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From Vision to Reality: mRNA Technology Transfer Programme Building Sustainable Vaccine Manufacturing Ecosystems in LMICs

On By ModernMedia
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The groundbreaking mRNA Technology Transfer Programme, launched in 2021, has achieved what was once unthinkable: from zero mRNA manufacturing capabilities in low- and middle-income countries (LMICs) in 2020, the initiative is positioned towards establishing 11 state-of-the-art good manufacturing practices (GMP) certified mRNA manufacturing facilities across 10 countries by 2030 and a further five facilities following later.

With all manufacturers in the Programme working on R&D across various diseases, this network is designed to meet the Global South’s R&D and mRNA vaccine needs. It stands ready to respond to any future pandemic to secure mRNA vaccine access across continents.

The transformative Programme, established by the World Health Organization (WHO) and the Medicines Patent Pool (MPP), works with the South African Consortium, Afrigen, Biovac, the South African Medical Research Council (SAMRC), and the Department of Science and Innovation and programme partners in Kenya, Brazil, Indonesia, India, Egypt, Nigeria, Ukraine, Bangladesh, Senegal, Tunisia, Serbia, Pakistan, Vietnam, and Argentina. 

The Programme, support by South Africa, France, Belgium, Canada, the European Union, Germany, Norway, and the ELMA Foundation, has propelled LMICs to the forefront of pandemic preparedness. It represents an unprecedented global effort to ensure equitable health solutions, enabling LMICs to respond rapidly and independently to global health crises. 

Charles Gore, Executive Director of the Medicines Patent Pool, stated, “From a standing start in 2020, the Programme’s growth has been nothing short of remarkable. After successfully developing a COVID-19 vaccine as proof of concept, the Programme is now expanding to address many other diseases relevant to LMICs. We are now poised to establish a sustainable mRNA vaccine production capacity that will benefit millions across the Global South, truly redefining what health equity can look like on a global scale.”

In a significant step forward, Sinergium Biotech is researching a human avian influenza (H5N1) mRNA vaccine candidate, and four R&D consortia have been formed in Southeast Asia, with more expected across other regions. The vaccines developed through this initiative will be shared across participating LMICs.

A map of the world with colored arrows and colored dots Description automatically generated

Unprecedented Capacity for Pandemic Preparedness and Resilience

With the manufacturing companies across four continents all based in LMICs, the Programme has fundamentally altered the mRNA vaccine production landscape. The initiative is projected to yield at least 60 million doses annually by 2030, with the potential to scale up to larger volumes that could supply up to two billion doses in the event of a declared pandemic. Leveraging future dose-reduction technologies, the Programme would have the capacity to cover all the mRNA vaccine requirements of the Global South.

As of December 2024, the mRNA Technology Transfer Programme has made significant progress, with nearly all site assessments completed. Half of the participating manufacturers have finalised their technology plans, with the remaining plans scheduled for completion by December 2025. Over a quarter of these manufacturers will have successfully received the technology platform transfer from Afrigen by the end of 2024, with the rest to be completed in 2025, marking an important milestone in the Programme. By December 2026, all manufacturing partners are expected to have demonstrated the technology at their respective sites, culminating in the full transfer of mRNA technology across all participants.

Prof. Petro Terblanche, CEO of Afrigen, highlighted, “The mRNA Programme has not only achieved our initial goals but exceeded them in every way. Afrigen’s work with our global partners has shown that LMICs can lead in R&D and manufacturing, transforming healthcare outcomes from diseases that affect the Global South. This Programme yet again demonstrates the power of partnerships and global collaborations.”

Dr Martin Friede, Coordinator at WHO, emphasised, “This mRNA Technology Transfer Programme exemplifies the power of collaboration in global health. We are delighted that WHO and the partners have signed an MOU with Prof Drew Weissman of the University of Pennsylvania to promote R&D of mRNA products for public health. We hope other institutions will also follow and share knowhow. We are committed to securing the necessary support to see these efforts through so that LMICs have the scientific and material resources to maintain this unprecedented level of pandemic preparedness.”

The Critical Role of Funding

Despite remarkable progress, additional funding is required to fully achieve the Programme’s ambition. An estimated US$200 million is needed to advance all manufacturers to GMP standards and continue to strengthen the R&D pipeline in support of at least 12 mRNA products currently in development. Encouragingly, Programme success has already attracted substantial catalytic co-investments. For example, for every dollar contributed by the Programme in the AFRO region, an estimated US$17 has been invested by regional stakeholders and other public health organisations.

