Transfer of technology and project planning and management

PRESENTATION ON

1) TRANSFER OF TECHNOLOGY

2) PROJECT PLANNING AND MANAGEMENT

Ajit Kumar Jha

1st Sem. M.Pharm

(Pharmaceutics)

School Of Pharmacy,

Apeejay Stya University,

Sohna, Haryana

Dr. Swati Gupta

Dept. Of Pharmaceutics

School Of Pharmacy,

Apeejay Stya University,

Sohna, Haryana

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

contract.

CONTD….

WIPO says technology transfer (TOT) is:

“defined as transfer of new technologies fromuniversities and research institutions to partiescapable of commercialization”

or in the sense of transfer of technologiesacross international borders, generally fromdeveloped to developing countries.

Generally TOT consists of knowledge or IPrights 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.

CONTD….

Wikipedia says

Technology transfer is the process of sharing of

skills, knowledge, technologies, methods of manufacturing, samples of manufacturing and facilities

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 into

new products, processes, applications, materials or services.

It is closely related to (and may arguably be considered a subset of) knowledge transfer.

CONTD…..

The reference to skills, knowledge, technologies, methods of

manufacturing, samples of manufacturing and facilitiesis 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 business

between various entities or branches of a business group in a franchising operation from the franchisor to the

franchisee between international organisations and national

organisations between industrialised economies and developing

economies

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 efforts

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 enterprise.

TYPES OF TECHNOLOGY TRANSFER

Scientific Knowledge Transfer, Direct Technology

Transfer, Spin-off Technology Transfer

Informal Technology Transfer & FormalTechnology Transfer

Internal Technology Transfer & ExternalTechnology Transfer

INTERNAL TECHNOLOGY TRANSFER

Internal Technology Transfer refer to such technologytransfers/investments where control on theownership & usage of technology resides withthe transferor.

It is a complex process involving following decisions:

Timing : When to introduce new technology / products in the market?

Location : Where to transfer new technology / products?

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

TRANSFER

R & D goals are not known to Production

Department.

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 /

customer needs.

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

management system

d. Use multi-functional teams.

e. Proper integration between R&D, Production &

Marketing sub-systems

f. Ensure effective communication

4. Carrying out trial production on small scale and

test marketing

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

mutual trust

Core competencies of the parties & compatibilty

thereof

Organizational culture of the parties & mutual

understanding thereof

METHODS OF EXTERNAL TECHNOLOGY

TRANSFER

Co-operative & collaborative ventures / strategic

alliances

Licensing agreements

Contracting agreements

Enterprise acquisition.

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 innovation

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 change

BARRIERS TO EXTERNAL TECHNOLOGY

TRANSFER

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 small issues

Lack of mutual trust between two parties may hinder full & timely transfer

BARRIERS TO EXTERNAL TECHNOLOGY

TRANSFER

There is risk of loss of control over technology and the transferee / recipient may use technology in an arbitrary manner

Transfer may render existing technology & its related products / services / processes obsolete

Transferee may turn a potential competitor in future.

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 feasibility etc

4. Negotiation

5. Agreement

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

TRANSFER

Lumpsum payment or periodical instalments

Royalities as a %age of sales over next few years

Cross-licensing agreements

Contracted supply of output

Issue of equity shares in lieu of technology

transferred

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 realizethrough the quality as designed during the manufacture. Even if the production starts, thetechnology 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

Research phase:

This phase is concerned with the quality design of the product. For Drug Products, thequality design corresponds to so called pharmaceuticals design-to-design properties andfunctions such as elimination of adverse reactions, improvement of efficacy, assurance ofstability during distribution, and adding usefulness based on various data such as chemicaland physical properties, efficacy, safety and stability obtained form preclinical studies.

For drug substance, the quality design is to determine starting materials and their reactionpaths, and basic specification of the drug.

CONTD….

Development Phase

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 appropriatequality control method and manufacturing method, after detecting variability factors tosecure stable quality in the scale-up validation that is performed to realize factoryproduction 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 quality.

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.

CONTD….

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.

Production Phase

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.

CONTD….

Feed back from Production and Technology Transfer of Marketed Products:

Technical information of developed products areobtained from data of a limited amount of batches,various standards have been established from the limiteddata, and quality evaluation method established indevelopment phase in not always sufficient for factoryproduction, it is highly desired to feed back andaccumulate technical information obtained from repeatedproduction, if necessary. In addition, it is important toappropriately modify various standards establishedbefore based on this information, and accountability andresponsibility for design and manufacturing should beexecuted.

TECHNOLOGY TRANSFER DOCUMENTATION:

Technology transfer documentation are generally interpreted as documents indicating contentsof technology transfer for transferring and transferred parties. The raw data of the documentsshould be prepared and compiles according to purposed, and should be always readilyavailable and traceable. For successful technology transfer, task assignments andresponsibilities should be clarified, and acceptance criteria for the completion of technologytransfer concerning individual technology to be transferred.

