Roche launches first in vitro lung cancer diagnostic test

pharmatimes | June 10, 2019

Roche Diagnostics has launched its first in vitro diagnostic test to target ROS1 positive lung cancers, VENTANA ROS1 (SP384) Antibody. The biomarker is the first and only in vitro diagnostic ROS1 immunohistochemistry assay on the market and looks promising to provide a cost-effective and efficient means to initially identify the presence of elevated ROS1 protein expression in cancer. Mutations of the ROS1 gene are present in some non-small cell lung cancer (NSCLC) cases and can help indicate which patients would respond with a targeted treatment. As these types of cancer are rare, found in up to 2% of non-small cell lung cancer cases, the use of a ROS1 IHC biomarker may provide a cost-effective and efficient means of identifying cases with elevated ROS1 protein expression, before confirming by another method, such as by fluorescence in situ hybridisation (FISH) or next¬ generation sequencing (NGS). “Our highly sensitive ROS1 test is the first in vitro diagnostic test available for recommended lung cancer testing guidelines, with the added benefit of rapid turnaround time,” said Pierre Hazlewood, marketing director at Roche Diagnostics. He continued, “While this is important in non-small cell lung cancer cases today, ROS1 is also being investigated in a number of clinical trials in other cancer types.”

Spotlight

This paper, authored by Alireza Shabani, Founder & CEO of Qulab, describes the necessary computational architecture for pharmaceutical firms to accelerate R&D and drug discovery, especially utilizing special purpose silicon and quantum processors.


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BUSINESS INSIGHTS

Satio and Institut Pasteur de Dakar Form Strategic Partnership on Research, Development, Manufacture, and Distribution

Satio, Inc and Institut Pasteur de Dakar | August 24, 2022

Satio, Inc., a privately held medical device company developing breakthrough, consumer-driven diagnostic and drug delivery solutions, announced a strategic partnership agreement with Institut Pasteur de Dakar. By combining SatioRxTM intradermal patches and Institut Pasteur de Dakar technologies, the partnership aims to accelerate clinical development of and access to vaccine patches for addressing epidemics, as well as diagnostic patches for blood sampling, genetic testing, and pathogen surveillance. Both entities also collaborate with INTACT, an innovative aseptic packaging company. The collaboration will enable access to immunization by exploring alternatives to vials such as plastic pouches for vaccines, and by replacing traditional needles with SatioRxTM intradermal patches and INTACT aseptic fluid transfer technology. The focus for the three-way collaboration will be for epidemics with pandemic potential. “Satio’s technologies are designed to transform the workflows in healthcare for blood draw, diagnostics and drug delivery using our patented patch-based technology. It’s an honor to partner with Institut Pasteur on these important initiatives specifically for Africa.” Namal Nawana, Executive Chairman and Founder of Satio "The global COVID pandemic has further highlighted the need for rapid and broad access to vaccines and, diagnostics in Africa and beyond. Satio’s technology has the potential to radically simplify the healthcare workflows and to enable delivery at a significantly lower total cost in healthcare systems globally" said Sharad Joshi, President & Chief Executive Officer of Satio. Dr. Amadou Alpha Sall, General Administrator of Foundation Institut Pasteur de Dakar, Senegal, said “Access to innovative health technologies for epidemics is critical to ensure an effective response to global threats. This collaboration aims to put Africa at the heart of vaccine innovation.” About Satio, Inc Satio, Inc., is a privately held medical device company focused on point-of-care patches with on board diagnostic and therapeutic solutions leveraging low-cost and user-friendly technology. The company is developing three different platforms. The first is a vaccine and drug delivery patch that allows for intradermal delivery. The second is a dry blood spot and whole blood sampling patches that allows for a wide variety of lab-based and genomic testing. The third is consumer-based diagnostic patch. About Institut Pasteur de Dakar The Institut Pasteur de Dakar (IPD) is a non-profit public interest foundation located in Senegal with the mission to advance public health in Senegal and Africa by conducting research, providing training and education, sharing scientific knowledge, and advancing vaccine production. Since its founding in 1896, IPD has been at the forefront of the fight against infectious diseases in West Africa. IPD is one of the four WHO prequalified manufacturers for yellow fever vaccine.

