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6 Simple Tips for Compelling Scientific Presentations in 2022

January 4, 2022

Eric Monlin | Public Speaking Coach & Founder, Public Speaking Inc., New York

The twenty-first century is a century of ideas, and ideas, when effectively packaged and delivered, are changing the world. Some people are exceptionally good at presenting their ideas. They have the skill that elevates them and gives them influence over their peers and society. As scientists, we all have ideas and passions, and yearn to inspire others. So, wouldn’t be amazing if we can identify the exact techniques used by the world’s greatest communicators, and apply their secrets to wow our audiences? In this article, I provide insights, based on personal research of hundreds of TED presentations, direct interviews with speakers and personal experience from years of coaching ordinary leaders and speakers over a 20 year period, to help you speak with confidence and authority, whether it is delivering presentation at your company, or a major scientific conference.

The anatomy of great presentations

In 2012, civil rights lawyer Bryan Stevenson gave a talk to an audience of 1,000 people in California. He received a standing ovation and his TED talk has been viewed online over one-and-half million times. For around twenty minutes, Stevenson captivated his audience by appealing to their heads and hearts. At the end of the talk, the attendees donated a total of $1 million to his charity, The Equal Justice Initiative. That’s equivalent to $50,000 for each minute he spoke!

What is remarkable is that Mr. Stevenson did not use any Power Point, visuals or props. It was only through the power of his narrative that carried the moment. I am sure you have viewed other riveting presentations. Some of these were probably backed by engaging slides and graphics. What is clear that there are many ways to share ideas. Some speakers tell stories, and others provide rich data. Great speakers are entertaining, captivating and inspiring; they understand the science and art of persuasion.

The late Steve Jobs, Apple cofounder and technology visionary is famous for his presentation skills. His iPhone launches and commencement speech at Stanford University in 2005 show his ability to captivate audiences. It is little wonder that CEOs everywhere have now adopted Steve Jobs methodology.

Dale Carnegie – The Art of Public Speaking

A key starting point for students of public speaking is Dale Carnegie self-help book, The Art of Public Speaking, first published in 1915. Dale Carnegies recommended that speakers keep their talks short. He said stories where powerful ways of connecting emotionally with audiences, and suggested the use of rhetorical tools such as metaphors and analogies. He understood the role of enthusiasm, practice, and strong delivery to touch people.

Now, while everything Carnegie recommended over 100 years ago remains true today and is the foundation of effective communication today, he did not have the tool we have today. Today’s speakers have Power Point, video and the internet.

We’re all Salespeople

It also is the case that the most effective speakers have understood the knack of getting their ideas to stand out in a sea of noise. Effective salespeople are good at inspiring potential buyers. This is the same blueprint if you want to be an effective speaker. You need to learn how to sell yourself and your ideas more persuasively. If you can’t inspire anyone else with your ideas, it doesn’t matter how great your technology is – there will be no takers!

What makes a presentation compelling?

All great and inspiring talks have three components:

Emotion-they touch hearts
Novelty-they reveal something new
Memorable-they present content in ways people never forget

Emotion

Great communicators reach heads and touch hearts. The problem with the majority of us (especially within the sciences) is that we forget the ‘heart’ bit. We therefore need to learn how to identify our passions and use them in our stories, thereby creating deeper connections with audiences.

Novelty

Novelty is one of the most effective way to capture a person’s attention. Humans, it seems, are hardwired to give attention to new things. Research released by YouTube Trends has shown that content that is truly unique and unexpected gets noticed on the platform. Thus, a key aspect of effective communication is engaging audiences is to give them new perspectives, the wow moments.

Memorable

What’s the point of sharing great ideas if nobody remembers what you spoke about the moment you hand over the microphone? Research shows that to be memorable, a presentation has to be of an ideal length of time, and has to create vivid, multisensory experiences that allow the audience to recall the information successfully.

Here are 6 tips to effective presentations

Better than average communicators are generally more successful than most people, but great communicators are the ones that start movements. They are remembered long after their speeches. Think Jefferson, Churchill, Gandhi, Kennedy, King, Mandela and Obama, to name but a few.

Failure to communicate effectively in science can means research won’t get funded, products won’t get sold, projects won’t get backing, and careers won’t thrive. As career scientists, your ability to deliver captivating talks can mean the difference between acclaim and toiling in obscurity.

So here are my six simple tips you can adopt in 2022 to move your presentations to a new level, enabling you to communicate in ways that are passionate, powerful, and inspiring.

Tip #1: Unleash the Master Within

Thomas Jefferson, the third President and Founding Father of the United States of America is highly regarded even today as one of America’s most influential leaders. He was a passionate believer in democracy and considered it essential to the expression of society. He promoted national self-determination, public education, and a free press.

As the principal author of the United States Declaration of Independence, he wrote many inspiring speeches, which went on to shape the course of history. The preamble to the Declaration of Independence, for example, evokes the original spirit of the American nation:

‘We hold these truths to be self-evident, that all men are created equal, that they are endowed, by their Creator, with certain unalienable Rights, that among these are Life, Liberty, and the pursuit of Happiness….’

Passion and public speaking are intimately linked. To touch your audience, you need to dig deep to identify how you’re uniquely and meaningfully connected to your presentation topic. This is where you’re operating at people’s emotional level. Passion is your why, or inspiration. It is not a passing interest or a hobby but rather that thing that’s core to what makes you, you! It is what gives you the authority, mastery and command, and your presentation will be empty without it.

Bear in mind that in some situations, what fires you up might not be obvious. Often, it is dressed up as something else. Howard Schultz, the former Chairman and Executive of Starbucks once said his passion was not coffee, but rather creating a third place between work and home! Coffee was only the by-product.

Passion is what makes successful speakers always enthusiastic about sharing their ideas. They have bags of charisma. They radiate joy and positivity about their ideas, and they are motivated by ‘good’ intentions, such as a desire to make a difference, create impact or leave a legacy.

Just as we know that happiness at and passion about the work are vital to career success, it is the same with public speaking. If you’re not having a great time in your job, how do you expect to generate enthusiasm in your presentation about it?

So while we can talk about effective storytelling, designing beautiful PowerPoint slides or how to use body language more effectively in your public speaking but the fact, and it is a fundamental fact, that effective presentations require passion first. Effective stories, slides or body language mean little if the speaker does not radiate passion and enthusiasm about what they’re communicating.

Tip #2: Master the Art of Storytelling

In this information-saturated age that we live, you won’t be won’t be heard unless you tell compelling stories. Facts and figures, and all the rational things that we think are important in science actually don’t stick in our minds that well. However, stories create “sticky” memories by attaching emotions to things that happen.

Stories also affirm who we are. We all want affirmations that our lives have meaning. And nothing does a greater affirmation than when we connect through stories.

This is why people who know how to weave stories about their work and share good stories have a powerful advantage over others.

But what constitutes a good story? Consider the case of major film studios, such as MGM, Pixar and Disney. They have individually mastered the ability to move audiences deeply, causing adults to tear up next to children, while persuasively transporting us into make-believe worlds.

Their perennial success in the business of movies is down to the way they choose ideas, create compelling characters, invoke empathy, drama and conflict, create villains and heroes, and the endings (the moral), that is, storytelling. It is the same with great speakers.

Aristotle, the Greek philosopher, believed that persuasion happened when three components were represented: ethos, logos, and pathos. Ethos is credibility. We tend to trust and agree with people we respect for their achievements, titles, experiences, etc. Logos is about persuasion through logic and data. Pathos is the act of appealing to emotions.

You can see this approach in Stevenson’s TED talk. For instance, he started with his personal experiences. The first five minutes (30 percent of the presentation) were on his personal stories and experiences. Data about incarceration in U.S. prisons came in later to support his ideas. He chose his approach to make it easy for the audience to connect with him on a personal and emotional level.

Studies have shown that inspiring communicators use three types of story.

The first types of story are personal stories about who we are. They should be descriptive and rich with imagery to enable the listener to imagine themselves with you at the same time. Delivered well, a captivating story makes your audience know something about you, which builds trust. Granted, personal stories are a sensitive subject, but if you choose them carefully, nothing comes close to grabbing the audience’s attention early on. A personal experience that produced an unexpected outcome often works well. The key thing is not to make them show how great you are, etc.

The second types of story are stories about other people who have learned a lesson the audience can relate to. The power of such stories is that they shed light on our shared humanity. So while personal stories can evoke empathy, it is stories about other people that audiences mostly empathise with. Empathy is the capacity to recognise and feel others’ experiences.

The third type of story are stories about successes or failures of products or brands. Harvard Business School is famed for the Case Method to teaching MBA students. These cases usually tell stories (real or simulated) about challenges faced by business executives and lessons that can be learnt from their experiences. This way, students are able to relate to business theorems with particular challenges.

Just as a great novel or movie goes about storytelling, a great presentation has to have a narrative, a cast of characters (hero and villain) and the moral of the story. The story should reveal a challenge (villain) being faced, a protagonist or hero (your solution) who is committed to rising to the challenge, the townspeople (customers) to be freed by the villain, and the outcome (the people who will be freed and live happily ever after their struggles are ended).

Tip 3: Have a Conversation

Great speakers deliver their content in a natural, authentic way, akin to having a comfortable conversation with a friend. It is a skill learned through practice and is not something that can just be memorised and perfected in an instant.

Think of the times you had a genuine conversation with a friend. Hopefully, you’re typically operating in a zone of emotional rapport. You were able to persuade your friend because you had gained their trust, and your voice, gestures, and body language were all in sync with your words.

This authenticity does not happen spontaneously. It is something that is learned, through practice. It takes hours of practice, searching for the right words that best represent the way you feel, delivering those words in a powerful way for maximum impact.

Good verbal delivery is based on what is called in the military as ‘commanding presence’. Commanding encompasses the following key elements:

Rate: the speed at which you speak
Volume: the loudness or softness
Pitch: high or low inflections
Pauses: short pauses to put emphasis on key words
Gestures, facial expressions, and body language

Great communicators speak at the right rate (the ideal rate of speech is between 180 and 200 words per minute), they speak concisely and precisely, and their voices project across the entire room because they speak from their diaphragms. They compliment the words with the gestures and facial expressions, to make a strong argument even stronger.

Tip 4: Reveal Something New

Great speakers incorporate new information or perspectives that are completely new to their audiences. The information may be packaged differently or presented in a way to solve an old problem. Revealing new perspectives works because our human brains love novelty. Unfamiliar, unexpected or unusual outcomes in a presentation audience, jolts them out of their preconceived notions, and provides them with new perspectives.

One of the most captivating public speakers on the web today is Professor Hans Rosling. He often talks about population, economic development and global health issues. As well as delivering data in a fascinating and easy-to-digest way, he is able to reveal completely new perspectives.

This is the same approach taken by all successful communicators. They opt to deliver content in ways that reveal something that is entirely new; things the audience was not familiar with.

Seth Godin, the popular blogger and author, has made a career out of delivering ideas differently. He told a TED audience in 2003 that in a society with information overload, the natural instinct is for audiences to ignore most of it. Thus, delivering the same old, tired content using the same boring methods as everyone else is bound to fail. Adding a little spin to content allows the audience to be more receptive to the message.

