Digital Health Technologies Hold Key to New Parkinson’s Treatments

Global stakeholders come together to collaborate with urgency to address unmet needs for Parkinson’s therapies.

TUCSON, Ariz., July 20, 2021 — The use of digital health technologies across health care and drug development has accelerated. A new paper titled “Digital Progression Biomarkers as Novel Endpoints in Clinical Trials: A Multistakeholder Perspective,” co-authored by experts across diverse disciplines, highlights how new remote monitoring technologies present a tremendous opportunity to advance digital medicine in health care even further, specifically in Parkinson’s disease. This perspective paper is co-authored by the academic leader of the largest funded project for digital technologies in Europe, Professor Lynn Rochester, University of Newcastle; European Medicines Agency (EMA) scientific leader, Dr. Maria Tome; young investigator and Ph.D. candidate Reham Badawy; physician and Parkinson’s patient, Dr. Soania Mathur; and Dr. Diane Stephenson, Executive Director of the Critical Path for Parkinson’s (CPP) Consortium.

Global collaborative efforts are underway with the goal of advancing the use of digital health technologies for use in Parkinson’s clinical research and therapeutic trials — yet several gaps and barriers stand in the way of success. These include data security issues, the rapidly evolving nature of the technology, lack of consensus on data standards, vast diversity of distinct studies carried out on different devices and the need for open science.

CPP’s Digital Drug Development Tool team at Critical Path Institute consists of industry members, scientific academic advisors, patient research organizations and people living with Parkinson’s all collaborating across the globe to seek advice early and often from regulatory agencies. Companies advancing innovative therapies for the treatment of Parkinson’s see the promise of digital technologies, yet they also recognize that there are gaps that are too challenging to overcome on their own. CPP’s focus on the voice of people living with Parkinson’s aligns with the U.S. Food and Drug Administration (FDA) and EMA’s vision for patient-focused drug development. Sharing costs, risks and knowledge will streamline a more efficient runway for regulatory endorsement in the future.

“We felt it was imperative to come together on this paper, at this moment, to bring attention to how existing digital health technologies can complement traditional modalities and transform and accelerate clinical research and therapeutic development,” said Rochester.

Dr. Mathur, who has lived with Parkinson’s for 22 years, inspired the team of five women leaders to work on this paper across different countries during the pandemic. “It is vital to include the patient voice to drive the sense of urgency when it comes to Parkinson’s research. As patients, we fully experience the unrelenting progression of this disease, the ongoing daily challenges that we live with. From the direction of research to identifying the tools that can estimate relevant outcome measures in the search for new therapeutics that are directed towards disease modification or improved quality of life, patient input is absolutely integral to its success. This collaboration kept that sense of urgency at the forefront.”

“EMA works with the FDA to assure that digital technologies are aligned with what is important to patients,” said Dr. Tome. “The pace of progress is going to be accelerated by applying principles of what it took the world to tackle the COVID-19 pandemic,” Stephenson added. “True collaborations amongst all stakeholders are urgently needed to make efficient progress, avoid duplication of effort, share costs and risks and advance with warp speed.”

Professor Bas Bloem, editor-in-chief of the Journal of Parkinson’s Disease and author of the book “Ending Parkinson’s Disease” said, “We are very excited to publish this very important paper in our journal, as it provides a clear and visionary glimpse into the future of better care and innovative research approaches in the field of Parkinson’s disease.”

The paper is featured in Journal of Parkinson’s dedicated issue Digital Health in Parkinson’s Disease here https://content.iospress.com/articles/journal-of-parkinsons-disease/jpd202428. For more information, visit CPP’s website or read Digital Technology Driving Tangible Advancements in Parkinson’s Disease Research and Clinical Care.

Critical Path Institute is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) and is 56.5% funded by FDA/HHS, totaling $16,749,891, and 43.5% funded by non-government source(s), totaling $12,895,366. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. Government. For more information, please visit FDA.gov.

The views expressed in this release are the personal views of the authors and may not reflect the position of the various groups or parties represented.


About CPP

Created in partnership with Parkinson’s UK, one of the world’s largest charity funders of Parkinson’s research, the Critical Path for Parkinson’s Consortium was launched on October 14, 2015. This is a global collaboration that promises to pave the path to new treatments for Parkinson’s. By facilitating collaboration among scientists from the bio-pharmaceutical industry, academic institutions, government agencies, and patient-advocacy associations, CPP fosters consensus and data-driven research to increase efficiency, safety, and speed in developing new therapies.

