Candidate partners, developing

The recommendations for a "supply chain stage-gate process" call for early consideration of needed supply chain changes. The initial assessment at Gate 1 is whether a supply chain change is needed at all. At Gate 2 developers should know the type of product it is in the case of a new-product situation. At this point, we believe candidate partners should be identified. The business case at Gate 3 should produce a discovery-driven plan that requires documentation of supply chain assumptions. 

Evaluation of the process as a candidate for scale-up and further development evidently did not meet the Lilly or Takeda requirements. It could be that a champion of the new technology never emerged. Indeed, when Schering-Plough took up the idea for the manufacture of Ceftibuten intermediates, our partner, Shionogi, based on their earlier knowledge of Eli Lilly and Takeda work, were only lukewarm supporters. The main objections were as follows ... 

This chapter describes the early hit discovery project to identify inhibitors of Hsp90 at Vemalis in 2002-2003. This generated the initial ideas from which series of preclinical candidate compounds were discovered, some of which continue in clinical trials for treatment of cancer [11, 17]. The very early work (virtual and fragment screening) was carried out within Vemalis before a collaboration was initiated with the group of Paul Workman at the Institute of Cancer Research. Subsequently, the project was partnered with Novartis, who were responsible for preclinical development and clinical trials while work at Vemalis continued on identification and optimisation of backup and follow-up compounds. 

Figure 2.4 Simplified model of drug discovery startup development. Succeed and Fail first refer to the ability to attract a corporate partner, then later to the production of a promising drug candidate in clinical trials.

B. Phase 2 Development The Development Representative will ensure the screening of product candidates. External evaluation by selected customers (technical partners) may be initiated to obtain early performance feedback, especially in areas where the company is unable to perform the key tests necessary, or to obtain early vahdation of company test results. In Phase 2 there is no commitment to commercialization. The Director of Marketing of the Business Unit responsible for the experimental product area must approve in writing sampling an R D substance outside of the company and shall ensure compliance with Procedure Number Lab. 5, Sampling R D Substances to Third-Parties. If sampling is to a destination outside of the United States, the Director of Marketing shall inform the MRC who shall determine if the substance is subject to the export notification requirements ofTSCA 12(b). 

Identification and selection of disease-specific targets is one of the most important steps toward personalized medicine. The simultaneous identification of disease-specific protein targets and their small molecule binding partners, suitable as drug candidates after validation with a cell-based approach (a reverse chemical genetics approach), could radically reduce the timeline and costs of drug discovery and develop-menf. Diverse small molecule microarrays were applied to identify such profeins directly from cancer cell lysates/fractions in comparison with... 

Table 20.1 describes potential partnership solutions for implementing the strategy. The column Candidate Partnerships contains options for developing the activity jointly with partners. Partnership Type describes ways in which the activity will help Acme become a better partner to its customers. The table uses our characterization system, or partnership taxonomy, from Chapter 19 to identify the type of partnership required to implement the activity. 

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