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PHARMACY MARKET

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Astellas Pharma Inc. | September 05, 2022

Astellas Pharma Inc. announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause. MOONLIGHT 3 is a 52-week single-arm Phase 3 clinical trial investigating the long-term safety and tolerability of fezolinetant 30 mg taken once daily in 150 women in mainland China seeking treatment for relief of VMS associated with menopause. The study's primary endpoint is the frequency and severity of adverse events which were generally consistent with previous Phase 3 studies of fezolinetant. Detailed results will be submitted for publication in the near future. "The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant. We are evaluating the full MOONLIGHT data sets and remain committed to developing innovative treatments in this therapeutic area with the hope of delivering a first-in-class, nonhormonal treatment option for women with moderate to severe VMS." Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas Fezolinetant is an investigational selective neurokinin-3 receptor antagonist and is not approved anywhere in the world. In the U.S., a New Drug Application for fezolinetant for the treatment of moderate to severe VMS associated with menopause is under review. The NDA submission is based on results from two pivotal Phase 3 clinical trials, SKYLIGHT 1™ and SKYLIGHT 2™, and the Phase 3 long-term safety study, SKYLIGHT 4™. About the MOONLIGHT Phase 3 Clinical Trials MOONLIGHT 1™ is designed to investigate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause in women in Asia. The study is double-blinded and placebo-controlled for the first 12 weeks, followed by a 12-week non-controlled extension treatment period. A total of 302 women with moderate to severe VMS associated with menopause were enrolled at nearly 60 sites in mainland China, Korea and Taiwan. MOONLIGHT 3™ is a 52-week single-arm Phase 3 clinical trial designed to investigate the long-term safety and tolerability of fezolinetant in women in mainland China with VMS associated with menopause. A total of 150 women were enrolled at 34 sites in mainland China. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ and SKYLIGHT 2™ enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About VMS Associated with Menopause VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.1,2 Worldwide, more than 50% of women 40 to 64 years of age experience VMS and, in East Asia, the prevalence of VMS has been estimated to be around 80% of women 40 to 65 years of age, with 55% having moderate to severe VMS.3,4 VMS can have a disruptive impact on women's daily activities and overall quality of life.1 About Fezolinetant Fezolinetant is an investigational oral, nonhormonal therapy in clinical development for the treatment of moderate to severe VMS associated with menopause. Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to moderate neuronal activity in the thermoregulatory center of the brain (the hypothalamus) to reduce the frequency and severity of moderate to severe VMS associated with menopause.5,6,7 The safety and efficacy of fezolinetant are under investigation and have not been established. There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.

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PHARMA TECH

ArisGlobal's LifeSphere Regulatory IDMP Product Leader Invited to Chair American National Standards Institute Global MPID Project

ArisGlobal | August 23, 2022

ArisGlobal, the leading provider of life sciences software that automates core drug development functions with its end-to-end technology platform LifeSphere®, today recognizes and applauds the accomplishments of their LifeSphere® Regulatory IDMP product leader, Robin Schilling, for her acceptance into American National Standards Institute (ANSI) and the nonprofit's specific ISO Health Informatics Technical Committee, Working Group 6, which helps develop standardizations for Pharmacy and Medicines Business. ANSI is a private non-profit organization that oversees the development of voluntary consensus standards for products, services, processes, systems, and personnel in the United States. Schilling is the product owner of LifeSphere IDMP, a solution recognized by analyst group Gens & Associates as leading in IDMP Readiness. Schilling's work with ANSI Working Group 6 will include chairing a committee to lead the effort in developing a global Medicinal Product ID under the IDMP umbrella to help improve the efficiency and resilience of the supply chain. IDMP is scheduled to go live in the European Union (EU). The regulation pertains to all companies who are doing business within the EU, not just those who are based there. Both the work being done by ANSI and the EMA will help improve drug and patient safety, while encouraging a global dialogue around drug development. "It is in incredible honor to be a part of the American National Standards Institute and Working Group 6," shares Schilling. "Having a seat at the table to discuss these core, pressing matters in R&D will help improve drug safety, reduce drug shortages, and mitigate supply chain risks by allowing manufactured products and ingredients to be tracked down to the lot level. It's a tremendous move in the right direction and towards continued, growing regulation that keeps patient safety at the center of medicinal products." "Our people are at the heart and soul of what we do, so to have an organization like ANSI recognize the talent and impact Robin Schilling has in the standards and regulations space is well-deserved and commendable. Robin is an excellent example of the incredible talent we have at ArisGlobal. She is a leader on our Regulatory team and has such a robust professional background, we are confident she will do great things and continue to make an impact in our organization and beyond." Clint Wolfe, Chief Human Resource Officer at ArisGlobal About ArisGlobal ArisGlobal is transforming the way today's most successful Life Sciences companies develop breakthroughs and bring new products to market. Our end-to-end drug development technology platform, LifeSphere®, integrates our proprietary cognitive computing engine to automate all core functions of the drug development lifecycle. Designed with deep expertise and a long-term perspective that spans more than 30 years, LifeSphere® is a unified platform that boosts efficiency, ensures compliance, delivers actionable insights, and lowers total cost of ownership through multi-tenant SaaS architecture. About LifeSphere® LifeSphere is the trusted partner for global pharmaceutical and biotechnology companies, health authorities, and contract research organizations. Helping accelerate product development, organize clinical trials, manage compliance, and streamline collaboration across teams, LifeSphere empowers safer, faster life science breakthroughs. As the flagship product of ArisGlobal, LifeSphere is a market-leading solution built on 40 years of industry partnership and continues to evolve in collaboration with hundreds of trusted customers.

