Abstract
Historians will likely look back at the early part of the 21st century and note that it was a time that society searched for, out of necessity, a new economic equilibrium. Escalating costs for goods and services, dwindling resources, global environmental challenges, aging populations, etc, have either contributed to the need for a new economic realignment or will be impacted by the consequences of one. The new economic realignment will certainly call for novel, better, and more efficient products and the processes to make them. Toxicologists cannot ignore the impact that a new economic equilibrium and the process of achieving it will have upon how they practice their profession.
Some commercial enterprises have no choice but to adopt a “do more with less” approach to find their place in the new economy. Other segments can and should implement a “waste reduction” strategy in finding their newly defined economic positions. Toxicology, with its ubiquitous presence, has both a vertical (within an individual product life-cycle) and lateral (across a wide variety of product-types) place in the economy. This diversity of toxicology’s involvement provides an opportunity to participate and contribute in the new economic equilibrium by increasing efficiency within diverse product developments. Toxicology not only can but must continue with its traditional mandates of identifying hazards and contributing to risk assessments. However, toxicologists have an opportunity to contribute an increased efficiency to the evolving new economic equilibrium.
How can this happen? To be sure, an enlightened business management leadership, specifically in commercial development, is necessary, but that leadership requires guidance. Predictive Toxicology in Drug Safety, reviewed on page 452, provides a foundation and the essential elements for toxicology to make commercial developments of all kinds more efficient. The themes expressed in the book are not only spoken to the toxicologist but are also words for product development managers.
As the editors of Predictive Toxicology in Drug Safety initially state in the Prologue and finally emphasize in the Epilogue, the costs associated with assessing human risks for drugs is huge, both in direct costs and hidden costs of delayed market entry. Some sources put the costs for an individual drug development in hundreds of millions to over a billion dollars (US). The precision of the actual figure is unimportant; it is a single digit to which a large number of zeros is added. More significantly, the monetary costs are less important than the delayed delivery of therapeutic agents to patients in need and in the case of non-drugs these costs are lost opportunity costs. Compounding the monetary costs and delays in treating diseases is the added problem of the large number of potential candidates necessary to find the one successful drug. The mission of predictive toxicology is to reduce development costs, deliver therapies to patients quicker, and eliminate nonviable candidates early in the development path of drugs is a noble one. The editors' words ring true for all types of commercial developments in which toxicology plays a role.
While the editors of the book and their contributing authors for each of the chapters are associated or closely aligned with the pharmaceutical industry, the practice of toxicology, as they describe it, has universal applicability in other industries. The book lays out ideas, approaches, and methods for practicing toxicologists in a generic commercial setting using drug development as an example.