💉 Eli Lilly and Verve target Lp(a); Astellas partners with Cullgen on protein degraders; Valneva retires manufacturing plant
#364 | Sandoz’s push for biosimilar adoption; Jell-O-like electrodes for medical devices; NHS brings back retirees
Hello and welcome to this week’s last edition of The Kable, where retired health professionals and retired vaccine plants are both looking for new purpose.
In the UK, the NHS is hoping to shorten long waiting lists by offering retired doctors the option to get back to work. Starting this autumn, retired doctors can sign themselves up on a new digital platform to help trusts across England with outpatient appointments. Maybe now the UK will stop stealing health workers away from LMICs.
Eli Lilly is entering a $60 million deal with Verve Therapeutics to collaboratively develop a pre-clinical in-vivo, gene-editing therapy to target lipoprotein(a) which is associated with atherosclerotic cardiovascular disease risk. Lilly already has two similar drug candidates in its pipeline, but those would require chronic dosing. Verve’s therapy, on the other hand, could potentially be a one-time treatment.
Astellas is shelling out $35 million upfront to partner with biotech startup Cullgen to develop targeted protein degraders, which have emerged as a potential solution to undruggable proteins. Under the terms of the deal, Astellas will have an exclusive option to license any drugs that emerge from the collab; it will also pay Cullgen $85 million if it licenses the startup’s lead programme – a potential solid tumour treatment.
Sanofi’s Consumer Healthcare Business Unit has launched a new Open Innovation Portal to source disruptive solutions in the consumer health space. Startups, entrepreneurs, accelerators, universities and other research institutions can respond to identified challenge areas like sustainable packaging sustainable sourcing, mental wellness and lots more. Successful submissions will get the chance to collaborate with Consumer Healthcare at Sanofi on their projects. Head on over to the portal to submit your idea.
Meanwhile, it seems Valneva is the Gen Z equivalent of the pharma industry: ready to retire before even beginning to work. The company had built a manufacturing facility in Livingston, Scotland to produce its Covid vaccines and possibly even Ixiaro and its chikungunya vaccine. But as Valneva struggled with developing its Covid shot, the UK cancelled its supply agreement of 100 million doses, Europe cut its vaccine order by many millions of shots, the company suspended manufacturing. Now Valneva is wondering what to do with the 75,000-square-foot plant which it had to send into retirement way too early.
In India, the government of the state of Kerala is hoping to set up a vaccine manufacturing centre in the state, and it is hoping to do so with the help of Cuba’s state-run biotech BioCubaFarma.
Egg and sperm to make a baby? That’s so 2022. Researchers from the US and the UK have created the first synthetic human embryo-like structure from stem cells. Bioethics experts are alarmed by sophisticated models such as this, especially since there are no comprehensive regulations governing such synthetic embryos. But the researchers are highlighting that these aren’t embryos, but rather embryo models which can help advance research into genetic diseases and pregnancy-linked complications.
And finally, in a lovely surprise, scientists have discovered cannabidiol, or CBD, in the fruits and flowers of a common Brazilian shrub called Trema micrantha blume. All the benefits of cannabis barring the high of THC. Though methods to extract the CBD and the compound’s effectiveness as a medical treatment are still being studied.
The week that was
In spite of the occasional light day, this has been a typically heavy news week in the life sciences domain. Starting with UN research which found that gender inequality has been stagnant for the past decade, suggesting that it is unlikely to reach its goal of gender parity by 2030.
In big partnership news, Swiss pharmaceutical giant Novartis is acquiring US biotech company Chinook Therapeutics for up to $3.5 billion. The acquisition will enhance Novartis's late-stage drug pipeline with a new treatment for rare severe kidney disease.
Novo Nordisk is investing about $2.3 billion to expand its manufacturing capacity in Hillerød, Denmark, to make APIs for its future portfolio of serious chronic disease medicines.
A survey has found that during the pandemic, public confidence in vaccines declined across sub-Saharan Africa. In the 8 countries surveyed – the DRC, Ivory Coast, Kenya, Niger, Nigeria, Senegal, South Africa, and Uganda – doubts about the safety and effectiveness of Covid as well as other shots were on the rise.
However, at the Global Vaccine Impact Conference in Spain, the vaccine alliance Gavi announced that preliminary data suggests that 2022 was a “year of rebound” for routine childhood vaccinations.
Authorities in India have launched a probe into an allegation that a local pharma regulator accepted a bribe to switch samples of cough syrups which were linked to deaths in The Gambia before they were tested by an Indian lab.
Sanofi is going all in on AI, having adopted a new app called plai, developed with the AI company Aily Labs, to support Sanofi teams across company-wide activities and help them to make more informed decisions.
