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Deconstructing the Drug Development Process: The New Face of Innovation

Over the years the world has witness major innovation and advancement of research and development in many sectors of sciences and industries but not in pharmaceutical. The other industries have made tremendous growth due modification of their research and development methods and process. On the other hand, due to lack of innovation the pharmaceutical industry has continued to use old processes in the development of drugs which are slow, risky, inefficient and expensive.
According to the article the major reason for slow in the development and innovation is the patent rights. The major players in the industry are busy merging to avoid patent cliff than enhance research and development activities. Moreover, the middle players in the industry and drugs approval bodies are concentrating on the economic value of the drug than its usefulness. However, the major challenge is lack of advance of technology in pharmaceutical which will ensure manufacturing o f drugs that are safe at a lower cost. As result of poor technology it takes long years to develop a drug and put it in the market.
Other reasons which have contributed to the slow development is the multifaceted and interrelated of the industry, patient recruitment and retention, more preapproval of drugs, poor earnings by drugs company and protocol complexity. Thus for the innovation to be realized the players in the industries must develop good relations, large companies should embrace new technology in their research development of drugs and the drugs company should form partnership which bring change to the industry. Additionally, the academic bodies in the industry should promote innovation by transiting from basic research to commercialization and applied clinical research.

International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary

In the recent decades efforts have been made to globalize the technologies and distribution of drugs right from the development stage, manufacturing and marketing processes. However, due to lack of uniform drug regulations policy around the globe, the advancement in drug development has been hampered. This has seen the manufacturers and distributors shy away from some counties which are perceived to be strict. Thus, there is urgent need to harmonize regulations around the globe which promote efficiency of development of drugs, evaluation processes and improve the quality of drugs. The Institute of Medicine’s (IOM’s) has been on the forefront in advocating for the harmonization of the drug relations around the globe.
According to the article harmonization of the regulation will help in the reduction of production cost, duplication, optimize use of resources, reduce the number of clinical trials and encourage sharing of knowledge and experience. This will help patient access the drugs easy and faster at affordable price. The major barrier for the pharmaceutical companies is performing clinical tries in almost every country. This slows down development and it’s an expensive process. In addition there is wide gap in the regulatory and expertise capacity between the developed and undeveloped countries. As such, region bodies and WHO help the undeveloped countries in assessing the safety of drugs. This also poses a problem as some of these bodies lack expertise in some cases. This divergent in the regulation is the main reason for the slow advancement in the pharmaceutical industry.

Question

Who is to be blamed for the lack of innovation and advancement in the pharmaceutical industry?