About C-Path

Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona and C-Path, Ltd. EU is headquartered in Dublin, Ireland, with additional staff in multiple other locations. For more information, visit c-path.org and c-path.eu.

Media Contact:

Kissy Black
C-Path
615.310.1894
kblack@c-path.org

First-ever biomarker qualified for Parkinson’s is a vital step toward improved clinical trials

FOR IMMEDIATE RELEASE

Contact:
Kissy Black
615.298.1144
kissyblack@lotosnile.com

 

Tucson, AZ — July 26, 2018 – The Critical Path Institute’s (C-Path) Critical Path for Parkinson’s Consortium (CPP), in partnership with Parkinson’s UK, announces that the European Medicines Agency (EMA) has issued a positive qualification opinion on an imaging test (biomarker) as a tool to enrich Parkinson’s clinical trials. The purpose of this enrichment biomarker is to serve as a measurement that can be used to select people with Parkinson’s who are most suitable to take part in clinical trials.

The biomarker is used to determine the presence of dopamine transport deficiency in the brain, and has been qualified as an enrichment biomarker for clinical trials targeting early stages of Parkinson’s soon after diagnosis. The qualified biomarker involves the intravenous injection of a small amount of a radioactive tracer before the brain images are acquired, and can be done at any one of many specialist imaging centers. The imaging agent binds very specifically to dopamine transporter sites on the neurons that are lost in Parkinson’s disease. The use of this biomarker can help better identify patients that are more likely to exhibit significant progression in their motor signs and symptoms, thus helping select patients for clinical trials. The CPP consortium is a global public-private partnership consisting of industry, academics, advocacy organizations, and government agencies collaborating to develop solutions to optimize drug development for Parkinson’s. This qualification represents a major milestone in this regard as the first biomarker for Parkinson’s to receive such a regulatory designation. In 2015, the U.S. Food and Drug Administration issued a letter of support for the use of this imaging biomarker for use in Parkinson’s clinical trials.

“This endorsement from the European Medicines Agency represents many years of hard work and incredible collaboration among companies, universities, and charities facilitated by the Critical Path Institute,” says Dr. Diane Stephenson, Executive Director of CPP, who led the work. “These brain scans in themselves are not new, but until now there has not been a clear consensus that they can and should be used to select participants for clinical trials. Through our global project, we’ve been able to bring all the data and expertise together to make a powerful case, so we’re delighted that this endorsement from the EMA will improve the quality and chances of success for future trials of Parkinson’s treatments. This success is just the first in a suite of new tools that we hope to deliver for Parkinson’s.”

Studies suggest that up to 15% of individuals taking part in clinical trials for new Parkinson’s treatments may not exhibit a measurable progression in motor signs and symptoms over the course of such trials. Furthermore, the rate of uncertainty in predicting disease progression is higher at earlier stages of the condition. These individuals are extremely unlikely to benefit from the new therapies being tested, and their inclusion can affect both the trial results and, ultimately, the future of the potential treatment.
Professor David Dexter, Deputy Research Director of Parkinson’s UK, which funds CPP, comments, “Scientific breakthroughs mean that there is now a new wave of exciting treatments that genuinely could slow, stop, or reverse the condition, but it’s crucial that we’re able to test them properly in clinical trials. Being able to rule out individuals who are unlikely to have Parkinson’s could be the difference between a successful trial and failure. This is a vital step forward in our mission to deliver, as quickly as possible, better treatments, and one day a cure, to people living with Parkinson’s.”

Because Parkinson’s is a progressive condition caused by the gradual loss of cells in the brain, the best chance to intervene with treatments that can slow, stop, or reverse damage is during the earliest stages of the condition. During these early stages, however, signs, and symptoms tend to be mild, which makes selecting the right people to participate in trials very difficult.

“The use of these brain scans is already being included in new clinical trials at Biogen.” said Dr. Michael Ehlers, Executive Vice President of Research and Development at Biogen. “We believe that this new approach will introduce greater efficiency in terms of cost and speed, while ensuring that the right patients are being included in our trials.”


