New collaboration launches at ISPOR 2024, offering pharmaceutical and biotech companies rapid access to unique, customizable data and expert guidance to bridge HTA evidence gaps.

London, UK, 18 November 2024 – Leading Market Access consultancy Decisive Consulting and, uMed, a pioneering healthcare evidence-generation and technology company, have announced a strategic partnership aimed at accelerating market access initially for therapies targeting Cardiometabolic Disease (CMD) and Parkinson’s Disease (PD). 

Combining uMed’s cutting-edge data collection and linkage capabilities within these disease areas, with Decisive Consulting’s extensive expertise in navigating healthcare technology assessments (HTAs) and evolving evidence needs worldwide, this collaboration promises to address key challenges that hinder therapies from reaching patients. 

Launching officially at ISPOR Europe 2024 in November, the partnership offers a unique consultancy service that empowers pharmaceutical, biotechnology and medical device companies with fast, efficient access to both retrospective and prospective patient data, alongside expert-driven strategic recommendations. This approach is designed to identify and address critical evidence gaps, helping customers shape their market access strategies and ultimately prove value to HTA bodies. 

As the healthcare industry faces increasing pressure to prove the value of high-cost treatments, and medicines with uncertain long-term benefits, this partnership will directly address several key industry challenges. 

HTA decisions rely on comprehensive and high-quality clinical data, but real-world evidence is often lacking or incomplete. uMed’s platform links real-world, clinical and patient-generated data to provide a dynamic, customisable dataset that can be smartly adapted to meet specific HTA needs, unlike traditional static databases.  

Furthermore uMed’s direct-to-patient data collection captures outcomes that are difficult to quantify, such as quality of life and patient satisfaction, providing a clearer picture of treatment impact. 

With access to pre-consented patient cohorts, organizations will be able to rapidly gather insights that enable quicker decisions on strategic positioning and evidence requirements, providing competitive advantage in a fast-moving market.  

By aligning this unique, patient-generated data with comprehensive evaluations of evidence gaps from experienced HTA consultants who understand both the scientific and economic landscape, the partnership enables companies to mitigate gaps in their evidence base, ultimately enhancing their ability to meet HTA criteria for clinical and cost-effectiveness. Customers can also expect to receive full support for the publication of evidence, helping to translate data into actionable insights for HTA submissions. 

Dr. Matt Wilson, CEO & Founder of uMed, commented: “This partnership enables us to become an essential partner to our customers by extending our services beyond the provision of custom datasets, to now also offer meaningful insights that substantiate value propositions and improve chances of market success. This is especially timely as we see the exponential development of innovative therapies for obesity and associated cardiometabolic conditions.” 

Esther Nzenza, CEO & Founder of Decisive Consulting, added:  “This strategic collaboration enhances our shared capabilities beyond evidence strategy and into evidence action, allowing identification of gaps and rapid delivery of targeted insights to support a range of different needs. In fast-evolving fields such as CVM, addressing these gaps is often crucial for market access and HTA success. Together, we empower clients to find and proactively address evidence shortfalls, strengthen their value propositions, and improve their ability to navigate complex market access requirements” 

Dr. Matt Wilson, CEO & Founder of uMed, commented: “This partnership enables us to become an essential partner to our customers by extending our services beyond the provision of custom datasets, to now also offer meaningful insights that substantiate value propositions and improve chances of market success. This is especially timely as we see the exponential development of innovative therapies for obesity and associated cardiometabolic conditions.” 

Esther Nzenza, CEO & Founder of Decisive Consulting, added:  “This strategic collaboration enhances our shared capabilities beyond evidence strategy and into evidence action, allowing identification of gaps and rapid delivery of targeted insights to support a range of different needs. In fast-evolving fields such as CVM, addressing these gaps is often crucial for market access and HTA success. Together, we empower clients to find and proactively address evidence shortfalls, strengthen their value propositions, and improve their ability to navigate complex market access requirements” 

 

About uMed  

uMed is a leading health data platform that combines real-world evidence with patient-generated data, bridging critical evidence gaps in life science research. With a pre-consented patient cohort, uMed accelerates the collection of high-quality, customizable  data for clinical and real-world studies. 

 

About Decisive Consulting  

Decisive Consulting is a global market access consultancy with a proven track record of successfully supporting the launch of innovative medicines and technologies. Decisive specialises in helping clients anticipate requirements and navigate complexity, ensuring products meet the clinical and cost-effectiveness criteria set by HTA bodies and other decision makers. 

