News Article | May 11, 2017
OrthoPediatrics Corp. was a Double Diamond sponsor of the 2017 combined EPOSNA meeting, which took place May 3 – 6 in Barcelona, Spain. This was a joint meeting of the European Paediatric Orthopaedic Society (EPOS) and the Pediatric Orthopedic Society of North America (POSNA). Over 1300 Pediatric Orthopedic Surgeons from across the United States and Europe participated in the program. OrthoPediatrics has been a leading sponsor of both organizations since the company’s inception. During the meeting, OrthoPediatrics also sponsored a lunch symposium titled “Modern Approaches to the Treatment of Complex Hip Disease”, featuring an international panel of key opinion leaders. Moderated by Dr. Pablo Castañada and Dr. Rudolf Ganger, panelists discussed diagnoses, pre-operative planning, and surgical techniques for the treatment of complex hip disease in children and adolescents. OrthoPediatrics’ CEO, Mark Throdahl said, “Our support of EPOS and POSNA, which is out of all proportion to our size, sets the priority for everything else we do. It builds corporate character and keeps us true to the cause of helping children throughout the world.” About OrthoPediatrics Corp. Founded in 2006, OrthoPediatrics is the only orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market in order to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 19 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma and deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics also has the only global sales organization focused exclusively on pediatric orthopedics and distributes its products to 34 countries outside the United States.
News Article | May 8, 2017
This program will focus on training in six subspecialties of ophthalmology including glaucoma, retina, retinopathy of prematurity (ROP), oculoplastics, pediatric cataract and strabismus. Orbis will also train the staff at the eye clinic at CTCH to screen for common eye problems seen in children in the region, including premature babies at risk of ROP—a disease that can lead to permanent blindness and is on the rise in middle-income countries like Vietnam 1. Children with more complex eye problems will be transferred to CTEH for further treatment and follow-up care if required. By leveraging the high-profile Flying Eye Hospital, the Can Tho program also helps raise awareness of the prevention and early detection of childhood blindness among the general public in the Mekong Delta region, where Can Tho is located. The Mekong Delta has a large population of around 17.5 million people in southern Vietnam2, but its rural areas are among some of the most under-resourced communities in the country. Natural disasters often affect the livelihood of local people, and pediatric eye care services are almost non-existent. It is estimated that 300,000 children in the Mekong Delta region have eye diseases3 which could otherwise prevent permanent vision loss. Treating children for eye diseases is very different from treating adults. Children's eyes are not just smaller, but they require special, trained surgical techniques, including nursing and anesthesia. Although significant progress has been made to address avoidable blindness (low vision or blindness that could be otherwise prevented or cured by known, cost-effective means) in adults in recent years, there is a shortage of trained pediatric ophthalmologists to meet the needs of the 3 million visually impaired children in the country 4. Anesthesia requirements and the need for better pediatric follow-up care remain challenging in the country, especially in the Mekong Delta region. "We are delighted to be back in Vietnam, working with the government and our partners to continue to help build capacity to prevent and manage childhood blindness," said Dr. Jonathan Lord, Orbis Global Medical Director. "We have set up six pediatric eye centers in Hanoi, Hue, Da Nang, Ho Chi Minh City, and recently in Can Tho and Binh Dinh. Our long-term goal is to develop Can Tho into a pediatric eye care hub for patients in the Mekong Delta, and progress is already underway." "Orbis began working with Vietnam's ophthalmic communities through hospital-based projects in 1996, and later a permanent office was established in Hanoi in 2003," said Huong Tran, Country Director of Orbis in Vietnam. About Orbis Orbis is a leading global non-governmental organization that has been a pioneer in the prevention and treatment of blindness for over 30 years. Orbis transforms lives by delivering the skills, resources and knowledge needed to deliver accessible quality eye care. Working in collaboration with local partners including hospitals, universities, government agencies and ministries of health, Orbis provides hands-on ophthalmology training, strengthens healthcare infrastructure and advocates for making eye health a priority. Orbis operates the world's only Flying Eye Hospital, a fully accredited ophthalmic teaching hospital on board an MD-10 aircraft. To learn more, please visit orbis.org. 1 WHO: Prevention of Blindness and Visual Impairment: Priority eye diseases – childhood blindness, from http://www.who.int/blindness/causes/priority/en/index3.html 2 General Statistics Office, Statistical Handbook of Vietnam, Hanoi: Statistical Publishing House, 2014 3 Health Policy and Strategy Institute, Situation Analysis and Paediatric Eye Care in Vietnam, 2014 4 The Rapid Assessment of Avoidable Blindness (RAAB) study, 2007 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/orbiss-flying-eye-hospital-lands-in-vietnam-300453532.html
News Article | May 11, 2017
