Friday, June 29, 2012

Regulatory issues!


For past many months there has been issues related GMP production whether it’s Roche, Sanofi and Hospira and the issue was cGMP compliance in manufacturing. For Roche the issue was API production in their API manufacturing in North carolina, US and later Sanofi with their TB drug production in Canada. Why is that developed nations facing the CGMP issues as their regulatory bodies are the most stringent ones in the world?What should be the next steps for this company, third party manufacturing of active API's and products ?

Wednesday, June 20, 2012

Social Media Bug in Pharma!


Social media in some years has become a hot topic or rather then talk of the town, In FMCG scenario it has worked wonders and made some old products come back into shelf after consumer's persuasion. But I feel for Pharma there is an overall different story. Pfizer had closely watched effort for patient recruitment for clinical trials, One year after launching its so-called clinical-trial-in-a-box.

Pfizer is planning to discontinue enrollment in the first such study that was designed to allow the patients to participate from home by using computers and smart phones rather going back to hospital or doctor's office for medicines and after check-ups. While this effort created lot of Buzz in the virtual world but the drug maker was not able to pursue the patients to come up front to participate in trial, which was for testing the Detrol overactive bladder drug.

Time will say Social media success in Pharma and biopharma sector?