Newsworthy
Act4Biosimilars. Biosimilars have been around for a couple of decades, but access and usage are still quite low. Globally, biosimilars have an adoption rate of only 14% in countries which were tracked, whereas reference drugs represent 86% of all biologics treatments. According to Sandoz, in the Americas, barriers to increasing access include “unregulated biocopies, legal and regulatory decisions, and misaligned incentives within healthcare delivery models”. In many countries elsewhere, biosimilars are still unavailable.
With the purpose of increasing patient access to biologic medicines, Sandoz has announced the launch of a global roadmap called the Act4Biosimilars Action Plan. The goal is to increase global biosimilar adoption by a minimum of 30% in 30+ countries by 2030. The roadmap not only highlights the most critical challenges preventing wider global access to biosimilars, but it also provides actionable steps which can accelerate their adoption.
This action plan will be complemented by a series of reports, the first of which spotlights the Americas. It throws light on the confusion that regulation has caused for patients and healthcare professionals in the US, the risks presented by gaps in regulatory pathways in Colombia and Ecuador, a lack of stakeholder alignment in Brazil, Canada and the US, and unsustainable procurement in Mexico and Brazil. The report also features 12 key initiatives to aid local stakeholders in developing an environment conducive to biosimilar adoption.
(Sandoz)
A journey of hope? In sub-Saharan Africa, the average physician ratio is two doctors for every 10,000 people. Their overall health worker ratio is 1.55 physicians, nurses and midwives for every 1,000 people, as compared to the WHO threshold of 4.45. These low numbers are resulting in long wait times for patients (even critically-ill ones), increasing workloads for existing staff, decreasing patient access to care, and posing severe threats to healthcare systems and people’s health outcomes on the continent.
As if to reprimand us for blaming only the UK for Africa’s health worker crisis in Synopsis, Devex has offered a look at the other factors influencing the exodus of health workers from Africa. Mainly, better $$$, a good working environment, and social services of a quality their home countries can’t offer.
Over the past few months, we’ve covered the strikes by health workers for better working conditions and fair compensation across countries in Africa. Nigeria is trying to mandate medical students to practice in the country for at least five years in order to get their full license, while Zimbabwe is trying to make it illegal for other countries to hire its health staff. But such coercive measures have seen backlash from health personnel who feel that the underlying causes of mass emigration are not being addressed. Mass emigration is leaving massive gaps in health service delivery in Africa, and if working conditions aren’t improved, it appears health professionals will continue to find ways to leave the continent, regardless of red lists and proposed coercive actions.
(Devex)
R&D
Not all ageing is the same. And no, we’re not talking Benjamin Button v the rest of us. We’re talking about how, for instance, neurons in our brains live longer than the cells in our gut lining. A research team with scientists from Baylor College of Medicine, Genentech and a bunch of other collaborating institutions has come up with the first ageing fly cell atlas (AFCA). This atlas is a detailed characterization of the ageing process in 163 distinct cell types in, you guessed it, a fruit fly lab model. The team carried out a detailed genetic analysis of individual cells to find that different cell types aged differently, with each undergoing specific patterns of gene expression changes.
The AFCA could be a useful resource for researchers involved in studying fruit flies, yes, but also ageing and age-related diseases in pursuit of an elixir of life. Though we suspect the more likely solutions they’ll find to the ageing problem are in diet, drugs and exercise.
(Science)
Mum’s microbes. Differences have been identified in the microbiomes of c-section babies and vaginally-delivered children, with the former having higher levels of opportunistic bacteria days after birth and fewer immune function-supporting gut microbes months later. It appears that neurodevelopmental outcomes for C-section babies may also not be the same as for babies born from a regular delivery. But there’s a simple fix for that. Scientists, who have had their work published in Cell Host & Microbe, claim that it appears safe to swab c-section babies with their mother’s vaginal fluids with the aim of developing a microbiome. This vaginal microbiota transfer may improve brain development; in a randomized trial, babies who had been swabbed achieved a slightly higher number of neurodevelopmental milestones at the three- and 6-month marks. But it’s still early days, and we don’t know how meaningful these differences might be in the long run; the current data doesn’t yet have any clinical significance.
(Cell Host & Microbe)
Jelly > metal. Implantable medical devices need electrodes to fulfil their job duties - stimulating muscles, nerves, and whatnot. These electrodes are usually made of metals because, well, they conduct electricity. But metals are not so kind inside our bodies. The electrodes in use today can cause scarring and inflammation, they can aggravate tissues, and can degrade implant performance.
But an unlikely hero has come to the rescue: jelly. Okay not the jelly you eat, but a jelly-like material, a polymer hydrogel, which is conductive like metal and can be 3D-printed into flexible electrodes. A co-author of the study sees this innovation as particularly useful for people recovering from heart surgery who need a few weeks of electrical support to avoid a heart attack as a side effect of surgery.
