Studneva et al. The EPMA Journal (2015) 6:18 DOI 10.1186/s13167-015-0040-4

REVIEW Open Access

Strategic aspects of higher educationreform to cultivate specialists in diagnosticand biopharma industry as applicable toPredictive, Preventive and PersonalizedMedicine as the Medicine of the Future

М. Studneva2, M. Mandrik2*, Sh. Song7, E. Tretyak8, I. Krasnyuk2, Y. Yamada9, A. Tukavin10, A. Ansari11, I. Kozlov14,C. Reading12, Y. Ma13, K. Krapfenbauer3, A. Svistunov2 and S. Suchkov1,2,3,4,5,6

Abstract

Predictive, Preventive and Personalized Medicine as the Medicine of the Future represents an innovative modelfor advanced healthcare and robust platform for relevant industrial branches for diagnostics and pharmaceutics.However, rapid market penetration of new medicines and technologies demands the implementation of reformsnot only in the spheres of biopharmaceutical industries and healthcare, but also in education. Therefore, theproblem of the fundamental, modern preparation of specialists in bioengineering and affiliated fields is becomingparticularly urgent, and it requires significant revision of training programs of higher education practice into currentmedical universities. Modernization and integration of widely accepted medical and teaching standards requireconsolidation of both the natural sciences and medical sciences that may become the conceptual basis for auniversity medical education. The main goal of this training is not simply to achieve advanced training andexpansion of technological skills, but to provide development of novel multifaceted approaches to build academicschools for future generations.

Keywords: Predictive, Preventive and Personalized Medicine, Education, Companion diagnostics, Pharma industry,Innovation, Drug design, Targeting, Bioinformatics, Translational medicine, Integration of science and education

ReviewLimitations of the current diagnostic and therapeuticparadigmBiopharma as an industrial branch has always been con-sidered as a strategic industry, being an important com-ponent of national security that includes the followingtypical enterprises and organizations:

� Chemical and pharmaceutical departments andresearch chemical and pharmaceutical institutes

� Supervising institutions and organizations forspecific categories of medicinal products

* Correspondence: marubinimark@gmail.com2I.M.Sechenov First Moscow State Medical University, Moscow, RussiaFull list of author information is available at the end of the article

© 2016 Studneva et al. Open Access This artInternational License (http://creativecommonsreproduction in any medium, provided you gthe Creative Commons license, and indicate if(http://creativecommons.org/publicdomain/ze

� Departmental organizations (particularly of theMinistry of Defense) and so on

� Biopharmaceutical industries including productionof active ingredients

Hence, a complete manufacturing chain has beenavailable—from the selection of active biological mole-cules and potential pharmacotherapeutic targets to theproduction of the final product and marketing thereof.This requires corresponding personnel support and aprofessional preparation system, including higher edu-cational institutions, specialized secondary schools, andpost-graduate education (post-graduate qualification, doc-toral degree, career development system) [1].Development of medicinal products and preparations

and diagnostic instruments of each next generation is a

icle is distributed under the terms of the Creative Commons Attribution 4.0.org/licenses/by/4.0/), which permits unrestricted use, distribution, andive appropriate credit to the original author(s) and the source, provide a link tochanges were made. The Creative Commons Public Domain Dedication waiverro/1.0/) applies to the data made available in this article, unless otherwise stated.

Studneva et al. The EPMA Journal (2015) 6:18 Page 2 of 14

long, science-intensive and costly process. The junctionof complex biosystems theory and translational medicinehas led to the rampant development of systems biology,resulting in the active introduction of principally newapproaches into the practice of specialists in pharma-ceutical design: these are now oriented to the creation ofmarket products with exclusively high-tech level.The area of use of such products has been greatly ex-

panded covering the segments of therapeutic-diagnostic(theranostic), predictive-prognostic, preventive-prophy-lactic, and rehabilitation instrumentation. This, in turn,has been dictated by the birth of technological platformsof principally new generations, on the one hand, and in-ternal restructuring of the healthcare model replacing thecorresponding segments with groundbreaking innovationtechnologies of Predictive, Preventive and PersonalizedMedicine (PPPM), on the other hand. And that is whytoday the existing market situation strongly requires notonly the update of the biopharmaceutics engineering ideol-ogy and its technological inventory, but also the acceptanceof more radical steps in terms of rotation of the personneland renovation of the whole system infrastructure. Whyso? The latter, having been capable of ensuring the bio-engineering sectors of the pharmaceutical industry as aneconomy segment with personnel, is nowadays progres-sively and, more importantly, hopelessly and irreversibly

