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Expedition medicine

Monika Lavan, Stephen R Byrn, Gregory Knipp
Traditionally, drug discovery and development research have been primarily focused on the mitigation of disease treatment for the general adult population, often overlooking the medical needs of pediatric patients. While remarkable progress toward the discovery of better medicines has been made, the pharmacological differences between children and adults are often neglected as part of the translation process. In fact, until recently, children have been considered therapeutic orphans due to the lack of significant drug discovery, formulation development, and dosage form design specifically tailored for pediatric patients...
January 10, 2019: AAPS PharmSciTech
Jarno Hoekman, Wouter Boon
Drug regulatory agencies around the world increasingly implement expedited regulatory pathways allowing for approval of medicines that intend to address unmet medical needs based on lower evidentiary standards than would be conventionally required. Few studies have investigated how companies and regulators utilise these pathways. We therefore conducted a longitudinal analysis of the emergence and implementation of the conditional marketing authorisation (CMA) instrument in the European Union. Drawing on archival documents, procedural data and interviews, we show that there was substantial ambiguity among regulators and companies about how to strike a new balance between evidentiary requirements and patient needs...
December 19, 2018: Social Science & Medicine
Zihai Li, Wenru Song, Mark Rubinstein, Delong Liu
The immune system is the hard-wired host defense mechanism against pathogens as well as cancer. Five years ago, we pondered the question if the era of cancer immunotherapy was upon us (Li et al., Exp Hem Oncol 2013). Exciting progresses have been made at all fronts since then, including (1) sweeping approval of six agents by the US Food and Drug Administration (FDA) to block the PD-1/PD-L1 pathway for treatment of 13 cancer types; (2) a paradigm shifting indication of PD-1 and CTLA4 blockers for the management of a broad class of cancers with DNA mismatch repair defect, the first-ever tissue agnostic approval of cancer drugs; (3) real world practice of adoptive T cell therapy with two CD19-directed chimeric antigen receptor T cell products (CAR-T) for relapsed and/or refractory B cell malignancies including acute lymphoid leukemia and diffuse large B cell lymphoma, signaling the birth of a field now known as synthetic immunology; (4) the award of 2018 Nobel Prize in Physiology and Medicine from the Nobel Committee to Tasuku Honjo and James Allison "for their discovery of cancer medicine by inhibition of negative immune regulation" ( www...
December 21, 2018: Journal of Hematology & Oncology
Mohamad Shebley, Rajeev M Menon, John P Gibbs, Nimita Dave, Su Y Kim, Patrick J Marroum
Pediatric drug development is a challenging process due to the rarity of the population, the need to meet regulatory requirements across the globe, the associated uncertainty in extrapolating data from adults, the paucity of validated biomarkers, and the lack of systematic testing of drugs in pediatric patients. In oncology, pediatric drug development has additional challenges that have historically delayed availability of safe and effective medicines for children. In particular, the traditional approach to pediatric oncology drug development involves conducting phase 1 studies in children once the drug has been characterized and in some cases approved for use in adults...
December 18, 2018: Journal of Clinical Pharmacology
Joseph Carson, Stephanie Gottheil, Sherri Lawson, Tim Rice
BACKGROUND: Long-term care (LTC) homes expressed concern that patients had experienced medication incidents after hospital discharge as a result of poor coordination of care. OBJECTIVE: The London Transfer Project aimed to reduce LTC medication incidents by 50% within 48 hours of discharge from general medicine units at the London Health Sciences Centre. DESIGN: This quality improvement study involved 2 hospitals and 5 LTC homes in London, Ontario, Canada...
December 4, 2018: Journal of the American Medical Directors Association
Lawrence Liberti, Neil McAuslane, Pieter Stolk, Alasdair Breckenridge, Hubert Leufkens
BACKGROUND: As regulatory agencies come under increased pressure to review medicines of critical importance through efficient regulatory systems to provide equitable access, the benefits of using expedited review pathways are being explored. These facilitated regulatory pathways (FRPs) provide a variety of review strategies that can also expedite assessments. Stringent regulatory authorities (SRAs) use primary FRPs to accelerate development or to shorten review time. Some emerging national regulatory authorities can implement primary FRPs but are more likely to use secondary FRPs that rely on or recognize an SRA or reference agency decision, the World Health Organization Collaborative Prequalification of Medicines Programme, "altruistic" reviews, or collaborative work sharing...
