|
Mapi Values Expands Capabilities and Expertise on the U.S. West Coast [POSTED November 2011]
Mapi Values recognizes the importance of connecting locally with our clients. So that we may more easily meet your needs, on your schedule, in the Pacific and Mountain states, we have bolstered our local expertise on the West Coast for more efficient and effective partnering. Three of our team members are now based in your area to help you understand and demonstrate the treatment benefits of products from a patient perspective, by generating the evidence needed to clarify and communicate the value for decision makers. Working as part of our integrated global teams, Benjamin Banderas, Kristina Fitzgerald, and Somali Misra Burgess are bringing the full breadth of Mapi Values’ to you.
Adelphi Group company receives award from the U.S. Public Health Service for its engagement into a mission which ultimate goal is to improve public health on a global scale [POSTED October 2011]
Patrick Marquis, MD, President, Mapi Values, was honored with a governmental Challenge Coin for participation in a recent workshop. The award is given by members of the U.S. Military to dignitaries and civilians in recognition of a well-defined mission.
Dr. Marquis received the coin for “engaging the scientific and medical communities on the evidentiary basis of measures used in clinical trials, an urgent public health issue,” the documentation said.
Workshop participants discussed measurement principles for clinical outcome assessments (COAs) for use in clinical trials for new drugs. The workshop was designed to provide information and gain perspectives on various aspects of the development and implementation of COAs in the evaluation of treatment benefit. For a top line summary of the workshop please contact John Perry.
Meet us at ISPOR [POSTED October 2011]
Mapi Values will be exhibiting at ISPOR Madrid 5-8th November, along with the Mapi and Adelphi Groups.
Visit us at booth 18/19 or come along to the Issues Panel, exploring how market access strategies and regulatory practices regarding PRO endpoints have changed since the publication of the FDA draft guidance on patient-reported outcomes (PRO) and the EMA reflection paper on health-related quality of life (HRQL). Moderated by Benoit Arnould and Linda Abetz on 6 Nov 14:45-15:45.
There is also a workshop and many other poster presentations throughout the Congress, please follow the links below for full details of these events and to see which Mapi Values team members will be at ISPOR.
http://www.mapivalues.com/pdf/ISPOR2011.pdf
http://www.mapivalues.com/pdf/@ISPOR2011.pdf
For more information or to arrange a confidential meeting, please contact email Vicky Hope
Comparative effectiveness evidence: comparing apples and oranges? [POSTED October 2011]
Read the article from Jeanni Van Loon, featured on pharmaphorum.com.
Mapi Values helps Shire with FDA Advisory Committee Success [POSTED October 2011]
Shire plc, the global specialty biopharmaceutical company, announced last month that the Pulmonary-Allergy Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended, by a vote of twelve to one, that the efficacy and safety data provided substantial evidence to support approval of FIRAZYR® (icatibant injection) for the treatment of acute attacks of HAE in patients 18 years and older. In addition, by a vote of eleven to one, with one abstention, the Committee recommended self-administration of the drug by patients. Mapi Values played a key part in the validation of the primary and key secondary endpoints for the trials. Shire partnered with Mapi Values to validate the patient reported outcomes (PRO) strategy for FIRAZYR, drawing upon... READ MORE
Fundraising for the Red Cross [POSTED July 2011]
The Mapi Values UK Green Team 2011 summer fundraiser raised £113.47 for the Red Cross. The Green Team held a lunchtime juice and smoothie bar, selling healthy and tasty drinks to everyone in Adelphi. As an international company Mapi Values were keen to support the vital work of the Red Cross who help people in need around the world; responding to natural disasters and protecting people in conflict. Thank you to everyone who helped and donated time, money, and fruit!
Demonstrating Value - Start Early and Build a Story [POSTED July 2011]
Read Dr Bruce Charlesworth's recent post on pharmaphorum.com, encouraging our clients to demonstrate value throughout the development process and challenge current thinking in 'Market access'.
Senior Team Expands in Breadth & Depth [POSTED June 2011]
Recent additions to our senior team reinforce our commitment to finding and developing passionate people to provide our clients with superior services led by senior directors with real industry, research and regulatory insight.
Bonnie Teschendorf PhD, Somali Misra Burgess PhD, Alan Shields PhD all join the US business as Director, Patient Reported Outcomes and Stacie Hudgens M.A. (AbD) joins as Director, Clinical & Economic Evidence. In the UK, Professor Paul Trueman MA joins as EU Development Director and Steven Handley is now Director for Value Insight & Communication.
Our new colleagues will provide senior strategic input to projects, whilst driving continued team development and growth. We continue to offer our clients the very best in the investigation and development of scientific evidence to understand the benefit of healthcare products to both patients and decision-makers.
