| REGISTRAT-MAPI | MAPI EPI | MAPI INSTITUTE | MAPI RESEARCH TRUST | PROSANOS | JNBD | MAPI VALUES |
June 15, 2009
REGISTRAT-MAPI Becomes Industry’s Largest Global Late Phase CRO
LYON, FRANCE; LEXINGTON, KENTUCKY. In a joint statement issued today, MAPI Group (MAPI) of France announced its acquisition of controlling interest in the United States-based REGISTRAT, Inc.® (REGISTRAT). REGISTRAT-MAPI will offer global late phase research services to the biopharmaceutical and medical device industry as the industry’s largest clinical research organization (CRO) dedicated solely to “real-world” clinical research.
REGISTRAT-MAPI combines two established premier providers of late phase (peri- and post-approval) research services providing global biopharmaceutical and medical device companies a powerful new partner to meet the increasing demand to design and conduct registries, observational and epidemiological studies, and Risk Management Programs (REMS and EU-RMPs).
REGISTRAT-MAPI resources include 450 employees, nine offices, experience in more than 32 countries, and more than 40 clients including nine of the top ten biopharmaceutical firms. The senior management teams from both organizations remain intact and integrated into the new organization.
Bernard Jambon, CEO of MAPI Group and Co-CEO of REGISTRAT-MAPI explained that recent market developments and previous successful partnering efforts between the two companies convinced him and REGISTRAT founders and principals, Ron Christensen, M.D. and Stephen Webb that now was the ideal time to unite these two leading service providers. Said Jambon, “There are increasing demands on industry to enhance product safety, effectiveness, and commercialization, as well as address pressures brought on by globalization and the current economic environment. This means sponsors require a late phase partner that meets their needs for efficient strategic, international solutions. We are now that partner.”
Dr. Christensen, Co-CEO for REGISTRAT-MAPI along with Mr. Jambon, added that while REGISTRAT had been approached by potential partners over the years due to their leadership in late phase study design and execution and innovative technology support, MAPI’s late phase services were clearly the best strategic fit. “They have excellent pan-European late phase study and epidemiology experience. MAPI brings a worldwide network in patient reported outcomes (PRO), health economics, market access expertise, and linguistic validation services.”
Dr. Hubert Mechin, President, Europe remarked that REGISTRAT-MAPI provides our European clients “first class expertise in the largest market in the world.” Added Mechin, “we’re already speaking with many of them about the breadth of our new service offering.”
Stephen Webb, President, North America for REGISTRAT-MAPI, said that “our combined resources are unique and represent a major leap forward in providing full-service capabilities to our customers in a rapidly evolving regulatory and industry environment. This is a strategic opportunity to provide immediate and established operational critical mass important for global study execution.”
Peter Malamis, who is leading integration efforts of the two companies, serves as Chief Operating Officer for REGISTRAT-MAPI. “Fortunately, we’ve been collaborating for some time and have a mutual understanding and appreciation for each others systems, processes, and personnel,” said Malamis. “Most importantly, we know what we need to do to meet and exceed client expectations.”
“Current clients will see no change in their project-specific teams or processes,” said Jambon. “Current and future clients will benefit from a wealth of late phase resources never previously offered by a single CRO service provider. It is the most excited I’ve been about a new venture after more than thirty years of providing services to the biopharmaceutical industry.”
Other members of the new senior management team include: Carolyn Maki, VP, North American Business Development, Derenda Nichols, VP, North American Operations, and Dr. Xavier Fournie, VP, European Operations.
About REGISTRAT-MAPI :
Founded 30 years ago, MAPI Group is a multi-disciplinary provider of research services to the biopharmaceutical industry based in Lyon, France with offices throughout Europe, US, and Japan. Other holdings of the MAPI Group include MAPI Values, the MAPI Institute, JNBD, and ProSanos.
REGISTRAT, founded in 1997, is a full service CRO dedicated to conducting late phase clinical research to the pharmaceutical, biotechnology and medical device industries.
REGISTRAT-MAPI office locations include: Lexington, Kentucky; Philadelphia, Pennsylvania; Paris and Lyon, France; Rome, Italy; London, England; Utrecht, Netherlands; and Frankfurt, Germany.
April 29, 2009
SÆfetyWorks® Captures Prestigious Award at Industry Gathering in Boston
Harrisburg, PA. ProSanos Corporation is pleased to announce that SÆfetyWorks®, a web-based, semi-automated software system that helps scientists more quickly spot and measure the strength of associations between a drug and a medical condition found within large electronic healthcare databases was recognized by Bio-IT World during the fifth annual Best Practices Awards program last evening in Boston MA.