December 6, 2018: Therapeutic Innovation & Regulatory Science
H Kim Lyerly, Jun Ren, Renzo Canetta, Gi Hyun Kim, Sumimasa Nagai, Tomohiro Yamaguchi, Ken Hatogai, Hiroshi Katayama, Silvy Da Rocha Dias, Daniel McManus, Kathy Soltys, Zhimin Yang, Olufumilayo Olopade, Nancy Goodman, Greg Reaman, Thomas Gross
Advances in genetic sequencing and other diagnostic technologies have enabled the use of precision medicine in clinical cancer care, as well as the development of novel therapies that are targeted to specific molecular drivers of cancer. Developing these new agents and making them accessible to patients requires global clinical studies and regulatory review and approval by different national regulatory agencies. Whereas these global trials present challenges for drug developers who conduct them and regulatory agencies who oversee them, they also raise practical issues about patients with low-frequency cancers who need these therapies...
December 2018: Journal of Global Oncology
Neil McAuslane, Lawrence Liberti, Patricia Connelly
There is a growing interest in aligning accelerated regulatory pathways with flexible access and reimbursement pathways to expedite the equitable availability of high-quality, safe and effective medicines that provide a value-based approach to meeting society's most important healthcare needs. The Centre for Innovation in Regulatory Science (CIRS) identified key issues regarding the confluence of regulatory and health technology assessment processes from discussions and presentations given by international regulators, health technology assessment bodies, payers, patient representatives and multinational pharmaceutical company representatives on this topic at CIRS workshops held in 2014 and 2017 that focused on the commonalties and differences across these pathways...
November 25, 2018: Clinical Pharmacology and Therapeutics
Konoutan Médard Kafoutchoni, Rodrigue Idohou, Anthony Egeru, Kolawolé Valère Salako, Clément Agbangla, Aristide Cossi Adomou, Achille Ephrem Assogbadjo
BACKGROUND: Spices have always been used for their flavor-enhancement characteristics and for their medicinal properties. In Benin, scientific research on spices is scarce, despite their importance in the local population's daily needs. This study investigated the diversity of wild spices and documented the associated traditional knowledge that can be used for their valuation, domestication, and sustainable management in the Sudano-Guinean Zone of Benin. METHODS: Data were collected during field expeditions using semi-structured interviews in ten localities across the three phytodistricts of the zone...
November 15, 2018: Journal of Ethnobiology and Ethnomedicine
Travis W Heggie, Thomas Küpper
The participation of children and adolescents in wilderness and extreme environment sports is increasing. Engaging in these activities is not without risk of injury, illness, or death. To date, there is limited research investigating pediatric and adolescent injuries in wilderness and extreme environments. With the intent of creating awareness within the sports medicine field, this review begins by examining the growth in popularity of outdoor sports in wilderness and extreme environments and the injury impact they are registering...
2018: Research in Sports Medicine
Michael S Diamond, Julie E Ledgerwood, Theodore C Pierson
Zika virus (ZIKV) emerged at a global level when it spread to the Americas and began causing congenital malformations and microcephaly in 2015. A rapid response by academia, government, public health infrastructure, and industry has enabled the expedited development and testing of a suite of vaccine platforms aiming to control and eliminate ZIKV-induced disease. Analysis of key immunization and pathogenesis studies in multiple animal models, including during pregnancy, has begun to define immune correlates of protection...
November 2, 2018: Annual Review of Medicine
V Sekhar, E Wong, H A Elhassan, N Singh
BACKGROUND: Mules and other equine species have been used in warfare for thousands of years to transport goods and supplies. Mules are known for 'braying', which is disadvantageous in warfare operations. This article explores the fascinating development of surgical techniques to stop military mules from braying, with particular emphasis on the key role played by the otolaryngologist Arthur James Moffett in devoicing the mules of the second Chindit expedition of World War II. METHOD: The PubMed database (1900-2017) and Google search engine were used to identify articles related to devoicing mules in the medical and veterinary literature, along with information and images on the Chindit expedition...
October 29, 2018: Journal of Laryngology and Otology
A Marcell Szasz, Johan Malm, Melinda Rezeli, Yutaka Sugihara, Lazaro H Betancourt, Daniel Rivas, Balázs Gyorffy, György Marko-Varga
There is an increasing global interest to support research areas that can assist in understanding disease and improving patient care. The National Cancer Institute (NIH) has identified precision medicine-based approaches as key research strategies to expedite advances in cancer research. The Cancer Moonshot program ( ) is the largest cancer program of all time, and has been launched to accelerate cancer research that aims to increase the availability of therapies to more patients and, ultimately, to eradicate cancer...