Fig. 1 Multitargeting focused on realization of a therapeutic potential of thmodeling. A three-dimensional structure of the target explains a molecular mdocking or computer modeling of the ligand-protein interaction. The dockingof technology development, it is usually conformationally fixed) and the liganwith the receptor are modeled in the process of docking. The docking makesprocedure analogous to high-performance screening with the use of compumain advantage of which being that for real pharmacological tests, and it is ncompounds, but only “virtual prototypes.” When the target is selected, the libthis stage is to detect the compounds that after further modification and testpeople. b A pharmaceutical analogous to the ligand is bonded with a protein rtakes place. c A pharmaceutical simultaneously cooperates with several regulatothe protein regulators transmit information to the structural genes used to regu

aging, therefore requiring a radical reform from the pool ofbioengineers [2].The shortage of skilled personnel capable of solving

principally new tasks is felt today even in the majority ofdeveloped countries including the regions with powerfulbiotechnological and biopharmaceutical clusters (USA,Scandinavia, Hong Kong, and others). And this happensin spite of the fact that over 50 % of the graduates ofpharmaceutical departments of European universities areoriented to work in the specialized sectors of industriesand affiliated structures thereof.Thus, with due account of increase in the labor

market of biopharmaceutics and biopharmaceuticalindustries, the demand for qualified research and pro-duction personnel is essentially increasing. At thesame time, the demand for sales managers and mar-keting specialists is evidently decreasing. The com-panies oriented for high-technology developments increative segments, including (а) multitarget pharmaco-logical structures oriented for the components beingpart of various signal paths (Fig. 1), (b) “companion”diagnostics (Fig. 2), (c) next-generation sequencing(NGS) (Fig. 3), or (d) screening for presence of circu-lating tumor cells (CTCs) in the blood (Fig. 4), andothers are in need of creativity personnel to staff theirsearch and R&D subdivisions.

e drug designed. a Use of high-performance screening and molecularechanism of interaction of a ligand with protein; it is used for molecularuses the three-dimensional structure as startup information (at this staged structure whose conformational flexibility and mutual arrangementit possible to reduce the expenses and time due to conducting a

ter environment. This procedure is called virtual screening with theot necessary to acquire a complete library consisting of millions ofrary of compounds may be used as a startup set of ligands. The task ating may offer a candidate compound for further testing on animals andegulator but does not activate it. Complete inactivation of a pharmaceuticalrs, as a result of which its partial inactivation is observed. In the process,late protein synthesis

Fig. 2 The role and place of the “companion” diagnostics as a special segment of the biopharmaceutical market. The diagram shows the ratio ofthe number of patients who have obtained a positive result upon receiving a pharmaceutical to the number of patients whose quality of life hasdrastically improved after termination of their therapy [20]

Fig. 3 a Methods of next-generation sequencing (NGS). NGS relates to the determination of the initial sequence of DNA or RNA withfurther description of the primary sequencing item structure. This technology allows simultaneous reading of several genome sectionswhich is the main difference as compared with the existing methods of sequencing. NGS is performed with the help of multiple chainextension cycles induced by polymerase or multiple oligonucleotide ligation. b The ratio of the number of new-generation laboratoriesdealing with of genomics. Note that 44 % of the laboratories belong to the higher education structures (in the education category),38 % belong to the structure of biopharmaceutical enterprises, and 8 % of the laboratories belong to the government

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Fig. 4 a, b Volumes of sales of CTC-products in the world marketand prognosis for 2012–2018 in USD million. а The primary tumorcells are capable of breaking off from the main tumor mass andcirculate with the blood flow in the organism; such cells are calledcirculating tumor cells (CTCs). A solution of diagnostic and predictiveproblems is provided by a special technology and device (CellSearch™)capable of detecting СТСs in the course of blood analysis. The principleof action of the device is based on the method of immunomagneticseparation of fractions, followed by fluorescent identification of CTCs.b Prognosis of СТС technology sales for the period of 2012–2018

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Here, one talks about specialists of a new generation inprinciple, namely, specialists in the field of personalizedgenomics, proteomics, drug design, and bioinformatics.Exactly these specialists are capable not only of engineer-

ing pharmacological structures and predictive-diagnosticinstrumentation of new generations, but also of prognosti-cating selection of potential pharmacotherapeutic targetcandidates out of new (including earlier unknown) familiesby determining the production platforms and methods ofquality assurance with them in the corresponding configu-rations of operation therewith [3].

