Commercialization of biopharmaceutical knowledge in Iran challenges and solutions

Nassiri-Koopaei et al. DARU Journal of Pharmaceutical Sciences 2014, 22:29http://www.darujps.com/content/22/1/29

RESEARCH ARTICLE Open Access

Commercialization of biopharmaceuticalknowledge in Iran; challenges and solutionsNasser Nassiri-Koopaei1, Reza Majdzadeh2*, Abbas Kebriaeezadeh1,3*, Arash Rashidian4, Mojtaba Tabatabai Yazdi5,Saharnaz Nedjat2 and Shekoufeh Nikfar1,3

Abstract

Background: The objective of this study was to investigate the application of the university research findings orcommercialization of the biopharmaceutical knowledge in Iran and determine the challenges and propose some solutions.

Results: A qualitative study including 19 in-depth interviews with experts was performed in 2011 and early 2012. NationalInnovation System (NIS) model was employed as the study design. Thematic method was applied for the analysis. Theresults demonstrate that policy making, regulations and management development are considered as fundamentalreasons for current commercialization practice pattern. It is suggested to establish foundation for higher level documentsthat would involve relating bodies and provide them operational guidelines for theimplementation of commercialization incentives.

Conclusions: Policy, regulations and management as the most influential issue should be considered for successfulcommercialization. The present study, for the first time, attempts to disclose the importance of evidence input formeasures in order to facilitate the commercialization process by the authorities in Iran. Overall, the NIS model should beconsidered and utilized as one of the effective solutions for commercialization.

Keywords: Knowledge translation, Biopharmaceutical research, Facilitators and barriers

IntroductionBiotechnology science has proven to be a fast growingsource of new technologies and innovative medicines forthe pharmaceutical industries during the recent decades[1]. Biopharmaceuticals is presenting itself as the futurepromise for the safer, targeted and curative medicinesopening the scope for treatment of rare and incurablehealth conditions [2]. New pharmaceutical companiesare emerging with a portfolio of biotechnology drug candi-dates, while the current market leaders are transformingtheir pipelines to biotechnology derived lead compounds.The specific feature of biotechnology, in general, in be-ing based largely on academic and university researchesrenders the commercialization of research finding sub-stantial importance [3]. The sufficient research budgetsand innovation commercialization expertise to remains

* Correspondence: [email protected]; [email protected] Utilization Research Centre and School of Public Health, TehranUniversity of Medical Sciences, Tehran, Iran1Department of Pharmacoeconomics and Pharmaceutical Administration,Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, IranFull list of author information is available at the end of the article

© 2014 Nassiri-Koopaei et al.; licensee BioMedCreative Commons Attribution License (http:/distribution, and reproduction in any medium

as an ever growing issue to be addressed [4]. Speculatingthe Iranian Pharmaceutical market, which has been sub-stantially growing during past two decades, demon-strates that medical expenditures has increased as partof overall health system costs [5-7]. There are a satisfactorynumber of research institutes in the biopharmaceutical fieldin Iran, but the number of biopharmaceutical companieshas been limited to few ones. One possible explanation forthe perceived gap between research and production mightbe the malfunction of the commercialization practice. Inthe fields, including biopharmaceuticals, where an essentialpart of knowledge creation takes place in universities andresearch institutes, the fruitful application of the knowledgeneeds a transformation process, which involves inventinguses for new scientific ideas and making products orservices possible out of them [8,9]. Many universitieshave persuaded their academic staff and researchersto commercialize their findings and have establisheduniversity-industry cooperation offices to potentiate theseactivities, but these mere initiatives are not adequate toolsfor assuring commercialization prosperity [10]. Very fewresearch finding have been successful enough to turn into

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Nassiri-Koopaei et al. DARU Journal of Pharmaceutical Sciences 2014, 22:29 Page 2 of 11http://www.darujps.com/content/22/1/29

