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https://read.qxmd.com/read/30865569/establishing-and-maintaining-a-robust-sample-management-system
#1
William Janzen, Elizabeth Admirand, Jeffery Andrews, Matthew Boeckeler, Chatura Jayakody, Christina Majer, Garima Porwal, Surayya Sana, Samantha Unkuri, Andy Zaayenga
This paper has been written by the SLAS Sample Management Special Interest Group to serve as a guide to the best practices and methods in establishing and maintaining a high-quality sample management system. The topics covered are applicable to sample types ranging from small molecules to biologics to tissue samples. It has been put together using the collective experience of the authors in start-up companies, small pharma, agricultural research, IT, academia, biorepositories, and large pharma companies. Our hope is that sharing our experience will streamline the process of setting up a new sample management system and help others avoid some of the problems that we have encountered...
March 13, 2019: SLAS Technology
https://read.qxmd.com/read/30798772/the-emerging-world-of-tcr-t-cell-trials-against-cancer-a-systematic-review
#2
Jianxiang Zhang, Lingyu Wang
T-cell receptor-engineered T-cell therapy and chimeric antigen receptor T-cell therapy are 2 types of adoptive T-cell therapy that genetically modify natural T cells to treat cancers. Although chimeric antigen receptor T-cell therapy has yielded remarkable efficacy for hematological malignancies of the B-cell lineages, most solid tumors fail to respond significantly to chimeric antigen receptor T cells. T-cell receptor-engineered T-cell therapy, on the other hand, has shown unprecedented promise in treating solid tumors and has attracted growing interest...
January 1, 2019: Technology in Cancer Research & Treatment
https://read.qxmd.com/read/30770390/johnson-and-johnson-will-be-first-us-pharma-company-to-reveal-a-drug-s-price-in-tv-advertisement
#3
Owen Dyer
No abstract text is available yet for this article.
February 15, 2019: BMJ: British Medical Journal
https://read.qxmd.com/read/30770294/patient-reported-outcomes-following-enzalutamide-or-placebo-in-men-with-non-metastatic-castration-resistant-prostate-cancer-prosper-a-multicentre-randomised-double-blind-phase-3-trial
#4
Bertrand Tombal, Fred Saad, David Penson, Maha Hussain, Cora N Sternberg, Robert Morlock, Krishnan Ramaswamy, Cristina Ivanescu, Gerhardt Attard
BACKGROUND: In the PROSPER trial, enzalutamide significantly improved metastasis-free survival in patients with non-metastatic, castration-resistant prostate cancer. Here, we report the results of patient-reported outcomes of this study. METHODS: In the randomised, double-blind, placebo-controlled, phase 3 PROSPER trial, done at 254 study sites worldwide, patients aged 18 years or older with non-metastatic, castration-resistant prostate cancer and a prostate-specific antigen doubling time of up to 10 months were randomly assigned (2:1) via an interactive voice web recognition system to receive oral enzalutamide (160 mg per day) or placebo...
February 12, 2019: Lancet Oncology
https://read.qxmd.com/read/30709633/disease-free-survival-as-a-surrogate-for-overall-survival-in-patients-with-her2-positive-early-breast-cancer-in-trials-of-adjuvant-trastuzumab-for-up-to-1-year-a-systematic-review-and-meta-analysis
#5
Everardo D Saad, Pierre Squifflet, Tomasz Burzykowski, Emmanuel Quinaux, Suzette Delaloge, Dimitris Mavroudis, Edith Perez, Martine Piccart-Gebhart, Bryan P Schneider, Dennis Slamon, Norman Wolmark, Marc Buyse
BACKGROUND: Although frequently used as a primary endpoint, disease-free survival has not been validated as a surrogate for overall survival in early breast cancer. We investigated this surrogacy in the adjuvant setting of treatment with anti-HER2 antibodies. METHODS: In a systematic review and meta-analysis, we identified published and non-published randomised controlled trials with completed accrual and available disease-free survival and overall survival results for the intention-to-treat population as of September 2016...