The main terminology used in the pharmaceuticaldesign consists of pharmacotherapeutic target (PTT) andtarget pharmacological structure (TPS) (drug).PTT is a macromolecular biological structure sup-

posedly associated with a definite function, the violationof which may cause formation of pathological shifts atthe preclinical stage followed by clinical manifestation ofa disease, which requires a specific action to prevent.The most frequent targets are receptors and enzymes(Fig. 5).TPS is a chemical compound (or biological product)

specifically interacting with the target and capable ofmodifying the final cell response (Fig. 6).Therefore, one of the important aspects of pharma-

ceutical design is selection of the proper PTT throughwhich it is possible to specifically regulate some biochem-ical processes or complete metabolic scenarios withoutaffecting other pathways, if possible. A considerable rolein the process of development of PTT and pharmaceuti-cals as a whole is played by bioinformatics—integration ofmethods of applied mathematics and statistics enablingnot only analysis of the available genomic, proteomic,and interactive data, but also prediction of the inter-action of new level interactions on the basis of detectedregularities (Fig. 7).Quite recently, there has been formed a demand for

new professions: Government relations managers (GRmanagers) and experts in validation and pharmacovigi-lance (Figs. 8 and 9), etc.For instance, a GR manager is a specialist responsible

for building productive and successful liaisons between abiopharmaceutical company and government organiza-tions. By building up trustworthy informal relations withrepresentatives of public organizations, GR managerspromote prosperity of their enterprises and their sustain-able development. A GR manager is responsible for theorganization of cooperation, promotion, and protectionof the interests of his/her company in the state executivebodies and public organizations. The main tasks of GRmanagers are to organize meetings and negotiations withrepresentatives of state establishments, to participate inspecialized exhibition shows and conferences, and toconduct seminars and presentations for representativesof state bodies. It is also the competence of the govern-ment relations manager to organize a political analysisand keep track of the legislature and political trends andrelevant changes [4].When developing and introducing new medicines and

technologies into the pharmaceutical market, it is required,at each stage of a product creation, to evaluate the qualityof semi-finished or finished products. In this context, aspecialty of expert in validation and pharmacovigilancebecomes highly demanded. The duties of such a specialistare to control the quality of the products manufactured

Fig. 5 Families of potential pharmacotherapeutic targets in the human body. Kinases are enzymes acting as catalysts for the transfer of thephosphate group from the adenosine triphosphate (ATP) molecule to various substrates. Receptor tyrosine kinases (ТK) act as a catalyst for thetransfer of the phosphate residue from ATP to tyrosine residue of specific cell protein targets. Non-receptor tyrosine kinases are located in the cellcytoplasm and are attached to cytoplasmic membrane on the inner side. An example may be the SRC protein which has one changed aminoacid in it, inducing hyper-expression of genes and growth of the cell. An ion channel receptor is a pore-forming protein supporting the differenceof potential that exists between the outer and inner sides of the cell membrane in live cells. The GPCR receptor is a G protein-coupled receptor(relates to the family of transmembrane proteins). Zinc proteases: zinc is a coenzyme of over 60 enzymes in human body. Nuclear receptorsrepresent DNA-coupling transcriptional factors with conservative domain organization, the activity of which is controlled by lipophilic ligands,phosphorylation, and interaction with other proteins. Serine proteases are proteases used to modify other proteins by phosphorylation of serineresidue. Phosphatases are enzymes used to dephosphorylate the substrate as a result of ester decomposition of phosphoric acid

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including the documentary proof that the process ofmanufacture of the end product meets the correspondingrequirements and brings the expected results, to informmedical institutions about undesirable adverse reactions ofpharmaceuticals, and so on.

Fig. 6 Interaction pattern in a polymer-pharmaceutical-ligandconjugation

Fig. 7 Components of bioinformatics. Genomics is a branch ofscience studying structural and functional organization of a genome.Proteomics is a branch of science focusing on proteins and theirfunctions and interactions in living organisms. Metabolomics is abranch of science studying the particulars of metabolic pathways.Bioinformatics develops algorithms for the prognostication of thespatial structures of proteins and other biomolecules as well asevaluates the character of control of complex biological systems.Thanks to these informational technologies, it has become possibleto model pharmaceuticals, drastically reducing the time for creationof pharmacological structures of principally new generations

Fig. 8 Traditional process of selecting human resources by qualification

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Development of biopharmaceutical industries is im-possible without preparation of specialists on a wideinterdisciplinary basis including the following specialties:

(a)Chemists, biologists, and bioinformatics specialistsfocused on applied bioengineering and developingnot only drugs, but also the ideology of theircreation on the basis of mathematical modelingand selection of PTT in the course of designing oftherapeutic-diagnostic instruments of the future

(b)Pharmacologists and clinicians responsible forthe conduct of preclinical and clinical research

(c)Technologists of a biopharmaceutical plant equippedwith process lines and platforms of new generations

(d)Specialists in the field of certification, validation, andlicensing of the end product [5]

Fig. 9 The process of qualification selection. Activities of the FDA on super

Correspondingly, implementation of reforms in prac-tical healthcare and naturally in the spheres of bio-pharmaceutical industries as their integral componentrequires effective measures in the policy of human re-sources (HR), which may allow to qualitatively changethe HR potential in the biopharmaceutical industries, toadapt it to new conditions, and to execute the tasks fore-seen in the reforms.The concepts discussed above all point to the insight that

for successful commercialization of a biopharmaceuticalproduct, it is important that the specialists ensuring eachstage of its development have a clear picture of thecomplete “path” (a translation procedure) of the medicalproduct—from the search for a biologically active substanceor creation of its virtual biostructure to the marketing ofthe finished product. Therefore, educational programs of

vising the market release of validated pharmaceuticals

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medical, pharmaceutical, and technological institutions ofhigher education should be directed to satisfy the needs ofthe biopharmaceutical sector in the aforementioned spe-cialists—a subject of great interest to the professionalsociety.

