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News Article | July 17, 2017
Site: www.prnewswire.com

Mapi Language services and YPrime are leveraging cloud level integrations between technology platforms to establish a seamless operational interface between Mapi's ISO 17100 certified process and YPrime's eCOA platform facilitating Linguistic Validations and direct screenshot reviews enabling faster turnaround time and higher quality assurance of migrated instruments. The collaboration will also deliver integration for Mapi to directly develop and validate eCOAs on YPrime's platform eliminating the manual versioning and migrated questionnaire processes for new 'born on eCOA' questionnaires. The cloud facilitated integration process improves migration integrity of paper originated COAs. This expands Mapi's and YPrime's offering to support our mutual clients with simultaneous multi-lingual development of eCOAs directly on Y-Prime's platform. "Working with MAPI is part of YPrime's strategy to simplify access, and expedite start-up timelines to eCOA implementation for research organizations across the industry," said Mark Maietta, Chief Commercial Officer of YPrime. "We are thrilled about the opportunity to align our advanced platform with the largest provider of Patient-Centered Outcome instruments in this initiative. With established benefits in user experience, data quality and regulatory acceptance of eCOA solutions, I am confident this alliance will accelerate the already-burgeoning eCOA market adoption." The new process will reduce the Linguistic Validation cycle and accelerate deployment enabling quicker 'first patient in' timelines. Additionally, the alliance enables real time collaboration reducing review and correction cycles. The entire process tightly follows Mapi's ISO 17100 Certification and offers direct multi-language simultaneous development of validated eCOAs on YPrime's eCOA platform. "This collaboration demonstrates Mapi's commitment to transparency, quality and diligence in supporting our clients and YPrime's innovation in developing industry integrated platforms breaking the collaborative service barrier across COA licensing, Language Services and eCOA platform providers." Commented Elan Josielewski, Mapi's VP of Corporate Strategy and Global Marketing. About Mapi Language Services: Mapi Language Services is the worldwide leader in medical translation and linguistic validation of COAs. Mapi Language Services' experience represents more than 40,000 linguistically validated versions of over 2,500 Questionnaires into 170 languages. About YPrime For more than a decade, YPrime has specialized in providing technology and services that enable new and better ways of clinical trial information management. We design the most configurable software to meet study-specific requirements, and support the needs of sponsors, patients and sites throughout a clinical trial. YPrime's consulting services help clients use clinical systems efficiently and make informed decisions through the power of their own data.


News Article | July 10, 2017
Site: www.prnewswire.com

Register and learn more about Bridge the gap – SYNGAP, Syngap1 and the progress of the recent global registry click here The incidence of SYNGAP1 mutations reported are 1-4/10,000 individuals or approximately 1-2% of all cases of ID.  A mutation in the SYNGAP1 gene results in non-syndromic intellectual disability in children ranging from mild to severe with attention deficits, impulsivity, and/or mood disorders. Seventy to eighty percent of children with SYNGAP1 also have some type of epilepsy. "We are eager to talk with Monica Weldon and learn more of the challenges Rare Disease advocacy and driving research collaborations from the patient and care giver perspective in SYNGAP1," Commented Elan Josielewski, Mapi's VP of Strategy and Global Marketing. "Rare disease research comes with unique complexities that can delay or prevent valuable treatments from reaching patients. Engaging and working with Advocacy groups such as Bridge the Gap is critical to advancing research to improve the lives of children and their caregivers. Mapi is honored to host this webinar with Monica and promote all the amazing work she and the Bridge the gap team brings to life." About Mapi: Patients are at the heart of everything we do™ Mapi Group has over 40 years of experience supporting Life-Science companies in developing and implementing strategies for commercializing novel treatments through Strategic Regulatory Services, Pharmacovigilance,  Market Access, Language Services, and gathering Real-World Evidence on Pharmaceuticals, Biologicals, and Medical Devices. Mapi Group is the premier provider of Health Research and Commercialization services to Life-Science companies enabling Market Authorization, Market Access and Market Adoption of novel therapeutics.  Visit http://www.mapigroup.com for more information About Bridge the Gap – SYNGAP Education and Research Foundation Bridge the Gap – SYNGAP Education and Research Foundation 501(c)(3) is a non-profit organization whose mission is to serve, educate and fund research for families coping with the effects of SYNGAP1 mutations. Most children benefit from occupational, physical and speech therapy emphasizing that early diagnosis and developmental intervention is important to ensure that affected children reach their full potential. Currently there are no treatments as researchers and clinicians are still trying to understand the biology of the disease. Our international outreach for SYNGAP1 children gathers critical information, which is needed to drive research towards more immediate therapeutic solutions. Our mission is to improve the quality of life for people affected by SYNGAP1 and provide family support, accelerating research and raising awareness. Every child with SYNGAP1 provides information that can guides us to a cure.


