Torre del Greco, Italy
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" Questo è il primo studio clinico RCT sull'uso di un biosimilare in una malattia infiammatoria cronica intestinale. Pur disponendo già di moltissimi dati per CT-P13, sia del mondo reale che estrapolati, da qualche tempo i gastroenterologi avrebbero preferito essere rassicurati da uno studio clinico RCT, ed è quindi incoraggiante osservare i risultati positivi dello studio clinico RCT di Celltrion", è stato il commento di Jørgen Jahnsen, docente di gastroenterologia presso l'Università di Oslo, in Norvegia, ed esperto di primo piano. I risparmi reali sui costi associati all'uso di CT-P13 per tutte le indicazioni sono stati oggetto di studio in cinque paesi europei, a partire dall'inizio del 2015 fino al primo semestre del 2016. Secondo i dati presentati a ECCO, i risparmi complessivi sui costi rilevati per Germania, Italia, Spagna e Regno Unito sono stati pari a 32,4 milioni di euro, con risultati che suggeriscono la possibilità per altri 5.428 pazienti all'anno di accedere a questa importante terapia biologica. Non sono state rilevate riduzioni dei costi in Francia, in quanto il costo del biosimilare infliximab e dell'infliximab di riferimento era pari; ciononostante, il ricorso a CT-P13 è gradualmente aumentato nel paese.4 Le IBD rappresentano un aggravio importante per il sistema sanitario e per la società, con costi diretti calcolati in 4,6-5,6 miliardi di euro all'anno.6 Celltrion Healthcare effettua a livello mondiale attività di marketing, vendita e distribuzione dei biofarmaci sviluppati da Celltrion, Inc. tramite un'estesa rete internazionale che comprende più di 120 paesi diversi. I prodotti di Celltrion Healthcare sono realizzati a partire da colture cellulari di mammiferi in avanzate strutture studiate e realizzate per la conformità agli standard cGMP della FDA statunitense e agli standard GMP della UE. Per ulteriori informazioni visitare il sito: http://www.celltrionhealthcare.com/ Si tratta di uno studio clinico di fase III randomizzato, in doppio cieco e a gruppi paralleli mirato a esaminare l'efficacia e la sicurezza tra CT-P13 e l'infliximab di riferimento sui pazienti MC. Su 220 pazienti randomizzati in 58 centri di studio in 16 paesi, 214 pazienti hanno completato lo studio clinico fino alla settimana 6 per l'analisi primaria, e 180 pazienti hanno completato lo studio clinico fino alla settimana 30. Lo studio clinico è stato co-finanziato da Celltrion e Pfizer. CT-P13, sviluppato e prodotto da Celltrion, Inc., è stato il primo anticorpo monoclonale biosimilare approvato dall'Agenzia europea per i medicinali (EMA). È indicato per il trattamento di otto malattie autoimmuni, inclusa l'artrite reumatoide e le malattie infiammatorie intestinali. Ha ricevuto l'approvazione dell'EMA con il nome commerciale Remsima® nel mese di settembre del 2013 ed è stato lanciato in Europa agli inizi del 2015. La FDA statunitense ha approvato CT-P13 di Celltron nel mese di aprile 2016 con il nome commerciale Inflectra™. CT-P13 di Celltron è approvato in oltre 79 paesi (dati aggiornati al mese di gennaio 2017) inclusi Stati Uniti, Canada, Giappone e tutta l'Europa. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Consultabile al link www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Ultimo accesso: gennaio 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.


