Friday, February 8, 2008

CLINICAL RESEARCH CITY, a useful concept

I got this great picture for this article from HERE.

By now it is well documented that India is a gung-ho destination for clinical research. Most MNCs find doing clinical trials and other forms of clinical research in India, practical, sound business-sense, and trustworthy. Clinical research is a big money business concept now with high growth potential, just as medical tourism is an attractive option.

Recently, Narayana Hrudayalaya made it it to the headlines, twice. One: this famous institution headquartered in Bangalore has got an international accreditation. And, secondly, Narayana Hrudayalaya in collaboration with Biocon's chairperson, Ms. Kiran Majumdar, is setting up 5000 bed healthcities (Narayana Health City). The concept of Healthcities is to provide world class healthcare (surgical and non surgical), to both international and Indian patients.

Based on the health city concept, it would also be interesting to have a private - public partnership initiative of a CLINICAL RESEARCH CITY, that will ride on the clinical research wave. It is important to note that concepts such as, textile city concept, electronic city concept, Hitech IT city concept, Biotech Park, help create a focussed ecosystem for the concept. Thus, a CLINICAL RESEARCH CITY concept, will create an ecosystem for facilitating the receipt of orders for clinical trials, conduct of the clinical trial or research, and then process the results of the trials (by IT or ITES companies) within the precints of the city itself.

Most of the clinical research right now is not related to drug discovery (in time to come it will gain traction, particularly when new novel drugs like balaglitazone will succeed); it is bioequivalence (BE) and bioavailability (BA) studies that are the bread and butter business of clinical research in India, right now. These studies are done to launch new me-too products in India, and also to establish that generic equivalents are indeed on par with the innovator formulation.

The clinical research city concept will help India tap the chemopharmaceutical (fomulations based on synthetic chemicals), biopharmaceutical (formulations based on biologicals) opportunity, and herbopharmaceutical (herbal formulations) opportunities :

a) The multi billion US dollar generic opportunity. It is said, that a 70 billion USD worth of branded patented drugs will go off patent in 3 - 4 years, and to launch the generic equivalents for exports from India to USA, one needs to conduct BE/BA studies.

b) The biogeneric opportunity. India is said to be on the threshold of scripting a success story in the field of biogenerics, as certain biotech products too are going off patent. And to supply biogenerics, again clinical research studies will be required to establish that the biogeneric equivalent is indeed as safe and efficacious as the innovator brand.

c) For the Phase 4 (post marketing surveillance clinical trials), studies. As pharmacovigilance becomes more and more important, and regulatory standards are raised higher, Phase 4 clinical trials and data will begin to acquire more importance. After all, it was Phase 4 data that drove the proverbial last nail in the coffin of Vioxx. Phase 4 data will require a lot of statistical processing, the CLINICAL RESEARCH CITY can provide such locations for organizations that play on statistical processing.

d) Bioinformatics and personalized medicine is creating the buzz. Bioinformatics and personalized medicine concepts depend on the analysis of the genetics (genome) of a person or group of persons. Based on the genetic profile, therapies and drugs are designed. IBM has a computational biology department that is working in this direction. In fact, the CLINICAL RESEARCH CITY concept will attract such companies working on futuristic and cutting edge technologies to set shop, and thereby strengthen the clinical research ecosystem in India.

e) Drug discovery clinical research (Phase 1 to Phase 3, in particular) will get a filliip. These studies are long drawn and will mean a continuous or long term business for the clinial research provider, and a CLINICAL RESEARCH CITY will help create the ecosystem and confidence for collaboratively working on such projects with innovator companies.

f) Clinical research for herbopharmaceuticals. As regulatory standards raise their bar higher, and the public awareness grows on clinical research, herbopharmaceuticals will not be inured from conduct of good quality clinical research. It is the CLINICAL RESEARCH CITY, which will help such formulators to further strengthen the brand presence and launch new herbopharmaceutical formulations.

ALL IN ALL, A CLINICAL RESEARCH CITY (with a single window system) WILL PROVIDE A DEDICATED LOCATION, AND BUILD AN ECOSYSTEM FOR FURTHERING THE CLINICAL RESEARCH BUSINESS OPPORTUNITY IN INDIA. This concept will also help create the right infrastructure, and cut costs through pooling of certain infrastructural elements and equipment. Thanks for reading this article...please do read all the other articles in this blog.


sahel said...

You have very well stated that clinical research is now being taken up in India seriously. I must say that still there are not many institutions offering a course on such a sensitive topic. ICRI is one of the premier institutes of the country and aims at promoting clinical research in the country. With foreign recognition and good faculty, its future prospects seem to b very bright. A number of clinical research projects have been taken up by ICRI and hav produced medicines of great value. It should b seriously considered by all aspirants of research very seriously. To apply for the the college just click on the url..

Sunil S Chiplunkar said...

Well good information, thanks Sahel. Best of luck.