News Article | July 27, 2017
Site: www.businesswire.com

DUBLIN--(BUSINESS WIRE)--ICON plc (NASDAQ:ICLR), a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today reported its financial results for the second quarter ended June 30, 2017. Gross business wins in the second quarter were $649 million and cancellations in the quarter were $86 million, resulting in net business wins of $563 million, a net book to bill of 1.31. In the second quarter net revenue grew 5.0% year on year to $431.0 million from $410.6 million in the same quarter last year. This represented 6.0% constant currency growth and 2.6% constant dollar organic growth year on year. Revenue outside of ICON's top customer grew 17% year over year. Income from operations, before non-recurring charges, in the quarter increased by 9.9% to $85.8 million, or 19.9% of revenue, compared to $78.0 million or 19.0% for the same quarter last year. The effective tax rate in quarter 2 was 14% and the company now expects the full year 2017 effective tax rate to be 12%. Net income, before non-recurring charges, in the quarter increased by 10.7% to $71.6 million compared with $64.7 million in the same quarter last year. Earnings per share, before non-recurring charges, increased to $1.31 per share on a diluted basis, from $1.14 per share for the same quarter last year, an increase of 14.9%. Day’s sales outstanding, comprising accounts receivable and unbilled revenue less payments on account, were 53 days at June 30, 2017, compared with 47 days at the end of March 31, 2017 and 46 days at the end of June 2016. Cash generated from operating activities for the quarter was $9.1 million. Capital expenditure for the quarter was $6.9 million. Additionally, as part of ICON’s share buy-back program, $11.7 million was spent on share repurchases in quarter two. As a result, at June 30, 2017, the company had net debt of $34 million, compared to net debt of $30 million at March 31, 2017 and net debt of $97 million at end of June 2016. During the quarter the company recorded a charge of $7.8 million in relation to restructuring costs. US GAAP income from operations after these items amounted to $78.0 million or 18.1% of revenue. US GAAP net income for the quarter was $64.8 million or $1.19 per diluted share. CEO Dr. Steve Cutler commented, “During the quarter we delivered a record $563 million of new business, representing a book to bill of 1.31. Supported by a strong trailing twelve month book to bill excluding our top customer of 1.42x, our backlog grew to over $4.4 billion, an increase of 10% year over year. In Quarter 2 revenues grew 5% over the same period in 2016, with our top customer concentration reducing to less than 20% from 28% last year and revenue growth excluding this customer increasing by nearly 17%. In addition, we expanded our market leading service offering in the fast growing late phase market by completing the acquisition of Mapi Group. This acquisition, along with our revised tax rate, means we are increasing both our full year EPS guidance to a range of $5.18 - $5.38 and our revenue guidance to a range of $1.740 billion - $1.770 billion.” In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this press release contains certain non-GAAP financial measures, including non-GAAP operating and net income and non-GAAP diluted earnings per share. While non-GAAP financial measures are not superior to or a substitute for the comparable GAAP measures, ICON believes certain non-GAAP information is useful to investors for historical comparison purposes. ICON will hold its second quarter conference call today, July 27, 2017 at 9:00 EDT [14:00 Ireland & UK]. This call and linked slide presentation can be accessed live from our website at http://investor.iconplc.com. A recording will also be available on the website for 90 days following the call. In addition, a calendar of company events, including upcoming conference presentations, is available on our website, under “Investors”. This calendar will be updated regularly. This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov. ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 84 locations in 38 countries and has approximately 12,300 employees. Further information is available at www.iconplc.com.


LYON, France, June 2, 2017 /PRNewswire/ -- Mapi Research Trust, the leading curator and license distributor of Clinical Outcome Assessments (COAs) and Mapi Language Services, the most trusted provider of linguistic validation of COAs, will present three posters at the 21st International...


