Second, knowledge must exist in certain places like in someone’s head or documents and must be able to be presented, so no matter what it means it must be able to be transferred from one person to another. Licensing and Technology Transfer in Pharmaceutical Industry. International Journal of Technology Management 1995; 10(7/8): 643-64. 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. h)       Reviews process instructions (with process technologist) to verify capacity and capability. Your email address will not be published. Department of Pharmacy Practice, KMCH College of Pharmacy, Coimbatore, Tamil Nadu, India. IJPBS 2009; 1-3. Both parties should cooperate in implementing technology education training and validation at facilities where the transferred technology is actually used. The transferring party should prepare the plan before the implementation of the transfer, and reach an agreement on its contents with the transferred party 15. Introducing with a network of connected devices with monitoring sensors can reduce the risk of machinery malfunctions and guarantee precision production by detecting issues and making adjustments before they cause a problem. Shoaib Alam* and Javed Ahmad, Authors Address: The success of any particular technology transfer depends upon process understanding or the ability to predict accurately the future performance of a process. Technology transfer is a complex issue and should be deal with using holistic approach. ABSTRACT: The purpose of this review article is to discuss in detail about technology transfer in the pharmaceutical industry. j)        Considers the impact on local standard operating procedures (SOPs). These tiny pills or gadgets combined with a sensor could track digestion and the absorption of drugs after swallowing them. What research-based pharmaceutical companies are looking for in prospective recipient countries includes: Stages of Technology Transfer: Typically, technology transfer occurs during one of five stages in the product's lifecycle: early discovery, toxicological evaluation, clinical development, scale-up and commercial manufacturing, and in-line production 4, 5. Many of these are influenced by government policy decisions. Commercial technology transfer is mutually agreed, and goal destined. DAQRI, a California based augmented reality company has come up with the DAQRI smart helmet which is safety compliant for industrial use. For drug-target interaction prediction studies, AR-VR technologies can expand so far. A major decision focuses on that point where the idea or process is advanced from a research- oriented program to target toward commercialization. This report is a crucial file to point rationale for the quality design of drug substances and drug specifications and test methods. The goal of technology transfer activities is to transfer product and process knowledge between development and manufacturing, and within or between manufacturing sites to achieve product realization. 2019 Essential Ecommerce Features for Ecommerce Sites. The technology transfer does not mean one-time actions taken by the transferring party toward the transferred party but means continuous information exchange between both the parties to maintain the product manufacturing. Your email address will not be published. Int J Pharm Res Dev 2010; 2(10): 43-48. Using this technology, they then produced Spritam, which treats Epilepsy. 1.4.4 Between Academy, Private and Government Sectors:  In this type of technology transfer government provides necessary funds to the academic institutions in developing technology that can be transferred to the industry. Research-Based Pharmaceutical Industry Technology Transfer Policy Considerations Foreword 9 Executive Summary – Creating a Win-WinI. Procedures and documentation of technology transfer are indicated as follows. The core technology transfer team must be commissioned immediately following the decisions of the executive management to pursue the drug candidate to commercialization. If you continue browsing the site, you agree to the use of cookies on this website. An International Journal of Pharmaceutical Research 2016; 1(4): 141-42. The technology transfer consists of actions taken in these flows of development to realize the quality as designed during the manufacture. Testing drugs on humans or animals in the framework of costly and lengthy clinical trials are the past, “Organs on Chips” concept is the new hype. 0000026542 00000 n The product specification file should be reviewed at regular intervals, and incorporate various informations obtained after the start of production of the product, and be revised as appropriate. The achievement of any specific technology transfer depends upon method understanding or the flexibility to predict exactly the long term performance of a process 1. Mohite PB and Sangle SV: Technology transfer in the pharmaceutical industry- a review. In order to survive and thrive in this environment, it’s more essential than ever for companies in the industry to explore and invest in the latest technology and innovations. Cost Per Drug: $800 million — $2.5 billion, Success Rate: 1 in 5 drugs make it to market, Return: ~3.2%; only 1 in 3 drugs reaching the market recoup investment costs (is “profitable”). (5)   Approval by Quality Assurance Department: It is desirable that the quality assurance department should establish confirmation process for all kinds of technology transfer documentation, and should check and approve the documentation. Therefore, an evaluation of the raw materials proposed by the RU should be conducted. The Anatomy of Technology Transfer in the Pharmaceutical Sector: It’s much more than simply handing over technology: The transfer of R&D pharmaceuticals is providing a “tool box”. This review articles is also intended to propose some regulations to realize technology transfer necessary for high quality and stable manufacturing of developed products and existing products by reviewing technology transfer based on the following ideas. Various standards for manufacturing and tests will be established in process of reviewing factory production and Phase III study to realize the quality of design, and the quality of design will be verified in various validation studies, and will be upgraded to be the quality of product, and the actual production will be started. Effective technology transfer helps to provide process efficiency and maintain product quality. k)       Considers the training requirements of supervisors or operators. Authors: Journal of Technology Transfer 1990; 15: 1-2. discovery to product development to clinical In turn, this should theoretically improve the drug development success rate and streamline R&D efforts. For example, rather than taking months to see the effect of a particular drug on thousands of people, it will take seconds to see the effect of a drugs on billions of simulations of the human body’s physiology from the past records of patients. 0000018760 00000 n 2; 2009. d)       Reviews documentation to work out compliance with marketing authorization (MA). 0000015187 00000 n However, this is not always feasible. To assure the drug quality, it is desire to make sure that is what, when, and why information should be transferred to where and by whom and how to transfer, then share knowledge and information of the technology transfer each other between stake holders related to drug manufacturing. By collaboration of private firms with the institutions, money can be saved. There are so many areas in this industry to facilitate with blockchain like research and development,  manufacturing and distribution, consumers and patients identity management. The following exemplifies information to be contained in the development report. Journal of Intellectual Property Rights 2008; 13: 28-34. 0000032785 00000 n A plan must be devised to organize the personnel and the process steps. a case study of the pharmaceutical industry in India. f)        Initiates conversion of donor site documentation into local systems or format. This method is called the “silico trial”. For drugs as they have long product shelf life, documentation management should be performed assuming that the technology transfer would occur several decades after the completion of development. Basic Policies on the Establishment of the Guideline for the Technology Transfer. 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 contents impurities and dissolution. Also as in the case of technology transfer from research and development to production, responsibilities for the technology transfer should be clearly defined, documentation of technology transfer should be prepared, and the technology transfer should be implemented through adequate exchanges of technical information.