From DNA to NDA--the impact of recombinant DNA technology on new drug development.

Man's long-standing efforts to alter living things through genetic manipulation have become reality. Recent advances in recombinant DNA technology have the potential to alter the drug-development process profoundly. The pharmaceutical industry has had to adjust its research efforts and develop new state-of-the-art laboratories. In addition to the standard biological and in vivo assays, many new tests are required, e.g., amino acid sequencing, high-pressure liquid chromatography, and radioimmunoassays. Academic researchers have played a vital role in developing the new biotechnology, supplying most of the basic scientific knowledge and the initial supply of the scientific work force. The recent shifting of support for scientific training from the government to the pharmaceutical industry has resulted in unprecedented academe-industry relationships. Universities now stand to profit significantly from patent rights resulting from biotechnology research efforts. While the advances in biotechnology have had considerable impact on the pharmaceutical industry and academia, they have thus far had only a minor impact on the regulatory process. To date, the preferred regulatory path appears to be modification of existing procedures through the issuance of guidelines, which can be updated as knowledge increases.