Categories : Medical IndustryTags :

Pharmaceutical Task Group (PTG) Announces Appointment of Chairman and Deputy Chairman

On By ModernMedia

Zwelethu (Zweli) Bashman, has been appointed chairman of the Pharmaceutical Industry Association (PTG), and Dr Stavros Nicolaou as deputy chairman.  Four pharmaceutical associations, representing more than 80% of the industry, comprise the membership of the PTG.

Bashman is president of the Innovative Pharmaceutical Association South Africa (IPASA), and managing director of MSD South Africa and sub-Saharan Africa.

“Our goal is to contribute towards an environment that promotes growth and investment in the South African pharmaceutical industry while aspiring to broaden access to medicines for all people living in South Africa,” said Bashman.  

Stavros Nicolaou has assumed the role of deputy chairman after serving as chairman of the PTG for several years.

Categories : Healthcare Politics and Regulations Medical IndustryTags :

The EU Protects its Companies from Big Pharma. South Africa Needs to do the Same

On By ModernMedia
Photo by National Cancer Institute on Unsplash

By Fatima Hassan

Critical work done by South African scientists on mRNA vaccines for several diseases is at risk from patent claims from the pharmaceutical giant Moderna. Yet the government could easily protect this and other programmes by speeding up the passage of amendments to patent laws.

Every year, industry’s biggest players spend a combined US$4-billion on legal action. Even then, there was an audible gasp from the world’s media when Moderna, which developed a Covid vaccine with the US government, announced it was suing rivals Pfizer and BioNTech for “patent infringement”.

All three companies have made a fortune from selling Covid vaccines, and are now at war over the rights to the publicly-funded mRNA technology behind it.

After a year of suing and counter-suing in multiple jurisdictions, the European Patent Office stepped in two weeks ago and revoked one of Moderna’s patents covering “respiratory virus vaccines”. In doing so, the European Patent Office was seemingly defending BioNTech, a German company, from a ‘’threat’’.

This is not unusual. In most countries, governments can intervene to protect companies viewed as important to their national interest and can review, revoke, or withdraw patents. Most countries, but not South Africa.

Under Nelson Mandela, South Africa fought Big Pharma to secure affordable generic HIV medicines, and in the pandemic, the government made a valiant attempt to do the same for Covid vaccines by seeking a global waiver of intellectual property rules. But arcane apartheid-era laws still accept patent requests from companies – without substantive examination of the merits of the patent application and without the due process right to challenge it before it is granted. And, once a patent is granted, patient advocacy groups cannot easily revoke it.

There is legislation drafted which could give us the ability to challenge patents before they are granted, among other much needed mechanisms such as compulsory and government-use licensing.

In 2018, Cabinet approved a new Intellectual Property Framework which would give us this most basic right. It is compliant with international trade rules and should not be controversial. But, despite the fact the government has said it wants this legislation, has drafted it, and has even trained examiners on it, the law has sat languishing on the desk of the Minister of Trade, Industry and Competition Ebrahim Patel for several years. This has enabled Moderna to be granted far-reaching mRNA related patents in South Africa.

These patents put our widely-acclaimed mRNA vaccine manufacturing project, backed by the World Health Organisation (WHO) and others, at risk.

While the world quickly developed effective vaccines to combat Covid, intellectual property rules prevented us from making shots for ourselves. Western governments blocked our government’s efforts to suspend these global rules, leaving South Africa to wait at the back of the global queue, eventually paying unreasonably high prices for vaccines. Then at the height of our third wave of Covid infections, Johnson & Johnson exported vaccines which had been completed at a factory in the Eastern Cape to Europe, prioritising European customers over South Africa and the continent.

It was a dark time for South Africa. But amid the devastation, some hope came in the form of a small biotech company in Cape Town, Afrigen, when the WHO announced it would be at the centre of a new Global South programme to deliver vaccines.

Sharing technology

Moderna, Pfizer, and BioNTech have all refused to share their technology with the programme. But scientists from Afrigen and universities in South Africa as well as the South African Medical Research Council developed an mRNA vaccine of their own, using the publicly available information from the vaccine which Moderna developed with the US government. They have now begun sharing the technology with partners across the Global South – and are exploring vaccines for diseases such as TB too.

In a future pandemic, the programme could be used to rapidly share vaccine technology between low and middle-income countries, so that we don’t repeat the global inequality of the Covid vaccine rollout.