(Nature Materials)
The Kibble
Be smart. Don't do drugs. The world of "smart drugs" feels a bit like a scene from a sci-fi movie, where medical students use Adderall to learn faster, EA cultists gulp down Modafinil to work harder, and sleep. Well, who needs that? It's all about turbocharging the brain, right? In the fast-paced modern world, the desire for cognitive enhancement is driving a boom in "nootropics," and the numbers show it. In the span of just two years, smart drug usage in the US shot up from 20% to 30%; it tripled in the UK and quintupled in France. People seem to believe these pills make them smarter, more focused, and even more motivated. But, hold on to your hats, folks, because the plot twist is more shocking than a soap opera finale.
Researchers from the University of Melbourne and Cambridge have unearthed the grim truth - smart drugs might not be that smart after all. In fact, they might be making users less smart! In an experiment involving three popular drugs - Ritalin, Modafinil, and Dexedrine - it turned out that while users worked harder, their productivity actually dropped. Imagine running full speed on a treadmill while carrying a heavy backpack, thinking you're getting fitter, but in reality, you're just getting more exhausted. The "knapsack problem" used in the study mirrored real-world problem complexity, and the results were as comedic as a stand-up show: users thought they were becoming more systematic and productive, but in reality, they were flailing around like headless chickens. Isn't that the very picture of "smart" we all aspire to?
(Science Advances)
Bottom line
Fighting the good fight. UN Secretary-General, António Guterres, has launched a scathing attack on fossil fuel companies, accusing them of betraying future generations and undermining efforts to phase out what he termed a product “incompatible with human survival.” Guterres rejected suggestions from oil executives that fossil fuel firms could maintain production by capturing carbon emissions, stating this would merely transform them into "more efficient planet-wreckers." Notably, Guterres emphasised that the oil and gas industry only allocated 4 cents of every dollar spent on drilling and exploration to clean energy and carbon capture. He urged the sector to devise a convincing plan for a transition to clean energy.
Guterres’ comments come amid ongoing frustration with the fossil fuel industry's recent profit boom in the face of warnings from scientists about the dire climate implications of burning fossil fuels. The Secretary-General, however, did express some optimism, saying that even so-called conservatives had been behind some of the most daring progressive reforms in the past. He also urged wealthy countries to commit to phasing out coal, the most polluting fossil fuel, by 2030, with other nations following suit a decade later. The UN chief further called upon financial institutions to halt financing fossil fuel projects and championed those already doing so, encouraging them to persevere.
(UN News)
Small islands, big plans. The WHO has introduced the 2023 Bridgetown Declaration on Noncommunicable Diseases (NCDs) and Mental Health to tackle some of the most fatal diseases in Small Island Developing States (SIDS), which are particularly vulnerable. The declaration, a crucial result of the SIDS Ministerial Conference on NCDs and Mental Health, was co-hosted by the World Health Organization (WHO), the Pan American Health Organization (PAHO), and the Barbados government. SIDS are adversely affected by NCDs, which account for 74% of global deaths, due to their dependence on imported food, commercial influences, and climate change. Moreover, a new WHO report shows that half of the 15 countries at high risk of premature death from cardiovascular disease, cancer, diabetes, or chronic respiratory disease are SIDS. In addition, all ten nations with the highest obesity rates globally are SIDS in the Pacific, where over 45% of adults are obese.
Mental health conditions also represent a significant problem in SIDS, affecting an estimated 15.2% and 11.2% of the populations in the Caribbean and the Pacific, respectively. Those with mental health issues face higher risks of premature death due to unaddressed physical health conditions and suicide. Stigma, a shortage of specialised staff, and the impact of climate change exacerbate the situation in SIDS, calling for urgent intervention. The 2023 Bridgetown Declaration proposes robust steps to address the variety of social, environmental, economic, and commercial factors leading to NCDs and mental health conditions, emphasizing the need to respond to the climate crisis. As part of the Declaration, SIDS agreed to initiate a series of actions, such as social engagement, accelerating implementation, securing investments, aligning government efforts, and accounting for progress.
The WHO has pledged to rally financial resources to develop climate-resilient and environmentally sustainable healthcare facilities in SIDS, and to continue advocating for climate change adaptation and mitigation investments in lower-income countries. SIDS also committed to specific actions on NCDs and mental health, including improving access to mental health care, updating tobacco control legislation to include e-cigarettes and vaping, and reducing salt and sugar intake. These commitments align with WHO's 'best buys', a collection of cost-effective, evidence-based interventions to combat NCDs, recently updated to include a broader range of health issues. The Bridgetown Declaration and the conference will inform and influence forthcoming UN General Assembly High-Level Meetings on universal health coverage in 2023 and on NCDs in 2025.
(WHO)
Oh, and Gopal Nair doesn't want you to see this.