Tip #5: Incorporate Jaw Dropping Moments

A jaw-dropping moment in a presentation is when the speaker delivers a shocking, impressive or surprising moment that is very moving and memorable that it grabs the audience’s attention, and is remembered long after the presentation is over. Jaw-dropping moments are capable of heightening emotions, helping listeners recall and act on the message.

In 2009, Bill Gates, the founder of Microsoft delivered a talk at a technology conference about malaria. While on stage, he opened up a glass jar and said, “Malaria is spread by mosquitoes. I brought some here, just so you could experience this. We’ll let those roam around the auditorium little bit. There’s no reason only poor people should have the experience.” The audience roared with laughter, cheered, and applauded. Bill Gates had effectively delivered his jaw-dropping moment.

A few sentences earlier, Bill gates had talked about how many children lives’ could be saved through better medicines and vaccines. He was able to deliver an emphatic talk. He used shock and humour to drive his point home.

Journalists call the mosquito gimmick “the hook.” It’s the wow moment, the showstopper and the device used to capture the audience’s attention. Used cleverly, it allows listeners to share your story. So, before creating a Power Point presentation, take time to think about the story first. In the same manner a movie director storyboards the scenes before shooting, you should create the story before opening the tool. Aim to tap into al the senses – seeing, touching, feeling, and smelling.

Things that shock, surprise, bring fear, joy or wonder impact how vividly we remember them. It is the reason many of us remember our first kiss, the birth of a child, winning an award, break-ups or death of a loved one. It is as though these emotionally charged events are burned into our memories. Therefore, if you want to connect with an audience in an emotional level, you will need to present information that is vivid, using tools and examples that meaningful and concrete.

Tip #6: Be mindful of Cognitive Backlog

Most memorable presentations are noted for three key elements:

Are concise and organised systematically
Use multisensory approaches to paint mental pictures in their audiences
Are authentic, open and transparent.

Conciseness and Organisation

It is an undeniable fact that listening is mentally draining. Thinking, speaking and listening are physically exhausting. Think of the last time you sat through a one-hour lecture or power Point presentation. Too much information prevents the effective transfer of ideas, leaves the audience anxious and even frustrated. Researchers refer to this information overload as “cognitive backlog,” which is akin to piling on weights, which makes the mental load heavier.

This is the reason all TED talks are required to be no more than 20 minutes. TED believes that 20 minutes is short enough to hold one’s attention, and long enough to cover anything relevant.

If you must give longer presentations, it is necessary to split them into chunks, for instance, by adding breaks, videos, stories or demonstrations, every 10 minutes. The longer the presentation, the more the listener has to work to organise, comprehend and recall information.

John F Kennedy, the 35^th president of the United States, gave a famous speech at Rice University in late 1962. It was here that Kennedy outlined his vision for America to explore the moon. The speech, which lasted just over 17 minutes, captured the nation’s imagination about the importance of exploring space.

But it is not enough to be concise. In fact conciseness means nothing if the information is haphazard and unstructured. This is why some influential communications professionals talk of the rule of threes. This rule simply means that people remember three pieces of information well. Add more items and retention starts to wane quickly.

To make use of the rule of three, structure your story in three key chunks or messages around a central theme. It turns out that the rule of three pervades our work and social lives on a daily basis. You will find it in literature (the three little pigs and, the three musketeers), in the arts (three primary colours), politics (the three arms of government), etcetera. If it works for the world’s greatest writers and painters, it will work for presentations, too.

Use of Multisensory Experiences to Paint Mental Pictures

Think again about a particularly boring talk you had the misfortune of attending. What made it boring? What was your level of engagement? Chances are that it had too much text, lacked structure, was visually unappealing and the content was unengaging.

The fact is that boring does not wash well with the human brain. The brain craves multisensory experiences and will quickly switch off when it is exposed to stuff that is boring. Having presentations that include more than one sense: sight, sound, touch, and smell are difficult to ignore. This is why great talks use mesmerizing images, captivating videos, intriguing props, beautiful words, and more than one voice to bring the story to life.

Granted, some of these experiences, such as smell and taste, are difficult to incorporate in presentations. The key thing is to build a presentation around one or two main senses, and incorporate one other. The harder experiences can be simply described.

Slides should incorporate images and videos rather than text whenever possible. The audience is far more likely to recall information when it is presented in a combination of pictures and text rather than text alone.

The other important sense to use is sound. The auditory sensation is very powerful and how the content is delivered (pitch, rate, volume, intensity, sound effects) can all touch the listeners soul.

The final sensation to use is feeling. Feeling has been described as the “holy grail” of presentations owing to its ability to transport audiences to another place. The visual display of information helps the audience to see it while touching allows them to complete the journey.

Being Authentic, Open and Transparent

Although public speaking is an artform, it is not act one can put on. Am sure you have met a person who acts and speaks one way in private only to sound completely different when delivering a presentation. Such people act, look and sound like two different people. They lack authenticity, openness and transparency. Unfortunately, audiences are not thick – they can see through a fib, so trying to be somebody you’re not is a sure way to fail at building rapport with your audience.

If your goal is to inspire the audience and take them with you, you must be real. Here are some things to do:

Use your own voice – there’s no need to sound ‘posh’ or adopt some ‘esoteric voice.’ Chances are that it will make it difficult for your audience to keep up.
Disregard the fact this is a presentation. Instead, regard it as a conversation, the kind you typically have with family and friends.
Relax! This is not a sermon on the mountain, rather you’re just sharing your knowledge and expertise for people to take as much, or as little, as they wish.
Be yourself – you’re fantastic at it!

Finally, try to recapture your inner 3-year old-the times you were carefree, and had no hang ups. If you can get back to that, you’ll be an impactful public speaker.

2021 saw the successful introduction of COVID-19 Vaccines. Here’s what we learned

January 3, 2022

Although vaccines have proven to be effective, more is needed if we’re to end the pandemic

Following the approval of Pfizer’s COVID-19 vaccine, we started 2021 full of hope. With vaccines in the supply-chain, the idea was to get shots in people’s arms as quickly as possible, curb the pandemic and get life back to normal. That was the plan then.

12 months on, roughly 9 billion doses have been administered. In the United States, three vaccines—Pfizer-BioNTech, Moderna and Johnson & Johnson — are widely available. Elsewhere, about two dozen other vaccines have also been approved. In many higher-income countries, booster shots have already started to be administered.

But 2021 also gave us a wealth of knowledge about vaccines’ capabilities. With the emergence of aggressive unpredictable variants, inequitable distribution, hesitancy, and the natural course of waning effectiveness, we now know there still remains much work to do to bring this pandemic to an end. As if to hammer home the point, the detection of the Omicron variant in late November brought home the uncertainty of the pandemic’s trajectory.

So here are some of the key lessons we’ve learned in 2021 about COVID-19 vaccines.

COVID-19 vaccines work, even against emerging variants

Many COVID-19 vaccines proved effective over the last year, particularly at preventing severe disease and death. That’s true even with the emergence of more transmissible coronavirus variants.

In January, during a bleak winter surge that saw average daily cases in the United States peak at nearly a quarter a million, the vaccination rollout here began in earnest. Soon after, case numbers began a steep decline.

Over the summer, though, more reports of coronavirus infections in vaccinated people began to pop up. It was this time that we learnt protection against infection becomes less robust several months following vaccination for Pfizer’s or Moderna’s mRNA vaccines. But the vaccines’ original target — preventing hospitalization — remained stable, with an efficacy of between 80 percent to 95 percent.

Studies also showed that a single dose of Johnson & Johnson’s vaccine was less effective at preventing symptoms or keeping people out of the hospital than the mRNA jabs. The company claims, though, that there’s not yet evidence that the protection wanes. But even if that protection is not weakening, some real-world data hint that this vaccine may not be as effective as clinical trials had suggested.

It is against this evidence (of waning protection) that governments ultimately mooted the idea of COVID-19 booster vaccines for adults.

Concern about declining immunity came to a head amid the spread of highly contagious variants, including Alpha, first identified in the United Kingdom in September 2020, and Delta, first detected in India in October 2020. Currently, Delta is the dominant variant globally.

The good news is that vaccinated people aren’t unarmed against these mutated variants. Clinical data has demonstrated that vaccines trigger antibodies that are still able to attack Alpha and Delta, albeit with slightly less intensity than for the original Wuhan variant that emerged out of China two years ago. Antibodies also still recognize more immune-evasive variants such as beta, first identified in South Africa in May 2020, and gamma, identified in Brazil in November 2020. Although protection against infection dips against many of these variants, vaccinated people remain much less likely to be hospitalized compared with unvaccinated people.

Experts will continue to track how well the vaccines are doing, especially as new variants, like Omicron, emerge. In late November, the World Health Organization designated the omicron variant as the latest variant of concern after researchers in South Africa, and warned that it carries several worrisome mutations. Preliminary studies suggest that Omicron can reinfect people who have already recovered from an infection. The variant is at least as transmissible as Delta. We now know that Omicron may affect vaccine effectiveness. Pfizer-BioNTech’s two-dose vaccine, for instance, is about 30 percent effective at preventing symptoms from Omicron infections while a booster could increase effectiveness back up to more than 70 percent, according to estimates from Public Health England.

Vaccines are safe, with few serious side effects

With close to nine billion of doses administered around the world as of year-end, the shots have proved not only effective, but also remarkably safe, with few serious side effects.

Commonly reported side effects include pain, redness or swelling at the spot of the shot, muscle aches, fatigue, fever, chills or a headache. These symptoms usually last only a day or two.

But more rare and serious side effects have also been reported. However, none are unique to these vaccines. In deed other vaccines — and infectious diseases, including COVID-19 — also cause these adverse effects.

One example is myocarditis and pericarditis. Current estimates are a bit fluid since existing studies have different populations and other variables. However, two large studies in Israel estimated that the risk of myocarditis after an mRNA vaccine to about 4 of every 100,000 males and 0.23 to 0.46 of every 100,000 females. Researchers also reported in October in the New England Journal of Medicine. Yet members of Kaiser Permanente Southern California who had gotten mRNA vaccines developed myocarditis at a much lower rate: 5.8 cases for every 1 million second doses given, researchers reported, also in October, in JAMA Internal Medicine.

What all the studies have in common is that young males in their teens and 20s are at highest risk of developing the side effect, and that risk is highest after the second vaccine dose. But it’s still fairly rare, topping out at about 15 cases for every 100,000 vaccinated males ages 16 to 19, according to the larger of the two Israeli studies. Males in that age group are also at the highest risk of getting myocarditis and pericarditis from any cause, including from COVID-19.

Components of the mRNA vaccines may also cause allergic reactions, including potentially life-threatening anaphylaxis. The U.S. Centers for Disease Control and Prevention calculated that anaphylaxis happens at a rate of about 0.025 to 0.047 cases for every 10,000 vaccine doses given.

But a study of almost 65,000 health care system employees in Massachusetts suggests the rate may be as high as 2.47 per 10,000 vaccinations, researchers reported in March in JAMA. Still, that rate is low, and people with previous histories of anaphylaxis have gotten the shots without problem. Even people who developed anaphylaxis after a first shot were able to get fully vaccinated if the second dose was broken down into smaller doses.