 

For media inquiries, please contact: 

Lucy White 

Communications Manager, uMed 

lucy.white@umed.io 

 

Samantha Shannon

Partnerships Manager, Decisive Consulting

samantha.shannon@decisiveconsulting.co.uk

uMed has announced its continued involvement in the HARMONIE infant RSV Study, contributing to the delivery of a study extension designed to support further regulatory submission.

The Company’s involvement in the HARMONIE extension project follows the successful enrollment of 735 infants into the HARMONIE Phase 3b study within just 5 months.

Supporting the extension project, uMed will collect wheeze data from the patients’ health records 24 months after their participation in the HARMONIE study

uMed’s ability to directly engage primary care practices and securely access and link health record data at speed, without the requirement to recontact participants will significantly reduce the burden on trial sites and expedite data collection. Where required, uMed will also collect secondary care data on behalf of the trial site.

Read more about uMed’s involvement in the HARMONIE Phase 3b study here. 

If you’d like to discuss how uMed can support data collection or patient recruitment for your study, please don’t hesitate to contact us. 

• Genetic samples remotely collected as part of uMed’s AccessPD Cohort to contribute to the international GP2 Program. 
• Analyses of samples will be linked back to the AccessPD Core clinical dataset (combining electronic health record data and patient reported outcomes), providing PD researchers with comprehensive resources.
• AccessPD supports GP2’s mission to expand sample collection from groups traditionally  under-represented in PD genetics studies.

Cambridge, MA, June 18 – Healthcare evidence-generation and technology company uMed today announced they have entered into a partnership with the Global Parkinson’s Genetics Program (GP2) to support expansion of the international genetic initiative. uMed will be providing access to genetic samples collected as part of their AccessPD Cohort Study. 

The Aligning Science Across Parkinson’s (ASAP) initiative launched GP2 in 2019, building on previous funding efforts from The Michael J Fox Foundation for Parkinson’s Research (MJFF).  ASAP is a coordinated research initiative to advance targeted basic research for Parkinson’s disease (PD). ASAP is devoted to accelerating the pace of discovery and informing the path to a cure for PD through collaboration, research-enabling resources, and data sharing.  

AccessPD is a unique Cohort Study of patients diagnosed with PD, that remotely collects data from pre-consented patients at home and links with EMR and clinical data to build a comprehensive regulatory grade dataset that can be further augmented with custom endpoints. 

Under the announced agreement, uMed will be contributing anonymized genetic samples, remotely collected from consented participants within AccessPD.

GP2 will perform genetic analyses of the samples to feed into the program, and results will also be linked back to additional endpoints within the AccessPD clinical dataset including ePROs, eClinROs, EHR and device data.  

The ongoing collection of genetic samples is part of the AccessPD protocol. uMed observes on average a 72% completion rate of the saliva-based genetic tests sent to patients within the cohort, highlighting the formidable engagement of participants, and the strength of uMed’s ACCESS Cohort model to build patient communities and encourage participation and retention.

Dr Matt Wilson, CEO & Founder at uMed commented “We’re delighted to be contributing to the GP2 program and excited about the impact that this partnership will have on AccessPD and the future of Parkinson’s research. AccessPD already provides researchers with a comprehensive picture of the patient, and this partnership with GP2 allows us to expedite the expansion of this rich dataset.  It’s programs like AccessPD and GP2 that will be game changing to research in the future, and we are proud to be part of the process!”

In alignment with GP2’s mission to expand global genetics studies to include populations underrepresented in research, AccessPD’s unique decentralized approach will maximise the involvement of these populations in the program.

AccessPD is underpinned by uMed’s ACCESS Research Platform which is embedded across an expansive network of healthcare institutions across the US and UK, and allows for engagement with patients on behalf of the healthcare provider.  Combined with the remote collection of data from patients at home, this approach provides access to large patient populations, including those that would normally face economic, geographical and disease-related barriers.

Press release on prweb.com

Find out more about AccessPD here, or chat to our team to discover how AccessPD can support your research goals.

uMed helps Queen Mary University of London and University College London move closer to understanding Parkinson’s risk factors as first-of-its-kind study exceeds 10,000 participant milestone

• PREDICT-PD a joint study between Queen Mary University of London and University College London (UCL), and funded by Parkinson’s UK, has met its goal of enrolling more than 10,000 participants.
• The research project, which identifies and engages people aged between 60 and 80 years old who did not have Parkinson’s, aims to identify those at high risk of the disease before symptoms appear.
• uMed enrolled over 7,000 eligible participants through its network of 500 primary care group providers in the UK, and increased monthly enrollment by 275%.
• Over one in 10 patients invited by uMed consented to participate, compared to the industry average patient consent rate of 3% for clinical research.
• uMed’s involvement also led to the enrollment of a larger population of patients from ethnic minority groups, increasing diversity from ~3% to ~10% of the study’s total cohort.