October 24, 2018: Cell Biology and Toxicology
Yuan Jiang, Long Yan, Longkuo Xia, Xiaoyin Lu, Wenliang Zhu, Dewen Ding, Mingxia Du, Da Zhang, Hongmei Wang, Baoyang Hu
Human pluripotent stem cells hold great promise for improving regenerative medicine. However, a risk for tumor formation and difficulties in generating large amounts of subtype derivatives remain the major obstacles for clinical applications of stem cells. Here, we discovered that zinc finger E-box-binding homeobox 1 (ZEB1) is highly expressed upon differentiation of human embryonic stem cells (hESCs) into neuronal precursors. CRISPR/Cas9-mediated ZEB1 depletion did not impede neural fate commitment, but  prevented hESCs-derived neural precursors from differentiating into neurons, indicating that ZEB1 is required for neuronal differentiation...
October 18, 2018: Journal of Biological Chemistry
Su-Han Chang, Chiao-Hsuan Hsieh, Yi-Ming Weng, Ming-Shun Hsieh, Zhong Ning Leonard Goh, Hsien-Yi Chen, Tung Chang, Chip-Jin Ng, Joanna Chen-Yeen Seak, Chen-Ken Seak, Chen-June Seak
Background: Renal abscess is a relatively uncommon yet debilitating and potentially fatal disease. There is no clearly defined, objective risk stratification tool available for emergency physicians' and surgeons' use in the emergency department (ED) to quickly determine the appropriate management strategy for these patients, despite early intervention having a beneficial impact on survival outcomes. Objective: This case control study evaluates the performance of Mortality in Emergency Department Sepsis Score (MEDS), Modified Early Warning Score (MEWS), Rapid Emergency Medicine Score (REMS), and Rapid Acute Physiology Score (RAPS) in predicting risk of mortality in ED adult patients with renal abscess...
2018: BioMed Research International
Michael L Gross
Military medical research requires informed consent from test subjects, which is difficult to obtain for deployed (in-theatre) or prehospital studies where patients are incapacitated and legal representatives are not available. Although US and UK regulations make provisions for exceptions to informed consent, these are rarely used, thereby hindering trauma research and prospective experimental studies of new devices, surgeries or drugs. In their place, a survey of research articles published in the Journal of the Royal Army Medical Corps and Military Medicine between 2004 and 2018 shows how researchers turned to clinical surveys and retrospective, case or animal studies instead...
October 15, 2018: Journal of the Royal Army Medical Corps
Vicki Hunt, Dave Anderson, Richard Lowrie, Colette Montgomery Sardar, Susan Ballantyne, Graeme Bryson, John Kyle, Peter Hanlon
UK, home-based patients with COPD receive specialist care from respiratory physicians, nurses, and general practitioners (GPs), but increasing complexity of therapeutic options and a GP/Nurse workforce crisis suggests merit in testing the role of home visits by a clinical pharmacist. We conducted a non-randomised intervention study with a contemporaneous comparator group, in Glasgow (Scotland). A clinical pharmacist (working closely with a consultant respiratory physician) visited patients with COPD living at home, assessing respiratory and other co-morbid conditions, and medicines then, with patient approval, agreed treatment modifications with a consultant physician...
October 10, 2018: NPJ Primary Care Respiratory Medicine
Hafiz M N Iqbal
In recent years, the Antimicrobial Resistance (AMR) or Multidrug Resistance (MDR) and viral infections have become serious health issues, globally. Finally, after decades of negligence, the AMR/MDR and viral infection issues have now captured a worldwide attention of the global leaders, public health community, legalization authorities, academia, research-based organizations, and medicinal sector of the modern world, alike. Aiming to resolve these issues, various methodological approaches have been exploited, in the past several years...
2018: Open Virology Journal
Fengyun Vicky Han, Karen Weiss
The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulations, often driven by the local economy and market dynamics, exist, the overall trend in the AP region is toward international harmonization and global convergence. More markets are now participating in the International Council on Harmonization (ICH), and there is growing interest in identifying and incorporating best practices from competent regulatory agencies...
September 24, 2018: Therapeutic Innovation & Regulatory Science
Lauren R Frank, Patrick F P Roynard
The increase in client willingness to pursue surgical procedures, the heightened perceived value of veterinary patients, and the desire to provide comprehensive medical care have driven the recent demand of using an integrative treatment approach in veterinary rehabilitation. Physical therapy following neurologic injury has been the standard of care in human medicine for decades, whereas similar rehabilitation techniques have only recently been adapted and utilized in veterinary medicine. Spinal cord injury is the most common neurologic disease currently addressed by veterinary rehabilitation specialists and will be the primary focus of this review; however, research in other neurologic conditions will also be discussed...
June 2018: Topics in Companion Animal Medicine
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