Technology transfer-WPS Office.pptx

Technology Transfer

1. T e c h n o l o g y t r a n s f e r P r e s e n t e d b y M i s s S u d i p t a R o y

2. W h a t i s t e c h n o l o g y t r a n s f e r ? Technology transfer is transferring of details of concerning formulation and analytical strategies from one area to another area that's from R&D to Production department and succeeding drug product from the laboratory scale to the production scale .

3. In pharmaceutical Industry "Technology transfer" referes to a method of victorious steps forward from drug discovery to product development, clinical trials and at last to full-scale commercialization.Researcher of technology creates his technology existing to a commercial collaborator which will make use of the technology.

4. T y p e s o f t e c h n o l o g y t r a n s f e r 1. Vertical 2. Horizontal

5. Vertical technology transfer refers to the transfer of dat a s from basic study to development and production respectively.

6. Horizontal technology transfer refers to the movement and application of technology is to b e used in one place or context to different place.

7. Goals of Techology Transfer . To explain the processing information to transfer technology from R&D to production site by listing out the information gathered during R&D.

8. Methods for Technology Transfer : Licensing is the most common method of technology transfer. There are two strategies for licensing one is licesnsing in and licensing out. In licensing -in strategy , small companies and lack facilities to basic research and these facilities want to buy other research . In case of licensing -out strategy , the company right is given to another party.

9. Facts of technology transfer : Government labs to the private sector. Between the private sector firms of the same country. From academia to private sector firms. Academia , government and industry collaborations.

10. Between the private sector firms of the same country : This type of technology generally occurs due to lack of appropriate financial resources or inadequate knowledge of regulatory requirements thus , the private sector that develops the technology is paid by another sector that absorbs the technology.

11. Importance of technology transfer : Technology transfer shows important in extended benefits of R&D to the society. In the pharmaceutical industry , designing of dosage form needs scale up at several stages, such as pilot-scale from 0.5 - 2 kg batch can be scaled up to 5/10 kgs then to 20/100 kg. P roduction scale typically ranges from 200 kg to 1000 kg . It involves manufacturing of drug product with increasing their batch sizes with the help of large equipment. Generally scale-up involves transfer of technology and transfer of knowledge that has been accumulated during small scale development of product and process. Usually research has been carried out on a small scale before it produced for large scale commercial batch. Technology transfe r is important for re s e arch activities to materialize on a large scale for commercialization especially in case of developing a drug product.

12. Technology transfer in the pharmaceutical industry. Technology developer-Technology Receiving site-Feasibility study-Scale u a p-Exhibit batches-Stability study-Process validation batches-Production batches .

13. Reason for Technology transfer . Lack of manufacturing capacity . Lack of Resources to launch procduct commercially .

14. Factors that affect the process if technology transfer in the pharmaceutical industry. Investment in R&D. Eastablishing the link between production and research. Data development within the field of technology transfer methods. Organizational , equipment and informational infrastructures. Factors that affect the process if technology transfer in the pharmaceutical industry.

15. Steps invloved in technology transfer . Transfomation of pharmaceutical prototype into a successful product needs the cooperation of many people. During development of formulation , It is vital to understand procedure of operations used, critical and noncritical parameters of every operation , production of environment , instrumentation and excipient convenience , that ought to be taken into consideration throughout the first phases of development of formulation , so that successful scale up can be carried out.

16. Representation of technology transfer . Quality control and assurance . Research and development. Product development and laboratory. Analytical development and validation Product and commercialization Design and choice of excipients by R&D.

17. Identification of specifications and quality by R&D. Quality of product ought to meet the specifications of an innovator product. For this stability , studies are carried out for innovator product and for product that is to be manufactured. Technology transfer from R&D to production (Development phase). R&D provides technology transfer dossier (TTD) document to a product development laboratory that contains all data of formulation and drug product as given below.

18. Master formula card (MFC) . It includes product name along with its strength. The generic name , MFC number , page number , effective date , shelf life and market.

19. Master Packaging Card. It provides data regarding packaging sort , the material used for packaging , stability profile of packaging and shelf life of packaging. Master Packaging Card. It provides data regarding packaging sort , the material used for packaging , stability profile of packaging and shelf life of packaging.

