Transfer of technology and project planning and management
1) TRANSFER OF TECHNOLOGY
2) PROJECT PLANNING AND MANAGEMENT
Ajit Kumar Jha
1st Sem. M.Pharm
School Of Pharmacy,
Apeejay Stya University,
Dr. Swati Gupta
Dept. Of Pharmaceutics
School Of Pharmacy,
Apeejay Stya University,
Presented By: Presented To:
WHAT IS TECHNOLOGY TRANSFER ?
Technology Transfer is the process by which
technology is disseminated.
It involves communication of relevant knowledge
by the Transferor to the Recipient.
It is in the form of technology transfer transaction
which way or may not be a legally binding
WIPO says technology transfer (TOT) is:
“defined as transfer of new technologies from
universities and research institutions to parties
capable of commercialization”
or in the sense of transfer of technologies
across international borders, generally from
developed to developing countries.
Generally TOT consists of knowledge or IP
rights that are:
licensed in the form of intellectual property,
the subject of formal consulting or training agreements,
communicated in the work place or research settings
diffused by publication or other means.
Technology transfer is the process of sharing of
skills, knowledge, technologies, methods of
manufacturing, samples of manufacturing and
among governments and other institutions
to ensure that scientific and technological developments
are accessible to a wider range of users
who can then further develop and exploit the technology
new products, processes, applications, materials or
It is closely related to (and may arguably be considered
a subset of) knowledge transfer.
The reference to
skills, knowledge, technologies, methods of
manufacturing, samples of manufacturing and facilities
is probably wide enough to refer to the subject of transfer
But there are more locations of transfer.Transfer can be
between Public Universities or Government Research
Institutes and private industry
between the research and development (R&D)
departments and the other departments of a single
between various entities or branches of a business group
in a franchising operation from the franchisor to the
between international organisations and national
between industrialised economies and developing
WHAT IS TECHNOLOGY ACQUISITION ?
Twoterms technology transfer and technology are
normally used interchangeably.
The verb “Acquire” means
To come into possesion of; get as one’s own
To gain for oneself through one’s actions or
Technology Acquisition is the process of acquiring a
new technology, new product, process or service
; by efforts of an individual or an enterprise or
any other macro entity. This process can be
conducted either internally or externally to the
TYPES OF TECHNOLOGY TRANSFER
Scientific Knowledge Transfer, Direct Technology
Transfer, Spin-off Technology Transfer
Informal Technology Transfer & Formal
Internal Technology Transfer & External
INTERNAL TECHNOLOGY TRANSFER
Internal Technology Transfer refer to such technology
transfers/investments where control on the
ownership & usage of technology resides with
It is a complex process involving following decisions:
Timing : When to introduce new technology /
products in the market?
Location : Where to transfer new technology /
Multi-functional teams --Which staff members
should be involved in transfer process ?
Communication methods & procedures – What
type of Communication methods & procedures
be adopted to facilitate transfer ?
BARRIERS TO INTERNAL TECHNOLOGY
R & D goals are not known to Production
Difficulties in stopping current production to test
new products / processes
R&D Department does not understand needs &
capability of Production Department.
In general, Production Department is resistant to
innovation and is bound by routine.
Non-linkage of new technologies to marketing /
STEPS IN INTERNAL TECHNOLOGY
ACQUISITION BY A FIRM
1. Planning new products / services / processes to
be offered – planning must incorporate voice of
the customer & user needs
2. Screening new products, processes or services –
only viable / feasible items be offered as only one
out of 4/5 becomes a commercial success.
3. Initiating development process – must be properly
designed and carried out so that it facilitates
success. Enterprises should
a. Consist of temporary system capable of adapting
to dymanics of change
b. Organize the systems around problem solving
STEPS IN INTERNAL TECHNOLOGY
ACQUISITION BY A FIRM
c. Have flexible management system & replace rigid
d. Use multi-functional teams.
e. Proper integration between R&D, Production &
f. Ensure effective communication
4. Carrying out trial production on small scale and
5. Improving design & production processes based
on experiences / feedback
6. Commercialization i.e. mass production & sales
EXTERNAL TECHNOLOGY TRANSFER
In these transfers, control on the ownership &
usage of technology usually does not remain with
transferor and it passes on to the recipient, like joint
venture with local control, licensing agreement etc.