Vooraanstaand expert Jørgen Jahnsen, hoogleraar Gastro-enterologie aan de Universiteit van Oslo, Noorwegen, gaf commentaar op de studie: “ Dit is de eerste RCT om het gebruik van een biosimilar bij inflammatoire darmaandoeningen te onderzoeken. Hoewel we al een schat aan geëxtrapoleerde en parktijkgegevens voor CT-P13 hebben, wilden gastro-enterologen al enige tijd de zekerheid van een RCT, en het is bemoedigend om dergelijke positieve data te zien van het RCT-onderzoek van Celltrion.” De werkelijke kostenbesparingen in verband met het gebruik van CT-P13 voor alle indicaties werden onderzocht in vijf Europese landen vanaf begin 2015 tot de eerste helft van 2016. Volgens de op ECCO gepresenteerde data bedroegen de totale kostenbesparingen waargenomen voor Duitsland, Italië, Spanje en het Verenigd Koninkrijk € 32,4 miljoen, en de bevindingen suggereren dat hierdoor nog eens 5428 patiënten per jaar toegang kunnen krijgen tot deze belangrijke biologische therapie. Er waren geen kostenbesparingen in Frankrijk, omdat de prijs van de biosimilar en het referentieproduct infliximab gelijk waren. Desondanks is het gebruik van CT-P13 in dit land echter geleidelijk toegenomen.4 Man Hoon Kim, President en CEO van Celltrion Healthcare, verklaarde: “ Bij Celltrion zijn we toegewijd aan het aanpakken van de behoeften van de klinische gemeenschap door middel van robuuste wetenschappelijke exploratie. Een pivotaal RCT-onderzoek naar de ziekte van Crohn is hiervan een belangrijk voorbeeld. De resultaten van dit cruciale onderzoek zijn in overeenstemming met onze andere RCT's en vele IBD-praktijkstudies die zijn uitgevoerd. Meer in het algemeen is het bevredigend om de veranderingen te zien die CT-P13 maakt in de voor financiële problemen staande gezondsheidszorgsystemen in Europa.” Inflammatoire darmziekten (IBD) zoals de ziekte van Crohn (CD) en colitis ulcerosa (UC) zijn chronische invaliderende gastrointestinale aandoeningen die van invloed zijn op het gehele leven van een patiënt.5 Ongeveer 2,5 - 3 miljoen mensen in Europa worden er door getroffen;6 CD treft ongeveer drie personen per 1.000 en UC ongeveer 5 personen per 1000.5 Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ De studie is een gerandomiseerde, dubbelblinde, parallelgroep, Fase Ⅲ studie om de werkzaamheid en veiligheid te onderzoeken van CT-P13 en referentie infliximab bij CD-patiënten. Van 220 patiënten gerandomiseerd in 58 studiecentra in 16 landen, maakten 214 patiënten vol tot week 6 voor de primaire analyse en 180 patiënten tot week 30. De studie werd in gelijke mate gefinancierd door Celltrion en Pfizer. CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Beschikbaar op www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [laatst bekeken januari 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.


