Reducing R&D Time, Slashing Costs
The industry focus also has been to reduce the cost and time for new drug development. The role of genetically based diagnostics
in the development of personalized medicines has already shortened the R&D cycle for some products. These new technologies
will improve understanding of diseases and link genomic and clinical data. The convergence of therapeutics and medical devices,
which started in earnest with the drug-releasing stents, will continue and will become increasingly sophisticated, improving
efficacy and reducing the risk profile of many existing therapeutic agents.
The ultimate beneficiaries of the changes in the industry and the technology that supports them will be the patients. Patients
will benefit from improved treatments and will get them more quickly and less expensively than they do now. The reliability,
safety, and efficacy of medicines and practices will increase multifold. Researchers can look forward to much higher processing
speed, data crunching technologies, real-time data acquisition, and data synchronization.
The current R&D model of four-phase clinical trials that typically end in submission for a drug license and market approval
will be replaced by collaborative in-life testing and "live licenses" being issued based on the performance of the drug during
the trial. The industry will conduct smaller, more focused clinical trials, continuously sharing results with regulators.
If testing confirms that a medicine is safe and effective, a live license will be issued permitting the company to market
the drug on a restricted basis. Further in-life testing will extend the license to cover a larger number of patients or a
different patient population. The use of biological models, bioinformatics, and biomarkers to identify toxic or ineffective
drugs early in the development process will help to drive down development costs, increase revenues, and improve overall industry
productivity. It may be possible that the time between target identification and market launch will be reduced from almost
12 years to less than 5. We might also anticipate an increase in the success rates of bringing products to market by a factor
of four, while the costs of clinical studies are slashed from an average $800 million to as little as $200 million. Already,
several national and regional regulators have begun to collaborate by sharing safety and efficacy data. There may well be
one global regulatory system by 2020, administered by national or federal agencies responsible for ensuring that new treatments
meet the needs of patients within their respective domains. Such a system would help to reduce the spiraling costs of regulatory
compliance and reduce time to market.
Milind Joshi, vice president,
Life Sciences Practice, Patni Computer Systems
Industry experts give their predictions for the next 30 years. Read Editor-in-Chief Michelle Hoffman's introduction here. See what's next in:
Strategy and Regulation