In the era of personalized medicine, pharmaceutical companies are actively seeking partners to develop Companion diagnostics. Common choices of partners include large diagnostic manufacturers and traditional Contract Research Organizations (CROs), neither of which provides an entire solution. Diagnostics companies have an intrinsic bias toward internal product lines, and are therefore incentivized to direct diagnostics development toward an existing technology platform. The expertise of a CRO lies in the monitoring of pharmaceutical programs, not in diagnostics. In addition, few traditional partners have significant clinical laboratory experience or offer accredited clinical laboratories to ensure that the diagnostic clinical trials are designed for, and conducted in, laboratories that meet regulatory standards. Lastly, these organizations are inexperienced in managing and coordinating the multiple partners required in the development process. The Contract Diagnostics Organization (CDO) is a new concept designed to aid pharmaceutical companies in addressing challenges in companion diagnostics development. This business model provides pharmaceutical companies a complete outsourcing partner to initiate and manage the parallel development of companion diagnostic tests in synergy with drug development. The CDO combines all of the necessary services, including diagnostics research, an accredited clinical laboratory, project management and regulatory, manufacturing, and consulting in an integrated, technology-independent manner. Thus, the CDO focuses on its pharmaceutical partner's business objectives and ensures the speediest path to market a valuable, personalized drug for patients.
Juniperus phoenicea is an ornamental shrub that is also used to flavor food and to supply medicines and timber. Its micropropagation is of industrial concern and can occur by axillary shoot multiplication. Microcuttings of J. phoenicia were established in vitro on Murashige and Skoog (MS) and Rugini Olive (OM) media in glass tubes (25 mm x 150 mm). Factors studied were explant length (0.5 or 1.5 cm) and orientation (horizontal or vertical), media strength (OM, ½OM, MS, ½MS) and the following growth regulators: the anti-auxin 2,3,5-triiodobenzoic acid (TIBA), the cytokinins 6-benzyladenine (BA) and thidiazuron (TDZ), and the growth retardant daminozide (DM). Microcuttings placed vertically on the surface of OM, ½OM and ½MS media without hormones exhibited axillary bud differentiation, but they were swollen and turned brown one month later when placed horizontally on the medium surface. The number of shoots, averaged across OM, ½OM and ½MS media, was significantly higher from longer (1.5 cm) than shorter (0.5 cm) microcuttings (4.11 versus 1.57 shoots microcutting -1 ) after 60 days of culture. TIBA or DM at 0.1 mg l -1 included in OM medium enhanced leaf differentiation, callus induction and formation of adventitious shoots over three months from 0.5 cm long microcuttings taken from in vitro shoots. The formation of adventitious shoots was sporadic and occurred at a rate of 1 shoot microcutting -1 in the presence of 0.1 mg l -1 DM. OM supplemented with 0.1 mg l -1 TIBA resulted in significantly the highest leaf differentiation (55 leaves microcutting -1 ), with a rooting rate of 40%. Contents of phenols, flavonoids and antioxidants were compared for cuttings from young seedlings, callus, in vitro shoots, and seeds. Antioxidant activity was significantly the highest for shoots grown on hormone-free OM medium and callus maintained on OM medium containing 0.1 mg l -1 2,4-D (94.7 and 94.3% inhibition of DPPH free radicals, respectively). Thus, different routes for in vitro regeneration of J. phoenicea can be of potential use for many biotechnological, pharmaceutical and food industry applications.
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