As R and D shrinks, UK trials new payment scheme for antibiotics

pharmaphorum | July 09, 2019

As R and D shrinks, UK trials new payment scheme for antibiotics
With big pharma still abandoning R and D into antibiotics and resistant infections on the rise, the UK has launched a new payment system that it hopes will incentivise the development of new drugs. A new subscription approach will see companies paid upfront for access to new antibiotics based on their value to the NHS, rather than the volume of medicines sold, according to Health Secretary Matt Hancock. The idea is that this will give companies who develop innovative antimicrobials a greater return on their R&D investment than would occur if those drugs are held in reserve for resistant infections, and so only used sparingly. It also removes the incentive for companies to market antibiotics in order to boost sales at a time when the NHS is trying to reduce their use to counter the emergence of antimicrobial resistance (AMR). Hancock said the UK cannot act alone, however, and he urged other countries to follow suit. AMR is becoming a major public health concern around the world, resulting in around 700,000 deaths each year at the moment with fatalities expected to increase as the antibiotic armamentarium loses its potency. Companies are now being asked to propose identify medicines that could be considered for inclusion in the pilot, which will use an adapted NICE health technology assessment (HTA) approach to determine payments teased by Hancock at the World Economic Forum in Davos earlier this year.  “Imagine a world in which a papercut can lead to infection that can’t be controlled. We must stop that from happening,” said Hancock. “Tackling superbugs needs global leadership and peoples’ lives depend on us finding a new way forward.” For decades, pharma companies have been gradually withdrawing from antimicrobial research because they find it hard to get a return on the estimated £1 billion it costs to develop a new drug, turning their attention to more lucrative therapeutic areas such as cancer and diabetes.

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It takes an ecosystem to build a startup and world-class innovation to build a good biotech company. And to develop a scientific discovery into a life-changing drug or technology, it takes experts from various fields. All of this and more can be found nestled between the borders of France and Germany, namely, in the Basel Area in Switzerland.

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BUSINESS INSIGHTS

Azzur Group Announces Executive Leadership Changes

Azzur Group, LLC | January 13, 2022

To support rapid company growth and best meet the demands of the business, Azzur Group announces new executive leadership appointments. Originally founded in Philadelphia in 2010, Azzur is a market-leading provider of GxP services for the pharmaceutical, biotechnology, medical device, and healthcare industries with offices and on-demand cleanrooms locations throughout the United States. Today, the organization provides comprehensive GxP solutions through its on-demand cleanrooms, consulting and advisory services, microbiology labs, and aseptic and GxP training. Ryan Ott has been promoted to Chief Operating Officer of Azzur Group. A long-time partner at Azzur, Ryan most recently served as Chief Administrative Officer. During his tenure, he has been instrumental in the overall strategic development of Azzur Group, initially in the Greater Philadelphia Region, while taking on additional responsibility with ongoing national expansion. In his new role, he collaborates with corporate and service-line leaders throughout the organization to execute on Azzur Group's strategic business plan. This includes Shaleen Parekh, who has been appointed to Sr. Vice President of Professional Services, with continuing oversight for Azzur Consulting, Azzur Labs, and Azzur Training Center; and Molly McGlaughlin, who has been appointed Sr. Vice President of Facilities Services, with continuing oversight for Azzur Cleanrooms on Demand™ as its Chief Operating Officer. Appointed to the new role of Chief Innovation Officer is Ravi Samavedam. In this role, he will focus on bringing forward new business concepts and service areas for Azzur's continued expansion. Ravi's extensive life sciences industry experience and dynamic leadership of Azzur Cleanrooms on Demand™ from its creation in 2018 through its national expansion, ideally position him to proactively identify novel service offerings for the enterprise. Most recently, Ravi served as President and COO of Azzur Cleanrooms on Demand™. He has been a member of Azzur Group since 2014. Ilya Vasserman has been promoted to Chief Information Officer (CIO) of Azzur Group and is responsible for overseeing the management and scale-out of Azzur's corporate information technology infrastructure while forming and leading a new corporate-wide procurement group. Ilya will also continue to spearhead technology adoption and internal tool development, furthering our business insights capabilities. Ilya most recently served as Senior Director of Financial Services and has been a member of Azzur Group since 2016. After nearly two years with Azzur Group, David Frank has been promoted to Vice President of Client Development, furthering the growth and maturation of Azzur's business development and marketing capabilities. As part of his expanded responsibilities, David will work closely with the executive leadership team to develop client-centric strategies across the organization to meet customer needs. Since joining Azzur Group in 2020, David has served as the Senior Director, Sales and Marketing. "I'm incredibly thrilled to announce the changes to the Azzur Group executive leadership team. Not only have these individuals proven to be excellent strategic partners for our enterprise, but each embodies Azzur Group's core values in their daily leadership. I offer my sincerest congratulations to Ryan, Ravi, Shaleen, Molly, Ilya, and David, and wish them much success in their new roles." Michael Khavinson, Azzur's Chief Executive Officer About Azzur Group Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