January 29, 2019: Lancet Oncology
https://read.qxmd.com/read/30700441/experts-question-recent-pharma-acquisitions
#6
(no author information available yet)
Bristol-Myers Squibb recently purchased Celgene, and Eli Lilly bought Loxo Oncology. These acquisitions probably don't indicate a shift in the types of cancer drugs companies plan to develop, but experts doubt that they will prove profitable and expect that higher drug prices will result, at least in the short term.
January 30, 2019: Cancer Discovery
https://read.qxmd.com/read/30698321/new-clinical-trial-designs-in-the-era-of-precision-medicine
#7
REVIEW
Elena Garralda, Rodrigo Dienstmann, Alex Piris, Irene Braña, Jordi Rodon, Josep Tabernero
Cancer treatment has made significant strides towards the promise of personalized medicine. Recent scientific advances have shown that there are numerous genetic deregulations that are common in multiple cancer types, raising the possibility of developing drugs targeting those deregulations irrespective of the tumour type. Precision cancer medicine was born out of accumulated evidence matching targeted agents with these tumour molecular deregulations. At the same time, the therapeutic armamentarium is rapidly increasing and the number of new drugs (including immune-oncology agents) entering drug development continues to rise...
January 30, 2019: Molecular Oncology
https://read.qxmd.com/read/30693792/standardized-scalable-and-timely-flexible-aav-vector-production-using-frozen-high-density-hek-293-cell-stocks-and-celldiscs
#8
Benjamin Strobel, Kai Zuckschwerdt, Gudrun Zimmermann, Christine Mayer, Ruth Eytner, Philipp Rechtsteiner, Sebastian Kreuz, Thorsten Lamla
Adeno-associated virus (AAV) vectors currently represent the most attractive platform for viral gene therapy and are also valuable research tools to study gene function or establish disease models. Consequently, many academic labs, core facilities and biotech/pharma companies meanwhile produce AAVs for research and early clinical development. Whereas fast, universal protocols for vector purification (downstream processing) are available, AAV production using adherent HEK-293 cells still requires time-consuming passaging and extensive culture expansion before transfection...
January 29, 2019: Human Gene Therapy Methods
https://read.qxmd.com/read/30664998/the-innovation-ecosystem-an-analysis-of-a-decade-of-approved-and-failed-drugs
#9
REVIEW
Xiong Liu, Craig E Thomas, Christian C Felder
Pharmaceutical companies are relying more often on external sources of innovation to boost their discovery research productivity. However, more in-depth knowledge about how external innovation may translate to successful product launches is still required in order to better understand how to best leverage the innovation ecosystem. We analyzed the pre-approval publication histories for FDA-approved new molecular entities (NMEs) and new biologic entities (NBEs) launched by 13 top research pharma companies during the last decade (2006-2016)...
January 18, 2019: International Journal of Pharmaceutics
https://read.qxmd.com/read/30465228/dinutuximab-beta-for-treating-neuroblastoma-an-evidence-review-group-and-decision-support-unit-perspective-of-a-nice-single-technology-appraisal
#10
REVIEW
Becky Pennington, Shije Ren, Samantha Barton, Mariana Bacelar, Steven J Edwards
As part of its Single Technology Appraisal (STA) process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer (EUSA Pharma) of dinutuximab beta (Qarziba® ) to submit evidence of its clinical and cost effectiveness for treating neuroblastoma. The BMJ Technology Assessment Group (BMJ-TAG) was commissioned to act as the Evidence Review Group (ERG), reviewing the submission from the company. The Decision Support Unit (DSU) was commissioned to review additional evidence submitted by the company and to undertake further analyses...