The only side effect of the COVID-19 vaccines not seen with other vaccines is a rare combination of blood clots accompanied by low numbers of blood-clotting platelets. Called thrombosis with thrombocytopenia syndrome, or TTS, it’s most common among women younger than 50 who got the Johnson & Johnson vaccine or a similar vaccine made by AstraZeneca that’s used around the world.

About 5 to 6 TTS cases were reported for every 1 million doses of the J&J vaccine, the company reported to the U.S. Food and Drug Administration. The clots may result from antibodies triggering a person’s platelets to form clots. Such antibodies also cause blood clots in COVID-19 patients, and the risk of developing strokes or clots from the disease is much higher than with the vaccine. In one study, 42.8 of every 1 million COVID-19 patients developed one type of blood clot in the brain, and 392.3 per 1 million developed a type of abdominal blood clot, researchers reported in EClinicalMedicine in September.

Getting everyone vaccinated is not easy

The quest to vaccinate as many people as quickly as possible last year faced two main challenges: getting the vaccine to people and convincing them to take it. Strategies employed so far — incentives, mandates and making shots accessible — have had varying levels of success.

“It’s an incredibly ambitious goal to try to get the large majority of the country and the globe vaccinated in a very short time period with a brand-new vaccine,” says psychologist Gretchen Chapman of Carnegie Mellon University in Pittsburgh, who researches vaccine acceptance. Usually “it takes a number of years before you get that kind of coverage.”

Globally, that’s sure to be the case due to a lack of access to vaccines, particularly in middle- and lower-income countries. The World Health Organization set a goal to have 40 percent of people in all countries vaccinated by year’s end. But dozens of countries, mostly in Africa and parts of Asia, are likely to fall far short of that goal.

In contrast, the United States and other wealthy countries got their hands on more than enough doses. Here, the push to vaccinate started out with a scramble to reserve scarce appointments for a free shot at limited vaccination sites. But by late spring, eligible people could pop into their pharmacy or grocery store. Some workplaces offered vaccines on-site. For underserved communities that may have a harder time accessing such vaccines, more targeted approaches where shots are delivered by trusted sources at community events proved they could boost vaccination numbers.

Simply making the shot easy to get has driven much of the progress made so far, Chapman says. But getting people who are less enthusiastic has proved more challenging. Many governments and companies have tried to prod people, initially with incentives, later with mandates.

Free doughnuts, direct cash payments and entry into million-dollar lottery jackpots were among the many perks rolled out. Before the pandemic, such incentives had been shown to prompt some people to get vaccines, says Harsha Thirumurthy, a behavioral economist at the University of Pennsylvania. This time, those incentives made little difference nationwide, Thirumurthy and his colleagues reported in September in a preliminary study posted to SSRN, a social sciences preprint website. “It’s possible they moved the needle 1 or 2 percentage points, but we’ve ruled out that they had a large effect,” he says. Some studies of incentives offered by individual states have found a marginal benefit.

“People who are worried about side effects or safety are going to be more difficult to reach,” says Melanie Kornides, an epidemiologist at the University of Pennsylvania. And with vaccination status tangled up in personal identity, “you’re just not going to influence lots of people with a mass communication campaign right now; it’s really about individual conversations,” she says, preferably with someone trusted.

As COVID-19 mandates went into effect in the fall, news headlines often focused on protests and refusals. Yet early anecdotal evidence suggests some mandates have helped. For instance, after New York City public schools announced a vaccine requirement in late August for its roughly 150,000 employees, nearly 96 percent had received at least one shot by early November. Still, about 8,000 employees opted not to get vaccinated and were placed on unpaid leave, the New York Times reported.

Many people remain vehemently opposed to the vaccines, in part because of rampant misinformation that can spread quickly online. Whether more mandates, from the government or private companies, and targeted outreach will convince them remains to be seen. — Jonathan Lambert

Vaccines can’t single-handedly end the pandemic

One year in, it’s clear that vaccination is one of the best tools we have to control COVID-19. But it’s also clear vaccines alone can’t end the pandemic.

While the jabs do a pretty good job preventing infections, that protection wanes over time. Still, the vaccines have “worked spectacularly well” at protecting most people from severe disease. As more people around the world get vaccinated, fewer people die, even if they do fall ill with COVID-19.

“We have to make a distinction between the superficial infections you can get — [like a] runny nose — versus the lower respiratory tract stuff that can kill you,” such as inflammation in the lungs that causes low oxygen levels, Luning Prak says. Preventing severe disease is the fundamental target that most vaccines, including the flu shot, hit, she notes. Stopping infection entirely “was never a realistic goal.”

Because vaccines aren’t an impenetrable barrier against the virus, we’ll still need to rely on other tactics to help control spread amid the pandemic. “Vaccines are not the sole tool in our toolbox,” says Saad Omer, an epidemiologist at Yale University. “They should be used with other things,” such as masks to help block exposure and COVID-19 tests to help people know when they should stay home.

For now, it’s crucial to have such layered protection, Omer says. “But in the long run, I think vaccines provide a way to get back to at least a new normal.” With vaccines, people can gather at school, concerts or weddings with less fear of a large outbreak.

Eventually the pandemic will end, though when is still anyone’s guess. But the end certainly won’t mean that COVID-19 has disappeared.

Many experts agree that the coronavirus will most likely remain with us for the foreseeable future, sparking outbreaks in places where there are pockets of susceptible people. Susceptibility can come in many forms: Young children who have never encountered the virus before and can’t yet get vaccinated, people who choose not to get the vaccine and people whose immunity has waned after an infection or vaccination. Or the virus may evolve in ways that help it evade the immune system.

The pandemic’s end may still feel out of reach, with the high hopes from the beginning of 2021 a distant memory. Still, hints of normalcy have returned: Kids are back in school, restaurants and stores are open and people are traveling more.

References and Citations

Johnson & Johnson. Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S. Press release, September 21, 2021.

W.H. Self et al. Comparative effectiveness of Moderna, Pfizer-BioNTech, and Janssen (Johnson & Johnson) vaccines in preventing COVID-19 hospitalizations among adults without immunocompromising conditions — United States, March – August 2021. Morbidity and Mortality Weekly Report. Vol. 70, September 24, 2021, p. 1337. doi: 10.15585/mmwr.mm7038e1.

Witberg, et al. Myocarditis after COVID-19 vaccination in a large health care organization.New England Journal of Medicine. Published online October 6, 2021. doi: 10.1056/NEJMoa2110737.

Mevorach, et al. Myocarditis after BNT162b2 mRNA vaccine against COVID-19 in Israel.New England Journal of Medicine. Published online October 6, 2021. doi: 10.1056/NEJMoa2109730.

Simone, et al. Acute myocarditis following COVID-19 mRNA vaccination in adults aged 18 years or older. JAMA Internal Medicine. Published online October 4, 2021. doi:10.1001/jamainternmed.2021.5511.

G. Blumenthal, et al. Acute allergic reactions to mRNA COVID-19 vaccines. JAMA. Vol. 325, March 8, 2021, p. 1562. doi:10.1001/jama.2021.3976.

Janssen Biotech, Inc. Briefing material. U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee meeting. October 15, 2021.

Taquet et al. Cerebral venous thrombosis and portal vein thrombosis: A retrospective cohort study of 537,913 COVID-19 cases. EClinicalMedicine. July 31, 2021. doi: 10.1016/j.eclinm.2021.101061.

Thirumurthy et al. Association between statewide financial incentive programs and COVID-19 vaccination rates. SSRN.com. Posted September 3, 2021. doi: 10.2139/ssrn.3912786.

Lytras et al. Interventions to increase seasonal influenza vaccine coverage in healthcare workers: A systematic review and meta-regression analysis. Human Vaccines and Immunotherapeutics. Vol 12, May 5, 2016 p. 671. doi: 10.1080/21645515.2015.1106656.

Economic Outlook for Pharma in 2022

December 1, 2021

Throughout 2020 and 2021, navigating the pandemic has been an all-consuming endeavour for all sectors. As the pandemic raged, pharma responded with leadership and purpose, managing to deliver a vaccine in record time. However, with the looming energy crisis, supply chain crunch and labour market tightening all coming to a head, the question on most people’s minds is what does the economy hold out for pharma in 2022 and beyond?

Economic picture

Last month, leading economists at the World Bank, the International Monetary Fund, the OECD and the Conference Board released global economic growth forecasts for 2022 through to 2026.

World growth for 2022 is forecast at 3.9%; with growth across all mature economies forecast to be up by 3.9%. The US and China, the main engines of global economic growth are expected to grow at 3.8% and 5.5% respectively.

Real GDP (average annual) % change	Actual	Actual	Actual	Estimate	Forecast	Forecast	Trend
	2000-2009	2010-2019	2020	2021	2022	2023	2022-2026
United States	1.9	2.2	-3.4	5.7	3.8	3	2.1
Europe	1.7	1.7	-6.6	5	4.1	1.7	1.2
Euro Area	1.4	1.3	-6.9	4.7	3.9	1.5	1
United Kingdom	1.6	2	-9.7	7	4.5	1.4	1.1
Japan	0.4	1.2	-4.7	2.5	3.3	1.4	0.8
All mature economies	1.8	2	-4.6	5.1	3.9	2.3	1.7
China	8.9	6.3	2.2	5	3.3	3.2	3.7
India	6.8	7.2	-7.1	7.5	8.5	4.3	4
Brazil	3.4	1.4	-4.4	5.2	1.5	1.7	1.6
Russia	5.4	2	-2.9	4.5	2.1	1.8	1.6
Turkey	3.9	5.8	1.6	8.9	2.5	3.3	3.6
All emerging econo	5.7	4.7	-2.1	5.2	4	3.2	3.2
World	3.4	3.3	-3.3	5.1	3.9	2.8	2.5

The pharmaceuticals market is expected to grow, fuelled by new scientific and operational opportunities, as companies rearrange their operations and recover from COVID-19 , which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $1700.97 billion in 2025 at a CAGR of 8%.

Among the upside and downside risks identified in the forecast, global supply chain problems, labour issues, and businesses technology investments pause the greatest risks to growth.

Supply chain

The reason supply chain problems are concerning this time round is that, unlike past disruptions (from natural disasters, international trade tensions, cyberattacks, and even, the global pandemic), the current crises appears much harder to resolve.

There is little companies or a single sector can do when its cargo ships are having to wait to unload in goods in ports. The current crisis is compounded by energy price inflation, and the resulting shortages of critical inputs, such as active pharmaceutical ingredients and excipients. This is why this supply shock has no quick fixes, and a rapid return to business as usual does not seem to be on the horizon, anytime soon.

Labour shortages

Labour shortages are crucial to growth. The economists believe that to a certain extent, workers have become more selective in the kind of work they’re taking on post-pandemic. We think this argument is overly simplified and the reality is far more complex.

Taking the US as a case study, three million more workers retired than were expected to retire during the pandemic. In part, this was because older workers are at greater risk of being harmed by COVID. But many older workers found that their retirement plans, and the value of their homes, increased significantly in value. On the other hand, younger workers have had more choices for work.

