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Scientific Journal «ScienceRise: Pharmaceutical Science» №5(27) 2020
24
UDC: 615.1:658.7
DOI: 10.15587/2519-4852.2020.214999
SCIENTIFIC AND PRACTICAL APPROACHЕS OF FORMATION OF LOGISTIC
INNOVATIVE SYSTEMS IN PHARMACEUTICAL COMPANIES
O. Posilkina, E. Litvinova, A. Lisna
The aim of the work is to analyze and generalize the existing scientific approaches and substantiate the mecha-
nisms of formation of the logistics innovation system of the pharmaceutical company, which is the most im-
portant condition for creating modern effective domestic drugs under optimal use of resources and time.
Materials and methods. Studies were conducted using databases on the Internet: the State Expert Center, the
Ukrainian Patent Office, scientific and metric databases. It has used retrospective, logical, graphic research
methods, content analysis.
Results. The relevance of the implementation of the logistics concept of innovation management in domestic
pharmaceutical companies is substantiated. A key aspect of this concept is the integration of individual parts of
the innovation process through the maximum use of information exchange between participants in this process,
active innovation, use of existing and creation of new knowledge, which become the main asset of innovation-
oriented pharmaceutical company. The essence of the logistics innovation system of a pharmaceutical company
is determined, the model of interrelations within the open logistics innovation system of a pharmaceutical com-
pany is substantiated. It is proved that with the help of a logistics innovation system it is possible to carry out
planning, management, actualization of creation and implementation of innovative medicines at the optimal level
of used resources and time for the implementation of relevant innovation projects. It is determined that the logis-
tics innovation system of a pharmaceutical company is related to the management of incoming information and
innovation flow (results of basic and applied research, data on clinical and preclinical study of medicines,
pharmaceutical development), internal information and innovation flow (information exchange in the internal
environment - resource, scientific and informational, organizational, personnel component), the initial infor-
mation and innovation flow (information for government agencies, consumers, suppliers, the public, organiza-
tions interested in using the research results). These flows are integrated and relate to various aspects of the
company's innovation.
Conclusions. Thus, in order to intensify and activize innovation in domestic pharmacy, it is promising to expand
the scope of logistics methods for the development and implementation of innovative medicines. The purpose of
the logistics innovation system is to provide the pharmaceutical company with the information necessary for
completeness, relevance, reliability, timeliness at a rational cost of their provision, for effective management of
material resources
Keywords: logistics innovation system, pharmaceutical company, innovative medicine, information and innova-
tion flow
Copyright © 2020, O. Posilkina, E. Litvinova, A. Lisna.
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0).
1. Introduction
Pharmacy today is one of the most dynamic and
knowledge-intensive sectors of the economy in Ukraine
and around the world. The viability and prospects of
economic development of pharmacy in all countries of
the world are largely determined by the scale, quality and
level of research and the level of used technological
processes [1–3]. Prolonged lack of innovation means
stagnation of pharmaceutical production, reduced quality
and competitiveness of pharmaceutical products, and
hence the decline in economic performance of pharma-
ceutical market players, on the one hand, and the threat
of epidemics and pandemics due to resistance, on the
other [4, 5].
In order to intensify and activation of innovation
activity in domestic pharmacy, it is promising to expand
the scope of logistics methods for the development and
implementation of innovative medicines.
The logistics approach involves continuous im-
provement and optimization of existing processes, allows
to organize innovation processes as a cross-cutting inte-
grated flow, optimize time and cost of innovation pro-
jects, gain competitive advantage by optimizing material,
information and other flows.
The current state of logistics development is char-
acterized by a process approach to management, inte-
grated logistics paradigm, based on understanding the
importance of all flows and perception of logistics as a
methodology for optimizing flow processes in any sys-
tem, understanding the high role of information technol-
ogy as a modern basis for logistics processes.
Since the late 90's in the world's leading pharmaceu-
tical companies integrated logistics management systems for
innovation has been actively creating. Under these condi-
tions, the development and implementation of innovations
turns into a continuous logistics business process.
Scientific Journal «ScienceRise: Pharmaceutical Science» №5 (27)2020
25
Innovations are integrated into long-term produc-
tion plans and programs of pharmaceutical companies.
