Top Banner
ics to quickly search databases, analyze DNA sequence information, and predict protein sequence and structure from DNA sequence data. Because informatics is ap- plicable to various disciplines, several aca- demic and industry pundits have predicted it to be the next fundamental discipline. Most familiar to those conducting phar- maceutical and biopharmaceutical research is bioinformatics, a broad field that inte- grates molecular biology, genomics, high- end computer analysis and programming, computation science, and statistics to de- termine how genetic information affects biological functions. Applications include problems in computational chemistry, functional genomics, pharmacogenetics, pharmacogenomics, pharmacometrics, proteomics, and structural biology. Bio- informatics can, for example, be used to analyze the gene patterns in tissues from various species and to study the gene pat- terns in diseased organs. High-powered algorithms are developed to manipulate immense amounts of data stored and processed on high-performance comput- ers to quickly access genomic or protein sequence data. Several bioinformatics research insti- tutes have been established worldwide. Plans are under way for construction of The Buffalo Center of Excellence in Bioin- formatics facility in the downtown Buffalo Niagra Medical Campus (Buffalo, NY). The 150,000-ft 2 multifunctional, high-tech facility will house drug design and research laboratories, high-performance computa- tional facilities, three-dimensional visual- ization capabilities, product commercial- ization space, and workforce training facilities. The University of Buffalo (New York) is the lead research partner in the center, which will be led by Jeffrey Skol- nick, PhD, a scientist in the field of com- putational biology. The University of the Sciences in Philadelphia (USP) has established a bio- informatics program at both the under- graduate (bachelor of science) and gradu- ate (master of science) levels. The program, the first to be approved by the Board of Ed- ucation in Pennsylvania, was initiated by Those who are either new to the job market or established employees looking for advancement will have to meet the de- mands of an industry known for its in- novation, fast-paced ingenuity, and com- petition as well as its highly regulated environment. To this end, several colleges and universities have added new areas of study to their curriculum while continu- ing to emphasize fundamental skills. Informatics Perhaps the most apparent change in re- search is the implementation of infor- matics. Informatics is a means of acquir- ing, storing, processing, analyzing, and presenting vast amounts of data using computer and statistical techniques. In ge- nomics research, scientists use informat- 32 Pharmaceutical Technology August 2002 www.pharmtech.com he vitality of any industry relies on the talent of its researchers, educa- tors, managers, and manufacturers. The success of each employee’s job begins with proper education and training. A review of the curricula offered at several schools of pharmacy reveals the extent to which advanced areas such as genomics and information technology have revolutionized the tools used to teach pharmaceutical science today. Those who thought mastering a graphing calculator in school was a triumph would be quite impressed at the computational horse- power that is giving a big boost to current drug discovery and development efforts. Clearly, at every stage of their education students of pharmaceutical science are get- ting a lot more bang for their tuition buck. Maribel Rios T Lessons in Excellence Expanding Curricula in Pharmaceutical Education and Training Maribel Rios is the managing editor of Pharmaceutical Technology, [email protected]. UNIVERSITY OF THE SCIENCES IN PHILADELPHIA To prepare the next generation of pharmaceutical scientists, colleges and schools of pharmacy are implementing the latest technical innovations in drug discovery, design, development, and manufacturing.
5

Expanding Curricula in Pharmaceutical Education …files.pharmtech.com/alfresco_images/pharma/2014/08/22/7...2014/08/22  · is bioinformatics, a broad field that inte-grates molecular

May 31, 2020

Download

Documents

dariahiddleston
Welcome message from author
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Page 1: Expanding Curricula in Pharmaceutical Education …files.pharmtech.com/alfresco_images/pharma/2014/08/22/7...2014/08/22  · is bioinformatics, a broad field that inte-grates molecular

ics to quickly search databases, analyzeDNA sequence information, and predictprotein sequence and structure from DNAsequence data. Because informatics is ap-plicable to various disciplines, several aca-demic and industry pundits have predictedit to be the next fundamental discipline.