commercialized products [4]. Moreover different goalsand terminology wielded in academic and industrial con-texts, a function of translation to render the two sides adual comprehension capability is required. So prior to asimple transfer of knowledge, we need an active mechan-ism making the newly formed knowledge understandableand available for the various technical contexts [11]. Bio-pharmaceutical industry, among the other high tech ones,encounters with the growing and uncertainty inherent intechnological changes, difficulties in handling forthcomingchanges due to the immaturity of the industry and theshortage of intrinsic management skills. In addition,dependent on the well-established pharmaceutical andchemical industries, biopharmaceutical industry needsto be assisted with introducing its developing productsinto market place [12]. All these issues render know-ledge translation a substantial importance. In Iran, bio-pharmaceutical researches have a remarkable history;from when Pasteur and Razi institutes were establishedin 1919 and 1930, respectively [13]. Recently, more researchinstitutes and academic groups have been engaged in bio-pharmaceutical research. Some biopharmaceutical corpora-tions have been founded in early previous decade. Thenumber has grown but some experts believe that this cap-acity can be further potentiated. University-industry rela-tionship has been a topic of concern in Iran. To date somesteps have been taken to strengthen such a relation, butoutcomes might not fulfill the primary goals. In the presentstudy we aim at investigating the commercialization of thebiopharmaceutical knowledge in Iran and determining thebarriers and then proposing facilitations possible to furtherstrengthen university knowledge utilization.

MethodsThe present qualitative study, in 2011 and early 2012, wascarried out on some groups: biopharmaceutical professionals,policy makers and some activists involved in the industry, apurposive sampling method was admitted and included 19in-depth interviews. Ethics Committee approval was receivedfor the study from Tehran University of Medical

Table 1 The groups interviewed in the study on ‘Commerciali

Group Subgroup’s characteristics Individ

Researcher andacademics

Researchers in units under MOHME’s authority AcadePasteu

Researchers in units under authority ofMinistry of science and technology

Policy makers Pharmaceutical market managers and policymakers in FDO and related organizations

MOHMFood adevelomanagInsuranBiopha

Research managers and policy makers inMOHME and related organizations

BiopharmaceuticalIndustry experts

Experts in the biopharmaceutical industry

MOHME, Ministry of Health and Medical Education.

Sciences research deputy. Involvement in research anddevelopment, science and technology or drug policymaking level, industrial and business background wereconsidered while defining the subgroups of the study.The study’s subgroups are shown in Table 1. Re-searchers were selected from the faculty members ofTehran University of Medical Sciences and Pasteur in-stitute of Iran. Both the academic organizations possessbiopharmaceutical department, conducting researchesand offer PhD degrees in pharmaceutical biotechnology.These instruction and research organizations have greatbackground in the biopharmaceuticals in Iran and themost important biopharmaceutical companies in Iranhave derived from these institutes. In-depth interviewswere held with all the participants in the study. Inter-views and discussions on the questions listed in Table 2were done until the point of saturation. Totally 19 indi-vidual in-depth interviews, each lasting for 0.5 to 1.5 h,were conducted. Data gathering on the research outputof the research organizations were done, regarding theoutcome of the current status of putting research intoaction in two important research institutes. In thisstudy, term definition was as follows: linking research toaction or knowledge translation has been considered asthe collection of activities that range from ‘designing theresearch question up to application of its results with theaim of improving health and healthcare services [14] andtechnology commercialization is the process of bringingtechnical innovation to the marketplace. In the study, thebarriers and solutions of knowledge translation in the bio-pharmaceutical sector have also been studied. Due to theactive role of the researcher as a researcher at the depart-ment of pharmaceutical biotechnology at the faculty ofpharmacy, Tehran University of Medical Sciences, theinterviewer became a research fellow observer for theTehran University of Medical Sciences as a typical ex-ample of Iranian research institutes being analyzed in thisstudy [15]. Some interviewees function simultaneously orhave background in different positions such as academicstaff, industry shareholder and manager or policy making

zation of biopharmaceutical knowledge in Iran’

uals interviewed

mic staff and researchersfrom Tehran University of Medical Sciences,r institute, Tehran university, Shahed university

E’s Deputy of Research and Technology, Ex-director general of deputy ofnd Drug, Office of health technology at MOHME, Office of researchpment at MOHME, Office of biological products at FDO, Feasibility studyer at the Ministry of Industry, mine and commerce, Governmentalce company manager, Chancellor of faculty of pharmacy,rmaceutical production unit managers, industrial factories

Table 2 Questions to conduct the in dept interviews

Question

1 What is your perspective on commercializing university research findings in the field of biopharmaceutical knowledge in Iran?

2 What are the main challenges in commercialization of university research findings in the field of biopharmaceutical knowledge in Iran? How doyou assess them?

3 What do you propose to meet these challenges? And what will be the ideal situation of biopharmaceutical knowledge commercialization in Iran?


that causes the lack of separation in the sample throughdifferent groups.

