VIEWPOINT

The Nation Needs a Comprehensive

A
recent re-examination by the US Food and ucation system. It is fragmented and diffuse (e.g.,
Drug Administration of the current phar- few focused university programs, diverse in-house
maceutical quality decision-making system on-the-job training, and casual for-profit educa-
raised fundamental questions about its efficiency tional programs). The academic pharmaceutical
and its continuing effectiveness to address the in- science programs have limited resources and are
creasing complexity of pharmaceutical systems. burdened by a practice environment that restricts
FDA’s analysis improves our understanding of some their ability to generate knowledge with broad ap-
factors that make this a reactive decision-making plicability. Much of the focus today, especially in
system. Those factors include the low success rate pharmaceutical industrial operations and associ-
Ajaz Hussain, PhD, is for identifying the root cause of deviations and out- ated regulatory functions, seems to be based on a
the deputy director of the of-specification observations as well as the pre- “documentation and checkbox” approach, in which
Office of Pharmaceutical dominant focus on end-product testing—often deviations are a source of significant inefficiency
Science at the Center for based on an inadequate statistical consideration and contribute to cross-disciplinary and cross-
Drug Evaluation and
Research at FDA, 5600
of inherent variability and static process condi- organizational circular arguments of art versus
Fishers Lane, Rockville, MD, tions—which, some argue, evolved to facilitate science. A reactive decision-making system, in turn,
20852, tel. 301.443.5405, regulatory document expectations for “process works in a cumulative manner to undermine the
[email protected]. validation.” FDA also has recognized that a reac- credibility of the pharmaceutical industrial com-
tive decision-making system is not conducive to munity. The current pharmaceutical science
innovation or continuous improvement. In a re- educational system is in dire need of transforma-
active environment, it is difficult to remove built- tion to ensure that we continue to meet our pub-
The pharmaceutical in inefficiency; the public bears the burden of this lic health and security objectives efficiently and to
inefficiency because its cumulative costs reduce maintain a highly competitive environment for the
science education our ability to serve our customers well (1). US pharmaceutical industry.
In current public debate, the pharmaceutical in- Transforming the focus from industrial phar-
system must be
dustrial community is generally viewed as reactive. macy to pharmaceutical engineering would create
transformed to For example, pharmaceuticals often are regarded as a more rigorous quantitative approach, to provide
a healthcare cost or burden; counterarguments a means to create a new professional identity and a
ensure that we highlighting the cost-saving contributions of phar- structure for considering opportunities for profes-
maceuticals generally are drowned out. Adding to sional licensing and a culture of continuous edu-
continue to meet
the challenge are growing concerns about drug cation. Several points of view on a need for a phar-
our public health safety, drug shortages caused by manufacturing dif- maceutical engineering approach have been
ficulties, highly publicized manufacturing problems expressed previously, often by individuals who re-
objectives and to with significant economic impact on companies ceived their basic training in disciplines other than
and their investors, counterfeit drugs, and unethi- pharmacy (2–4). This paper provides the point of
maintain a
cal compliance practices by a few “bad apples.” This view of an individual who received basic training in
competitive challenge is significant and long-term. Ideally, the the discipline of pharmacy.
environment in which the pharmaceutical indus- The proposed transformational change should
industry. trial community operates should facilitate its abil- be guided by the lessons learned from the evolution-
ity to meet, and preferably exceed, the needs (ther- ary path of several engineering disciplines, particu-
apeutic, affordability, and informational) and larly mechanical and chemical engineering (see
expectations of patients and society. Continued on page 121
The objective of this column is to share a point
Your opinion matters.
of view that the symptoms observed in the current
To contribute to this column, send your
pharmaceutical system are, in part, a reflection of proposal to [email protected].
the current state of the pharmaceutical science ed-
122 Pharmaceutical Technology SEPTEMBER 2005 www.phar mtech.com
Viewpoint
Continued from page 122
Figure 1), and the process by which the Na-
tional Science Foundation’s (NSF) policies Systems

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can provide a platform for discussing how

