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https://www.readbyqxmd.com/read/29145936/biosimilars-state-of-clinical-and-regulatory-science
#1
Agnes Victoria Klein, Jian Wang, Brian G Feagan, Mark Omoto
On May 12, 2017, various issues and challenges associated with biologics were discussed during a session of the annual joint conference of Canadian Society for Pharmaceutical Sciences and Canadian Chapter of Controlled Release Society at Hyatt Regency Hotel, Montréal, QC, Canada.  An update on the Canadian regulatory guidelines for biosimilars was given, followed by viewpoints expressed by regulatory, academic and industry scientists.  Topics of discussion included: reference biologic drug, clinical considerations, immunogenicity, extrapolation and clarification of terminology, product monograph, international collaboration, switching and interchangeability, naming conventions, clinical and non-clinical evaluation, authorization of indications, statistical equivalence, the nor-switch study and biologics marketplace...
2017: Journal of Pharmacy & Pharmaceutical Sciences: a Publication of the Canadian Society for Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29143971/industry-perspective-on-biomarker-development-and-qualification
#2
Cory V Gerlach, Mazin Derzi, Shashi K Ramaiah, Vishal S Vaidya
Pharmaceutical and biotechnology companies routinely use biomarkers to obtain quantitative metrics for drug exposure, efficacy, and safety and to inform clinical trial design with regard to patient selection, treatments, and outcomes. Biomarker science has the unique capability to catalyze precompetitive collaborations between academia, industry, regulatory agencies, and other stakeholders with the ultimate goal of accelerating the delivery of safe and effective medicines to patients, particularly in areas of high unmet need...
November 16, 2017: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/29132120/rna-based-dynamic-genetic-controllers-development-strategies-and-applications
#3
REVIEW
Sungho Jang, Sungyeon Jang, Jina Yang, Sang Woo Seo, Gyoo Yeol Jung
Dynamic regulation of gene expression in response to various molecules is crucial for both basic science and practical applications. RNA is considered an attractive material for creating dynamic genetic controllers because of its specific binding to ligands, structural flexibility, programmability, and small size. Here, we review recent advances in strategies for developing RNA-based dynamic controllers and applications. First, we describe studies that re-engineered natural riboswitches to generate new dynamic controllers...
November 10, 2017: Current Opinion in Biotechnology
https://www.readbyqxmd.com/read/29130838/the-psychology-of-rituals-an-integrative-review-and-process-based-framework
#4
Nicholas M Hobson, Juliana Schroeder, Jane L Risen, Dimitris Xygalatas, Michael Inzlicht
Traditionally, ritual has been studied from broad sociocultural perspectives, with little consideration of the psychological processes at play. Recently, however, psychologists have begun turning their attention to the study of ritual, uncovering the causal mechanisms driving this universal aspect of human behavior. With growing interest in the psychology of ritual, this article provides an organizing framework to understand recent empirical work from social psychology, cognitive science, anthropology, behavioral economics, and neuroscience...
November 1, 2017: Personality and Social Psychology Review
https://www.readbyqxmd.com/read/29126988/morinda-officinalis-how-a-comprehensive-review-of-traditional-uses-phytochemistry-and-pharmacology
#5
REVIEW
Jian-Hua Zhang, Hai-Liang Xin, Yue-Ming Xu, Yi Shen, Yu-Qiong He, Hsien-Yeh, Bing Lin, Hong-Tao Song, Juan-Liu, Hai-Yue Yang, Lu-Ping Qin, Qiao-Yan Zhang, Juan Du
ETHNOPHARMACOLOGICAL RELEVANCE: The medicinal plant Morinda officinalisHow. (MO) and its root have long been used in traditional medicines in China and northeast Asia as tonics for nourishing the kidney, strengthening the bone and enhancing immunofunction in the treatment of impotence, osteoporosis, depression and inflammatory diseases such as rheumatoid arthritis and dermatitis. AIM OF THE REVIEW: This review aims to sum up updated and comprehensive information about traditional usage, phytochemistry, pharmacology and toxicology of MO and provide insights intopotential opportunities for future research and development of this plant...