To attract the workers needed, companies are having to pay new workers higher wages and offer better benefit plans. As the young go back to work in 2022, the need to do this will decrease.

Demographic issues, in the longer term, will also contribute to a shortage in workers. The citizenry is aging in the established economies as well as China. To overcome this, businesses are increasingly investing in digital technologies.

However, one economist warned, the decade before the pandemic hit had the slowest growth in productivity in many decades. Nonetheless, in certain industries, technology is clearly replacing humans and that the pandemic has helped accelerate this shift.

While supply chain and labour issues will depress growth, it is important to put this in perspective. Global economies will grow significantly faster than is the norm.

You can read the report in its entirety through this link.

Global Economic Outlook 2022: Global GDP growth forecast (conference-board.org)

Additional reporting by Niall P Hughes

Medication Swallowing Difficulties: The 3 Steps Needed To Improve Patient Experience

December 1, 2021

Dr. E Vickers (with additional contributions from E Mwesigwa) | Pharmacentral.com

Individuals with swallowing difficulties face inequalities in their access to safe medicines and could be at a greater risk of poor health outcomes compared with the general population. This article sets out to highlight the scale of the problem and suggests actions that the pharmaceutical industry and regulators can take to improve the situation.

What are Swallowing Difficulties?

Swallowing, the act by which we ingest solid food, liquids or medication, is in fact a highly intricate process that requires the interplay of several nerves and muscles in the oral cavity, pharynx and oesophagus in order to safely transfer bolus into the stomach.

While the vast majority of us do this simple act without much thought, there are millions of people who, for one reason or another, struggle to swallow. For them, the ability to initiate and complete a normal swallow is tortuous, accompanied by anxiety, pain, choking or aspiration.

Swallowing disorders occur in all age groups, either as a result of congenital abnormalities, damage to structures in the oropharyngeal anatomical structures and or short-term or long-term medical conditions. In some age groups and populations, however, swallowing difficulties are far more significant and pernicious. For example, in children with learning disabilities as well as senior citizens who need daily medication to alleviate their conditions.

In some situation, an inability to swallow solid medication can be a matter of life and death. For instance, in those with Parkinson’s disease where 70-80% of sufferes have swallowing problems or those who have had a stroke, where swallowing difficulties run at 90%.

Read about our article on Empathy – What the pharmaceutical industry can learn from the IT Industry

The main causes of swallowing difficulties catalogued in the medical literature include:

Dysphagia, the most well-known among swallowing disorders, refers to a group of disorders characterised by changes in the structures or neurological control of the swallow. Studies show that dysphagia affects 3 % of the general population.
Odynophagia which refers to pain swallowing caused by irritation or infection of the oral mucosae and oesophagus, particularly in individuals with acquired immunodeficiency syndrome, oesophagitis or disorders of motility of the oesophagus.
Phagophobia which is the fear and avoidance of swallowing foods, liquids or medication, usually based on the person’s fear of choking. It is on a psychological dimension and characterized by swallowing complaints but no abnormalities upon physical examination or investigation.

Note that difficulty to swallow is not in itself a disease, rather it may be an indication of an underlying structural, neurological or other dysfunction for which proper medicare should be sought since factors that lead to abnormal swallowing, whether it is dysphagia, odynophagia or phagophobia, can be life limiting, and if severe, life threatening.

Anatomy and Physiology of Swallowing

The normal swallow permits an individual to handle a wide range of solid and liquid products of varying volumes, textures and consistencies. This process can generally be divided into different phases, depending on whether the material is a liquid or a solid.

But first, it is essential to quickly review the anatomy and physiology of swallowing as a basis for appreciating swallowing difficulties and how to design effective interventions.

The anatomy of the oral cavity, pharynx, larynx and the innervations of the muscle in the oral cavity are shown in the figure below:

The tongue has both oral and pharyngeal surfaces. The oral cavity is separated from the pharynx by the faucial pillars. The pharynx has a layer of constrictor muscles that originate on the cranium and hyoid bone, and the thyroid cartilage anteriorly.

Note that the anatomy of the head and neck of infants is different from that of adults. In infants, teeth are not erupted, the hard palate is flatter, and the larynx and hyoid bone is higher in he neck to the oral cavity. The epiglottis touches the back of the soft palate so the larynx is open to the nasopharynx, but the airway is separated from the oral cavity by a soft tissue barrier.

The physiology of normal eating and swallowing is described by two models: the four stage model for liquids and the process model for solids.

Although there are differences in the sequence of events in the two models, it is possible to reduce the swallow to three main phases as follows:

Oral Phase

Upon introducing a liquid or solid into the mouth, the material is prepared into a bolus and or transported to the middle of the tongue. During this stage, the posterior part of the oral cavity will be sealed by the action of the soft palate and tongue, thus preventing premature leakage of bolus into oropharynx before the swallow. Note that the tendency for leakage increases with age.

After a brief moment the anterior tongue rises, touching the alveolar ridge of the hard palate just behind the upper teeth. The posterior tongue drops, opening the back of the oral cavity. The surface of the tongue lifts upward, propelling the bolus back along the palate and into the pharynx.

Pharyngeal Phase

The pharyngeal swallow is a swift activity that follows the oral phase. It serves two main purposes:

(1) to permit bolus to be propelled through the pharynx and the upper oesophageal sphincter and into the oesophagus, and

(2) to protect the airway by preventing entry of food into the larynx and trachea.

In this phase, the soft palate elevates and contacts the walls of the pharynx, leading to the closure of the nasopharynx at the point the bolus hurtles into the pharynx. The base of the tongue retracts, pushing the bolus against the pharyngeal walls. Constrictor muscles of the pharynx then contract, squeezing the bolus downward, and together with retraction of the base of the tongue, pushes the bolus downward.

For obvious reasons, the ability to safely pass bolus through the pharynx without aspirating or regurgitation into the nasal cavity is important in human swallowing. Therefore, there are several mechanisms at play which the body uses to prevent entry of food particles into the airway during swallowing.

Oesophageal Phase

The oesophageal phase describes the transport of the bolus through the oesophagus. The oesophagus is a tube-shaped structure originating from the lower part of the upper oesophageal sphincter and terminating at the lower oesophageal sphincter.

During the swallow, the muscles relax allowing the bolus to pass down. Movement is facilitated by a series of peristaltic waves, as well as gravity, both of which effectively transport the bolus through lower oesophageal sphincter and into the stomach.

Swallowing Abnormalities

Abnormal swallowing can result from a wide range of conditions and disorders related to the anatomy and or physiology or the oral, pharyngeal and oesophageal dysfunction.

Swallowing difficulties manifest in different ways, which include:

Painful chewing or swallowing
Dry mouth (Xerostomina)
Difficulty controlling solids or liquids in the mouth
Hoarse or wet voice quality
Coughing or chocking before, during or after swallowing
Feeling of obstruction (globus sensation)

Dysphagia

Dysphagia arises from abnormalities in structure or motility and ranges from inability to initiate swallowing to solids getting stuck in the oesophagus.

Generally, two main types of dysphagia are recognised:

Oropharyngeal dysphagia, whereby patients are unable to transfer food into the oesophagus by swallowing. Oropharyngeal dysphagia is subdivided into structural/obstructive and neurological/propulsive.

From a clinical point of view, any difficulties swallowing solids indicates either structural or propulsive oropharyngeal dysphagia, while difficulty swallowing liquids indicates propulsive or neurological oropharyngeal dysphagia.

Oesophageal dysphagia is when patients can initiate swallowing process however as the food passes down the oesophagus and into the stomach, they experience discomfort. The underlying causes can also be structural or propulsive abnormalities.

The table below lists some of the most common causes of oral and pharyngeal dysphagia

Common Causes of Oral and Pharyngeal Dysphagia

Neurological disorders and stroke

Structural lesions

Psychiatric disorders

Cerebral infarction

Brain-stem infarction

Intracranial haemorrhage

Parkinson’s disease

Multiple sclerosis

Motor neurone disease

Poliomyelitis

Myasthenia gravis

Dementias

Thyromegaly

Forestier’s disease

Congenital web

Zenker’s diverticulum

Ingestion of caustic material

Neoplasms

Psychogenic dysphagia

Polymyositis

Connective tissue diseases: Polymyositis & Muscular Dystrophy

Iatrogenic Causes:

Surgical resection

Radiation fibrosis

Medication

From: Palmer Jb et al, 2006. In Braddom R (ed): Physical Medicine and Rehabilitation, Elsevier, Philadelphia. Pp 597-616.

Odynophagia

Odynophagia is the disorder in which swallowing is associated with pain. It differs from dysphagia, which is simply difficulty when swallowing — and does not associate with pain, whereas odynophagia always does.

Odynophagia can be caused by infective and non-infective inflammatory processes, benign and malignant esophageal disorders such as achalasia, gastro-esophageal reflux disease and carcinoma.

Some of the conditions associated with odynophagia include:

Gastroesophageal Reflux Disease
Esophagitis
Candidiasis
Esophageal Cancer

Phagophobia

Phagophobia is a relatively rare type of anxiety disorder associated with swallowing. It is often mixed up with pseudodysphagia, which is the fear of choking. The key difference between these two phobias is that individuals with phagophobia are anxious about the act of swallowing whereas those with pseudophagia are afraid that swallowing will lead to choking.

Irrespective, phagophobia and pseudodysphagia can be life limiting, and in the case of medication, life threatening. This is especially the case in the small but significant cohort of individuals, who for reasons still to be known, have phagophobia and pseudodysphagia related to medication.

Unfortunately, the causes of phagophobia are poorly understood and may even be multifactorial, involve past experiences, underlying health conditions or simply learned through observing others who struggle to swallow certain things.

It has been found that individuals who watch others experience difficulties (e.g pain or embarrassment) when swallowing may go on to develop phagophobia.

Finally, phagophobia may occur in the absence of any underlying triggers.

Symptoms of phagophobia include:

Anticipatory anxieties before ingestion of meals
The tendency to eat very small mouthfuls or drinking frequently or large amounts of liquids during meals as a way to aid swallowing
Extreme anxiety and fear at the thought of swallowing
Panic attacks
Rapid heart rate and breathing
Reluctance or avoidance of eating or drinking in front of others
Sweating
Switching to an all-liquid diet as a way to alleviate anxiety around swallowing
Weight loss (skipping medication and exacerbation of illness if related to medication)

Oral Medicines and Swallowing Difficulties

The prevalence of swallowing difficulties varies greatly, including population under consideration, comorbidities and assessment methods. Experts contend that prevalence may actually be greater than published figures would indicate since many patients may not report symptoms.

Generally, 70 – 90% of all seniors have some degree of swallowing difficulty. In certain cases, for instance, Parkinson’s disease and Stroke, swallowing difficulties are the norm, and have been reported to be as high as 90%. According to a recent study, swallowing difficulties run at 3% in the world adult population, but are 10 times higher in those with neurological and or psychological conditions, such as learning disabilities, severe mental illness or dementia.

With oral administration of medication being the most preferred route, the swallowing of solid medication, particularly tablets and capsules, presents specific challenges to anybody with swallowing problems. To make matters worse, solid dosage forms need to be taken with water, which requires the same individuals to control a thin fluid, which complicates matters even more.