Charity Run [POSTED April 2011]
Mapi Values Netherlands employees ran in the Wheel of Energy 365 at Schiphol Amsterdam Airport on Tuesday 24 May 2011 to raise money for cancer research.
The Wheel of Energy 365 is an initiative from Richard Bottram. Richard’s wife Elise died of lung cancer in 2005 and since then Richard has been raising money for cancer research. His foundation sponsors projects managed by the Dutch KWF Cancer Society and the Union for International Cancer Control.
BMJ reports on Mapi Values at ISOQOL
[POSTED November 2010]
At the recent ISOQOL meeting in London, we conducted a workshop on the challenges and solutions for selecting or developing PRO measures for clinical trials involving children. The British Medical Journal reported on the workshop this week. Linda Abetz-Webb and Rob Arbuckle from Mapi Values described how researchers needed to take particular care with questionnaires to obtain valid information that reflected the experience of children and young people accurately according to their age and development. The BMJ quoted Linda reinforcing that “You shouldn’t just take a PRO instrument developed for adults and just plug it into children,” with Rob stating that “parents tend to rate a child’s level of health as worse than the child [does].” Click here to see the abstract.
A Clear Position & New Roles in ‘Market Access’ [POSTED December 2010]
A lot of companies claim to do Market Access, but no one does it like we do. Our expertise is structured into three core disciplines; Patient Reported Outcomes (PRO), Clinical & Economic Evidence (CEE), and Value Insight & Communication (VIC). These seamless divisions acknowledge the variety and depth of skills and experience required, whilst facilitating collaboration and delivering the best outcomes, whatever the challenge. To enable our work across these disciplines we are pleased to announce that Zoë Philips will take a new role leading the European Clinical & Economic Evidence Team (CEET) and developing our CEE discipline across Europe. Jeanni Van Loon and Bruce Charlesworth will take on additional responsibilities as the Global Leads for CEE and VIC respectively.
BMJ reports on Mapi Values at ISOQOL
[POSTED November 2010]
At the recent ISOQOL meeting in London, we conducted a workshop on the challenges and solutions for selecting or developing PRO measures for clinical trials involving children. The British Medical Journal reported on the workshop this week. Linda Abetz-Webb and Rob Arbuckle from Mapi Values described how researchers needed to take particular care with questionnaires to obtain valid information that reflected the experience of children and young people accurately according to their age and development. The BMJ quoted Linda reinforcing that “You shouldn’t just take a PRO instrument developed for adults and just plug it into children,” with Rob stating that “parents tend to rate a child’s level of health as worse than the child [does].” Click here to see the abstract.
Fresh Clinical Insight and Leadership for Mapi Values UK [POSTED June 2010]
In order to build upon our global reputation for quality, scientific excellence and strategic thinking we are pleased to announce the appointment of a Managing Director for our UK division; Dr Bruce Charlesworth.
With a medical degree from the University of Leeds Bruce worked as a hospital doctor and specialised in anaesthesia prior to embarking on a career in healthcare product development. Bruce brings a wealth of experience from a career spanning blue chip healthcare companies, a private equity backed start-up business, strategic consultancy and the consumer goods sector. His pharmaceutical experience includes leading the Zomig global clinical development in acute migraine, heading up a large multi-site Medical Science function within the clinical development organisation at AstraZeneca, running the Medical Affairs capabilities at Pfizer UK and implementing large scale transformation projects. He also benefits from experience in the diagnostics market, having led the growth of a start up company in this field. Bruce recently augmented his healthcare pedigree by honing his commercial, change management and strategic abilities in the strategy department of a multinational consumer goods company.
In joining the UK team, Bruce will apply a unique mix of clinical knowledge, industry insight and proven strategic leadership to develop the UK business. He hopes to further the reach of Mapi Values by working closely with clients at the right level, integrating strategic expertise, clarifying our offerings and maximising emerging business opportunities for our services – both in Patient Reported Outcomes (PRO) and Market Access. As a strong hands-on people leader Bruce also believes passionately in providing appropriate opportunities for the team, a clear vision and an enviable environment in which to work.
Mapi Values Shares Award for Top 10 Journal Article [POSTED 24 May 2010]
Research conducted by Mapi Values with Elizabeth Juniper, Jean Bousquet, Eric Bateman and the 'Gaining Optimal Asthma Control’ (GOAL) Study committee into how asthma control can be assessed, has recently been honoured with a Top 10 Cited Paper award by the journal Respiratory Medicine.
Monitoring how well a patient’s asthma is controlled has become the major focus of asthma management in recent years, and the 'Gaining Optimal Asthma Control’ (GOAL) Study was the first major international trial to investigate how asthma control, as defined in the guidelines, can be achieved. In the study analysis, Mapi Values' statistical and PRO teams worked with the other authors to determine appropriate cut-offs for well-controlled and not well-controlled asthma using the Asthma Control Questionnaire (ACQ). The resulting manuscript in the journal Respiratory Medicine has recently received a Top 10 Cited Paper award for the journal between 2006 and 2008.