News Article | February 22, 2017
Site: www.PR.com

SMi’s Paediatric Clinical Trials show returns to London for the 11th year on 20th-21st March 2017. London, United Kingdom, February 22, 2017 --( Through a series of interactive conference sessions, presentations and a workshop led by industry experts; the 2017 agenda will discuss current clinical trials, implementation, drug development, recruitment and retention, ethical issues and regulations. Key presentations not to be missed: - Bianca McDade, Director Regulatory Affairs, GSK - Tom Willgoss, Senior Outcomes Research Scientist, Patient-Centred Outcomes Research, Roche - Karl-Heinz Huemer, Scientific Committee Member and Expert, EMA, PDCO - Hernando Patino, Paediatric Drug Development Lead, Johnson & Johnson - Deborah Lee, VP Clinical Development, Insys Therapeutics - Andy Kenwright, Senior Statistical Scientist, Roche - Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, Genentech Highlights for 2017: - Update from the EMA on the PDCO's 10 year review into paediatric investigation plans - Discuss clinical trial legislation in the EU and US - Review challenges in paediatric drug development for rare diseases - Optimise approaches to paediatric drug formulation to improve clinical success - Evaluate recruitment and retention - Discuss hot topic of data extrapolation In the lead up to the event SMi have released some pre-conference interviews with some of the speakers. For further insight into the topics being discussed at this year’s conference and an overall look into the paediatric trials field visit the download centre of the event website to access the 2017 speaker interview series. Interviews available to download include: Roche, Insys Therapeutics, Paediatric Research Consultancy, The Birmingham Children’s Hospital and Klausrose Consulting. Countries attending Paediatric Clinical Trials 2017 include: Australia, Austria, Belgium, Denmark, France, Germany, Netherlands, Spain, Switzerland, United Kingdom & USA. For those who are interested in attending register online at the event website www.paediatric-trials.co.uk/prcom Paediatric Clinical Trials 20-21 March 2017 Copthorne Tara Hotel, London, UK www.paediatric-trials.co.uk/prcom Sponsorship enquiries: Contact Alia Malick on: +44 (0) 20 7827 6168 or email amalick@smi-online.co.uk Group bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email abegum@smi-online.co.uk About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, February 22, 2017 --( PR.com )-- With just 4 weeks to go, registration will be closing soon for SMi’s Paediatric Clinical Trials 2017. The event will bring together Clinical Operations Leads and Heads of Clinical Trials to review the developments leading to the advancement of paediatric medicines.Through a series of interactive conference sessions, presentations and a workshop led by industry experts; the 2017 agenda will discuss current clinical trials, implementation, drug development, recruitment and retention, ethical issues and regulations.Key presentations not to be missed:- Bianca McDade, Director Regulatory Affairs, GSK- Tom Willgoss, Senior Outcomes Research Scientist, Patient-Centred Outcomes Research, Roche- Karl-Heinz Huemer, Scientific Committee Member and Expert, EMA, PDCO- Hernando Patino, Paediatric Drug Development Lead, Johnson & Johnson- Deborah Lee, VP Clinical Development, Insys Therapeutics- Andy Kenwright, Senior Statistical Scientist, Roche- Robert Kahn, Former Senior Safety Science Leader, Global Pediatric Oncology, GenentechHighlights for 2017:- Update from the EMA on the PDCO's 10 year review into paediatric investigation plans- Discuss clinical trial legislation in the EU and US- Review challenges in paediatric drug development for rare diseases- Optimise approaches to paediatric drug formulation to improve clinical success- Evaluate recruitment and retention- Discuss hot topic of data extrapolationIn the lead up to the event SMi have released some pre-conference interviews with some of the speakers. For further insight into the topics being discussed at this year’s conference and an overall look into the paediatric trials field visit the download centre of the event website to access the 2017 speaker interview series. Interviews available to download include: Roche, Insys Therapeutics, Paediatric Research Consultancy, The Birmingham Children’s Hospital and Klausrose Consulting.Countries attending Paediatric Clinical Trials 2017 include: Australia, Austria, Belgium, Denmark, France, Germany, Netherlands, Spain, Switzerland, United Kingdom & USA. For those who are interested in attending register online at the event website www.paediatric-trials.co.uk/prcomPaediatric Clinical Trials20-21 March 2017Copthorne Tara Hotel, London, UKwww.paediatric-trials.co.uk/prcomSponsorship enquiries: Contact Alia Malick on: +44 (0) 20 7827 6168 or email amalick@smi-online.co.ukGroup bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email abegum@smi-online.co.ukAbout SMi Group:Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