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1925: Unit operations
to structure a national education and re- 1940: Industrial pharmacy
1905–1915: Industrial chemistry
search agenda.
It is recognized that efforts to improve
pharmaceutical science and engineering ed- Figure 1: The evolutionary path of chemical engineering suggests a dynamic process moving
ucation have existed for several years, and toward molecular transformations, multiscale analysis, and a systems approach for addressing
new programs have been initiated recently the needs at all scales and supplying tools to deal with dynamics, complexity, uncertainty, and
(2–7). A significant concern remains, how- external factors (10).
ever, that these efforts are scattered and may
not be sufficient or sustainable without the consist of a body of theoretical and empir- is not simply an academician’s [or a reg-
long-term commitment of a stable funding ical knowledge about design, computa- ulator’s] lament; the cost of [pharma-
mechanism and an improved system for tional methods and tools for design, and ceuticals] is enormous and the risk to
recognizing the talent and contributions of a new curriculum for the next generation public safety daunting.
scientists and engineers working in this field. of designers. • “And like the heroes of the French Rev-
Such mechanisms will be essential to con- To summarize this point of view, it seems olution, we look to a future that will
tinue attracting high-caliber scientists, en- appropriate to draw a parallel between chal- bring us everything or nothing, depend-
gineers, and students to this field of study. lenges facing pharmaceutical and software ing on the public trust” (9).
The pharmaceutical community must con- systems using a thought-provoking analy-
sider developing a national agenda for de- sis of software engineering education (9). References
bate and planning activities leading to the The following selected statements highlight 1. US Food and Drug Administration, Pharma-
development of a comprehensive pharma- some of the broad issues in software engi- ceutical cGMPs for the 21st Century—A Risk-
Based Approach: Final Report (FDA, Rockville,
ceutical engineering education and research neering; to illustrate their relevance, certain MD, Sept. 2004), http://www.fda.gov/cder/
system. terms (e.g., industrial pharmacy), relevant gmp/gmp2004/GMP_finalreport2004.htm and
To engage a broad range of stakehold- to this discussion have been added or in- http://www.fda.gov/cder/gmp/gmp2004/
ers in these discussions at the national or serted (in brackets) in place of the original manufSciWP.pdf (accessed Aug. 18, 2005).
international level, we first must overcome terms (9): 2. L. Mendricks, J. Vanroeyen, and H.Y. Wang,
“The Future of Pharmaceutical Engineering,”
the disciplinary and organizational divide • Despite years of hard work and dedi- J. Pharm. Sci. 93 (2), 235–238 (2004).
within our community and avoid the cated champions, [industrial pharmacy] 3. M.T. Klein, “PAT and Process Understand-
“blame game” that arises in the regulated, still struggles to become the discipline ing: A Call to Arms,” Pharm. Technol. 29 (4),
multidisciplinary, applied scientific envi- its founders envisioned. Its educational, 206 (2005).
ronment in which decision-making re- industrial [and regulatory] constituents 4. H. Leuenberger and M. Lanz, “Pharmaceu-
tical Powder Technology—from Art to Sci-
sponsibility is divided to facilitate “com- have not only failed to converge on a ence: The Challenge of FDA’s PAT initiative,”
pliance.” A multidisciplinary collaborative set of foundational principles, but the Adv. Powder Technol. 6 (1), (2005).
framework and positive vocabulary will be already large gap between [pharmaceu- 5. Center for Pharmaceutical Process Research,
essential. A new NSF funding program, the tical education] and industry [and reg- http://www.cppr.purdue.edu/ (accessed Aug.
Science of Design (SoD), may be useful in ulatory practice] continues to grow. 18, 2005).
6. The National Institute for Pharmaceutical
this regard (8). Although the current SoD • Curricula are diffuse, [pharmaceutical] Technology and Education, http://www.
program is directed at the scientific study systems continue to have ever large purdue.edu/dp/nipte/ (accessed Aug. 18, 2005).
of the design of software-intensive systems, error counts, and the financial risks of 7. The MIT Center for Biomedical Innovation,
it is intended to address challenges famil- taking on [pharmaceutical] projects are http://cbi.mit.edu/ (accessed Aug. 18, 2005).
iar to the pharmaceutical community: In growing. 8. National Science Foundation’s Science of De-
sign program, www.nsf.gov/publications/
software systems, as in pharmaceutical sys- • [The chemical and mechanical] engi- pub_summ.jsp?ods_key=nsf04552 (accessed
tems, complex interdependencies pose a neering disciplines have done the job Aug. 18, 2005).
challenge for creating, maintaining, com- right, and [genetic] engineering is at 9. J.H. Poore, “A Tale of Three Disciplines and
prehending, and controlling these systems. least trying to do the job right. They a Revolution,” IEEE Computer, 37 (1), 30–36
The SoD program seeks to rectify this sit- have managed vast complexity and (2004).
10. Adapted from information on chemical en-
uation by building a foundation for the achieved a high level of public trust. gineering education at the MIT Web site,
systematic creation of software-intensive [Industrial pharmacy] could take les- http://mit.edu/che-curriculum/2003/index.
systems. This foundation is proposed to sons from either discipline—and this html (accessed Aug. 18, 2005). PT
Pharmaceutical Technology SEPTEMBER 2005 121