Op Ex & Lean Six Sigma

On Transforming Pharmaceutical Technology Education

A looming crisis in the availability of qualified graduates signals the need for a paradigm shift in pharmaceutical technology education.

By Lee E. Kirsch, Ph.D., Associate Professor, Division of Pharmaceutics, University of Iowa

* 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.[1] 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.[2]

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 agencies—even those with growing budgets, such as NIH and NSF—have failed to increase or even decreased support for research and education initiatives in physical sciences and engineering.[2] 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.[1] 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),[3] 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.[3]

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.[3]

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.

Current NIPTE Participants

Duquesne University
Illinois Institute of Technology
Purdue University
Rutgers University
U. Puerto Rico San Juan/Mayaguez
University of Connecticut
University of Iowa
University of Kansas
University of Kentucky
University of Maryland – Baltimore
University of Minnesota

The implementation plan includes training students in degree programs at the individual institutions using shared curricular materials. In addition, summer training programs and industrial internships are envisioned via a network of industrial and institutional collaborators. The curriculum is based on the precepts of interdisciplinary approaches strongly advocated by the National Academy of Sciences and constructivist learning theories important in the development of modern engineering and science higher education.[4-6]

Pharmaceutical technology is inherently interdisciplinary, involving a broad range of biological, physical, chemical and mathematical topics. The interdisciplinary nature of “pharmaceutics” is likely part of the reason that support for research in this discipline has “fallen through the cracks”: too much of a physical/engineering science focus for support from NIH and too biomedical for support from NSF. In fact, for many years pharmaceutics scientists have been involved in advancing the scientific foundations underpinning in vitro and in vivo drug product performance and rational drug delivery system design and development. The NIPTE approach profoundly extends the interdisciplinary nature of pharmaceutical technology education by merging the pharmaceutical sciences traditionally associated with pharmaceutics with modern engineering approaches.

The NIPTE consortium is strongly represented by both pharmaceutical science and engineering faculties from leading institutions with specific expertise in pharmaceutical chemistry and manufacturing systems. This merger of pharmaceutical science and engineering disciplines has been especially exciting. And the NIPTE faculty strongly believes that the engineering and pharmaceutics approaches are complementary, and their merger is essential for advancing our fundamental understandings of pharmaceutical product design, development and manufacturing processes.

Within the NIPTE curriculum, direct partnerships with industrial practitioners will be manifested in two ways. Firstly, industrially-based educators and technology experts are expected to directly contribute to course content in the development of realistic simulation models, lecture materials and practice problems. Secondly, an industrial internship program will be instituted to provide students with the opportunity to gain experience in industrial best practices.

The curriculum is envisioned as a constructivist approach to education whereby students are provided the opportunity through computer simulations, laboratory exercises and internships to explore principle-based or empirical models in order to solve pharmaceutically-relevant problems and develop an understanding of their underlying principles. In addition, the curriculum includes training in experimental design and modeling tools to provide the students the wherewithal to build both principle-based and empirical models and to operate their models for the tasks of designing, predicting, and optimizing product and manufacturing performance.

To date, the development of the curriculum has primarily involved a committee of about 30 faculty members from all NIPTE institutions in a series of 11 workshops held over the last three years. In addition, two open-invitation stakeholder meetings were held and attended by nearly one hundred representatives from various non-NIPTE academic institutions, professional associations, NGOs (e.g., USP), federal agencies (e.g., FDA and NSF), and the pharmaceutical industry. 

The current version of the curriculum consists of a set of core courses that cover various physical pharmaceutical chemistry topics, mathematical and statistical modeling, material science, and biopharmaceutics, and a series of pharmaceutical technology courses that focus on manufacturing development and control and product design and development. In addition, more than a dozen elective modules have been proposed that delve into various specialty topics and advanced subjects. 

Clearly, many important unresolved issues face us as we move forward, including the development of innovative course content, new textbooks and well-crafted, principle-based simulation models; the incorporation of the NIPTE curriculum into individual institution-based degree programs; the training of versatile faculties to support course delivery at each institution; the development of mechanisms for meaningful curricular assessment, management and improvement; and the establishment of collaborative connections with interested industrial, governmental and academic stakeholders. But the NIPTE collaborators have drawn on their collective energies and are determined to see the fruition of this transformative effort.


References

1. Rising Above the Gathering Storm: Energizing and Employing America for a Brighter Economic Future, National Academy of Sciences (2007).
2. Trends in Federal Support of Research and Graduate Education, National Academy of Sciences (2001).
3. Augsburger, L.L. Ensuring the Supply of Highly Qualified Pharmaceutical Scientist Specialists in Product Development and Related Technologies for Present and Future Needs—Report of the 2004 PT Section Education Committee. AAPS PharmSciTech, 8 (1) Article 19 (2007). (
http://www.aapspharmscitech.org)
4. Facilitating Interdisciplinary Research. National Academy of Sciences (2004).
5. Jarvis, P, Holford, J, and Griffin, C. The theory and practice of learning, Kogan Page, London (1998).
6. Crawley, E.F., Brodeur, D.R., Soderholm, D.H. The Education of Future Aeronautical Engineers: Conceiving, Designing, Implementing and Operating. Journal of Science Education Technology (2008).

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