Kedrion Biopharma | October 19, 2021
Kedrion Biopharma, the rapidly growing international biopharmaceuticals company that produces and distributes plasma-derived treatments for rare diseases, has announced that it has completed the acquisition in North America of the Prometic life sciences business.
Prometic, which has a team of 130 employees in Laval, Québec, has developed the first ever FDA-approved treatment for Congenital Plasminogen Deficiency. The new drug, called Ryplazim®, , has been approved for the treatment of all the clinical manifestations of Plasminogen Deficiency, which can lead to blindness, respiratory failure and other severe complications.
The company is now working toward a launch in the United States in early 2022.
"We are very pleased to have completed this important and strategic acquisition, which will bring badly needed therapies to patients who suffer from this rare disease,"
- Paolo Marcucci, Chairman of Kedrion Biopharma.
With the acquisition of Prometic BioTherapeutics Inc., Kedrion has finalized a series of transactions that began last June with the announcement that it was acquiring from the Nasdaq-quoted Liminal Biosciences Inc. the plasma purification plant at Laval in Quebec, and the license to distribute the new product in the United States.
"Ryplazim is very significant because it really allows us to fulfil our mission of putting patients first. This is the first drug to ever be approved by the FDA for the treatment of the rare Congenital Plasminogen Deficiency, Type 1, so we are very honored to help speed the product to market."
- Val Romberg, Kedrion's CEO
Trial Interactive | November 12, 2021
TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, announced the release of the Trial Interactive (TI) Clinical Trial Management System (CTMS). This release marks the industry's only mobile-first CTMS, placing important actions and information at the fingertips of study managers and CRAs and supporting a full author-to-archive process.
Trial Interactive delivers user-friendly document and trial management solutions to help pharmaceutical, biotechnology, medical device, and contract research organizations (CROs) effectively streamline product development life cycles. The platform improves speed, quality, and compliance across site identification, site feasibility, study start-up, site personnel training, regulated content management, eISF, and eTMF management. The addition of TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record. A fully connected solution, Trial Interactive offers fast-to-implement and cost-effective solutions in a secure 21 CFR Part 11-compliant environment.
Designed by clinical professionals for clinical professionals, TI CTMS benefits include
World-Class User Experience – The time-saving and pain-free mobile-first interface, with full-text and segmented metadata search, flexible filtering and exports, dark mode, and one-click navigation, creates the industry's friendliest user experience.
By Clinical, for Clinical – Enjoy greater efficiency without the hassle, and get started quickly with no heavy configuration required and best practices built into the default configuration.
True SaaS Solution – TI CTMS is a single-study or enterprise SaaS solution developed by experts. TransPerfect's award-winning service teams support rapid implementation plans with full validation.
Enterprise Ready – With the flexibility to align with large-scale operations, TI CTMS enables enterprises with complex study teams to easily update the system to meet unique requirements and have access to a comprehensive web services API supporting third-party integrations.
Author-to-Archive Platform – Streamline processes and oversight with content management solutions supporting the workflow of documents across the life cycle from site and study personnel to the eTMF in one seamless process.
As clinical operations become more decentralized, TI CTMS continues Trial Interactive's mission of providing practical innovation to improve the efficiency of global clinical processes while reducing costs.
"Having consulted with many organizations and colleagues over the years about CTMS, we've recognized common challenges like time-consuming configurations, difficult navigation, and user experiences that are clearly developed without the input of clinical operations experts. The end result is that existing platforms have fallen short of the features that study managers and CRAs really needTI CTMS was built by clinical professionals for clinical professionals and cuts configuration times while delivering powerful capabilities in a clean user experience that perfectly addresses the needs of sponsors and CROs."
Michael Smyth, Division President of TransPerfect Life Sciences
TransPerfect President and CEO Phil Shawe stated, "The launch of TI CTMS comes at a time when conducting remote and decentralized clinical trials is more important than ever. The CTMS is connected to our eTMF and other platform solutions to deliver a mobile-first experience that ensures study teams can work effectively and at scale from any location."
About Trial Interactive
TransPerfect's Trial Interactive is an industry leader in practical eClinical innovation that simplifies and automates clinical processes for sponsors, CROs, and sites around the world. The 21 CFR part 11 compliant unified platform delivers an author to archive collaboration experience with solutions for clinical document management, site selection, site activation, eLearning, compliance training, quality, and more with seamless solution interoperability and indexing to the eTMF. Trial Interactive is consistently selected by clinical professionals for providing the most comprehensive yet intuitive experience with the most complete offering of technology and expert TMF services. Trial Interactive helps study teams streamline their operations by cutting unnecessary expenses, expediting timelines, reducing compliance risks, and improving operational excellence.
About TransPerfect Life Sciences
TransPerfect Life Sciences specializes in supporting global development and commercialization of drugs, treatments, and devices designed to improve and save lives. Our comprehensive solutions include eTMF and eClinical technologies, paper TMF migration, pharmacovigilance and safety solutions, translation and language services, and call center support. With offices in over 100 cities worldwide, TransPerfect is the ideal partner to ensure that your global launch makes a global impact.
TransPerfect is the world's largest provider of language and technology solutions for global business. From offices in over 100+ cities on six continents, TransPerfect offers a full range of services in 170+ languages to clients worldwide. More than 5,000 global organizations employ TransPerfect's GlobalLink® technology to simplify management of multilingual content. With an unparalleled commitment to quality and client service, TransPerfect is fully ISO 9001 and ISO 17100 certified. TransPerfect has global headquarters in New York, with regional headquarters in London and Hong Kong.
Sensyne Health, Phesi | May 24, 2021
Sensyne Health plc, the Clinical AI company, today announced that it has entered a joint commercial clinical development partnership in an undisclosed disease area with a major pharmaceutical company that is an existing client of Phesi with its U.S.-based strategic partner Phesi Inc.
Sensyne and Phesi have entered into a joint commercial collaboration with a pharmaceutical customer for the first time since forming a strategic alliance in January 2021. The development work will consist of comparing anonymized and de-identified real-world patient data available to Sensyne with Phesi's clinical trial data to optimize the design of a clinical trial program for the client.
This collaboration's financial terms have not been disclosed.
About Sensyne – Phesi Strategic Alliance
Sensyne and Phesi decided to partner on an exclusive basis to offer synthetic clinical trial arms and clinical decision support tools that combine clinical trial data with real-world patient data under the terms of the strategic partnership arrangement. Many of the world's leading pharmaceutical and biotechnology companies are among Phesi's clients.
About Sensyne Health
Sensyne Health plc is a clinical artificial intelligence company with a unique business model – a for-profit plc with a positive social impact that shares its financial returns with health systems. Clinical AI is used by the company in the healthcare and life science industries. Sensyne provides remote patient monitoring and real-time decision-making services of healthcare for medical institutions and their patients. Sensyne analyses large complex anonymized data sets in life sciences to assist life sciences companies in accelerating the development of new medicines.
About Phesi Inc.
Phesi is a profitable, privately held company headquartered in Connecticut, United States. The goal of the organization is to enable data-driven drug development and commercialization through predictive analytics powered by patient-centric data science. Phesi's integrated offerings include the entire clinical development process, from development planning and indication evaluation to protocol evaluation and design (including a synthetic control arm), site selection, and trial implementation management. The company works with life science companies to deliver novel therapies quicker and at a lower cost, including all stages of clinical development and a wide range of indications, including rare diseases.