CVS head of specialty pharmacy sees future of healthcare at home after Covid-19

Medcity news | May 26, 2020

Mail-order prescriptions are nothing new, but pharmacists have turned to a number of other tools to help patients access their prescriptions during the Covid-19 pandemic.  The head of CVS Health’s specialty pharmacy strategy, Prem Shah, said he expects to see more patients continue receive healthcare at home after the pandemic ends. Though CVS Health had been building up its arsenal of digital tools before the Covid-19 pandemic, stay-at-home orders forced the pharmacy giant to lean more on them. The company has seen a surge in the use of its support services since the beginning of March.

Spotlight

Expiring patterns and growing pressure from authorities to reduce drug prices are testing pharma industry. Digital transformation is the avenue which will help companies succeed in mitigating these challenges. Digital transformation provides keys to unlocking the patient access and interaction challenges.

Spotlight

Expiring patterns and growing pressure from authorities to reduce drug prices are testing pharma industry. Digital transformation is the avenue which will help companies succeed in mitigating these challenges. Digital transformation provides keys to unlocking the patient access and interaction challenges.

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PHARMA TECH

Innovation Zed Announce 2022 Launch of InsulCheck DOSE Add-on Technology for Insulin Pens

Zed | November 15, 2021

Innovation Zed, developer of novel diabetes management technologies headquartered at NovaUCD, at University College Dublin, Ireland are delighted to announce today the arrival of the much anticipated InsulCheck DOSE technology that will be coming to market in 2022. "It is with great excitement that we announce the arrival of our InsulCheck DOSE by Innovation Zed. As the third generation product of the InsulCheck family, this technology has been a dream of our company from its very inception and this product is the culmination of over a decade of work to support multiple daily injection (MDI) pen users. We understood the difficult challenges presented by various injection pens and in particular the difficulties in working on a technology to reliably and accurately support low-cost disposable pens. This is the reason we at Innovation Zed took an incremental approach to developing the InsulCheck DOSE product.We have taken a unique approach in developing this technology by working closely with users, caregivers, software developers, medical device specialists and previous generations of InsulCheck products to design and develop a product that bolsters and supports the needs of all stakeholders.'' Dr Dean Minnock, CEO at Innovation Zed Innovation Zed has collaborated with SHL Medical in the development of InsulCheck DOSE. SHL Medical is a world-leading provider of drug delivery solutions and also offers design-to-build and contract manufacturing services for various medical products through its subsidiary, SHL Technologies. What is InsulCheck DOSE? InsulCheck DOSE is a single unit add-on device for pen injectors that automatically captures dose value dialled, injection event time stamp, temperature and mounting/unmounting events. Through Bluetooth® Low Energy (BLE) technology, InsulCheck DOSE transmits these data points to a paired companion software platform in real time for inclusion in diabetes management therapy. "InsulCheck DOSE technology supports MDI users by enhancing their traditional injection pen and transforming it into a smart pen that can optimise their treatment and reduce the stresses caused by MDI therapy. Through this technology we are enabling every MDI user to make their existing injection pen a smart pen without having to compromise or change from their existing HMO or health service provider" - said Dr Minnock. InsulCheck DOSE Features The technology utilises a multi-sensor approach to accurately detect and register the actual dosage dialled and provide an injection event time stamp to log the event. The incorporated temperature sensors constantly monitor the ambient temperature of the area surrounding the injection pen, providing safety notifications to the user if the surrounding temperature may affect the drug housed inside the pen. Using an OLED display, InsulCheck DOSE provides visual information and feedback to the user, helping improve best practice procedures. A rechargeable lithium battery powers the DOSE device and is capable of operating well over 1 week at a time between charges. As a BLE enabled product, all data captured by InsulCheck DOSE is transferred in real time to a paired mobile application. If the user does not wish or is unable to remain connected with a companion software platform, InsulCheck DOSE has built-in memory to store over 40 days' worth of injection history at a time. Through modification of the sleeve component and firmware refinement, InsulCheck DOSE can become applicable to all injection pens for various drug treatments. At launch, it will support a range of reusable and disposable injection pens on the insulin market from Novo Nordisk, Lilly and Sanofi. "Our ability to learn, adapt and improve our technology is one of the key aspects of InsulCheck DOSE and one that separates us greatly from our competitors. The future-proof design of InsulCheck DOSE means that it can be adapted to support the various pen mechanisms in use today, whilst maintaining accuracy and reliability for the patient. Among the numerous unique features of this product is the built in Firmware Over The Air (FOTA) capability which allows continuous optimisation of the device's firmware even when deployed in the field. That future-proofing allows InsulCheck DOSE to adapt to physical injection pen variations from the pen manufacturers and improve on device performance 'on the go' from real world user behaviours" - said Dr Minnock. Value Proposition The InsulCheck DOSE device helps patients, automatically track their daily injection and monitor treatment adherence. The intended use of InsulCheck DOSE is as a supporting component in a management ecosystem for therapy optimisation, remote monitoring and enhanced connected care. Dr Minnock explained, "InsulCheck DOSE is a disruptive technology that will revolutionise an entire market and change the lives of millions of MDI users worldwide. Innovation Zed have entered into discussions with market leaders in the diabetes management sector with the intention of finding a strategic global partner in taking this InsulCheck DOSE technology to the market. InsulCheck DOSE is an attractive offering to any organisation working in this space as it can significantly enhance their existing offering to become more competitive and command new growth and additional market share." Conclusion InsulCheck DOSE enters production at the end of Q2 2022 and will be available as an FDA registered and CE marked product. Manufacturing of InsulCheck DOSE will be handled by Innovation Zed's existing manufacturing partner SHL Technologies, a subsidiary of SHL Medical. If you wish to understand InsulCheck DOSE or any of our technology offerings in greater detail, please feel free to visit our website or reach out to us directly.

