COMMENTARY

The Future of Pharmaceutical Engineering

L. MENDRICKS, J. VANROEYEN, H.Y. WANG InterPro—Pharmaceutical Engineering Program, The University of Michigan, Ann Arbor, Michigan 48109

Received 25 April 2003; revised 7 August 2003; accepted 11 August 2003

The healthcare industry is changing. Unmet failures sooner in the research and develop- medical needs, an aging population, rising health- ment (R&D) process5 to maintaining manufactur- care costs, and sparse pharmaceutical pipelines ing compliance with federal regulations and are forcing healthcare companies to reevaluate improving efficiency, pharmaceutical companies their competitive strategies. Also, consumers are are actively searching for innovative solutions to playing a larger role in healthcare. Patients these complex problems. Decreasing a promising are more knowledgeable and assertive regarding candidate’s time to market in drug development is their individual healthcare decisions and are especially important due to dwindling patent pro- putting additional pressure on the industry to tection, increased generic competition, and early lower cost through innovation.1 The healthcare introduction of competitor’s ‘‘me-too’’ products. sector, comprised of pharmaceutical, biotechnol- Increasingly, technical and scientific decisions ogy, medical device companies, government agen- are coupled with business, legal, and marketing cies such as the Food and Drug Administration priorities. Corporate strategy, generally aimed at (FDA), healthcare providers, insurers, and con- identifying and producing blockbuster drugs, may sumers, is a dynamic and unique entity, rapidly be shifting toward strategies targeting smaller moving towards highly automated and electronic patient populations with safer and more effective environments in which the storage, management, medicines through pharmacogenomics.1,6 Geno- and use of complex information is essential for mics and other biotechnology tools are beginning success. to find their way into large pharmaceutical com- Pharmaceutical companies lie at the center panies as biotech products start to compose a of America’s healthcare debate. In response to significant portion of many companies’ pipelines.7 market and regulatory forces, the industry is re- However, the integration of biotechnology with the structuring, consolidating, and reevaluating their pharmaceutical industry will require significant competitive strategies. The cost to bring a single changes in R&D and manufacturing strategies.4 new drug product to market has steadily increased Industry experts cite the need for quality and to $500–$800 million.2,3 As much as 75% of the efficiency to be built into each area of drug dis- total cost of each marketed drug is attributed to covery, development, and manufacturing. New high failure rates of other candidates due to FDA initiatives are promoting quality and effi- efficacy and safety problems.4 The high risk of ciency by implementing a risk approach through drug development places increased pressure on all continuous assurance programs. To help prevent levels of the organization to reduce cost and in- the production of poor quality products, programs crease productivity. From identifying candidate such as quality manufacturing operations, risk assessment, and risk management are being implemented.8,9 The integration of discovery, deve- lopment, and manufacturing and increased inter- Correspondence to: L. Mendricks (E-mail: [email protected]) action among industry, academia, and government Journal of Pharmaceutical Sciences, Vol. 93, 235–238 (2004) are avenues to improve efficiency within the health- 5 ß 2004 Wiley-Liss, Inc. and the American Pharmacists Association care sector. This drive for improved product

JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 93, NO. 2, FEBRUARY 2004 235 236 MENDRICKS, VANROEYEN, AND WANG quality and process efficiency within the industry is scientific foundation will provide the backbone to increasing the demand for new crossfunctional each individual student’s course of study. Second, scientists and engineers to tackle difficult and com- additional academic courses in statistical analysis, plex problems. Today’s pharmaceutical scientists risk assessment, intellectual property, corporate and engineers are found working in the pharma- business strategy, and technology development ceutical, biotechnology, and medical device indus- will elaborate on the student’s academic core. tries. Informatics, high-throughput screening, Knowledge gained from these courses will be cru- simulations, and process analytical technologies cial components for decision making at all levels (PATs) are some examples of current and new of an organization. These classes, coupled with science and technology tools that are affecting the several seminar/lecture series on current health way in which discovery, development, and manu- science and engineering-related topics will create facturing of therapies, diagnostics, and devices are a solid platform from which the student can ad- performed.5,8 vance into the third and final component of Developing new and innovative graduate re- practical training. Hands-on industry experience search and training programs in Pharmaceutical will pull together the students’ prior studies and Engineering is necessary to educate and train the experiences to instill the foundation for advanced healthcare industry’s future technical leaders. crossfunctional thinking. To develop the future Such programs are a means to provide the technical leaders for the pharmaceutical and life foundation for developing crossfunctional skills science industries, new Pharmaceutical Engineer- in engineering, life sciences, regulations, and ing programs should emphasize the development management as applied to the pharmaceutical, of both technical and ‘‘soft’’ skills to prepare the biotechnology, and medical device industries. students for a competitive and teamwork-driven Through academic and practical training, stu- environment. Universities with strong engineer- dents should be exposed to different aspects of the ing, pharmacy, medical, business, and law colleges healthcare industry early in their careers by pro- are ideal institutions to administer such strong viding them the opportunity to learn from mem- interdisciplinary graduate training and life-long bers of industry, academia, and government. This learning programs. Successful programs should exposure will allow students to better understand incorporate collaboration with industrial partners the complexities involved in this constantly chan- who are willing to provide technical and financial ging, technology-driven environment. Students resources along with practical training opportu- can enhance their technical knowledge within nities for students. Recruitment of students should pharmaceutical and biotechnology industries come from both undergraduate science and engi- through practical training in discovery, process neering programs and industry. Recent graduates development, formulation, and manufacturing. will benefit significantly from a learning environ- Additionally, they can gain knowledge in social, ment that includes working professionals with regulatory, legal, and business aspects of the varied educational backgrounds and experiences. healthcare industry through formal and informal Figure 1 illustrates the broad realm of disci- active participation in frequently held discussions. plines involved in pharmaceutical discovery and Interdisciplinary programs emphasizing the deve- development. In the past, more traditional curri- lopment of crossfunctional skills will give students cula in Pharmaceutical Engineering, or Industrial the education and training needed to succeed in Pharmacy, have been narrowly defined, focusing bringing innovative and practical solutions to the education and training on the late-stage devel- future healthcare industry. opment and manufacturing processes. Future In the true spirit of crossfunctional training and pharmaceutical engineers should be trained more learning, programs should be available to eligible broadly, learning the roles they can play as cross- students from a variety of undergraduate back- functional technical leaders and managers in a grounds with solid fundamental engineering and variety of job functions depicted on this pharma- science training. In a properly structured and de- ceutical and biopharmaceutical discovery and manding environment, diverse backgrounds foster development process flow diagram. This includes innovative and ‘‘out-of-the-box’’ thinking among pharmaceutical/clinical development and manu- students. For the successful implementation of a facturing, as well as discovery and early-stage strong, interdisciplinary degree program in Phar- development operations. The need for well-trained maceutical Engineering, a three-tiered approach engineers in all disciplines of pharmaceutical dis- may be used. First, a strong engineering and covery and development is increasing as the scope

JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 93, NO. 2, FEBRUARY 2004 THE FUTURE OF PHARMACEUTICAL ENGINEERING 237

Figure 1. Modern pharmaceutical discovery and development process. of therapeutics expands beyond small molecular nology (PAT) tools for evaluation and scale-up weight compounds to new and more complex bio- of pharmaceutical solids and semisolids unit pharmaceuticals and combination therapies. The operations. In the areas of pharmaceutical and convergence of the biomedical device and drug biopharmaceutical manufacturing, pharmaceuti- markets has led to the development and manufac- cal engineers will be concerned with current Good ture of innovative products such as drug eluting Manufacturing Practice (cGMP) compliant opera- stents for cardiovascular disease treatment. The tions, as well as the introduction and implementa- possibilities of combination products and thera- tion of robust PAT tools for process and product pies are endless as healthcare companies move validation and continuous improvement. In ad- from disease treatment toward disease manage- dition to quality management, Pharmaceutical ment.1 The increased complexity in healthcare Engineering graduates may also use their knowl- products has further emphasized the demand for edge and expertise to participate with policy- crossfunctionally trained and technology-driven making and regulatory agencies such as the FDA. professionals. As the healthcare industry continues to face Upon graduation, new pharmaceutical engi- significant challenges, pharmaceutical companies neers may find themselves supporting drug dis- in particular have an increased demand for techni- covery and/or development with high throughput cally competent leaders throughout the entire screening (HTS) procedures, total quality manage- discovery, development, and manufacturing pro- ment (TQM) to reduce false positive and false cesses. This complex and evolving industry re- negative results, and developing computational quires innovative technologies and improved tools in bioinformatics or cheminformatics. Exam- knowledge of cutting-edge science to overcome ples of specific projects in pharmaceutical/biophar- the challenges ahead. New interdisciplinary Phar- maceutical development that may be led by maceutical Engineering graduate education and pharmaceutical engineers include the develop- training programs have the potential to produce ment of experimental and computational tools for tomorrow’s leaders with the technical knowledge biopharmaceutical and pharmacokinetic para- and skills needed to meet the challenges presented meters (ADME) and toxicology evaluation to by the evolving healthcare industry. It is these reduce drug candidate failure. These pharmaceu- leaders who will define the Pharmaceutical Engi- tical engineers may also be involved in developing neering discipline and ultimately help to shape the quantitative models and process analytical tech- future of the healthcare industry.

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REFERENCES 5. Pharma 2010: The threshold of innovation. IBM Business Consulting Services; 2002. 6. Outlook 2003. Tufts Center for the Study of Drug 1. Pharma 2005: Marketing to the individual. IBM Development; 2003. Business Consulting Services; 2002. 7. Pharma 2005: Silicon rally: The race to e-R&D. IBM 2. Pharma 2005: An industrial revolution in R&D. IBM Business Consulting Services; 2002. Business Consulting Services; 2002. 8. Pharmaceutical cGMPs for the 21st century: A risk- 3. Tufts center pegs cost of a new prescription medicine based approach. US Food and Drug Administration. at $802 million. Tufts Center for the Study of Drug http://www.fda.gov/cder/gmp/index.htm. Development; 2001. 9. Process analytical technologies (PAT) initiative. US 4. A revolution in R&D: How genomics and genetics are Food and Drug Administration. Center for Drug transforming the biopharmaceutical industry. Bos- Evaluation and Research. http://www.fda.gov/cder/ ton Consulting Group; 2001. OPS/PAT.htm.

JOURNAL OF PHARMACEUTICAL SCIENCES, VOL. 93, NO. 2, FEBRUARY 2004