Our analyses showed that the crossover point between 'well-controlled' and 'not well-controlled' is close to 1.00 on the ACQ, but to be confident that a patient has well-controlled asthma, the optimal cut-point is 0.75, and to be confident that the patient has inadequately controlled asthma, the optimal cut-point is 1.5. This knowledge of cut-points can be applied to enhance clinical decision-making, patient screening for clinical studies and the evaluation of new and existing treatments. For more information, please contact Linda Abetz.
Full citation:
Juniper EF, Bousquet J, Abetz L, Bateman ED, The Goal Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respiratory Medicine (2006) 100, 616-621.
Trials and Tribulations: Validation of PRO Endpoints within a Clinical Trial [POSTED 11 November 2009]
We are proud to introduce a new lunch and learn workshop on a topic which is becoming critical for our clients: the psychometric validation of patient-reported outcome (PRO) questionnaires within clinical trials. In addition to a robust development process that includes qualitative research with patients, the scientific community and regulators such as the FDA and EMEA highlight the need to validate a PRO measure in the targeted patient population. Standalone validation can create critical impacts on a drug development program in terms of cost as well as expensive delays in already very tight timelines. As a solution, many companies consider in-trial validation, or a “piggy-back” analysis. The information disseminated during this lunch and learn session outlines the benefits of this approach as well as crucial issues to consider a priori for the appropriate implementation, analysis and interpretation of psychometric results from PRO data collected within a clinical trial. Concrete examples and solutions are discussed.
Kathleen Rosa, PhD, Director of Psychometrics and Statistics at Mapi Values, will present the lunch and learn workshop. This workshop is complimentary for a limited time.
Please contact Kathleen Rosa to schedule your workshop in the US or Muriel Viala for Europe.
Webinar on the FDA PRO Measures Final Guidance [POSTED 11 November 2009]
The final FDA PRO guidance is now available. What is new or changed from the original draft PRO guidance? What does this final guidance mean for your future PRO endpoint submissions? Based on our unique insight and in-depth interactions with FDA, our team is organizing a Webinar to provide you our thoughts on the implications of the new guidance for industry. Three Senior Research Directors will share with you their recommendations from three complementary perspectives:
- Jane Scott PhD, former SEALD endpoint reviewer, will comment from the regulatory reviewer perspective
- Kathy Lasch PhD, with an academic experience in sociology of 20 years, will comment on the implications for qualitative research
- Kathleen Rosa PhD, senior psychometrician and statistician with 20 years CRO experience in clinical trial design and analysis, will comment on the psychometrics and analytical implications
Join us Thursday December 17th or Wednesday January 6th at 8:30 EST / 13.30 GMT / 14.30 CET or Thursday January 7th at 8:30 PST / 11:30 EST / 16.30 GMT / 17.30 CET for 1 hour and 30 minutes for this opportunity to ramp-up your understanding of how FDA reviews PRO submissions in light of the final guidance and what it takes to succeed. To join this Webinar, please RSVP to John Perry.
Mapi Values and ISOQOL Team Up to Assist Local Schools of New Orleans [POSTED 11 November 2009]
Mapi Values is pleased to announce its successful collaboration with the International Society for Quality of Life Research, ISOQOL. The long-lasting and shattering effects of Hurricane Katrina have impacted the local and surrounding communities of New Orleans since August 2005. In an effort to assist the children of a local school district, our two organizations decided to contribute essential school supplies needed on a day-to-day basis. During the ISOQOL conference held in New Orleans between 29th and 31st October, Mapi Values and ISOQOL teamed up with ISOQOL donating backpacks and Mapi Values providing school supplies suitable for students aged 6 to 14 to the Orleans Parish Public Schools. Approximately 300 bags with supplies were efficiently distributed among the children.
Pediatric PRO Research Webinar – Thursday October 8th, 2009 [POSTED 1 September 2009]
We have a team of pediatric experts with more than 20 years’ experience in developing and validating pediatric PRO primary and secondary endpoints to be used in clinical trial research. We use our knowledge of the FDA and EMEA, along with our experience in child development, to design the most appropriate pediatric PRO strategies. Please join our webinar on Thursday October 8th to learn more about how to establish developmentally appropriate pediatric PRO strategies. Topics to be covered include: choosing suitable concepts, questionnaire items and recall periods, and using age and developmentally appropriate language and response options.
For more information and details on how to join the webinar, please contact Linda Abetz-Webb.