Which medication types are suitable for dysphagia and other swallowing difficulties?

Most medication in use today is formulated as tablet dosage forms. According to the British Pharmacopoeia, a tablet is circular in shape with either a flat or convex faces prepared by compressing the active pharmaceutical ingredients with excipients.

In reality, they are available in a wide range of sizes, shapes, colours and indentations. In addition, tablets may be sugar or polymer film coated as well.

The oral route of drug administration is the most preferred route of taking medicine, and understandably, manufacturers of medicines recognise this. As a result, oral medicines account for more than 70% of all medicines in use.

Tablets (and more specifically, standard compressed tablets) are the single most popular dosage form, responsible for 50% of all pharmaceutical preparations manufactured and sold. Some of the reasons for popularity of tablets include:

Tablets allow accurate dosage of medicament to be prefabricated and administered simply and conveniently
Tablets are consistent with respect to weight and appearance
Drug release rate can be fine-tuned to meet physiological and pharmacological needs of patients
Tablets can be mass-produced simply and quickly, which allows the wider public to have access to medicines that would otherwise be too costly.

However, to anyone with swallowing difficulties, swallowable tablets are a nightmare. Problems with the neural control or the structures involved in swallowing mean that swallowable tablets are not ideal sufferers of dysphagia. Too big (frankly, most are) and they are a choking hazard. Too small and they become difficult to detect on the tongue and move around in the mouth to initiate a safe swallow.

If the tablets can be crushed beforehand, it can greatly help pass them down however, as with anything that requires precision, the possibility of errors increases with the number of additional manipulations. Thus, having technologies that enable dosing without the need for additional dilution, elaboration or mixing as is always needed in paediatric, geriatric or other swallowing disorders would be of great benefit.

There are alternatives to swallowable tablets, which depending on the type of drug substance and its intended use, may be considered:

Buccal Tablets
Caplets and Coated Tablets
Chewable tablets
Effervescent Tablets
Lozenges
Mintablets
Multiparticulates
Orally Disintegrating Tablets (ODTs)
Powders for reconstitution
Sublingual Tablets
Hard Gelatin Capsules
Soft Gelatin Capsules
Chewing Gums
Gummies
Topical Products (Ointments, Creams, Lotions and Transdermal Patches)
Parenteral Products
Inhalation Products

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Key Characteristics of Different Tablets Types

Type of tablets	Description and Advantages	Key Considerations
Swallow Tablets	The vast majority of tablets fall in this category. These tablets are designed for per-oral administration by swallowing	Most tablets belong to this category. They are designed to be swallowed whole although some may be crushed/split up to ease ingestion.
Buccal Tablets	Buccal tablets are designed to be placed under the cheek mucosa or between the lip and gum. Typically designed for slow release and absorption.	Buccal tablets permit administration without the requirement for water/swallowing Drugs should not be bitter or unpleasant in the mouth Usually very small and flat and do not require addition of a disintegrant
Sublingual Tablets	Sublingual are designed to be placed under the tongue. Unlike buccal tablets, they allow rapid absorption through blood vessels under the tongue while avoiding 1st-pass effect.	Sublingual tablets permit administration without the requirement for water/swallowing Drugs should be soluble, typically low dose and not be bitter or unpleasant in the mouth Careful selection of excipients required
Orally Disintegrating Tablets (ODTs)	ODTs are designed to rapidly disintegrate on the tongue into a smooth solution or suspension that can be swallowed without the need for water.	Two key characteristics that a dosage form labelled as an ODT must possess is a rapid disintegration time of 30 s or less, and a tablet weight of 500 mg or less
Chewable Tablets	Chewable tablets consist of a mild effervescent excipient base which can be chewed and broken down into a smooth consistency which can be swallowed.	To provide fast disintegration and dissolution, the tablet should be designed to be soft or easy to chew. The active drug substance must not be unpleasant to the taste, and frequently, flavours and sweeteners are required.

Unfortunately, too many products on the market today are formulated with little consideration of those with swallowing difficulties. Products for children are perforce prepared from products designed for adults; and the same applies for the elderly, who often have swallowing problems while also requiring prolonged, non-crushable tablets. In 2020, for instance, out of the 200 best-selling medicines in the United States, only six were offered in easy-to-swallow formats. It is not funny any longer. It is unsafe and something needs to be done soon.

That people have to crush medication in the 21^st century so that children and seniors can be treated despite the wide availability of technologies and excipients and knowhow is disgraceful.

Actions needed to reduce inequalities in dysphagia

The prescription remains the most widely used medical intervention today. Yet it is estimated that up to 50 % of all patients prescribed medication fail to take it correctly. This not only leads to waste of resources but could lead to treatment failure and sub-optimal outcomes.

If society is to equitably offer quality healthcare to all, it will be necessary to take a whole person approach, by recognising the many root causes of inequality, and engender system-wide action, from regulators, pharmaceutical companies, patient groups as well as healthcare workers as the immediate contact points for patients.

Here is a range of preventative actions that local areas can take to reduce inequalities and improve health outcomes and the lives of people with mental illness.

1. A better understanding of the scale of the problem

Although dysphagia and other swallowing disorders are widespread, the scale of the problem, especially as it relates to medication, is still poorly understood.

It is generally known that patients, for one reason or another, tend to underreport their problems during contact with healthcare providers. The lack of understanding on the scale of the problem generally hinders society’s ability to deliver equitable healthcare.

Therefore, investment in data gathering is urgently required if we are to fully understand the scale of this problem. When delivering care, providers and institutions need to ask patients if they have issues swallowing solid medicines and know the implications of not offering working solutions.

In the 21^st century, it is not just a patients’ physical comfort that is important but also their emotional well-being. This way, more joined-up interventions can be implemented.

2. Partnership between the public, government and pharmaceutical companies

With growing healthcare needs, increasing expectations from the health systems, and challenges of insufficient resources, it is unlikely that health services can be provided solely by a single actor. More than ever before, healthcare requires profit and social purpose to converge.

Public-private partnerships (PPPs) have traditionally taken many forms, varying in the level of participation or risk taken by different parties. We are not talking about PPPs as such, but rather, collaborative framework in which patient organizations, the pharmaceutical industry and healthcare providers work together, get closer to patients and gain deeper insights about their individual issues and not just as patients.

Although there is no-one-size-fits-all model, such a collaborative model can actually facilitate development of better therapies.

3. Legislation and incentivisation of marketing authorisation applicants

Providing medicines for marginalised or neglected demographics, such as those with swallowing problems, has been an endemic oversight in the pharmaceutical industry. This has been partly because marginal groups have not always been a viable commercial market or because companies were simply not bothered.

Given how prevalent dysphagia and other swallowing issues are, urgent action is required. There is need to join forces to pressure regulators and drug producers to address this inequality. One way is to require applicants for marketing authorisations to provide introduce alternative formats aimed at those with swallowing difficulties at launch in return for reduced regulatory fees or marketing exclusions.

It is clear that the current strategy of relying on the largesse of individual companies is not working, and a more sustainable approach is required.

Final thoughts

The vast majority of medication available today is in the form of swallowable tablets. These formats are often not appropriate for patients with dysphagia or other swallowing difficulties. Lack of availability of suitable formats for suffers predisposes these groups to sub-optimal treatments and contributes to healthcare inequalities.

If society is to equitably offer quality healthcare to all, it is necessary to take a whole person approach, recognise the many root causes of inequality, and engender system-wide action, from regulators, pharmaceutical companies, patient groups as well as healthcare workers as the immediate contact points for patients.

Sources Used

Overview of Drug Therapy in Older Adults. The Merck Mannual. (available at https://www.msdmanuals.com/en-gb/professional/geriatrics)

Wright, D., 2014. Prescribing Medicines for Patients with Dysphagia. New York: Grosvenor House Publishing, pp.1-101.

Lisa Tews, Jodi Robinson.,2007. Dysphagia. In Kauffman T, L et al., (editors). Geriatric Rehabilitation Manual (Second Edition), Churchill Livingstone, pp 381-385. https://doi.org/10.1016/B978-0-443-10233-2.50063-8. (https://www.sciencedirect.com/science/article/pii/B9780443102332500638)

Dysphagia. National Institute on Deafness and other Communication Disorders. (available at https://www.nidcd.nih.gov/health/dysphagia)

Beating Burnout: A Practical Guide for Pharmaceutical Scientists

October 30, 2021

Unrealistic pressures to perform and deliver results are creating burnout among many career scientists. If not adressed, work-related chronic reduces productivity, mental health deterioration.

At the last summer Olympics in Tokyo, Simone Biles, the four-time Olympic champion, stunned and also won applaud when she announced her withdrawal from the gymnastic team final and women’s individual finals to focus on her mental health.

For most of us engrossed in the world of chemicals and drug substances, the pommel horse is as far away as it gets, yet we can easily relate with the daily struggles of work, very much like Ms Biles. We may hate Mondays, find it hard to get motivated for even the smallest tasks, we often feel like we’ve lost skills, and the career that excited us and brought so much happiness is no more! Some of us have even contemplated leaving the field altogether, or even worse.

According to recent studies, these feelings are very common. It is just that among scientists, the rates of mental health are higher than those in the general public. In some reports, one in three PhDs is at risk of developing a mental-health disorder, including depression.

Many mental health problems are driven, in part, by the immense pressure on scientists to win funding, publish work in reputable periodicals, land jobs or create innovations in an unforgivingly competitive environment, where tolerance for failure is low. And COVID-19 has not helped matters.

To cap it all, studies have identified that scientists have poor mentorship, poor access to counselling services and those in their line management lack the training to manage wellbeing. This is why universities and employers are now being urged to improve mental health support services, revise leave-of-absence policies, and provide mentorship training all those in line management roles.

In this article, I describe burnout, a common cause of mental health deterioration among working professionals. I describe its causes and risk factors and how it can be prevented. Finally, I outline practical steps on how to recover if you have work-related stress.

What is burnout?

Burnout or chronic work-related stress, is a condition characterised by exhaustion. According the World Health Organisation, burnout is a syndrome arising from chronic workplace stress that has not been successfully managed. It is characterized by three dimensions:

feelings of energy depletion or exhaustion;
increased mental distance from one’s job, or feelings of negativism or cynicism related to one’s job; and
reduced professional efficacy.

Three of the world’s experts on burnout, Susan Jackson, Christina Maslach and Michael Leiter, all agree that burn-out is an occupational phenomenon, specifically defining as a psychological response to interpersonal stressors of work. It is different and apart from experiences in other areas of life.

It is important to mention that work-related stress is not an official medical condition in itself, it is usually only a symptom of other underlying issues, such as depression.

The sinister thing about burnout is that it may even go unnoticed and sufferers may not even be aware that the source of burn-out is their job!

Suffice to say burn-out, whether formally diagnosed or not, has the ability to impact both mental and physical health. And for this reason, it is important that burnout is recognised early and a plan put in place to help one recover from it.

How to tell if you have work-related stress

According to psychologist Susan Maslach, burnout manifests in the form of three symptoms, namely exhaustion, cynicism and inefficacy due to chronic stressors at work.