The Disease Activity Score (DAS-28) was developed by Piet Van Riel and aims at following and predicting disease activity in patients with rheumatoid arthritis (RA). Since its publication in Prevoo et al., Arthritis Rheum in 1995, it has become a reference tool used in almost every clinical practice and clinical research projects in RA. It includes swollen and tender joint counts, assessment of disease activity and erythrocyte sedimentation rate (ESR), providing a 0-10 disease activity score. "Collaborating with Mapi will lead to the production of high quality and harmonized translations and electronic versions of the DAS-28 and their dissemination within the scientific community, while respecting the integrity of the original instrument," said Piet van Riel. "The distribution of the DAS-28 by Mapi Research Trust will facilitate the access to the official original questionnaire and all its derivatives such as translations and electronic versions through an easy and controlled access," said Katrin Conway, Managing Director of the Mapi Research Trust. "The DAS-28, largely used both in clinical research and practice for twenty years, deserves the highest linguistic validation and electronic migration standards established by Mapi, for the benefit of the whole scientific community," added Ana Bayles, Global Director – Mapi Language Services. Mapi is organizing an author webinar on the DAS-28 on July 13rd during which Prof Dr Piet van Riel will present the instrument and its advantages for clinical practice and research. To register for free to this webinar, please consult http://mapigroup.com/eventcalendar/author-webinar-disease-activity-score-das-28/ For any request about the DAS-28 or to view the DAS-28's description, please consult https://eprovide.mapi-trust.org/ Mapi Language Services is the worldwide leader in medical translation and Linguistic Validation of COAs for nearly 3 decades. Mapi has first-hand knowledge of local languages and cultures, regulations, and healthcare practices. We work in close collaboration with developers, assure conceptual equivalence and international harmonization of all language versions. Mapi Language Services' experience represents more than 40,000 translated versions of 2,500 Questionnaires in 170 languages.  Visit http://www.mapigroup.com for more information. Mapi Research Trust is a Non-Profit arm of Mapi Group and works in collaboration with Academic Researchers, Life-Science Companies and Regulatory bodies. It is the largest curator of Clinical Outcomes Assessments (COA) and their translations, the largest single COA licensing provider and the most trusted name in distribution of COA instruments exclusively representing over 300 questionnaires.  Visit http://mapi-trust.org/ for more information. Professor Dr Piet van Riel is Rheumatologist at the Radboud University Nijmegen, the Netherlands. Some of his current activities are President of the DREAM-RA registry and practicing rheumatologist at Bernhoven, Uden, The Netherlands. Prof Dr van Riel is an active member of many professional societies, including the Dutch Society of Rheumatology, of which he was Chairman from 2003 up to 2009, the American College of Rheumatology and the British Society of Rheumatology. From 1999 to 2003 he was Chairman of the EULAR Standing Committee for International Clinical Studies Including Therapeutic Trials. Prof Dr van Riel's research interests include clinical research in rheumatology, clinical pharmacology and clinimetrics.  He is on the editorial board of a number of journals, and has authored or co-authored several books and over 700 international publications. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mapi-research-trust-appointed-as-exclusive-distributor-and-mapi-language-services-as-exclusive-translator-of-the-disease-activity-score-das-28-300484190.html