A New Consortium in IBS and the Critical Path Institute [POSTED 1 March 2009]
Mapi Values is fully supportive of the aims of C-Path’s PRO Consortium*, and is working on ways to share our existing experience with leading a PRO consortium and how it might benefit this important initiative. We have identified the proposed working group in IBS as one potential area for collaboration. The FDA has highlighted the lack of documentation concerning the content validity of PRO endpoints in IBS in a number of reviews. As a result, many clinical programs have been delayed or are on hold. In order to speed the resolution of this situation, Mapi Values has undertaken research activities, including focus groups with IBS patients. This state-of-the-art qualitative research documents the patients’ experience of IBS symptoms and their impact in an unbiased way. We will make the data available to the PRO Consortium IBS working group when this is launched by C-Path. Meanwhile, the data may be used by our sponsors to support the content validity of the PRO endpoint in their NDA submission in any upcoming or ongoing discussions with the FDA. The data include:
-
A comprehensive literature review and critical evaluation of existing PRO instruments in IBS;
-
The results of the focus groups (four in IBS-C and four in IBS-D), conducted using the FDA standards for endpoint development and documentation;
-
Preliminary conceptual frameworks with documented evidence of saturation with regard to concepts for patient-reported symptom severity for IBS-C and IBS-D.
This strategy enables sponsors to establish a symptom assessment with documented content validity as quickly as possible, while satisfying the FDA agenda to work collaboratively on the development of PRO endpoints in IBS. If you want more information on the project or a presentation of the data, please contact us by email or phone: (+1) 617 720 0001.
* The Critical Path Institute (C-Path) is an independent, non-profit organization dedicated to implementing the FDA's Critical Path Initiative. C-Path's mission is to enable innovative collaborations between regulators, academics and the industry, to make the process of developing medical products faster, safer and smarter. C-Path has identified the development and evaluation of PRO instruments for regulatory medical decision-making and to support labeling claims as an area that would benefit from a collaborative approach.
Mapi Values expands its Market Access offering in the USA [POSTED 15 Jun 2008]
In order to better serve our US clients, we are proud to announce we have expanded our global Market Access team with US-based researchers and consultants. Together with their colleagues in the UK and the Netherlands, the US Market Access team is at the forefront of developments in methodology and policy, applying cutting-edge outcomes research techniques for Health Technology Assessment. We offer a range of services with a specific focus on Evidence synthesis, Indirect/mixed treatment comparisons and Comparative effectiveness. Our Market Access team comprises a total of more than 35 researchers and senior consultants with multi-disciplinary experience in industry, consultancy, regulatory affairs, and academia. As a global company, Mapi Values has an integrated team culture, fostering efficient international project management and delivery. Our approach ensures that we are able to effectively generate, interpret, and communicate Clinical, PRO and Health Economic evidence in order to optimize local market access for your product. For more information, contact Jeroen Jansen, PhD.
The Cancer-Related Fatigue Measurement Consortium [POSTED 1 Febuary 2008]
Mapi Values has recently launched an exciting new initiative to further the study of cancer-related fatigue (CF). The objective of the Cancer-Related Fatigue Measurement Consortium is to standardize the conceptualization and measurement of CF, to benefit clinical research and improve patient care. This work sets the foundation for inclusion of a CF measure as a Patient-Reported Outcome (PRO) endpoint in clinical trials, supporting a CF-based label claim – never yet granted by the FDA. The SEALD group of the FDA has committed to actively participating in the Consortium in order to optimize the success of this initiative.
Mapi Values gains insight on the Asian market with new office in Tokyo [POSTED 15 Nov 2007]
Mapi Values officially opened its Asian office in the Fall of 2007 in order to meet increased demand for market access and PRO services in Japan, Korea, China, Thailand, Taiwan and other countries. Since establishing a presence in Asia, Mapi Values has conducted burden of disease, cohort, medical record database and psychometric validation studies in Japan; modeling work, HTA review and workshops in Korea; PRO assessments in China and training with the Thai FDA and Japanese PMDA. Meetings with regulators and reimbursement decision makers have allowed Mapi Values to implement studies in a pragmatic and scientific manner.
During the recent ISPOR meeting in Seoul, Mapi Values’ General Manager for Asia, Bruce Crawford, ran a short course in conjunction with Watcharee Leurmankul from Family Health International Thailand, on Quality of Life Assessment and Patient-Reported Outcomes. In addition, two well-received workshop presentations were given to attendees: (1) Meta-analysis Methods that Allow for the Comparison of Interventions in the Absence of Head-to-Head Data and (2) Expert Opinion and Country Specific Model Adaptations. Mapi Values also had two posters looking at item response theory and cultural differences in the transferability of PRO data.
For more information, contact Bruce Crawford, MA, MPH in our Asian office.
|