Exhaustion is the main symptom of burnout. It encompasses deep emotional exhaustion, physically, cognitively and emotionally, leading to an individual’s inability to function.

Cynicism or depersonalisation refers to a loss of connection and engagement with one’s work. Essentially, the sufferer of chronic burnout feels mentally removed from work, including colleagues, customers or assignments.

Inefficacy refers to feelings of failure and a lack of sense of accomplishment or productivity. Individuals who experience inefficacy feel their skills are eroding and may worry that they will not be successful in other areas of work.

The signs or symptoms can be physical, psychological and behavioural:

Physical symptoms include:

Fatigue
Muscular tension
Headaches
Heart palpitations
Sleeping difficulties, such as insomnia
Gastrointestinal upsets, such as diarrhoea or constipation
Dermatological disorders.

Psychological symptoms include:

Depression
Anxiety
Discouragement
Irritability
Pessimism
Feelings of being overwhelmed and unable to cope
Cognitive difficulties, such as a reduced ability to concentrate or make decisions.

Behavioural symptoms include:

An increase in sick days or absenteeism
Aggression
Diminished creativity and initiative
A drop in work performance
Problems with interpersonal relationships
Mood swings and irritability
Lower tolerance of frustration and impatience
Disinterest
Isolation.

Questions to ask yourself:

Do you constantly feel like you do not have energy for anything?
Is your sleep interrupted? For instance, do you sleep during the whole day or have problems falling or staying asleep?
Do you feel like you have to force yourself to go into work? Do you struggle to get started with work tasks?
Do you notice that you are easily irritated or impatient with work colleagues, clients or customers?
Have you become particularly critical or cynical about your work or others at work?
Do you feel you’re not as productive as you were in the past? Are you struggling to focus on your work?
Do you feel you no longer take interest in your achievements? Has your passion for the job gone?
Are you increasingly binge-eating to feel better? Are you using alcohol or drug to improve your mood?
Do you frequently suffer from headaches, unexplained stomach problems or any other unexplained pains or twitches?

Note that the mere fact that you answered yes to any of these questions, it does not necessarily mean you have work-related stress. Equally, you shouldn’t have to live with any of these feelings. Seeking help from professionals will help you deal with it early enough so that you can regain your mojo back and start living life to its fullness.

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Common causes of burnout

Chronic work-related stress is a growing concern in the workplace around the world. Health experts attribute the rise in burnout to increase in work demands and lack of awareness on practical ways to manage it.

All the following issues have been identified as potential stressors at workplaces. A risk management approach will identify which ones exist in your own workplace and what causes them. They include:

Organisation culture
Bad management practices
Job content and demands
Physical work environment
Relationships at work
Change management
Lack of support
Role conflict

If a job saps a lot of energy and exposes you constantly to stress, for instance the pressure to meet very tight deadlines, absence of social and supportive network or if the job is chaotic or monotonous, the chances of experiencing burnout are much higher.

Some of the factors that commonly cause burnout include:

Long hours
Heavy workload
Changes within the organisation
Tight deadlines
Changes to duties
Job insecurity
Lack of autonomy
Boring work
Insufficient skills for the job
Over-supervision
Inadequate working environment
Lack of proper resources
Lack of equipment
Few promotional opportunities
Harassment
Discrimination
Poor relationships with colleagues or bosses
Crisis incidents, such as an workplace death
Unclear expectations

How to prevent or handle early stages of burnout

Thanks to ongoing research by psychologists and health professionals, our understanding of causes and solutions for burnout is much improved. We have a better understanding of what to do once the symptoms of burnout are picked up.

So here are some strategies that have been successful across the board:

Focus on self-care and wellbeing

It’s crucial to refill your physical and emotional energy, as well as your ability to focus by prioritising sleep hygiene, nutrition, exercise, social networks, and practices that promote mental calmness, such as meditation, journaling and nature appreciation.

If for one reason or another you find it difficult to squeeze in these activities in your schedule, take a week to examine how you spend your time.

You can then take a look at each block of time in your day and record how you spend time, i.e., what you do, the people you spend the time with and how you feel. Then score each activity in terms of how valuable it is or how it leaves you (1 = drained, 10 = energised).

This can enable you find breaks and opportunities to reduce exposure to situations that do not build you, and this way, find breaks for rejuvenating moments away from work.

Shift your outlook

Although relaxation, resting and rejuvenation can help alleviate exhaustion, address cynicism and improve productivity, they do little as far as mollifying the underlying causes of burnout.

Back at work, you may still have to contend with the same unmanageable workload, conflicts or lack of resources. It is therefore important to take a look at your expectations with respect to work:

Which aspects of work can be changed? It helps to ask yourself what tasks can be delegated to free up energy for other meaningful tasks. Perhaps some aspects of your work could be changed to allow you regain some level of control over your workday.

And if it is cynicism, look into ways of sheltering yourself from parts of the workplace that antagonise or frustrate you and instead re-engage with those aspects of the job that are most meaningful.

It also greatly helps if you can find supportive relationships and networks that can help counteract those that drain you.

Eliminate or reduce exposure to stressors

Reduction of job stressors requires you to recognize those particular activities and relationships that trigger unhealthy stress. This might require a reset of expectations from colleagues, clients and even family members regarding what and how much you are willing to take on as well as the ground rules for walking together.

You may, of course, experience resistance as you go about this; the most important thing, however, is to assure yourself that the changes you’re making will improve your long-term productivity as well as protecting your wellbeing.

Invest in connectivity

It has been found that one of the most effective remedies for burnout, especially when its driven by cynicism and inefficacy, are finding and making rewarding interpersonal connections and seeking professional growth. Reaching out to and engaging in coaching and with suitable mentors that can help identify opportunities for growth can be highly rewarding.

Another issue is finding opportunities to volunteer in your community or to help others in similar situations can be a very powerful way to break out of a negative cycle of cynicism and lack of motivation.

Finally, given the role of the situational dimension to burnout, chances are that others in your organisation have burnout, too. So finding and identifying with others in a similar predicament will help identify organisation-wide problems and lasting ways to address them.

Nip burnout in the bud

Getting aware of the problem is the first step to addressing burnout. However, this is often the most difficult simply because we tend not to accept ‘weakness’ or reassess aspects of our behaviour.

If you hear family or colleagues express any concerns about your work, its important to take heed. Granted, accepting that you are heading into a crisis will be hard to take, however, and at the end of the day, your wellbeing is what counts.

Get support

It is crucial to find someone who is willing to challenge your assumptions and give you a different take on things. This may be a trusty friend, a coach, family member or therapist. This is because burnout has the potential to cloud your thinking and decision making. Hence, if you can be helped with finding and mapping out work-life boundaries, it will be easier to to find that happy medium.

Take time to recharge even if you love your job very much

It’s common to get exhausted from time to time, particularly on those occasions when the job is all consuming. This is not full burnout. Still, it is important not to let things slip, so here are some quick ways to recharge:

Take breaks during the day. In order to perform at your best consistently, you need to find opportunities to restock your mental energy. Taking regular breaks allows to step away and clear your headspace.

Put away digital devices for a moment. Today, we find ourselves carrying our offices wherever we go with no downtime at all. It is a good practice to place your work phone away when you arrive home so that you’re not tempted to check work emails during out of office hours.

Take weekend breaks. Short breaks have been shown to help reduce stress, aid with maintain peak performance while also reducing the need for long lay-offs. Make sure that while you’re away, you completely switch off from work.

How to recover if you already have burnout

The first step to take in order to recover from burnout is to regain your perception of control of your situation first. During the state of burnout, people often feel as if their circumstances are out of their grasp, a few others may even feel the rest of the world is working against their interests. This mentality creates a virtuous cycle and block them from dealing with their circumstances.

But what is resilience? Simply it is an individual’s ability to positively respond to stress, pressure, risk and adversity.

To fully appreciate resilience, we need to borrow from the British Army’s highly acclaimed mental resilience programme for its soldiers. This programme recognises soldiers do not only need physical strength but also mental toughness if they are to effectively face the many challenges of their careers. It comprises the following principles:

SELF-BELIEF – confidence in your own abilities and judgement

POSITIVE AFFECT – the ability to interact with life in a positive way

EMOTIONAL CONTROL – the ability to understand and express your emotions

MENTAL CONTROL – the ability to control thinking, attention, concentration, focus, self-awareness, reflexivity, problem-solving

SENSE OF PURPOSE – the motivation that drives you forward

COPING – adaptability, natural coping strategies you have learnt through coping in previous stressful situation

SOCIAL SUPPORT – the social network you have and the ways you use it.

Here are some of the things you can do to build mental toughness:

1. Develop a positive mindset

To increase your resilience, the first thing that one has to do is refocus on building a strong, positive mindset in everyday life.

2. Know your why

Another aspect of building resilience is constantly being aware of your “why” when it comes to your short and long-term goals. If you’re going to achieve a big goal knowing why you need to do it in the first place cushions you against discouragements and disengagements as soon as you experience your first setback.

3. Find strength in others

Developing resilience is much about your inner fortitude as much as embracing the idea that you’re not in it alone. Even the most successful people among us rely and count on others for support, mentorship, guidance and encouragement when times are difficult. So you should have the confidence to do the same.

4. Learn to pick yourself up

Finally, it is worth remembering that building resilience isn’t easy! Anyone who’s ever achieved massive success knows that obstacles, setbacks, and failure are inevitable, and you’re no different.

As you work on your goals, you’re going to face many ups and downs, but this doesn’t mean that you don’t have mental toughness, willpower, or discipline.

In summary, you can build resilience through learning to recognize negative tendencies and taking action to correct them early on with healthy habits. Developing resilience is not about eliminating weakness, but learning how to deal with it and overcome it.

Final Thoughts on Burnout

The never-ending pressures to deliver new knowledge and products and be on top of things have undesirable consequences for scientists’ wellbeing. Burnout, the term that is sometimes used for all sorts of work-related stresses, is, in realty a serious red-flag that things are not going well. Unmanaged, chronic burnout leads to low productivity, negative emotions and mental ill-health. Recognising burnout early and taking steps to deal with its causes is important. But equally, all stakeholders, from line managers, to the boardroom, need to understand and recognise burnout and institute processes to address it so that workplaces are supportive and more productive.

Reference

Diane Wood. Corporate burnout affecting the mental health of 20% of top performers in uk businesses. Personnel today, may 3, 2017.
Christina Maslach and Susan E Jackson. The Measurement of Experienced Burnout. Journal of Occupational Behaviour 2 (1981): 99-113.

Opinion | What Does the Recent Pig-to-Human Kidney Transplant Mean for Tissue Therapeutics?

October 29, 2021

In a pioneering procedure, a team of surgeons at New York University Langone Health Grossman School of Medicine in New York City managed to attach a pig kidney to a human patient. The kidney functioned normally for 54 hours.

Last week, a team of surgeons in New York City were to able to successfully attach a pig kidney to a human patient and watch the organ function normally for a whole 54 hours. While procedures of this kind are not new in nonhuman primates, it is the first time that a pig kidney has been transplanted into humans and not been immediately rejected.

The process of transplanting living cells, tissues or organs from one species into another is what scientists call xenotransplantation. However, owing to genetic differences between species, past xenotransplantation efforts have not been successful, leading to immediate organ rejection by the human immune system.