(Prague, 11 May, 2017) Experts at the 50th Annual Meeting of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) are today warning that young children who follow a vegan diet without medical and dietary advice carry the risk of a number of nutrient deficiencies, including vitamin B12, calcium, zinc and high quality protein, which can have potentially devastating health effects. Studies have shown that children who follow a vegan diet are leaner and smaller than those children who consume meat or those who have vegetarian diets. "It is difficult to ensure a healthy and balanced vegan diet in young infants, and parents should understand the serious consequences of failing to follow advice regarding supplementation of the diet. The risks of getting it wrong can include irreversible cognitive damage and, in the extreme, death. Our advice is that if parents pursue a vegan diet for their child, they must seek and strictly follow medical and dietary advice to make sure their infant receives adequate nutrition. Both mother and infant should follow advice regarding supplementation" advises Professor Mary Fewtrell, chairman of ESPGHAN's nutrition committee comments: The biggest risk to vegan children is that of vitamin B12 deficiency. Foods derived from animals have been shown to be the only reliable source of vitamin B12 and a deficiency of the vitamin can have devastating effects. Vitamin B12 is essential to the creation of DNA, indispensable for the maintenance of the nervous system, and a lack of it can result in haematological and neurological disorders, causing damage in young children which can be irreversible. Presenting to healthcare professionals at the ESPGHAN conference today, Professor Myriam Van Winckel said: "The more restricted the diet of the child, the greater the risk of deficiency and this is by far highest in vegan children, but the risk does not stop there. Vegan mothers who breastfeed also need to be aware that their children can develop vitamin B12 deficiency between 2 and 12 months because of the lack of reserves in their body at birth, even if the mother is not showing any signs of deficiency herself." Infants on vegan diets are also at risk of protein and calcium malnutrition, a situation made worse because parents can be misled by milk supplements. Rice milk, almond milk and soy milk suggest that they are suitable substitutes for milk, but experts say these should be properly labelled as 'drinks', because their nutritional value is not comparable to milk. Maintaining healthy levels of calcium is important for ensuring lifelong normal bone density, and rickets has been found in toddlers on a calcium-deficient diet consuming large amounts of non-supplemented soy drink. However, unlike vegan diets, varied lacto (ovo) vegetarian and semi-vegetarian diets are generally safe. Although long term follow-up studies are scarce, they do not show a detrimental effect of vegetarian diets in children but instead point to beneficial health outcomes compared to omnivore diets, such as favourable lipid profile, antioxidant status, dietary fiber intake as well as tendencies towards a lower risk of being overweight. For further information, or to speak to an expert, please email email@example.com or call James M. Butcher at ESPGHAN's official press agency, Spink, on +44 (0) 1444 811 099. Myriam Van Winckel is head of paediatric gastroenterology at the University Hospital Ghent, Belgium. Her areas of interest include paediatric gastroenterology, hepatology and nutrition and parenteral nutrition and enteral feeding in children. Mary Fewtrell is Professor of Paediatric Nutrition at University College London and specialises in the nutritional programming of bone health, body composition and obesity, human lactation and the design of infant formula, complementary feeding and the duration of exclusive breastfeeding, and infant growth and its association with later-life health. She is also the Chair of ESPGHAN's Nutrition Committee. The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) is a multi-professional organisation whose aim is to promote the health of children with special attention to the gastrointestinal tract, liver and nutritional status, through knowledge creation, the dissemination of science based information, the promotion of best practice in the delivery of care and the provision of high quality education for paediatric gastroenterology, hepatology and nutrition professionals in Europe and beyond. Find out more by visiting http://www. The 50th Annual Meeting of ESPGHAN is taking place from Wednesday 10 to Saturday 13 May 2017, in Prague, Czech Republic. Every year the ESPGHAN meeting attracts the key opinion leaders in the field of Paediatric Gastroenterology, Hepatology and Nutrition from across Europe and all five continents, turning it into the largest conference of its kind worldwide. The Annual Meeting attracts over 4,000 experts from over 100 countries, all operating in the fields of Paediatric Gastroenterology, Hepatology and Nutrition, turning it into the largest conference of its kind worldwide. This year the meeting has received a record number of 839 accepted abstracts. Fewtrell, M., Bronsky, J. et al. Complementary Feeding: A Position Paper by the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) Committee on Nutrition. JPGN. 2017. V. 64. No. 1. pp. 119-132. Van Winckel, M. Vegetarian and vegan diets; pros and cons in infants, children and adolescents. Presented at the Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Prague, Czech Republic, 11 May, 2017. Van Winckel, M., Vande Velde, S. et al. Clinical practice: Vegetarian infant and child nutrition. European Journal of Pediatrics. 2011. V. 170. No. 12. pp. 1489-1494.
