This need is not consistent with what is currently available to patients in the UK however, as to qualify for a clinical trial, patients must be in the advanced stages of Alzheimer’s – often exhibiting severe symptoms that can, quite drastically, negatively affect quality of life for the individual.

Scientists at Case Western Reserve University, Ohio, US, may have solved this issue of early diagnosis after developing a machine learning program that outperforms other methods for diagnosing Alzheimer’s disease. The program integrates known disease indicators and symptoms to predict the likelihood of Alzheimer’s onset. Multiple stage comparisons, which includes associated symptoms that are not always present in Alzheimer’s, allow the program to make a more accurate prediction of who is most vulnerable.

Development of such programs could help initiatives such as the 100,000 Genomes Project which aims to provide the NHS with a new genomic medicine service that can offer better diagnosis and more personalised treatments.  


 Baroness Susan Greenfield

Baroness Susan Greenfield. Image: National Assembly for Wales

Interested in Alzheimer’s disease?

SCI is running a Public Evening Lecture in London on Wednesday 28 February – The 21st Century mind: Blowing it, expanding it, losing itThe talk will be given by Baroness Susan Greenfield, neuroscientist and CEO of Neuro-bio. It is free to attend, but spaces are limited. Don’t miss out – booking opening soon.

Health & Wellbeing

The next five years will be the most promising in the fight against cancer with immunotherapies – such as CAR-T and moderating T-Cell approaches, and innate immunity therapies – delivering far better patient outcomes.

In the last five years, the industry has rapidly advanced its understanding of the body’s immune response and genetic markers. As a result, combination therapies – chemotherapies will continue to play an important role – are forecast to become an increasingly standardised treatment, with pharma keen to invest.

 

These newer options are bringing in transformative remission rates, and check-point inhibitors have already been seen to elicit long-term cures in patients, with success rates two-to-three times higher than standard chemotherapy approaches. 

Over the next ten years, we will see significant breakthroughs as the industry’s understanding of the immune system improves. There are currently more than 130 biotechs – in addition to 20 big pharma companies – working on new therapies and it is believed the smaller companies are more aggressively bringing newer innovations to market. In the long run, pharma will undoubtedly absorb the most promising players in an effort to become leaders in combination therapy approaches, which many argue will deliver the best outcomes.

The current investor frenzy is comparable to that of the genomics industry at the turn of the century. Experts argue that a more complete understanding of the genome and promise of clinical data of these transformative modalities will create a golden age for cancer therapy over the next few years.

There are, however, a number of immediate challenges. For example, CAR-T, although demonstrating good efficacy in blood cancers, has yet to show enough efficacy in solid tumours. Another challenge is how far towards cures for all patients we can get, particularly for patients with late stage metastatic cancer.

Immunotherapies are moving cancer from treatment options that simply extend life or improve experience to more effective cures. The cost of newer therapies is also coming into focus; however, this is a positive pressure on companies to produce significant, not just incremental, outcomes for patients.

Health & Wellbeing

The next five years will be the most promising in the fight against cancer with immunotherapies – such as CAR-T and moderating T-Cell approaches, and innate immunity therapies – delivering far better patient outcomes.

In the last five years, the industry has rapidly advanced its understanding of the body’s immune response and genetic markers. As a result, combination therapies – chemotherapies will continue to play an important role – are forecast to become an increasingly standardised treatment, with pharma keen to invest.

 

These newer options are bringing in transformative remission rates, and check-point inhibitors have already been seen to elicit long-term cures in patients, with success rates two-to-three times higher than standard chemotherapy approaches. 

Over the next ten years, we will see significant breakthroughs as the industry’s understanding of the immune system improves. There are currently more than 130 biotechs – in addition to 20 big pharma companies – working on new therapies and it is believed the smaller companies are more aggressively bringing newer innovations to market. In the long run, pharma will undoubtedly absorb the most promising players in an effort to become leaders in combination therapy approaches, which many argue will deliver the best outcomes.

The current investor frenzy is comparable to that of the genomics industry at the turn of the century. Experts argue that a more complete understanding of the genome and promise of clinical data of these transformative modalities will create a golden age for cancer therapy over the next few years.

There are, however, a number of immediate challenges. For example, CAR-T, although demonstrating good efficacy in blood cancers, has yet to show enough efficacy in solid tumours. Another challenge is how far towards cures for all patients we can get, particularly for patients with late stage metastatic cancer.

Immunotherapies are moving cancer from treatment options that simply extend life or improve experience to more effective cures. The cost of newer therapies is also coming into focus; however, this is a positive pressure on companies to produce significant, not just incremental, outcomes for patients.