20. Specifications and standard test procedures (STPs). These help to know activ ingredients and excipients profile , in process parameters and specifications, product release specifications and finished product details.

21. Optimization and production (production phase ). a . Validation studies. Validation studies verify that method will stabilize the product based on transferred manufacturing formula and production is enforced once validation studies.

22. b. Scale up for production. Scale up involves the transfer of technology throughout small scale development of the product and processes. Its essential to contemplate the production surroundings and system throughout the development of the method .

23. Since the early 1970s, considering the difficulties and complexities faced by managers of technology transfer projects , researchers , consultants and practitioners of technology transfer have been proposing models of technology transfer that colud facilitate the effective planning and implentation of technology transfer projects.

24. Bar-Zakay (1971) developed a rather comprehensive Technology tranfer model based on a project management approach.He divided the technology transfer process into the search , Adaptation , Implementation and Maintenance stages. He depicted the activities , milestones and decision points (go or no-go) in each of these stages .

25. The Behram and Wallender Model. Behrman and wallender (1976) have proposed a seven stage process for international technology transfer that may be more relevant to multinational corporations.The seven stages are :

26. Manufacturing proposal and planning to arrive at decisions regarding location and preparing a business case including good resource assessments. Deciding the product design technologies to be transferred. Specifying details of the plant to be designed to produce the product and other aspects related to construction and infrastructure development. Plant construction and production start up. Adapting the process and product if needed and strengthening production systems to suit local conditions. Improving the product technology transferred using local skills. Providing external support to strenthen the relationship between the transferor and transferee.

27. One of the weaknesses of this model is that , during the first three stages , the transferor develops the te chnology transfer project with minimal involvement of the trans feree thereby reducing dependency. However , in fifth and sixth stages there is considerable scope for the transferee to assimilate improve both product and process technology.

28. The lessons that can be learnt from this model are following. There is a need for the transferee to be involved right from the begining in the planning and implementation of a technology transfer project.

29. The Dahlman and Westphal Model : Dahlman and Westphal (1981) carried out considerable work in the Republic of Korea and based on their experience in rapidly industralising countries during the 1980s, in the Far East , have proposed a nine stage process model as follows. Carry out pre-investment feasibility to gather information and carry out a technoeconomic analysis to eastablish project viability. Carry out a preliminary identification of technologies needed, based on the feasibility study.

30. Carry out basic engineering studies that involve the preparation of process flow diagrams , layouts , material and energy balances and other design specifications of the plant and machinery and identification of the peripheral technology needed to make the transfer effective. Carry out the selection of suppliers for equipment and subcontracting services to assemble the plant and machinery and plan for the co-ordination of the work among various parties. Prepare and execute a training and education plan , in consultation with the suppliers of technology, for the workers who would be employed in the technology transfer project.

31. Commence operations. Develop trouble-shooting skills and put in place arrangements to solve design and operational problems as they arise , especially during the years of operation. This model may be regarded as an improvement of Behrman and Wallender model with great emphasis on transferee involvement at all stages of the technology transfer project. Its major weakness is that it assumes that the transferee will have access to high-level engineering skils. This may not be true in many developing countries.It also pays very little attention to negotiation and post-implementation assimilation initiatives.

32. The important lessons that this model presents include following : A technology transfer project is best studied using a sequential process perspective. Any technology transfer project should not be commenced without a careful feasibility study since such projects often require heavy resource commitments. The transferee should be involved in the planning right from the beginning. It is important for transferees to develop sound engineering and project management skills without which the technology transfer process cannot be managed effectively.

33. The schile , Radnor and Wad Model . Schile et al (1987) propose a simple , generic model that delineates seven elements that can influence the planning , implementation and eventual success of any technology transfer project. These seven elements are listed below . The transferor , which is the entity selling the technology to the recipient. The transferee ,which is the entity buying the technology. The technology that is being transferred. The transfer mechanism that has been chosen to transfer the chosen technology.