EXTERNAL TECHNOLOGY TRANSFER
Successful external technology transfer depends
upon following factors:
Type of the technology being transferred
Complexity of the technology being transferred
Transfer mechanism selected
Relationships between the parties – building of
Core competencies of the parties & compatibilty
Organizational culture of the parties & mutual
WHY EXTERNAL TECHNOLOGY TRANSFER
Technology already developed saves time & efforts
Sometimes Growth objectives or competitive goals
cannot be reached through internal development
Lack of risk taking ability for innovations
Lack of internal resources (physical & human) for
Firm does not have core competencies to deal with
complex technological developments.
Need to keep up with competitors
Need to cope up with acceleration of technological
BARRIERS TO EXTERNAL TECHNOLOGY
Associated costs – usually high prices are required
to be paid in the form of royalities, technical &
knowhow fees etc over medium to long term period
Appropriatesness of technology i.e. its suitability to
core competencies and market needs is always a
point of discussion and investigation
Heavy reliances on foreign technology- may make
transferee / recipient technologically dependent on
external technology providers / transferors even for
Lack of mutual trust between two parties may
hinder full & timely transfer
BARRIERS TO EXTERNAL TECHNOLOGY
There is risk of loss of control over technology and
the transferee / recipient may use technology in an
Transfer may render existing technology & its
related products / services / processes obsolete
Transferee may turn a potential competitor in
Mismatch in core competencies of the transferor &
transferee may create difficulties in transfer
Different organisation cultures may create
difficulties in transfer
Lack of effective communication between the
parties may also create difficulties in transfer
STEPS IN EXTERNAL TECHNOLOGY
ACQUISITION BY A FIRM –
1. Identification of Need
2. Developing list of suitable technology providers
3. Short listing / selecting suitable technology
providers on the basis …. Cultural compatibility,
compatibility of core competences,
appropriateness of technology, technical
6. Payments as per agreement
7. Transfer of specifications, blueprints, designs,
documents, CDs to purchaser
8. Training of technical personnel of purchaser
MODES OF PAYMENT FOR TECHNOLOGY
Lumpsum payment or periodical instalments
Royalities as a %age of sales over next few years
Contracted supply of output
Issue of equity shares in lieu of technology
WHY TECHNOLOGY TRANSFER TAKES PLACE?
To elucidate necessary information to transfer technology from R&D to actual manufacturing by
sorting out various information obtained during R&D;
To elucidate necessary information to transfer technology of existing products between various
manufacturing places; and
To exemplify specific procedures and points of concern for the two types of technology transfer in
the above to contribute to smooth technology transfer.
Generally it has been seen that an organization forms alliances with other organization to make
product viable and thus technology transfer occurs. These alliances may be:
The developer of the technology might have the resources to take the technology to particular state
of development, such as up to animal studies and toxicology studies, but dose not have the
resources to take the technology through its clinical and regulatory phases, and must collaborate
with another organization to take it through these phases, and into the market.
The developer of the technology may have taken the technology to a state of development so that
it is near market ready, but dose not have the clean room manufacturing capability or resources to
manufacture the product, and must partner with another organization that dose have that capability.
Exploitation in a different field of application. Or the developer of technology has no commercial
capabilities. Like universities or research campus.
PROCESS OF TECHNOLOGY TRANSFER:
Technology transfer consists of action taken in these flows of development to realize
through the quality as designed during the manufacture. Even if the production starts, the
technology transfer will take place in process such as changes in manufacturing places.
The processes are classified into the three categories.
1. Research Phase
2. Development Phase
3. Production Phase
This phase is concerned with the quality design of the product. For Drug Products, the
quality design corresponds to so called pharmaceuticals design-to-design properties and
functions such as elimination of adverse reactions, improvement of efficacy, assurance of
stability during distribution, and adding usefulness based on various data such as chemical
and physical properties, efficacy, safety and stability obtained form preclinical studies.
For drug substance, the quality design is to determine starting materials and their reaction
paths, and basic specification of the drug.
a. Research for Factory Production
b. Consistency between Quality and Specification
c. Assurance of consistency through development and manufacturing
d. Technology Transfer from R&D to Production
Research for Factory Production
To manufacture drugs with qualities as designed, it is required to establish appropriate
quality control method and manufacturing method, after detecting variability factors to
secure stable quality in the scale-up validation that is performed to realize factory
production of drug designed on the basis of result from small-scale experiments.