The role of bioengineering and biopharmaceuticalindustries in modern societyThe achievements of modern bioengineering and bio-technology have a qualitative effect on many spheres ofhuman activities and play an ever greater role in solvingkey problems of human life. Naturally, these achieve-ments ensure controlled obtainment of useful productsfor various spheres of human life and are based onutilizing the functional potential of separate biomole-cules, cells, whole cell systems, and living systems ofvarious degrees of complexity.However, a real breakthrough in the sphere of pharma-

ceutical design has been provided by completion of the“Human Genome Project,” leading to a totally new ap-proach to the search and selection of potential pharma-cotherapeutic targets of new generations, accessible toanalytics directly in the genome text. The instrument forthe analysis of such type of data massif will be bioinfor-matics, which has already led to a revolution indeed inbiotechnology [6–8].Clearly, progress and leadership of the USA in bio-

technology and affiliated fields may be explained notonly by huge investments into biopharmaceutical indus-tries, but also by special attention to the role of profes-sional specialists of new generations. Preparation of suchspecialists is one of the most important elements of theUnited States educational policy, the basis of whichamong other things is the phenomenon of intensivecooperation of university science with private pharmaco-logical business.Strong attention to the development of biotechnology is

paid in the countries of the European Union, where thetotal biotechnological market has crossed the mark of 120billion euro. Positions are also strong in South Korea,China, Japan, Great Britain, Germany, and Scandinavia.It is precisely for this reason that the problem of prep-

aration of specialists in bioengineering and affiliatedfields is becoming particularly urgent.

The objective necessity of educational reform in thesphere of bioengineering and biopharmaceuticalindustries: problems and solutionsIn the world of accelerated scientific and technical pro-gress that we are now witnessing, the today’s obsoleteeducation model does not give fundamental knowledge.As discussed above, the increase in quality of training pro-grams in universities is a priority of modern educationalpolicy; this increase shall be based, in terms of quality

assurance issues, on the role of the government in regulat-ing, financing, and monitoring through the procedures ofaccreditation, licensing, and attestation [9].Higher quality of the system of preparation of new-

generation professionals implies not only the quality ofthe functioning system final results, but also as the qual-ity of the process itself, which should start as early asfrom a pre-higher education training of future bioengi-neers. Special significance here should be paid to theviability of the system to select talented young specialistsand promptly involve them into creative activities [10].Then follows university education, the effectiveness of

which may be evaluated with the help of the followingcomplex criteria: the content quality of the main andpost-higher educational institution educational programsand the quality of the process of realization of educa-tional programs. At this stage, most important becomesthe integration of science, education, and real productionwhich helps integrate the resources of universities, theRussian Academy of Sciences, and business structures byway of creating various integrated structures (for instance,technology incubators, education-production centers, andothers) and thus considerably increasing the effectivenessof preparation of personnel. This in turn requires the devel-opment and employment of problem-oriented technologiesof biopharmaceutical education within the framework ofcontinuous programs of specialist preparation. It becomesquite evident that higher, secondary-level and first-level edu-cation should be integrated into a single chain having themain task—to create a bioengineer of the future [11, 12].

Issues of preparation of personnel for bioengineering andpharmaceutical design, and ways of solutionAt present, one of the main problems of preparation ofbiotechnologists and bioengineers is the absence of mod-ern and well-equipped bases for the production practiceand, correspondingly, absence of a possibility for practicaltraining and forming of adequate sets of professional skillswith the trainees (future specialists) [13].One of the solutions for this issue has become the

introduction of federal state standards of secondary-levelvocational education of the new generation. The maindifference of the federal state standards of this thirdgeneration from the previous educational standards is amodular-competence carrying approach.Competences is an algorithm of specialist actions which

manifest themselves in practical activities and social inter-actions. It is exactly the module as a new structural elem-ent that holds the central place in the content of vocationaleducation, since the requirements to the results of trainingare formed as a list of the types of professional activitiesand corresponding professional competences. A graduateof the training course should, first of all, acquire practicalexperience based on the complex of skills and knowledge