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PHARMA TECH

Phanes Therapeutics reveals SPECpair™ technology platform that enhances manufacturability of bispecific antibodies

Phanes Therapeutics | September 13, 2021

Phanes Therapeutics, Inc., an emerging leader in innovative drug discovery research and development in immuno-oncology announced today that it has developed a proprietary technology platform, SPECpair™, which enables the use of the conventional monoclonal antibody (mAb) manufacturing process in the production of native IgG-like bispecific antibodies. This is the third technology platform Phanes has developed since the launch of the PACbody™ and ATACCbody™ platforms, which are designed to construct bispecific antibodies with native IgG-like structures and modulated activities, respectively. "SPECpair™ represents a milestone where we have brought our innovative research to the process development and manufacturing space. This technology solves a huge and common problem in manufacturing bispecific antibodies with native IgG-like structures," said Dr. Hui Zou, PhD, Chief Scientific Officer (CSO) of Phanes Therapeutics. "Phanes is an emerging leader in innovative drug research in biologics aimed at targeting various cancers. In the span of only a few years, we have built not only a differentiated pipeline but also three technology platforms. Our technology platforms solve important problems in both the research and manufacturing steps. I believe we are in a very strong position to leverage these technologies to advance our own pipeline and help advance the innovation of others in our industry," said Ming Wang, PhD/MBA, CEO of Phanes Therapeutics, "At Phanes, our mission is to become a source of innovation in the biopharma industry and we are fully committed to expanding the reach of our innovation by building partnerships with various pharma and biotech companies."

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PHARMACY MARKET

Takeda is poised to commercialize next generation Hunter's disease therapy through collaboration with JCR Pharmaceuticals