Data analysisThe in-depth interviews were documented by a note takerand audio-recorded. Qualitative analysis was performed

Table 3 Categories and codes extracted from the in dept inte

No. Category

1 Policy making, regulations and management development

2 Investment and financial contribution

3 Improving the research capability

4 Extending the relations

5 Human resource development

6 Encouraging the entrepreneurship

7 Industrial manufacturing capacity

8 Promoting values (attitudes) and the public culture

through the thematic method; the documented interviewsand their transcripts were studied several times by theinterviewer. Thereafter thematic coding process was doneon the interviews and their transcripts by the interviewerwhile other members of the team regarded the themesand the categories were extracted [15].

rviews

Code

Policy making, legislation and management procedure reform

Reform in authorities

Transparency

Concentration in policy making and legislation

Stability

Management challenges

Market control and expansion policies

Standards setting

Control and auditing regulations

Facilitating regulations

Prioritization

Financial support management and targeting

Private sector capacity use

Private investment

Purposeful research

Research and education system reform

Scientific, technological and trade relations

Interaction between the authorities and consistent approach

International relations

Instruction and evaluation

Provocation and leading

HR pyramid development

Entrepreneurial training and culture

Commercialization and entrepreneurial facilitation

Professional commercialization and entrepreneurial services

Knowledge and corporation management

Pharmaceutical industry renewal and amendment

Providence

Cooperation, perseverance and lack of exaggeration

National production support

Innovation and risk taking


ResultsThe eight categories extracted in the study were policymaking, regulations and management development, invest-ment and financial contribution, improving the researchcapability, human resource development, encouraging theentrepreneurship, industrial manufacturing capacity,promoting the social culture and values and extendingthe relations (Table 3). These categories were extractedwhile the National Innovation System model was ad-mitted as the cornerstone for the structure of thematicanalyses and formulation of categories. In each sectorthe challenges and barriers are presented and then thefacilitations possible.

Policy making, regulations and management developmentChallengesAccording to the topics noticed by the interviewees, themost critical factors affecting the commercialization ofthe biotechnology in Iran lie within this category, asexpressed by all. One of the academic staff said:

“We have everything but one; that is management!”

In the past twenty years, a great amount of policies havebeen made to promote biotechnology commercializationbut there has been no organized structure to monitorand document their outcomes. Short term decisions toreact to day-by-day issues have been prevalent.Prioritization in the national needs has been lacking.Nearly all experts agreed that management practiceand method has slowed down the process by obscureprotocols, extensive bureaucracy, outdated technology,lacking predefined and clear workflow and very longperiod to acquire new knowledge impeded smooth pro-gress. Moreover, standards and criteria for performancewere not well defined or lacking. Planning and definingtargets did not comply with scientific principles of man-agement and in most cases based on personal prefer-ences. One manager at a science park said that:

“Incubators are managed through personal preferenceswithout any performance criteria.”

Legislation has not followed specific methodology andpractice. Most interviewees emphasized that:

“Introduction of intellectual property law should beregarded as a basement factor.”

Conflicting regulations, very late legislation, ambiguousand interpretable regulations and regulations opposing theoverall national laws and policies were among the mostvital issues noted. On the other hand the authorities incharge of the pharmaceutical sector engaged themselves

in the medicine supply rather than control and audit-ing, that could endanger serious quality improvementby abating the competition in the market. Transpar-ency was stressed as the underpinning reason for asubstantial portion of secrecy among researchers, mal-function of the granting system and conflict of interestin the whole pharmaceutical sector. Moreover lack ofassurance to implementation of regulations in practicevigorously damaged public trust, in spite of decentra-lized decision making, especially in granting. Regar-ding the unorganized manner under which supportsare offered, conflicting decisions in distinct institu-tions, conflict of interest and consecutive managementchanges, dispensed policy making renders the entre-preneurial context unstable and undesirable for invest-ment. Some interviewees believe that strict marketcontrol, pricing policy, generic medicine scheme andconfinement deteriorates market power of companies.In this regard one policy maker said:

“The government of Iran had better withdraw itselffrom medicine supply.”

Definition of standards attracts great attention in theexperts as management practices are not well controlledand the outcomes do not serve any feedback for any cor-rective actions. Some criteria for the scientific boardpromotion, as explained earlier, appear to create obsta-cles for innovative researches.

SolutionsIntroduction of responsible management into the phar-maceutical sector without conflict of interest and ina stable situation was suggested. Using the course ofaction adopted by pioneering countries while accom-modating to the local circumstances and taking ad-vantage of domestic or international consultants canbe suitable. Successes and losses pursuit and cau-sation would be a solution. One of the industrial ac-tivists said:

"No one knows where others have gone; we progress bytry and error."