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to be mastered. Each module may be mastered independ-ently, and their integrity permits to reach final competencein a particular professional sphere.Complex, synchronized study of theoretical and prac-

tical aspects of each type of professional activities is per-formed within the framework of such modules. Withregard to the abovementioned, the excessive theoreticaldisciplines are not so much reduced as their content isrevised. That is, one envisions a kind of “sifting” of ex-cess theory and reshuffling of the volume to emphasizethe most necessary theoretical knowledge to enable mas-tery of the competences by arranging them in an orderlyfashion and systematizing them, which, in the long run,increases the motivation of the trainees [14].The central moment in the work to introduce the

competence approach modular technology into the edu-cational process is such forms of organization of educa-tional activities that are based on self-dependence andresponsibility for the results of work on the part oftrainees themselves. The organized training processenables the student to develop self-dependence duringlectures, seminars, laboratory classes, and extracurricularworks, and allows independent execution of individualtasks which greatly expands one’s knowledge, developsskills, and helps develop a creative approach and abilityto find one’s place in the growing flow of scientificinformation.One more important problem is the quality of educa-

tion being received. To solve this problem, it is proposedto introduce into practice new pedagogical technologiesdirected at full and conscientious understanding of thematerial under study. One of such models is the modelof interactive training of students (Fig. 10, diagrams 1and 2) [15].As distinguished from active methods, the interactive

methods are oriented for wider interaction of studentsnot only with the instructor, but also with one anotherand for the dominancy of activity of students in theprocess of training. Interactive material presentationshould be planned beforehand, since such training re-quires constant control over the trainees. When theinstructor addresses the students with questions or triesto involve them into discussion, he/she should alwaysknow in which direction the discussion may go and

Fig. 10 Forms of interaction of students with lecturer

control the course of discussion. The task of the in-structor is to help the group to point out a definite problemand direct the course of discussion towards clarificationand solving the problem set. By using answers and consid-erations proposed by the students, the instructor encour-ages the students to work over the material and boosts uptheir interest in the issue under discussion in order to ac-centuate the correct provision. The “directed discussion”requires skill and ability on the part of the instructor toclearly set up the direction of the discussion by smoothlychanging the course of discussion as well as re-phrasing theanswer by giving it the right tint and stressing the rightaccents.The directed discussion may be dedicated to the whole

lesson, or a small series of questions-answers may bebuilt into the speech of the instructor. An effectivemethod to attract attention of students to importantinformation is listing of questions at the beginning ofthe lecture. Besides, it is necessary to show that the in-structor has noted the efforts made by the student. Themain objective of the directed discussion is activation ofbrainwork of students and their involvement in thetraining process. Important difference of interactiveexercises and tasks from ordinary ones is that whenperforming interactive exercises, students not only andnot so much as make fast the already studied material,as study new material.The interactive training expects the logics of the train-

ing process to differ from the ordinary process: not fromtheory to practice, but from shaping new experience toits theoretical understanding through the use of the lat-ter. Experience and knowledge of educational processparticipants serve as a source of their mutual trainingand mutual enrichment. By sharing their knowledge andexperience, the participants take upon themselves aportion of the instructor’s educational functions, thus in-creasing their motivation and training productivity.An effective interactive method, very important for

formation of skills for work, is demonstration. The fea-ture of this method is the possibility to illustrate the sub-ject under discussion for its better adoption. Thus, byusing interactive methods, we set ourselves a task notonly to give the students general knowledge, but also toform a definite level of expertise and skills so that in fu-ture work, particularly when using biological agents (mi-croorganisms, plant and animal cells, and parts thereof:cell membranes, ribosomes, mitochondria, chloroplasts),future specialists in biotechnology and pharmaceuticaldesign may feel at ease and demonstrate maturity andcommon sense when trying to obtain valuable productsand carrying out target transformations [16].Integration of science and education is important to in-

crease the quality of preparation of specialists. For example,within the framework of higher educational institution

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structural integration, there may be integrated universitydepartments and research institutes with similar intereststo create scientific and educational complexes having acommon academic council and administration system. Bydoing this, university lecturers do scientific work in re-search institutes, researchers give lessons in universitydepartments, and the academic council coordinates all thiscomplex work and approves educational plans of depart-ments and research plans in research institutes.A number of universities have already organized educa-

tion-science-innovation complexes (ESIC) for the purposeof increasing the quality of education and strengtheningthe liaison with the production. The specifics of ESIC con-sists in that, thanks to the cooperation of scientificresearch and educational and production capacities, thereis ensured a new quality of education, development ofresearch, and commercialization of the results of scientificand technological joint performance.Creation of ESIC on the basis of a structural sub-

