In-licensing

On the other hand, the technical and market risk involved in licensing technology, the difficulty in assessing the value of a particular inteUectual property, and the fact that the technology is developed outside the Hcense company often makes licensing less than desirable. Like Hcensing-out,... 

Initially PSAs were used, primarily, to evaluate risk imposed on the public or workers. This includes the use of PSA in licensing and/or review procedures to assure protection of public health and safety. Examples by user are ... 

The studies revealed that problems in licensing pharmaceutical establishments can be grouped into those relating to legal stmctures and those relating to implementation. 

Manufacture of ruthenium precatalysts for asymmetric hydrogenation. The technology in-licensed from the JST for the asymmetric reduction of ketones originally employed BINAP as the diphosphine and an expensive diamine, DAIPEN." Owing to the presence of several patents surrounding ruthenium complexes of BINAP and Xylyl-BINAP, [HexaPHEMP-RuCl2-diamine] and [PhanePHOS-RuCl2-diamine] were introduced as alternative catalyst systems in which a cheaper diamine is used. Compared to the BINAP-based systems both of these can offer superior performance in terms of activity and selectivity and have been used in commercial manufacture of chiral alcohols on multi-100 Kg scales. 

Increasing knowledge is undertaken through a global R D network with academic centers and companies worldwide, as well as in-licensing opportunities for novel technologies, which complement their own R D capabilities. 

Johnson Matthey, Catalysis and Chiral Technologies (Synetix) In licensed chiral ligands, process R D. Metal precursors and M-L complexes in technical quantities recovery of noble metals [112]. 

Dilead hexacyanokisferrate, 14 535 Diligence provisions, in licensing agreements, 24 379... 

With the increase in licensing agreements between pharmaceutical companies, safety data frequently needs to be exchanged between one or more parties. If the case volume is sufficient, it is worth considering electronic data exchange between the databases involved. In addition to preventing rekeying of data, this minimizes discrepancies between the data sets. With the adoption of proposed ICH standards in the future, this will become a much simpler process. 

In 2000, Merck in-licensed threo (3, P32/98) and alio (4) isoleucine thiazolidides from Probiodrug so as to fast forward the internal program and increase our understanding of DPP-4 inhibition. These two compounds are equipotent against DPP-4 (IC5o = 440 nM for 3 and 460 nM for 4), and each compound showed similar in vivo efficacies in oral glucose tolerance tests (OGTT) administered to diet-induced... 

These plans envision assembling a portfolio of in-licensed drug candidates for which collective development risk is deemed to be relatively low. The idea is to in-license molecules that either are too specialized (small market potential) for large pharma or are not visible to their radar because they come from places like Eastern Europe. These stories are favorites of professional investors, because rNPVs can be calculated with relatively low development risk on the basis of demonstrated clinical utility and/or pipeline diversity. Examples include Dura Pharmaceuticals, who marketed prescription products that treat infectious and respiratory diseases, and Gilead who marketed antiviral nucleotides discovered in the Czech Republic. 

Pharmaceutical firms often choose to in-license compounds to beef up their developmental pipeline or round out their existing product portfolio. Structurally, in-licensing can be represented with a simple extension of the basic stock/flow framework, as shown in Figure 35.19. 

In-licensing opportxmihes can enter the drug development process at the level of phase trials and the on patent stage. In either case, the simulahon model can assign a cost necessary to obtain in-licensed compoxmds (cost per in-licensed compound), which can be compared... 

Multiple choice questions are increasingly used to test knowledge and understanding objectively at an undergraduate level and in licensing exams. They can be formative as self-assessment exercises with feedback and are particularly useful for revision purposes and as a means of identifying an area for further study. 

European clinical trial products do not currently require manufacture to GMP however, a new clinical trial directive is undergoing implementation and will necessitate the manufacture to GMP in licensed premises. 

Because of the rising future demands and delays in licensing, the Minister of Health announced on 11 March 1987 that he had commissioned a study of the control of medicines in the United Kingdom. The terms of reference were ... 

And what can consumers or patients do Fear all medicines they come across No, counterfeit medicines are not invariably present in all pharmacies and hospitals. Consumers should learn to go back to their pharmacist or their doctor when they feel that the medicines they regularly takes seem to work differently, when a new medicine does not work as expected, or every time they experience a side effect. In most cases there will be no counterfeit medicine to blame. However, it is important that patients know what to do when they have a doubt about a medicine. Consumers should always purchase medicines from the officially licensed outlets as there is evidence that the incidence of counterfeits medicines is much lower in licensed outlets. 

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