Determining the national priorities and broadcast-ing them for all the researchers was proposed. Intel-lectual property right regulations were regarded as asubstantial need for the productive researches, sinceprotected rights, as the driver for efforts to do in-novative researches, warrants the ultimate possibleprofits. Stability in the management and enforcementof the regulations and policies should be assured bythe government. Briefly, management practices, regu-lation and policy making must be revised.


Investment and financial contributionChallengesFinancial support plays an undeniable role in conductionof purposeful research. Nevertheless, noted by most in-terviewees, the current flow of monetary support wouldnot suffice further growth and assist the researchesthrough to commercialization, except that more re-sources in a consistent manner be underway. Terms andconditions under which the supports are allocated is apoint of controversy since there are not any transparentand predetermined procedure approved for the grantingand some conflicts of interest, of course, exist. An aca-demic staff said:

"Research budget undergoes great lobbies and suffersfrom conflict of interest and personal tastes."

Venture capitalist funds are neither present nor function-ing properly in Iran. Almost all interviewees emphasizedthe supportive and facilitating role of such funds. Publish-ing articles has turned to the pervasive outcome of mostthe researches, a fact that has been criticized by a greatnumber of research and development experts. Patenting asan alternative would better be introduced to the Iranian sci-entific society, especially biopharmaceuticals and other hightech fields to help them protect their research findings forprobable future commercialization which needs financialcontribution. Another issue, as specified by nearly allinterviewee groups, which could open the way up tothe commercialization and knowledge translation, isprivatization in the biopharmaceutical sector. Indus-trialists agreed that the few presently functional cor-porations are private and almost all entrepreneursprefer establishing private ones to prevent tackling thegovernmental bureaucratic management style. Effortsshould focus on capital marketing within the privatesector to attract more investment to the newly formedscience based companies. One of the industrialists said:

"There is a great deal of money nested in the privatesector seeking the opportunity to enter the field."

SolutionsSo revising the resource allocation policies and earmark-ing them to more efficient universities and institutes andsimultaneously to research priorities appointed by a jointcollaboration between researchers and industrialists arestrictly recommended. Financial support from patentingremains to be considered. A growing amount of grantsare being awarded to the researchers especially in largeruniversities. One of the academic staff said:

"The government should direct its money correctly tothe most efficient parts."

Improving the research capabilityChallengesIncreasing the number of researches and improving itscontent was regarded as necessary that are both applic-able and purposeful in nature. Such types of researchesneed good research planning by the institution manage-ment. Those researches should include all fields relatingto the biopharmaceutical sciences such as cellular andmolecular biology, microbiology, genetic engineeringand process engineering that involve facilitated commu-nications between those disciplines. Basic sciences con-stitute a pivotal part of the knowledge needed in thebiopharmaceutical industry which is somehow ignored.Prioritization in the biopharmaceutical sector accordingto the domestic market needs would aid the better re-search topic and field selection. In spite of the speedymovement of the universities in the world towards know-ledge generation and turning that knowledge to wealth,Iranian universities are struggling with the ambiguity ofrole and mission and have not redirected their work flowtoward that aim yet. One researcher said:

"Our universities wonder how to act; human resourceproduction or research or commercialization."

Assuming the structural and management practicemodification, universities can consolidate dynamismand dexterity in electing to research novel and hightech disciplines. Most interviewees complained aboutthe low amount of research budget. A pharmaceuticalbiotechnologist added:

"With the current funds we are going nowhere!"

SolutionsMost universities in Iran are pursuing the human resourcetraining goals and recently have fortunately paid attentionto the research. In this regard, universities must redefinetheir mission and vision. Redefining and redirecting theresearch budgets should be considered. Searching for newfinancial sources especially from the private sector wasdeemed as a feasible solution. A technology policy makerholds that:

"We can let the private sector to establish its researchinstitutes and substitute the governmental bodies.

Human resource (HR) developmentChallengesMost interviewees emphasized that both the quantityand quality of the graduates should be regarded; propos-ing a national or sector-wide qualification system. Al-though some level of disagreement was observed in theinterviewees on the qualifications of the HR, some


regulators and policy makers stated that the presentgraduates are well trained and qualified but some others,most of whom rooted in academia, expressed that quali-fied and experienced graduates are few in quantity incomparison to the needs. One of the interviewees en-gaged in policy making believed that:

"There is quite enough number of biotechnologyexperts in Iran and they should be appropriatelyassigned and recruited."

While another interviewee as an academic staff, heldthat:

"We have not adequate quantity and quality workersand experts in the biotechnology industry, albeit agrowing number of higher education students graduateevery year."