November 22, 2018: PharmacoEconomics
https://read.qxmd.com/read/30450224/predictive-factors-for-hyperglycaemic-progression-in-patients-with-schizophrenia-or-bipolar-disorder
#11
Ichiro Kusumi, Yuki Arai, Ryo Okubo, Minoru Honda, Yasuhiro Matsuda, Yukihiko Matsuda, Akihiko Tochigi, Yoshiteru Takekita, Hiroyoshi Yamanaka, Keiichi Uemura, Koichi Ito, Kiyoshi Tsuchiya, Jun Yamada, Bunta Yoshimura, Nobuyuki Mitsui, Sigehiro Matsubara, Takayuki Segawa, Nobuyuki Nishi, Yasufumi Sugawara, Yuki Kako, Ikuta Shinkawa, Kaoru Shinohara, Akiko Konishi, Junichi Iga, Naoki Hashimoto, Shinsaku Inomata, Noriko Tsukamoto, Hiroto Ito, Yoichi M Ito, Norihiro Sato
Background: Patients with schizophrenia or bipolar disorder have a high risk of developing type 2 diabetes. Aims: To identify predictive factors for hyperglycaemic progression in individuals with schizophrenia or bipolar disorder and to determine whether hyperglycaemic progression rates differ among antipsychotics in regular clinical practice. Method: We recruited 1166 patients who initially had normal or prediabetic glucose levels for a nationwide, multisite, l-year prospective cohort study to determine predictive factors for hyperglycaemic progression...
November 2018: BJPsych Open
https://read.qxmd.com/read/30442029/costs-of-quality-in-clinical-development
#12
Bolennart Eriksson
BACKGROUND: The basis for this article is an individual project during a Master of Science program at Cranfield University, UK. Research and development (R&D) costs in the pharmaceutical industry have increased at a rate where costs have doubled compared to previous decades since the 1980s. In parallel, during recent years, there has been an increased focus on quality management within clinical development. Furthermore, pharma companies are talking about quality as a competitive advantage with an increased focus on quality metrics...
November 15, 2018: Therapeutic Innovation & Regulatory Science
https://read.qxmd.com/read/30362915/using-previous-medication-adherence-to-predict-future-adherence
#13
Hiraku Kumamaru, Moa P Lee, Niteesh K Choudhry, Yaa-Hui Dong, Alexis A Krumme, Nazleen Khan, Gregory Brill, Shun Kohsaka, Hiroaki Miyata, Sebastian Schneeweiss, Joshua J Gagne
BACKGROUND: Medication nonadherence is a major public health problem. Identification of patients who are likely to be and not be adherent can guide targeted interventions and improve the design of comparative-effectiveness studies. OBJECTIVE: To evaluate multiple measures of patient previous medication adherence in light of predicting future statin adherence in a large U.S. administrative claims database. METHODS: We identified a cohort of patients newly initiating statins and measured their previous adherence to other chronic preventive medications during a 365-day baseline period, using metrics such as proportion of days covered (PDC), lack of second fills, and number of dispensations...
November 2018: Journal of Managed Care & Specialty Pharmacy
https://read.qxmd.com/read/30321128/disease-awareness-advertising-daa-in-emerging-economy-a-comparison-between-views-of-consumers-and-pharmaceutical-professionals
#14
Saikat Banerjee, Sampada Kumar Dash
Research on effectiveness of DAA is limited. Existing researches explore impact of DAA only on relationship between drug manufacturers and consumers. However, in reality, pharma marketing revolves around three major stakeholders: the pharmaceutical companies, physicians and consumers. Pharmaceutical professionals on behalf of drug manufacturers have last mile connectivity with end users and they are an important stakeholder in this entire marketing relationship network. So, it is important for marketers to capture views of pharma professionals in addition to physicians and consumers...
October 15, 2018: Health Marketing Quarterly
https://read.qxmd.com/read/30309442/rumble-over-drug-rebates-as-pharma-payers-duke-it-out
#15
Thomas Reinke
Pharma says rebates are a primary driver of high drug prices because drug companies raise prices in response to payers' demands for rebates in exchange for preferred placement on their formularies. PBMs and payers object. They say the rebates they get from drugmakers are largely passed on to health plans and patients and save consumers billions of dollars in the form of lower premiums and copays.