Except that Moderna filed far-reaching patents in South Africa which could be interpreted as covering any mRNA technology. And, under our faulty, unchanged intellectual property regulation system, the patents were granted.

Dozens of health and legal organisations have warned that the mRNA programme is vulnerable to patent claims from Moderna. While the company has given assurances that it will not enforce patents on its Covid vaccine in some lower-income countries, including South Africa, the work of the programme on other diseases remains under threat.

The Medicines Patent Pool, which is implementing the project for the WHO, wants each programme partner (in the Global South) to resolve the issue of patents itself. But, by suing Pfizer and BioNTech, Moderna has signalled that it wants a total monopoly on mRNA technology. What, then, is Plan B if Moderna turns on the WHO-backed programme next?

When earlier this year, the Health Justice Initiative took legal action to force the Department of Health to disclose secret contracts with Covid-19 vaccine manufacturers, we won – and the documents revealed that vaccine procurement negotiations were one-sided, with pharmaceutical companies pressuring our government into unfair prices, terms and conditions.

Back to court

Now we are once again preparing to take the government to court to pass key provisions of the Patent Amendment Act. At the very least, we need proper patent examination, ways to oppose patents before and after they have been granted, and easy-to-use compulsory and government-use procedures in place. And we need this quickly.

We have seen how big pharmaceutical companies including Johnson & Johnson use our patent provisions to evergreen patents and then charge the state and sick patients more than they should by holding on to their patent monopolies.

We want to ensure that:

  • monopolies are not granted without examining their merits;
  • the public can exercise its right to oppose a patent before it is granted; and
  • the government can override patents and allow generic production where needed, as do the governments of many other countries.

It is our right in a constitutional democracy.

Hassan is founder and director of the Health Justice Initiative.

Views expressed are not necessarily those of GroundUp.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

Source: GroundUp

Categories : Medical Industry New Compounds and TreatmentsTags :

Christmas Came Early with These FDA Approvals

On By ModernMedia
AI art generated by GenCraft.

After the stupendous effort for COVID vaccines and treatments, it may seem like other diseases were being neglected. Nevertheless, the US Food and Drug Administration suddenly had a fire lit underneath it, and got cracking with accelerated drug approvals. Now, 2023 seems to have brought plenty of new drugs to bolster the physician’s armamentarium – some are the first-ever treatment for their indications. Hopefully, with FDA and European Medicines Agency (EMA) approvals, South African approvals should not be too far behind.

Since the pandemic, hotly anticipated drugs have made a big splash or sunk without a trace. In 2021, semaglutide was approved for weight management, unleashing a wave of people using (and some abusing) the GLP-1 agonist for weight loss. Adagrasib, which targets KRAS, previously thought undruggable, was a major advance for the treatment of non-small-cell lung cancer and was one of a few notable new non-COVID pharmaceuticals.

Aducanumab/Aduhelm was the top tip for new drugs in 2021, but turned out to be an absolute debacle: it wound up being an astronomically expensive, mostly ineffective drug with significant side effects. There were even questions raised over how it got approved in the first place.

Alzheimer’s disease

Last year, Aduhelm seemed like yet another false start in the long battle against Alzheimer’s disease. This year though, it looks like help finally arrived for fight against the dreaded neurodegenerative disease with not one but two breakthrough drugs, both  antiamyloid antibodies.

Up first is lecanemab/Leqembi from Eisai/Biogen. It targets the buildup of amyloid proteins in the brain, which otherwise lead to the formation of amyloid plaques and neurofibrillary tangles of tau protein, the hallmarks of the disease.

The other candidate is donanemab, which did not secure FDA approval last year, after pharma company Eli Lilly witnessed the disaster that was Aduhelm. It did show a reduction in decline in one measure of Alzheimer’s disease but not another, so its effects are a mixed bag.

Like Aduhelm, donanemab and lecanemab both have a serious downside: brain swelling, which claimed the lives of at three donanemab trial participants.

