Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 335

Posts Tagged ‘clinical’

The smart choice in early-stage clinical research

Posted by fidest press agency su sabato, 19 ottobre 2019

To mark the opening of the Clinical Trials Phase I and Phase IIA Summit today in Philadelphia, the non-profit partnership CATALIS Québec has announced a promotional campaign to showcase the advantages of conducting early-stage clinical research in Quebec.In the coming weeks, The Smart Choice will present 10 physician-scientists and nine world-renowned research hospitals, with an eye to fostering university-industry collaboration in this cutting-edge sector.
Phase I and II trials are the first studies conducted on humans to provide scientific proof of the safety and efficacy of an experimental drug or a new therapeutic approach. This research often represents an opportunity to find an additional treatment for patients with serious diseases when standard therapies have failed.The pharmaceutical companies and contract research organizations that collaborate with Quebec’s university research centres to conduct their clinical trials benefit from an ecosystem geared towards operational excellence.“To continue to be a global leader in early-phase clinical trials, CATALIS Québec coordinates the efforts of several public and private partners in developing resources and tools and in helping to standardize ethical and contractual processes, to ensure that, for all industry players, Quebec remains the smart choice,” concluded Danika Laberge.

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Clinical Programs in Prostate and Ovarian Cancers at the ESMO Congress 2019

Posted by fidest press agency su lunedì, 16 settembre 2019

Clovis Oncology, Inc. (NASDAQ: CLVS) today announced that three posters highlighting studies from the Rubraca® (rucaparib) clinical development program will be presented at the ESMO (European Society for Medical Oncology) Congress 2019, September 27 – October 1, 2019, in Barcelona, Spain.The accepted abstracts summarize clinical trials in which Rubraca is being evaluated as a single agent in advanced ovarian and prostate cancers. These posters include updated results from the ongoing Phase 2 TRITON2 clinical trial of Rubraca in advanced mCRPC and additional analyses of data from the Study 10, ARIEL2 and ARIEL3 clinical trials in advanced ovarian cancer, which evaluated safety and efficacy in the treatment and maintenance settings.
The data from the TRITON2 trial will be presented in a poster by Professor Ray McDermott, Consultant Medical Oncologist, Tallaght University Hospital and Cancer Trials Ireland, and have been selected for inclusion in a poster discussion session on Sunday, September 29. TRITON2 is an ongoing international, multicenter, open-label, Phase 2 trial of Rubraca in men with advanced prostate cancer with a deleterious BRCA gene mutation (germline or somatic) or deleterious mutation in other homologous recombination repair genes in the metastatic castration-resistant setting.In October 2018, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for Rubraca for the treatment of adult patients with BRCA1/2-mutated mCRPC who have received at least one prior androgen receptor-directed therapy and taxane-based chemotherapy.Additional analyses of data from the Study 10, ARIEL2 and ARIEL3 clinical trials, which supported the European Union (EU) and FDA approvals of Rubraca for women with advanced ovarian cancer in the treatment and maintenance settings, will also be presented.

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“Global Clinical Research Services – Procurement Market Intelligence Report”

Posted by fidest press agency su venerdì, 13 settembre 2019

The spend momentum for this market is attributed to the increase in R&D expenditure to cater to the pressing requirement for new drugs and devices in emerging countries such as India, China, Brazil, and Argentina. Prevalence of chronic diseases and the aging demography will create demand for newer and better drugs in these countries.This report provides actionable insights to improve source-to-contract cycle performance in the Global Clinical Research Services Market. It helps sourcing professionals formulate better category strategies, enhance savings, understand supplier and market challenges, and implement sourcing best practices.
The report provides up-to-date information about market shifts and potential risks, as well as in-depth knowledge of products and services, which can help in planning and in executing category management activities. It focuses on the cost-saving aspects of procurement and on providing insights that can lead to optimization of category spend.

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QIAGEN’s New QIAstat-Dx Gastrointestinal Panel Demonstrates Excellent Performance in Multicenter Clinical Study in Europe

Posted by fidest press agency su domenica, 18 agosto 2019

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the publication of a multicenter clinical study demonstrating the accuracy of its QIAstat-Dx syndromic testing solution for diagnosing the causes of acute gastroenteritis. The QIAstat-Dx Gastrointestinal Panel delivered high performance compared to other, existing multiplex tests in this study which evaluated 385 patient samples at university hospital laboratories across Europe.The study showed the QIAstat-Dx Gastrointestinal Panel was highly sensitive (98.2% positive percent agreement, a measure of ability to detect pathogens) and specific (99.9% negative percent agreement, a measure of ability to identify true negative samples). Multiple pathogens were identified in nearly one-third of the patient samples that tested positive. Authors emphasized the system’s “ease of use” and that the system and assay yielded results in approximately one hour. The study also cited the ability of the QIAstat-Dx panel to provide cycle threshold (CT) values and amplification curves, quantitative indications of the amount of nucleic acids detected, as a unique advantage in interpreting diagnostic findings for gastrointestinal syndromes, which can be complicated by co-infections or false positives in testing. These are important capabilities which other currently widely used syndromic platforms do not offer.The article, “Multicenter evaluation of the new QIAstat Gastrointestinal Panel for the rapid syndromic testing of acute gastroenteritis,” has been accepted for publication by the European Journal of Clinical Microbiology & Infectious Diseases (EJCMID) and is available online. The study was conducted at Copenhagen University Hospital Hvidovre in Denmark and University Hospital of Bonn in Germany.
Introduced in Europe in early 2018 and the United States in mid-2019, the QIAstat-Dx system enables fast, cost-effective and easy-to-use syndromic testing with novel Sample to Insight solutions. The QIAstat-Dx Gastrointestinal Panel provides differential detection of more than 20 bacterial, viral and parasitic pathogens implicated in gut infections. The panel is already available in Europe. The QIAstat-Dx Respiratory Panel, for detection of more than 20 common viral and bacterial infections in respiratory syndromes, is currently available in Europe and the United States.QIAGEN is developing a broad pipeline of planned assays for the QIAstat-Dx content menu, spanning infectious diseases, oncology, companion diagnostics and other disease areas.

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Japan’s new molecular oncology clinical research

Posted by fidest press agency su giovedì, 20 giugno 2019

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that its QIAGEN Clinical Insight (QCI) offering was selected by the National Cancer Center of Japan, as part of the Japan’s Ministry of Health, Labour and Welfare’s precision medicine program, for the analysis, interpretation and reporting of molecular oncology and oncogenetic screening of cancer patients to contribute to the identification of targeted therapy treatment and clinical trial options.Japan’s Center for Cancer Genomics and Advanced Therapeutics (C-CAT), a unit within the National Cancer Center (NCC) of Japan, will use QIAGEN’s QCI platform including expert curated evidence knowledge bases, bioinformatics software and data center infrastructure to support the C-CAT’s molecular profiling services for core and cooperative hospitals of the country’s cancer genomic medicine program. QIAGEN has established an in-country data center in Tokyo, compliant with Japanese data security and privacy regulations, to support this national program.QCI is a cloud-based clinical decision support software platform used to generate actionable insights from next-generation sequencing (NGS) data. QCI leverages QIAGEN’s expert manually curated evidence knowledge base that includes more than 10 million biomedical findings and thereby be far represents the world’s largest commercial database of curated evidence data on somatic and inherited genetic variants. QCI-Interpret minimizes the complexity and cost of determining the significance of NGS data and automates guidelines for clinical actionability from leading oncology and pathology organizations.

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Brain Stimulation Improves Depression Symptoms, Restores Brain Waves in Clinical Study

Posted by fidest press agency su sabato, 16 marzo 2019

With a weak alternating electrical current sent through electrodes attached to the scalp, UNC School of Medicine researchers successfully targeted a naturally occurring electrical pattern in a specific part of the brain and markedly improved depression symptoms in about 70 percent of participants in a clinical study.The research, published in Translational Psychiatry, lays the groundwork for larger research studies to use a specific kind of electrical brain stimulation called transcranial alternating current stimulation (tACS) to treat people diagnosed with major depression.
“We conducted a small study of 32 people because this sort of approach had never been done before,” said senior author Flavio Frohlich, PhD, associate professor of psychiatry and director of the Carolina Center for Neurostimulation. “Now that we’ve documented how this kind of tACS can reduce depression symptoms, we can fine tune our approach to help many people in a relatively inexpensive, noninvasive way.”Frohlich, who joined the UNC School of Medicine in 2011, is a leading pioneer in this field who also published the first clinical trials of tACS in schizophrenia and chronic pain.
His tACS approach is unlike the more common brain stimulation technique called transcranial direct stimulation (tDCS), which sends a steady stream of weak electricity through electrodes attached to various parts of the brain. That approach has had mixed results in treating various conditions, including depression. Frohlich’s tACS paradigm is newer and has not been investigated as thoroughly as tDCS. Frohlich’s approach focuses on each individual’s specific alpha oscillations, which appear as waves between 8 and 12 Hertz on an electroencephalogram (EEG). The waves in this range rise in predominance when we close our eyes and daydream, meditate, or conjure ideas – essentially when our brains shut out sensory stimuli, such as what we see, feel, and hear.Previous research showed that people with depression featured imbalanced alpha oscillations; the waves were overactive in the left frontal cortex. Frohlich thought his team could target these oscillations to bring them back in synch with the alpha oscillations in the right frontal cortex. And if Frohlich’s team could achieve that, then maybe depression symptoms would be decreased.His lab recruited 32 people diagnosed with depression and surveyed each participant before the study, according to the Montgomery–Åsberg Depression Rating Scale (MADRS), a standard measure of depression.
Prior to the study, Frohlich set the primary outcome at four weeks, meaning that the main goal of the study was to assess whether tACS could bring each individual’s alpha waves back into balance and decrease symptoms of depression four weeks after the five-day intervention. He set this primary outcome because scientific literature on the study of tDCS also used the four-week mark.But when Frohlich’s team looked at data from two weeks after treatment, they found that 70 percent of people in the treatment group reported at least a 50 percent reduction of depression symptoms, according to their MADRS scores. This response rate was significantly higher than the one for the two other control groups. A few of the participants had such dramatic decreases that Frohlich’s team is currently writing case-studies on them. Participants in the placebo and control groups experienced no such reduction in symptoms.

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Medical Devices and clinical investigations

Posted by fidest press agency su martedì, 24 aprile 2018

Milan May, 9th 2018 – Piazza Borromeo 12, 17:30 – 19:00 Seminar. This seminar is aimed at medical device and medical technology companies or organisations that are planning to develop new medical devices that will need to undergo clinical investigations.
The seminar will explore the new trends with respect to clinical investigations on medical devices in the light of the application of the EU medical devices regulations.We will discuss the main challenges to be faced by companies in order to comply with the new regulations, both in Italy and in the UK, whilst considering the context of the evolving legal and regulatory landscape (e.g., recent legislative changes to the ethics committees system in Italy, Brexit, etc.). Moreover, we will provide recommendations in relation to clinical investigation contracts and the processing and possible uses of patients’ sensitive personal data.The Portolano Cavallo’s Life Sciences team will discuss with Richard Dickinson and Jackie Mulryne from the EU life sciences London based practice of Arnold & Porter.This seminar will be held in English.This event has limited seating.

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FDA Lifts Clinical Hold on Fitusiran

Posted by fidest press agency su sabato, 16 dicembre 2017

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, and Sanofi Genzyme, the specialty care global business unit of Sanofi, announced today that the U.S. Food and Drug Administration (FDA) has lifted the hold on clinical studies with fitusiran, including the Phase 2 open-label extension (OLE) study and the ATLAS Phase 3 program. Alnylam and the FDA had previously reached alignment on new clinical risk mitigation measures, including protocol-specified guidelines and additional investigator and patient education concerning reduced doses of replacement factor or bypassing agent to treat any breakthrough bleeds in fitusiran studies. The FDA has now approved the protocol amendments and other updated clinical materials for fitusiran studies. Fitusiran is an investigational RNAi therapeutic targeting antithrombin (AT) for the treatment of patients with hemophilia A and B. It is designed to lower levels of AT with the goal of promoting sufficient thrombin generation to restore hemostasis and prevent bleeding.“We are pleased with the FDA’s decision to lift the clinical hold, as fitusiran holds the potential to help improve the lives of people living with hemophilia,” said Akin Akinc, Ph.D., Vice President and General Manager, Fitusiran at Alnylam. “With the additional risk mitigation measures in place, we look forward to the continued late-stage development of fitusiran and expect to resume dosing around year-end.”

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Cerevance Appoints David H. Margolin, MD, PhD as Senior Vice President of Clinical and Translational Medicine

Posted by fidest press agency su mercoledì, 29 novembre 2017

Cerevance, a drug discovery and development company focused on brain diseases, today announced that it has appointed David H. Margolin, M.D., Ph.D., as Senior Vice President of Clinical and Translational Medicine. Prior to joining Cerevance, Dr. Margolin served in several leadership roles at Sanofi-Genzyme over a 14-year period. There, he leveraged his expertise in designing and leading translational medicine initiatives as well as clinical trials from phase 1 to phase 4 across various neurologic and rare disease indications, spanning biologics, small molecules and cell and gene therapies. Notably, Dr. Margolin served as the medical lead for the development of Lemtrada (alemtuzumab) which is now marketed in over 60 countries.A board-certified neurologist with additional expertise in cell and molecular immunology, Dr. Margolin obtained his bachelor’s degree from Harvard College magna cum laude and his M.D. and Ph.D. degrees from the University of Pennsylvania. He completed his residency at Massachusetts General Hospital, followed by a research fellowship at Beth Israel Deaconess Medical Center and Harvard Medical School. Dr. Margolin served on the faculty in neurology at Harvard Medical School for 15 years, has authored more than 30 publications in peer-reviewed journals including The Lancet, New England Journal of Medicine, Brain, Blood, and Neurology, and is an inventor on several patents.“David brings a critical combination of skills to Cerevance, with a stellar track record leading clinical development as well as a deep knowledge of neuroscience,” noted Brad Margus, CEO of Cerevance. “He will ensure the thoughtful execution of our more advanced programs while concurrently helping us dive into our rich human brain tissue datasets to select new drug targets with which we can expand our pipeline.” “Cerevance’s unique platform provides an opportunity to identify novel targets for neurological and psychiatric diseases on an unprecedented scale,” said Dr. Margolin. “I look forward to joining Cerevance’s team, advisors and investors in pursuing their vision of creating innovative and highly effective treatments for the millions of people with these diseases.”

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Cellectis Reports Clinical Hold of UCART123 Studies

Posted by fidest press agency su lunedì, 11 settembre 2017

Cellectis (Paris:ALCLS) (NASDAQ:CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today having received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold was placed on both UCART123 ongoing Phase 1 studies, respectively in acute myeloid leukemia (AML) and in blastic plasmacytoid dendritic cell neoplasm (BPDCN).Cellectis is working closely with the investigators and the FDA in order to resume the trials with an amended protocol including a lowered dosing of UCART123.The clinical hold was initiated after Cellectis reported one fatality in the BPDCN clinical trial (ABC study). This was the first patient treated in the BPDCN study, a 78-year-old male treated with one prior therapy, who presented with relapsed/refractory BPDCN with 30% blasts in his bone marrow and cutaneous lesions (biopsy-proven BPDCN) at baseline prior to conditioning regimen. He received 30mg/m2/day fludarabine for 4 days and 1g/m2/day cyclophosphamide for 3 days, as a preconditioning regimen. On August 16, 2017 (Day 0), he received 6.25×105 UCART123 cells per kilogram, the first dose level explored in the protocol, without complication. At Day 5, the patient experienced a grade 2 Cytokine Release Syndrome (CRS)1, and a grade 3 lung infection, which quickly improved after a first dose of tocilizumab and institution of anti-infective therapy (broad spectrum intravenous antibiotics). He then experienced at Day 8 a grade 5 CRS, together with a grade 4 Capillary Leak Syndrome2. Despite a treatment in keeping with CRS management including administration of corticosteroids and tociluzumab x 2 as well as intensive care unit support, the patient died on Day 9.The first patient treated in the AML study was a 58-year-old woman, with 84% blasts in her bone marrow at baseline prior to conditioning regimen. On June 27, 2017 (Day 0), the patient received the same preconditioning regimen and the same dose of UCART123 as the BPDCN patient, without complication. She experienced an initial grade 2 CRS at Day 8, worsening to a grade 3 at Day 9 and resolving at Day 11 with treatment management in intensive care unit. She also experienced a grade 4 Capillary Leak Syndrome at Day 9, resolved at Day 12.

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Congresso internazionale di osteoporosi

Posted by fidest press agency su mercoledì, 10 marzo 2010

Firenze dal 5 all’8 maggio Fortezza da Basso il più grande appuntamento mondiale per gli specialisti, unitamente al decimo congresso europeo sugli aspetti clinici ed economici dell’osteoporosi e dell’osteoartrite. Previsti quattromila partecipanti. Per l’occasione si terranno congiuntamente due dei più grandi eventi mondiali della medicina specialistica: il World Congress on Osteoporosis e il 10th European Congress on Clinical and Economic Aspects of Osteoporosis and Osteoarthritis. I due congressi sono co-organizzati da IOF – International Osteoporosis Foundation e da ESCEO – European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis, sotto gli auspici di GREES (Group for the Respect of Ethics and Excellence in Science). «Il congresso», illustra il professor René Rizzoli, co-presidente dello Scientific Programme Committee, «offrirà una visione d’insieme dei più recenti sviluppi della ricerca nel campo della patofisiologia, della diagnosi, della prevenzione e del trattamento dell’osteoporosi e dell’osteoartrite, oltre a tutte le implicazioni nel campo della politica e dell’economia sanitaria». In un simposio così internazionale, ci sarà spazio anche per la ricerca italiana. Sabato 8 maggio, dalle 16.390 alle 18.00, un gruppo di specialisti parlerà delle fratture patologiche causate dalle malattie, sotto gli auspici della fondazione FIRMO, dedicata alla ricerca sulle malattie delle ossa, della Società italiana di medicina generale (SIMG), della Società italiana dell’osteoporosi del metabolismo minerale e delle malattie dello scheletro (SIOMMMS) e della Società italiana di ortopedia e traumatologia (SIOT) e della stessa ESCEO.Il Firenze Convention Bureau (FCB) è una società non-profit nata nel 1995 per coordinare al meglio la ricca filiera congressuale fiorentina. Raccoglie oltre 50 soci con le quattro associazioni alberghiere più importanti (con oltre 350 unità), centri congressi, Aeroporto di Firenze, event agency, società di allestimenti e arredi, audiovisivi, cartellonistica e catering, centri prenotazione, agenzie di ricerche di mercato, ristoranti, provider di servizi culturali; agenzie di spettacolo e intrattenimento, di traduzione e interpretariato e di trasporti. Si propone come interlocutore indispensabile per consigli e appoggio nell’organizzazione di qualsiasi tipologia di evento e garantisce assistenza tecnica secondo i più alti standard internazionali. Tra i servizi: prenotazione di degli spazi e delle camere, contatti professionali con i soci, pianificazione delle visite alle strutture e stampa di materiale informativo.

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