Commonwealth Informatics, a Genpact company | January 25, 2022
Commonwealth Informatics, an independently-operated subsidiary of Genpact, and leading technology and services company with industry expertise in medical product safety and public health surveillance, today announced that it has expanded its relationship with the Medicines and Healthcare products Regulatory Agency, a medical regulatory body for the United Kingdom.
MHRA has selected Commonwealth Informatics' state-of-the-art signal detection and signal management solution, Commonwealth Vigilance Workbench (CVW), to support the MHRA transformation of safety monitoring through a single integrated platform across all medicines, vaccines, blood components and devices.
"The MHRA is looking to transform our vigilance services through new ways of working, underpinned by the technology we use and how we operate our services. We see our partnership with CVW enabling us to deliver a more responsive safety surveillance system through innovative technology."
Mick Foy, Head of Pharmacovigilance Strategy at MHRA
"We are delighted to have the opportunity to build on our longstanding research collaboration with the MHRA and deliver future value through greater efficiencies within signal detection," said Bill Blackwell, Commonwealth VP Safety Science Solutions. "The collaborative partnership will enable us, together with the MHRA, to bring new innovative methodologies to safety surveillance on behalf of patients."
Commonwealth's solution will be implemented to perform signal detection and signal management across multiple data sources leveraging advanced automation, such as artificial intelligence, to ensure more accurate multivigilance analysis and processing. CVW is an integrated cloud-based signal management system supporting the detection, tracking and refinement of safety signals using evidence across multiple data sources.
The MHRA is deploying Insife's HALOPV solution for case processing management, advanced automation, and real-time reporting and analytics. Commonwealth Informatics has partnered with Insife, to integrate CVW with HALOPV and to collaboratively deploy the end-to-end multi-vigilance platform in Q2 2022. Insife, headquartered in Denmark, offers specialist consulting services in multivigilance (Medicines and Devices), Regulatory Affairs (RA), and Information Technology (IT) implementation. Insife's services are based on expertise across the life sciences value chain with an understanding of digital transformation and drug safety assurance through process optimisation and automation.
About Commonwealth Informatics
Commonwealth Informatics is a technology and services company with industry expertise in medical product safety and public health surveillance. Pharmaceutical and biotechnology companies, government agencies, and healthcare providers use Commonwealth's products and services to assemble relevant data and answer complex clinical and safety analysis questions quickly and accurately. Commonwealth is an independently-operated subsidiary of Genpact, a global professional services firm focused on delivering digital transformation.
About Medicines and Healthcare products Regulatory Agency
MHRA, based in London, is an executive agency sponsored by the Department of Health and Social Care, that regulates medicines, medical devices and blood components for transfusion in the United Kingdom. Recognised globally as an authority in its field, the agency plays a leading role in protecting and improving public health and supports innovation through scientific research and development.
Foresee Pharmaceuticals Co., Ltd | February 24, 2022
Foresee Pharmaceuticals Co., Ltd. a Taiwan and US-based biopharmaceutical company and TRPharm, a leading Turkish healthcare company, announced today that they have entered into an exclusive license agreement for the co-development and commercialisation in Turkey and certain MENA countries of Foresee's FP-045 program, an oral allosteric Aldehyde Dehydrogenase 2 (ALDH2) activator for the treatment of Fanconi Anemia and other rare and severe diseases. Under the terms of this partnership, Foresee and TRPharm will collaborate to initially expedite the development of FP-045 in Fanconi Anemia. Turkey and the surrounding region has a high prevalence Fanconi Anemia as well as other rare diseases. Foresee will own all development data which will be used as part of its global development and registration dossier. Upon approval and commercialization in the territory, Foresee will receive significant royalties from the revenue in the territory. TRPharm will have exclusive rights to register and commercialize in the territory and will cover all related costs.
"We are very pleased to have established this collaboration with TRPharm, whose established track record of successful development, registrations and launches of rare disease products, including in hematology, makes us confident that they will make a remarkable partner for our FP-045 program. This is our second partnership with TRPharm and we look forward to continuing working together."
Dr. Ben Chien, Founder, Chairman and CEO of Foresee
İsmet Ince, General Manager of TRPharm, commented "Our purpose in TRPharm is to be the platform where health meets innovative solutions and I can think of no better example for it than this collaboration on FP-045 with Foresee. We are thrilled to have this opportunity to blaze a trail in Fanconi Anemia, which has a particularly high prevalence in our core regions, and provide relief to the patients with significant unmet need. It is an even greater pleasure to be doing this with Foresee, an esteemed international biopharmaceutical company with whom we share common views and a history of productive partnership. This collaboration also marks a step change in our R&D approach and is the culmination of a unique set of capabilities which we have developed over many years. We are confident that they will contribute materially to making this collaboration a rapid success."
About Foresee Pharmaceuticals Co. Ltd.
Foresee is a Taiwan and US-based biopharmaceutical company listed on the Taipei Exchange (6576.TWO). Foresee's R&D efforts are focused in two key areas, namely its unique stabilized injectable formulation (SIF) depot delivery technology with derived drug products targeting specialty markets, and secondly its transformative preclinical and clinical first-in-class NCE programs targeting rare and severe disease areas with high unmet needs. Foresee's product portfolio includes late stage and early stage programs. CAMCEVI® 42 mg is now approved in the U.S. and under regulatory review in the EU. Additionally, U.S. and EU regulatory submissions are in preparation for CAMCEVI® 21 mg. FP-025 – a highly selective oral MMP-12 inhibitor targeting inflammatory and fibrotic diseases, currently in Phase 2/3 studies, including a Phase 2/3 study for COVID-19 virus-induced acute respiratory distress syndrome (ARDS). FP-045 – a highly selective oral small molecule allosteric activator of ALDH2, a mitochondrial enzyme, for which a Phase 1b/2 study is currently planned for Fanconi Anemia.
Conducting its activities with the vision of becoming a global and innovative healthcare company, TRPharm plays a leading role in Turkey & MENA and the neighboring regions thanks to its unique business model and emphasis on intellectual capital. Aiming at making its presence felt in every field with unmet healthcare needs, TRPharm focuses on enabling innovative healthcare solutions for the patients. It does so by leveraging its extensive experience at every stage, from development to commercialization, with extraordinary results. TRPharm has an extensive product portfolio in oncology/hematology, neurology, immunology and rare diseases.
Resilience | February 16, 2022
National Resilience, Inc. a technology-focused manufacturing company dedicated to broadening access to complex medicines, announced a manufacturing services agreement with Takeda’s Plasma-Derived Therapies Business Unit.
As part of the agreement, Resilience will focus on supporting the development and manufacture of multiple products in Takeda’s plasma-derived medicines portfolio out of its facility in Mississauga, Ontario.
“I’m proud to establish this relationship with Takeda, a company that has been pioneering plasma-derived therapies for more than 75 years. By bringing new technologies and innovation to biomanufacturing, we aim to help companies like Takeda reach more patients in need.”
Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience
Resilience’s 136,000 sq ft (12,800 m2) biomanufacturing facility in Mississauga provides process and analytical development, scale up, drug substance and drug product / fill finish manufacturing for a variety of medicines.
“We are delighted to form this strategic collaboration with Resilience, leveraging their expertise in both plasma therapy development and manufacturing to complement our current infrastructure and capabilities,” said Andreas Liebminger, Head of Pharmaceutical Sciences and Devices for the Plasma-Derived Therapies Business Unit at Takeda. “Our partnership will allow us to optimally use our combined assets to continue to bolster our portfolio, drive innovation and help more patients around the world realize the benefits of plasma medicines.”
Resilience is a technology-focused manufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the medicines of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives.