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Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan
Conclusions: To adequately design a multi-arm clinical trial, it is important within sample size calculation to consider whether to perform multiplicity adjustment, select MCPs, and define their power. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Sakamaki, K., Kamiura, T., Morita, Y., Iba, K., Yoshida, S., Wakana, A., Tsuchiya, S., Fukimbara, S., Suganami, H. Tags: Statistics Source Type: research

The PharmD/MD Dual-Degree Program and Its Potential Value in the Pharmaceutical Industry
The first dual-degree program combining both the doctor of pharmacy (PharmD) and the doctor of medicine (MD) degrees was designed and launched by Rutgers, The State University of New Jersey, in academic year 2013-2014. This joint effort was led by the Ernest Mario School of Pharmacy (EMSOP) and the Robert Wood Johnson Medical School (RWJMS) to combine expertise in both diagnostic and treatment facets of health care and to prepare graduates for leadership roles in providing and managing comprehensive patient care in a variety of settings. One area of potential value of these skill sets is the drug development industry. A su...
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Shah, K. S., Marwah, U., Bundra, K., Goldin, C. S., Toscani, M., Barone, J. A., Colaizzi, J. L. Tags: Policy Source Type: research

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data
We describe a collaborative process and provide free software for eliciting the required prior information and calibrating operating characteristics through simulation. We illustrate the use of our procedure with a case study composed of a combination of real and simulated data. Our procedure provides good operating characteristics for detecting higher than expected rates of adverse events in the drug treatment group, and is appropriate for inferring the rate of adverse events in multi-armed clinical trials with blinded data. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Schnell, P. M., Ball, G. Tags: Product Safety Source Type: research

Postmarketing Benefit-Risk Assessment for Erythropoiesis-Stimulating Agents Using a Health Care Database
Conclusions: B-R assessment can be performed using the BRAT framework with a health care database, but limitations exist when using a single data source. Care should be taken when selecting data for extraction and defining outcomes of interest. Further research is necessary to facilitate practical application of this approach. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Sugitani, Y., Udagawa, Y., Matsuda, S., Yamada, K., Miyawaki, N., Konishi, I. Tags: Product Safety Source Type: research

Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development
Conclusions: If assumptions regarding a pediatric disease process, such as KD, do not include age stratification with inclusion or response, then the wrong decision could result with regard to age-appropriateness or approval of a drug. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: McMahon, A. W., Watt, K., Wang, J., Green, D., Tiwari, R., Burckart, G. J. Tags: Special Populations Source Type: research

Can Registration Procedures of Pharmaceuticals Inadvertently Contribute to Off-Label Prescribing in Children?
Conclusions: Off-label prescribing does not necessarily mean that efficacy and safety data are unavailable. Variances in the product literature of medicines having the same active ingredients but imported from different countries may cause divergent prescribing practices, leading to inadvertent off-label use. The various stakeholders, including member states such as Malta, should devise strategies to harmonize the most recent labeling information in order to support the safe and effective use of pediatric medicines, thereby decreasing off-label use. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Ellul, I., Grech, V., Attard-Montalto, S. Tags: Special Populations Source Type: research

Pharmaceutical Organizational Size and Phase 3 Clinical Trial Completion Times
Conclusions: Recent years have witnessed increasingly larger pharmaceutical R&D organizations, as many companies have worked to achieve the scale benefits of organizational size for R&D as well as commercial activity. Larger pharmaceutical companies may still achieve scale benefits. Faster phase 3 study completion times is not one of them. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Glass, H. E., Glass, L. M., Tran, P., Alghamdi, H. Tags: Clinical Trials Source Type: research

A Toolkit for the Management of Protocol Deviations
Conclusions: This article expands on the position paper to include concrete tools for the management of protocol deviations, including best practices for detection, classification, mitigation, and management of protocol deviations with a goal to reduce the impact on subject safety and data integrity. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Mohan, S., Mehra, M., Petrizzo, M., Katz, T. Tags: Clinical Trials Source Type: research