Consistency between Quality and Specification:
When product specification is established on the basis of the quality of product determined
in the above, it is required to verify that the specification adequately specifies the product
In short, the consistency between quality and specification is to ensure in the products
specification that the quality predetermined in the quality design is assured as the
manufacture quality, and the product satisfies the quality of design.
Assurance of consistency through development and manufacturing:
To make developed product have indications as predetermined in clinical phases, the quality of design should be
reproducible as the quality of product (assurance of consistency).
For this purpose, the transferring party in charge of development should fully understand what kind of technical
information is required by the transferred party in charge of manufacturing, and should establish an appropriate
evaluation method to determine whether a drug to be manufactured meets the quality of design.
Technology Transfer from R&D to Production:
Transfer of the technical information is necessary to realize manufacturing formula established in the above in the
actual production facility. Technical information to be transfer should be compiled as R&D report.
a. Phase validation & Production
b. Feedback from production & technology transfer of marketed products
Phase Validation & Production:
Production is implemented after various validation studies verify that it is able to stably product based on
transferred manufacturing formula. While the manufacturing facility accepting technology is responsible for
validation, the research and development department transferring technology should take responsibility for
validation such as performance qualification, cleaning validation, and process validation unique to subject drugs.
Feed back from Production and Technology
Transfer of Marketed Products:
Technical information of developed products are
obtained from data of a limited amount of batches,
various standards have been established from the limited
data, and quality evaluation method established in
development phase in not always sufficient for factory
production, it is highly desired to feed back and
accumulate technical information obtained from repeated
production, if necessary. In addition, it is important to
appropriately modify various standards established
before based on this information, and accountability and
responsibility for design and manufacturing should be
TECHNOLOGY TRANSFER DOCUMENTATION:
Technology transfer documentation are generally interpreted as documents indicating contents
of technology transfer for transferring and transferred parties. The raw data of the documents
should be prepared and compiles according to purposed, and should be always readily
available and traceable. For successful technology transfer, task assignments and
responsibilities should be clarified, and acceptance criteria for the completion of technology
transfer concerning individual technology to be transferred.
Quality assurance department should established conformation process for all kinds of
technology transfer documentation, and should check and approve the documentation.
Technology transfer documentation are indicated as follows:
1. Organization for Technology Transfer:
One of the most significant elements for successful technology transfer is closed
communication between transferring and transferred parties. Therefore, organization for
technology transfer should be established and composed of both party members, roles, scope
of responsibilities of each party should be clarified and adequate communication, and feedback
of information should be ensured. It is desirable that this organization complies with GMP.
2. Research and Development Report:
To realize quality assurance at all stages from drug development to manufacturing, transfer to
manufacturing, transfer of technical documents concerning product development or
corresponding documents should be considered.
The research and development report (development report) is a file of technical development, and the research
and development department is in charge of its documentation. Informations to be contained in the development
a. Historical data of pharmaceutical development of new drug substances and drug products at
stages from early development phase to final application of approval.
b. Raw materials and components.
c. Synthetic route.
d. Rational for dosage form & formula designs and design of manufacturing methods.
e. Rational and change histories of important processes and control parameters.
f. Quality Profiles of manufacturing batches ( including stability data).
g. Specifications and test methods of drug substances, intermediates, drug products, raw materials, and
components, and their rationale.
3. Product Specification File:
The product specification is to compile information, which enables the manufacture of the product, and to define
specification, manufacturing and evaluations method of the product and its quality, and the transferring party is
responsible for documenting the file. The product specification file should be reviewed at regular intervals, and
incorporate various information obtained after the start of production of the product, and be revised as
For new products, the development report can be used as a part of product specification file.
4. Technology Transfer Plan:
The technology transfer plan is to describe items and contents of technology to be
transferred and detailed procedures of individual transfer and transfer schedule, and
establish judgment criteria for the completion of the transfer. The transferring party should
prepare the plan before the implementation of the transfer, and reach an agreement on its
contents with the transferred party.
5. Technology Transfer Report:
It is to report the completion of technology transfer after data of action taken according to
the technology plan is evaluated and the data is confirmed pursuant to the predetermined
judgment criteria. Both transferring and transferred parties can document the technology
transfer report; however, they should reach an agreement on its contents.
