Emerging markets new gate away for Medical devices!

Some years back I was doing research on emerging market based medical devices companies. From the early 90's I have seen a trend that Top 10 medical devices companies have been opening their shop, initially the R&Ds focus was to support the global R&D in terms of software and technology development, but then these companies shifted their strategies on making devices and software for emerging markets, whether its Philips innovation in china or GE with their devices for the Indian market. Medtronic also ventured into the race by plan of an R&D in China, and hope that it comes out with some innovation for emerging market

Social Media Bug........

Sanofi eyes diabetics with social media

In the past two weeks I have seen two news releases regarding Big Pharma like Bayer and Sanofi going for social media services to know their target audience with metabolic disease Diabetes.

Both the German and the French drug maker have found the social media as a very important tool and have found that social media serves as a useful windows into people perception which includes the patients, physicians, regulators, Kol's and the payers  

As the competition intensifies I hope social media will be able to create wonders for Pharma as it has lead to change in scenario in FMCG market segment

Gilead product life cycle extension Strategy..........

Last time I had refereed to interest of Merck in expanding its HIV portfolio and how difficult it will be for Merck to grown in this specific segment, I feel now the competition will be more tough as some 4 days back Gilead Sciences announced that it had entered into agreement for Collaboration on promoting access to high quality generic version of Gilead HIV medicine emtricitabine (FTC), and also its fixed dose in developing countries with Mylan labs (Hyderabad), Ranbaxy (Gurgaon) and Stride Acrolab (Bangalore)

Under the said agreement Gilead will provide technology transfer to these giants and further funding for process improvements to reduce overall manufacturing cost......Gilead has now safely positioned it in the high margin segment and low price strategy segment......Now Cipla will have difficulty in growing in the said specific HIV indication per say........Real good strategy of safeguarding its monopoly 

Europe- New Regulatory guidelines!

From my B. pharmacy days i used to follow FDA and their guidelines but America has to learn many things from the Europeans in terms of regulatory guidelines recently for which there is lot of discussion happening in NICE front for new regulatory development, where in Macro level involvement of specific groups have been initiated for decision making for approval of drugs, there is lot to learn from NHS (National health services) and NICE UK. Will it be possible in India to implement these all regulations?

Generics?????

Generics have been eating our pie of revenue is the buzz following everywhere in Social media by the big players, whether its BMS and Astra, Astra at this point is in pretty bad shape as a giant which BMS was there 10 years back, BMS recovered with strategic partnership and alliances but what about Astra will it be able to cope?

These Big Pharma knew that generics will one or the other day will eat their pie of revenue and the best way to stop them is by making stringent regulations for sales and promotion.......

Astra should have thought beforehand about all this when it was making strategic blunders over the last three years ??????

After the generics and counterfeits ......it’s time for biosimilars to eat the revenue of big players  

Merck-Will this strategy help???

Today one of the top line news is that Merck and company is expanding in HIV arena, by signing two licensing agreements for investigational drug candidates. One deal is with Chimerix, based in Research Triangle Park, NC, and the other is with Yamasa of Choshi, Japan. With respect to its own portfolio Merck is also planning to advance an internally developed HIV candidate, MK-1439, which is into a Phase IIb trial. The question which is bugging my mind is that will Merck be able to penetrate the market which is majorly monopolized by Gilead for more than decade and if it is thinking of penetrating to the emerging markets, then will it be able to displace the stiff competition from companies like Cipla who have been playing the low price game for more than 3 decades? Food for thought ………..

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 ?

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?