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Confounding Issues in Cancer Progress--The Impact of Investor Requirements on Senior Management Compensation and Regulatory Decisions: Tivozanib and Aveo Pharmaceuticals
Previous research has demonstrated that profits are a key requirement in private pharmaceutical development. We sought to examine the extent that pressure of financial incentives exerted by investors and the board of directors, including senior management financial rewards, have on regulatory decisions made by senior management. Our selected case study involved Aveo Pharmaceuticals Inc (Aveo). The specific question was to what extent the terms of financing, particularly the corporate governance goals which determined executive bonus compensation, may have dictated Aveo’s regulatory approach in the drug application pr...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Babiarz, J. C., Melaragni, F., Kerr, S., Kuchimanchi, P. Tags: Ethics Special Section Source Type: research

Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations
To raise awareness and promote dialogue leading to action, this article provides proceedings on ethical and legal considerations associated with medicine use during pregnancy discussed during the 2014 DIA Medicines and Pregnancy Forum. A key focus of discussion at the forum was "When is it ethically appropriate to include or unethical not to include pregnant patients in clinical studies, and how can ethical barriers be addressed?" Also debated was the question "What are the most appropriate methods to collect and share data on medication use in pregnancy, and what is the best process for sharing such information?" Goals of...
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Clemow, D. B., Nolan, M. R., Michaels, D. L., Kogelnik, A. M., Cantrell, S. A., Dewulf, L. Tags: Ethics Special Section Source Type: research

Pharmaceutical Ethics Comes to Life in Therapeutic Innovation & Regulatory Science
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - April 30, 2015 Category: Drugs & Pharmacology Authors: Lipworth, W. Tags: Ethics Special Section Source Type: research

Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral Drugs
Conclusions: The adult adverse event experience provides preliminary data for pediatric drug safety, yet the specific types of adverse effects and frequencies may not be predicted in children based exclusively on adults. As adult safety data do not fully inform the pediatric safety profile, pediatric safety studies should continue to be conducted separately for drugs undergoing testing in pediatric patients. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Momper, J. D., Chang, Y., Jackson, M., Schuette, P., Seo, S., Younis, I., Abernethy, D. R., Yao, L., Capparelli, E. V., Burckart, G. J. Tags: Special Populations Source Type: research

The First Paediatric Use Marketing Authorisation: A Case Study
This article describes the assessment procedure and the key regulatory issues that were addressed. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Watson, J., Nowacki, K. Tags: Special Populations Source Type: research

Principled Structured Incorporation of Clinical Knowledge Into Strategic Development Decisions
Efficient use of limited pharmaceutical product development resources requires integrating multiple attributes, such as efficacy, safety, pharmacology, and so on, to decide at any stage whether the development of a product should proceed aggressively or slowly or be terminated. The decision process proceeds most effectively when the knowledge and experience of a product development team are transparently and reproducibly integrated with the findings from completed experiments and trials. In this article, the authors describe an approach for quantitatively and objectively assessing evidence at any stage of development, one ...
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Gould, A. L., Krishna, R., Khan, A., Saltzman, J. Tags: Product Development and Innovation Source Type: research

Introducing Internet Retailing of OTC Drugs in Japan: Revision of the Pharmaceutical Affairs Law
This article briefly touches on the decision process and also illustrates the key points of the new rules for Internet retailing. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Nakai, K., Tanaka, T. Tags: Global Perspectives Source Type: research

Actions of the National Regulatory Authorities in 10 Low- and Middle-Income Countries Following Stringent Regulatory Authority Safety Alerts on Rosiglitazone
On September 23, 2010, the US Food and Drug Administration and the European Medicines Agency issued safety alerts for medicines containing rosiglitazone. The authors monitored the actions of national regulatory authorities (NRAs) from 10 low- and middle-income countries to identify the time lag between the issuance of safety alerts by these two stringent regulatory authorities and any actions by these select NRAs. Two NRAs outside Africa took regulatory actions related to safety of rosiglitazone within 2 weeks of stringent regulatory authority safety alerts. For the 7 of the 8 African NRAs where the authors could confirm t...
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Nwokike, J., Kabore, L., Stergachis, A. Tags: Global Perspectives Source Type: research

