AI Article Synopsis
- The Committee for Advanced Therapies in the EU assesses marketing applications for advanced therapy medicinal products, including gene and somatic cell therapies.
- They also set the standards for the quality and development of these products, ensuring rigorous scientific evaluation.
- A reflection paper on managing risks related to insertional mutagenesis was adopted in April 2013, emphasizing a multidisciplinary approach.
Article Abstract
In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead in defining the scientific framework for the quality, nonclinical and clinical development of such products. This reflection paper represents the Committee's current thinking on management of clinical risks deriving from insertional mutagenesis. A multidisciplinary approach to insertional mutagenesis is provided. This reflection paper has been adopted by the committee in its April 2013 meeting.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1089/humc.2013.119 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Guidance on selecting and evaluating AI auto-segmentation systems in clinical radiotherapy: insights from a six-vendor analysis.
Phys Eng Sci Med
January 2025
School of Physics, Mathematics and Computing, The University of Western Australia, Crawley, WA, Australia.
Artificial Intelligence (AI) based auto-segmentation has demonstrated numerous benefits to clinical radiotherapy workflows. However, the rapidly changing regulatory, research, and market environment presents challenges around selecting and evaluating the most suitable solution. To support the clinical adoption of AI auto-segmentation systems, Selection Criteria recommendations were developed to enable a holistic evaluation of vendors, considering not only raw performance but associated risks uniquely related to the clinical deployment of AI.
View Article and Find Full Text PDFEnhancing safety in CT-guided lung biopsies: correlation of MinIP imaging with pneumothorax risk prediction.
Insights Imaging
January 2025
Department of Diagnostic, Interventional and Paediatric Radiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Objectives: This study aimed to evaluate whether minimum-intensity projection (MinIP) images could predict complications in CT-guided lung biopsies.
Methods: We retrospectively analyzed 72 procedures from January 2019 to December 2023, categorizing patients by pneumothorax and the severity of hemorrhage (grade 2 or higher). Radiodensity measurements were performed using lung window (LW) and MinIP (10-mm slab) images.
Lutetium-177 PSMA radioligand therapy in taxan-naive first- and second-line metastatic castration resistant prostate cancer after first-line ARPI therapy.
Eur J Nucl Med Mol Imaging
January 2025
Department of Urology, University Hospital Frankfurt, Goethe University Frankfurt Am Main, Frankfurt, Germany.
Purpose: Lutetium-177 Prostate-specific membrane antigen (Lu-PSMA) radioligand therapy is EMA-approved for metastatic castration resistant prostate cancer (mCRPC) after androgen receptor pathway inhibition (ARPI) and taxan-based chemotherapy. However, its effect in taxan-naïve patients is under current investigation.
Methods: We relied on the FRAMCAP database to elaborate Lu-PSMA therapy outcomes of progression-free (PFS) and overall (OS) in taxan-naïve mCRPC patients after previous ARPI treatment.
PARADIGM-PV: a randomized, multicenter phase 4 study to assess the efficacy and safety of ropeginterferon alfa-2b in patients with low- or high-risk polycythemia vera.
Ann Hematol
January 2025
Department of Medicine, School of Clinical Medicine, LKS Faculty of Medicine, the University of Hong Kong, Hong Kong, China.
Polycythemia vera (PV) is characterized by clonal hematopoietic stem or progenitor cells with constitutively active somatic mutation(s) in the Janus kinase 2 gene. Phlebotomy (Phl) and aspirin are often used alone for low-risk PV patients. However, data from the Low-PV study demonstrated that Phl and aspirin may not be adequate for patients.
View Article and Find Full Text PDF2024 HRS perspective on advancing workflows for CIED remote monitoring.
Heart Rhythm O2
December 2024
Philips, San Diego, California.
Cardiac implantable electronic devices (CIEDs) generate substantial data, often stored in image or PDF formats. Remote monitoring, now an integral component of patient care, places considerable administrative burdens on clinicians and staff, in large part due to the challenge of integrating these data seamlessly into electronic health records. Since 2006, the Heart Rhythm Society, in collaboration with the CIED industry, has led an initiative to establish a unified standard nomenclature.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!