Creating a more flexible and comprehensive system of
innovation logistics management focused on the devel-
opment of highly efficient medicines, reengineering the
innovation process stimulates the creation and implemen-
tation of innovations with a world level of novelty
through end-to-end logistics management of innovation:
from idea to implementation. All this determines the
relevance of the research topic.
Innovative processes in modern conditions are
considered not only as priority factors of socio-economic
development as individual enterprises, industries and
national economies, but also as a foundation for in-
creasing the social welfare of the population and im-
proving its quality of life. Considering the importance
of research related to the development of new medi-
cines, high cost and duration of innovation processes in
pharmacy, logistics approaches and technologies should
become an important tool for management in pharma-
ceutical companies.
Problems of the innovative paradigm of logistics
have been studied in the works of some foreign scientists –
Ron Adler, James F. Morore, D. Suruvka-Marshalek,
I. Svyatovets and others [6, 7]. Among domestic scien-
tists who have studied the implementation of logistics
approaches in the management of innovation processes,
it has been identified the work of M. Yu. Grigorak,
E. V. Krykavsky, and others [8, 9]. Their works also
considered the problems of the evolution of the paradigm
of the logistics concept of management, analyzed them,
explored the main features of innovative and intelligent
logistics.
The monograph of Posylkina O. V., Sahaidak-
Nikitiuk R. V., Hromovyk B. P. [10] is devoted to the
study of one of the most pressing problems facing do-
mestic pharmacy in market conditions: optimal resource
management. The broad factual material shows the de-
pendence of the efficiency of pharmaceutical companies,
their financial well-being on the state and strategy of
resource management. Methodological bases of for-
mation of effective system of management of resources
of the pharmaceutical enterprises, tools and methods of
an estimation of efficiency of its functioning and direc-
tions of improvement are considered.
Dorokhova L.P. et al. considered the problems of
interaction of participants in innovation development at
the regional level, proposed mathematical approaches
and formulations for modeling [11].
The implementation of innovation strategy in
modern conditions is seen as a network integrated pro-
cess, which is carried out through a single, but intercon-
nected transactions of knowledge and experience be-
tween all stakeholders. The object of management in
innovation logistics is the flow of innovations – the di-
rected movement of discoveries, inventions, innovation
proposals, patents, know-how, etc. In high-tech, science-
intensive industries, including pharmacy, the parameters
of cost and time become determinants of integrated man-
agement of the innovation flow in the development of
new pharmaceutical products. Today, companies focus
not only on creating high value products in the eyes of
consumers, but also the development cost, as well as
optimizing the time required to develop, manufacture and
product launch. In pharmacy, the timely completion of
the innovation process, its acceleration and timely medi-
cine launch is not only important economically, but also
socially.
Innovation activity is accompanied by the same
logistics flows as activities in other areas: material, in-
formation and financial flows. At the same time, the
peculiarities of logistics management are connected
with the peculiarities of specific stages and types of
innovation processes. Effective innovation manage-
ment requires effective organization of appropriate
logistics processes, which would take into account
their features [12].
Conducted studies have shown that currently there
is no unified scientifically-based methodology for the
formation of a logistics innovation system of a pharma-
ceutical company. Solving this problem is an important
area of research.
The aim of the work is to analyze and generalize
the existing scientific approaches and substantiate the
mechanisms of formation of the logistics innovation
system of the pharmaceutical company, which is the
most important condition for creating modern effec-
tive domestic medicines under optimal use of re-
sources and time.
2. Planning (methodology) of the research
The following research plan has been developed:
– analyzed and generalized theoretical and scien-
tific-practical approaches to the use of a logistical ap-
proach to the management of innovation flows;
– substantiation of scientific and practical ap-
proaches to the use of logistics information system in
pharmacy;
– construction of a logistics information system
for a pharmaceutical company.
3. Materials and methods
Studies were conducted using databases on the In-
ternet: State Expert Center, Ukrainian Patent Office,
scientific and metric databases. It has used retrospective,
logical, research methods, content analysis.
