Industry news round-up: updates from January 2023
In this latest instalment of our regular monthly column, we summarize a selection of key industry developments that have taken place over the past month.
This month, CorEvitas and Target RWE launched new registries to collect real-world data (RWD), whilst Verana Health, in collaboration with Sight Sciences, will use existing RWD registry data, all with the aim of learning more about patient outcomes to advance care. January has also seen pioneering studies using new technologies, with AstraZeneca and Clinithink working together to use AI to advance lung cancer screening and Strados Labs partnering with Boehringer Ingelheim to carry out a pilot study of wearable biosensor technology to remotely monitor patients with idiopathic pulmonary fibrosis. Aetion have also announced they are working with the FDA to find and analyze suitable fit-for purpose RWD sources. Further news was released from the FDA with regards to how the agency should use user fee collected through MDUFA V support premarket real-world evidence (RWE).
From Industry
Verana Health and Sight Sciences announce collaboration to conduct research on glaucoma using real-world data from the IRIS Registry
Verana Health announced it has joined forces with Sight Sciences, Inc. to learn more about the real-world outcomes for people with glaucoma. Sight Sciences will utilize Verana Health’s Qdata® Glaucoma RWD module, which curates data from the Intelligent Research in Sight (IRIS) Registry, to examine various aspects of its OMNI® Surgical System, a minimally invasive, implant-free glaucoma procedure. The research partnership aims use data from the IRIS Registry to gain insights that could lead to better results for individuals with from primary open-angle glaucoma (POAG).
CorEvitas announces launch of new patient registry in alopecia areata
CorEvitas announced the launch of its ninth clinical registry, which will focus on patients with the autoimmune disorder alopecia areata. The CorEvitas® Alopecia Areata Safety and Effectiveness Registry will be the first registry of its kind for this condition and will be used to collect and analyze data from patients in order to improve the understanding of alopecia areata, track the effectiveness of existing treatments and help with the development of new treatments.
Target RWE announces launch of 35 new observational disease state registries and milestone in TARGET-DERM registry
Target RWE announced the launch of 35 registries in a range of high unmet need conditions that will continuously capture RWD, natural history data and patient outcomes. Across registries such as TARGET-NEURO, TARGET-METABOLIC and TARGET-AUTOIMMUNE, Target RWE will gather patient feedback through digital surveys (patient-reported outcome measures) and collect whole blood, plasma, serum, and tissue samples for its exclusive biorepository. These registries will help deliver meaningful disease insights into these disease communities to allow stakeholders to generate and analyze RWD for healthcare decisions and inform drug development and RWE initiatives.
Pioneering use of AI in RWD screening to detect early-stage lung cancer: technology company Clinithink announces collaboration with AstraZeneca
AstraZeneca and Clinithink announced joint AI/RWD project to improve the early detection of lung cancer. The RWD study will use Clinithink’s healthcare AI CLiX unlock to screen unstructured electronic medical records to identify people who could benefit from lung disease screening, leading to earlier diagnosis of the disease and potentially improving patient outcomes and reducing costs for the NHS.
Aetion and the FDA join forces to advance RWE in oncology
Aetion announced they are collaborating with the FDA Oncology Center of Excellence over the next 5 years to find and analyze suitable fit-for purpose RWD sources to answer important questions related to cancer prevention, treatment, diagnostics and care. The FDA Oncology Center of Excellence will work with Aetion to leverage RWD gathered through the Aetion Evidence Platform, a software tool for RWD generation and RWE analysis that allows users, such as pharma/biotech, regulators, payers, and health technology assessment bodies, to inform healthcare decision-making, drug development, reimbursement, and policy. Using the Aetion Evidence Platform, both organizations will evaluate real-world outcomes, test causal inference techniques, and address health disparities to promote equity in healthcare.
Boehringer Ingelheim and Strados Labs to carry out pilot study of wearable biosensor technology to remotely monitor patients with idiopathic pulmonary fibrosis
Strados Labs announced they are collaborating with Boehringer Ingelheim to advance research into new treatments for idiopathic pulmonary fibrosis (IPF). In a new pilot study, Boehringer will used the FDA-cleared RESP Biosensor to monitor cough and crackles in patients with IPF at home, symptoms that have been shown to be indicative of worsening outcomes in people with IPF. Boehringer will use the data collected by the RESP Biosensor device to learn more about how these patient-reported outcomes can be used to assess the status of patients with this disease.
From the Regulators
FDA asks for stakeholder feedback on using MDUFA V user fees to advance real-world evidence
As part of the recently reauthorized Medical Device User Fee Amendments (MDUFA V), the US FDA is seeking public comment on how they should use medical device user fees, not related to the National Evaluation System for Health Technology (NEST), that are distributed to external organization(s) to support RWE for premarket submissions.