Novel Gastroretentive Controlled Release Formulations for Once-Daily Administration: Assessment of Clinical Feasibility and Formulation Concept for Raltegravir
Conclusions: The findings from these studies offer valuable insights into modifying the absorption of candidate drugs with limiting colonic permeability and solubility characteristics and the interplay between meal, dose timing, and GR formulation performance. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Krishna, R., Rizk, M. L., Larson, P. J., Schulz, V., Friedman, E., Gupta, P., Kesisoglou, F., Connor, A., McDermott, J., Smith, R., Evans, P. Tags: Product Development and Innovation Source Type: research

Drug Target Identification and Validation: Global Pharmaceutical Industry Experts on Challenges, Best Strategies, Innovative Precompetitive Collaboration Concepts, and Future Areas of Industry Precompetitive Research and Development
Focused interviews were conducted with global pharmaceutical company representatives in order to derive a consistent view on drug target identification/validation challenges, collaborative strategies, and future developments in a precompetitive space. Analysis revealed translation into clinical utility as a major hurdle of novel drug target validation, originating from lack of biological understanding, irreproducibility of published results, and lack of valid animal models. Direct and close collaborations with academia are the preferred model to tackle basic research on novel drug targets in high-risk projects. Efforts to ...
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Bergauer, T., Ruppert, T., Essioux, L., Spleiss, O. Tags: Product Development and Innovation Source Type: research

Public- and Private-Sector Contributions to the Research and Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy
Conclusions: Our analysis indicates that industry’s contributions to the R&D of innovative drugs go beyond development and marketing and include basic and applied science, discovery technologies, and manufacturing protocols, and that without private investment in the applied sciences there would be no return on public investment in basic science. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Chakravarthy, R., Cotter, K., DiMasi, J., Milne, C.-P., Wendel, N. Tags: Product Development and Innovation Source Type: research

Evaluating the Effectiveness of Repricing for Market Expansion in the Japanese Drug Pricing System
Conclusions: On the basis of these results, we propose that the current repricing system be replaced with one using a market mechanism that can evaluate the value of drugs from an economic perspective and help improving the financial performance of the national health insurance system. We also suggest that the number of generic medications on the market in Japan be increased to a ratio equivalent to those of the US and EU. We hope that the perspectives on Japan’s unique drug pricing system obtained from this article are utilized by pharmaceutical companies in developing their businesses in Japan. (Source: Therapeutic...
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Shibata, S., Uemura, R., Suzuki, T. Tags: Global Perspectives Source Type: research

Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression
Conclusions: Appropriate doses of drugs for older patients may differ from approved doses in certain diseases. Complex situations such as a lot of polypharmacy, comorbidity, and functional impairment in older patients in clinical practice make it difficult to evaluate safety based on data from clinical trials. In the future, utilization of a database created from the EMR of older patients should be considered for assessment of drug safety in older patients in clinical practice. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Tanemura, N., Uyama, Y., Nagashima, K., Suzuki, T., Asahina, Y., Kobayashi, Y., Iyo, M., Yokote, K., Hanaoka, H. Tags: Global Perspectives Source Type: research

An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency
Conclusions: Results suggest there is no clear evidence that Swissmedic was substantially different in its initial regulatory decisions or SPC recommendations compared with the EMA or FDA. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Dörr, P., Wadworth, A., Wang, T., McAuslane, N., Liberti, L. Tags: Global Perspectives Source Type: research

Prospects for Harmonizing Regulatory Science Programs in Europe, Japan, and the United States to Advance Regenerative Medicine
Conclusions: Just as consistent and predictable regulatory support founded on common principles in regulatory science provide the confidence and certainty required to bolster investment in regenerative medicine, harmonization is essential to building that framework on a global scale. (Source: Therapeutic Innovation and Regulatory Science)
Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: Milne, C.-P., Mittra, J., Kojima, N., Sugiyama, D., Awatin, J., Simmons, G. Tags: Global Perspectives Source Type: research