About the Organizations:

C-Path (Critical Path Institute) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include over 1,500 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and dozens of pharmaceutical and biotech companies. C-Path is headquartered in Tucson, Arizona, with additional staff in multiple remote locations. For more information, visit www.c-path.org.

Every hour, someone in the UK is told they have Parkinson’s.

It affects 127,000 people in the UK – which is around one in 500 of the population.

Parkinson’s is a degenerative neurological condition, for which there currently is no cure. The main symptoms of the condition are tremor, slowness of movement and rigidity.

Parkinson’s UK is the UK’s leading charity supporting those with the condition. Its mission is to find a cure and improve life for everyone affected by Parkinson’s through cutting edge research, information, support and campaigning.

For advice, information and support, visit www.parkinsons.org.uk or call our free, confidential helpline on 0808 800 0303.

Parkinson’s UK Contact:
Molly Horsburgh
Senior Media and PR Officer
0207 963 9351
mhorsburgh@parkinsons.org.uk
Out of hours: 07961 460248

Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials

Oct 10, 2016

 

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Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials

 

London and Tucson, Ariz., October 10, 2016 — The Critical Path Institute (C-Path), in partnership with Parkinson’s UK, announced today that the European Medicines Agency (EMA) has issued a letter of support for Parkinson’s disease (PD). EMA is supporting the use of an imaging biomarker as a tool to help researchers select people in the earliest stages of PD to participate in clinical trials of new treatments for the condition.

The EMA issued a letter of support on Oct 7, 2016, supporting the use of neuroimaging biomarker dopamine transporter imaging as an exploratory biomarker for early PD. The public letter was issued to the Critical Path for Parkinson’s Consortium (CPP), in response to the consortium’s submission of data supporting the use of the biomarker.

Dopamine transporter activity, as assessed by single-photon emission computed tomography (SPECT) imaging, measures the expression of dopamine nerve terminal function in the living brain. Low levels of dopamine transporter binding serve as a marker of the loss of dopamine nerve terminals, a hallmark of PD. Use of this biomarker in patients at the time of early clinical presentation will help to identify patients who are likely to show clinical progression of motor symptoms.

The letter of support is a step along the way to CPP’s ultimate goal of achieving biomarker qualification with EMA and FDA. Why is EMA qualification significant? According to Dr. Arthur Roach, Director of Research at Parkinson’s UK, qualification would relieve trial sponsors of the burden of having to convince the regulators that the biomarkers are reliable and reproducible every time they run a trial. “Qualification could save both the regulators and sponsors a tremendous amount of time and money.” CPP’s executive director, Diane Stephenson, states: “Parkinson’s disease treatments are urgently needed, and shaving off time and cost serves to incentivize companies to invest in more trials…. More shots on goal mean more chances of getting approved drugs past the finish line.”

Professor Donald Grosset, University of Glasgow, a key global leader in Parkinson’s disease research that is contributing data to CPP, commented that embedding biomarkers in clinical trials, with support from regulatory agencies, could ultimately facilitate their use as both prognostic and therapeutic indicators. “This will all happen more quickly due to the significant progress we are making in sharing data across several major studies,” Grosset wrote. “This action from the EMA is certainly good news for the field.”

In 2015, the US Food and Drug Administration (FDA) issued a letter of support for this same biomarker and its application in drug development. These letters convey that the FDA and EMA recognize the potential value of a biomarker and encourage its further evaluation. A total of seven FDA and three EMA letters of support have been issued to C-Path.

Global regulatory agencies see value in compiling data from several sponsors in a noncompetitive setting, rather than receiving data from one sponsor at a time in support of biomarker qualification. Integration of data across different clinical trials and longitudinal studies is a core competency of C-Path and a key goal of the multinational CPP.

About the organizations:

pr-c-path-logo

C-Path (Critical Path Institute) is an independent, nonprofit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the US Food and Drug Administration (FDA). C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established 12 global, public-private partnerships that currently include over 1,450 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona. For more information, visit www.c-path.org.


 

pr-c-path-logo

Every hour, someone in the UK is told they have Parkinson’s.

It affects 127,000 people in the UK—which is around one in 500 of the population.

Parkinson’s is a degenerative neurological condition, for which there currently is no cure. The main symptoms of the condition are tremor, slowness of movement and rigidity.

