Transfer of technology and project planning and management

Technology Transfer and project planning and management

1. Presentation on 1) Transfer Of Technology 2) Project Planning and Management Ajit Kumar Jha 1 st 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:

2. 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.

3. Contd…. 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.

4. 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 .

5. Contd….. 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 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 And so on

6. What is Technology Acquisition ? Two terms 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.

7. Types of Technology Transfer Scientific Knowledge Transfer, Direct Technology Transfer, Spin-off Technology Transfer Informal Technology Transfer & Formal Technology Transfer Internal Technology Transfer & External Technology Transfer

8. Internal Technology Transfer Internal Technology Transfer refer to such technology transfers/investments where control on the ownership & usage of technology resides with the 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 ?

9. 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.

10. Steps in Internal Technology Acquisition by a firm Planning new products / services / processes to be offered – planning must incorporate voice of the customer & user needs Screening new products, processes or services – only viable / feasible items be offered as only one out of 4/5 becomes a commercial success. Initiating development process – must be properly designed and carried out so that it facilitates success. Enterprises should Consist of temporary system capable of adapting to dymanics of change Organize the systems around problem solving

11. Steps in Internal Technology Acquisition by a firm Have flexible management system & replace rigid management system Use multi - functional teams. Proper in t egration between R&D, Production & Marketing sub-systems Ensure effective communication Carrying out trial production on small scale and test marketing Improving design & production processes based on experiences / feedback Commercialization i.e. mass production & sales

12. 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.

13. 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

14. Methods of External Technology Transfer Co-operative & collaborative ventures / strategic alliances Licensing agreements Contracting agreements Enterprise acquisition.

15. 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

16. 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

17. 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

18. Steps in External Technology Acquisition by a firm – Identification of Need Developing list of suitable technology providers Short listing / selecting suitable technology providers on the basis …. Cultural compatibility, compatibility of core competences, appropriateness of technology, technical feasibility etc Negotiation Agreement Payments as per agreement Transfer of specifications, blueprints, designs, documents, CDs to purchaser Training of technical personnel of purchaser

19. 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

20. 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.

21. 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 Research 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.

22. Contd…. Development Phase Research for Factory Production Consistency between Quality and Specification Assurance of consistency through development and manufacturing 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 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.

23. 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 Phase validation & Production 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.

24. Contd…. 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 executed.

25. 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.

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

27. Contd…. 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.  

28. Conclusion: 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 manufacturing. 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 transfer.

29. 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".

30. 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 .

31. 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.

32. 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.

33. Approaches  The traditional approach  PRINCE2  Critical chain project management  Process-based management Agile project management  Lean project management  Extreme project management  Benefits realization management

34.  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

35. Typical development phases of an engineering project

36. 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.

37. 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.

38. Contd….

39. 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.

40.  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.

41. 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

42. Contd….

43. 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 .

44. 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.

45. 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.

46. Processes  Initiating  Planning and design  Executing  Monitoring and Controlling Closing  Project controlling and project control systems

47. Contd….

48. 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.

49. 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

50. 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.

51. 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.

52. 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.

53. Contd….

54. 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

55. 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. 

56. Contd….

57. 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.

58. Monitoring and controlling cycle

59. 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

60. Contd….

61. 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

62. 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

63. 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

64. Thank you