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PHARMA TECH

Fareva and ApiJect sign a licensing agreement to create a France-based 500M unit annual capacity for single-dose prefilled vaccine injections

ApiJect Systems Corp. | December 10, 2021

Fareva and ApiJect Systems, Corp. announced a 10-year licensing agreement to install three Blow-Fill-Seal production lines that when operational will be able to fill-finish more than 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect's innovative prefilled injector technology. Fareva intends to invest more than €50M for these three manufacturing lines, with support from the Government of France, through the "France Relance" industry initiative and the Investments for the Future Program. The three manufacturing lines and ApiJect's technology utilize the Blow-Fill-Seal aseptic packaging process. BFS has demonstrated its ability to package certain vaccines and large molecule formulations, and ApiJect is helping to expand BFS's capabilities to additional drug products, including temperature sensitive pharmaceuticals. When cleared by regulators, ApiJect will provide the necessary needle hub and other attachable components to convert finished BFS single-dose containers from these lines into easy-to-assemble, ready-to-use prefilled injectors. COVID-19 has demonstrated the strategic importance of regional pharmaceutical manufacturing to ensure strong and reliable medical supply chains. By investing in these three BFS lines and installing ApiJect technology, Fareva is helping to increase Europe's high-speed, high-volume fill and finish capacity by potentially more than 500 million doses per year. And, the compact polyethylene-based supply chain of BFS helps establish and maintain dependable and resilient fill-finish capacity, even in the face of additional COVID-19 pandemic waves and their supply chain repercussions. "This commitment by Fareva, with the support of the French Government, to expand fill-finish capacity is the right step at the right time. We are proud to partner with Fareva in bringing the next generation of injection technology to global health." ApiJect CEO and Chair Jay Walker commented Mr. Walker continued: "Our mission at ApiJect is to support and execute a strategy of expanded distributed fill-finish capacity in the U.S. and regionally around the world. This is desperately needed in the battle against COVID, particularly as we continue to face emerging variants. Distributed fill-finish capacity will also yield huge dividends when future pandemics and other possible bio-emergencies threaten our populations. Fareva, along with its support from the French Government, is showing itself to be a vital leader in confronting and defeating the COVID threat." The new lines will be situated in Fareva Excelvision, located in Annonay, France, which has more than 50 years of experience manufacturing BFS containers and exporting products around the world. The BFS machines will be purchased from Rommelag in Germany. Clean rooms for these new lines will be operated in a Biosafety Level 2 (BSL2) environment, allowing them to handle most vaccines. The objective is to start the first validation batches in June 2022. In addition, this capacity expands ApiJect licensing of its BFS manufacturing and device technology to the USA and Europe. Olivier Dussopt. Minister Delegate for Public Accounts said: "I am very happy that Fareva, and their manufacturing site of Annonay in Ardeche, invests in such a development project, concerning 3 production lines for an amount of 50 million euros. The government will support those investments with a program of 36,9 million euros. This is an excellent news for the local territory as it will create 150 jobs and this is also an excellent news for France and Europe that will benefit from this high technology for the manufacturing of pharmaceutical drugs and more precisely of vaccines. " Agnès Pannier-Runacher, Minister Delegate for the Industry declared: "I welcome the project implemented by Fareva in collaboration with ApiJect, a world premiere that will enable the production up to 500 million of injectable pharmaceutical products from 2022. This ambitious 50 million euros project will strengthen our healthcare industry in France and shows that innovation is not only in the vaccines but also stands in the injection devices. It is also the reason why we have agreed to support it with the France Relance program." ABOUT APIJECT SYSTEMS, CORP. ApiJect Systems, Corp. is a public-benefit medical technology company working to bring prefilled, single-dose injections to more people in every market. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own ApiJect-licensed Blow-Fill-Seal packaging lines or at one of our world-class manufacturing partners. ABOUT FAREVA Fareva, a family-owned company, whose strength lies in its financial independence, is one of the world's leading CDMOs in the pharmaceuticals, cosmetics, make-up, and industrial and homecare fields. Fareva operates in 12 countries with 42 factories and employs more than 13 000 employees with annual revenues reaching € 1.8 billion in 2020. ABOUT "FRANCE RELANCE" France Relance is a €100 billion investment plan designed to support economic recovery in France in the wake of the COVID-19 pandemic. The program supports businesses, new production models, transformation of infrastructure, and training investment.