Global Regulatory Dissonance: A Case Study of Industry Views on the Development of Drugs for Postmenopausal Osteoporosis
Conclusions: The results suggest that global access to new drugs may be enhanced through a greater understanding of GRD. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Storm, N. E., Richmond, F. J. Tags: Global Perspectives Source Type: research

Implementing a Process to Review Product-Specific Misinformation in Online Drug Information Compendia
Health care professionals and consumers often use online drug information compendia, which are intended to be user-friendly, readily available, accurate, and up-to-date. While these resources can be valuable, it has been shown that some compendia contain inaccuracies and outdated information, motivating the Medical Services (medical information) Department at Purdue Pharma LP to implement a periodic, standardized review of select online drug information compendia. Monographs within compendia for up to 9 Purdue products were reviewed and compared to their current Full Prescribing Information, with a focus on identifying saf...
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Talwar, S. R., Crudele, N. T., Dankiewicz, E. H., Randhawa, A. S., Haddox, J. D. Tags: Regulatory Science Source Type: research

Breakthrough Therapy Designation: Bringing Innovation Swiftly to Patients
In early 2012, the Breakthrough Therapy Act was introduced into the US House of Representatives and the Senate. The bills received bipartisan support and were included as an amendment to the Food and Drug Administration Safety and Innovation Act in the Prescription Drug User Fee Act V. On July 9, 2012, the breakthrough therapy designation was signed into law. As of June 13, 2014, a total of 48 products have been designated as breakthrough therapies by the Center for Drug Evaluation and Research, and 4 of those have received FDA new molecular entity approval. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Shah, A. Tags: Regulatory Science Source Type: research

openFDA: An Open Question
(Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Pitts, P. J. Tags: Regulatory Science Source Type: research

General Principles for the Education and Training of GCP Inspectors: The Outcome of Discussions by International Regulatory Experts in the Discussion Group on the ICH E6 Guideline
This article summarizes the background and past activities of the E6 Discussion Group, established under the Regulators Forum. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Uyama, Y., Yamazaki, E., Clark, K., Wang, C.-Y., Woro, E., Tong, F. Y., Sachidanandan, S., Rodriguez, A., Oh, H., Saleh, K., Cirunay, J., Wapeewuttikorn, A., Rogov, E., Alshahwan, K. W., Herrera, I., Mthetwa, J., Fakudze, F., Osawa, T., on behalf of the E Tags: Regulatory Science Source Type: research

Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union: A Summary From the 2013 DIA Meeting on Combination Products
This article summarizes the current status of the evolving combination product development landscape and potential options to address key challenges facing combination product developers. Continued collaboration and transparency among regulators, combination product developers, and other stakeholders is essential to streamlining the global combination product development and review process to ensure the availability of high-quality new products that are being used in a way that is safe and effective. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Tsourounis, M., Stuart, J., Smith, M., Toscani, M., Barone, J. Tags: Regulatory Science Source Type: research

A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center
Delays in trial opening should be considered critical for the sake of not only the sponsor but the patients, as they may result in inequities of care. The Asan Medical Center, in Seoul, Korea, implemented a trial activation initiative in July 2012, in an aim to expedite the trial initiation timeline. Time intervals between trial initiation steps and the rate of institutional review board (IRB) and clinical trial agreement (CTA) parallel submission were assessed. A higher rate of parallel IRB and CTA submissions was observed after initiative implementation (25.5% vs 52.3%; P < .001). Initiative applications were shown to...
Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Choi, Y. J., Jeon, H., Kim, S., In, Y., Park, S. Y., Park, M., Park, S., Lee, Y., Kim, S., Kim, K.-p., Koo, H. Y., Kim, T. W. Tags: Clinical Trials Source Type: research