Parkinson’s UK is the UK’s leading charity supporting those with the condition. Its mission is to find a cure and improve life for everyone affected by Parkinson’s through cutting edge research, information, support and campaigning.
For advice, information and support, visit www.parkinsons.org.uk or call our free, confidential helpline on 0808 800 0303.

C-Path Contact:
Kissy Black
+1.615.298.1144
kissyblack@lotosnile.com

 

Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials

Oct 10, 2016

 

pr-c-path-logo gaain

 

Critical Path for Parkinson’s Consortium achieves regulatory support in Europe for use of imaging biomarker in Parkinson’s disease clinical trials

 

London and Tucson, Ariz., October 10, 2016 — The Critical Path Institute (C-Path), in partnership with Parkinson’s UK, announced today that the European Medicines Agency (EMA) has issued a letter of support for Parkinson’s disease (PD). EMA is supporting the use of an imaging biomarker as a tool to help researchers select people in the earliest stages of PD to participate in clinical trials of new treatments for the condition.

The EMA issued a letter of support on Oct 7, 2016, supporting the use of neuroimaging biomarker dopamine transporter imaging as an exploratory biomarker for early PD. The public letter was issued to the Critical Path for Parkinson’s Consortium (CPP), in response to the consortium’s submission of data supporting the use of the biomarker.

Dopamine transporter activity, as assessed by single-photon emission computed tomography (SPECT) imaging, measures the expression of dopamine nerve terminal function in the living brain. Low levels of dopamine transporter binding serve as a marker of the loss of dopamine nerve terminals, a hallmark of PD. Use of this biomarker in patients at the time of early clinical presentation will help to identify patients who are likely to show clinical progression of motor symptoms.

The letter of support is a step along the way to CPP’s ultimate goal of achieving biomarker qualification with EMA and FDA. Why is EMA qualification significant? According to Dr. Arthur Roach, Director of Research at Parkinson’s UK, qualification would relieve trial sponsors of the burden of having to convince the regulators that the biomarkers are reliable and reproducible every time they run a trial. “Qualification could save both the regulators and sponsors a tremendous amount of time and money.” CPP’s executive director, Diane Stephenson, states: “Parkinson’s disease treatments are urgently needed, and shaving off time and cost serves to incentivize companies to invest in more trials…. More shots on goal mean more chances of getting approved drugs past the finish line.”

Professor Donald Grosset, University of Glasgow, a key global leader in Parkinson’s disease research that is contributing data to CPP, commented that embedding biomarkers in clinical trials, with support from regulatory agencies, could ultimately facilitate their use as both prognostic and therapeutic indicators. “This will all happen more quickly due to the significant progress we are making in sharing data across several major studies,” Grosset wrote. “This action from the EMA is certainly good news for the field.”

In 2015, the US Food and Drug Administration (FDA) issued a letter of support for this same biomarker and its application in drug development. These letters convey that the FDA and EMA recognize the potential value of a biomarker and encourage its further evaluation. A total of seven FDA and three EMA letters of support have been issued to C-Path.

Global regulatory agencies see value in compiling data from several sponsors in a noncompetitive setting, rather than receiving data from one sponsor at a time in support of biomarker qualification. Integration of data across different clinical trials and longitudinal studies is a core competency of C-Path and a key goal of the multinational CPP.

About the organizations:

pr-c-path-logo

C-Path (Critical Path Institute) is an independent, nonprofit organization established in 2005 with public and private philanthropic support from the Arizona community, Science Foundation Arizona, and the US Food and Drug Administration (FDA). C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established 12 global, public-private partnerships that currently include over 1,450 scientists from government and regulatory agencies, academia, patient advocacy organizations, and dozens of major pharmaceutical companies. C-Path is headquartered in Tucson, Arizona. For more information, visit www.c-path.org.


 

pr-c-path-logo

Every hour, someone in the UK is told they have Parkinson’s.

It affects 127,000 people in the UK—which is around one in 500 of the population.

Parkinson’s is a degenerative neurological condition, for which there currently is no cure. The main symptoms of the condition are tremor, slowness of movement and rigidity.

Parkinson’s UK is the UK’s leading charity supporting those with the condition. Its mission is to find a cure and improve life for everyone affected by Parkinson’s through cutting edge research, information, support and campaigning.
For advice, information and support, visit www.parkinsons.org.uk or call our free, confidential helpline on 0808 800 0303.