Most familiar to those conducting phar-maceutical and biopharmaceutical researchis bioinformatics, a broad field that inte-grates molecular biology, genomics, high-end computer analysis and programming,computation science, and statistics to de-termine how genetic information affectsbiological functions. Applications includeproblems in computational chemistry,functional genomics, pharmacogenetics,pharmacogenomics, pharmacometrics,proteomics, and structural biology. Bio-informatics can, for example, be used toanalyze the gene patterns in tissues fromvarious species and to study the gene pat-terns in diseased organs. High-poweredalgorithms are developed to manipulateimmense amounts of data stored andprocessed on high-performance comput-ers to quickly access genomic or proteinsequence data.

Several bioinformatics research insti-tutes have been established worldwide.Plans are under way for construction ofThe Buffalo Center of Excellence in Bioin-formatics facility in the downtown BuffaloNiagra Medical Campus (Buffalo, NY).The 150,000-ft2 multifunctional, high-techfacility will house drug design and researchlaboratories, high-performance computa-tional facilities, three-dimensional visual-ization capabilities, product commercial-ization space, and workforce trainingfacilities. The University of Buffalo (NewYork) is the lead research partner in thecenter, which will be led by Jeffrey Skol-nick, PhD, a scientist in the field of com-putational biology.

The University of the Sciences inPhiladelphia (USP) has established a bio-informatics program at both the under-graduate (bachelor of science) and gradu-ate (master of science) levels. The program,the first to be approved by the Board of Ed-ucation in Pennsylvania, was initiated by

Those who are either new to the jobmarket or established employees lookingfor advancement will have to meet the de-mands of an industry known for its in-novation, fast-paced ingenuity, and com-petition as well as its highly regulatedenvironment. To this end, several collegesand universities have added new areas ofstudy to their curriculum while continu-ing to emphasize fundamental skills.

InformaticsPerhaps the most apparent change in re-search is the implementation of infor-matics. Informatics is a means of acquir-ing, storing, processing, analyzing, andpresenting vast amounts of data usingcomputer and statistical techniques. In ge-nomics research, scientists use informat-

32 Pharmaceutical Technology August 2002 www.pharmtech.com

he vitality of any industry relies onthe talent of its researchers, educa-tors, managers, and manufacturers.The success of each employee’s jobbegins with proper education and

training. A review of the curricula offeredat several schools of pharmacy reveals theextent to which advanced areas such asgenomics and information technologyhave revolutionized the tools used to teachpharmaceutical science today. Those whothought mastering a graphing calculatorin school was a triumph would be quiteimpressed at the computational horse-power that is giving a big boost to currentdrug discovery and development efforts.Clearly, at every stage of their educationstudents of pharmaceutical science are get-ting a lot more bang for their tuition buck.

Maribel Rios

T

Lessons in ExcellenceExpanding Curricula in Pharmaceutical Education and Training

Maribel Riosis the managing editor ofPharmaceutical Technology,[email protected].

UN

IVE

RS

ITY

OF

TH

E S

CIE

NC

ES

IN

PH

ILA

DE

LP

HIA

To prepare the nextgeneration of pharmaceuticalscientists, colleges andschools of pharmacy areimplementing the latesttechnical innovations in drug discovery, design,development, andmanufacturing.

Page 2: Expanding Curricula in Pharmaceutical Education …files.pharmtech.com/alfresco_images/pharma/2014/08/22/7...2014/08/22  · is bioinformatics, a broad field that inte-grates molecular

34 Pharmaceutical Technology August 2002

www.pharmtech.com

members of the school’s faculty, includingJames C. Pierce, current director of USP’sundergraduate program, whose specialtylies in genomics. “It’s clear to me that thefield of biological sciences in general ismoving into a very data-intensive type ofdiscipline,” says Pierce. “Biology has be-come an information science.”

The demand for bioinformatics exper-tise also has intensified the recruitmentefforts of several pharmaceutical andbiotechnology companies, long-estab-lished companies such as IBM and Com-paq Computer Corporation, and acade-mic and government research centers.Those who are valuable to the industryare those who are able to use computersto manipulate biological information.Computer scientists often don’t under-stand the biology, what type of questionsto ask, or what the information means,says Pierce, and the average molecular bi-ologist doesn’t really know how to builddatabases, write the algorithms, or use thetools in a productive manner. A bioin-formatics specialist can blend those twoareas together. In fact, the majority of thestudents who have enrolled in USP’s grad-uate program are professional molecularbiologists who already are working in thepharmaceutical and biotechnology in-dustries and wish to retrain themselves incurrent computer technology methods.