34. The transferor environment which is the immediate set of conditions of in which the transferor is operating . Attributes of the transferor environment that can influence the effectiveness of the transfer process include, among others , economic status , business orientation (inward versus outward), stability , attitude and commitment to the transfer project and oparating policies. The transferee environment which is immediate set of conditions under which the transferee is operating . Attributes of the transferee environment that can influence the absorptive capacity of the transferee is oparating . Attributes of the transferee environment that can influence the absorptive capacity of transferee include physical and organisational infrastructure , skills availability , attitude and commitment to the transfer project , technological status , businesee orientation (inward versus outward), economic status and stability.

35. The greater environment which is that surrounding both the transferor and the transferee. There may be layers of this environment that are sub-regional , regional and global. Even if the immediate operating environments of the transferor and the transferee are favourable to the technology transfer .

36. Factors in the greater environment such as political relationships between countries , exchange rates , investment climates , trade negotiations , balance of trade , relative technological levels , and the status of intellectual property protection regimens colud have a great influence on the success of a technology transfer project.

37. The seven elements of this model are valid even in today's business setting . The way that they manifest themselves can however change with time . The weakness of this model is that it offers no guidelines as to what a transferee should do.

38. The valuable lessons that emerge from this model are as follows : The many changes that have taken place and are taking place in the global business setting today have made it imperative for managers of technology to gain good insights into the transferee environment , transferor environment , and the greater environment when planning and implementing a technology transfer project.

39. The chantramonklasri model. The Dahlman and Westphal Model has been further improved by Chantramonklasri (1990) who proposes a five phase model. The Five-phase model of international technology transfer Source : Jagoda (2007) The five phases of this model are as follows : Carrying out a preinvestment and feasibility study. Developing engineering specifications and design based on the feasibility study Commence capital goods production based on the engineering specifications and designs that have been developed. Commisioning and start-u-including comprehensive of the workforce

40. Commence commercial production While the first two phases of this model are valid it is not clear whether the required capital goods can be produced within the transferee setting unless the transfer arrangement also includes the transfer of technology needed to manufacture these. While this may be valid in large , technologically advanced countries such as china and India , It may not be so in other smaller developing countries. As in the Dahlman and Westpal Model the negotiation and assimilation elements are missing. The lessons that may be learnt in this case are similar to those of the Dahlman and Westphal Model.

41. Qualitative models of technology transfer. There are other models that have been developed. Lee et al. (1988) have developed a longitudinal model of technology transfer based on a study of developing and rapidly industrialising countries. They point out that transferee firms needs to put in place strategies to be able to go thorough the stages of acquisition , firm needs to put in place strategies to be able to go through the stages of acquisition , assimilation and eventual improvement. As the firm advances technologically, it needs to choose appropriate mechanisms of transfer, depending on the stage of the life cycle of the technology and their own technological capability profile. They also note that the mechanisms chosen by transferor to transfer technology , its strategic importance to the transferor firm, and the level of intecllectual property protection needed.

42. Reddy and Zhao (1990) , in a model similar to that of schile et al. (1987) stat that any international technology transfer (ITT) project should examine three main components , which they refer to as the home-country component , host-country component and transaction component. The home country component involves as examination of issues such as home-country government policies on technology transfer (restrictions etc) , the role and strategy of transferring firms from a foreign direct investment point of view, the nature and importance of technology to be transferred , and the firm's global and R & D investment strategy.

43. The host country component involves issues such as host country government policies related to foreign investment and technology transfer, the relative suitability of the technology being considered for transfer , technological capability of the transferee and the scope for upgrading , mechanisms of transfer being considered, and the scope for assimilation of the transferred technology . The transction component consists of important business issues such as the pricing technology , intellectual property protection , payment modalties , potential conflicts and measures for ensuring effective transfer.

44. Keller and chinta (1990) argue that effective technology transfer would be determined by the extent to which the transferor and transferee manage the barriers that impede transfer and strengthen intiatives that facilitate it . The facilitating initiatives refer to the willingness of the partners to adapt their respective strategic and operational postures to ensure a ''win-win'' outcome . The barrriers could be political , legal , social , cultural , economic and technological .Thet also stress the importance of selecting the correct mechanism to transfer the technology.