C-Path Contact:
Kissy Black
+1.615.298.1144
kissyblack@lotosnile.com

The Michael J. Fox Foundation for Parkinson’s Research Joins Multinational Critical Path for Parkinson’s Consortium

May 19, 2016

 

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The Michael J. Fox Foundation for Parkinson’s Research Joins Multinational Critical Path for Parkinson’s Consortium

  • Consortium, led by Parkinson’s UK and the Critical Path Institute, aggregates and analyzes study data to develop a model for quantitative characterization of Parkinson’s progression
  • This asset would enrich the design of trials for novel therapies
  • Consortium will work with international regulators for acceptance of a quantitative model to streamline review processes

 

NEW YORK, LONDON AND TUCSON (May 18, 2016) — The Michael J. Fox Foundation for Parkinson’s Research (MJFF), with Parkinson’s UK and the Critical Path Institute (C-Path) in Tucson, Arizona, announce that MJFF has joined the Critical Path for Parkinson’s Consortium (CPP). The consortium aims to create a quantitative model of Parkinson’s progression from its earliest stages that will allow researchers to optimize clinical trial design for faster and more effective testing of novel therapies.

Parkinson’s UK and C-Path launched the CPP in October 2015, and seven major pharmaceutical companies, the Parkinson’s Disease Foundation, the Davis Phinney Foundation and Cure Parkinson’s Trust have subsequently signed on to the initiative.

“More therapies with potential to slow or stop Parkinson’s progression in its early stages are moving through clinical trials,” said MJFF Senior Vice President of Research Programs Mark Frasier, PhD. “A quantitative characterization of that early progression would help evaluate the impact of these treatments and usher effective therapies to the people who need them.”

Currently clinical trials for potential new therapies are time-consuming and costly. Due to the variability in Parkinson’s symptoms and progression and the lack of objective biomarkers, trials must enroll hundreds of patients and follow them for many months if not years. Development of a quantitative model of Parkinson’s progression, potentially combining both biological and clinical factors, may allow for efficient trials that aim to treat the right patient with the right drug at the right time.

To create the model, C-Path will standardize and aggregate data from several large-scale Parkinson’s studies — including the MJFF-led Parkinson’s Progression Markers Initiative (PPMI) comprising nearly 1,000 participants, which has made its data available in real time since it launched in 2010. C-Path will apply modeling and computational tools using the pooled database to produce the quantitative progression model — which will be submitted to the U.S. Food and Drug Administration and the European Medicines Agency for feedback — with the ultimate goals of saving time and money and providing a platform for the best chance of a positive outcome.

In future stages, the consortium plans to develop a clinical trial simulation platform. Drug developers make educated guesses on the number of volunteers to enroll, how long to follow them and how to evaluate therapeutic impact. The simulation platform will inform trial sponsors of the required parameters when planning a trial and allow them to enter data on individual participants to determine the number of subjects and the length of the trial required. For example, with a study population of “fast progressers” as defined by the CPP progression model, sponsors may be able to plan a shorter trial. Such a tool would help drug developers plan efficient studies and avoid false negative results.

“We are very pleased to welcome The Michael J. Fox Foundation to this important collaboration,” said Martha A. Brumfield, president and CEO of C-Path. “The Foundation’s unwavering commitment to helping patients with PD, their years of experience in articulating the patient perspective, and their research priorities will enrich the work of the Critical Path for Parkinson’s Consortium.”

Arthur Roach, PhD, director of research at Parkinson’s UK, the principal funder of the consortium, says: “Parkinson’s UK is determined to get better treatments to people living with this devastating condition in years, not decades. A key part of this is joining forces with regulators, researchers, pharma and medical research charities such as MJFF to maximize the benefit of data-sharing and learnings. Working with CPP partners will play a crucial role in helping develop and evaluate the effectiveness of potential new therapies, which could one day lead us to a cure for Parkinson’s.”

The PD data platform will serve as the resource for advancing the regulatory science goals of CPP, including qualification of drug development tools, and eventually will be made available to qualified researchers. Through CPP analyses or independent investigation, the standardized, aggregated data may allow researchers to identify events that underlie trajectories of decline and biomarkers or other determinants of early Parkinson’s disease.

About the organizations:

pr-c-path-logo

As the world’s largest nonprofit funder of Parkinson’s research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $600 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit us on the Web, Facebook, Twitter, and LinkedIn.