At the heart of bioinformatics is the cre-ation, manipulation, and maintenance oflarge databases of biological information.“It doesn’t really matter what field you arestudying—it could be molecular biologyor biochemistry. You’re going to have tobe skilled in your ability to manipulatedatabases, to use computers to study prob-lems, and to analyze data,” says Pierce. Ex-periments in genomic science generate vastamounts of data, but not all of it is useful.Traditional methods of setting up an ex-periments and recording and analyzing re-sults are inadequate in today’s life sciencescommunity. The approach now is to set upa system, collect the data, and then try to

interpret and understand the tens of thou-sands of data points that are generated.“We’ve gone from the first case in whichwe hope to get an answer to the second casein which we always have too much infor-mation coming in faster than we can han-dle it,” Pierce points out. “There’s a tremen-dous amount of information out there, butif you don’t know how to access it and useit, it’s useless to you.”

Pierce perceives the information to havethree levels: genomics, which involves ob-taining all the genetic information of anorganism at the DNA level, organizing it,and analyzing it; functional genomics,which entails taking the information to theRNA and protein level and trying to de-termine what it means; and systems biol-ogy, which involves looking at the entirepackage together and attempting to builda model of living cells, for example, on acomputer and to manipulate the model.Progress in functional genomics alreadyhas been made in the study of cancer cells.By analyzing the differences in the globalpatterns of gene expression between a nor-

mal cell and a cancer cell, researchers maybe able to determine potential targets suchas the proteins, enzymes, receptors, orother biomolecules that one would wantto interact with a drug or have a drug bindto for a therapeutic result.

USP’s undergraduate bioinformaticscurriculum comprises a four-year studythat includes molecular biology, chem-istry, computer and database program-ming, biochemistry, biostatistics, genet-ics, two semesters of bioinformatics, anda bioinformatics project (see sidebar,“Bioinformatics in microarray technol-ogy”). The master of science track requiresan additional year of biotechnology, sta-tistics, computer algorithms, and pro-gramming as well as an independent mas-ters project. The first undergraduate classbegan in fall 2001 with seven students, andapproximately 30 students applied for thesecond undergraduate class. The first grad-uate program began in fall 2000 withclasses completely filled, and more than20 graduate students enrolled.

The USP undergraduate degree was de-signed to provide a foundation in bioin-formatics that prepares students for entrylevel positions in pharmaceutical orbiotech companies or in academic labo-ratories. The program itself provides a lotof flexibility; students can choose whetherto emphasize programming, data analy-sis, or Web-based interactive programs.These projects may involve various typesof programming languages, includingPERL, a very popular computer pro-gramming language used in bioinformat-ics. The projects also may involve molec-ular modeling, in which students are askedto analyze various types of compoundsand determine their three-dimensionalstructures and whether they might begood drug candidates. Several students inthe program also work off campus, fulltime, as research scientists in pharma-ceutical and biotechnology companies.

Students who have earned a bachelor’s de-gree have some laboratory skills and haveused bioinformatics tools, but they are notprepared to use them at a high level, notesPierce. For example, the final exam in hiscourse is a three-week practical exam. Stu-dents are given raw DNA sequence data,and they must manipulate that data frombeginning to end and be able to turn itinto a protein, understand the various as-pects of the gene, go into the databases tofind out who it is related to, and other in-formation that may be embedded. Tocomplete the master’s project successfully,students must demonstrate that they canwork independently and creatively on abioinformatics problem.

Admittedly, teaching such a rapidlychanging field can be challenging. It makeslittle sense to train a student in the use ofone platform such as a particular computerlanguage. “But knowledge of DNA is notgoing away, and gene expression patternsare not going away,” says Pierce. “The realgoal is to get students to be skilled in a cer-tain subset of skills, including algorithms,computational biology, computer pro-gramming, database analysis, and, becausethis is bioinformatics, to understand howlife works at the molecular level.”