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RESEARCH

Nanoform Releases Next-Generation AI-based Drug selection Tool

Nanoform | March 23, 2021

Nanoform innovative nanoparticle medicine enabling company next generation of its STARMAP® AI artificial intelligence platform nanoparticle bioavailability excipient microns nm CESS technology silico pharma drugs lifecycle managementNanoform, an innovative nanoparticle medicine enabling company, has today dispatched the next generation of its STARMAP® AI (artificial intelligence) platform, v2.0. The technology uses scanty information AI to expand trial results from its CESS® nanoparticle designing process with detailed master information, permitting dependable expectations to be made in regards to accomplices' likely success of nanoforming their medication atoms. CESS® is a nanoparticle platform technology which produces unadulterated homogeneous medication particles from arrangement in a without excipient process. By diminishing the molecule size e.g., from 10 microns to 50 nm, the particular surface territory can be expanded by as much as 1000-crease, subsequently improving disintegration rate, solvency, and bioavailability. Subsequently, Nanoform can help pharma accomplices progress atoms into advancement that in any case might not have been conceivable. It additionally opens up energizing opportunities for a wide scope of novel medication conveyance applications. STARMAP® is a computerized form of the CESS® technology that empowers in silico tries in enormous amounts, making quick forecasts of which atoms ought to be nanoformed. This is significant since there are more potential medication atoms than particles in the known universe. STARMAP® can be a useful asset for pharma accomplices to pick appropriate medication contender for additional improvement from their huge libraries. The benefits may incorporate quicker way to advertise and additional opportunities for widening and extending drug pipelines while at the same time expanding the likelihood of medication improvement success. The STARMAP® platform can have wide materialness in drug disclosure and advancement just as in lifecycle management for existing promoted drugs and 505b2-like item improvement methodologies. "AI algorithms developed for big data have so far struggled to live up to expectations in pharma because the data, especially for early assets (drug discovery, drug screening), that is available to pharma is typically insufficient for generating reliable predictions. We believe sparse-data AI will work much better - in practice, this means augmenting experimental results with detailed expert knowledge, which can be used to prevent the AI from predicting outcomes that are nonsensical based on prior understanding. There is a lot of untapped potential in sparse-data AI for the pharma industry and the field continues to undergo rapid development in both academia and the industry in general," said Prof. Jukka Corander, Head of AI at Nanoform. "By determining which drug candidates are ideal for our CESS® process, the next-gen STARMAP® platform can potentially create new opportunities for our pharma partners. These can include both revisiting drug candidates unnecessarily discarded by AIs trained on old particle engineering techniques, and rapidly picking winners among new drug candidates. Ultimately, the benefit of more advanced AI will be felt by patients as new therapies are accelerated to market," commented Christian Jones, Chief Commercial Officer at Nanoform

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Spotlight

It takes an ecosystem to build a startup and world-class innovation to build a good biotech company. And to develop a scientific discovery into a life-changing drug or technology, it takes experts from various fields. All of this and more can be found nestled between the borders of France and Germany, namely, in the Basel Area in Switzerland.