Data integrity remains a perennial hot topic impacting the pharma biotech industry and the trend has been picking up steam; the number of data integrity-related warning letters has increased consistently since 2010. A number of new guidance documents came out in 2016 by FDA, MHRA, EMA PIC/S and the WHO and yet companies continue [...]
Why becoming more risk literate is so vital
Organizational change can take on many guises. Most changes are planned and orchestrated by company management. However, some of the most impactful changes are nearly impossible to predict.
Crystallization of active pharmaceutical ingredients (API) and related pre- and early formulation development play critical roles in successful drug development and manufacturing.
I recently had a meeting with a CEO to help solve his company’s pain points. He was in need of a big dose of a strong analgesic. Falling prices, suffocating complexity, poor product development, supply chain disruption, product shortages, increasing operational costs and unhappy investors were taking him beyond his pain threshold. One pain [...]
YOUR CHANCE TO CONTRIBUTE Ever participated in one of those benchmarking exercises? You know what I mean. When a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware. BENCHMARKING CAN BE DANGEROUS Trying to copy and follow others [...]
Implementing a Planned Professional Maintenance Procedure Increases Productivity for World-Leading Pharmaceutical Company
The User Operating since 1876, Eli Lilly and Company is one of the largest pharmaceutical companies in the world. Their manufacturing plant in Spain alone has more than 1200 employees working in a variety of areas including therapeutics, biomedicines, oncology and animal health, and is one of the eight research and development plants owned by Eli [...]
After chairing a session on risk at the recent Pharma Integrates 2017, Martin Lush, Global Vice President, NSF Pharma Biotech and Medical Devices, was compelled to put "pen to paper" to get people thinking and debating this issue before it’s too late! How the pharmaceutical industry manages risk is appalling. There you go. I’ve said it. I’ve [...]
Few recent trends have had as profound an effect on life sciences organisations as the healthcare industry’s transition to value-based care with its focus on outcomes. No longer is it enough to deliver drugs and devices that have proven to be effective in clinical trials. Today, life sciences organisations are being asked to assume part [...]
Intuitive analysis and insights into methods of optimising in vivo efficacy studies and what developments might be coming to fruition in the future Scientists involved in biopharmaceutical and biomedical research seek to generate the highest quality data for their studies by employing an optimal combination of in vivo and ex vivo models. The 3Rs principle [...]