Recruiting students to study a new fieldalso can be a problem. Many high schoolstudents and teachers do not know whatbioinformatics is nor are they aware of itsrole in the industry, so students may bereluctant to apply to a bioinformatics pro-gram. Although the Human Genome Pro-ject accelerated bioinformatic activity, thefield itself is still very new, and gettingpharmaceutical scientists up to speed willtake some work.

In addition, the tools used in bioinfor-matics research often become obsolete be-fore the student graduates. “The programthat I used five years ago is completely outof date,” says Pierce. “Our bioinformat-ics program is only two years old and we

E D U C A T I O N

The University of the Sciences in Philadelphia isimplementing a National Science Foundation grantfor incorporating microarray technology into thebioinformatics and biology undergraduatecurriculum. Two projects are planned to introducethis technology to their students. These projects willbe used in formal courses and are designed to providea foundation for data sets and class projects as theyrelate to microarray technology.

The first project concerns the design, construction,and analysis of a DNA microarray. Students willdesign a chip that can be used to identify bacteriathat are commonly used in the microbiology teachinglaboratory. Dr. Pierce will have students usepolymerase chain reaction equipment to amplifyvarious portions of the ribosomal RNA 16S gene anduse it as the substrate for the microarray chips. Thestudents will make the chips and then perform a

microarray experiment to identify an unknownbacterial isolate. Using various bioinformatic tools,the students should be able to determine not onlythe identity of the sample but its relationship to otherbacteria using a phylogenetic approach.

The second project will use the yeastSaccharomyces cerevisiae as a model system to studygene expression. Microarray chips containing all ofthe yeast gene (�6200) will be used to study howyeast responds to various types of environmentalchanges (e.g., a blast of UV light) or genetic changes(a specific mutant) and how these changes affectglobal gene expression in this single-celledeukaryote. Students will use bioinformatic tools tostudy the microarray data, analyze the geneexpression clusters, and determine the roles thevarious genes may have in the life cycle ormetabolism of yeast.

Bioinformatics in microarray technology

UNIVERSITY OF THE SCIENCES IN PHILADELPHIA

Page 3: Expanding Curricula in Pharmaceutical Education …files.pharmtech.com/alfresco_images/pharma/2014/08/22/7...2014/08/22  · is bioinformatics, a broad field that inte-grates molecular

36 Pharmaceutical Technology August 2002 www.pharmtech.com

are already updating the software through-out the entire internal network, whichmeans all of the other programs must beupdated too.” The bioinformatics labora-tory includes 15 workstations of iMacsrunning OS X, a new Unix system that in-terfaces with the school’s high-end ma-chines. The goal is to provide studentswith a workstation where they can inter-act with all the main types of tools thatthey will be using in a bioinformatics en-vironment, including DNA sequenceanalysis programs. Students also must beable to access databases, mainly throughthe Web, and perform Web-based dataanalysis as well as present the data usingmodeling programs and HTML.

In comparison with traditional meth-ods, however, the efficiency, speed, andpower of an effective bioinformatics sys-tem far outweigh the cost of maintenanceand upkeep. The amount of informationcoming from genomics, genetics, and pro-teomics requires more than the use of sim-ple algorithms or any other comparablemethods of analyzing, warehousing, andmanipulating data. In fact, says Pierce,bioinformatics may well be the tool thatpharmaceutical companies of the genomicera can’t afford not to have. “If you’regoing to be in the business of life sciencesin the twenty-first century, you have to dobioinformatics. It’s not going away.”

PharmacometricsPharmacometrics is a branch of infor-matics that involves the development ofmathematical models of pharmacokineticand pharmacodynamic (PK/PD) datathrough theoretical and practical knowl-edge in statistics, computer programming,and numerical analysis. Companies suchas Quintiles, a contract research organi-zation specializing in drug and biologicdevelopment, have recruited scientists ex-perienced in pharmacometric techniquesfor analyzing and reporting PK/PD datafrom clinical trials.

The University at Buffalo School ofPharmacy and Pharmaceutical Sciences(UB, Buffalo, NY), which is scheduled toenroll approximately 28 students at the un-dergraduate level of pharmaceutics andnearly twice that many at the graduate levelin pharmaceutics, recently formed an in-tensive masters degree program in pharma-ceutics that focuses on pharmacometrics.The program integrates pharmacology withcomputational and statistical analysis. Ac-cording to Wayne Anderson, dean of theschool, students skilled in pharmacometrictechniques are heavily recruited in the phar-maceutical industry, and many have offersbefore they graduate because all pharma-ceutical companies must conduct clinicaland preclinical trials and are looking forefficient methods of analyzing the datafrom these trials.

