What's Next In: Information Technology

Dec 02, 2007

Predictions


(IMAGE: PHOTOS.COM/MELISSA MCEVOY)
I foresee dramatic future changes in five distinct areas of the pharmaceutical industry: Research, Regulatory Approval, Production, Sales & Marketing, and IT Infrastructure.

Research (30 years out) Thirty years from now we will not make much of a distinction between biotechnology and synthetically driven drug development. The biologics will be considered just another way to synthesize chemical entities. We will have much more knowledge about the biological effects of specific substructures within molecules. By analyzing a molecular structure, we will be able to accurately predict a chemical entity's bioavailability, stability, toxicity, and efficacy to specific tissue, organ, or nerve targets. Companies will use their IT infrastructure to maintain massive chemical structure databases with proprietary metadata about the interoperability of specific molecular substructures. Most chemical syntheses will be created by that suggests optimized synthetic steps in much the same way a GPS system generates the shortest route between two addresses. Network security will become paramount as corporations embrace the hacker and virus model to steal confidential information.

Research (100 years out) Advancements in our scientific understanding of both chemical and biological processes will give rise to sophisticated modeling and programming in both areas. Models of organic and inorganic chemistry will allow computer systems to suggest new chemical entities that have specific therapeutic properties. The computer systems will also recommend the steps necessary to synthesize those entities. The trick will be engineering the equipment to physically reproduce theoretically possible chemical processes. On the biologics side, advancements in our understanding of DNA, stem cells, and cloning will allow the emergence of the new discipline of Genetic Programming. Genetic Programmers will use their education in programming and biology to structure the DNA of proposed organisms from scratch. These DNA sequences will be created in the laboratory, inserted into stem cells, and ultimately cloned into organisms designed for a specific purpose. These organisms might be designed to create a chemical entity that cannot feasibly be produced by synthetic means. Or the organism may be designed to ingest specific unwanted bacteria, viruses, or cells in the living body. These programmers will, of course, make mistakes. But in that case they really will be bugs.

Regulatory Approval (30 years out) Approval of new medicines will change dramatically. No longer will approval be something that "happens": It will be something that is "managed" on a continual basis. We are all familiar with adverse event management systems. New systems will also track efficacious events. Each use of a medicine will be audited and will add to the background of information. Adverse events will subtract from a medicine's approval for use, and each efficacious event will add to it. The more efficacious events, the broader the approval and more likely the medicine will be prescribed. Each adverse event will have the opposite effect. The profile of efficacious and adverse events will be matched against the profile of a patient to determine whether the patient is a good fit for a particular medicine. Automated prescribing systems will suggest the combination of medicines and procedures with the best likelihood for the optimal patient outcome. These changes will have a profound effect on pharmaceutical marketing practices, perhaps even eliminating it.

Regulatory Approval (100 years out) The only change is to the regulatory bodies themselves. Our notion of the state evolves so that multinational corporations wield as much political influence and have similar infrastructure profiles as current day governments. The profit motive behind regulatory oversight becomes paramount. Medicines and procedures have wide approval profiles if they reduce the overall cost-of-living. People will have to make choices between living longer and living better, and people will have wildly different notions of what "better" means.

Sales and Marketing (30 years out) The current day conception of a sales force with advertising and brand management goes away. Automated prescribing systems diminish the influence of the sales force. The Marketing department becomes a scientific discipline and functions to increase the prescribing profile of a product by performing deep-diving research into every adverse event to make sure that the impact on the prescribing profile is minimized.