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project. Rather, patents are obtained and a company is started. I marvel at the recent reports of a new technique in cardiothorasic surgery being performed using the laparoscopic approach. Instead of reading about the advances in JAMA, the discussion centers in the Wall Street Journal and the possible IPO that will be forthcoming. Entrepreneurs and academicians are forming alliances that may speed a procedure or chemical entity into a viable product for development. While the free exchange of ideas may be limited and scientific discourse suffer a bit, the possibility of widespread clinical use facilitated by commercial development is enhanced. The pros and cons of this approach are not for us to debate, but rather to accept as a trend that is ongoing and growing considerably. I do think that the nimbleness of these small dynamic companies, coupled with their lower overhead cost, offers considerable benefit to pharmaceutical discovery and development. Drugs are being developed that the larger concerns would not have considered. The advancement in niche areas like orphan drugs are for the most part being pursued by smaller companies. I believe this is a healthy trend and one that will force all of the industry to streamline. Combined with the trend of small niche companies in drug development has come the parallel corporate trend of downsizing and the hesitancy to expand divisions to take on temporary projects. More and more of the large companies are contracting for critical aspects of drug discovery and development. Compounds can be manufactured under contract. Consultants can put together manufacturing specifications and preclinical testing, and stability work can be done under contract. Clinical studies are performed by CROs with the data handled by contract statistical analysis. A consulting team can put together a NDA under the supervision of a small core group at corporate headquarters. This can be done for the small company or the very largest of the pharmaceutical giants. Parts of a projects can be subcontracted. Indeed it is not uncommon for intermediate-to-small projects at the largest companies to be entirely subcontracted. For these reasons, the CROs and other contract service companies (CSAs) have been most successful. A bonanza of new business has created exponential growth for these types of companies. The companies are competitive and the work relentless, but results are what makes the industry thrive and drug development has been speeded up considerably in some instances using this piecework approach. |
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There are dangers with the fragmented approach. Outside companies can be less dependable; projects can fall apart when the capitalization of the company is inadequate and they go under; and less than favorable schedules can sometimes develop since the project is not necessarily the highest priority of the contracting company. The fragmented approach can create situations wherein the contracting company is less able to alert the primary company to important clinical findings that should alter the development program or to serious toxicities that need to be taken into account. If studies are performed |
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