Pharmacometrics allows one to math-ematically relate the properties and char-

acteristics of a drug as a chemical entityto PK and PD data. “These relationshipsare then used to determine how the drugmust be modified to decrease toxicity, in-crease efficacy, and avoid metabolic pit-falls,” says Anderson. Pharmacometricshas various applications in genomics aswell. Humans can be categorized in sub-populations according to how individu-als respond to specific drugs, he says. Twoindividuals may respond differently to thesame drug—not because the drug is faulty,but because people are genetically differ-ent. Students skilled in pharmacometricscan relate genetic and proteomics infor-mation to predict toxicology and efficacy.

The UB program has been successful inrecruiting students who already hold adoctorate degree but who go back toschool to obtain a masters degree in phar-macometrics. In fact, the first graduatefrom the pharmacometrics program hada PhD in biochemistry, says Anderson.

Combinatorial chemistryHaving been a part of drug discovery re-search for the past decade or so, combina-torial chemistry is an established yet stillrelatively new technique. Taking into ac-count the use of computer-aided model-ing and high-throughput synthesis, how-ever, one could argue that new drug entitiesare more often designed than discovered.

David Hangauer, professor of medici-nal chemistry in the UB department ofchemistry, teaches a course about the com-binatorial synthesis of molecules as well asa graduate course about the computeraided design of combinatorial libraries. Hisresearch focuses on molecules with mole-cular weights below 500 because they aremore likely to be active as a solid dosageform. Hangauer’s work is a broad approachto the study of many types of cancer.

A combinatorial library is a large col-lection of related molecules. Dependingon how these molecules are prepared, thelibrary could consist of anywhere from ahundred to a billion molecules that aresimilar yet slightly different in their con-figuration. The “combinatorial” partmeans that the library was constructed byappending combinations of various sidechains to a core molecule. For example, ifthe core molecule has three positions atwhich a structure might bind and each ofthese positions has 10 possibilities, a totalof 1000 (10 � 10 � 10) compounds arelikely candidates for a new drug entity.

“One can then use the computer to de-sign a library of 1000 molecules or morethat are the type that could bind to the tar-get,” says Hangauer. Computer programscan rank these molecules from most likelyto work to least likely to work. From thislibrary, the chemist chooses a subset (typ-ically 100) most likely to work, and theyare synthesized simultaneously. High-throughput tests must be conducted todetermine which ones would be the most

successful because “nature seems to be notas predictable as we think she should be,”says Anderson, “so rather than spendinga decade on the computer and going tomake that drug only to find that drugdoesn’t work, one designs a family ofdrugs using combinatorial chemistryaround the fundamental concept of whatthe receptor looks like.”

Robotics and special reactors are usedto quickly make the 100 or 1000 com-pounds that have been designed. Thosecompounds are then tested against thebiological target in a real assay. All com-pounds that are synthesized in Hangauer’slaboratory are tested because it costs moremoney to synthesize the compounds thanit does to test them.

The test process can quickly narrow thelist of potential new drug entities. For ex-ample, from a possible 1000 compoundstested in vitro against the isolated protein,perhaps five would look promising. Thesewould be tested in vivo, in an animal sys-tem. Of these, perhaps two would still lookpromising. These two compounds wouldadvance to the development phase inwhich they are tested for stability, solu-bility, formulation, and so forth beforeproceeding to clinical trials. The processfrom designing the library to synthesizingthe library to testing the library typicallyoccurs in a period of 6 months, saysHangauer.

Genomics has vastly increased the num-ber of potential drug targets (enzymes, re-ceptors, or other biomolecules). “Thathasn’t directly translated into an increasednumber of drugs so far,” says Hangauer,“but that’s the hope. For medicinalchemists, our job just got bigger.”

Pharmaceutical engineeringPharmaceutical engineering approachespharmaceutical manufacturing problemswith engineering concepts. In 1995, Rut-gers (Piscataway, NJ) implemented the firstprogram that combined pharmaceuticsand engineering as its Pharmaceutical En-gineering Training Program (PETP) (1).