There was remarkable agreement on the following is-sues, although some interviewees did not express ifthey were for or against. Pharmacy curriculum revisionseems necessary, incorporating the fundamentals ofpharmaceutical biotechnology as well as the industrialand downstream processing aspects and the fieldsmentioned earlier. Education system reform shouldalso introduce more applied and experimental trainingrather than pure ones, a matter that is regarded as adeleterious problem with the trainings offered in theuniversities. Designing and establishing auxiliary coursesto complement the content of pharmacy training with em-phasis on the industrial and entrepreneurial aspects arenecessary. Researcher’s welfare is another factor that canaffect the proper research performance in the universities.

SolutionsTraining more and more number of students to conductresearch on the biopharmaceutical issues is an importantneed, a prevalent thought among the interviewees. Guid-ing the students for their career is a must. Applied andpurposeful research is denoted as one of the most influ-ential factors on the commercialization in Iran. One aca-demic staff said:

"Our students amaze in their career and most of themhave no plan to how to select their research field."

Leading the researchers toward the national prior-ities may be regarded as remarkable choice for re-directing the research. Providing incentives for appliedresearches as performed currently by the Iranian Nano-technology Initiative Council (INIC), is deemed to be effi-cient a way.A researcher on the academic policies said:

"Continuous training and knowledge improvement bythe researchers and the industrial work fellowsincluding managers and research and development(R&D) staff is some task that could be accomplishedby the universities, as well as involvement in thetechnology transfer process."

Encouraging the entrepreneurshipChallengesLearning commercial thinking seems scarce and spor-adic among the scientific society in Iran that may derivefrom the social attitude toward wealth. One policymaker as well as an academic staff said:

"In general the rich are regarded as negative andpursuing such morale equates accepting levels ofstigmatization."

On the other hand some regulations had previously re-stricted researchers from establishment of science basedcompanies, but recently revoked. Offering the courses andtrainings relevant to entrepreneurship presently is lackingin the pharmacy and other disciplines education curricu-lum, even in primary and elementary schools. Designingand facilitating the procedures for commercialization wasstated by nearly all the interviewees to be of substantial crit-icality. Presently there are no defined structures or organi-zations responsible for fostering the commercializationprocess and researchers have to personally seek some sup-ports. One biotechnologist stated that:

"There are no paved ways to commercialization; theway is so rough that withdrawal is by far wiser."

The role of the existing incubators and science andtechnology parks are somehow ambiguous and undefined.These entrepreneurial centers function less efficientlyhowever successful progenitors do exist. Providing specificservices to the researchers seeking ways for supplyingtheir services needs through specialized corporations isabsent currently, albeit an efficient example exists withinthe Nanotechnology Network of Iran. Unspecialized func-tion of the incubators and science and technology parks inthe defined fields render them non professional and inef-ficient, for example Tehran University of Medical Scienceshas established its incubator (pharmaceutical productdevelopment center) as a specialized incubator. Thinktanks, commercialization consultation centers and ideaevaluation centers are absent. As mentioned earlier, thecommercialization and entrepreneurial activity in the bio-pharmaceutical sector depends upon the national eco-nomic growth. So, further growth in biopharmaceuticalsector is subject to macroeconomic policies. An industri-alist said:


"In comparison, most countries experiencingconsiderable biotechnology growth, also experiencehigh economic growth rates."

SolutionsCommercialization and entrepreneurship advocacy cancontribute to more extended efforts by the researchersand students through to the goal. One policy maker said:

"We have not learned entrepreneurship in the schoolsand feel stranger with that concept."

Establishing offices dedicated to entrepreneurial fa-cilitations in universities would put a breakthrough tothe present situation. Management practices revisionas mentioned in the first part is recommended by theexperts. Active pathways for informing the researchersabout the policies and regulations in concordance withintroducing further transparency in the managementare suggested.

Industrial manufacturing capacityChallengesThe pharmaceutical industry is mainly possess by thegovernment and its related bodies, most companies areoutdated ones and should undergo renewal and recon-struction to cope with continuously tightening currentgood manufacturing practice (cGMP) requirements andcan hardly absorb new technologies that may be ascribedpartly to management practices applied and productioncapabilities. However the few biopharmaceutical com-panies are private. Not sufficient are the experienced,well educated and innovative middle and top level man-agers in the industry. Knowledge and technology man-agement, organizational excellence models, innovationfriendly atmosphere are not frequent in the industry butsome movements have formed recently. An academicstaff with industrial experience said:

"Managers in the biopharmaceutical industry are,most, not science and technology oriented enough toattract innovation."