News Article | February 17, 2017
Site: www.businesswire.com

BARCELONA--(BUSINESS WIRE)--Today at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO), Celltrion Healthcare presented the primary outcome from its pivotal randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease. The data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease (CD) is comparable to those treated with reference infliximab.1 The Phase III RCT in 220 patients with CD examined whether CT-P13 is comparable to reference infliximab as determined by the Crohn’s Disease Activity Index (CDAI), a measurement used to quantify the symptoms of CD patients. According to the 6 week and 30 week data, similar clinical remission, CDAI-70 and CDAI-100 response rates were observed in both CT-P13 and reference infliximab treatment groups.1 Leading expert Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway commented on the study, “ This is the first RCT to examine the use of a biosimilar in inflammatory bowel disease. While we already have a wealth of extrapolated and real-world data for CT-P13, gastroenterologists have for some time wanted the reassurance of an RCT and it’s encouraging to see such positive data from Celltrion’s RCT trial.” Celltrion Healthcare also presented data from two observational studies. The first study evaluated the efficacy and safety of CT-P13 in 74 paediatric patients with CD (naïve patients: 26, switch patients: 25) or ulcerative colitis (UC) (naïve patients: 16, switch patients: 7). The data show that CT-P13 is effective in both treatment-naïve and switch paediatric patients over 30 weeks and is well-tolerated.2 The second study examined 204 CD patients (fistulising CD: 24, CD patients: 180) in South Korea from July 2012-2016. CT-P13 was found to be clinically consistent to reference infliximab and well tolerated up to six months in patients with moderate-to-severe CD and those with fistulising CD.3 Real-world cost savings associated with the use of CT-P13 across all indications were studied in five European countries from the beginning of 2015 to the first half of 2016. According to the data presented at ECCO, total cost savings observed for Germany, Italy, Spain and the UK amounted to €32.4 million and the findings suggest that this could allow an additional 5,428 patients a year access to this important biologic therapy. There were no cost savings in France, as the price of biosimilar and reference infliximab were the same, however despite this, use of CT-P13 has gradually increased in this country.4 Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “ At Celltrion, we are committed to addressing the needs of the clinical community through robust scientific exploration. A pivotal RCT in Crohn’s disease is an important example of this, and the results from this pivotal trial are consistent with our other RCTs and many real-world IBD studies that have been conducted. More broadly, it’s rewarding to see the changes that CT-P13 is making in financially-constrained health systems in Europe.” Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.5 They affect an estimated 2.5-3 million people in Europe;6 CD affects about three people per 1,000 and UC about 5 people per 1,000.5 IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.6 Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ The study is a randomised, double-blind, parallel- group, phase Ⅲ study to investigate efficacy and safety between CT-P13 and reference infliximab with CD patients. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis, and 180 patients completed up to week 30. The study was funded equally by Celltrion and Pfizer. CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017.P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.


1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017.P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.


