HPV vaccine to be offered to school-age boys

Pharmatimes | July 11, 2019

From September 2019, boys in school year eight will be offered the free Human Papilloma Virus (HPV) vaccine for the first time. Modelling produced by the University of Warwick estimate that the HPV vaccine programme could prevent over 64,000 cervical cancers and nearly 50,000 non-cervical cancers by 2058. Despite this being the first introduction of the vaccine for boys, girls have been offered the jab free from the NHS since 2008. So far, 10 million doses of vaccine have been given to young women in this country meaning over 80% of women aged 15 to 24 have received the vaccine. Two doses are needed to be fully protected, and so the first dose will be offered to boys and girls aged 12 and 13 in year eight, with the second dose being given anytime between six to 24 months after. Girls and boys who have their first vaccination after the age of 15 will need to have three doses. Studies have already shown that the vaccine protects against HPV infection for at least 10 years, although experts expect protection to last for much longer and may be lifelong. Head of Immunisation at Public Health England, Dr Mary Ramsay, said that the universal programme offers the opportunity to “make HPV-related diseases a thing of the past and build on the success of the girls’ programme.”

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Description: Every medicine you buy has an expiration date printed on it somewhere, but does it actually go bad? This week on Reactions, we explain the chemistry of drug expiration dates.


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BUSINESS INSIGHTS

Bruker Acquires Optimal Companies for Pharma PAT Software and Biopharma Manufacturing Automation Expertise and Technologies

Bruker Corporation | April 06, 2022

Bruker Corporation announced the acquisition of Optimal Industrial Automation and Technologies, a leader in pharma and biopharma process analytical technology pharma manufacturing automation and Quality Assurance (QA) software and systems integration, based in the United Kingdom. The Optimal biopharma tools acquisition strengthens Bruker as a key software and solutions provider for small molecule, biologics and new drug modalities pharma companies. Financial details of the acquisition were not disclosed. Optimal’s 2022 revenue is expected to be approximately $10 million, and Optimal’s revenue growth rate and operating margins are projected to be accretive to Bruker in 2023 and beyond. The Optimal biopharma tools and automation capabilities complement Bruker’s innovative and differentiated high-value NMR, mass spectrometry, SPR, molecular spectroscopy and X-ray scientific instruments, and life-science solutions for biopharma drug discovery and development, as well as for PAT analytical and QA solutions. Together these biopharma tools enable Bruker’s global biopharma customers to bring efficacious and safe medicines to market more quickly. Optimal has a focus on the automation and optimization of batch and continuous processes in the biopharma industry – from R&D to manufacturing. As an integrated PAT solutions provider, Optimal offers development, testing, deployment and support of quality-centric pharmaceutical production systems. Optimal has more than 30 years of experience in successfully delivering regulatory-compliant biopharma solutions, ranging from the development of automated control systems for process control to the market-leading, vendor-agnostic PAT knowledge management software synTQ®. The synTQ PAT software can interface between multiple analytical instruments (spectral and univariate), multi-variate analysis (MVA) packages, manufacturing control systems and a range of adjacent software solutions to ensure quality in real-time. As a 2021 Pharma Innovation Award winner, synTQ is a proven enabler of quality-by-design (QbD) via PAT. For users of synTQ, this can significantly increase productivity and quality, while reducing waste, time-to-manufacture and time-to-market, with proven Optimal use cases tripling biopharma productivity. While remaining a vendor-agnostic biopharma solutions provider, Optimal can integrate bioanalytical technologies such as nuclear magnetic resonance (NMR), mass spectrometry (MS) and FTIR/NIR/Raman systems into innovative drug discovery, development, PAT and quality control workflows. Combining next-generation, high-performance technologies with Optimal solutions eases the transition from development to biopharma manufacturing, while remaining in regulatory compliance. “The acquisition of Optimal is a very exciting step for Bruker as it supports more comprehensive solutions for the biopharmaceutical industry, now adding the capabilities to integrate cutting-edge systems into biopharma manufacturing processes and workflows. We welcome the Optimal team with their strong PAT and automation expertise and, together, are eager to support biotech and pharmaceutical companies in increasing their manufacturing efficiency and flexibility – a global need highlighted by the response to the pandemic crisis.” Dr. Falko Busse, President of the Bruker BioSpin Group Mr. Martin Gadsby, the CEO and Co-Founder of Optimal Industrial Automation and Technologies, added: “We are delighted to become part of the Bruker family. Optimal and Bruker together are a perfect fit – we share the common ethos of innovation with integrity, together with our industry recognition as a high-quality solutions provider delivering tangible benefits to our customers. The whole Optimal team is excited by this new chapter in our history and looks forward to delivering benefits to even more biopharma customers and ultimately to patients around the world.” About Optimal Industrial Technologies and Automation A well-established system integrator with more than 30 years of experience, at Optimal we specialize in automating a client’s R&D or manufacturing system to ensure that their processes remain at the highest level of efficiency. The demands being placed on manufacturers in relation to production costs, product quality and business sustainability are ever increasing, and our primary aim within Optimal is to assist you in being the most competitive supplier of your product to the highest level of quality in the worldwide marketplace, and to ensure that you continue to maintain your lead in the years ahead. We have a rare and wide-ranging skill set covering a multitude of automation technologies, manufacturing processes and industry types, with very specific knowledge in highly regulated environments. In addition, we manufacture the world leading PAT Data Management software package - synTQ® and the widely used integrated Print and Inspect system - synTI®. The combination of our PAT implementation knowledge and synTQ® product together with our automation experience positions us with unique skills that can be leveraged to great advantage by our customers. About Bruker Corporation Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology.