News Article | July 27, 2017
Site: www.businesswire.com

DUBLIN--(BUSINESS WIRE)--ICON plc, (NASDAQ:ICLR) a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that it has acquired the Mapi Group, a leading Patient-Centered Health Outcomes Research and Commercialisation company. The acquisition strengthens ICON’s existing Commercialisation and Outcomes Research business adding significant commercialisation presence, analytics, real world evidence generation and strategic regulatory expertise. The combined organisation will be a leader for real world evidence, post approval research, language services, consultancy services supporting clinical outcomes assessments, pricing and market access and scientific communications. The acquisition also enables ICON to have direct access to Mapi Research Trust, the industry’s most subscribed library of Clinical Outcomes Assessments (COAs), with exclusive distribution of over 300 families of validated questionnaires, including licensing of COA services used by commercial, academic and regulatory research organisations. "The late phase CRO market continues to grow as our customers face greater scrutiny from regulators and reimbursement bodies around real-world evidence of product value and safety,” commented Dr. Steve Cutler, Chief Executive Officer, ICON plc. “The acquisition of Mapi extends the breadth and depth of ICON’s late phase capabilities, creating an industry leading provider of post-approval research, spanning evidence generation, strategic regulatory services, scientific communications and commercial strategy. Our customers will also benefit from ICON’s access to the industry’s broadest set of COA tools and instruments as well as new and enhanced real world data sets. Mapi has been a pioneer of late phase and outcomes research since their foundation and we are delighted to welcome their team of experts to ICON.” “By combining with ICON, our customers will have access to a broader global footprint, additional depth of experience, new scientific communication services and access to innovative solutions to capture real world data from patients," commented James Karis, CEO of Mapi Group. “In addition, our customers will have access to a wide range of global clinical services, spanning all phases of development. Mapi and ICON are an ideal combination, having complimentary services and a shared mission to provide superior research solutions that help improve the lives of patients globally." “I am delighted that Mapi will become part of ICON, a company that has a similar culture and vision that will enable Mapi to continue the focus on innovation that we have developed over the last forty-three years,” commented Bernard Jambon, Mapi’s founder and Chairman of the Board of Directors. Mapi Group has over 40 years of experience supporting Life-Science companies as the world leading Patient-Centered Research company in commercializing novel treatments through Real-World Evidence, Strategic Regulatory Services, Pharmacovigilance, Market Access, Language Services. Mapi Group is the premier provider of Health Research and Commercialization services to Life-Science companies enabling Market Authorization, Market Access and Market Adoption of novel therapeutics. Visit http://www.mapigroup.com for more information. ICON plc is a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development - from compound selection to Phase I-IV clinical studies. With headquarters in Dublin, Ireland, ICON currently, operates from 84 locations in 38 countries and has approximately 12,300 employees. Further information is available at www.iconplc.com This press release contains forward-looking statements. These statements are based on management's current expectations and information currently available, including current economic and industry conditions. These statements are not guarantees of future performance or actual results, and actual results, developments and business decisions may differ from those stated in this press release. The forward-looking statements are subject to future events, risks, uncertainties and other factors that could cause actual results to differ materially from those projected in the statements, including, but not limited to, the ability to enter into new contracts, maintain client relationships, manage the opening of new offices and offering of new services, the integration of new business mergers and acquisitions, as well as economic and global market conditions and other risks and uncertainties detailed from time to time in SEC reports filed by ICON, all of which are difficult to predict and some of which are beyond our control. For these reasons, you should not place undue reliance on these forward-looking statements when making investment decisions. The word "expected" and variations of such words and similar expressions are intended to identify forward-looking statements. Forward-looking statements are only as of the date they are made and we do not undertake any obligation to update publicly any forward-looking statement, either as a result of new information, future events or otherwise. More information about the risks and uncertainties relating to these forward-looking statements may be found in SEC reports filed by ICON, including its Form 20-F, F-1, S-8 and F-3, which are available on the SEC's website at http://www.sec.gov.


News Article | August 17, 2017
Site: globenewswire.com

NESS ZIONA, Israel, Aug. 17, 2017 (GLOBE NEWSWIRE) -- Mapi Pharma Ltd., a privately held, fully integrated, clinical stage biopharmaceutical company has completed an investment round of $10 million by aMoon Fund. aMoon Fund is an Israeli investment firm focused on innovative Israeli healthcare and life science ventures, founded by Marius Nacht and Dr. Yair Schindel. Mapi Pharma is engaged in the development of high barrier-to-entry, high added-value lifecycle management pharmaceuticals and complex active pharmaceutical ingredients (“APIs”) and formulations. The funds raised will support Mapi’s future development and enable the initiation of the Phase III trial for the company’s lead product, Glatiramer Acetate (Copaxone®) Depot, or GA Depot, for the treatment of multiple sclerosis (MS).  Mapi Pharma recently completed a successful Phase II, open-label, two arm, multicenter, study to assess safety, tolerability, and efficacy of once-a-month, long-acting IM (intramuscular) injection of 80mg or 40mg glatiramer acetate in patients with relapsing remitting multiple sclerosis (RRMS). “I am pleased the aMoon Fund team has decided to invest in Mapi and support our future plans. Their commitment to the company is a strong testament to the promise inherent in our clinical assets and technology platform. Their investment will enable us to advance the development of GA Depot as a potential treatment for multiple sclerosis,” said Ehud Marom, Chairman and CEO of Mapi. “The aMoon Fund was established in order to enable exceptional Israeli healthcare companies to raise the needed funding and achieve their next significant leap. The life science industry is one of Israel’s most invaluable assets for future economic growth and Israeli investors should make sure it is not lagging behind the rest of the world due to under investments,” said Dr. Yair C. Schindel, Managing Partner at aMoon. “We saw in Mapi all the necessary ingredients to build a fully-integrated Israeli-based but global pharmaceutical company, including its management, IP, technology, product pipeline and facilities. Our goal is to support Mapi’s development and production into Phase III.” Mapi is a clinical stage pharmaceutical company, engaged in the development of high barrier-to-entry and high added-value life cycle management (“LCM”) products that target large markets and generic drugs that include complex active pharmaceutical ingredients (“APIs”) and formulations. The GA Depot injection, administered once every four weeks, is the first in a series of depot long-acting injections in the company’s pipeline, for the treatment of MS. The product is an LCM of Copaxone®, which requires injections daily or every other day. Mapi is built on strong chemical and pharmaceutical R&D capabilities, a deep understanding of the global market and of regulatory needs and its ability to foster local cooperation and enduring relationships in all of the countries in which it operates. Mapi is headquartered in Israel, with R&D facilities in Israel and China, and an API production facility in the Neot-Hovav Eco Industrial Park south of Beersheba, Israel. Mapi has a strong IP position, filing numerous patent applications for APIs and formulations. For more information, please visit: www.mapi-pharma.com. Founded in 2016 by Marius Nacht, Chairman of Check Point, and Dr. Yair C. Schindel, former CEO of the National Bureau “Digital Israel”, CEO of Start-up Nation Central, investor and board member in successful healthcare start-ups.  aMoon Fund is an investment management firm operating in the Israeli healthcare and life science sector, focusing on companies which offer either life-saving solutions or significant cost savings for global healthcare systems. The goal of the fund is to turn Israel into a major contributor in global healthcare, and fuel the development of cutting edge innovations that will increase the number of individuals leading healthier, longer and more productive lives.