Fernando Muzzio, professor and di-rector of PETP, believes that pharma-ceutical manufacturing should always

have been primarily an engineering ef-fort. Because engineers were hired mostlyby oil and chemical industries, engineer-ing education focused on those processes,whereas the pharmaceutical industry re-mained a concern of pharmacy practice,and schools of pharmacy deemphasizededucation in manufacturing processes.“A lot of this has to do with funding,”Muzzio says. “Pharmacy faculty can getgovernment funding to do drug discov-ery and drug delivery research, but theyhave a hard time attracting funding inmanufacturing.”

To optimize manufacturing processes,he says, engineering students must have astrong mathematical background, moreso than what the pharmaceutical disciplinerequires. “Engineers apply math to design,optimize, and control processes in manyindustries,” Muzzio explains. But the phar-maceutical industry has been slow to in-corporate engineering tools. Muzzio pointsto the use of computer simulation as anexample. Computer simulation to designfluid-mixing processes in the chemical in-dustry is nearly standard. The aviation in-dustry and the automotive industry alsouse computer simulation before testing ina lab. “In the pharmaceutical industry,” hesays, “almost nobody does any type ofcomputer simulation. You can find iso-lated examples, but it’s not standard, andit reflects the background of the peopledoing it.” Computer simulation would notonly be less expensive, but it would pro-vide an in-depth understanding of themanufacturing process. “Because engi-neering has a stronger mathematical foun-dation, engineers can bring to the tableprocess design, process analysis, andprocess optimization tools that allow theindustry to do a more systematic selectionof materials and methods,” says Muzzio.

Students in the Rutgers pharmaceuticalengineering training program are exposedto various pharmaceutical manufacturingapplications such as blending, drying, sam-pling, compression, dissolution, and crys-tallization. These are much of the same ap-plications used in the industry. Researchis conducted at both the graduate and un-dergraduate levels. Most undergraduates

The American Association of Colleges of Pharmacy,which conducts annual studies of the status ofcolleges and universities in the United States thatoffer accredited professional degree programs in thepharmaceutical sciences, has released its report,“Academic Pharmacy’s Vital Statistics.” The report isbased on the association’s Profile of Pharmacy Faculty,Pharmacy School Admission Requirements, and Profileof Pharmacy Students. According to this report:� There are 83 colleges and schools of pharmacy with

accredited professional degree programs as of fall2001.

� Of these 83 institutions, 64 offer graduate programsin the pharmaceutical sciences at the MS leveland/or PhD level.

� There were 3777 full-time and 776 part-timepharmacy faculty members at 83 colleges andschools of pharmacy in fall 2001.

� The total fall 2001 full-time graduate studentenrollment was 3084. Of these, 2264 students wereenrolled in PhD programs and 820 in MS programs.

� In 2000–2001, 375 PhD degrees were awarded,which was a 16.1% increase from the numberawarded in the 1999-2000 academic year. Thenumber of MS degrees that were awarded alsoincreased from 354 in 1999–2000 to 461 in 2000-–2001.

� The majority of MS degrees conferred in2000–2001 was in pharmaceutics (31.7%),followed by pharmacology (19.3%), and socialadministrative sciences (18.9%). Slightly more than17% were in disciplines such as quality assuranceand regulatory affairs.

� Pharmaceutics also was the leading discipline ofPhD degrees awarded in 2000–2001 (36.5%),followed by pharmacology (26.4%), and medicinalchemistry (24.5%). However, of the total number ofPhD degrees conferred, only 1.9% were given in thefield of pharmaceutical and biomedical science.

Vital signs

E D U C A T I O N

Page 4: Expanding Curricula in Pharmaceutical Education …files.pharmtech.com/alfresco_images/pharma/2014/08/22/7...2014/08/22  · is bioinformatics, a broad field that inte-grates molecular

38 Pharmaceutical Technology August 2002 www.pharmtech.com

perform at least two semesters of researchrelated to unit operations used to makepharmaceutical products.