RSV

Previously minimised by the pandemic’s social distancing and routine masking, respiratory syncytial virus (RSV) experienced a resurgence in the wake of lifting these restrictions. RSV afflicts primarily those over 60 and young children. Among those 65 and older with RSV in the US, the Centers for Disease Control estimated 120 000 annual hospitalisations, with up to 10 000 of whom dying. Among children under 5, the figures are 58 000 annual hospitalisations and 100 to 300 deaths. Historically, RSV vaccine developments wound up being ineffective. Fortunately, this year saw the first approval for an RSV vaccine. A 120µg dose of their Arexvy vaccine produced statistically significant and clinically meaningful reductions in cases of lower respiratory tract disease caused by RSV in adults aged 60 years and older. Pfizer and Moderna are hot on HSK’s heels with their own vaccine applications.

Age-related macular degeneration

Apellis got an approval for pegcetacoplan this year, for geographic atrophy (GA) secondary to age-related macular degeneration, in its intravitreal injection. This is the first and so far only treatment for this indication. “The approval of SYFOVRE is the most important event in retinal ophthalmology in more than a decade,” said Eleonora Lad, MD, PhD, lead investigator for the phase 3 study. “Until now, there have been no approved therapies to offer people living with GA as their vision relentlessly declined. With SYFOVRE, we finally have a safe and effective GA treatment for this devastating disease, with increasing effects over time.”

Interestingly, Apellis also got an approval for paroxysmal nocturnal haemoglobinuria (PNH) with a patient-injectable version of pegcetacoplan. The disease results from the destruction of red blood cells by the immune system.

Lymphoma

Abbvie and Genmab’s epcoritamab, for certain cases of large B-cell lymphoma (LBCL), got accelerated FDA and EMA approval earlier this year. The FDA has also granted accelerated approval to Roche’s glofitamab. The drugs bind to binding to CD20 on malignant B cells and CD3 on T cells to kill cancer cells, creating an effect like CAR-T cell therapy but without the complexity (and presumably, cheaper too).

Major depressive disorder, postpartum depression

Mental health is full of gaps needing to be filled by effective treatments. Not much has made been added for depression since selective serotonin reuptake inhibitors (SSRIs) came onto the market in the 1990s. Zuranolone, from Biogen and Sage Therapeutics, is the first oral treatment for postpartum depression, which previously was treated only by IV injection in a healthcare facility. Unlike slow-acting SSRIs, this treatment, which targets the GABA-A receptor, is a short course.

Inflammatory bowel disease

There has been a steady drip of new biologic drugs for inflammatory diseases, such as bimekizumab (psoriasis and deucravacitinib which recently received FDA approval. Eli Lilly entered this crowded marketplace with ixekizumab. Now, after trouncing Novartis’ Cosentyx for psoriasis with its own mirikizumab, it pulled its application for that indication and switched it to ulcerative colitis – beating about a dozen competitors to be the first IL-23 inhibitor. It aims to get an approval for Crohn’s disease in 2025. Pfizer’s etrasimod for ulcerative colitis got approval in October 2023, and should receive EMA approval in 2024. Its phase 3 trial achieved 27% remission versus 7.4% for placebo.

Pulmonary arterial hypertension

Last is sotatercept, a new drug for pulmonary arterial hypertension (PAH), which previously had no real treatment. Unlike the current therapy aimed at simply dilating blood vessels, sotaracept targets BMPR-II signalling, addressing the cause of PAH. It earned a priority preview by the FDA based on its phase 3 trial data, with possible approval by March 2024.

Categories : COVID Medical IndustryTags :

From Molecule to the Shelf

On By ModernMedia
Bada Pharasi, CEO of The Innovative Pharmaceutical Association of South Africa (IPASA)

Lessons from the COVID-19 pandemic have underlined the importance of continued investment into pharmaceutical innovation and R&D to not only bring life-saving medications to those in need, but to improve public health outcomes, writes Bada Pharasi, CEO of The Innovative Pharmaceutical Association of South Africa (IPASA).

From treatments for cancer, cardiovascular diseases and more recently, the COVID-19 vaccine, the pharmaceutical industry has made significant progress in the development of over 470 medications in the last 10 years alone.1

While the innovative pharmaceutical process typically takes between 10 and 15 years from discovery to regulatory approval2 – owing to factors including immense R&D costs, regulatory compliance, and the protection of patents3 – the fast-tracked development and approval of COVID-19 vaccines laid bare the need for pharmaceutical companies to be prepared to mitigate the risk of future outbreaks – and this means continued investment in innovation and R&D.

The pandemic underlined the need for countries to be prepared for outbreaks on the horizon. To ensure we can meet the next challenge, pharmaceutical innovations must match the pace at which diseases mutate. This kind of innovation is non-negotiable and requires continued investment as a safeguard against losing lives and endangering South Africa’s fragile healthcare system.