News Article | March 1, 2017
Site: www.PR.com

SMi’s 13th annual show dedicated to discussing Asthma & COPD will be returning to London this March. London, United Kingdom, March 01, 2017 --( Boris Ferko, Head of Research & Development will be presenting from EURRUS. Boris will be providing attendees with his presentation entitled 'Development of a Novel Glutarmide Derivative XC8; A candidate oral drug for allergic asthma therapy'. He will speak about: • A novel non-steroid compound glutarimide histamine (XC8) was developed as an oral tablet for allergic asthma therapy • In multiple animal asthma models oral administration of XC8 efficiently suppressed eosinophilic lung inflammation, mortality of animals from anaphylactic reactions and methacholine-induced airway hyper-responsiveness (AHR). XC8 also decreased eosinophils numbers in bronchalveolar lavages (BAL) and numbers of degranulated mast cells and basophils in the lung tissue as well as mucus hypersecretion and antigen-specific serum IgE or IgG1 • Moreover, an antiviral effect of XC8 was determined against RSV, rhino- and influenza virus infections was shown in experimental animals • Chronic toxicity and genotoxicity studies revealed an excellent safety profile of XC8 thus providing support for phase I and phase II clinical trials running at the moment in Germany, Austria and Russia Adnan Custovic, Clinical Professor of Paediatric Allergy will be representing Imperial College London and will be speaking on 'Disaggregating asthma: Towards stratified treatment and prevention', where he will discuss: • Heterogeneity of asthma now widely accepted -General consensus: There are different asthma endotypes - No consensus: What these are and how best to define them • Major challenge is to bridge the gap between: - Identifying subtypes of asthma in clinical and general populations - Understanding their causal mechanisms (both shared and unique) - Translating this knowledge into biomarkers and strategies to facilitate stratified prevention and management strategies Other topics to be covered across the two days include ongoing issues, cutting edge developments and novel approaches to treatment surrounding key areas such as biomarkers and targeted treatment, device development and drug delivery. Furthermore the event will deepen attendees understanding of the problems relating to these respiratory diseases, and discuss the hot topic of electronic health monitoring. A CPD certified pre-conference workshop will be hosted alongside the conference by Cambridge Consultants on ‘The future of Asthma & COPD management; from connected inhalers to therapy management’. For further information on the two day agenda or those wishing to attend, visit the event website on www.asthma-copd.co.uk/prcom Asthma & COPD 2017 is sponsored by Vitalograph and Nemera. For sponsorship packages: Contact Alia Malick on +44 (0)20 7827 6168 or email amalick@smi-online.co.uk For group delegate bookings: Contact Ameenah Begum on +44 (0)20 7827 6166 or email abegum@smi-online.co.uk For media enquiries, contact Zoe Gale on +44 20 7827 6138 or zgale@smi-online.co.uk 13th annual Asthma & COPD 29-30 March 2017 London, UK www.asthma-copd.co.uk/prcom Sponsored by Vitalograph and Nemera Contact e-mail: zgale@smi-online.co.uk Contact tel: +44 (0) 207 827 6166 #asthmacopdsmi About SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk London, United Kingdom, March 01, 2017 --( PR.com )-- EURRUS and Imperial College London have recently been added to the expert speaker panel at this year’s event. They will present alongside respiratory specialists from MHRA, GSK, Boehringer Ingelheim, Glenmark Pharmaceuticals, Janssen, Teva UK, AstraZeneca, MedImmune and many more to reflect on the ongoing issues and latest developments of these two diseases.Boris Ferko, Head of Research & Development will be presenting from EURRUS. Boris will be providing attendees with his presentation entitled 'Development of a Novel Glutarmide Derivative XC8; A candidate oral drug for allergic asthma therapy'. He will speak about:• A novel non-steroid compound glutarimide histamine (XC8) was developed as an oral tablet for allergic asthma therapy• In multiple animal asthma models oral administration of XC8 efficiently suppressed eosinophilic lung inflammation, mortality of animals from anaphylactic reactions and methacholine-induced airway hyper-responsiveness (AHR). XC8 also decreased eosinophils numbers in bronchalveolar lavages (BAL) and numbers of degranulated mast cells and basophils in the lung tissue as well as mucus hypersecretion and antigen-specific serum IgE or IgG1• Moreover, an antiviral effect of XC8 was determined against RSV, rhino- and influenza virus infections was shown in experimental animals• Chronic toxicity and genotoxicity studies revealed an excellent safety profile of XC8 thus providing support for phase I and phase II clinical trials running at the moment in Germany, Austria and RussiaAdnan Custovic, Clinical Professor of Paediatric Allergy will be representing Imperial College London and will be speaking on 'Disaggregating asthma: Towards stratified treatment and prevention', where he will discuss:• Heterogeneity of asthma now widely accepted-General consensus: There are different asthma endotypes- No consensus: What these are and how best to define them• Major challenge is to bridge the gap between:- Identifying subtypes of asthma in clinical and general populations- Understanding their causal mechanisms (both shared and unique)- Translating this knowledge into biomarkers and strategies to facilitate stratified prevention and management strategiesOther topics to be covered across the two days include ongoing issues, cutting edge developments and novel approaches to treatment surrounding key areas such as biomarkers and targeted treatment, device development and drug delivery. Furthermore the event will deepen attendees understanding of the problems relating to these respiratory diseases, and discuss the hot topic of electronic health monitoring.A CPD certified pre-conference workshop will be hosted alongside the conference by Cambridge Consultants on ‘The future of Asthma & COPD management; from connected inhalers to therapy management’.For further information on the two day agenda or those wishing to attend, visit the event website on www.asthma-copd.co.uk/prcomAsthma & COPD 2017 is sponsored by Vitalograph and Nemera.For sponsorship packages: Contact Alia Malick on +44 (0)20 7827 6168 or email amalick@smi-online.co.ukFor group delegate bookings: Contact Ameenah Begum on +44 (0)20 7827 6166 or email abegum@smi-online.co.ukFor media enquiries, contact Zoe Gale on +44 20 7827 6138 or zgale@smi-online.co.uk13th annual Asthma & COPD29-30 March 2017London, UKwww.asthma-copd.co.uk/prcomSponsored by Vitalograph and NemeraContact e-mail: zgale@smi-online.co.ukContact tel: +44 (0) 207 827 6166#asthmacopdsmiAbout SMi Group: Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk Click here to view the list of recent Press Releases from SMi Group


