Premier Research: holistic approach benefits development
WEBOct 6, 2020 · Holistic design starts off with designing a target product profile that considers the end goal early in the development planning. Also, part of a successful holistic approach, Sharif suggested, is asking thoughtful, appropriate questions at the outset, making sure to consider outcome-focused impactful issues at every stage of development.
Canine cancer research startup impacts treatment in humans
WEBApr 19, 2021 · To help improve outcomes for canine cancer, life-science startup One Health has launched FidoCure, a novel program that uses genomics and artificial intelligence (AI) to bring precision cancer treatments to dogs—and the research is impacting research in human oncology. Outsourcing-Pharma spoke with One Health co …
Overcoming Challenges of Clinical Data Review
WEBJun 10, 2021 · Clinical data review is intrinsic to clinical development, assuring patient safety, determining drug efficacy, and assessing data quality. It involves rigorous analysis of a wide variety of clinical trial data and often necessitates data integration from multiple sources to extract actionable insights. Learn about the common challenges of clinical data review that stall clinical trials and the ...
The rise of the integrated research organization: A conversation …
WEBSep 11, 2019 · Behind the term is NC-based Javara, which made its official debut in June 2018 . The company’s CEO Jennifer Byrne told us the name ‘integrated research organization,’ or IRO, emerged as the descriptor for the new clinical research model following discussions with Wake Forest Baptist Health.
Direct data capture a 'game changer' for trials: Clinical Ink
WEBFeb 24, 2021 · Jonathan Andrus, chief business officer, Clinical Ink. JA: Direct data capture, or DDC for short, is the method by which data are captured directly from the patient at the time of the visit (at the clinic, at home, or virtually). As the data are being entered directly into the DDC tool, the system is providing real-time feedback on incongruent ...
Thermo Fisher: $17.4b PPD buy ‘natural extension’ for pharma
WEBApr 26, 2021 · In mid-April, laboratory technology specialist Thermo Fisher Scientific announced its acquisition of global contract research organization (CRO) PPD in a deal valued at $17.4b USD. Marc Casper—chairman, president, and CEO of Thermo Fisher—addressed the reasons for the significant purchase, how company leaders expect the move to benefit ...
3M Drug Delivery Systems relaunches as Kindeva Drug Delivery
WEBMay 4, 2020 · 3M Drug Delivery Systems relaunches as Kindeva Drug Delivery. News and analysis on clinical trial services and contract research and development. The launch of the renamed, newly independent company follows its acquisition by Altaris Capital Partners. After selling its drug delivery systems to Altaris in a transaction valued at $650m (£523 ...
Excipients, raw materials & intermediates
WEBThe raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success. Continuous Manufacturing Technology continues to gain importance in pharmaceutical manufacturing. Formulation of bi-layer or multi-layer tablets enables the combination of two or more drugs that may be ...
GSK reduces contract manufacturing - outsourcing-pharma.com
WEBFeb 10, 2020 · GSK’s decision to pull back from low-margin contract manufacturing contributed to flat performance at the consumer health unit in the fourth quarter and restricted it to a 2% increase in sales for the full year. In effect, GSK sacrificed growth to get out of low-margin work. James Gordon, an analyst at …
Report highlights vulnerabilities in US pharma supply chain
WEBAug 24, 2021 · Of the 47 most-prescribed antivirals, 97% had no US source of API. Of the 111 most-prescribed antibiotics, 92% had no US source of API. Anthony Sardella, adjunct professor, Olin Business School, Washington University in St. Louis. According to Sardella, the vulnerabilities highlighted in the report should be setting off alarm bells.