BUSINESS INSIGHTS, PHARMA TECH
Elligo Health Research | January 25, 2023
On January 24, 2023, Elligo Health Research®, the leading healthcare-enabling research organization, presented the DataAI Connect, a new data and technology platform that will facilitate data-driven, rapid clinical research. DataAI Connect, a scalable, end-to-end data platform, optimizes the clinical research workflow by decreasing human error and rapidly digesting patient data to speed up clinical studies.
Elligo has created an industry-first AI-driven platform that sources, processes, analyses, and distributes patient real-world data (RWD) by bringing together data, processes, and clinical expertise. That means an end-to-end solution that solves clinical trial issues directly rather than being an add-on technology. The platform is adaptable and reusable, and it includes the following
An RWD repository of electronic health records (EHRs) and clinical data storage that incorporates EHR, clinical trial, and patient data for analytics, artificial intelligence (AI), and research
A comprehensive medical records retrieval and analytics solution that transforms data into searchable, actionable insights and personalized patient journey information within minutes using NLP, ML, and clinical experience.
A data-driven protocol development service that puts designs to the test in the real world.
Elligo's Chief Data Officer, Michael Ibara, commented, "The application of AI approaches to healthcare and clinical study data is moving from the moon-shot approach to more practical applications." He added, "An example of this approach is the process of getting patients' medical records, which involves manual, non-scalable activities such as getting accurate information on patients' providers, asking sites to track down records, and having humans triage hundreds of pages of medical records. The judicious and intelligent application of natural language processing (NLP), machine learning (ML), and other AI approaches increases speed, accuracy and quality, while removing the burden from the sites and patients."
(Source – Business Wire)
About Elligo Health Research
Founded in 2016, Elligo Health Research® is a leading healthcare-enabling clinical research organization. With access to known patients and their HIPAA-compliant healthcare data, its IntElligo® Research Stack technology and eSolutions Research Accelerator PatientSelect approach expedite clinical trials through healthcare. Elligo's Site Solutions, combined with the largest Known Patient Access Network, enable healthcare practices and research sites to engage in clinical studies. Its services expedite the development of novel pharmaceutical, biotechnology, medical device, and diagnostic products through the adaptive involvement of known patients and clinicians.
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PHARMACY MARKET, PHARMA TECH
Jazz Pharmaceuticals plc and Zymeworks Inc. | December 28, 2022
Jazz Pharmaceuticals plc and Zymeworks Inc. recently informed that the former has chosen to keep its exclusive rights to develop and sell Zymeworks' Zanidatamab in key markets, such as the U.S., Europe, and Japan, as part of the license and collaboration agreement made in October 2022.
A pivotal trial in previously treated HER2-amplified biliary tract tumors (BTC) found that 41.3% (95% CI: 30.4, 52.8) of recruited patients with HER2-amplified and expressing (IHC2+ and 3+) illness achieved an objective response as judged by independent central review. The median response length was 12.9 months (95% CI: 5.95 to not attained). In this trial, Zanidatamab's safety profile was similar to what had been found in previous studies of monotherapy, while no new safety signals were found.
Jazz Pharmaceuticals stated that the compelling top-line clinical data from the pivotal study in patients with BTC demonstrated the transformative potential of Zanidatamab. This big win gives the company more confidence that it can make this medicine better for cancer patients who have big unmet needs. Even though its main focus will be on the ongoing clinical trials for BTC and GEA, these data will add to the growing amount of evidence that Zanidatamab is effective against a wide range of HER2-expressing cancers.
Zymeworks expressed that the collaboration with Jazz is going well, which will speed up the global development of Zanidatamab in many types of cancer and may give patients with hard-to-treat cancers and few treatment options access to a basic HER2-targeted drug.
Jazz will pay Zymeworks $325 million to exercise its option to develop and sell Zanidatamab in all countries except Asia-Pacific in the fourth quarter of 2022.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals, founded in 2003 and located in Dublin (Ireland), innovates to improve the lives of patients and their families. The company transforms biopharmaceutical discoveries into innovative medications to reimagine what's possible.
About Zymeworks
Zymeworks develops next-generation multifunctional biotherapeutics. Zanidatamab is a new Azymetric™ HER2-targeted bispecific antibody being examined in numerous Phase 1, Phase 2, and pivotal clinical trials globally as a targeted therapeutic option for patients with HER2-positive solid tumors. Zanidatamab Zovodotin (ZW49) is a bispecific antibody-drug combination in Phase 1 clinical development. It combines Zanidatamab's unique design and antibody framework with Zymeworks' ZymeLink™ linker-cytotoxin.
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BUSINESS INSIGHTS, PHARMA TECH
ClinChoice | March 03, 2023
ClinChoice, a leading global clinical CRO, recently announced that it has acquired CROMSOURCE S.r.l., an ISO-certified full-service contract research organization. CROMSOURCE has its corporate headquarters in Verona, Italy, its US headquarters in Cary, NC, and subsidiaries in the US and seven countries throughout eastern and western Europe.
With a proven track record of providing excellent clinical research and staffing services to multinational pharmaceutical, biotechnology, and medical device clients, CROMSOURCE's acquisition will strengthen ClinChoice's global network and further enhance its full-service capabilities.
ClinChoice is known for its commitment to providing high-quality services and timely delivery, resulting in the successful completion of clinical trials and functions, including regulatory, biometrics, safety, medical, and clinical operations across various sectors such as drug, medical devices, vaccines, cosmetics, and consumer health using both project-based and FSP models.
The company offers services covering the development lifecycle for biotechnology, pharmaceutical, consumer products and medical device companies worldwide. With a broad clientele ranging from the largest multinationals to startup and emerging companies, ClinChoice has completed over 1,500 clinical studies in various therapeutic areas such as CNS, oncology, ophthalmology, rare disease, respiratory and metabolic.
CROMSOURCE's acquisition was advised by Fairmount Partners, while Crosstree Capital represented ClinChoice.
About ClinChoice
ClinChoice is a leading global clinical CRO that provides comprehensive services to biotechnology, pharmaceutical, medical device, and consumer products clients worldwide. With a successful 25-year track record, it is considered the standard for excellence in clinical operations, biostatistics, data management, CDISC, statistical programming, regulatory affairs, medical affairs, and pharmacovigilance. The company has established major delivery centers in Europe, the US, Canada, China, India, Japan, and the Philippines, employing over 3,000 people worldwide. ClinChoice has a strong and talented team and is expanding its clinical operations in seven countries across North America, Asia, and Europe.
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