The biggest changes in pharmaceuticalmanufacturing most likely will be in thematerials companies will have to handle,says Muzzio. For example, manufactur-ing equipment and processes will have tobe updated to accommodate nanotech-nology. “The existing technology was de-veloped and incorporated when most ofthe products were granulated,” saysMuzzio. “Already, direct compressionproducts are challenging the abilities ofolder, standard-style equipment.”

The nature of pharmaceutical materialshas changed significantly and, given the reg-ulatory framework, current methodologiesare antiquated. “Drugs are becoming morepotent and also more insoluble. For themto be effective [the industry] will need tomake smaller and smaller particles that mustbe handled accurately,” he says. Low-tem-perature nanotechnologies will need to beimplemented to effectively manufactureand process products that contain smallamounts of these highly potent molecules.

Even the basic aspect of personnel pro-tection will need to change becausenanoparticles are smaller than the smallest

tolerances of current equipment. Much isstill unknown about these materials, in-cluding how to assay them, how to com-press them, how to blend them with par-ticles that are much larger, how todetermine particle-size distribution—allof the current methodologies don’t workfor nanoparticles. “Pharmaceutical manu-facturing methods will have to change dra-matically to accommodate these majorchanges in the materials that we’re work-ing with, and that’s a major scientific effortthat must be put in place,” says Muzzio.“Engineers, physicists, chemists, mathe-maticians, and pharmacists will be needed.Students who have the right engineeringbackground and who have been exposedto these experiences will be needed.”

Muzzio et al. have outlined other areasof manufacturing that are in need ofchange, including� controlling crystal size distribution and

developing methods for making in-creasingly smaller crystals of increasedpurity

� drying very small particles, which tendto agglomerate upon drying

� improved scale-up and control of granu-lation processes

� methods for mixing or dispersing tiny

portions of mostly minute particles withina matrix of much larger ingredients

� better testing methods and blending per-formance assessment strategies

� more reliable and physiologically mean-ingful dissolution tests (2).Drug delivery systems also may change

as a result of advances being made in themicro- and nanoscale delivery of con-trolled-release drugs. Robert Langer, writ-ing in Science, has predicted that “in thefuture, the intersection between nano-technology and drug delivery may see ex-citing developments. Approaches involv-ing microelectrical mechanical systems(MEMS) or microchips are being stud-ied.” An implantable system consistingof nanoliter-capacity reservoirs contain-ing various drugs or different doses of thesame drug may someday be realized (3).

Muzzio recommends that pharmacy stu-dents interested in careers in industry takesome engineering courses. Courses fromindustrial engineering to general systemsdesign to particle technology classes thattypically are offered by material science de-partments could be beneficial. “I expectthat for the foreseeable 10 to 20 years, theactual design of pharmaceutical productsas well as the manufacturing of productswill increasingly rely on engineering skills.A growing number of companies are hir-ing engineers for jobs that 10 years agowould only be filled by pharmacists.”

The interdisciplinary approachAcademic research at both the graduateand undergraduate levels has traditionallybeen conducted by one student or a smallteam of students and one faculty advisor,

Academic leaders agree that there are fundamentalskills that no student, regardless of the discipline ofstudy, should be without. To be successful in theindustry, students should be proficient in� independent thinking and problem solving� written and verbal communication� mathematics� computer science/computational techniques.

Beyond knowing how to use state-of-the arttechnology and current tools of science, says WayneAnderson, dean of The University at Buffalo School ofPharmacy and Pharmaceutical Science, it is importantthat a student be able to think. In five years, these

tools will have evolved and the knowledge base willhave grown immensely. Students benefit the mostwith small classes, hands-on laboratory skills,discussion learning, and educators who are also onthe cutting edge of research. “One cannot overstressthe importance of a program that allows a student tosee how to analyze a problem and use problem-solving skills. Those who will succeed are the oneswho are able to solve problems,” says Anderson. “Ifthey don’t have thinking and problem-solving skills,they’re only as good as the first few weeks after theygraduate or until the technology changes.”