The breakthrough procedure, which was announced at a news conference and widely reported in the media on October 21, represents a giant step towards the aim of increasing availability of life-saving organs for transplantation. Waiting list for donated organs around the world are in the millions, and demand is not expected to drop anytime soon despite a rise in organ donation registrations.

Speaking on condition of anonymity, a nephrologist at Abbott Northwestern Hospital, Minneapolis, MN said the fact that transplant survived three days with full function and no signs of rejection was an “incredible achievement,” and gives fresh confidence that “patients will have access to additional sources of organ for transplantation in the near future”.

However, several years of more of research, clinical trials and regulatory scrutiny are required before we can start to see pig kidneys on surgical tables.

In a press release, Robert Montgomery, MD and chair of the department of surgery at NYU Langone and director of the NYU Langone Transplant Institute, noted that the future of this work is not limited to kidneys.

“Transplanting hearts from a genetically engineered pig may be the next big milestone,” he said. “This is an extraordinary moment that should be celebrated — not as the end of the road, but the beginning. There is more work to do to make xenotransplantation an everyday reality.”

Why pigs?

In the quest to address the chronic shortage of organs, scientists have long sought the use animal organs. Pigs have emerged as an interesting choice because their organs are anatomically similar to those of humans, and they can be easily bred in a highly controlled manner.

However, it is more that ease of breeding. In the mid-20th century, xenotransplantation scientists noticed that transplanted animal organs quickly turned black, a phenomenon known as hyperacute rejection.

As knowledge has improved, scientists have been able to use genetic engineering to overcome some of these challenges. For example, it was found that aggressive immune responses seen after a pig xenotransplant was due to antibodies detecting alpha-gal, a sugar moiety found on porcine vasculature.

Disabling the gene that codes for alpha-gal was key to addressing hyperacute rejection of pig organs. Until now, a test of this sort of transplant hadn’t been done successfully in humans.

So what did the New York University Langone Health team do?

In order to overcome the many ethical hurdles of performing such an operations in humans the surgical team approached the family of a woman with brain stem death kept alive on a ventilator. Although the woman was an organ donor, her organs were not suitable for donation.

Over a period of several hours, the surgical team worked to attach the pig kidney, which had been genetically engineered to remove the alpha-gal sugar to blood vessels, in the upper leg of the patient. The kidney was kept outside of the body so the team could assess its function in real time.

In order to improve chances of acceptance, the team also transplanted the animal’s thymus gland, which aids the education of the immune system to recognize the kidney as part of the body. The patient was also given specific drugs that suppress the immune system.

Within minutes, the kidney started producing large amounts of urine and showed other signs of normal functioning. The pig kidney functioned just like a human kidney transplant. The research team stopped monitoring at 54 hours in line with IRB ethical guidance.

The patient was taken off life support after the procedure.

What’s next for these sort of transplants?

To survive 54 hours represents a significant development but to become mainstream, animal kidneys will need to survive for years not days. For this to happen, researchers will need to show that these organs can withstand immune system attacks for years in the human body.

A key aspect of this journal is to show that transplants are safe in the long-term and obtain approval from health authorities, including the U.S. FDA and the European Medicines Agency.

Are there any ethical concerns about breeding pigs for organ harvesting?

Using any animal for the sole benefit of humans raises important ethical questions. Advocates for xenotransplantation argue the potential benefits of expanding the organ supply are worth any potential harm done to animals.

The jury is still out on how acceptable the idea of breeding millions of pigs in order to harvest organs for human transplantation is.

PETA (People for the Ethical Treatment of Animals), a campaigning organisation against the use of animals in research, contests the whole idea that we should consign animals as sources of spare parts for humans (see their statement through this link).

Questions or comments on this article? E-mail us at editor@pharmacentral.com.

Sources

NYU Langone Health. Progress in xenotransplantation opens door to new supply of critically needed organs. Published online October 21, 2021.

What does COP26 mean for the pharmaceutical sector?

October 29, 2021

The stakes for this year’s UN Climate Change Conference couldn’t be higher. But what can we expect from the talks in Glasgow? And how will the summit impact industry?

From the 31st of October to the 12th November 2021, the United Kingdom and Italy will jointly host the 26th UN Conference of the Parties on Climate Change (COP26) in Glasgow. Heads of state, climate scientists and other stakeholders will gather to flesh out and agree on joint steps to combat climate change.

What is a COP?

‘COP’ simply means ‘Conference of the Parties’. In the world of climate change, ‘the Parties’ are the governments that have signed the UN Framework Convention of Climate Change (UNFCCC).

The COP brings these signatory governments together once a year to discuss how to jointly address climate change crisis.

COP conferences are attended by world leaders, ministers, and negotiators but also by representatives from civil society, business, international organizations, and the media.

The COP is hosted by a different country each year and the first such meeting – ‘COP1’ – took place in Berlin, Germany in 1995.

COP26 is the 26th climate change COP. It is being co-hosted by the UK and Italy. COP26 was originally scheduled to take place in November 2020 in Glasgow, UK but it was postponed by one year due to the COVID-19 pandemic. It is now due to take place 31 October-12 November 2021.

The ‘pre-COP’ (a preparatory meeting) took place in Milan, Italy, from 30 September-2 October.

COP26 builds on the Paris Agreement, an international treaty signed by almost all countries in the world at COP21 in Paris in 2015. This landmark treat aimed to keep the rise in the global average temperature to ‘well below’ 2 degrees above pre-industrial levels, strengthen the ability to adapt to climate change and build resilience; and align all finance flows with ‘a pathway towards low greenhouse gas emissions and climate-resilient development’.

The Paris Agreement has a ‘bottom-up’ approach, namely, each signatory country was to decide by how much it would reduce emissions by a certain year. These countries communicate these targets to the UNFCCC in the form of ‘nationally determined contributions’, or ‘NDCs’.

Goals of COP26

COP26 arrives at an important time in the global climate action debate. If the world is to have a chance of limiting warming to 1.5 degrees, emissions must halve by 2030 and reach ‘net-zero’ by 2050. Unprecedented action is needed if this goal is to be achieved.

It has long been argued that the NDCs submitted in 2015 were not ambitious enough to limit global warming to ‘well below’ 2 degrees, never mind 1.5 degrees. The signatories of the Paris Agreement are, however, expected to submit new – and more ambitious – NDCs every five years, known as the ‘ratchet mechanism’.

COP26 is the first test of this ambition-raising function. One of the main ‘benchmarks for success’ in Glasgow is that as many governments as possible submit new NDCs and, when put together, these are ambitious enough to put the world on track for ‘well below’ 2 degrees, preferably 1.5.

As of September 2021, 86 countries and the EU27 have submitted new or updated NDCs to the UNFCCC.

A few governments, like China and Japan, have pledged new 2030 targets but are yet to submit them officially.

The UK has, for instance, pledged to reduce emissions by 68 per cent by 2030 compared to 1990 levels, and 78 per cent by 2035. The European Union (EU) is aiming for a reduction of at least 55 per cent by 2030 relative to 1990 levels, and the US target is ‘a reduction of 50-52 per cent’ compared to 2005 levels.

However, the NDC updates only narrow the gap to 1.5 degrees by 15 per cent at most.

Around 70 countries are yet to communicate new or updates targets. And several – Australia, Brazil, Indonesia, Mexico, New Zealand, Russia, Singapore, Switzerland and Vietnam – have submitted without raising ambition.

A successful outcome in COP26 is for developed countries to honour a 2009 pledge of mobilising $100 billion per year by 2020 to support climate action in developing countries. This goal has not been met to date.

The recent announcement by President Joe Biden to double US climate finance has been welcomed but more will need to be done to restore credibility and strengthen trust between developing and developed nations.

No doubt discussions at COP26 will focus on mobilizing finance but other issues will be touched upon, especially how best to operationalise the Paris Agreement’s.

Against this background, here below are COP26 main goals:

Securing net-zero by the middle of the 21st century in a bid to keep global temperature increases below the critical 1.5C threshold.
Making progress on climate adaptation measures to protect lives, ecosystems and economies from the impact of global warming.
Mobilising private finance to address the climate challenge.
Fostering international collaboration to accelerate progress on climate goals.

Ways your pharmaceutical business can get involved

The World Economic Forum has identified environmental degradation, climate and environmental disruptions (like extreme weather, droughts, wild fires and resource depletion) as the greatest dangers to businesses going forward.

This is because of the ability of these factors to reduce the availability of raw materials, disrupt supply chains, wither demands for goods and services, and change resource availability while increasing costs.

The New York Times referenced a study which asked companies to calculate how climate change could affect their business financially. After analyzing submissions for 215 of the world’s 500 biggest corporations, it was potentially put at $1 trillion in costs related to climate change.

But it’s not just the Fortune 500 firms that face substantial losses, because when the environment loses, the whole world loses. According to a report by insurance giant Swiss Re, the world’s global domestic product (GDP) could drop up to 18%, or $23 trillion, by 2050 if no action is taken.

Experts agree the poorest nations would be most adversely affected by climate change, although even the major economies would suffer irreparable harm. The U.S. GDP could dip as much as 10.5% by 2100.

This is not just an issue for companies that rely on oil, natural gas, or other natural resources. Any business that uses petroleum-based plastics (over 99% of plastic is produced using fossil fuels) along its supply chain or generates greenhouses gases has a part to play. The pharmaceutical industry is not immune – the vast number of precursors used in synthesis are petroleum derived, not to mention the energy used as well as other inputs need to make pharmaceutics.

This is why every company, irrespective of size, influence, or availability of resources, can and should make a collective effort to address climate change.

So here’s how pharmaceutical businesses can join the climate action plan and do their bit:

Set science-based and net-zero targets

Setting a net-zero target in line with a 1.5°C future is necessary for businesses to make a dent in limiting the worst impacts of climate change. Join the Business Ambition for 1.5°C, which is an urgent call to action from a global coalition of UN agencies, business and industry leaders, in partnership with the Race to Zero.

Take the lead by going 100% renewable

While many companies are already reducing their carbon emissions, they could go further and commit to using 100% renewable power and resources.

Switch to electric transportation

Keeping global average warming below the 1.5°C thresholds requires a large shift in the way companies operate. Making the switch to electric vehicles is something that many companies should immediately consider, if they have not yet done so.

Reassess supply chain choices

All good charity starts at home, and while companies can concentrate on their own internal practices, greater change can be achieved if businesses reach out across their value chains, and probe the environmental commitments of suppliers and partners to ensure they are aligned with their own environmental goals

Prepare to be held accountable

All around the world, people want companies to lead on climate change instead of waiting for governments. They expect CEOs to speak out and champion change and not just talk the talk. But expectations come with accountability, and businesses can soon expect the public to start demanding answers.

Final thoughts

Pharmaceutical businesses can play a pivotal role in achieving new climate targets, and also integrating needed changes. Climate changes creates risks to all businesses regardless of the exact outcome of the conference, with changes needed within corporate strategy, governance, finance and operations.

We hope that COP26 acts as a catalyst for businesses to set the new standards on climate stewardship, with a specific focus on practices and encourage them to step up to the challenge, tackling climate risk head-on.

