PBOS | September 30, 2022
Kubota Vision Inc. a clinical-stage specialty ophthalmology company and a wholly-owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. announced today that the Company and Joslin Diabetes Center have entered into a material transfer and collaboration agreement for our Patient Based Ophthalmology Suite in-home optical coherence tomography device.
Joslin Diabetes Center is conducting two clinical studies to evaluate the ability of PBOS to identify cases of diabetic macular edema that may need treatment compared to a commercially-available OCT device. The studies will be led by Dr. Paolo S. Silva at Joslin Diabetes Center. Dr. Silva is the Co-Chief of Telemedicine at the Beetham Eye Institute of the Joslin Diabetes Center. His work is focused on innovative and investigative work in a field at the intersection of clinical care and technology with the hope of providing an ideal model for the delivery of evidence-based, highly effective, and efficient diabetes eye care to the population that needs it the most.
Joslin Diabetes Center, which is affiliated with Harvard Medical School, is a one-of-a-kind institution on the front lines of the world epidemic of diabetes — leading the battle to conquer diabetes in all of its forms through cutting-edge research and innovative approaches to clinical care and education.
Dr. Silva stated, “Through these studies, we will determine if home-based in-home optical coherence tomography is useful in the evaluation of diabetic macular edema and how we monitor patients at risk for losing vision from the condition.”
“Diabetic retinopathy is one of the most common diseases in the world. The use of our technology brings us great excitement as we continue to focus on the development of medical devices and explore further possibilities.”
Ryo Kubota, MD, PhD, Chairman, President, and CEO of Kubota Vision Inc.
PBOS is a low cost, home-based, ophthalmic self-monitoring OCT device. This small handheld device addresses needs in mobile Health applications for self-monitoring of retina health by patients, in the home and in remote field locations. The PBOS aims to improve ophthalmic treatment outcomes in patients diagnosed with and treated for wet age-related macular degeneration, diabetic macular edema and other neovascular retinal diseases. PBOS is being designed to detect nascent disease progression and support patient re-treatment prior to irreversible vision loss due to disease progression. Key features are low cost and a patient-friendly design, to be used directly by patients at home. PBOS is being designed to capture changes in retinal anatomy. Network connectivity and cloud-based technologies are used to alert the patients and their physicians of disease progression and re-treatment needs.
About Kubota Vision Inc.
Kubota Vision Inc. is a wholly owned subsidiary of Kubota Pharmaceutical Holdings Co., Ltd. committed to translating innovation into a diverse portfolio of drugs and devices to preserve and restore vision for millions of people worldwide. Kubota Pharmaceutical group’s pipeline includes a wearable device for myopia control using Kubota GlassTM technology and a handheld OCT device for the monitoring of neovascular retinal diseases, to be used directly by patients.
Cellusion and Celregen | September 12, 2022
Cellusion Inc. a Japanese regenerative medicine startup aiming to solve the global corneal transplant waiting list problem with a unique differentiation induction method from iPS cells to Corneal Endothelial Cell Substitute from iPS Cells for bullous keratopathy novel treatment and Hangzhou Celregen Therapeutics Ltd. a member of Shanghai Fosun Pharmaceutical Co., Ltd. and focus on regenerative medicine and cell therapy and incubated by New Drug Fund of Fosun Health Capital announced an exclusive license agreement in the Greater China region for Celregen to develop, manufacture and commercialize CLS001.
Under the Agreement, Celregen will have the exclusive right to develop, manufacture and commercialize CLS001 for bullous keratopathy in the Greater China region, including Mainland China, Hong Kong, Macau and Taiwan. On the other hand, Cellusion retains the rights of development, manufacturing and commercialization of CLS001 in other regions including Japan, the USA, and EU.
Under the terms of the agreement, Cellusion will potentially receive over 100 million US dollars including upfront payment, development milestones and sales milestones as well as tiered royalties.
“We are very enthusiastic about combining our knowledge of the underlying iPS cellular biology with Celregen and Fosun Pharma in the development and commercialization of innovative medicine in China. Together, we are committed to make best efforts on launching CLS001 for the patient suffering from bullous keratopathy due to the cornea donor shortage in the greater China region.”
Shin Hatou, M.D. Ph.D., CEO of Cellusion
“Today’s announcement with a global industry leader in iPS cells derived corneal endothelial regenerative therapy such as Cellusion, is an important and strategic step to build a long-term foundation for cell therapy in China,” said Cui Zhiping, the Chairman of Celregen, Fosun Global Partner, Chief Consultant of VC investment of Fosun Pharma and CEO of Fosun New Drug Fund. “This partnership, which leverages each company’s respective strengths, will help us bring novel regenerative medicine products to patients in greater China.”
According to reports, there are about millions of people in China who are blind due to corneal diseases, and this number is increasing at a rate of 100,000 per year. Most of the patients with corneal blindness need corneal transplantation to restore their sight, but only less than 20,000 corneal transplants are conducted due to severe donor cornea shortage issues.
Cellusion has already announced that the patient recruitment began for the First-in-Human Investigator-Initiated Study of CLS001 to initiate in 2022 at the Keio University Hospital and has been preparing to start Cellusion initiated clinical trial in Japan within a few years followed by global studies in the US and EU region.
Cellusion is developing CLS001, CECSi cells for Corneal Endothelial regeneration to cure Bullous Keratopathy which is applied to more than half of all cases of corneal transplantation. CLS001 is expected to replace the current supply limitations by combining “CECSi Cells made from iPS cells with excellent proliferative properties” and “a simple injection cell delivery procedure without needs of human expertise.”
Celregen, incubated by New Drug Fund of Fosun Health Capital, focuses on stem cell and transformed cellular regenerative medicine. This platform adopts a variety of modes of cooperation with leading biotech and scientists. It is expected to be a head biotech in regenerative medicine in China.
About Fosun Pharma
Founded in 1994, Fosun Pharma is a global innovation-driven pharmaceutical and healthcare industry group deep-rooted in China. Fosun Pharma directly operates businesses including pharmaceutical manufacturing, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company enriches its innovative product pipeline through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma has formed technological platforms for innovative small molecule drugs, antibody drugs, and cell therapy with a focus on key disease areas including oncology and immunomodulation, metabolism and digestive system, and central nervous system.
About Fosun New Drug Fund
New Drug Fund, under the management of Fosun Health Capital, is the first VC established by Fosun Pharma. The Fund focuses on innovative biopharmaceutical-based drug fields at the start-up and expansion stages, including gene therapy, cell therapy, bio-conjugate drugs, and medical aesthetics, etc. The Fund has committed to incubate cutting-edging science and revolutionary technologies from world top universities, research institutes and biotech, through which path we can establish and adopt a variety of models of cooperation.
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
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.
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.