Covering the basics

E D U C A T I O N

Circle/eINFO 28

Page 5: Expanding Curricula in Pharmaceutical Education …files.pharmtech.com/alfresco_images/pharma/2014/08/22/7...2014/08/22  · is bioinformatics, a broad field that inte-grates molecular

40 Pharmaceutical Technology August 2002 www.pharmtech.com

all from the same department or researcharea. Students would work within their fieldand have little or only introductory knowl-edge of other disciplines. However, researchhas become much more complex, requir-ing an interdisciplinary or multidiscipli-nary approach. Combining concepts of sev-eral disciplines such as chemistry andcomputer technology or engineering andpharmaceutics has become more than atrend in education, it has become a neces-sity for solving real-world problems.

“That’s just reality,” says Pierce. “Theonly way that you can tap these problemsis from many different angles. You needsomebody that understands the biologi-cal system to get the molecules, isolate theDNA or isolate the RNA from the tumors.You need someone who can do the bio-chemistry in the lab. You need someonewho can get that information into a dig-ital format. You need a computer scien-tist who can then develop algorithms orthe programs that are used to understandit and then have to flow back to the biol-ogist so that he or she can interpret it. Andyou should be able to take all of those dif-ferent skills and wrap them up into oneindividual or group of individuals, eachwith their subspecialty.”

Collaboration among individuals ofvarious areas of expertise is part of Dr.Hangauer’s work. His research team con-sists of cancer biologists who conduct invivo testing, a scientist who conducts en-zymology studies, and another who con-ducts PK studies.

Cross-functional team environments arean integral part of solving problems in anindustrial setting as well. Cooperation be-tween team members of a multitude of spe-cialties is necessary to successfully carry adrug or delivery system through develop-ment and approval. Team members shouldat the very least know how the data thatthey are given have been generated. Thosewho discover or design the drug know in-formation about the molecule’s specificcharacteristics that could be useful to drugdevelopers, who in turn have informationuseful for drug manufacturers.

According to Muzzio, “We need amultidisciplinary approach in which phar-macists contribute a lot of the under-standing of the pharmacokinetics and themedicinal chemistry, the chemists knowa lot about the basic material, and the en-gineer can conduct detailed modeling thatallows for optimal design of the deliverypathway and the systematic manufactur-

ing method to make it quickly, reliably,accurately, and stable.”

ConclusionSeveral reports have been written abouttrends in pharmaceutical science educa-tion. However, trends come and go, andtheir long-term staying power is ques-tionable at best. Of the more than 3000graduate-level students preparing them-selves for an industry that requires lead-ing-edge technologies and a highly skilledworkforce (see sidebar “Vital signs”),those who will succeed are those best pre-pared to combine their technical skillswith the fundamental skills for profes-sional growth and longevity (see sidebar“Covering the basics”). Bioinformatics,pharmacometrics, combinatorial chem-istry, and pharmaceutical engineering aresome of the disciplines very likely to playvital roles in how pharmaceutical scienceis taught, how information is communi-cated, and ultimately the pace at whichthe industry progresses as a whole.

AcknowledgmentThe author thanks James Pierce, WayneAnderson, David Hangauer, FernandoMuzzio, Ellen Goldbaum, and Lynsey

Grady for their time and expertise. Moreinformation about the programs discussedin this article can be obtained from � University of the Sciences in Philadel-

phia: www.usip.edu/bioinformatics� Buffalo Center of Excellence in Bioin-

formatics: www.bioinformatics.buffalo.edu

� Rutgers University, Pharmaceutical En-gineering and Training Program: De-partment of Chemical and BiochemicalEngineering, 98 Brett Rd., Piscataway,NJ 08854

� American Association of Colleges ofPharmacy: www.aacp.org.

References1. B.J. Glasser, J. Cole, and F.J. Muzzio, “A

Comprehensive Approach to Pharmaceuti-cal Engineering Training,” Pharm. Technol.25 (12), 34–36.

2. F.J. Muzzio, T. Shinbrot, B.J. Glasser, “Pow-der Technology in the Pharmaceutical In-dustry: The Need to Catch Up Fast,” PowderTechnol. 124, 1–7 (2002).

3. R. Langer, “Drugs on Target,” Science 293,58–59 (6 July 2001).

4. M. Rios, “Pharmaceutical Technology–Pharmaceutical Technology Europe Em-ployment Survey 2001,” Pharm. Technol. 25(12), 24–32. PT

Circle/eINFO 30

E D U C A T I O N