November 7, 2017: Journal of Ethnopharmacology
https://www.readbyqxmd.com/read/29124666/study-design-and-evaluation-of-risk-minimization-measures-a-review-of-studies-submitted-to-the-european-medicines-agency-for-cardiovascular-endocrinology-and-metabolic-drugs
#6
Giampiero Mazzaglia, Sabine M J Straus, Peter Arlett, Daniela da Silva, Heidi Janssen, June Raine, Enrica Alteri
INTRODUCTION: Studies measuring the effectiveness of risk minimization measures (RMMs) submitted by pharmaceutical companies to the European Medicines Agency are part of the post-authorization regulatory requirements and represent an important source of data covering a range of medicinal products and safety-related issues. Their objectives, design, and the associated regulatory outcomes were reviewed, and conclusions were drawn that may support future progress in risk minimization evaluation...
November 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29124112/concise-informed-consent-to-increase-data-and-biospecimen-access-may-accelerate-innovative-alzheimer-s-disease-treatments
#7
REVIEW
Ann M Hake, Penny A Dacks, Stephen P Arnerić
Introduction: Informed consent forms that restrict the distribution of data and samples have been an impediment to advancing Alzheimer's disease (AD) understandings and treatments. The Coalition Against Major Disease public-private partnership developed concise addenda to responsibly broaden data access of informed consent forms. Methods: Coalition Against Major Disease members identified key elements for ensuring data and biospecimen access, and patient privacy protection according to applicable US law...
November 2017: Alzheimer's & Dementia: Translational Research & Clinical Interventions
https://www.readbyqxmd.com/read/29118898/power-to-the-people-data-citizens-in-the-age-of-precision-medicine
#8
Barbara J Evans
Twentieth-century bioethics celebrated individual autonomy but framed autonomy largely in terms of an individual's power to make decisions and act alone. The most pressing challenges of big data science in the twenty-first century can only be resolved through collective action and common purpose. This Article surveys some of these challenges and asks how common purpose can ever emerge on the present bioethical and regulatory landscape. The solution may lie in embracing a broader concept of autonomy that empowers individuals to protect their interests by exercising meaningful rights of data citizenship...
2017: Vanderbilt J Entertain Technol Law
https://www.readbyqxmd.com/read/29117388/neurofibromatosis-type-1-associated-mpnst-state-of-the-science-outlining-a-research-agenda-for-the-future
#9
Karlyne M Reilly, AeRang Kim, Jaishri Blakely, Rosalie E Ferner, David H Gutmann, Eric Legius, Markku M Miettinen, R Lor Randall, Nancy Ratner, N L Jumbé, Annette Bakker, David Viskochil, Brigitte C Widemann, Douglas R Stewart
Malignant peripheral nerve sheath tumor (MPNST) is an aggressive soft tissue sarcoma for which the only effective therapy is surgery. In 2016, an international meeting entitled "MPNST State of the Science: Outlining a Research Agenda for the Future" was convened to establish short- and long-term research priorities. Key recommendations included the: 1) development of standardized, cost-efficient fluorodeoxyglucose positron emission tomography and whole-body magnetic resonance imaging guidelines to evaluate masses concerning for MPNST; 2) development of better understanding and histologic criteria for the transformation of a plexiform neurofibroma to MPNST; 3) establishment of a centralized database to collect genetic, genomic, histologic, immunohistochemical, molecular, radiographic, treatment, and related clinical data from MPNST subspecialty centers in a standardized manner; 4) creation of accurate mouse models to study the plexiform neurofibroma-to-MPNST transition, MPNST metastasis, and drug resistance; 5) use of trial designs that minimize regulatory requirements, maximize availability to patients, consider novel secondary end points, and study patients with newly diagnosed disease...
August 1, 2017: Journal of the National Cancer Institute
https://www.readbyqxmd.com/read/29113941/human-relevance-of-rodent-liver-tumors-key-insights-from-a-toxicology-forum-workshop-on-nongenotoxic-modes-of-action
#10
Susan P Felter, Jennifer E Foreman, Alan Boobis, J Christopher Corton, Adriana M Doi, Lynn Flowers, Jay Goodman, Lynne T Haber, Abigail Jacobs, James E Klaunig, Angela M Lynch, Jonathan Moggs, Arun Pandiri
The Toxicology Forum sponsored a workshop in October 2016, on the human relevance of rodent liver tumors occurring via nongenotoxic modes of action (MOAs). The workshop focused on two nuclear receptor-mediated MOAs (Constitutive Androstane Receptor (CAR) and Peroxisome Proliferator Activated Receptor-alpha (PPARα), and on cytotoxicity. The goal of the meeting was to review the state of the science to (1) identify areas of consensus and differences, data gaps and research needs; (2) identify reasons for inconsistencies in current regulatory positions; and (3) consider what data are needed to demonstrate a specific MOA, and when additional research is needed to rule out alternative possibilities...
