PRIMENA AGILNE METODOLOGIJE U PROJEKTIMA

FARMACEUTSKE I IT INDUSTRIJE
dr Katarina B. Pavlović, dr Ljiljana Berezljev
Fakultet za projektni i inovacioni menadžment, Beograd

Abstrakt
Farmaceutski i IT projekti imaju mnogo toga zajedničkog. Kompleksni su, u realizaciji se
oslanjaju na multidisciplinarne timove, često se ne završavaju na vreme i i budžet. Pored toga,
obe navedene vrste projekata određuju isti faktori kvaliteta: pouzdanost, bezbednost i
efikasnost. 1
Projektni timovi za razvoj software-a kao i timovi za razvoj novih lekova imaju cilj da naprave
usaglašen, efikasan, bezbedan, efektivan i komercijalno prihvatljiv proizvod. Razlika je u tome
sto dok farmeceutski timovi koriste stari “waterfall” pristup, IT timovi koriste “agilni” pristup, koji
donosi visestruke prednosti.
U ovom radu razmatraju se mogucnosti primene agilnog pristupa i u farmaceutskoj industriji sa
osvrtima na prednosti i ogranicenja.

Ključne reči: “Agilna” metodologija, projektni menadžment, razvoj lekova

“Agile” pristup

AutorHighsmithdefiniše “agilnost” kaosposobnostbalansiranjaizmeđufleksibilnostiistabilnosti.2U

razvoju software-a “agilnirazvoj” je opštiterminkoji se koristizaskupmetodologija. PremaLarman-
u, metodeagilnograzvojaprimenjujuvremenskiskraćeniiterativniievolutivnirazvoj,
adaptivnoplaniranje, evolutivnudostavuidrugevrednostiiprakse, kako bi se
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podstakaobrzifleksibilanodgovornapromenu u procesu.
Farmaceutskaindustrijaidaljekoristi “Waterfall” razvojnipristup, jedan od
najčešćihinajpoznatijihprocesnihmetodologijasekvencijalnogdizajna. Inicijalno je
bionamenjenproizvodnomigrađevinskomsektoru, a ime mu potičeodnačinanakoji faze
tekunadolekao“vodopad”.
Metodloškipristup “vodopada” najuspešnije se primenjuje u projektima u
kojimasuzahtevistatičniijasnodefinisani.

1Characteristics of good software. (2013). Preuzeto 20.11. 2013.,

from http://www.ianswer4u.com/2011/10/characteristics-of-good-software.html#axzz2l1yAqJV4
2
Highsmith, J. (2002). Agile software development ecosystems. (Vol. 13). Addison-Wesley Professional.
3Larman, C. (2004). Agile and Iterative Development: A Manager’s Guide. Addison-Wesley. p. 27.
4Beck, K.; et al. (2001). Manifesto for Agile Software Development. Agile Alliance. Retrieved November 18, 2013,

from http://agilemanifesto.org/.

1
Unapredpostavljenizahteviiusaglašenivremenskiokviribudžetzahtevajurobusnumenadžerskustru
kturu, 5

U “vodopad” projektnompristupu u razvojuproizvoda, projektnimenadžeriidentifikujunizkoraka do

završetkaprojekta, koji se sprovodesekvencijalnoi u zavisnostiodvrsteprojektaobičnouključuju:
Zahteve, Dizajn, Implementaciju, Verifikaciju, ZatvaranjeiOdržavanje.

Metodologija “vodopada” se zasnivananepraktičnompristupuprikupljanjaisvihinformacijaizahteva

u tokuprve faze.6 Sa ovakvimpristupomkomunikacijasakorisnikom je “zaključana” u
fazipostavljanjazahteva. Kada se ova fazazavrši, proces se
nastavljanadole.7Ovakavpristupzahtevapreopširnuidetaljnuspecifikacijuproizvoda, zatošto se
zahtevidefinišu u fazikadanemadovoljnopraktičnogiskustva. Pored toga,
možedonetiinerealanosećajpreciznosti, a sasobomnosiirizikstvaranjadetaljne, ali “zastarele”
dokumentacije.8

