The accepted definition of a biomarker is 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.” This definition was derived from a 2016 partnership between the U.S. FDA and the National Institutes of Health (NIH). Biomarkers are not diagnostic…
How an integrated product development strategy can drive speed and innovation across biopharma
Biopharma companies are grasping the key role an integrated product development strategy can play in the drug development process. A recent industry survey found growing uptake of this multidisciplinary approach to improving efficiency and reducing costs and timelines, though the barriers to successful implementation were similar across the board. The potential savings a strong integrated…
Why growth for pharmaceutical companies can be dangerous
Prosperity can be a double-edged sword for pharma companies. While there are obvious financial advantages to selling more drugs, growth phases often lead to an uptick in quality problems, said Craig Wylie, managing partner USA at Arthur D. Little. A solid plan is needed to help pharma companies keep track of their processes as they…
Inside Genoskin’s quest to use human skin scraps to accelerate drug research
“How do you maintain human skin alive so that you can generate data from what would otherwise be trash?” asked Eric Merle, chief business innovation officer of Salem, Massachusetts–based Genoskin. “We work with surgical discards.” Founded a decade ago, Genoskin collects human skins from cosmetic surgeries such as face-lifts and abdominal surgeries that would otherwise…
Insilico Medicine announces PROTAC partnership with Arvinas
Insilico Medicine (Hong Kong) has entered into an R&D pact with Arvinas (NSDQ:ARVN) to explore applications of Insilico’s AI technology to PROTACs. By regulating protein function, PROTACS can optimize the sensitivity to drug-resistant targets, as an article in Signal Transduction and Targeted Therapy notes Insilico and Arvinas will partner in designing treatment modalities for current and next-generation…
How to build a foundation for the next phase of Alzheimer’s disease research
Alzheimer’s disease has one of the highest financial burdens. The Alzheimer’s Association estimates that the cost of the disease in the U.S. will hit $355 billion in 2021. “Not only is Alzheimer’s one of the most expensive, it’s probably one of the most devastating diseases of humans,” said Dr. Allan Levey, professor and chairman of…