The pharmaceutical industry is experiencing unprecedented late-stage setbacks, product recalls, and difficulties in generating high-quality drug candidates. The problems are not specific to any one company or research effort but rather a result of the industry's limited knowledge of biology and chemistry. (See "Depth of the Problem," page 47.) Therefore, a key challenge is the industry's ability to transition to "new biology" -- genomics and proteomics -- which seeks to understand the causes of diseases through their biological structures and functions at the cellular level.
Those problems raise fundamental questions about the core of the industry's future:
Despite the excitement surrounding the Human Genome Project and other recent breakthroughs, the number of validated targets has not increased significantly. Carbohydrate-like targets or phospholipid signaling systems could yield new drug targets but are beyond R&D's reach because of their complex chemistry. Companies are already using many of the simpler and well tolerated chemicals and are now faced with the challenge of using the remaining chemicals, which are structurally more complex, bigger, and not as well tolerated. Additionally, the increasing demands from physicians, consumers, managed care companies, and regulators have also raised the bar for new therapies.
New Game Plan The industry has begun to expedite drug development and discovery through redesign and the introduction of new technologies such as interactive voice response for clinical supply chain management, remote/electronic data capture for clinical trials management, high-throughput screening, and predictive toxicology assays. Pharma companies should continue to aggressively take advantage of new technologies, but they cannot counteract the inherent limitations of the current R&D model. On the other hand, investments in biology predictive software, combinatorial chemistry, and screening technologies have the potential to extend the use of already validated targets.