“Agilni” pristuprazvojuproizvoda

“Agilni” pristuprazvoju software-a izgrađen je

naprincipimaupravljanjaputeminterakcijaizmeđuljudi. Zarazlikuodpredhodnoopisanogpristupa
“vodopada”, gde je svepredhodnoplanirano, u “agilnom”
pristupuprojektnimenadžerdefinišeprojekatkaoserijumanjihzadataka I
završavaihnaadaptivannačin. U ovompristupnijepotrebnoznatisvezahteve. Pored
metodologijaExtreme Programming, Crystal, Dynamic Systems Development Method, Lean
Development, and Feature-Driven Development, “Scrum” je jedna od metodologija “agilnog”
pristupakoja se najvišekoristi. 9

Od američkogfudbala do razvoja software-a

“Scrum” je rečkojapotičeizameričkogfudbala, a u projektnommenadžmentupodrazumeva

“fleksibilnu, holističkustrategiju u razvojuproizvoda u
kojojceotimradinaostvarenjuzajedničkogcilja, što je suprotnoklasičnom “sekvencijalnom”
pristupu. 10 U američkomfudbalu, “Scrum” je jedanodnačina da igraponovopočne.

5Rising, J. (2009). Sashimi Waterfall Software Development Process. Retrieved May 6, 2009,
from http://www.managedmayhem.com/2009/05/06/sashimi-waterfall-software-development-process/
6Kee, W. H. (2006, November).FUTURE implementation and integration of agile methods in software development
and testing. Innovations in information technology, Dubai. doi: 10.1109/INNOVATIONS.2006.301945
7Hoffer, J. A.; George, J. F.; Valacich, Joseph S. (2008). Modern Systems Analysis and Design. Upper Saddle River,

New Jersey: Pearson Education, Inc.

8Komus, S.; Komus, A. ; Noble P. (2013). Scrum in the Regulated Environment, Opportunity or Risk for Computer

Systems Validation? Retrieved November 16, 2013, from http://www.komus.de/fileadmin/downloads/public/2012-

09-Scrum_in_regulated_environment-CHEManager-EUROPE-print.pdf
9
Cairns, A. (2012).Comparing Agile and Waterfall Methods of Project Management. Retrieved November 16, 2013,
from http://www.pmhut.com/comparing-agile-and-waterfall-methods-of-project-management

10Takeuchi, H.; Nonaka, I.(1986). The new product development game. Harvard Business Review, Jan-Feb, 137-146.

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Igračisvakogtima se grupišu u gustuformacijukako bi došli do loptekoja je bačenameđunjih. U
poslovnomsvetu, istareč se
koristizaopisivanjeagilnogprocesazaupravljanjeikontrolurazvojaproizvoda u
situacijamabrzihivelikihpromena u okruženju. 11
“Scrum” je specifičannačintimskograda u razvojuproizvoda, obzirom da je
projekatpodeljennavišemanjihdelova. 12To je postupakgrađenjaceline, u kome se
gradideopodeoisvakinovideo je vezanzapredhodni. Kad god je jedandeozavršen, podstiče se
kretaivnostidaje se dovoljnoprostoratimu da odgovorinapovratnereakcijeipromene. Scrum je
jednostavanokvirzatimski rad u kompleksnimprojektima u kojimapostojimali set
osnovnihpravilanaosnovukojihpostojiminimalnastruktura, koja je
dovoljnazadanašnjaokruženjaifokussamogtima.13

Cilj Scrum pristupa je mogućnostbrzogodgovora I fleksibilnosti u procesurazvojaproizvoda, a

bez ugrožavanjakvaliteta, kontroletroškova, motivacijeiliočekivanjakorisnika. U
donsounapreteranoplaniranje I opterećujućudokumentaciju,
ovajpristupnaglašavapotrebustalnoguključivanjakorisnika I focus u tokusvihrazvojnihfaza. 14

Osnovniprincip Scrum pristupa je da podelirazvojni process nadeloveilirazvojnecikluse. U Scrum

metodologiji, oviciklusi se nazivaju I “sprintovima” I odnose se
napredhodnodefinisanezadatkezarešavanjepredhodnodefinisanihciljevaprojekta. “Dnevni
scrum” trajesamo 15 minuta I koristi se da se uporedetrenutnirezultatisazadacima I
sanjimapovezanimteškoćamailiproblemima. Na krajusvakogsprinta, prezentuju se rezultatikoji bi
trebalo u tom trenutku da mogu da se prikažu.

Svaki sprint obuhvatavremenskiokvirodokomesec dana, u kome sprint timupravljasamsobom,

pravikoraknapred u realizaciji I konstatuje da je zadatakodrađen. Novi sprint
počinjeodmahpozavršetkupredhodnog I svakipodrazumevaplaniranjesprinta, dnevni scrum,
razvojniposao, pregledsprinta I retrospektivusprinta.