Resources:

UN Climate Change Conference (COP26) at the SEC Glasgow 2021 (https://ukcop26.org/uk-presidency/what-is-a-cop)

How Large is the Excipients Market Size? We Compared 3 Market Reports

October 17, 2021

There is no shortage of market reports online that purport to estimate the global excipients market (currently estimated between 7.5 – 8.5 $ billion – 2021).

The question is how representative are these figures? Is the pharmaceutical flavour market really worth $400m?

We appraised 3 market reports, compared reported estimates with first hand primary data for specific products that we know very well.

The results are summarised in this post.

Excipients Value Chain

Excipients are specialty raw materials included in formulations of medicines, medical devices, some cosmetic products or nutraceutical food supplements. They are used to perform specific purposes, such as:

stabilisation
bulking
aids to processing

As a sub-sector of the wider chemicals industry, the excipients sector plays an important role in the medicines value chain, making a real contribution to the world economy and human welfare.

Below is a simplified value chain:

You can read more about the excipients sector by downloading a Fact Sheet. about the global excipients sector through this link.

End-users of Excipients

Excipients are utilised mainly in the manufacture of bio-pharmaceutical products, which accounts for the lion share of utilisation. However, other industries also use excipients, namely:

Personal & Home Care
Animal & Human Health
Specialty Agriculture/Horticulture
Topical & OEM Medical Devices
Upstream applications (intermediates, fermentation, etc)
Nutraceuticals/Dietary Supplements
Industrial (e.g paper making, yes, paper making)

Comment

Over the years, we have found that market reports tend to ignore several excipient categories and materials, such as:

starter materials and intermediates in other excipients.
active pharmaceutical ingredient synthesis
materials used in upstream biological manufacturing
nutraceutical, medical devices and some food products
industrial goods

Uptake into other sectors is also ignored. As an example, hyromellose and acacia can be used on their own or incorporated /co-processed into other excipients.

Leading Manufacturers

These are the top 10 excipient manufacturers (by product focus):

Ashland
BASF
Cargill
Colorcon
Dow/Dupont/IFF
Evonik
JRS Pharma
Roquette Freres
ShinEtsu
Tereos

Other companies that are significant but often missed out in analyses:

Angus
IOI Oleochemicals
Cargill
Ingredion
Merck KGaA
Samsung
K+S Group
CP Kelco

Comment

The failure by some researcher to companies such as Colorcon Inc. in the top tier of excipient manufacturers is a mistake.

This company commands a market share in excess of 80% for film coatings and has annual sales in excess of $800 million (both from sales of coatings & distribution

On the other hand, companies such as ADM and Lubrizol are always counted in – ADM may well be a large food ingredients producer – but their excipient portfolio are relatively small.

Sector Outlook

The three market reports we appraised (BCC Publishing, Markets & Markets, and Transparency Market Research) estimated the global excipients to be between $ 6.9 – 8.3 billion in 2021 rising to $ between $10.0 -10.7 billion.

The CAGR is quoted as being 5 – 5.8% for the study period (compare these to an earlier study period (2013-2018):

Markets & Markets and Transparency Market Research projected growth from $5.0 and $5.7 billion to 7.4 and 7.5 billion.

In terms of regional market share, we do not agree with their projections. Europe is pitched as the largest (approx. 32% share).

North America at 31%. Asia Pacific, including Japan, is estimated at 25%, while the rest of the world is put at 12 – 13%.
With respect to specific product or categories, the following are the estimated market sizes (2019 estimates):

Microcrystalline cellulose: $300 million
Povidone: $400 million
Artificial sweeteners: $36 million
Flavours: $400 million
Film coatings: $800 million

Comment

We found a number of inconsistencies in projections the three market research companies presented.

First, the largest regional market is not Europe but North America. The excipient market closely tracks the wider pharmaceutical market, and currently, the North American region is the largest.

That said, there are some specific segments where Europe clearly leads, for instance, in inorganic salts and oxides, and sugars.

Secondly, when one takes a deep dive into particular products where we have very accurate results, the inconsistencies are even more glaring:

For instance, the total worldwide market for microcrystalline cellulose is $1billion (add $200 million if food use is included). China is the largest producer, closely followed by North America and finally, Europe.

The largest single producer is IFF (formerly, Dupont/FMC – Avicel®).

Other discrepancies, based on primary market data (actual producer data) are shown below (in 2021):

Thirdly, market researchers ignore an up-and-coming product category, which is elastomers, rubbers and silicones, which are increasingly used in transdermal drug delivery and topical medical devices.

Fourthly, there are further inconsistencies with respect to country data for individual product market size.

A case in point is that the total flavour market (it is just not possible to put this at $400m), we would say it is more like $100 million – and possibly half that (50 – 70 million, at best).

We established that generally, market research companies underestimate the total excipient market by around 15%. The more accurate figure should be in the region of $9 to 10 billion in 2021.

Market Drivers

The major growth drivers are rightly identified as growth in demand for drugs across the world, which drives the demand for functional materials.

All the three reports identify growing demand for co-processed, full-formulated excipient systems and technologies that enhance patient convenience, such as orally disintegrating products, film coatings and modified release.

The role of biologicals, which have consistently accounted for up to 40% of new drug approvals, is mentioned, as are patent expirations and entry of generics. Both factors create new markets for raw materials.

Biological products have been the fastest growing segment for the last two decades, and this trend shows no signs of slowing down.

Market constraints are identified as increasing regulations, a rise in pharmaceutical product R&D costs, a lack of innovation and increasing requirement for supply chain transparency.

The long development cycles and high attrition rates, and particularly, very costly late-stage failures that are emblematic of pharmaceutical R&D, are major dampeners of excipient market growth. It takes on average 4 years, from the point a pharmaceutical company takes a sample for assessment, to make a commercial sale for an excipient!

A lack of innovation is also rightly identified. Innovation is what traditionally drives market growth, and with nearly two decades since the last brand new excipient was introduced, it is not difficult to see why growth in the sector has remained lacklustre for a while.

Comment

While it is the case that the sector has increasingly demanded supply chain transparency, the reasons were not due to outsourcing to low cost countries, but rather, the Falsified Medicines Directive.

We think that the contribution of biologicals to market growth is over played. This is because biologicals generally require relatively simple salts (buffers, and occasionally, cryoprotectants) to formulate, meaning that, from an excipient perfective, they are not significant.

Finally, the role of IPEC and EXCiPACT GMP to market growth is also over played in the analyses since, as per current regulations, GMPs are not mandatory for excipients.

Final thoughts

In our judgement, the current excipient market size of between 7.5 – 8.5 $ billion (2021) underestimates the size of sector by 15%, and the true figure should be between $9.5 and 10.5 billion.

We have also identified a number of omissions and errors in presented figures for individual products and country data, which do not tally with primary market information from excipient manufacturers (for example, MCC, silica, flavours, povidone, sugars and film coatings).

In our judgement, BCC Research excels in their strategic assessments, and their total market estimates also tended to be more in line with primary data that we have access to.

On the other hand, Transparency Research had more accurate data on regional market-shares, data on film coatings as well as xxx. However, data on specific product categories were less accurate.

Disclaimer

The information in this post idoes not constitute any offer, recommendation or solicitation to any person to enter into any transaction or adopt any hedging, trading or investment strategy, nor does it constitute any prediction of likely future value.

Pharmacentral is not an investment adviser, and is not purporting to provide you with investment, legal or tax advice. We accept no liability and will not be liable for any loss or damage arising directly or indirectly from your use of this information

You should seek your own advice regarding the appropriateness of investing in any securities, financial instruments or investment strategies referred to on this post.

Statements regarding future prospects may not be realised.

Merck’s new Covid drug, Molnupiravir is a game changer, early trial results show

October 4, 2021

An antiviral drug originally developed to treat influenza has been shown to reduce hospitalisation and death from Covid-19 by as much as 50 per cent in patients recently infected with the virus, early trial results suggest.

It is now hoped the drug, administered in oral form, will be play a key role in treating people who test positive for Covid-19 and prevent their infection from culminating in severe disease.

Molnupiravir (development codes MK-4482 or EIDD-2801) was developed at Emory University before being acquired by Ridgeback Biotherapeutics, who later partnered with Merck & Co. to develop and commercialise the molecule further.

It is thought molnupiravir works by interfering with an enzyme that the virus needs to replicate, thereby preventing it from further spreading throughout the body.

If authorised for use as planeed, molnupiravir will be the first oral antiviral medication for Covid-19. There are currently two approved ways of treating the disease: using steroids, such as dexamethasone, or by administering monocloncal antibodies intravenously.

Preliminary data from Merck’s trial is based on around 800 adult patients with mild to moderate Covid-19 judged to be at greater risk of serious disease owing to underlying comorbidities such as obesity, diabetes or heart disease.

Among the half of patients taking molnupiravir twice a day, 7.3 per cent were admitted to hospital over the course of 30 days. This compared with 14.1 per cent of the second group of patients who were given a placebo.

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The drug also appeared to lower the risk of mortality by 50 percent, though the numbers are small and experts have cautioned against over-interpreting the data. There were no deaths among the molnupiravir group, while eight of those who received the placebo died from Covid-19.

Upon reviewing the data, the US FDA recommended stopping the phase three trial early to begin the process of applying for emergency authorisation.

A course of molnupiravir is expected to cost around £500 or $650. An official at Merck said the company will only be able to make 10 million doses before the end of the year, 1.7 million of which are reserved for the US.

EMA evaluating booster doses of COVID-19 vaccines

October 4, 2021

Evaluation of data on booster doses of Comirnaty and Spikevax are now underway at the European Medicines Agency (EMA), according to a recent press release.

Comirnaty, the name for Biotech – Pfizer mRNA vaccine, is authorised for use in people aged 12 and older. EMA’s Committee on Human Medicines (CHMP started evaluating an application for the use of a booster dose of Comirnaty to be given 6 months after the second dose in people aged 16 years and older as a way to boost protection after it has waned.

Spikevax (formerly COVID-19 Vaccine Moderna) is also to be given after six months of the second dose in people aged 12 years and older.

CHMP plans to carry out an accelerated assessment of data submitted by the two companies, including data from ongoing clinical trials. Depending on the strength of evidence, CHMP will recommend whether updates to the product information are required.

Both EMA and the European Centre for Disease Prevention and Control (ECDC) have already made clear what their positions are on booster doses, which was that booster doses were not necessarily critical in fully vaccinated people, unless they were immunocompromised.

EMA has already reviewed evidence on vaccine effectiveness and duration of protection, and verified the highly protective effects of all authorised vaccines against COVID-19-related hospitalisation, severe disease and death.

However, with around 30% of all adults in the EU yet to be inoculated, EMA believes the urgency should be to vaccinate all those eligible individuals who still have to complete vaccination courses.

National immunisation technical advisory groups of individual member states still retain prerogative on how vaccinations are to be given remains. EMA’s role is simply to assess relevant data, and member States are free to consider contingency plans for booster doses and additional doses.

Comirnaty and Spikevax received conditional marketing authorisation across the EU, respectively on 21 December 2020 and 6 January 2021.

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