Strategic alliances and clusters are new to the industry.However uncompetitive domestic market hinders qualityimprovement.

SolutionsBiopharmaceutical industry as the direct interface bet-ween biopharmaceutical innovation and the market re-quires attention. Privatization of the industry and the totaleconomy is a necessity. An industrialist said:

"Till the economy is ruled by the government nomajor outbreak in the pharmaceutical and bioindustry is probable."

Biopharmaceutical industry human resources shouldalso be well replaced and trained.

Promoting values and the public cultureChallengesCultural factors are important items that determine thebackground and context for entrepreneurial activity inthe society, as emphasized by most academic staff andpolicy makers.One academic staff stressed that:

"Nowadays most researchers prefer rather short termand fast resulting fields. Long term investment has notyet been prevalent and most investors prefer fieldswith immediate profitability, which can hinder thevital R&D time and long term investment."

Some research policy makers believed that:

"Policy makers, on the other hand, should follow andforesee the trends in the industry and research field toprepare for the situations coming forth as well as theresearchers and industrial activists."

Being bound to team work culture was shown to be akey issue that could render the current research capacitymore efficient and fruitful. This issue is not so prevalentin the universities and research institutes. Most inter-viewees shed light on the fact that team work is a must:

"We should oblige ourselves to team work, an ignorednecessity."

Values like perseverance, lack of egoism, not exagger-ating the achievements, team work and international co-operation are necessary for the whole system; as mostinterviewees mentioned. Industrial activists, especially,pointed at some basic cultural determinants like con-suming the national products and self esteem in theprovision of the domestic market needs and meanwhilefocusing efforts towards export of science based andhigh technology products that should be fixed in thewhole society of the country. Another considerable as-pect, mentioned iteratively by the academic staff, is thepromotion of innovation and the need for change in thestudent and researchers attitudes. Regarding the fundamen-tal impact of seeking innovation on the commercializationand applicability of the researches being conducted, onecan comprehend the influence of people looking for newproducts and process on the overall economic growth in


the biopharmaceutical sector. One of the policy makersstated that:

"We, naturally, try to copy and imitate others efforts;not looking for being different."

Policy makers and industrial activists stated that risktaking and continuous improvement among the man-agers is drastically not evident, a matter that negativelyaffects the organizational development especially in thehigh technology fields. Evidence based policy and deci-sion making, as proposed by most interviewees, is cap-able of lessening a great deal of issues.

SolutionsProvidence and long term thinking in the research and de-velopment should be incorporated. Perseverance in theapplied fields of research helps the commercializationprocess. “Management by values (MBV) principles” inthe organizations such as universities and small andmedium-sized enterprises (SMEs) can also promote theentrepreneurial motions.Cultural modifications require the involvement of top

level bodies responsible for the public culture to actproperly. Being free of any obligations for the selectionof the study discipline is somehow approached as thebasic element to allow the researchers function properly.One policy maker said:

"Most students have to achieve ambitions and wishesof their parents."

Innovative ideation can promote novel and modern re-search areas and technologies for the biopharmaceuticalindustry.

Extending the relations and communicationsChallengesMiscellaneous efforts in the universities and contemporaryefforts in the industry are being done but not cooperatingto synergize the expenditure and time. Approach towardscientific and technological cooperation among the activ-ists from both sides must be modified and the false selfsufficiency be exchanged by the interactionism. Brokeringis neglected in the Iranian biopharmaceutical industry aswell as other industries. One of the industrialists said:

"We approach the brokers as negative characters whilethey can help us."

Communication with the pioneering sources includingoutstanding universities, international biopharmaceuticalcompanies and consultancy incorporations are not ex-panded as much as needed. Most experts but especially

industrialists laid stress on the scientific communicationsto extrapolate biotechnology commercialization advocacyamong the researchers. Relations between the authoritiesand policy making and regulatory bodies were per-ceived as cornerstone aspect for the biopharmaceuticalcommercialization that functions unsatisfactorily. Adop-ting consistent and stable policies within different autho-rities specifically on the manufacturing policies is animportant challenge, although firm centralization in legis-lation and policy making is presently applied. It wasregarded as a crucial point that international relations ofthe country drastically influenced the whole economy andas a sector, the biopharmaceutical industry. A science andtechnology policy maker cited:

“We cannot restrict ourselves in the national borders;since, today, the product and raw material market isan international one.”

Scientific communications with developed countries, re-gional and international organizations relating to biotech-nology, entering commercial and industrial treaties withpioneers, extending the market beyond the national and localboundaries, among others, are all heavily overshadowed bythe extent to which the international relations may protrude.