As we are in the midst of a cholera epidemic, as well as the recent measles outbreak,4 it’s important to continue driving innovation to treat diseases, with medicines developed by innovative pharmaceutical companies benefiting millions across the country every day.

This is evidenced by mortality rates for HIV/AIDS and TB in the country falling by 59.2% and 55.7% between 2007 and 2017, with at least 60 new medicines currently in the R&D pipeline to treat TB.5

While patents in pharmaceutical innovation protect the originators’ intellectual property, it is important that innovative medications be developed to ensure a continuous pipeline of access to generics once the patent has lost its exclusivity. This will drive consumer accessibility and affordability of life-saving treatments and medications that may otherwise be unattainable for many.

As we continue racing against the proverbial clock in protecting against current and future diseases, pharmaceutical companies should continue to invest in innovation and R&D to outsmart existing dreaded diseases, and provide agility and preparedness should the next unknown pandemic threaten. Our health, and lives, depend on it.

References:
1. #AlwaysInnovating: The pharmaceutical innovation journey [Internet]. IFPMA. 2023 [cited 2023 Jun 28]. Available from: https://www.ifpma.org/initiatives/alwaysinnovating/
2. Derep M. What’s the average time to bring a drug to market in 2022? [Internet]. N-SIDE; 2022 [cited 2023 Jun 28]. Available from: https://lifesciences.n-side.com/blog/what-is-the-average-time-to-bring-a-drug-to-market-in-2022
3. Ancliff S. 10 challenges facing the pharmaceutical industry in 2024 [Internet]. [cited 2023 Jun 29]. Available from: https://blog.i-nexus.com/10-challenges-facing-the-pharmaceutical-industry
4. Yoganathan V. Prepare for more pandemics in the future, experts warn [Internet]. Juta MedicalBrief. Medical Brief; 2023 [cited 2023 Jun 30]. Available from: https://www.medicalbrief.co.za/prepare-for-more-pandemic-in-the-future-experts-warn/
5. South Africa – the innovative hub for pharmaceutical development [Internet]. B2B Central. New Media; 2021 [cited 2023 Jun 29]. Available from: https://www.b2bcentral.co.za/why-south-africa-is-an-innovation-hub-for-pharmaceuticals/

Categories : Medical Industry Medical Research & TechnologyTags :

A New Wave of Academia Spinouts is Shaking up Drug Development

On By ModernMedia
Photo from Pixabay

In recent times, new drug discoveries by independent large pharmaceutical companies have become increasingly rare, with almost 60% of new drugs discovered through mergers and acquisitions and drug licensing. Fortunately, an emerging trend of spinouts from academia and R&D investments heralds a promising shift in the industry’s interorganisational deal networks to improve research and development in the future. Researchers explore this new trend in Drug Discovery Today.

Launching a new drug in the market is risky, thanks to a low probability of success during the research and development (R&D) phase and the high costs involved. But through an improved understanding of disease biology, decision-making can be more streamlined through the effective use of scientific information.

With this in mind, researchers from Ritsumeikan University, Japan, led by Associate Professor Kota Kodama are uncovering how the trends in interorganisational deals in the pharmaceutical industry are changing to improve R&D productivity and drug discovery. “The network structure of innovation creation in the pharmaceutical industry has changed with the increasing emergence of start-up companies spinning out from academia and research institutions as players in the source of innovation,” explains Dr Kodama.

Their research suggests that the knowledge necessary for breakthrough innovation in drug discovery is more often than not obtained through alliance networks. Over the past decade, large research-based pharmaceutical companies have used research collaborations, innovation incubators, academic centres of excellence, public-private partnerships, mergers and acquisitions (M&As), drug licensing, and corporate venture capital funds as typical methods for external innovation. The researchers now aim to define the changes in the network structure and nature of such alliances that have occurred over the past decade to provide future strategic insights for industry and academic players involved in drug discovery.

Using data from the Cortellis Competitive Intelligence database, the researchers identified nearly 50 000 deals of various kinds related to pharmaceutical R&D across pharmaceutical, digital health software, animal drug, and medical device companies to uncover trends in the creation of new drugs for human use. They also studied the trends of 13 of the largest pharmaceutical companies with annual revenues of more than US$10 billion, who saw an improvement in their CAGR (compound annual growth rate) since 2015. The researchers noticed that the rising CAGR correlated to a significant change in M&A-related deals after 2015, indicating that M&A-related deals drive revenue growth for large pharmaceutical companies.

