Medical practice is undergoing a radical transformation in the post-genomic era where disease management is demanding more advanced diagnostics that are designed to work on an individual rather than a population level thus spearheading the age of personalized medicine. Future trends indicate that diagnostics will need to focus on the internal manifestation of the disease i.e. genotypes rather than the outward manifestation of disease which are based on symptoms that physicians referred to as "phenotypes".
Era of pharmacogenomics
The seeds of personalized medicine were sown in 1998 at Mayo Clinic, Rochester, USA when a team led by Dr.Weinshilboum made a ground breaking discovery that explained why a childhood leukemia drug, Azathioprine, which proved efficacious in most children, caused fatality in some. The fatality was pinned down to a missing enzyme, TPMT (thiopurine methyltransferase) which led to the build up of the drug and caused acute bone marrow failure. The missing enzyme was attributed to a faulty gene and thus began the era of "pharmacogenomic medicine". Since then, a large number of commonly used drugs have been known to have variable responses thus questioning the "one drug fits all" approach taken by pharmaceutical companies.
A hub for differentiated medicine
India offers, perhaps, one of the most affordable development bases for personalized medicine. Developing well validated personalized therapies will demand extensive clinical data to be generated from well differentiated patient populations. India and China are clearly the two countries with the most desired disease and patient profiles that can enable such studies. Coupled with this is the need for a large number of novel diagnostics based on gene and non-gene based platforms that are both predictive and qualitative in terms of disease status. These are clearly large opportunities for Indian biotech companies to pursue. Personalized drugs also address the affordability factor for expensive therapies such as those that are involved with cancer where early diagnosis and new diagnostics can substantially reduce dosages and even eliminate expensive chemo-therapy in certain cases.
Information technology and new medicine
The advent of personalized medicare will require a strong informatics approach that combines both software and biotech skills in augmenting high-speed data mining of both genotypic and phenotypic information with a view to evolving new forms of medical diagnostics and therapies. Genomics and Proteomics are churning out endless reams of data which need to be statistically evaluated and harnessed for commercial end use. India has a powerful advantage in addressing these emerging opportunities in personalized medicine through its well developed capabilities in information technology. It is envisaged that in the years ahead there will be a number of collaborative initiatives between software, biotech and pharma companies.
Today big pharma is in troubled waters with declining R&D productivity, disintegrating blockbusters, generic competition, rising clinical development costs and shrinking profits. The way forward for these ailing giants is to pursue licensing, partnering and acquisition opportunities with biotechnology companies. There are currently more than 350 biotech drugs in late stage of development addressing a wide disease area from cancer, to CNS and metabolic as well as autoimmune disorders.
The opportunity for international bio-partnering is a fallout of the trend of declining risk capital in the West that seems to have dried up for companies engaged in early-stage discovery work. Venture capitalists seem only willing to fund companies who have reached the post proof-of-concept stage. Therefore there exists a large number of companies whose resources are simply too frugal to take their ideas to the next stage. Indian companies would be their natural collaborators to reduce burn rates, optimize R&D spends and extend survival time lines. An "India strategy" offers an effective de-risked model for VCs who are in a dire need for exit or survival strategies for their investees. To the biotech companies, an "India strategy" offers a life line for product development and the most affordable and effective way to move up the value as well as valuation curve. International bio-partnering has already gained visibility in India where several collaborative partnerships have been initiated such as Biocon's JV with Cuba's CIMAB and its investment cum co-development programmes with Nobex & Vaccinex to develop proprietary products. Chiron's recent predicament with respect to the acute shortage of flu vaccine, has prompted alliances with Panacea Biotec and others. Serum Institute, Bharat Biotech and others already have on-going arrangements with Wyeth.
(The author is CMD, Biocon Group, Banglaore)