Newsletter - July 16, 2015
Should Prescription Drugs Cost be Controlled in the US
The public opinion in the US is getting increasingly negative for the high prices of prescription drugs. A course of treatment for some hepatitis drugs could cost $95,000; multiple cancer drugs cost about $150,000 per course, while a couple of drugs for the rare disease cystic fibrosis could cost more than $300,000 for a single course of treatment. The US drug prices are the highest in the World. The same drugs by the same companies cost a fraction of their US prices in other countries that practice various forms of drug price control. Read More...
SOP Deficiencies and Documentation Errors Dominate EMA GCP Audit Findings
In a report released by European Medicines Agency (EMA) earlier this month, auditors from the Agency found many clinical sites to have several major deficiencies in compliance with Good Clinical Practices (GCP). About 58% of the findings related to errors in study documents, either poor source documents or bad documentation practices, while about 15% findings were related to SOP errors. Auditors also found many instances of poor trial management by the sponsors including areas such as clinical monitoring practices, data management and poor sponsor audits. Read More...
Manufacturers of Biologics to Increasingly Use Single-Use Technologies
Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the need for the same. The single-use and disposal technology has been used for decades in the research and development setting where biological cultures routinely use disposable culture ware, pipettes, storage bottles and small-scale bioreactors. Read More...
Should Prescription Drugs Cost be Controlled in the US
The public opinion in the US is getting increasingly negative for the high prices of prescription drugs. A course of treatment for some hepatitis drugs could cost $95,000; multiple cancer drugs cost about $150,000 per course, while a couple of drugs for the rare disease cystic fibrosis could cost more than $300,000 for a single course of treatment. The US drug prices are the highest in the World. The same drugs by the same companies cost a fraction of their US prices in other countries that practice various forms of drug price control. Read More...
SOP Deficiencies and Documentation Errors Dominate EMA GCP Audit Findings
In a report released by European Medicines Agency (EMA) earlier this month, auditors from the Agency found many clinical sites to have several major deficiencies in compliance with Good Clinical Practices (GCP). About 58% of the findings related to errors in study documents, either poor source documents or bad documentation practices, while about 15% findings were related to SOP errors. Auditors also found many instances of poor trial management by the sponsors including areas such as clinical monitoring practices, data management and poor sponsor audits. Read More...
Manufacturers of Biologics to Increasingly Use Single-Use Technologies
Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the need for the same. The single-use and disposal technology has been used for decades in the research and development setting where biological cultures routinely use disposable culture ware, pipettes, storage bottles and small-scale bioreactors. Read More...