45. The UNIDO (1996) model , in what appears to be an endorsement of the Bar-Zakay approach , suggests that , in manufacturing sector , once the need for a technology transfer project is eastablished, the steps of search , evaluation , negotiation , contract execution and technology adaptation and absorption should be followed sequentially to ensure effectiveness.

46. Durrani et al. (1998) have proposed a generic model consisting of five steps. Eastablishing market place requirements. Identifying technology solutions. Classifying the identified technology solutions. Eastablishing sources from where the desired technology could be acquired. Finishing the technology acquisition decision.

47. This model stops with technology acquisition decision. Its major lesson is that it stresses the imortance of eastablishing the need for a technology transfer project and the need for identifying multiple sources of technology for enabling a better choice of transferor.

48. Bozeman (2000) has proposed a contingent effectiveness model of technology transfer. While the emphasis is on technology transfer from universities and government laboratories to industry, the model is also relevant to inter firm technology transfer. In this model , the key elements of the transfer process are : Transfer agent (the transferor) The transfer mechanism The transfer object (the content and form of the technology being transferred) The transfer recipient (the transferee) The demand environment (market and non-market factors vis-avis the need for the technology)

49. This model also stresses importance of eastablishing the need for a technology transfer project and the need for identifying multiple sources of tehnology for enabling a better choice of transferor. Six ''out-the-door'' measures are proposed. These are market impact , economic development , political benefits , opportunity , costs and development of scientific and human capital as a result of the transfer . The importance of impact assessment is a valuable lesson that this model imparts.

50. A brief overview of some Quantitative technology transfer models . The literature is sparse when it comes to quantitative models of technology transfer . Some of the more important models are described briefly . For the sake of brevity , the mathematics has been left out and interested reader may wish to refer to the original publications.

51. Perhaps, the earliest quantitative model is due to shariff and Haq (1980). This model proposes the concept of potential technological distance (PTD) between a transferor and transferee and argues that when the PTD is either too great or too small between transferor and transferee , the effectiveness of the transfer is low. It suggests that when a transferee first looks for a potential transferor it is important to look for one with an optimal PTD.

52. From a practical point of view , a potential transferor at the firm level may not be willing to easily divulge information that could enable an assessment of the PTD. The greatest value of the model is that it draws attention to the need for incorporating the concept of a PTD in deciding the transferor.

53. Raz et al, (1983) have presented a model of technological 'catch-up' that shows how a technology leader , through technology transfer , can assist the rate of technological development of a technology follower.The model examines three phases of growth of a technology follower namely , the slow initial phase with high technological capability gap , the faster learning phase with the decreasing gap , and catch up phase when the technological gap is very small or closed .

54. The argues that this type of analysis would enable technology leaders to develop clear pol a icies , based on considerations of competitiveness , security and other related issues , when enetering into technology transfer agreements.

55. Using an economic model , Klein and Lim (1997) have studied the technology gap between the general machinery and electrical and electronic industries of korea and Japan. Their findings suggest that technology transfer from leaders can play a critical role in upgrading the technological levels of follower firms. Their study also shows that the followers should supplement the transfer by independently putting in place measures to assimilate , modify and localise the technology transferred from the leader.

56. This model thus emphasises , based on empirical evidence , the need for post-implementation activities that facilitate assimilation and modification of the transferred technology . It also clearly delineates the need for a firm , as it grows technologically , to link its technology transfer activities with internal R&D

57. It may be said that the main contribution of the quantitative models is their emphasis on the need for partners in technology transfer projects to develop skills to be able to use formal , analytical approaches that can generate needed information for better technology transfer planning.

58. An examination of the models of technology transfer shows that there are several valuable lessons that they convey. These are summarized below . It is important to expand comprensive analytical effort in eastablishing the need for a technology transfer project prior to the commencement of a technology transfer project. A technology transfer project should not be commenced without a careful feasibility study since such projects often require heavy resource commitments.