Quality assurance department should established conformation process for all kinds oftechnology 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 closedcommunication between transferring and transferred parties. Therefore, organization fortechnology transfer should be established and composed of both party members, roles, scopeof responsibilities of each party should be clarified and adequate communication, and feedbackof 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 tomanufacturing, transfer of technical documents concerning product development orcorresponding documents should be considered.

CONTD….

The research and development report (development report) is a file of technical development, and the researchand development department is in charge of its documentation. Informations to be contained in the developmentreport are:

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, andcomponents, and their rationale.

3. Product Specification File:

The product specification is to compile information, which enables the manufacture of the product, and to definespecification, manufacturing and evaluations method of the product and its quality, and the transferring party isresponsible for documenting the file. The product specification file should be reviewed at regular intervals, andincorporate various information obtained after the start of production of the product, and be revised asappropriate.

For new products, the development report can be used as a part of product specification file.

CONTD….

4. Technology Transfer Plan:

The technology transfer plan is to describe items and contents of technology to betransferred and detailed procedures of individual transfer and transfer schedule, andestablish judgment criteria for the completion of the transfer. The transferring party shouldprepare the plan before the implementation of the transfer, and reach an agreement on itscontents with the transferred party.

5. Technology Transfer Report:

It is to report the completion of technology transfer after data of action taken according tothe technology plan is evaluated and the data is confirmed pursuant to the predeterminedjudgment criteria. Both transferring and transferred parties can document the technologytransfer 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 theproduct, the transferring party should verify with appropriate methods such as producttesting and audit that the product manufactured after the technology transfer meets thepredetermined quality and should maintain records of the results.

CONCLUSION:

In pharmaceutical industry technology transfer means actionto transfer information and technologies necessary to realizequality of design of drugs during manufacturing. Appropriatetechnology transfer is important to upgrade the quality ofdesign to be the quality of product, and ensure stable and highquality of the product. The technology transfer does not meanone-time actions taken by the transferring party toward thetransferred party, but means continuous information exchangebetween the both parties to maintain the productmanufacturing.

The consistency in product quality, in this competitiveenvironment require the transfer of skills in personnel and thetransfer of process too. Current scenario demands thetechnology transfer with in and out sourcing technologytransfer.

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".

CONTD….

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.

CONTD….

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.

APPROACHES

The traditional approach

PRINCE2

Critical chain project management

Process-based management

Agile project management

Lean project management

Extreme project management

Benefits realization management

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

control):

initiation

planning and design

execution and construction

monitoring and controlling systems

completion

TYPICAL DEVELOPMENT PHASES OF AN

ENGINEERING PROJECT

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 defined framework.

CONTD….

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.

CONTD….

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

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

pre-planned process

CONTD….

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

is standardization.

EXTREME PROJECT MANAGEMENT (XPM)

Extreme project management (XPM) refers to

a method of managing very complex and very

uncertain projects.

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

heavy formalism.

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.

PROCESSES

Initiating

Planning and design

Executing

Monitoring and Controlling

Closing

Project controlling and project control systems

CONTD….

INITIATING

The initiating

processes determine

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.

CONTD….

The initiating stage should include a plan that

encompasses the following areas:

analyzing the business needs/requirements in

measurable goals

reviewing of the current operations

financial analysis of the costs and benefits including

a budget

stakeholder analysis, including users, and support

personnel for the project

project charter including costs, tasks, deliverables,

and schedule

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.

CONTD….

Project planning generally consists of

determining how to plan (e.g. by level of detail or rolling wave);

developing the scope statement;

selecting the planning team;

identifying deliverables and creating the work breakdown structure;

identifying the activities needed to complete those deliverables and networking the activities in their logical sequence;

estimating the resource requirements for the activities;

estimating time and cost for activities;

developing the schedule;

developing the budget;

risk planning;

gaining formal approval to begin work.

EXECUTING

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.

CONTD….

CONTD….

Execution process group include:

Direct and manage project execution

Quality assurance of deliverables

Acquire, develop and manage Project team

Distribute information

Manage stakeholder expectations

Conduct procurement

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

project.

CONTD….

CONTD….

Monitoring and controlling includes:

Measuring the ongoing project activities ('where we

are');

Monitoring the project variables (cost, effort, scope,

etc.) against the project management plan and the

project performance baseline (where we should

be);

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.

MONITORING AND CONTROLLING CYCLE

CLOSING

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 phase.

Project close: Finalize all activities across all of the

process groups to formally close the project or a

project phase

CONTD….

PROJECT CONTROLLING AND PROJECT

CONTROL SYSTEMS

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 project parameters

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 project regulations

the establishment of methods to accomplish an appropriate project structure, project workflow organization, project control and governance

creation of transparency among the project parameters

CONTD….

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:

investment analysis

cost–benefit analyses

value benefit Analysis

expert surveys

simulation calculations

risk-profile analyses

surcharge calculations

milestone trend analysis

cost trend analysis

target/actual-comparison

REFERENCES….

Y. Anjaneyulu, R. Marayya “ Quality Assurance and

Quality Management in Pharmaceutical Industry ”

Published by: PharmaMed Press, Hydrabad,2013

Wikipedia/Project Management

Wikipedia/Transfer of Technology

Wikipedia/Project Planning