LONDON, 14 February 2024: PREDICT-PD a groundbreaking research project, which aims to identify people at higher risk of Parkinson’s disease or before the symptoms appear, has exceeded its milestone of 10,000 participants.

uMed, the health and research technology company that has supported PREDICT-PD since March 2020, played a crucial role in expanding the study’s participant base through its network of over 500 primary care provider groups representing five million patients in the UK. It achieved this by linking aggregated health record data to pre-screen eligible participants, meaning it was able to rapidly engage 36,269 patients via text message on behalf of the patients’ healthcare providers, without imposing any additional workload.

By making the study accessible to a wider population and engaging only suitable patients, uMed has recruited over 7,000 participants to PREDICT-PD, increasing monthly enrollment by a staggering 275%. Over one in 10 patients invited by uMed on behalf of their recognised healthcare provider consented to participate in the study, which is a significant achievement given that only 2% of the population in England participates in clinical trials each year, underscoring uMed’s ability to engage a larger portion of the UK population in vital clinical research.

Professor Alastair Noyce, Consultant Neurologist and Researcher at Queen Mary University of London’s Wolfson Institute of Population Health, comments: “Our study was one of the first to focus on the earliest phases of Parkinson’s, offering critical insights into this stage of the disease, and recruitment has progressed at a pace we never expected. We are another step closer to understanding who in the general population might be more likely to be diagnosed with Parkinson’s and expedite the discovery of improved treatments and, ultimately, a cure for this debilitating condition.

“The success of the PREDICT-PD study demonstrates the impact of leveraging technology and the use of health record data to accelerate research. uMed’s ability to rapidly identify large populations of eligible participants using EHR, combined with automated communication sent on behalf of the patient’s healthcare provider, has meant we’ve seen a significant increase and speed in enrollment each month since working with them.”

Dr Katherine Fletcher, Research Communications Lead at Parkinson’s UK, comments: “This is one of several ground-breaking studies Parkinson’s UK is proud to be funding and we are delighted that there’s been such a positive take-up in research participation for PREDICT-PD.”

“We know Parkinson’s doesn’t discriminate. It is vital that research is representative of the whole Parkinson’s community, something that currently is not the case. Having a wider pool of the UK population involved in clinical trials means we can ultimately learn more about the progression of Parkinson’s, speed up diagnosis and access to new and better treatments for all.”

Notably, uMed’s involvement has led to the enrollment of a large population of patients from ethnic minorities, increasing diversity of the study’s total cohort from 3% to 10%. Its technology enabled participating healthcare providers to move away from standardised patient outreach to individually tailor communications. By using Electronic Health Records (EHR) to segment cohorts into different subgroups, eligible patients could be targeted with bespoke messages or visuals, increasing participation of underrepresented groups.

Ethnic diversity is a vital issue in Parkinson’s research however people from minority backgrounds continue to be underrepresented. The large majority of UK participants are affluent, well-educated and white. This is currently reflected in research not only in the UK but across Europe and North America It means understanding the genetic basis, environmental risk factors, clinical manifestations and response to treatment is heavily biased, as described in Ethnic Variation in the Manifestation of Parkinson’s Disease, a paper co-authored by Professor Alastair Noyce.

Dr Matt Wilson, uMed’s founder and CEO, adds: “Despite a step change in awareness on the need for diverse participants, clinical trials in western health systems fail to reflect real world diversity. Particularly, there is limited evidence on the risk factors of Parkinson’s in Black, Asian and Hispanic populations but PREDICT-PD has clearly increased ethnic diversity and therefore the generalisability of its findings for the general UK population.

“The study team at Queen Mary University of London achieved this by targeting eligible participants, who identified as being from an ethnic minority, with images of ethnically diverse patients in study communications. Tailoring communications in this way resulted in a significant increase in the proportion of participants coming from a minority background.”

In addition to uMed’s collaboration with Professor Alastair Noyce on the PREDICT-PD study, he is also principal investigator on uMed’s ongoing observational study AccessPD, a next-generation patient registry supporting the development of better treatments for patients with Parkinson’s.

For more information about uMed and how the company is supporting Parkinson’s Disease research, please get in touch.