News Article | February 17, 2017
Site: www.eurekalert.org

A study by researchers at the University of Southampton shows that antibiotics may be an effective treatment for acute non-complicated appendicitis in children, instead of surgery. The systematic review of existing literature is published in Pediatrics. The condition, which causes the appendix -- a small organ attached to the large intestine -- to become inflamed due to a blockage or infection, affects mainly children and teenagers. Appendicitis is currently treated through an operation to remove the appendix, known as an appendicectomy, and it is the most common cause of emergency surgery in children. The review, led by Nigel Hall, Associate Professor of Paediatric Surgery at the University of Southampton, assessed existing literature published over the past 10 years that included 10 studies reporting on 413 children who received non-operative treatment rather than an appendectomy. It shows that no study reported any safety concern or specific adverse events related to non-surgical treatment, although the rate of recurrent appendicitis was 14 per cent. Mr Hall, who is also a Consultant Paediatric and Neonatal Surgeon at Southampton Children's Hospital, commented: "Acute appendicitis is one of the most common general surgical emergencies worldwide and surgery has long been the gold standard of treatment. But it is invasive and costly, not to mention extremely daunting for the child concerned and their family. Our review shows that antibiotics could be an alternative treatment method for children. When we compared the adult literature to the data in our review it suggested that antibiotic treatment of acute appendicitis is at least as effective in children as in adults. This now needs to be explored more widely." The review says that longer term clinical outcomes and cost effectiveness of antibiotics compared to appendicectomy require further evaluation, preferably as large randomised trials to reliably inform decision making. To further this research Mr Hall and his team in Southampton, along with colleagues at St George's Hospital in Tooting, Alder Hey Children's Hospital in Liverpool and Great Ormond Street Hospital, are currently carrying out a year-long feasibility trial which will see children with appendicitis randomly allocated to have either surgery or antibiotic treatment. Mr Hall said: "In our initial trial, we will see how many patients and families are willing to join the study and will look at how well children in the study recover. "This will give us an indication of how many children we may be able to recruit into a future larger trial and how the outcomes of non-operative treatment compare with an operation." The study -- known as CONservative TReatment of Appendicitis in Children a randomised controlled Trial (CONTRACT) -- is being funded through a £483,000 grant from the National Institute for Health Research Health Technology Assessment Programme and co-ordinated by the University of Southampton's clinical trials unit in collaboration with the University of Bristol, the University of Liverpool and University College London.