Furthermore, the number of organisations involved in interorganisational deals has been increasing yearly from 2012 to 2021. Although the number of organisations involved and the number of deals may be increasing, the density of the deal networks is decreasing annually, suggesting that networks are becoming more non-cohesive. The concentration of business relationships between organisations of certain areas in the network changed to dispersion around 2015, and new networks connecting different groups started to form after 2017. These trends are an important illustration of how the industry landscape is gradually evolving away from the traditional network in which large pharmaceutical companies drove drug discovery output. Now, interorganisational deals among more diverse players have become active and are driving R&D productivity for startups in biotechnology and pharmaceuticals.

A clear increase in the number of academia-owned spinouts of advanced technology and expansion of investment in start-ups is a positive sign. The emergence of new chemical modalities, such as biologics, oligonucleotides, and peptides that differ from traditional small molecule drug discovery indicate remarkable changes that have taken place over the past two decades. The trend of increased financing for start-up companies in personalised drug development is beneficial for patent creation and will positively impact innovation creation in the coming years.

“The presence of academia to support the technologies of these start-ups is becoming very important, and government and private support and investment in this area is boosting innovation. Our study shows that such medium- and long-term support may ultimately benefit the health and well-being of humankind,” concludes an optimistic Dr Kodama.

Source: Ritsumeikan University.

Categories : Environmental Effects Medical IndustryTags :

Can Fungi Transform Plastic Waste into Drug Components?

On By ModernMedia
Photo by Louise Reed on Unsplash

Research on fungi has helped transform tough-to-recycle plastic waste from the Pacific Ocean into key components for making pharmaceuticals, using a genetically altered version of an everyday soil fungus, Aspergillus nidulans. The researchers described their chemical-biological approach in Angewandte Chemie, a journal of the German Chemical Society.

“What we’ve done in this paper is to first digest polyethylenes using oxygen and some metal catalysts – things that are not particularly harmful or expensive – and this breaks the plastics into diacids,” said co-author Berl Oakley, professor at the University of Kansas.

Next, long chains of carbon atoms resulting from the decomposed plastics were fed to genetically modified Aspergillus fungi. The fungi, as designed, metabolised them into an array of pharmacologically active compounds, including commercially viable yields of asperbenzaldehyde, citreoviridin and mutilin.

Unlike previous approaches, Oakley said the fungi digested the plastic products quickly, like “fast food.”

“The thing that’s different about this approach is it’s two things – it’s chemical, and it’s fungal,” he said. “But it’s also relatively fast. With a lot of these attempts, the fungus can digest the material, but it takes months because the plastics are so hard to break down. But this breaks the plastics down fast. Within a week you can have the final product.”

The KU researcher added the new approach was “bizarrely” efficient.

“Of the mass of diacids that goes into the culture, 42% comes back as the final compound,” he said. “If our technique was a car, it would be doing 200 miles per hour, getting 60 miles per gallon, and would run on reclaimed cooking oil.”

Previously, Oakley has worked with corresponding author Clay Wang of the University of Southern California to produce about a hundred secondary metabolites of fungi for a variety of purposes.

“It turns out that fungi make a lot of chemical compounds, and they are useful to the fungus in that they inhibit the growth of other organisms – penicillin is the canonical example,” Oakley said. “These compounds aren’t required for the growth of the organism, but they help either protect it from, or compete with, other organisms.”

Oakley’s lab at KU has honed gene-targeting procedures to change the expression of genes in Aspergillus nidulans and other fungi, producing new compounds.

The researchers focused on developing secondary metabolites to digest polyethylene plastics because those plastics are so hard to recycle. For this project, they harvested polyethylenes from the Pacific Ocean that had collected in Catalina Harbor on Santa Catalina Island, California.

“There’ve been a lot of attempts to recycle plastic, and some of it is recycled,” Oakley said. “A lot of it is basically melted and spun into fabric and goes into various other plastic things. Polyethylenes are not recycled so much, even though they’re a major plastic.”

The KU investigator said the long-term goal of the research is to develop procedures to break down all plastics into products that can be used as food by fungi, eliminating the need to sort them during recycling.