division of a higher educational institution/university (adepartment, laboratory of a research institute, pilot-scaleproduction of university) without establishment or attrac-tion of a legal entity permits to avoid problems associatedwith the interaction of two and more legal entities, espe-cially when they have different forms of incorporation. Inthis case, it becomes easier to solve questions associatedwith intellectual property and organize joint educational,scientific, and innovation processes. Setting up of ESIC onthe basis of a university and a large industrial enterprisepermits developing long-term cooperation and prepar-ation of duly trained personnel for the needs of the bio-pharmaceutical industry.A problem of great concern is how to prepare gradu-

ates of secondary-level schools to education in universi-ties—our potential students. Today, we are forced toadmit the discrepancy between the skills of a secondary-level school graduate and the skills necessary for the fastand successful adaptation of a student to study in a univer-sity. To overcome this, we need to think about organizinga close contact in the “secondary school-university” link. Inthis regard, a sufficiently attractive idea is to “incorporate”the last stage of secondary-level education into the struc-ture of higher education. We need to revive old traditionsand offer universities the resources and possibilities toorganize a pre-university training in our physico-technical,physico-mathematical, and ecological-biological system andother schools operating on the basis of universities. Thiswill help to attract academic staff to teach at such schools,make use of higher school teaching technologies, and re-duce the time for adaptation of students.In addition to the creation of a “secondary school-uni-

versity” cluster with the aim to increase the quality ofeducation, a particular place in preparation of bioengi-neers is occupied by the “secondary school-university/

college-production” cluster. The cluster pattern of thissystem will help prepare a competent employee for the re-gional labor market and achieve maximum result in aminimum time limit. Exactly, the cluster approach prede-termines a mutually beneficial relationship, uninterrupted-ness, and cooperation. It is evident that active jointfunctioning of educational establishments with pro-duction facilities will create favorable conditions forincreasing their investment attractiveness and competi-tiveness of graduates at the regional labor markets [17].The demonstrated “good practices” uniting educational

and innovation activities in universities show that with theestablished ties with revived or newly organized private en-terprises, the scientific and educational cooperation startsits active growth. In short, the state, market and produc-tion, universities, and research institutes should promoteexpansion of the biopharmaceutical sector of economics,contribute to effective national industrial policy, and sti-mulate innovations of small businesses, thus facilitatingthe progress of society as a whole.

PPPM as an innovation model of advanced healthcareand sector of biopharmaceutical industry andpharmaceutical designThe purpose of employment of the knowledge, skills, andresources of biopharmaceutical science and biopharma-ceutical industry is to predict and prevent diseases, in-crease the life expectancy, and strengthen and preservehuman health through organized efforts of society.The essence of the new model of advanced health-

care—PPPM—is in guiding the human body reserves,and its main purpose is not healing the diseases, butdetecting concealed anomalies in organisms and takingtargeted measures directed at the liquidation of suchanomalies and preventing diseases. Naturally, such type ofglobal change could be obtained only with active introduc-tion of fundamental science achievements into life,making it possible to get inside the affected biostructureswith conditions to visualize the damaged sites (includingthose concealed from the doctor’s eyes) with furtherliquidation thereof at the preclinical stage and thus pre-venting the beginning of disease.Today, we already observe growth in the share of pre-

dictive and preventive medications in the overall spectrumof developed and manufactured drugs. This requires or-ganizing, in the medical and chemico-pharmaceuticalhigher educational institutions, special educational pro-grams incorporating technological and other aspects ofmodern biopharmaceutics including the tasks of PPPM-affiliated branches of the biopharmaceutical industry [18].In this regard, the reform of pedagogical process and cre-

ation in the structure of medical universities of relevantchairs and later PPPM departments will reflect the system-atic approach to form innovation infrastructures with the

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purpose to modernize the present-day profile of the bio-pharma industry. The requirements to the specialists of thefuture, i.e., specialists in the field of pharmaceutical design,traditional medicine, and bioinformatics, will also change.Correspondingly, at this stage, the training programs

should include the tasks of training the students andplanting skills in the following fields:

� Understanding of the key molecular mechanismsof disease development and designing models ofpathophysiologic mechanisms of the latter withpreliminary selection of potential pPTT

� Identification of basic structural-functional shifts inthe physiological architectonics of cell biomoleculescausing generation of cell pathology, pathology ofintercellular interactions, and, as a result, the overallpattern of clinical symptomatics

� Screening of biomarkers necessary for use inpredictive diagnostics, prognostication, andmonitoring of diseases at the preclinical andclinical stages of disease

� Understanding of the principles of moderndiagnostics, and analysis and interpretation oflaboratory data permitting to perform identification ofkey cellular shifts when various pathologies are formed

� Use of molecular targets with the aim ofprophylactics and prevention of disease at theclinical stage or typical pathological process at thepreclinical stage

A graduate of specialized courses should naturallyknow the following:

� Theoretical and methodological basis offundamental medicine corresponding to thecontemporary level of world knowledge in the fieldof systems biology and fundamental biomedicine

� Principles of designing of a model of pathologicalprocess with identification of biomarkers andselection of targets necessary for effective controlof pathological process

� Pool of modern technologies used to improve theeffectiveness of the analytical cascade includingthe use of interdisciplinary approaches andmodernization of the integrated infrastructure ofthe biopharma industry

The PPPM specialists should be experts not only ininterdisciplinary (legal, organizational, and statistical) fieldsof action, but also in the fundamental spheres that offer, onthe one hand, a clue to the principally new pharmaceuticalsand diagnostic technologies, and, on the other hand,personalization of diagnostic reports, prevention, andprophylactics. Such researchers-experts should possess

technologies of planning and standardization, and theirpreparation requires restructuring of programs for pre-university (school), university, post-graduate, and basicmedical education with the formation of principallynew interdisciplinary programs which will be orientedfor training and retraining of specialists in the PPPM-affiliated directions.Correspondingly, preparation of specialists capable of

building the interdisciplinary healthcare system of thefuture should be built on the novel principles taking intoaccount the following:

� Common architectonics of pre-university, university,and post-graduate education

� Features of introducing a secondary school-universitypair into international educational environment

� The role of additional or further education andbioinformational technologies as the basis of suchenvironment

� Principles of design in the structure of additionaleducation and design of business, research, andengineering

� A rigid necessity of a multiple-level testing and dialogin the learner-teacher pair with due account of person-ality characteristics of the two when forming vocationalself-sufficiency and professional potential of a specialistas a personality of the future

� The value of innovation risks of the educationalprocess and possibility to monitor such risks in caseof emergency situations

This educational model should contain the following:

� Educational-methodological kernel� Key platforms of basic knowledge and qualities� A system of group and individual vectors

demonstrating priority directions and substantivepotentials of intensiveness and quality of knowledgedevelopment

Thus, for instance, the first (pre-university) level ofeducation familiarizes school children with the modernmodel of PPPM (without deep study of any separateaspects).The second (university) level implies deep studying of

fundamental (theoretical) and applied (translational) as-pects of PPPM among the students.The core of the third (post-graduation) level is dedi-

cated to interdisciplinary aspects of PPPM affiliated toresident doctors and post-graduate students.In this respect, the starting point of training in the field

of high technologies of school children is of particularimportance (mainly senior school children), this trainingbeing organized on the basis of leading academic and

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industry research institutes. The procedure of forming aspecialist and upbringing his/her creative personalityshould not only be solved at the stage of post-universityadaptation in real work, but also start at the stage of train-ing sessions in the pre-university (at school) phase withsimultaneous conduction of specialized workshops. And,since the school program is of great importance to the fu-ture education and vocational careers of our specialists, itis necessary to unite efforts of teachers, administrators ofuniversities, and political leaders for the development ofeducational programs on modern biopharmaceuticals inthe secondary-level schools and colleges [19].

A team of young scientists—our hope in thedevelopment of domestic biopharma industryTaking into consideration the current trends and personalexperience, we have made first steps for closer liaison ofthe secondary school-university pair and restructuring ofspecialized (medical-biological) classes to turn school chil-dren towards direct participation in the modernization ofthe biopharmaceutical industry system. Guided by theabovementioned facts, a quite non-standard approach hasbeen the organization of a young scientist team which hasacquired an official status with the international researchgroup in the European Association for Predictive, Prevent-ive, and Personalised Medicine (EPMA). The characteristicfeature of this group was that in addition to the residentdoctors and students of Moscow universities, the groupcomprised the first school children of Education Center

Fig. 11 Creators-founders of the international young scientists team

No. 204 named after А.M. Gorky (a Federal State-FundedEducational Institution) and students of non-medicaluniversities having interest in allied profession (Figs. 11,12, and 13).Used as an educational-methodical kernel is a three-

level basic education system (pre-university, university,and post-university education). The genome and post-genome technologies have occupied a special placeamong the basic platforms as well as methods of cellularand tissue-specific bioengineering. Group and individualvectors as part of the basic inventory are represented bythe branch segments including pharmaceutical design,translational medicine, bioinformatics, and others—i.e.,vectors incorporating all modern technological platforms.Attention should be paid to a number of essential mo-

ments which appeared as a result of the first experiments.First, not only students of universities, but also individualschool children have started their research work by select-ing leading academic research institutes, and as the subjectof research, they have chosen most recent technologies re-lating to genome and post-genome topics requiring fromthe specialists-bioengineers many a year of continuoustraining for forming corresponding competences.Second, one of the most pressing and controversial prob-

lems in the system of innovation specialist preparation isthe problem of adaptation of university graduates in thereal production environment, i.e., at innovation biopharma-ceutical enterprises connected with research centers thatgenerate innovation products. Here, for senior school age,

Fig. 12 Members of the international young scientists team at the First International Congress on PPPM, Bonn, Germany, 2011

Studneva et al. The EPMA Journal (2015) 6:18 Page 12 of 14

the leading type of activities is the design and research ac-tivity as a means of his/her professional self-determination;hereby, the “object of design” is the schoolchild who de-signs (“forms”) his/her abilities necessary to master thechosen profession. Actually, as for schoolchildren, this isthe research work which gives rise to love of sciences andthe creative profession of a bioengineer.