News Article | March 1, 2017
Site: www.gizmag.com

Hari Rajyaguru was one of the first to test drive the Rolls-Royce SRH at the company's Goodwood Studio, just like all Rolls-Royces VIP customers Going into surgery can be stressful enough for well-informed adults, but spare a thought for children on their way to the operating theater. As a way to make such journeys a little more enjoyable, Rolls-Royce has constructed a pint-sized vehicle that lets kids drive themselves to the OR in luxury. The car was built to cruise the corridors of St. Richard's Hospital Pediatric Day Surgery Unit, which is reflected in the vehicle's name: the Rolls-Royce SRH. The hospital is located in the home town of Roll-Royce Motor Cars Limited, Chichester, West Sussex, and features "traffic signs" along the halls that drivers are presumably expected to obey. Seating just the driver, the Rolls-Royce SRH is powered by a 24-volt gel battery driving an electric motor that propels the car to a top speed of 10 mph (16 km/h). However, parents wanting their child to maintain a "statelier" speed can limit it to 4 mph (6.4 km/h). The car was produced by The Roll's-Royce Bespoke Manufacturing team, who spent over 400 hours of their own time putting it together, making use of 3D printing and hand-crafting techniques for various components, such as the Spirit of Ecstasy hood ornament and bespoke paddle controls. Other features include two-tone steering wheel, seats and self-righting wheel centers that are colored to match the vehicle's St James Red coachline. This hand-applied coachline contrasts with the two-tone Andalusian White and Salamanca Blue paint scheme. "It's wonderful seeing a smiley face on the way to theater, rather than an apprehensive one, and everyone caring for children at St Richard's is so grateful to Rolls-Royce for this unique donation," says Sue Nicholls, Paediatric Matron at Western Sussex Hospitals NSH Foundation Trust. "We know boys and girls alike will love driving it and in the coming years it will help turn a daunting experience into a more fun and enjoyable one for hundreds and hundreds of children."


