The new biology has far reaching consequences on the practice of healthcare. There are various challenges for the new biology in the future and directions.
As the early stages of discovery will be increasingly linked to the later stages of clinical development, molecular, pharmacological and patient clinical data will need to be captured at various phases and integrated into a knowledge management system that will be used to facilitate rational drug design around molecular diseases.
The challenge lies in database design, developing software for database access and manipulation, and data entry procedures to compensate for the varied computer procedures and systems used in different laboratories. India should take lead by providing customized services.
Providing a clinically validated assay for assessment of a patient's probable response to drug is a major challenge in pharmacogenomics. Other challenges before realising the promise of personalsed medicine include-limitation of access to large and well-characterised patient populations / clinical tissue samples for several diseases, coupled with high genotyping costs; ethical, legal and social considerations; and physician and patient education.
The low level of genetics training in medical schools, coupled with fast pace of discovery and innovation, is creating a huge information gap that needs to be filled. This creates a new opportunity and challenge for pharmacists to build on their roles as an information resource on pharmacogenomics for physicians and patients.
Strong IPR protection laws are required to be implemented to ensure that all patents filed using genetic resources of the country disclose the source of the material and economic interest of the original source of the material and economic interest of the original source. World class IPR protection will facilitate the research investments in India by pharmaceutical and biotech MNCs.
Today, several pharma companies are designing their clinical trials to enable the routine collection and storage of DNA and other biological specimens that will be used in future pharmacogenomic studies. It is envisaged that routine collection and analysis of DNA in clinical trials shall soon become mandatory regulatory requirement to show that there are identifiable genetic factors affecting drug response.
The process of drug discovery is shifting to virtual laboratories. Biological targets are being identified and drugs are being designed on the screen before taking it to actual laboratory.
Pharma companies will reap the benefit of reduced costs of target identification and lead discovery, and will be able to develop new methods / novel concepts for curing diseases through genomics/proteomics technologies. Pharmacogenomics will provide the link between an individual's mole-cular and clinical profiles, allowing physicians to make the customized patient care decisions and providing patients the opportunity to make informed healthcare decisions.
Bioinformatics will increasingly replace conventional technologies in accelerating drug discovery and development programmes. There is huge demand for top class, high throughput database management. India can take a lead in providing customized data bases and bioinformatics solutions.
Mining data for discovery to generate intellectual property and get the drug in the market first is the gold rush that leading pharma and biotech companies are keen on. Often these goals are achieved through strong IPR protection and partnerships between companies having complimentary expertise.
Time is ripe for Indian pharmaceutical industry to take this opportunity to benefit significantly by participating in global drug discovery race.
- (The article is an extract from his book 'Pharmacy Pathfinder For GATE And Other Recruitment Examinations', Part II.) The author is in-charge- Assistant Drug Controller (India), Sub-Zonal Office, CDSCO, Ahmedabad.)