We are living in the most exciting period in the history of pharmaceuticals, as new options lead to new opportunities for those of us in the field and those about to join us. Pharmacists are at a zenith in their ability to manage, cure and prevent diseases. Demographics in the country practically ensure a bright future for those entering the profession. We are witnessing a double dynamics in our population growth in the number of births and an extended lifespan for men and women. The record number of baby-boomers graduating into social security pensioners has set the stage for an increased use of drugs. When Medicare kicks in for the largest group of elderly ever seen, there will be a pronounced increase in pharmaceuticals usage. As a result, the number of prescriptions dispensed is expected to more than double. So it becomes but necessary for the discovery of new drugs.
In the days of the corner drugstore, when soft drinks came from soda fountains, the pharmacist might have been a part of the neighborhood landscape: a kindly, trusted figure who knows your family and your medical history. Who made medicines and healing seemed a little like magic. Even as the profession continued to develop considerably, one thing remained constant: public trust.
In medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are discovered and/or designed. In the past, most drugs have been discovered either by identifying the active ingredient from traditional remedies or by serendipitous discovery. The new approach has been to understand how disease and infection are controlled at the molecular and physiology level and to target specific entities based on this knowledge. The process of drug discovery involves the identification of candidates, synthesis, characterization, screening, assays, clinical trials, formulation and finally bulk manufacture.
Drug design is the approach of finding drugs by design, based on what and how the drug is targeting. Typically a drug target is a key molecule involved in a particular metabolic or signaling pathway that is specific to a disease condition or pathology. Unlike the historical method of drug discovery, by trial-and-error testing of chemical substances on animals, and matching the apparent effects to treatments, rational drug design begins with a knowledge of specific chemical responses in the body, and tailoring combinations of these to fit a treatment profile.
De novo design of small molecules is clearly becoming a valuable and integral part of the drug discovery, and the results are emerging. Computer-assisted drug design (CADD), also called computer-assisted molecular design (CAMD), represents more recent applications of computers as tools in the drug design process. In considering this topic, it is important to emphasize that computers cannot substitute for a clear understanding of the system being studied. That is, a computer is only an additional tool to gain better insight into the chemistry and biology of the problem at hand.
Cytokinetics drug discovery operations are organi-zed around the principle that aggregating informa-tics across biology and chemistry leads to predic-tive approaches to target identification, compound analoging and lead optimization and it introduces new efficiencies into drug discovery and development.
The creation of medicines in today's rapidly changing scientific environment calls for innovation. We are changing the way we conduct drug discovery and development to take greatest advantage of the advances made in understanding the root causes of disease. While harnessing the power of our size to capture new knowledge about how diseases develop and progress, we are also drawing upon the energy, drive and nimbleness of small groups of scientists to make the discoveries which will lead us to the development of new, safe and effective medicines.
Drug discovery and development is a business process supported by several line functions, including research, pre-clinical safety, clinical pharmacology, clinical research and development, regulatory affairs, clinical safety & epidemiology and marketing. They must continually cooperate with the highest precision in capturing information and sharing results from countless sequential and parallel tasks. As demanding and sophisticated as this seems, their greatest challenge lies in the application architecture, they process the operation on. Drug discovery and development architectures consist of numerous applications storing data in different physical formats and diverse DBMS /storage technologies.
In an age of cost-cutting and automation, people are still demanding the personal touch when it comes to their health. And changing ideas about the structure of the health care system are leading pharmacists to a kind of "high-tech, high-touch" practice. In this approach, counseling takes precedence over distribution; and pharmacists, physicians, and health professionals pool their expertise to provide drug therapy to patients. The term many use to describe this approach is "pharmaceutical care."
The role of the pharmacist has evolved with drug development over the last 25 years. Drugs have become stronger, more specialized, and certainly more in number. Drug therapy, is the most common mode of care in the world.
Over the years, the cost of developing new drugs has increased considerably and despite the strenuous efforts of companies, it is estimated that only 15 per cent of new drugs being developed are likely to reach the market. A majority of these research and development (R&D) expense occur at the clinical trial stage, and owing to the growing complexity of these trials, this proportion of R&D expenditure is continuing to rise. Faced with spiraling costs and diminishing margins, pharmaceutical companies are increasingly outsourcing their business processes as a way to develop innovative ideas, maximize the use of existing resources, and cut expenses.
Pharmaceutical companies are increasingly collaborating with biotech companies to leverage their expertise, products and operations to help overcome the productivity gap and promote future growth. Companies wanting to generate new breakthroughs have traditionally formed alliances with biotechnology firms, university research centres, contract research organizations (CROs) and other third parties.
Scientific developments in biotechnology have radically changed the global pharmaceuticals industry, since biopharmaceuticals can be tailored for specific medical problems in different individuals. Discovering and developing novel medicines that make a real difference in the lives of the people our service has always been complex, time-consuming and challenging. But we should never forget that every step we take to increase the speed at which we are able to discover and develop new medicines and vaccines means less suffering for the patients who are waiting for them. That vital consideration drives us to continue to find new ways to accelerate the process of discovery, while still safeguarding our unwavering commitment to patient safety and scientific excellence.
- (The authors are with Dept. of Pharmaceutics Al Ameen College Of Pharmacy, Bangalore)