News Article | March 1, 2017
Site: www.prnewswire.co.uk

Rolls-Royce Motor Cars has unveiled a seminal new concept in luxury, crafted for one very special customer, St Richard's Hospital Pediatric Day Surgery Unit in the marque's home town of Chichester, West Sussex. The appropriately-named Rolls-Royce SRH will allow children awaiting surgery to drive themselves to the operating theatre, through the Pediatric Unit corridors which are lined with 'traffic signs'. The experience of 'self-drive to theatre' aims to reduce child patient stress. Rolls-Royce Motor Cars welcomed two test drivers from the Pediatric Unit at St Richard's Hospital, Molly Matthews and Hari Rajyaguru, to the Home of Rolls-Royce. Molly and Hari viewed the car being unveiled in style at the company's Goodwood Studio in the same manner for all Rolls-Royces VIP customers. This exclusive event served as final validation and pre-delivery inspection of the Rolls-Royce SRH ahead of the official handover to the patients, their families and the devoted day surgery team at St Richard's Hospital. In true Rolls-Royce style, the two children and their families enjoyed VIP hospitality with one notable addition to the usual customer experience. Molly and Hari both enjoyed first drives on the Rolls-Royce production line, an exceptionally rare privilege usually reserved for the marque's Chief Executive during the validation process for new model families, and most recently actioned for the forthcoming Phantom 8. Molly, Hari and their families returned home in the chauffeured luxury of Rolls-Royce Ghosts. "We are a proud member of the community here in West Sussex. The Pediatric Unit at St Richard's Hospital, Chichester does such vital work in providing essential care to young people and their families," said Torsten Müller-Ötvös, CEO, Rolls-Royce Motor Cars. "We hope that the Rolls-Royce SRH will serve to make the experience for young people during treatment a little less stressful." Created from the ground-up by the dedicated Bespoke Manufacturing team, the Rolls-Royce SRH presents to its very important customer a landmark study in Bespoke luxury. Akin to the conception of every Rolls-Royce Bespoke commission, a restless desire to understand the customer's requirements informed every aspect of the design. The car is therefore specified with a two-tone paint-scheme of Andalusian White and Salamanca Blue and finished with a hand-applied St James Red coachline. The interior space is appointed with the same finesse and attention-to-detail afforded to every Rolls-Royce patron, with the two-tone steering wheel, seats and self-righting wheel centres perfectly colour-matched to the St James Red coachline. A top speed of 10mph is achieved in seconds courtesy of power derived from a 24 volt gel battery that propels the car with the same whisper-quietness as Rolls-Royce's magnificent V12 engines. For those preferring a more sedate journey, the speed setting is variable and can be limited to a statelier but no-less exhilarating 4mph. Sir Henry Royce's famous credo: "when it does not exist, design it," echoes around the marque's home in Goodwood, with this spirit highly evident in the conception of the Rolls-Royce SRH. The Bespoke Manufacturing team devoted over 400 hours of their own time to developing and hand-crafting this most extraordinary Rolls-Royce. In addition to developing competency in new chassis and electronic technologies, the project team also utilised 3D printing techniques for the design. This included production of the iconic Spirit of Ecstasy and the bespoke paddle controls. Lawrie Mewse, Project Leader of the Rolls-Royce SRH, said, "I am immensely proud of what the team has achieved. This project showcases the amazing skills and technology that exist in the Bespoke Manufacturing Team and across every area at the Home of Rolls Royce here at Goodwood. However, the most important thing is giving back to the local community and having a positive impact for children and their parents during their time in hospital." Marianne Griffiths, Chief Executive, of Western Sussex Hospitals NHS Foundation Trust, said, "Just like the joy it will bring to our young patients, the Rolls-Royce SRH is simply priceless. It is a very special gift and one of the most wonderful donations ever received by Love Your Hospital, our trust's dedicated charity. On behalf of everyone at Western Sussex Hospitals NHS Foundation Trust, I would like to say a heartfelt thank you to Rolls-Royce Motor Cars and especially the small team who volunteered so much of their own time in support of St Richard's Hospital in Chichester and the children we care for." Sue Nicholls, Paediatric Matron at Western Sussex Hospitals NSH Foundation Trust, said, "It's wonderful seeing a smiley face on the way to theatre, rather than an apprehensive one, and everyone caring for children at St Richard's is so grateful to Rolls-Royce for this unique donation. We know boys and girls alike will love driving it and in the coming years it will help turn a daunting experience into a more fun and enjoyable one for hundreds and hundreds of children." The official handover of the Rolls-Royce SRH to St Richard's Hospital will take place today. For more information including additional high resolution, downloadable photographs and video footage, visit our media website, PressClub - http://www.press.rolls-roycemotorcars.com You can also find the communications team at Rolls-Royce Motor Cars on Twitter and Instagram


DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "World Paediatric Vaccine Market - Opportunities and Forecasts, 2014 - 2022" report to their offering. Vaccine provides protection against particular diseases by improving immunity. Vaccines are the biological preparations of weakened or killed microorganism, its surface proteins or its toxins. The global paediatric vaccine market is expected to witness a strong growth during the forecast period due to launch of new products in the market. In-depth discussion of global paediatric vaccine market includes past and current trends with future forecast through 2020. Detailed study of market drivers, threats and opportunities would assist corporate professionals in their strategic decisions. The report also proffers detailed geographical segmentation and identifies profitable areas. The global paediatric vaccine market is expected to grow at a healthy CAGR in next few years. Increase in growth would be primarily attributed to improved understanding of immunology, which has resulted in launch of new vaccines products. Technological breakthrough has led to development of new vaccine class such as DNA vaccines, vector vaccines, intranasal vaccines, mucosal vaccines and others. However, manufacturing complexity and stringent regulatory compliance are the factors that hinder the market growth. Refusal to immunization and vaccines shortages are other restraints for this market. Emergence of vaccines as therapeutic agents has added new dimension to vaccine industry and it could be the answer to most of the chronic diseases including cancer. Alliances, partnerships and collaborations by big players to expand the business could also boost the market growth. The global paediatric vaccine market is segmented into two major categories such as type and geography. For more information about this report visit http://www.researchandmarkets.com/research/gt5m92/world_paediatric

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