Fig. 13 Members of international young scientists team at the Second Interesults, Brussels, European Parliament, 2013

In work with gifted children, the innovation technolo-gies occupy a special place, since the purpose of suchwork is the development of intellectual and creative po-tential of the child personality by developing the researchabilities of the latter. The results of mutual work and withgifted children and the relevant educational process hasbeen taken by us as the basis for the evaluation of the

rnational Congress on PPPM during discussion of training program

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results of the design work of the student-schoolchild pairor the post-graduate student-student-schoolchild triplet.

ConclusionsOur model for accelerated development of continuousvocational education in the sphere of biopharmaceuticsand biopharmaceutical industries is based on the com-binatorial approaches (competence, module, personality-activity, program-design, and problem-oriented) to theelucidation of innovative processes of modernizationof the existing system. Correspondingly, the unit tobuild up the content of educational programs and sitesis the task of pedagogics oriented for the innovationcontext in education development, and it allows eachhearer to organically combine individual and groupwork with the aim to enrich oneself with the experi-ence of the colleagues and also to use own professionalexperience.The use of the accelerated model for development of

continuous vocational education has required a new typeof organization of the educational process. The place offormalized methods and means of education focused onthe transfer and learning of information is now occupiedby innovation and interactive, problem- and practice-oriented, and research-and-design methods. All that en-sures solving of pedagogical problems on the basis of con-structive dialog, exchange of opinions, role and positionalinteraction, practical solution of educational tasks, and useof information technologies.

Competing interestsThe authors declare that they have no competing interests.

Authors’ contributionsМS and MM participated in the study’s conception and design, collecteddata, and secured the compromise outcome product in a form of themanuscript. SS, YY, and CR made an important contribution to the datainterpretation, wrote the parts of drug design and targeting, and madeamendments on the role and value of drug discovery to move the reformsof the Higher Pharmaceutical Education ahead. AA contributed to thesection of biobanking and biomarkers, and showed the role and value ofnew biomarker search and biobanks creating to move the reforms of theHigher Pharmaceutical Education ahead. IK, AT, and IK defined the basetrend of the manuscript, made conception of class-related educationcourses, and wrote the corresponding parts of the manuscript. YMcontributed to the section of the international cooperation to move thereforms of the Higher Pharmaceutical Education ahead and wrote thecorresponding parts of the manuscript. KK and AS made a strategy oftargeted investments and management in the area of reforms and wrotethe corresponding parts of the manuscript. ET assessed the role ofrenewed medical terminology in the international partnership andmultidisciplinary collaboration in PPPM to promote higher educationalreform. SS proposed the idea of reforms to be made in the area of highermedical education and created the core of the manuscript. All authorsread and approved the final manuscript.

AcknowledgementsMatthew Springer, Mark Sussman, and Jan Hoeijmakers participated in theinterpretation of data and critically revised the manuscript.

Author details1A.I.Evdokimov Moscow State University of Medicine and Dentistry, Moscow,Russia. 2I.M.Sechenov First Moscow State Medical University, Moscow, Russia.3EPMA (European Association for Predictive, Preventive and PersonalisedMedicine), Brussels, Belgium. 4New York Academy of Sciences, New York, NY,USA. 5ACS (American Chemical Society), Dallas, TX, USA. 6AMEE (EuropeanAssociation for Medical Education), Dundee, UK. 7Department ofPharmaceutics, University of Florida College of Pharmacy, Gainesville, FL,USA. 8Division of Ocular Diseases, Central Clinical Hospital No. 85, FMBA,Moscow, Russia. 9Department of Human Functional Genomics, Mie UniversityGraduate School of Medicine, Mie, Japan. 10St. Petersburg State Chemicaland Pharmaceutical Academy, Saint Petersburg, Russia. 11College of Science,King Saud University, Riyadh, Saudi Arabia. 12NeurMedix, San Diego, CA, USA.13College of Arts, Science and Business, Missouri University of Science andTechnology, Rolla, MO, USA. 14N.I.Pirogov Moscow Medical ResearchUniversity, Moscow, Russia.

Received: 20 May 2015 Accepted: 12 August 2015

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