U tokusprinta je važno ne pravitipromene da ne bi došlo do ugrožavanjasamogciljatogsprinta.

Ciljevikvaliteta se ne smanjuju, obim se možedodatnorazjasniti I
razvojnitimmožepregovaratisavlasnikomproizvoda, kakopristižu nova saznanja.
Ovakofleksibilnastrukturastvaravelikuprednost u projektima u kojimakorisnicimenajumišljenje u
vezisaonimštoželeištaim je potrebno. U razvojulekova,
korisnicimogubitimarketinškiiprodajnitimovi, dobavljači, proizvodni sector, pravnizastupnici,

11Scrum. (2013) Merriam-Webster.com. Retrieved November 19, 2013, from http://www.merriam-

webster.com/dictionary/scrum
12Cardozo, E. Et al. (2010). Scrum and productivity in software projects: A systematic literature review.’ 14th

International Conference on Evaluation and Assessment in Software Engineering (EASE). Keele University, UK.
Retrieved November 15, 2013
13What is scrum? (2013). Retrieved November 20, 2013, from https://www.scrum.org/Resources/What-is-Scrum
14Scrum in regulated environment. (2013). Retrieved November 20, 2013, from http://www.chemanager-

online.com/en/topics/pharma-biotech-processing/scrum-regulated-environment

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regulatorneagencije, ugovorniproizvođači I pakeri, lekari, pacijentiidrugi. U
tradicionalnimmetodamaovepromene se ne mogulakoprihvatitiniti se
možeupravljatiadaptabilnošću.
Agile PM is not new. Back in 2001, the Manifesto for Agile Software Developmentput forward four
basic principles. As they wrote at the time:
"We are uncovering better ways of developing software by doing it and helping others do it.
Through this work we have come to value:
Individuals and interactions over processes and tools
Working software over comprehensive documentation
Customer collaboration over contract negotiation
Responding to change over following a plan

You can simply change the word “software” to “drugs” and you’ll get the Manifesto for Agile
Drug Development, a new paradigm for Pharma R&D.
To be clear, this approach has profound differences from the ways things used to be done. In
software development, it has reduced costs and sped up product development. Better services
were created in less time.
Remember this supposed truism? “Better, faster, cheaper. You can pick any two.” Many argue
that Agile allows you to pick all three.
Among different agile project management approaches, Scrum Management is the most
applicable to the clinical trials. Here’s a quick summary of how it works.

Problemisaagilnimpristupom u farmaceutskojindustriji

Pharmaceutical regulations currently follow mainly a descriptive approach. Therefore, the

regulations in general terms define what must be accomplished and largely leave the question
of how to achieve it to the companies. Consequently, regulators expect companies to establish
their own documented development programs and show that their formulations and processes
are capable of providing safe, efficacious, and effective products.

There seem to be at least two major concerns with utilizing an Agile approach in the
pharmaceutical industry: the fact that Agile tends to “value individuals and interactions over
processes and tools” and the agile value of “working software over comprehensive
documentation.”4 However, following the agile or hybrid principle of gathering skilled people and
providing them with the means to work well just makes a robust process even stronger. This is
because it ensures that teams continuously ask themselves if any improvements are needed.
This is what regulators explicitly ask pharmaceutical companies to do.

In addition, both agile and regulated principles serve the same purpose, if we equate working
pharmaceutical product with safe and effective product. In the pharmaceutical industry,
documentation is not an end in itself. It is merely a means of showing that the product is going
to fulfil its intended use in a safe and effective manner, because it has been developed via a
robust process.

Given the current struggles to shrink the product development life-cycle in drug development, it
is clear that a more responsive, adaptive, and agile model is needed. The goal of Scrum,
responding fast and flexibly to changes in requirements during the project, without sacrificing

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quality, cost control, motivation or especially user requirements, is a best fit for product
development life-cycle in drug development.8

Agile methods like Scrum are only tools and not solutions. Agile methods strive to achieve
results and quality with the help of simple rules and less bureaucracy. They or hybrid models,
where agile and traditional methods are combined, must be integrated into the Quality
Management System when used in a regulated industry such as ours and perhaps to add
special sprints for covering formal documentation requirements.

