The Formedix platform is used by many pharma companies, biotechs, and CROs. Each organization has its own objectives and processes, and we work with customers to meet their individual needs. Common goals include: Developing internal standards that can be reused. Having a central place (MDR) t...
Many companies allocate their vendors into three groups by type: Strategic (key) vendors: High value, low volume and sole-source. Important vendors: Mid-value, there are alternative sources of supply Tactical vendors: Low value, high volume, lots of options Thoughtful categorisation simplifies colla...
OEMs can also use Twin Builder software to run all possible test cases in a virtual environment to comprehend vehicle performance. This facilitates an understanding of how many test validations are passing, how many are failing, and why failures occur....
Many are opting for the latter. The last eighteen months has piled pressure on CDMOs to deliver faster and better. The post-pandemic customer has seen the impossible made possible over the last eighteen months in terms of radically accelerated delivery times – and now expects ...
Part 1: Monte Carlo beam data validation for error-free TPS beam modelling and QA (presented by M. Kowatsch). Part 2: Error-free beam data scanning and commissioning with SMARTSCAN (presented by M. Adolph). M. Kowatsch explains during the first part how Monte Carlo is used to...
in research and development of ATMP (Advanced Therapy Medicinal Products), a broad category of medicinal products that includes cell and gene therapies and RNA therapeutics. This has resulted in many products reaching the market, with thousands of new therapies also in preclinical and clinical stages...
Irwin Hirsh has nearly 30 years of pharma experience with a background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. In 2008, Irwin joined Novo Nordisk, focusing on quality roles and spearheading initiatives related to QRM and life cycle...
The catch-up of latecomer firms has been a topic of interest because it is closely related to the changes in industry leadership. The reason why some countries are more successful in catch-up is because of their increasing mastery of technology managemen
Administration (FDA) as “a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes, or responses to an exposure or intervention, including therapeutic interventions.” There are various types of biomarkers, but many are used to predict and pr...
Novel oncogenic drivers and biomarkers have been described across different tumor types, leading to the development of targeted therapies and the design of innovative trials, many of which are evaluating tissue-agnostic therapies3. The first tissue-agnostic treatment approval was granted by the FDA to...