59. A process approach must be adopted in planning and implenting technology transfer projects and to ensure effective technology transfer there is need to comprehensively examine the entire process from technology search right through to post implementation activities. The many changes that have taken place and are taking place in the global business setting today have made it imperative for managers of technology to gain good insights into the transferee environment , transferor environment and the greater environment when planning and implementing a technology transfer project.

60. Multiple sources of technology must be identified to enable a good choice of transferor. The transferee must be involved right from the begining in the planning and implementation of a technology transfer project . It is important for transferees to develop sound engineering and project management skills without which the technology transfer process cannot be managed effectively. Partners in technology transfer projects need to develop skills to be able to use formal , analytical approaches that can generate needed information for better technology tranfser planning.

61. It is important to have milestones and decision points so that activities can be strengthned , mistakes corrected , or even the project terminated at any point in time. The mechanisms chosen by transferor to transfer technology depend on the transferor and transferee setting , the technological capability of the transferee , the relatives newness of the technology , its strategic importance to transferor firm , and the level of intellectual property protection needed. As a transferee firm advances technologically , it needs to choose appropriate mechanism of transfer , depending on the stage of the life cycle of the technology and its own techological capability profile.

62. A technology transfer project does not end with commencement of production. Unless explicit measures are in place to ensure assimilation of the transferred technology the technology transfer cannot be said to have been successful. The success of a technology transfer project would be determined by the extent to which transferor and transferee manage the barriers that impade transfer and strengthen initiatives that facilitate it.

63. However , what may also be noted is that there is no model that there is no model that tries to capture all of these important considerations .An electric model that presents all this wisdom in process oriented approach would be very useful to managers of technology transfer project. Such a model must also have the capacity to address many of the problems faced by firms , especially small and medium enterprises (SMEs) , when planning and implenting technology transfer. The next part will first presenet a summary of common problems faced by SMEs in planning and implementing technology transfer and then propose an electic process model called 'the life cycle Approach for Planning and implementing technology transfer.

64. The next part will first present a summary of common problems faced by SMEs in planning and implementing technology transfer that tries to incorporate the wisdom of the models discussed . It is envisaged that the adoption of this process model will enable SMEs to manage the common problems they face in planning and implementing technology transfer projects.

65. Documentation In Technology Transfer. Technology transfer document demostrates the contents of technology transfer from transferring and transferred parties. Each step from research and development to production should be documented, task assignments and responsibilities ought to be processed and acceptance criteria for completion of technology transfer regarding individual technology to be transferred. Its duty of the Quality Assurance department to examine and approve the documentation for all processes of technology transfer.

66. Development Report : It is used at pre-approval examination as a valid document for quality design of nw drug. The ultimae goal for successful technology transfer is to process documented evidence. The R&D report may be a file of technical development, and also the research and development department is accountable for its documentation. This report is a crucial file to point rationale for the quality design of drug substances and drug speifications and test methods . Additionally , this report can be used as raw data just in case of post-marketing technology transfer.

67. The development report contains the following : Data of Pharmaceutical development of new drug substances and drug products at stages from the early development phase to final application of approval. Data for raw materials and components.

68. Rational for the dosage form and formula designs and design of manufacturing ways. Modification in histories of vital processes and control parameters. Stability profile , specifications and test methods of drug substances, intermediates, drug products , raw materials and components which also include the validity of specification range of important tests such as content impurities and dissolution.

69. Rational for selection of test methods , reagents and columns verification of results. Technology transfer plant and exhibit : Plan t : The technology transfer plan describes the things and contents of technology to be transferred and elaborate procedures of indivodual transfer and transfer schedule , and to determine judgement criteria for the completion of the transfer.The transferring party ought to prepare the plan before the implementation of the transer and reach an agreement on its contents with the transferred party.

70. b) Report : Report completion of technology transfer is to be created once information is taken consequently to the plan and are evaluated to substantiate that the planned judgement criteria are met . Both transferring and transferred parties will document the technology transfer report, but they must reach an agreement on its contents. c) Exhibit : After taking a scale-up batch of the product , manufacturing of exhibit batches take place . In case of exhibit , batch sizes are increased along with equipment , and their process is involved. They are done for filling purposes in different regulatory agencies.