“I think everybody knows that plastics are a problem,” Oakley said. “They’re accumulating in our environment. There’s a big area in the North Pacific where they tend to accumulate. But also you see plastic bags blowing around – they’re in the rivers and stuck in the trees. The squirrels around my house have even learned to line their nest with plastic bags. One thing that’s needed is to somehow get rid of the plastic economically, and if one can make something useful from it at a reasonable price, then that makes it more economically viable.”

Source: University of Kansas

Categories : Medical IndustryTags :

New Sanofi GM Poised to Transform Southern Africa Medical and Pharma Industry

On By ModernMedia
Kagan Keklik, General Manager South Africa & Country Lead, Sanofi South Africa

Johannesburg, 30 August 22: Kagan Keklik has taken the reigns as General Manager South Africa & Country Lead of multinational pharmaceutical and healthcare company, Sanofi, in South Africa, at a time when revolutionary technology and medical interventions are set to change lives across Africa.

With all the business acumen needed, a passion for science and expertise across several therapeutic areas and products, Keklik is already inspiring excellence in the 500 plus workforce that he leads in South Africa.

Keklik has over 20 years of experience in the pharmaceutical sector where the positions he has held have spanned from managing products to leading teams in the Middle East, Eurasia, and South Asia. He has been with Sanofi for nearly 13 years, making him well-poised to take the company to new heights.

“Sanofi is dedicated to finding answers for patients by developing breakthrough medicines and vaccines. Our purpose is to chase the miracles of science to improve the lives of patients, partners, communities and our own people. We provide potentially life-changing treatments and life-saving vaccines to millions of people as well as affordable access to our medicines in some of the world’s poorest countries,” says Keklik.

Keklik is excited about the potential of the South African market. “South Africa is considered the gateway to the African continent and is an important market for the Sanofi Group. The people are driven and dynamic and there are great opportunities for growth. We are passionate about knowledge and technology transfer to ensure the local manufacturing of medicines. We sincerely look forward to helping to make a difference and I look forward to working with my team to drive change in the region,” says Keklik.

Keklik is a great proponent for forging important alliances, such as the strategic partnership with South African manufacturer, Biovac, for the local manufacture of vaccines through the transfer of manufacturing excellence, skills, and knowledge.

Keklik’s vision takes this even further: “As a world leader in the development and delivery of vaccines, we fully support continued investment in localised manufacturing and the sustainability of local vaccine supply. Through long-term partnerships such as the one we have with Biovac, we can ensure that South Africa can be a manufacturing hub that will improve the distribution of vaccines into neighboring countries.”

Supported by a strong team, Keklik is enthusiastic about unlocking not only the potential of the region but also of Sanofi itself. He sees himself as a transformative leader and believes in inspiring and empowering individuals and teams to achieve the company’s goals. At the same time, he is prepared to push limits to make a difference in both the prescription and over-the-counter medication markets.

“We are focused on growth and believe this can be achieved if we lead with innovation and accelerate efficiencies. I’ll be focusing on these levers over the next few years to ensure Sanofi maintains its position as a leading healthcare company, not only in South Africa, but throughout the region,” says Keklik.

Categories : Ethics and Law Medical IndustryTags :

Systematic Bias in Industry-sponsored Cost-effectiveness Studies

On By ModernMedia
Photo by Marek Studzinski on Unsplash

Industry-sponsored studies on a new drug or health technology are more likely to be found ‘cost-effective’ than independent studies, across a range of diseases, according to findings from a study published in The BMJ.

In a linked editorial, experts make a call for better reporting of results, more transparency, open-source cost-effectiveness models, and more independent studies, to reduce decision makers’ reliance on potentially biased cost-effectiveness analyses.

A cost-effectiveness analysis (CEA) provided the manufacturer is required by some countries to weigh up a product’s costs and effects.

This cost analysis evidence can be used to set the price for a drug or health technology or decide whether insurance policies will cover them. New drugs covered by insurance plans can be much more profitable than those not covered, which could lead to bias in CEAs funded by the drug and technology manufacturing industry.

While previous studies have consistently shown sponsorship bias in CEAs, most studies were limited to specific diseases, and are out of date. To fill in the gaps, Feng Xie and Ting Zhou from McMaster University, Canada, analysed data from all eligible CEAs published between 1976 and March 2021. 

They selected CEAs that reported an incremental cost-effectiveness ratio (ICER) using quality-adjusted life years or QALYs – a ‘value for money’ metric of years lived in good health.

The authors used data from the Tufts Cost-Effectiveness Analysis Registry. In total, 8192 CEAs were included in the study, of which nearly 30% were sponsored by industry. 