News Article | May 12, 2017
(Prague, May 13, 2017) The results from a Norwegian study show that a new genetic test for characterising intestinal microbiota may help to diagnose inflammatory bowel disease (IBD) in children and predict which children will develop the most extensive disease and need early, aggressive intervention. Researchers from Oslo, Norway today presented the results of a study that evaluated faecal microbiota profiles in more than 100 newly-diagnosed children with IBD and found a clear distinction between the profiles of these children and a healthy comparator group (1). The researchers also found that children with the most disturbed microbiota profiles (dysbiosis) had the most extensive IBD and were more likely to need biological therapy in the future. Speaking at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) in Prague, lead researcher, Dr Christine Olbjørn from the Department of Paediatric and Adolescent Medicine at Akershus University Hospital in Oslo said the study indicates that this type of profiling could be clinically useful in paediatric practice and long-term patient care. "IBD is often far more aggressive in children than it is in adults but it is very difficult to predict the individual disease course" she said. "We and other researchers are interested in the potential of faecal microbiota profiling to help us diagnose and manage these children and we have been helped by the availability of new genetic tests that can quantify different bacterial species in the gut." To undertake the study, Dr Olbjørn and colleagues from other specialist centres in Norway collected faecal samples from 235 children and adolescents (80 children with Crohn's disease, 27 with ulcerative colitis, three with unclassified IBD, 50 with symptoms, but no IBD diagnosis, and 75 healthy children). The samples were analysed using a new test called the GA-map™ IBD Dysbiosis Test (2), which uses advanced DNA profiling to identify up to 300 different bacteria on different taxonomic levels. The microbiota profiles were then compared between the children with IBD, those with symptoms but no IBD diagnosis, and healthy children. "We found that the probe signal intensity, which indicates the abundance of different bacterial species, was significantly reduced in the children with IBD and those with symptoms, but no IBD, compared to the healthy children", explained Dr Olbjørn. "What was perhaps more intriguing was that the children with more extensive IBD had significantly more Clostridiales, and those with extensive Crohn's disease had more Proteobacteria than children with limited disease. Children who were subsequently treated with TNF blockers had a lower diversity of Firmicutes, Tenericutes and Bacteroidetes as well as lower abundance of Actinobacteria before treatment than those who were ultimately treated with conventional medications." Dr Olbjørn believes that the results of this study add further support to the view that gut microbial dysbiosis play a key role in the pathogenesis of IBD in children. "Our findings suggest that faecal microbiota profiles may be used to identify which children are destined for a more severe form of IBD and which, therefore, need more intensive monitoring and possibly earlier, more aggressive treatment." For further information, or to speak to an ESPGHAN expert, please email firstname.lastname@example.org or call James M. Butcher on +44 (0) 1444 811 099. Download an infographic on Paediatric IBD here: http://www. Dr Olbjørn is a paediatric gastroenterologist, and has worked as a consultant at Akershus University Hospital outside of Oslo for several years. Her main interest is IBD- from diagnosis, treatment and follow-up, including transition of care from adolescence to adulthood. She is currently teaching medical students in paediatrics and working on her PhD thesis which elaborates on prognosis in IBD and how to improve individualised and personalised care. The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) is a multi-professional organisation whose aim is to promote the health of children with special attention to the gastrointestinal tract, liver and nutritional status, through knowledge creation, the dissemination of science based information, the promotion of best practice in the delivery of care and the provision of high quality education for paediatric gastroenterology, hepatology and nutrition professionals in Europe and beyond. Find out more by visiting http://www. About the 50th Annual Meeting of ESPGHAN The 50th Annual Meeting of ESPGHAN is taking place from Wednesday 10 to Saturday 13 May 2017, in Prague, Czech Republic. Every year the ESPGHAN meeting attracts the key opinion leaders in the field of Paediatric Gastroenterology, Hepatology and Nutrition from across Europe and all five continents, turning it into the largest conference of its kind worldwide. The Annual Meeting attracts over 4,000 experts from over 100 countries, all operating in the fields of Paediatric Gastroenterology, Hepatology and Nutrition, turning it into the largest conference of its kind worldwide. This year the meeting has received a record number of 839 accepted abstracts. 1. Olbjørn C, Småstuen MC, Thiis-Evensen E et al. Faecal microbiota profiles at diagnosis in paediatric inflammatory bowel disease. Prediction of disease severity and subsequent need of biologic therapy. Presented at the Annual Meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition. Prague, Czech Republic, 13 May, 2017. 2. Casén C, Vebø HC, Sekelja M et al. Deviations in human gut microbiota: a novel diagnostic test for determining dysbiosis in patients with IBS or IBD. Aliment Pharmacol Ther 2015;42(1):71-83.
