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Looks at the distinctive characteristics of the biotechnology industry. Profile of the U.S. biotechnology industry; Management style that is compatible with the special nature of the biotechnology industry; Need for biotechnology companies to promote collaborative partnerships with stakeholder groups; Difference of biotechnology companies with other types of business companies in terms of focus and goals.

Objective: To compare the value of the thyroid imaging reporting and data system proposed by Kwak (KWAK TI-RADS) and the 2015 American Thyroid Association (ATA) guidelines for diagnosis of medullary thyroid carcinoma (MTC) and papillary thyroid carcinoma (PTC). To confirm the role of cell block (CB)-assisted fine-needle aspiration (FNA) in final diagnosis of MTC., Design: Retrospective hospital-based cohort study., Patients: Ninety-three patients with 29 MTCs, 31 PTCs and 33 thyroid adenomas (TAs) who underwent thyroidectomy from January 2010 to May 2019 were retrospectively reviewed. The KWAK TI-RADS and ATA guidelines were used to assess each thyroid nodule. FNA, CB-assisted FNA and core needle biopsy (CNB) were performed in final diagnosis., Results: Age and ultrasound features (composition, echogenicity and shape) were significantly different between MTC and PTC. Sex and ultrasound features (echogenicity, margin and calcification) were significantly different between MTC and TA. The KWAK TI-RADS and ATA guidelines showed no significant difference for MTC (area under the curve [AUC]: 0.812 and 0.808; P = .37-.85) or PTC (AUC: 0.883 and 0.885; P = .25-.96). The KWAK TI-RADS and ATA guidelines showed high specificity and sensitivity for MTC (93.9% and 62.1%, 87.9% and 65.5%) and PTC (93.9% and 67.7%, 87.9% and 77.4%), respectively. For suspicious MTC (7 cases), CB-assisted FNA provide accuracy preoperative diagnosis., Conclusions: Although the diagnostic performance of the TI-RADS and ATA guidelines is worse for MTC than PTC, the difference is not statistically significant. CB-assisted FNA should be performed in thyroid nodules with 4a or lower suspicion to avoid misdiagnosis of MTC., (© 2019 John Wiley & Sons Ltd.)

Regulatory inspection of clinical trial is necessary in order for (1) assessing compliance with statutory requirements and regulatory requirement governing the conduct of clinical trials and (2) verifying the accuracy and reliability of clinical trial data submitted to regulatory agencies such as the United States Food and Drug Administration (FDA) in support of research or marketing applications. This article provides an overview of clinical inspection process and issues that are commonly encountered during the conduct of clinical trials. In addition, a couple of sampling plans for clinical inspection of relatively large trials are proposed. The proposed statistical process for clinical inspection that will achieve a desired degree of inspection accuracy and reliability is useful when the resources of inspectors are limited. The proposed 2-stage sampling plan can be applied to clinical inspection for multicenter and/or multinational multicenter clinical trials.