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RESEARCH

Hemogenyx Pharmaceuticals and Selexis SA Will Advance Hemogenyx’s Acute Myeloid Leukemia (AML) CDX Bispecific Antibody to Human Trials

Hemogenyx Pharmaceuticals plc | January 13, 2022

Hemogenyx Pharmaceuticals plc the biopharmaceutical group developing new therapies and treatments for blood diseases, and Selexis SA, a JSR Life Sciences company, have signed a service agreement to develop the cell line for Hemogenyx’s CDX bispecific antibody for the treatment of acute myeloid leukemia (AML). Under the agreement, Hemogenyx will leverage Selexis’ proprietary SUREtechnology Platform™, a suite of cell line development tools and technologies that significantly reduces the time, effort, and costs associated with developing high-performance mammalian cell lines. The CDX bispecific is made using the Hemogenyx’s proprietary humanised monoclonal antibody against a target on the surface of AML cells. CDX was co-developed by Hemogenyx Pharmaceuticals and Eli Lilly and Company (“Lilly”). This cutting-edge application of immune therapy offers a potentially more benign and effective form of treatment that, if successful, could have a significant impact on treatment and survival rates for AML. CDX is planned to be the Company’s second therapeutic candidate to enter clinical trials. Following the completion of the co-development phase, Lilly granted the Company an exclusive worldwide license to certain intellectual property developed by Lilly related to the CDX bispecific antibody for all uses, including the treatment of AML and other blood cancers. “We are delighted to partner with Selexis, and access its proprietary protein expression tools and technologies, IP and know-how. The partnership is key to advancing our CDX programme into clinical trials and accelerating the timeline to deliver this innovative therapy to patients in need of a more benign and effective treatment for AML.” Dr. Vladislav Sandler, Chief Executive Officer and co-founder of Hemogenyx Pharmaceuticals Mr. Dirk Lange, CEO of Selexis, added, “There’s an urgent need for effective treatments for AML, and we at Selexis are pleased to apply our technologies to help Hemogenyx advance the CDX bispecific antibody to the clinic. We’ve built a reputation for delivering cell lines rapidly and cost-effectively, without compromising safety. This is an exciting milestone for Hemogenyx and we welcome the opportunity to join the company on its journey toward delivering a promising and effective therapy for patients with AML.” Selexis’ modular SUREtechnology Platform™ facilitates the rapid, stable, and cost-effective production of recombinant proteins and vaccines, providing seamless integration of the development continuum from discovery to commercialization. About Hemogenyx Pharmaceuticals plc Hemogenyx Pharmaceuticals is a publicly traded company headquartered in London, with its US operating subsidiaries, Hemogenyx Pharmaceuticals LLC and Immugenyx LLC, located in New York City at its state-of-the-art research facility. The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx Pharmaceuticals is developing several distinct and complementary product candidates, as well as a platform technology that it uses as an engine for novel product development. For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. The Company’s technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation. About Selexis SA Selexis SA, a JSR Life Sciences company, is the global leader in cell line development with best-in-class modular technology and highly specialized solutions that enable the life sciences industry to rapidly discover, develop and commercialize innovative medicines and vaccines. Our global partners are utilizing Selexis technologies to advance more than 146 drug candidates in preclinical and clinical development and the manufacture of eight commercial products. As part of a comprehensive drug development process, the Company’s technologies shorten development timelines and reduce manufacturing risks.