4. Results of the research
The development of integration processes at dif-
ferent levels of innovation management has led to the
ineffectiveness of traditional approaches to the organiza-
tion of the innovation process as a closed, focused main-
ly on the internal environment and resources of the com-
pany. Today the main task of the enterprise innovative
activity is not so much the formation of an innovative
idea, but the rapid implementation of this idea in the
form of an innovative product (process) and obtaining
economic and / or social effect. Under these conditions,
the concept of open innovation is received more and
more recognition. According to G. Chesborough (found-
er of open innovation), “open innovation – is the use of
targeted input and output flows of knowledge to acceler-
ate innovation” [13].
The reasons for shifting the emphasis towards
open innovation, according to experts, are:
Scientific Journal «ScienceRise: Pharmaceutical Science» №5(27) 2020
26
– development of the knowledge economy,
which led to the active dissemination of knowledge
and information among the participants of the innova-
tion process;
– development of the intellectual property
market;
– development of innovation infrastructure and
institutional environment, which contributed to a more
active transformation of intellectual property into intel-
lectual capital;
– formation of chains of creation of streams of
value of innovative products and expansion of sphere of
commercialization of scientific researches, developments
and technologies.
Today, the effective organization of scientific
and innovative activities is not possible without effec-
tive management of material, financial, information,
service flows [14, 15]. And this is the reason to acti-
vate implementation of innovative logistics in the
activities of pharmaceutical companies, research insti-
tutions, higher education institutions that deal with the
development of new medicines and technologies for
their production.
The development of innovative logistics in the
pharmaceutical industry has to base on the following
principles:
– management of streaming processes oriented on
the factors of the current and internal environment and
using of all the available information;
– systematization in making management deci-
sions related to the management of flow processes at all
stages of the innovation process;
– decision-making on the basis of economic com-
promises taking into account the interests of various
stakeholders and participants in the innovation process;
– attitude to logistics as a tool to improve innova-
tion management.
Information logistics in pharmacy is a universal
tool for managing innovation in order to increase the
efficiency of the processes of creation and implementa-
tion of new medicines.
Logistics innovation system in pharmacy is a
communication environment that allows streaming to
receive, generate, analyze information about objects and
subjects (participants) of innovation, to model the most
effective combinations of resource use, to predict risks
and costs, which are associated with the unpredictability
of the results of scientific processes and research related
to the creation of new medicines (Fig. 1).The construc-
tion of such systems can significantly increase the
productivity of innovation and reduce the cost of its ad-
ministration.
Strategy
Social
environment Institutional
environment
Communication
support Technical
support
Partners Other stakeholders
(investors, customers)
Consumers of innovative
products
Innovations
Organizational construction
innovation activity
Motivation of innovative
activity
Innovative
risks
Staff
Innovative
resource
Innovative
costs
Fig. 1. Model of relationships within the open logistics innovation system of a pharmaceutical company
5. Discussion of the results
The modern pharmaceutical company in general
can be represented as a converter of its incoming infor-
mation and innovation flows: data from scientific and
experimental research of drugs, “open innovations”, the
results of scientific activities on pharmaceutical devel-
opment, intellectual property created at different stages
of the scientific process and can be successfully com-
mercialized, materials of registration medicines on drugs,
etc. (Fig. 2).
It is obvious that the prospects of scientific
achievements and commercial attractiveness of medi-
cines are determined in the early stages of pharmaceuti-
cal development by the number of scientific results, pub-
lications and citation index, patent applications, reports at
professional conferences and participation of certain
projects in exhibitions.
Incoming information flow is a set of data that al-
lows you to objectively justify the decision in the logis-
tics information innovation system of pharmaceutical
Scientific Journal «ScienceRise: Pharmaceutical Science» №5 (27)2020
27
companies about the development of innovation. It
should contain the following local flows: determination
of the world level and directions of active pharmaceutical
ingredient development, main markets and competing
firms and directions of medicines commercialization,
information about basic and applied research of active
pharmaceutical ingredients, preclinical and clinical re-
search of medicines, pharmaceutical development, com-
parison of technical and economic indicators with ana-
logues etc.