November 4, 2017: Regulatory Toxicology and Pharmacology: RTP
https://www.readbyqxmd.com/read/29112454/training-and-good-science-are-the-foundation-stones-for-animal-replacement
#11
REVIEW
Kelly S Davidge, J Malcolm Wilkinson
Good science, the training of energetic and enthusiastic young researchers, and the experience of industry veterans, will all be needed to drive the implementation and regulatory approval of animal replacement methods in industry.
November 2017: Alternatives to Laboratory Animals: ATLA
https://www.readbyqxmd.com/read/29108136/application-and-optimisation-of-the-comparison-on-extreme-laboratory-tests-cert-algorithm-for-detection-of-adverse-drug-reactions-transferability-across-national-boundaries
#12
Mun Yee Tham, Qing Ye, Pei San Ang, Liza Y Fan, Dukyong Yoon, Rae Woong Park, Zheng Jye Ling, James W Yip, Bee Choo Tai, Stephen Jw Evans, Cynthia Sung
PURPOSE: The Singapore regulatory agency for health products (Health Sciences Authority), in performing active surveillance of medicines and their potential harms, is open to new methods to achieve this goal. Laboratory tests are a potential source of data for this purpose. We have examined the performance of the Comparison on Extreme Laboratory Tests (CERT) algorithm, developed by Ajou University, Korea, as a potential tool for adverse drug reaction detection based on the electronic medical records of the Singapore health care system...
November 6, 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29105511/the-fda-oncology-center-of-excellence-and-precision-medicine
#13
Kirsten B Goldberg, Gideon M Blumenthal, Amy E McKee, Richard Pazdur
In January 2017, the U.S. Food and Drug Administration (FDA) formally established the Oncology Center of Excellence (OCE) to streamline the development of cancer therapies by uniting experts from FDA product centers to conduct expedited review of drugs, biologics, and devices. In May 2017, the FDA approved a cancer treatment based on a biomarker, without regard to the tumor's site, by granting accelerated approval to pembrolizumab for patients with solid tumors that have the microsatellite instability-high or mismatch repair deficient biomarker...
January 1, 2017: Experimental Biology and Medicine
https://www.readbyqxmd.com/read/29103811/crispr-cas9-based-plant-genome-editing-significance-opportunities-and-recent-advances
#14
Neelam Soda, Lokesh Verma, Jitender Giri
Precise genome editing is a quantum leap in the field of plant sciences. Clustered regularly interspaced short palindromic repeats (CRISPR) and its associated Cas9 protein have emerged as a powerful tool for precise genome editing. CRISPR-Cas9 system introduces small heritable mutations (indels) in the genome of an organism. This system also enables precise gene characterization in plants with complex genomes. Besides, it offers new opportunities of trait stacking, where addition of desirable traits or removal of undesirable traits can be achieved simultaneously in a single event...
October 27, 2017: Plant Physiology and Biochemistry: PPB
https://www.readbyqxmd.com/read/29081302/the-3rs-in-research-a-contemporary-approach-to-replacement-reduction-and-refinement
#15
Judy MacArthur Clark
First promulgated in 1959, the 3Rs of Replacement, Reduction and Refinement have evolved as fundamental principles underlying the use of animals and alternatives in science throughout the modern world. This review describes a contemporary approach to delivering the 3Rs through acknowledging the contribution of new technologies and emphasising that applying the 3Rs can be beneficial to good science as well as to animal welfare. This science-led approach moves the concept of the 3Rs out of an ethical silo where they were often considered by scientists to be an inconvenient obligation...
