* Permission to print the following article is granted by the National Institute of Pharmaceutical Technology and Education (NIPTE).
The future of the pharmaceutical technology workforce is of profound concern to those of us involved directly in or in support of the pharmaceutical industry. Historically, pharmaceutical innovations and discoveries have propelled this industry to great successes manifested in decades of strong economic growth and advances in effective drug therapy. The vitality of this technology-intensive industry has been attributed in large part to the highly-trained engineers and scientists who serve as a constant source of innovative ideas.
The possibility that this vitality may be stagnating due to a lack of interest in science by the current crop of students, or a lack of a strategic focus in the development of human resources, has troubled both policy-makers and leading scientists. Our future ability to capitalize on new biomedical discoveries and generate new business and growth is at risk, in part, because of a lack of support for the physical sciences and engineering. These disciplines directly impact progress in the technologies used to develop and commercialize biomedical discoveries.
The National Institute of Pharmaceutical Technology and Education (NIPTE) seeks to remedy this situation through two strategic objectives aimed at: 1) implementation of a technology research roadmap to advance the basic sciences supporting the development and manufacture of pharmaceuticals; and 2) implementation of an advanced curriculum to nurture the highly-trained professionals needed to advance our capabilities in pharmaceutical technology disciplines. The former strategic objective is elaborated in a Pharmaceutical Technology Roadmap, a document currently being finalized by NIPTE participants. The NIPTE approach to achieving the latter, a new curriculum, is described herein.
A Crisis at Hand?
Is there really an impending crisis in maintaining and advancing pharmaceutical technology innovations, and is it attributable to insufficient development of human resources? Since the early 1990s, various federal agencieseven those with growing budgets, such as NIH and NSFhave failed to increase or even decreased support for research and education initiatives in physical sciences and engineering. Funding for basic biomedical research and, especially, new drug and drug delivery system discovery has not been matched by that for the development and manufacturing of these biomedical innovations. Consequently, many of the current technologies used to develop and manufacture pharmaceutical products are largely identical to those used in the middle of the last century. And our fundamental understanding of pharmaceutical manufacturing technologies has advanced very little in the past 25 years.
Globalization has impacted the source of manufactured goods and components. But it has also begun to change the source of high-quality, knowledge-intensive jobs associated with the design, development and manufacture of pharmaceuticals. The drivers for outsourcing in the pharmaceutical industry, as in other industries, include the cost of labor, taxation environment, cost of capital, availability and quality of innovation talent, availability of qualified workforce and quality of research universities. The last three drivers are especially relevant to the current and future state of pharmaceutical technology education.
According to a recent survey of practicing industrial scientists conducted by AAPS (American Association of Pharmaceutical Sciences), 35% of respondents believe that current training for entry-level pharmaceutical development scientists is inadequate, 60% believe that there is a shortage of suitable candidates and nearly 70% asserted that there is an inadequacy in the number of US colleges focusing on industrial needs. These data point to a decline in the availability and quality of innovation talent.
Traditionally, the majority of pharmaceutical product development scientists have been trained in colleges of pharmacy under the auspices of industrial or physical pharmacy (pharmaceutics) programs. These programs have declined substantially in recent years because of two trends: 1) the emphasis in professional pharmacy programs on patient care rather than product knowledge; and 2) the lack of research funding in basic physical sciences underpinning development and manufacturing.
Both of these trends are national in scope. Pharmaceutical curricula have deemphasized basic laboratory sciences and converted available curriculum space to clinical pharmacy and practice courses and experiences. Meanwhile, research and training investments in the physical science and engineering fields, including those focused on the fundamentals of pharmaceutical technology issues, have declined. Thus the continuing supply and availability of entry-level pharmaceutical scientists for the industry has substantially decreased in recent years, as has the number of suitably trained new faculty with relevant pharmaceutical technology research interests.
The decline in the availability and quality of new pharmaceutical technologists, the stagnation of progress in the basic sciences underpinning pharmaceutical manufacturing and development, the possibility of lost opportunities for capitalizing on biomedical discoveries, and the potential problems associated with outsourcing pharmaceutical development and manufacturing have created an urgent need for a new transformative paradigm for pharmaceutical technology education. The paradigm needs to be principle-based, expansive in scope, and flexible in implementation; and it needs to take advantage of dispersed educational resources.
The NIPTE Plan
In an effort to address these issues, the NIPTE consortium (www.NIPTE.org; see Box) has set out to leverage its collective pharmaceutical technology expertise, to share educational assets, and to collaborate with industrial, governmental and academic stakeholders for the purpose of transforming pharmaceutical technology education. The goal is to formulate a pharmaceutical technology curriculum that will provide the highest caliber entry-level scientists/engineers for the pharmaceutical and biopharmaceutical industries.