Information logistics at the stage of basic re-
search takes special place. The main part of basic
research is information on new data, theories, hypoth-
eses, patterns. The purpose of applied research is to
find, research and develop principles and methodolo-
gies for solving certain practical problems. The meth-
odology of rational assessment of future medicines
should include its place in the range of existing medi-
cines. It is necessary to predict the strengths and
weaknesses of the medicine and in the early stages of
the study to strive to expand the range of its applica-
tion, to the preventive focus of pharmacotherapy based
on a clear knowledge of clinical manifestations, com-
plications and consequences of the disease.
Sources of "open innovation" PubMed,
FDA, EMEA, WHO, Cochrane Reviews,
scientific and metric databases
Resource component
Logistics innovation system of a pharmaceutical company
Materials of the registration dossier for medicine
State Expert Center
Registration and manufacturing production of medicine
Monitoring of clinical data
Corrective impact of
monitoring results
Institutes of basic research Institutes of applied research, institutions
of higher education, technology parks
Organizational support Scientific and information
component Staff
Ukrainian Patent Office
Obtaining a copyright protection document for intellectual
property
Monitoring for infringement of intellectual property rights
Corrective effects
Internal sources of scientific information
External sources of scientific information
Fig. 2 Pharmaceutical company as a converter of information and innovation flows
Internal information flow, as a set of data that
connect with each other and allow effective interaction of
all structural units of the organization – participants in
the development of innovative medicines, should be
formed as a system of direct and feedback, the common
goal of which is registration and marketing of new inno-
vative medicines.
Characterization of efficiency, productivity, relia-
bility and flexibility of the logistics information innova-
tion system of pharmaceutical company is proposed to be
carried out using resource, research and information,
organizational and personnel subsystems.
The initial information flow in the logistics infor-
mation innovation system connects the organization with
the key elements of its external environment. It should
include such local information flows as: information for
state authorized bodies (State Expert Center, Ukrainian
Patent Office), information for consumers, information
for suppliers, information for the public, scientific and
technical information for organizations interested in
using research results.
Upon registrationa medicine, the applicant
(pharmaceutical company) must indicate the grounds
for choosing the type of medicine to which the set of
available registration documents must correspond. The
applicant must submit a registration form of the medi-
cine according to the order of the Ministry of Health
of Ukraine dated 23.07.2015 No. 460 [16]. Details of
the innovation flow of pharmaceutical company are
shown in Fig. 3.
It should be noted that the national departmental
health authority of any country (for example, in Ukraine –
the State Enterprise “State Expert Center” of the Ministry
of Health of Ukraine) registers medicines in establishing
their pharmacological efficacy, health safety and quality.
The registration certificate is a permit for medical use,
which provides for the industrial manufacturing of
medicins, their promotion on the market and sale.
Scientific Journal «ScienceRise: Pharmaceutical Science» №5(27) 2020
28
Logistics innovation system of a pharmaceutical company
Medicine on full
application
(autonomous
dossier) Generic
medicine
Similar biological Medicine with
well established
use Fixed
combination Traditional
medicine
Medicine in bulk
State Expert Center of the Ministry of Health of Ukraine
Informative
flow
х011
х012
х013
х014
х015
х016
х017
Ukrainian Patent Office
Fig. 3 Detailing of the information flow in the logistics innovation system of pharmaceutical company
However, the registration certificate gives its
owner only positive rights to a particular medicine, i.e.
the right to use it in commercial circulation. These rights
are not exclusive, namely: the holder of the certificate
has no right to prohibit other persons from using the
developed medicine without his permission, namely to
prohibit other manufacturers to use the same brand of
medicine, produce it in the same way, use similar pack-
aging and so on.
The Patent Office grants the owners of copyright
protection documents (patents for inventions, utility
models, industrial designs; certificates for marks for
goods and services) the monopoly right to certain intel-
lectual property.
Thus, the information and innovation flow in the im-
plementation of innovative medicines is directed to both the
State Expert Center and the Ukrainian Patent Office.
It should be noted that information on scientific
development is first submitted as part of the registration
dossier at the time of medicine registration, and then
updated when new knowledge is obtained during the life
cycle of the medicine. Thus, the information flow, which
is associated with the introduction of medicines on the
market, circulates after registration of the medicine [15].