6. Verification of Results of Technology Transfer:
After the completion of technology transfer and before the start of manufacturing of the
product, the transferring party should verify with appropriate methods such as product
testing and audit that the product manufactured after the technology transfer meets the
predetermined quality and should maintain records of the results.
In pharmaceutical industry technology transfer means action
to transfer information and technologies necessary to realize
quality of design of drugs during manufacturing. Appropriate
technology transfer is important to upgrade the quality of
design to be the quality of product, and ensure stable and high
quality of the product. The technology transfer does not mean
one-time actions taken by the transferring party toward the
transferred party, but means continuous information exchange
between the both parties to maintain the product
The consistency in product quality, in this competitive
environment require the transfer of skills in personnel and the
transfer of process too. Current scenario demands the
technology transfer with in and out sourcing technology
WHAT IS PROJECT?
The word project comes from
the Latin word projectum from the Latin
verb proicere, "before an action" which in turn
comes from pro-, which denotes precedence,
something that comes before something else in
time (paralleling the Greek πρό) and iacere, "to do".
The word "project" thus actually originally meant
"before an action".
In contemporary business and science a project is
defined as a collaborative enterprise, involving
research or design, that is carefully planned to
achieve a particular aim.
Projects can be further defined as temporary rather
than permanent social systems or work
systems that are constituted by teams within or
across organizations to accomplish
particular tasks under time constraints. An on-going
project is usually called (or evolves into) a program.
WHAT IS PROJECT MANAGEMENT?
Project management is the process and activity of
planning, organizing, motivating, and controlling
resources, procedures and protocols to achieve
specific goals in scientific or daily problems.
A project is a temporary endeavor designed to
produce a unique product, service or result with a
defined beginning and end (usually time-
constrained, and often constrained by funding
or deliverables), undertaken to meet unique goals
and objectives, typically to bring about beneficial
change or added value.
The primary challenge of project management is to
achieve all of the project goals and objectives while
honoring the preconceived constraints. The primary
constraints are scope, time, quality and budget. The
secondary — and more ambitious — challenge is
to optimize the allocation of necessary inputs and
integrate them to meet pre-defined objectives.
THE TRADITIONAL APPROACH
A traditional phased approach identifies a sequence
of steps to be completed. In the "traditional
approach", five developmental components of a
project can be distinguished (four stages plus
planning and design
execution and construction
monitoring and controlling systems
TYPICAL DEVELOPMENT PHASES OF AN
PROJECTS IN CONTROLLED ENVIRONMENTS,
VERSION 2 (PRINCE2)
PRINCE2 is a structured approach to project
management released in 1996 as a generic
project management method. It combines the
original PROMPT methodology (which evolved
into the PRINCE methodology) with IBM's MITP
(managing the implementation of the total
project) methodology. PRINCE2 provides a
method for managing projects within a clearly
PRINCE2 focuses on the definition and delivery of
products, in particular their quality requirements. As such,
it defines a successful project as being output-oriented
(not activity- or task-oriented) through creating an agreed
set of products that define the scope of the project and
provides the basis for planning and control, that is, how
then to coordinate people and activities, how to design
and supervise product delivery, and what to do if
products and therefore the scope of the project has to be
adjusted if it does not develop as planned.
CRITICAL CHAIN PROJECT MANAGEMENT
Critical chain project management (CCPM) is a
method of planning and managing project execution
designed to deal with uncertainties inherent in
managing projects, while taking into consideration
limited availability of resources (physical, human
skills, as well as management & support capacity)
needed to execute projects.
Process-based management is a management
approach that views a business as a collection of
processes. The processes are managed and
improved by organization in purpose of achieving
their vision, mission and core value. A clear
correlation between processes and the vision
supports the company to plan strategies, build a
business structure and use sufficient resources that
require to achieve success in the long run.