SolutionsWell managed university and biopharmaceutical indus-try relation was mentioned as an obligation. Interactionand partnership in research among scientists from differ-ent fields relating to the biopharmaceutical industry wasdeemed to be helpful. Some academic staff stressed that:

“There are so many research problems that can besolved only through scientific cooperation.”

As the literature on knowledge translation denotes, ac-tive characterization and probing into the real knowledgeand technology needs can make remarkable assistance tothe commercialization process, a role which may beplayed satisfactorily by the brokers. Training in fields likecommercial management and international marketing canalso notably contribute to further extend the relations.Technology transfer might be perceived as a suitablechoice for making up the delay in the knowledge andtechnology creation by the research institutes. One policymaker stated that:

“We can compensate our lag in biotechnology bytransferring the critical technologies.”

DiscussionBiotechnology as a fast growing source of new technolo-gies and innovative, safer, targeted and curative medicines


for the pharmaceutical industries has obtained attention[1]. Biopharmaceuticals accounts for an increasing partof the expenditure on the pharmaceuticals. The specificfeature of biotechnology, in general, in being based largelyon academic and university researches renders the com-mercialization of research findings substantial importance.There are a satisfactory number of research institutes in thebiopharmaceutical field in Iran, but the number of bio-pharmaceutical companies has been limited to few ones.One possible explanation for the perceived gap between re-search and production might be the malfunction of thecommercialization practice [8,16]. All interviewees per-ceived university research finding commercialization asnecessary as the researches conducted in the biopharma-ceutical field [17,18]. They expressed that expending re-search budget on researches that were not to be applicableand help the country solve any problem, is of no signifi-cance, a situation referred to as valley of death for re-search. There was consensus on these facts: there are noadequate research budgets and grants while private sectoris so weak, purposeful and applied researches are rare,commercialization underpinned no structured and orga-nized system, communications in/outside the sector andinternational ones dose not fulfill the requisites, entrepre-neurial facilitations and knowledge is shortcoming andcultural basis is lacking [19]. Amendment and revision inpolicies, regulation and organizational management, asthe most critical issue expressed, in relating groundssuch as research, communications, entrepreneurial andcommercialization procedures must be considered [20].Moving towards free market and economic privatizationwas mentioned, requiring the lessened involvement ofthe government in medicine market. Regarding the com-plex and multi faceted nature of the commercializationprocess and to gather the more of the stakeholder’s ap-proaches toward the topic for provision of a policy makingaid and not testing hypotheses, a qualitative method waschosen to discover and develop more detailed body ofknowledge on the issue [21,22]. Sampling was based onthe stakeholders engaged in a purposeful way, while, per-haps naturally, the formal positions held influenced theirresponding pattern and attitudes, particularly thoseserving as policy makers and top level managers of thegovernmental authorities, as qualitative methodologypresupposes. However, very few studies have specificallyinvestigated the biopharmaceutical commercializationprocess in developing countries [23]. Various backgroundtypes like industrialists, policy making and researchers fo-cused on different aspect of the commercialization process.Technical biotechnology issues, pricing policy and marketcompetition regards were emphasized by the industrialistswhile policy makers mainly highlighted the social and pub-lic benefits for higher quality and moderate price and re-searchers underlined grants and entrepreneurial aspects

[24]. Although some experts who were involved in morethan one background like research and industry enteredthe study, a fact that eased the inter profession interpret-ation. However, each background potentiated some ap-proaches to some extent, especially in the industrialists. Wetried to include the most comprehensive informant societyof the research and industry and policy making sides, how-ever, some conflicts of interest and bias were noted andcared. Governmental interventions on the medicine marketcontrol, pricing and policy making raised some disagree-ments, which the impact of the interviewee position wasevident on. Different data gathering methodologies fairly in-creased the data accuracy and trustworthiness by triangula-tion of data sources [25] as well as the construct validity ofthe present study [26]. Ireland et al. [27] have studies differ-ent new biotechnology firms and developed a conceptualmodel to delineate how they had organized business andscience issues. They have concluded that the successfulfirms could have balanced their scientific and business is-sues. Terziovski et al. [28] have investigated managementpractices and strategies that are critical for successfulcommercialization in the biotechnology industry. Theyhave also specifies the challenges faced by the biotech-nology industry in human resources, financial issues,entrepreneurial and business skills and supply chainlinkages, however they have focused on the industry ra-ther than the university. Markman et al. [29] studied thefactors that could affect the speed of university technol-ogy to the market. They found some factors that influ-enced technology commercialization in the universityside of the commercialization process. They shed lighton the capabilities and resources available for the uni-versity technology transfer offices (UTTOs) and theirimpact on the commercialization speed. Fontes [12] hasstudied the role that biotechnology spin-offs could playin the commercialization of the knowledge produced bythe research organizations (ROs). It was shown thatthese spin-offs can be regarded as alternatives for technol-ogy transfer offices. The present study tries to provide acomprehensive approach into the commercialization ofbiopharmaceutical knowledge. Major barriers and chal-lenges in the successful commercialization process in Iranwere identified and the most influential factors for over-coming the challenges were introduced. The results implythat national innovation system can be respected as a suit-able model to go for investigating the barriers and provi-ding facilitators for commercialization practice [30-33].