"Mapi has been the industry innovator and leader in Patient Centered Research longer than most CROs have existed " said Will Maier, Chief Scientific Officer of Mapi. "Through this new business unit we help our clients seamlessly integrate and align Patient Centered Sciences; developing the most complete understanding of patients, their behaviour and preferences, integrating relevant Clinical Outcomes to support endpoints and value based treatment, as well as execute on these combined insights with the industry's most experienced Direct to Patient Contact experts. Mapi is considered the regulatory and peri- and post-approval research experts, enabling our clients to meet the evidence demands of both regulators and payers for over four decades." Experts from the new unit will be presenting at the annual June meeting of the Drug Information Association (DIA) in Chicago. About Mapi: Patients are at the heart of our research Mapi Group has over 40 years of experience supporting Life-Science companies in developing and implementing strategies for commercializing novel treatments through Strategic Regulatory Services, Pharmacovigilance,  Market Access, Language Services, and gathering Real-World Evidence on Pharmaceuticals, Biologics, and Medical Devices. Mapi Group is the premier provider of Health Research and Commercialization services to Life-Science companies enabling Market Authorization, Market Access and Market Adoption of novel therapeutics.  Visit http://www.mapigroup.com for more information. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/mapi-creates-dedicated-patient-centered-sciences-unit-by-combining-patient-centered-outcomes-patient-insights-and-engagement-and-direct-to-patient-contact-services-300475033.html


Jansen J.P.,Mapi | Jansen J.P.,Tufts University | Naci H.,The London School of Economics and Political Science
BMC Medicine | Year: 2013

Background: In the last decade, network meta-analysis of randomized controlled trials has been introduced as an extension of pairwise meta-analysis. The advantage of network meta-analysis over standard pairwise meta-analysis is that it facilitates indirect comparisons of multiple interventions that have not been studied in a head-to-head fashion. Although assumptions underlying pairwise meta-analyses are well understood, those concerning network meta-analyses are perceived to be more complex and prone to misinterpretation.Discussion: In this paper, we aim to provide a basic explanation when network meta-analysis is as valid as pairwise meta-analysis. We focus on the primary role of effect modifiers, which are study and patient characteristics associated with treatment effects. Because network meta-analysis includes different trials comparing different interventions, the distribution of effect modifiers cannot only vary across studies for a particular comparison (as with standard pairwise meta-analysis, causing heterogeneity), but also between comparisons (causing inconsistency). If there is an imbalance in the distribution of effect modifiers between different types of direct comparisons, the related indirect comparisons will be biased. If it can be assumed that this is not the case, network meta-analysis is as valid as pairwise meta-analysis.Summary: The validity of network meta-analysis is based on the underlying assumption that there is no imbalance in the distribution of effect modifiers across the different types of direct treatment comparisons, regardless of the structure of the evidence network. © 2013 Jansen and Naci; licensee BioMed Central Ltd.


NEW YORK, Nov. 15, 2016 /PRNewswire/ -- Nearly half of surveyed manufacturing executives lack confidence their assets are protected from external threats, according to a new study from Deloitte and the Manufacturers Alliance for Productivity and Innovation (MAPI) on "Cyber Risk in...

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