Thus, information support is a key process of
innovation activity of pharmaceutical company, which
largely consists in the formation of arrays of source
data, their use to produce new information (data on
innovative medicines) and in bringing new infor-
mation to all authors involved in the creation of medi-
cines. When building the process of information sup-
port of innovation, it is advisable to consider separate-
ly such areas as obtaining information from the exter-
nal environment (open and closed innovations), creat-
ing information and information exchange in the in-
ternal environment and transferring information to the
external environment – authorized state bodies (State
Expert Center , Ukrainian Patent Office).
The concept of logistics approach to information
support of innovative activity of the company provides
an active role of logistics in setting and solving problems
of determining the composition and movement of infor-
mation and is based on the followig provisions:
– the movement of information used in innovation
activities has a streamlined nature, which allows you to
apply logistics tools to it and determine its qualitative
and quantitative parameters;
– regularity (discreteness) of information flows is
determined by the content of innovation activities and the
type of necessary information and is normatively estab-
lished by the subject of management;
– the content of information flows should fully
and objectively reflect the whole set of data that charac-
terize the various aspects of decision-making and imple-
mentation necessary for the organization of the innova-
tion process.
The proposed logistics innovation system takes
into account the peculiarities of information and innova-
tion flow depending on the type of registration of medi-
cines by the pharmaceutical company: medicines with a
full registration dossier, generic medicines, hybrid medi-
cines, medicines with well-established medical use, fixed
combination, traditional medicines, medicines in prod-
ucts bulk. The information and innovation flow for all
the above types of medicines, regardless of their nature
and other features, must meet the general requirements
for the materials of the registration dossier (in the format
of the General Technical Document).
Limitations of the research. The articule does not
consider special requirements for information and innova-
tion flows with accelerated approvalof priority medicines.
Prospects for further development of this field.
The use of the proposed logistics innovation system in
the development of innovative medicines of different
pharmacotherapeutic groups is promising.
6. Conclusions
1. The relevance of the implementation of the logis-
tics concept of innovation management in domestic phar-
maceutical companies is substantiated. A key aspect of this
concept is the integration of individual parts of the innova-
tion process through the maximum use of information ex-
change between participants in this process, active imple-
mentation of innovations, use of existing and creation of
new knowledge, which become the main asset of innova-
tion-oriented pharmaceutical companies.
Scientific Journal «ScienceRise: Pharmaceutical Science» №5 (27)2020
29
2. The essence of the logistics innovation system
of pharmaceutical companies is determined, the model of
interrelations within the open logistics innovation system
of pharmaceutical companies is substantiated. It is
proved that with the help of logistics innovation system it
is possible to plan, manage, implement the creation and
implementation of innovative medicines at the optimal
level of resources used and time for the implementation
of relevant innovative projects.
3. It is determined that the logistics innovation
system of a pharmaceutical company is related to the
management of incoming information and innovation
flow (results of basic and applied research, data on
clinical and preclinical study of medicines, pharma-
ceutical development), internal information and inno-
vation flow (information exchange in the internal en-
vironment – resource, scientific and informational,
organizational, personnel component), the initial in-
formation and innovation flow (information for gov-
ernment agencies, consumers, suppliers, the public,
organizations interested in using the research results).
These flows are integrated and relate to various as-
pects of the company's innovation. The purpose of the
logistics innovation system is to provide the pharma-
ceutical company with the information necessary for
completeness, relevance, reliability, timeliness at a
rational cost of their provision, for effective manage-
ment of material resources.
Conflicts of interest
The authors declare that they have no conflicts of
interest.
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Received date 17.08.2020
Accepted date 22.09.2020
Published date 30.10.2020
Olga Posilkina, Doctor of Pharmaceutical Sciences, Professor, Department of Management, Economics and
Quality Assurance in Pharmacy, National University of Pharmacy, Pushkinska str., 53, Kharkiv, Ukraine, 61002
Elena Litvinova, Doctor of Pharmaceutical Sciences, Professor of Department of Management, Economics and
Quality Assurance in Pharmacy, National University of Pharmacy, Pushkinska str., 53, Kharkiv, Ukraine, 61002
E-mail: hlitvinova@gmail.com
Anastasiya Lisna. PhD, Associate Professor of Department of Management, Economics and Quality Assurance
in Pharmacy, National University of Pharmacy, Pushkinska str., 53, Kharkiv, Ukraine, 61002