October 30, 2017: British Journal of Nutrition
https://www.readbyqxmd.com/read/29074231/the-engage-study-integrating-neuroimaging-virtual-reality-and-smartphone-sensing-to-understand-self-regulation-for-managing-depression-and-obesity-in-a-precision-medicine-model
#16
Leanne M Williams, Adam Pines, Andrea N Goldstein-Piekarski, Lisa G Rosas, Monica Kullar, Matthew D Sacchet, Olivier Gevaert, Jeremy Bailenson, Philip W Lavori, Paul Dagum, Brian Wandell, Carlos Correa, Walter Greenleaf, Trisha Suppes, L Michael Perry, Joshua M Smyth, Megan A Lewis, Elizabeth M Venditti, Mark Snowden, Janine M Simmons, Jun Ma
Precision medicine models for personalizing achieving sustained behavior change are largely outside of current clinical practice. Yet, changing self-regulatory behaviors is fundamental to the self-management of complex lifestyle-related chronic conditions such as depression and obesity - two top contributors to the global burden of disease and disability. To optimize treatments and address these burdens, behavior change and self-regulation must be better understood in relation to their neurobiological underpinnings...
October 7, 2017: Behaviour Research and Therapy
https://www.readbyqxmd.com/read/29069173/solidarity-an-innovative-perspective-in-the-management-and-organization-of-sanitary-surveillance-actions
#17
Cristian Oliveira Benevides Sanches Leal, Carmen Fontes de Souza Teixeira
This is a theoretical essay about the development of the concept of solidarity, a word used in the regulatory framework and in political proposals to reorient the Brazilian Unified Health System (SUS). The methodology consisted of mapping authors addressing human action aspects related to this theme from Durkheim's tradition, linking them to his followers, like Marcel Mauss and authors from the "anti-utilitarianism" movement in social sciences. Solidarity is one way to express a "gift" and appears as a multidimensional action, where duty and freedom, instrumental interest and disinterest interpose and interlace...
October 2017: Ciência & Saúde Coletiva
https://www.readbyqxmd.com/read/29068816/concerns-and-responses-for-integrating-health-systems-science-into-medical-education
#18
Jed D Gonzalo, Kelly J Caverzagie, Richard E Hawkins, Luan Lawson, Daniel R Wolpaw, Anna Chang
With the aim of improving the health of individuals and populations, medical schools are transforming curricula to ensure physician competence encompasses health systems science (HSS), which includes population health, health policy, high-value care, interprofessional teamwork, leadership, quality improvement, and patient safety. Large-scale, meaningful integration remains limited, however, and a major challenge in HSS curricular transformation efforts relates to the receptivity and engagement of students, educators, clinicians, scientists, and health system leaders...
October 24, 2017: Academic Medicine: Journal of the Association of American Medical Colleges
https://www.readbyqxmd.com/read/29065200/basic-science-and-public-policy-informed-regulation-for-nicotine-and-tobacco-products
#19
Christie D Fowler, Cassandra D Gipson, Bethea A Kleykamp, Laura E Rupprecht, Paul T Harrell, Vaughan W Rees, Thomas J Gould, Jason Oliver, Deniz Bagdas, M Imad Damaj, Heath D Schmidt, Alexander Duncan, Mariella De Biasi
Introduction: Scientific discoveries over the past few decades have provided significant insight into the abuse liability and negative health consequences associated with tobacco and nicotine-containing products. While many of these advances have led to the development of policies and laws that regulate access to and formulations of these products, further research is critical to guide future regulatory efforts, especially as novel nicotine-containing products are introduced and selectively marketed to vulnerable populations...
August 3, 2017: Nicotine & Tobacco Research: Official Journal of the Society for Research on Nicotine and Tobacco
https://www.readbyqxmd.com/read/29062539/patient-organization-involvement-and-the-challenge-of-securing-access-to-treatments-for-rare-diseases-report-of-a-policy-engagement-workshop
#20
Koichi Mikami, Steve Sturdy
PLAIN ENGLISH SUMMARY: Patients with rare diseases often help to develop new treatments for their conditions. But once developed, those treatments are sometimes priced too high for many patients to access them. We became aware that this is a problem in the course of a social science research project that examines the place of rare diseases in health policy. We therefore organized a two-day workshop to try and understand why this problem occurs and what might be done about it. The people who participated in our workshop were: representatives of rare disease patient organizations, experts in matters of drug regulation and assessment of new health technologies, consultants involved with companies producing treatments for rare diseases, and social scientists researching related issues...
2017: Res Involv Engagem
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