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BUSINESS INSIGHTS

PCI Pharma Services Selects Thoughtworks for Digital Platform Transformation with Agile Approach

Thoughtworks | July 11, 2022

Thoughtworks a global technology consultancy that integrates strategy, design and engineering to drive digital innovation, today announced the signing of a multi-year agreement with PCI Pharma Services, a leading global contract development and manufacturing organization. Thoughtworks will help PCI in its journey to digitize its supply chain, with the goal of accelerating the time it takes to bring clients’ life-changing therapies to market for patients. By co-developing tools for digital business modernization, Thoughtworks will help PCI improve client visibility into its clinical and commercial drug supply chains for pharmaceutical and biotech companies of all sizes in 100+ countries. By digitizing the supply chain, Thoughtworks will help PCI deliver greater insights to clients to increase their overall efficiency, support their business goals and ultimately produce high quality treatments for patients. The agreement includes expanding and adapting pci | bridge, an industry first-of-its-kind, end-to-end data platform that provides real-time status of projects, automatically identifies risks, spots trends and provides business analytics insights. With this modern application programming interface (API), clients have the ability to seamlessly integrate their systems with PCI’s, creating greater transparency and a more simplified process for decision-making. “Digital transformation has been a key differentiating factor for PCI’s business strategy, and the evolution of pci | bridge will be critical to increasing client engagement and maximizing the value of data and analytics for PCI and our external partners. With Thoughtworks’ 28+ years of experience at the forefront of innovation, we look forward to making our clients’ lives easier through this partnership." Wayne Hull, Chief Digital and Technology Officer, PCI Pharma Services With a shared commitment to customer-centricity, the Thoughtworks and PCI product and engineering teams will create a new level of intuitive self-service solutions for clients. The partnership will also simplify the collection and analysis of information to reach business insights faster and streamline processes to develop useful new products for clients. The teams will do this by working side-by-side using agile development methods, including pair programming, test-driven development and continuous integration/continuous delivery (CI/CD) automation. “Recognized as a leader in global CDMO services, PCI Pharma Services is well on its digital transformation journey, providing clients with sophisticated supply chain solutions and a digitally integrated experience unlike anything else in the industry,” said Chris Murphy, Chief Executive Officer, Thoughtworks North America. “We are thrilled to partner with PCI Pharma Services as it empowers its clients to make even more powerful, life-impacting decisions through their expansive data and analytics ecosystems.” About PCI Pharma Services PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries and over 4,300 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives. For more information, please visit pci.com About Thoughtworks Thoughtworks is a global technology consultancy that integrates strategy, design and engineering to drive digital innovation. We are 11,000+ people strong across 49 offices in 17 countries. Over the last 25+ years, we’ve delivered extraordinary impact together with our clients by helping them solve complex business problems with technology as the differentiator.

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Spotlight

This paper, authored by Alireza Shabani, Founder & CEO of Qulab, describes the necessary computational architecture for pharmaceutical firms to accelerate R&D and drug discovery, especially utilizing special purpose silicon and quantum processors.

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