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BUSINESS INSIGHTS

Basetwo Launches No-Code Artificial Intelligence Platform for Pharmaceutical Manufacturing, Raises $3.8 Million

Basetwo | May 27, 2022

Basetwo, a SaaS AI platform for manufacturers, announced it secured a $3.8M seed round led by Glasswing Ventures and Argon Ventures with additional funding from Caffeinated Capital, Graphite Ventures, MaRs IAF, Pareto Holdings, Plug and Play, and Quiet Capital. The funding supports the launch of the category-making Basetwo AI platform, a first-of-its-kind solution that enables process engineers to rapidly build digital twins of their manufacturing plants leveraging a familiar no-code interface. Basetwo promotes the digitalization of manufacturing systems to foster intelligent manufacturing across the global supply chain. Basetwo intends to be the default platform for continuous improvement in the current Good Manufacturing Process (cGMP), beginning with the pharmaceutical market and expanding to the food and beverage and chemical markets. The pharmaceutical manufacturing market has been challenged in the past two years due to the pandemic and associated supply chain issues. In addition, the rate of drug development and demand for pharmaceuticals has increased at an unprecedented rate, fueled by technological and economic advancement globally. However, manufacturing optimization to meet this demand is still rudimentary and inadequate to meet today’s and future needs. According to ABI Research the pharma industry is predicted to spend over $4.5 billion on digital transformation by 2030, growing at a CAGR of 27%. In addition, the market for digital twins is forecasted to reach $35.5 billion by 2026, a 37% CAGR, according to a recent ResearchandMarkets report, primarily driven by the growing applications of digital twin technology in the pharmaceutical and healthcare industries. Basetwo’s platform powered by “physics-informed machine learning” is well suited for pharmaceutical manufacturing. The Company’s no-code approach brings highly sophisticated capabilities from pre-built models to data pipelines and integrations within a complex manufacturing process to a format familiar to process engineers. Basetwo's ability to predict and understand manufacturing processes improves as more data is gathered, improving return on investment over time. “The introduction of our no-code AI platform lets manufacturers of any size leverage the power of the Internet of Things (IoT) and machine learning (ML) to develop digital twins easily, quickly, and economically. We are excited to have the backing and the expertise from Glasswing Ventures, Argon Ventures, and all our investors as we scale the business.” Thouheed Abdul Gaffoor, Co-Founder and CEO of Basetwo Having previously co-founded and exited Emagin, an AI startup in the heavy industry, Thouheed has seen first-hand the challenges that manufacturers face with maximizing value from machine learning initiatives. To address this challenge, Thouheed left his previous role as Head of AI at Autodesk, and partnered with Thamjeeth Abdul Gaffoor, who co-founded and served as the CFO at Emagin, Tawfeeq Abdul Gaffoor, former Software Engineer at Lyft and Databricks, and Kiefer Eaton, a pharmaceutical industry specialist from Johnson & Johnson. Together, the Basetwo founding team brings deep domain expertise in manufacturing, technology, and pharmaceuticals. “The pharmaceutical manufacturing market is at a critical point, having been heavily challenged by the pandemic and supply chain issues. By creating a digital duplicate of a pharmaceutical manufacturing plant, the Basetwo AI platform allows process engineers to analyze where things might break down — or run more efficiently, and increase resilience,” said Rudina Seseri, Founder and Managing Partner of Glasswing Ventures. “As a category maker, Basetwo has delivered a revolutionary AI-based no-code solution that enables manufacturers to use digital twins for optimization. We anticipate that Thouheed and his team will disrupt the status quo in manufacturing and affect significant change in the industry.” About Basetwo Basetwo is the first no-code AI platform that enables process engineers to rapidly build and operationalize digital twins of their manufacturing plants. From process development to commercial manufacturing, manufacturers use the digital twins they build with Basetwo AI to improve process efficiencies across the value chain. About Glasswing Ventures Glasswing Ventures is an early-stage venture capital firm dedicated to investing in the next generation of AI and frontier technology startups that enable the rise of the intelligent enterprise. The firm was founded by visionary partners with decades of experience in these markets, a disciplined investment approach, and a strong track record of industry-leading returns. Glasswing leverages its deep domain expertise and world-leading advisory councils to invest in exceptional founders who transform markets and revolutionize industries. About Argon Ventures Argon Ventures is a venture fund with a mission to amplify the energy of founders to launch breakthrough products to build impactful, global businesses. The firm’s Intelligent Industry Solutions investment thesis is centered on cutting-edge software platforms that accelerate productivity & drive top-line revenue, transform markets through radical efficiency and create enterprise value through data at scale. Argon’s portfolio spans a number of markets, including digital health, future of work, manufacturing, and others. The founding General Partners collectively bring over four decades of experience as successful operators, investors, advisors, founders and C-level executives of global companies.