News Article | May 29, 2017
A new study highlights that children suffering from inflammatory bowel disease (IBD) are not meeting the daily recommended intake of calcium and vitamin D. The research, conducted at Great Ormond Street Hospital for Children in London, identified that only 26.6% and 21.3% of paediatric IBD patients were achieving the current recommended intake for calcium and vitamin D respectively. Medical experts from United European Gastroenterology (UEG) are therefore calling for immediate intervention to ensure that paediatric IBD patients are not put at risk of experiencing poor bone health and development, calcium homeostasis imbalance and vitamin D deficiencies. Achieving optimal levels of calcium and vitamin D is essential for developing children, especially in patients with IBD, as research suggests that children and adolescents with the disease develop suboptimal bone health in comparison to their peers. Therefore, they may not achieve optimal bone mineralisation, resulting in an increased risk of permanent height deficits. Vitamin D and calcium both play a major role in bone health and recently vitamin D has shown to potentiate the effect of anti-inflammatory treatments. However, ensuring a sufficient intake of vitamin D and calcium in children can be challenging. Rita Shergill-Bonner, Principle Dietician at Great Ormond Street Hospital for Children, London, explains, "When taking into account their young age and modern eating habits, coupled with the emotional, psychological and physical stress of living with IBD, it can be hard for paediatric patients to maintain a balanced diet and a sufficient intake of the right nutrients. We therefore urge the parents and carers of paediatric IBD patients to monitor their children's diets carefully to ensure they are consuming the right foods to help their disease course and ensure adequate and normal development." There is no solitary cause of IBD but it is thought to be due to a combination of genetic and environmental factors. Incidence rates have been steadily increasing over the past few decades and one in four cases of the disease are diagnosed during childhood. Physical IBD symptoms can be extremely debilitating, including severe abdominal pain, diarrhoea, weight loss and fatigue. The disease can also have a significant impact on a patient's psychological, emotional and mental health, with over half of sufferers feeling that the disease negatively affects their education. Professor Philippe van Hootegem, UEG IBD expert comments, "There are many effective drugs available to help treat IBD but there are still a lot of unmet needs in both child and adult patients. Interesting and hopeful new drugs, some of which are to be taken orally, are in their final development stage. Nevertheless, a definitive curative therapy is not on the horizon yet and future research is still needed." "It is imperative that healthcare professionals provide all IBD patients with regular and frequent advice on nutrition and healthy eating habits, including guidance on food sources that are rich in calcium and vitamin D", adds Professor Gigi Veereman, UEG paediatric IBD expert. "Tailored care services, long-term follow up, regular reviews and frequent medical interventions are required to minimise additional health risk in our paediatric patients" May 29th is World Digestive Health Day and this year health organisations from around the world are coming together to highlight the issues affecting patients living with IBD. For further information and to schedule an interview with Professor Philippe van Hootegem, Professor Gigi Veereman or Rita Shergill-Bonner, please email email@example.com or phone Luke Paskins on +44 (0)1444 811099 Professor Philippe van Hootegem is a member of the UEG Public Affairs Committee and a Consultant Gastroenterologist at the Sint-Lucas General Hospital, Bruges, Belgium. Professor Gigi Veereman is a member of the UEG Public Affairs Committee and a Paediatric Gastroenterologist at the University Hospital, Brussels, Belgium. Rita Shergill-Bonner is a Principle Gastroenterology Dietician at Great Ormond Street Hospital for Children, London, England. UEG, or United European Gastroenterology, is a professional non-profit organisation combining all the leading European societies concerned with digestive diseases. Together, its member societies represent over 22,000 specialists, working across medicine, surgery, paediatrics, gastrointestinal oncology and endoscopy. This makes UEG the most comprehensive organisation of its kind in the world, and a unique platform for collaboration and the exchange of knowledge. Find out more by visiting http://www. To advance standards of gastroenterological care and knowledge across Europe and the world, UEG offers numerous activities and initiatives, including: 1. Shergill-Bonner R., et al. Paediatric IBD patients do not meet the daily recommendations of vitamin D and calcium intake: survey based analysis in a tertiary centre. Presented at the 12th Congress of ECCO, Barcelona, February 15-18, 2017. Available here: https:/ 2. B. Wilson, S. Lönnfors, S. Vermeire. The true impact of IBD: a European Crohn's and Ulcerative Colitis patient life. IMPACT Survey 2010-2011. Available here: http://www.
News Article | February 17, 2017
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
SMis 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 firstname.lastname@example.org Group bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email email@example.com 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 firstname.lastname@example.orgGroup bookings: Contact Ameenah Begum on: +44 (0) 20 7827 6166 or email email@example.comAbout 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
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 | February 18, 2017
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
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."