The study defined CEA industry sponsorship as an analysis funded by drug, medical device, or biotechnology companies, either wholly or in part. 

The results show that the industry-sponsored CEAs were significantly more likely to conclude that the new medicine or health technology was cost-effective than those not sponsored by industry.

For example, industry-sponsored studies were more likely to report the intervention being studied as cost-effective below the commonly used threshold of $50 000 per QALY gained than non-industry sponsored studies.

Among 5877 CEAs that reported the intervention was more effective but more expensive than the comparator, the ICERs from industry sponsored studies were one third (33%) lower than those from non-industry sponsored studies.

While only having the registry information to work with was a limitation, the authors said their analysis provides a basis for comparison with previous investigations.

As such, they suggested that “sponsorship bias in CEAs is significant, systemic, and present across a range of diseases and study designs.”

In lower and middle-income countries, industry bias can increase drug prices, where fewer resources mean decision-makers often need to rely on published, rather than independent CEAs. 

In a linked editorial, Adam Raymakers at Cancer Control Research, Canada, and Aaron Kesselheim at Brigham and Women’s Hospital, USA, argue that decision-makers “should exercise caution when using published cost-effectiveness analysis in coverage decisions.”

They say finding solutions to tackle bias is more important than ever, and make the case for open-source analysis models, increased transparency, and increased funding for independent analyses, to help minimise reliance on industry-sponsored cost analyses.

Source: The BMJ

Categories : Ethics and Law Medical IndustryTags :

‘Extensive Network’ of Opaque Medical Industry Ties

On By ModernMedia
Image: Pixabay CC0

A study published by the BMJ shines a light on an extensive network of financial and non-financial ties maintained by the medical product industry with all major healthcare parties and activities.

The researchers called for greater oversight and transparency for this largely opaque and unregulated network, “to shield patient care from commercial influence and to preserve public trust in healthcare.”
While the medical product industry is a critical partner in advancing healthcare, especially with the development of new tests and therapies, they have financial returns to shareholders as their main objective.

In a landmark 2009 report [PDF], the Institute of Medicine described a multifaceted healthcare ecosystem rife with industry influence.

To date most research into medical industry conflict of interests have focused on a single party (eg. healthcare professionals, hospitals, or journals) or a single activity (eg. research, education, or clinical care). Thus, the full extent of industry ties across the healthcare ecosystem remains uncertain.

To address this gap, a team of US researchers set out to identify all known ties between the medical product industry and the healthcare ecosystem.

They searched the medical literature for evidence of ties between pharmaceutical, medical device, and biotechnology companies and parties (including hospitals, prescribers and professional societies) and activities (including research, health professional education and guideline development) in the healthcare ecosystem.

The researchers drew in data in 538 articles from 37 countries, along with expert input, to create a map depicting these ties. These ties were then verified, catalogued, and characterised to ascertain types of industry ties (financial, non-financial), applicable policies on conflict of interests, and publicly available data sources.

The results show an extensive network of medical product industry ties – often unregulated and non-transparent – to all major activities and parties in the healthcare ecosystem.

Key activities include research, healthcare education, guideline development, formulary selection (prescription drugs that are covered by a health plan or stocked by a healthcare facility), and clinical care.

Parties include non-profit entities (eg foundations), the healthcare profession, the market supply chain (eg payers, purchasing and distribution agents), and government.

For example, the researchers describe how opioid manufacturers provided funding and other assets to prescribers, patients, public officials, advocacy organisations, and other healthcare parties, who, in turn, pressured regulators and public health agencies to stifle opioid related guidelines and regulations.

They also warned that harms from industry promoted products remain unexplored. All party types were found to have financial ties to medical product companies, with only payers and distribution agents lacking additional, non-financial ties.

They also show that policies for conflict of interests exist for some financial and a few non-financial ties, but publicly available data sources seldom describe or quantify these ties.

The researchers acknowledge that their findings are limited to known or documented industry ties, and that some data might have been missed. However, they say their strategy of systematic, duplicative searching and feedback from an international panel of experts is unlikely to have missed common or important ties.

In light of this, they conclude: “An extensive network of medical product industry ties to activities and parties exists in the healthcare ecosystem. Policies for conflict of interests and publicly available data are lacking, suggesting that enhanced oversight and transparency are needed to protect patients from commercial influence and to ensure public trust.”

Source: EurekAlert!