According to a release issued earlier today by Bio-IT World, the awards program recognizes “outstanding examples of innovation and collaboration in the deployment of technologies and novel business strategies that will advance drug discovery, biomedical research and clinical trials.” The category for which SÆfetyWorks® won the award was “Translational and Personalized Medicine”, one of eight categories in the peer-reviewed competition. GLAXOSMITHKLINE, ProSanos’ partner in the development of SÆfetyWorks®, accepted the award.
About SÆfetyWorks®
The software system, pioneered by GSK and ProSanos, is an efficient way to perform active drug surveillance and complement traditional epidemiologic studies. Using SÆfetyWorks®, drug safety experts have the unprecedented ability to ask the same safety questions of different databases in real time. Data from traditional sources, like adverse event reports and epidemiological studies, can quickly and reliably be compared with information from observational sources like insurance claims and electronic medical records. In addition, pharmacovigilance professionals are then able to refine their analysis and to control for multiple confounding factors, helping them to quickly distinguish unusual conditions that may be associated with a drug from conditions that are disease-related or limited to specific cohorts of patients. SÆfetyWorks® is available to all pharmacovigilance and epidemiology professionals.
About ProSanos Corporation
The mission of ProSanos Corporation (www.prosanos.com) is to advance patient safety and care by providing clients and partners with superior products and services for the integration, analysis, and management of healthcare-related data. Founded in 2000 and known for its innovative approach to the analysis and mining of healthcare data, the company provides products and services that promote in-depth understanding of the treatment of specific diseases and conditions. ProSanos Corporation is headquartered in Harrisburg, PA.
Inquiries:
Jonathan Morris, M.D., President and CEO
ProSanos Corporation (717) 635-2140 safety@prosanos.com
June 2008
MAPI USA
The Mapi Group is proud to announce the opening of its new office in the United States: Mapi USA Inc. Based in Philadelphia - 1818 Market Street, Peter Malamis has taken on the position of Vice President and Managing director of US Operations. This new establishment will offer to the Mapi Group promising growth prospects in the Late Phase market.
April 1, 2008
JNB-Développement has joined the MAPI Group
Today our clients have to face increased challenges in order to establish and optimize their products' place in therapeutic strategies. With current demands for health security and world-wide reform of health systems and health insurance schemes, authorities' expectations will constantly rise if they are to guarantee that patients and users benefit from health products and services of the highest standards in terms of quality, security, efficiency, utility and effectiveness.
Accordingly, the MAPI Group and the JNB-Développement (JNBD) company have announced that they are combining their activities with a view to offering health industries a wide range of services spanning the life of products and covering all facets of the development and positioning of health products.
The MAPI Group is an entrepreneurial company established in Lyon in 1974 by Bernard Jambon and Jean-Louis Ménard. The Group provides multidisciplinary services for the evaluation of health products :
MAPI has established itself internationally and is present in the United States, the United Kingdom and the Netherlands. Its expertise covers a broad range of study techniques, in particular patient questionnaires. The Group is a world wide leading player in the field of PRO (Patient Reported Outcome). MAPI has a turnover of around 45 million euros.
JNBD provides strategic consultancy to the Health Industry. Founded in 1992 by Jacques N. Biot, the company has developed services in the field of :
JNBD has a unique reputation on the market, based on its understanding of health systems at both the regulatory and economic level, and its ability to anticipate the strategic impact of our environment on therapeutic innovations. JNBD employs some fifteen consultants and in 2007 had a turnover of the order of 3 million euros.
The financial situation of both companies is healthy and they share a dedication to operational excellence. Each one, in its own domain, enjoys longstanding relations with the Industry, with health authorities, prescriptors and patients.
To combine their activities, MAPI is acquiring 100% of shares of JNBD.
Jacques N. Biot will remain as Chairman of JNBD. He will continue to develop the company whilst joining the MAPI Board of Directors.
Operational entities will keep their independence and will lead to joint development by both companies of a wider, comprehensive range of services benefiting therapeutic innovation. It will contribute to the establishment of a French group of services for the health industry, capable of competing at the international level.
July 21, 2006
Mapi Group acquires a majority interest in ProSanos Corporation
July 2, 2006
Mapi and the EMEA "Reflection Paper"
"The Regulatory Guidance' for the Use of Health-Related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products" has been distributed since January 1, 2006.
On this occasion, Mapi Values organized a debate on the 7th of February 2006 in collaboration with Mapi Research Trust, regarding implications for submission of PRO in registry files.
EMEA: Response to the draft "Reflection paper on the regulatory guidance for the use of Health-Related Quality of Life (HRQL) measures in the evaluation of medicinal products" by ERIQA Group.
Consensus Conference
"Sortie du monde hospitalier et retour au domicile d'une personne adulte évoluant vers la dépendance motrice ou posychique"
Patient satisfaction is recognized by ANAES and SFES in the recommended text. www.sfes.fr or www.anaes.fr
Forums of discussion...
will be organized as soon as the FDA publishes the Guidance document "PRO in approval and labelling of medecines."
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