To sum up, agile methodology is showing itself a promising way of working and moving beyond
software development projects and soon will find its place in other industries like
pharmaceuticals.

Agility and efficiency are not words we commonly hear associated with the highly regulated
pharmaceutical industry. However, with drug pricing under intense scrutiny, the pharma business
model is changing and manufacturers are embracing a variety of efforts to improve their operational
efficiency.

When it comes to drug development, most of pharma still uses a traditional waterfall approach.
Waterfall methods are pre-planned, and rely on gathering all the project requirements in the first
phase of the project. Projects are broken down into steps and completed sequentially. Waterfalls
work best when the requirements of the project are not evolving. But the drug development process
is lengthy and complex, and undoubtedly things (such a patient needs, market demands, industry
regulations) change throughout the duration of the process.

Hence, many have argued that pharma needs to leave its traditional waterfall model behind in favor
of a more agile model. (For a great example of agile project management in practice, read our plant
tour story in the Nov. print issue, which discusses API provider Neuland Labs’ custom project
management system.) All companies have a shared goal of developing the best quality products in
the shortest amount of time. The patent expiration clock is always ticking. Scrum is potentially helpful
in this regard because not only does it allow for flexibility, it also maintains a level of urgency by
providing constant deadlines.

1. Characteristics of good software. (2013). Retrieved November 20, 2013,

from http://www.ianswer4u.com/2011/10/characteristics-of-good-
software.html#axzz2l1yAqJV4
2. Highsmith, J. (2002). Agile software development ecosystems. (Vol. 13).
Addison-Wesley Professional.
3. Larman, C. (2004). Agile and Iterative Development: A Manager’s Guide.
Addison-Wesley. p. 27.

5
4. Beck, K.; et al. (2001). Manifesto for Agile Software Development. Agile Alliance.
Retrieved November 18, 2013, from http://agilemanifesto.org/.
5. Rising, J. (2009). Sashimi Waterfall Software Development Process. Retrieved
May 6, 2009, from http://www.managedmayhem.com/2009/05/06/sashimi-
waterfall-software-development-process/
6. Kee, W. H. (2006, November).FUTURE implementation and integration of agile
methods in software development and testing. Innovations in information
technology, Dubai. doi: 10.1109/INNOVATIONS.2006.301945
7. Hoffer, J. A.; George, J. F.; Valacich, Joseph S. (2008). Modern Systems
Analysis and Design. Upper Saddle River, New Jersey: Pearson Education, Inc.
8. Komus, S.; Komus, A. ; Noble P. (2013). Scrum in the Regulated Environment,
Opportunity or Risk for Computer Systems Validation? Retrieved November 16,
2013, from http://www.komus.de/fileadmin/downloads/public/2012-09-
Scrum_in_regulated_environment-CHEManager-EUROPE-print.pdf
9. Cairns, A. (2012).Comparing Agile and Waterfall Methods of Project
Management. Retrieved November 16, 2013,
from http://www.pmhut.com/comparing-agile-and-waterfall-methods-of-
project-management
10. Patel, R (2013). Agile 101. Retrieved November 17, 2009,
from http://resource.grapii.com/articles/agile-development.pdf
11. Takeuchi, H.; Nonaka, I.(1986). The new product development game. Harvard
Business Review, Jan-Feb, 137-146.
12. Scrum. (2013) Merriam-Webster.com. Retrieved November 19, 2013,
from http://www.merriam-webster.com/dictionary/scrum
13. Cardozo, E. Et al. (2010). Scrum and productivity in software projects: A
systematic literature review.’ 14th International Conference on Evaluation and
Assessment in Software Engineering (EASE). Keele University, UK. Retrieved
November 15, 2013
from http://www.bcs.org/upload/pdf/ewic_ea10_session5paper3.pdf
14. What is scrum? (2013). Retrieved November 20, 2013,
from https://www.scrum.org/Resources/What-is-Scrum
15. Scrum in regulated environment. (2013). Retrieved November 20, 2013,
from http://www.chemanager-online.com/en/topics/pharma-biotech-
processing/scrum-regulated-environment
16. Scrum (2013). Retrieved November 20, 2013, from http
increments://www.scrum.org/Resources/Scrum-Glossary
17. Swaner, K.; Sutherland, J. (2103) The Scrum Guide. Retrieved November 12,
2013,
from https://www.scrum.org/Portals/0/Documents/Scrum%20Guides/2013/S
crum-Guide.pdf#zoom=100