October 2018: Managed Care
https://read.qxmd.com/read/30149734/european-pharma-oligonucleotide-consortium-a-move-to-consolidate-oligonucleotide-knowledge-and-share-experience-within-the-community
#16
Anna Tivesten, Nadim Akhtar, Jessica Stolee, Yannick Fillon, Rachel Orr, Malcolm L Hill, Leo Van den Bergh, Tom Huybrechts, Jale Muslehiddinoglu, Paul McCormac, John Amery, Andrea Brecht, Achim Geiser, Tobias Metzenthin, Thomas Eichinger
A consortium of seven pharma companies has been formed with the aim of sharing knowledge on and harmonizing approaches to oligonucleotide development. This letter aims to raise awareness of this new group and to set expectations for future publications.
November 2018: Therapeutic Innovation & Regulatory Science
https://read.qxmd.com/read/30124346/5-ht1a-receptor-ligands-and-their-therapeutic-applications-review-of-new-patents
#17
REVIEW
Jakub Staroń, Ryszard Bugno, Adam S Hogendorf, Andrzej J Bojarski
5-HT1A R was one of the first discovered serotonin receptors and is one of the most thoroughly studied. Dysfunctions associated with 5-HT1A R neurotransmission are linked to several psychiatric disorders, including anxiety, depression, and movement disorders. Areas covered: The current review covers patent literature published between January 2012 and May 2018. Queries were performed on Espacenet, SciFinder, clinicaltrials.gov, pharmacodia.com, and the websites of pharmaceutical companies. Expert opinion: Several novel therapeutic applications have been proposed for 5-HT1A R ligands, i...
September 2018: Expert Opinion on Therapeutic Patents
https://read.qxmd.com/read/30076203/emerging-kidney-models-to-investigate-metabolism-transport-and-toxicity-of-drugs-and-xenobiotics
#18
Piyush Bajaj, Swapan K Chowdhury, Robert Yucha, Edward J Kelly, Guangqing Xiao
The kidney is a major clearance organ of the body and is responsible for the elimination of many xenobiotics and prescription drugs. With its multitude of uptake and efflux transporters and metabolizing enzymes, the proximal tubule cell (PTC) in the nephron plays a key role in the disposition of xenobiotics and is also a primary site for toxicity. In this minireview, we first provide an overview of the major transporters and metabolizing enzymes in the PTCs responsible for biotransformation and disposition of drugs...
November 2018: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://read.qxmd.com/read/29954991/-tax-pharma-companies-if-they-fail-to-act-on-amr-says-review-chief-lord-o-neill
#19
(no author information available yet)
No abstract text is available yet for this article.
June 30, 2018: Veterinary Record
https://read.qxmd.com/read/29954923/delamination-propensity-of-glass-containers-for-pharmaceutical-use-a-round-robin-activity-looking-for-a-predictive-test
#20
Juan Cerdan-Diaz, Ken Choju, Carol R Flynn, Ludovico Gavioli, Ron Iacocca, Amy Meysner, Joachim Pfeifer, Holger Roehl, Volker Rupertus, Martina Scarpa, Huimin Sun, Jingwei Zhang, Daniele Zuccato, Massimo Guglielmi
Delamination, which is the formation of flakes in drug products due to specific and localized corrosion of glass vials, is a rare but very serious problems, and the FDA (U.S. Food and Drug Administration) put a warning to the pharma industry in 2011. Technical Committee TC12 of the International Commission on Glass (ICG) was created in 2012, with the aim to study the problems related to pharma packaging. The first task of TC12 was to address the problem of predicting the propensity of glass vials to delamination, leaving the study of the mechanism(s) of flake formation as a possible future activity...
June 27, 2018: PDA Journal of Pharmaceutical Science and Technology
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