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PHARMA TECH

AmerisourceBergen Partners with Chronicled to Optimize Pharmaceutical Chargeback Accuracy Using Blockchain-Powered Technology

AmerisourceBergen | April 22, 2022

Global healthcare company AmerisourceBergen announced its partnership with Chronicled, the administrator of the MediLedger Network, to leverage a new blockchain-powered solution designed to enhance pharmaceutical chargeback accuracy and significantly reduce chargeback rejections. The blockchain solution will allow AB to streamline and optimize the complex process of pharmaceutical chargebacks while creating greater connectivity for its suppliers and customers. Over the past three years, AB has collaborated closely with Chronicled to design and pilot the technology for commercial use. Chronicled provides AB and industry partners with a shared, decentralized infrastructure that offers real-time visibility and contract updates to significantly reduce chargeback disputes and improve pricing accuracy. The blockchain-powered solution effectively enforces the accuracy and integrity of chargebacks submitted across AB’s pharmaceutical supply chain. “At AmerisourceBergen, it’s our responsibility to develop and leverage innovative solutions that create seamless and efficient experiences for our customers and the patients they serve every day. This wouldn’t be possible without trusted partnerships across the supply chain. Being a part of the MediLedger Network and deploying this type of blockchain technology is a crucial step forward in AmerisourceBergen’s ongoing digital transformation journey.” Dina Barton, Vice President, Contracts & Chargebacks at AmerisourceBergen Chargeback errors can occur for many reasons, but always result in manual processing, duplicate effort, and back-and-forth communication between trading partners to resolve them. Suppliers, wholesalers, and GPOs are constantly looking for ways to reduce errors, minimize chargeback disputes, and streamline this process. The Contracts & Chargebacks solution on the MediLedger Network will help AB provide its partner suppliers and GPOs a single source of truth for GPO membership, customer identifier data, and contract pricing data that stays aligned between trading partners on the network. The network itself uses this aligned reference data to enforce chargeback accuracy. Blockchain technology and increased collaboration across the industry are essential in driving efficiencies, reducing costly errors, and significantly improving the chargeback process. "We are excited and thrilled to have AmerisourceBergen join the MediLedger Network," said Susanne Somerville CEO of Chronicled. "We share AmerisourceBergen’s commitment to innovation and driving efficiencies across the industry and look forward to supporting their partners joining the network.” By creating greater connectivity with supplier partners and customers, AB expects this new solution will deliver higher quality results across its supply chain network. About AmerisourceBergen AmerisourceBergen fosters a positive impact on the health of people and communities around the world by advancing the development and delivery of pharmaceuticals and healthcare products. As a leading global healthcare company, with a foundation in pharmaceutical distribution and solutions for manufacturers, pharmacies, and providers, we create unparalleled access, efficiency, and reliability for human and animal health. Our 42,000 global team members power our purpose: We are united in our responsibility to create healthier futures. AmerisourceBergen is ranked #8 on the Fortune 500 with more than $200 billion in annual revenue. About Chronicled Chronicled, a San Francisco-based technology company, enables automation, trust, and automatic settlement for intra-company transactions in the Life Sciences and Healthcare industry. Through the industry leading blockchain-powered MediLedger Network, Chronicled offers trading partners a new way to manage revenue, automate manual processes, and eliminate revenue leakage, while ensuring pricing accuracy and efficiency for health care providers and dispensers.

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Description: Every medicine you buy has an expiration date printed on it somewhere, but does it actually go bad? This week on Reactions, we explain the chemistry of drug expiration dates.

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