AGILE PROJECT MANAGEMENT
Agile project management approaches, based on
the principles of human interaction management,
are founded on a process view of human
collaboration. It is "most typically used in software,
website, technology, creative and marketing
industries." This contrasts sharply with the
traditional approach. In the agile software
development or flexible product
development approach, the project is seen as a
series of relatively small tasks conceived and
executed to conclusion as the situation demands in
an adaptive manner, rather than as a completely
LEAN PROJECT MANAGEMENT
Lean project management is the comprehensive
adoption of other lean concepts like lean
construction, lean manufacturing and lean thinking
into a project management context. Lean project
management has many ideas in common with other
lean concepts; however, the main principle of lean
project management is delivering more value with
less waste in a project context. Lean project
management has many techniques that can be
applied to projects and one of main methods
EXTREME PROJECT MANAGEMENT (XPM)
Extreme project management (XPM) refers to
a method of managing very complex and very
Extreme project management differs from
traditional project management mainly in its open,
elastic and undeterministic approach. The main
focus of XPM is on the human side of project
management (e.g. managing project stakeholders),
rather than on intricate scheduling techniques and
BENEFITS REALISATION MANAGEMENT (BRM)
Benefits realisation management
(BRM) (also benefits management or benefits
realisation) is one of the many ways of managing how
time and resources are invested into making
desirable changes. The popularity of BRM grew in the
UK with the inclusion of BRM by the UK Government in
their standardised approach to programmes, Managing
Successful Programmes (MSP).
In addition, BRM practices aim to ensure the alignment
between project outcomes and business strategies. The
effectiveness of these practices is supported by recent
research evidencing BRM practices influencing project
success from a strategic perspective across different
countries and industries.
Planning and design
Monitoring and Controlling
Project controlling and project control systems
the nature and scope
of the project. If this
stage is not performed
well, it is unlikely that
the project will be
successful in meeting
the business’ needs.
The initiating stage should include a plan that
encompasses the following areas:
analyzing the business needs/requirements in
reviewing of the current operations
financial analysis of the costs and benefits including
stakeholder analysis, including users, and support
personnel for the project
project charter including costs, tasks, deliverables,
PLANNING AND DESIGN
After the initiation stage, the project is planned to
an appropriate level of detail . The main purpose is
to plan time, cost and resources adequately to
estimate the work needed and to effectively
manage risk during project execution.
Project planning generally consists of
determining how to plan (e.g. by level of detail or rolling
developing the scope statement;
selecting the planning team;
identifying deliverables and creating the work breakdown
identifying the activities needed to complete those
deliverables and networking the activities in their logical
estimating the resource requirements for the activities;
estimating time and cost for activities;
developing the schedule;
developing the budget;
gaining formal approval to begin work.
Executing consists of the processes used to
complete the work defined in the project plan to
accomplish the project's requirements. Execution
process involves coordinating people and
resources, as well as integrating and performing the
activities of the project in accordance with the
project management plan.
Execution process group include:
Direct and manage project execution
Quality assurance of deliverables
Acquire, develop and manage Project team
Manage stakeholder expectations
Test the deliverables against the initial design
MONITORING AND CONTROLLING
Monitoring and controlling consists of those
processes performed to observe project execution
so that potential problems can be identified in a
timely manner and corrective action can be taken,
when necessary, to control the execution of the
Monitoring and controlling includes:
Measuring the ongoing project activities ('where we
Monitoring the project variables (cost, effort, scope,
etc.) against the project management plan and the
project performance baseline (where we should
Identify corrective actions to address issues and
risks properly (How can we get on track again);
Influencing the factors that could circumvent
integrated change control so only approved
changes are implemented.
Closing includes the formal acceptance of the
project and the ending thereof. Administrative
activities include the archiving of the files and
documenting lessons learned.
This phase consists of:
Contract closure: Complete and settle each
contract (including the resolution of any open items)
and close each contract applicable to the project or
Project close: Finalize all activities across all of the
process groups to formally close the project or a
PROJECT CONTROLLING AND PROJECT
Project controlling should be established as an independent
function in project management. It implements verification and
controlling function during the processing of a project in order
to reinforce the defined performance and formal goals.
The tasks of project controlling are also:
the creation of infrastructure for the supply of the right
information and its update
the establishment of a way to communicate disparities of
the development of project information technology based on
an intranet or the determination of a project key performance
index system (KPI)
divergence analyses and generation of proposals for potential
the establishment of methods to accomplish an appropriate
project structure, project workflow organization, project control
creation of transparency among the project parameters
Fulfillment and implementation of these tasks can
be achieved by applying specific methods and
instruments of project controlling. The following methods
of project controlling can be applied:
value benefit Analysis
milestone trend analysis
cost trend analysis
Y. Anjaneyulu, R. Marayya “ Quality Assurance and
Quality Management in Pharmaceutical Industry ”
Published by: PharmaMed Press, Hydrabad,2013
Wikipedia/Transfer of Technology