ConclusionThe present study tries to discover the major factors thatinfluence the commercialization of the biopharmaceut-ical knowledge and propose processes for moving re-search to marketplace. As the nature of qualitative studydenotes, results derived from one situation could hardly


be extrapolated to other ones, but some general issues canbe highlighted. Management practices, regulations particu-larly on the intellectual property right and policy making af-fects the entire commercialization process even theresearch as the antecedent. Financial support for the re-searches is a factor that can facilitate commercialization[18]. Globally, few university researches after long time maybe commercialized; therefore quantity and quality of the re-searches and their applicability may be respected. Humanresource management plays an important role in the bio-pharmaceutical industry, as a high tech field especiallytraining the HR. Entrepreneurial facilitations can encouragethe researchers for commercialization [34]. Cultural factorslike trust and team work influence whole the process [35].University-industry and international relations can affectthe applicability of the researches and knowledge transfer,while noticing the disadvantages of university-industry rela-tion [36]. Such a study that goes through this issue for thefirst time can open the way for further studies that specific-ally investigates each factor. Nearly all the intervieweesstated that the commercialization process has been fa-cilitated deeply during recent years, but there areothers to do to achieve what is desired. Iran as a devel-oping country can be regarded as a pattern for otherdeveloping countries while specific local situations be-ing kept in mind. We can conclude here that the fur-ther potentiation of the national innovation system canvitally facilitate the commercialization of biopharma-ceutical knowledge.

ConsentWritten consent was obtained from the interviewees fortape recording the interviews and the publication of thisreport.

AbbreviationsNIS: National Innovation System; MOHME: Ministry of Health and MedicalEducation; HR: Human Resource; INIC: Iranian Nanotechnology InitiativeCouncil; R&D: Research and Development; cGMP: Current GoodManufacturing Practice; MBV: Management by Values; SMEs: Small andMedium-sized Enterprises; UTTOs: University Technology Transfer Offices;ROs: Research Organizations.

Competing interestsThe authors declare that they have no competing interests.

Authors’ contributionsNNK conceived and implemented the strategy, performed the interviewsand data analysis and drafted the paper, RM conceived the strategy of studyand supervised the project, AK revised the strategy and supervised theproject, AR gave consultation on study design and qualitative methodologyand edited the draft, MTY gave consultation on biopharmaceutical industry,SN gave consultation on designing the study and qualitative methodology,SN gave consultation on the study implementation and edited the draft. Allauthors read and approved the final manuscript.

AcknowledgementsThe authors are thankful to the Research and Technology Deputy of Ministryof Health and Medical Education and researchers who entered the studyfrom research institutes, universities and biopharmaceutical companies.

Author details1Department of Pharmacoeconomics and Pharmaceutical Administration,Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.2Knowledge Utilization Research Centre and School of Public Health, TehranUniversity of Medical Sciences, Tehran, Iran. 3Pharmaceutical Policy ResearchCenter, Faculty of Pharmacy, Tehran University of Medical Sciences, EnqelabSquare, Tehran, Iran. 4Knowledge Utilization Research Centre andDepartment of Health Management and Economics, School of Public Health,Tehran University of Medical Sciences, Tehran, Iran. 5Department ofPharmaceutical Biotechnology, Faculty of Pharmacy, Tehran University ofMedical Sciences, Tehran, Iran.

Received: 17 June 2013 Accepted: 26 October 2013Published: 24 February 2014

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doi:10.1186/2008-2231-22-29Cite this article as: Nassiri-Koopaei et al.: Commercialization ofbiopharmaceutical knowledge in Iran; challenges and solutions. DARUJournal of Pharmaceutical Sciences 2014 22:29.

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Commercialization of biopharmaceutical knowledge in Iran challenges and solutions