A New, Emerging Imperative

In the near future, within the larger sphere of therapeutics, where will one find the more exciting, more rewarding career opportunities and options?

Pharmaceutical and biotechnology companies are increasing the productivity of their research organizations on a massive scale in order to deliver new, safer and more effective drugs, and to maintain competitive growth. There is also a pressing need to decrease the time (and cost) from therapeutic concept validation to new drug approval. During the past 40 years, the median cost to market a drug has increased from $50 million to $500 million. The time required for drug development and approval has increased from eight to thirteen or more years, while the failure rate of new drug lead compounds has stayed constant at about 90%. The needed productivity improvements become even more important with the drug market's anticipated increasing segmentation, which is driven in part by the 'omics? revolution (as in genomics, proteomics, etc.). The growing pharmacogenomic expectation is that new technology can be used to identify population subsets that are better targets for new drug development than the entire population. Industry's response, thus far, has been to expand and fortify technology domains along the discovery/development pipeline. The most visible are combinatorial chemistry, high-throughput screening, in vivo screening, analytical chemistry, drug safety, ADME adsorption, distribution, metabolism, and excretion toxicology, pharmacokinetics, genomics, proteomics, etc.).

I maintain that over the next 20 years that new diagnostic technologies will allow more new drugs to be targeted to specific subsets of patient populations. Such therapeutic "optimization" and individualization will require that the pharmaceutical and biotechnology private sector increase research and development efficiency in order to take advantage of the new, smaller market sectors for subset specific drugs. The pharmaceutical industry will face additional challenges with the continuing climate of mergers and acquisitions, which is certain to put extra burdens on the industry's resources due to the increasing need for research by cross-functional teams, remote geographical locations, diverse scientific and cultural backgrounds, and the diverse processes of the entrepreneurial segment of the business.

To meet this challenge it is imperative that companies leverage all the available knowledge, particularly at the intersection of experimentation, bioengineering, simulation, modeling, and informatics. The entire pharmaceutical R&D process is characterized by people making decisions. Yet to make better decisions, people require rapid access to intelligently organized knowledge and the emerging tools to mine for informational gems. A growing need exists to capture all available information and knowledge, including a company's past experimental data, corporate successes and failures, and so on, and to disseminate that knowledge in easily accessed form throughout the company. A critical factor for future success will be to find an efficient way to provide all decision makers, bench scientists, engineers, R&D managers, and business development, licensing executives, etc., access to semi-intelligent decision support tools that have direct access to the relevant knowledge and information.

Within the decade, as the genomics waves advance, the number of potential molecular therapeutic targets will increase by a factor of 10 to 60. The companies that will benefit most will be those that adopt a more systematic, computationally enhanced approach to drug discovery supported by an underlying, integrated engineering and informatics framework. Moreover, the implementation of such an integrated, enterprisewide framework is expected to leverage the improvements and innovations being made in each of the above technology domains that contribute to new drug approvals. That leveraging process will have a fundamental impact on the pharmaceutical and biotechnology industry, reducing the time and cost required to bring a new drug to market.

The future of the healthcare enterprise and its impact on human health will be dependent on how well the next generation of scientists is able to integrate all the technology domains across the R&D cycle into an integrated, informed strategy for drug discovery and realization. The critically important incorporation of clinical data into this strategy is expected to dramatically increase the probability that a lead compound will become a marketable drug, and so will further reduce the time and cost required for drug discovery and development. Such change, such evolution, affords tremendous opportunities for the new generation of scientists and bioengineers that will be joining the profession during the coming decade and beyond. Realizing that opportunity, however, will require changes in both philosophies and processes of research and graduate education. Those individuals who understand this biological and medical informatics imperative and are willing to adopt new technologies and mind-sets to help bring it to fruition will become the new leaders. They will help produce a fundamental, positive impact on human health and quality of life.

C. Anthony Hunt, PhD
The University of California, San Francisco
2001

 
 

The premise of the agent paradigm, its related theory and methodologies together with advances in multilevel modeling of complex systems of interactions opened new frontiers for advancing the physical, natural, social, military, and information sciences and engineering...