Takeda Pharmaceutical Company Limited | October 01, 2021

Takeda Pharmaceutical Company Limited and JCR Pharmaceuticals Co., Ltd. today announce a geographically focused exclusive collaboration and license agreement to commercialize JR-141, a recombinant fusion protein under development of a next-generation antibody against the human transferrin receptor and the enzyme iduronate- 2-sulfatase (IDS), used to treat Hunter's disease (also called mucopolysaccharidosis type II or MPS II). Hunter's disease is caused by the lack of IDS and manifests itself in different forms. Administered with J-Brain Cargo®, JCR's proprietary blood-brain barrier (BBB) ​​technology, the JR-141 was designed to deliver the therapeutic enzyme across the blood-brain barrier directly to the brain and somatic and address neuronopathic manifestations of the disease, Under the exclusive collaboration and license agreement, Takeda will exclusively market the JR-141 outside of the United States, including Canada, Europe, and other regions (excluding Japan and certain other Asia Pacific countries). JCR will receive an upfront payment for the ex-US license and is eligible to receive additional development measures and commercial milestones as well as multi-tier royalties on potential product sales. Both companies will work together to provide this form of therapy to patients as soon as possible after the completion of the global Phase III program run by JCR. Takeda has an option under a separate option agreement that allows Takeda to acquire an exclusive license to commercialize JR-141 in the United States upon completion of the Phase III program. Takeda is committed to continuously improving the therapy it offers to treat Hunter's disease. JR-141 introduces a new way of delivering proteins by crossing the blood-brain barrier. This will overcome our current challenges in treating the underlying neuronopathic manifestations of Hunter's disease and help maintain or improve cognitive function in these patients, We will work closely with JCR to apply our expertise in enzyme replacement therapies with the hope of delivering this potentially transformative form of therapy to patients as soon as possible. - Dan Curran, MD, Head, Rare Genetics & Hematology Therapeutic Area Unit at Takeda. JR-141 met its primary endpoint in an open-label Phase II / III study in Japanand was able to show a significant reduction in heparan sulfate (HS) concentrations in the CSF. HS is a biomarker for assessing the effectiveness of the drug in reducing the disease-causing substrate in the central nervous system. This proof could be provided in all patients for whom measurements were available after 52 weeks of treatment. Somatic disease control was retained in patients switched from standard enzyme replacement therapy (ERT). The study also showed an improvement in somatic symptoms in participants who had not received standard ERT prior to the start of the study. In addition, an assessment of neurocognitive development in 21 of 25 patients at one year showed the maintenance or improvement of age-appropriate function.1 About JR-141 JR-141 is a recombinant fusion protein of an antibody against the human transferrin receptor and the enzyme iduronate-2-sulfatase. This enzyme is absent or defective in patients with Hunter's disease. It is expected to be effective against neuronopathic manifestations of the disease by crossing the blood-brain barrier (BBB) ​​through transferrin receptor-mediated transcytosis using J-Brain Cargo®, JCR's proprietary BBB technology. Uptake into the cells is mediated by the transferrin receptor and the mannose-6-phosphate receptor. JCR has driven development activities by allowing the company to maintain the necessary evidence from the molecular design phase through to the non-clinical and clinical study phases. In addition, JCR has confirmed that using J-Brain Cargo® technology, enzymes are absorbed into different brain tissues. A decrease in substrate accumulation could also be confirmed in an animal model of Hunter's disease. 2,3,4 In several clinical studies with JR-141, JCR was able to show a reduction in CSF heparan sulfate concentrations. This is a biomarker for assessing the effectiveness of drugs by reducing the disease-causing substrate in the central nervous system. This is done in accordance with the results obtained in non-clinical studies. JCR also produced clinical results that could show the positive effects of JR-141 on neurocognition. 5,6,7,8 JR-141 is approved by the Ministry of Health, Labor and Social Affairs and has been marketed under the brand name "IZCARGO® IV Infusion 10mg" since May 2021. About Hunter's Disease Hunter's disease is a severely debilitating, rare lysosomal disease caused by insufficient activity of the enzyme iduronate-2-sulfatase. This enzyme has the task of breaking down substances known as glycosaminoglycans (GAG) in the body. 9 The absence of this enzyme (GAG) can trigger a number of symptoms. 9,10 Around two in three people with Hunter's disease also experience progressive loss of cognitive function. 11 Hunter's disease affects 1 in 162,000 live births and almost exclusively male patients. 12th About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited is a global, values-based, leading group with a focus on research and development in the biopharmaceutical sector headquartered in Japan. His pursuit of life-changing treatments is shaped by his dedication to patients, people, and the planet. Takeda's research and development efforts focus on four therapeutic areas: Oncology, Rare Genetic Diseases and Hematology, Neuroscience and Gastroenterology (GI). We also invest parts of our research and development budget specifically in therapies with plasma derivatives and vaccines. We focus on developing highly innovative drugs that help improve people's quality of life. To this end, we are opening up new treatment options and using our improved, synergistic research area and our combined skills to create a robust pipeline based on different modalities. Our employees are committed to improving the quality of life for patients and work with our healthcare partners in around 80 countries and regions. About JCR Pharmaceuticals Co., Ltd. JCR Pharmaceuticals Co., Ltd. is a global specialty pharmaceutical company that is redefining expectations and expanding opportunities for those with rare hereditary diseases around the world. We continue to build on our 46 year tradition in Japan as we expand our presence in the United States, Europe and Latin America. We improve the lives of patients by applying our scientific expertise and unique technologies to research, develop and deliver next generation therapies. Our approved products in Japan include therapies for the treatment of stunted growth, Fabry disease, acute graft versus host disease and renal anemia. Our test products, which are being developed around the world, aim, among other things, at the treatment of rare diseases, including MPS I (Hurler's disease, Hurler-Scheie and Scheie syndrome), MPS II (Hunter's disease) and Pompe disease. JCR strives to expand the possibilities for patients as the company accelerates medical advancement on a global basis. Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we can reach greater heights. For more information, see Our core values ​​- reliability, trust and perseverance - benefit all those involved, including employees, partners and patients. Together we reach greater heights.

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