 

pr-c-path-logo

Every hour, someone in the UK is told they have Parkinson’s. It affects 127,000 people in the UK, which is around one in 500 of the population. Parkinson’s is a degenerative neurological condition, for which there currently is no cure. The main symptoms of the condition are tremor, slowness of movement and rigidity. Parkinson’s UK is the UK’s leading charity supporting those with the condition. Its mission is to find a cure and improve life for everyone affected by Parkinson’s through cutting edge research, information, support and campaigning. For advice, information and support, visit www.parkinsons.org.uk.


 

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Established in 2005 as a nonprofit organization, C-Path was formed to deliver on the vision of FDA’s Critical Path Initiative. C-Path is committed to improving human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. An international leader in forming collaborations around this mission, C-Path has established twelve global, public-private partnerships that include more than 1,400 scientists from regulatory and other government agencies, academia, patient advocacy organizations, and 41 major pharmaceutical companies. C-Path has headquarters in Tucson, AZ, and has been funded by public and private philanthropic support from the University of Arizona, Science Foundation Arizona (SFAz), the US Food and Drug Administration (FDA), and the Tucson community. For more information, visit www.c-path.org.

C-Path Contact:
Kissy Black
+1.615.298.1144
kissyblack@lotosnile.com

 

Parkinson’s UK and Critical Path Institute Launch the Critical Path for Parkinson’s (CPP) Consortium

October 14, 2015
CPP

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Parkinson’s UK and Critical Path Institute Launch the Critical Path for Parkinson’s (CPP) Consortium

Data from past Parkinson’s trials will be collected, standardized, and integrated, in order to inform new approaches to designing clinical trials focused on early-stage Parkinson’s.

London and Tucson – October 14, 2015 – Parkinson’s UK, one of the world’s largest charity funders of Parkinson’s research, and Critical Path Institute (C-Path), a pioneering nonprofit organization dedicated to accelerating the pace and reducing the costs of medical product development, announced the formation of the Critical Path for Parkinson’s Consortium (CPP).

The consortium will bring together pharmaceutical companies and academic partners working toward a common goal of establishing best practices and more efficient protocols for planning and designing clinical trials in early Parkinson’s—ultimately improving the efficiency and success rates of much-needed treatments for people with Parkinson’s.

Parkinson’s UK has been a leader in bringing together many participants in the Parkinson’s research enterprise to find ways to share data and work collaboratively. Together, Parkinson’s UK and C-Path can maximize the benefit of data-sharing, which is critical for a condition such as Parkinson’s, for which there are no effective treatments.

“In the era of electronic knowledge exchange, only when data-sharing becomes the norm can we derive its full benefits,” says Sue Dubman, UCSF Cancer Bio-informatics Director, patient advocate, and Parkinson’s patient.

Parkinson’s UK Chief Executive Steve Ford says, “Despite huge scientific progress, there have been no major advances in the treatments available for Parkinson’s in the last decade.

“At Parkinson’s UK, we’re adopting a new approach: tackling the critical road blocks standing in the way of the scientific breakthroughs that could have a huge impact on the lives of people with Parkinson’s.

“It’s our goal that the partnership with the Critical Path Institute will improve the clinical trial process and deliver new and better treatments, faster, to the people who urgently need them.”

“The importance of the role of patient advocacy organizations, such as Parkinson’s UK, in making new innovations possible for patients has never been more critical. The partnership between C-Path and Parkinson’s UK will complement each organization’s strengths. With the extensive reach and data available from Parkinson’s UK, and C-Path’s scientifically rigorous approach to data standardization and clinical trial modeling and simulation, the potential value of this effort, both to those who develop treatments for Parkinson’s, and those who live with the condition, cannot be underestimated,” says Martha A. Brumfield, President and Chief Executive Officer of C-Path.

The new consortium will be co-directed by Dr. Arthur Roach (Director of Research, Parkinson’s UK) and Dr. Diane Stephenson (Executive Director, Critical Path for Parkinson’s Consortium , C-Path).

 

ABOUT PARKINSON’S:

Parkinson’s is a progressive neurological condition. Traditionally, Parkinson’s has been viewed as a disorder in which individuals don’t have enough of a chemical called dopamine because specific nerve cells inside their brain have died. Low levels of dopamine slow the body’s movement, which makes everyday activities, such as eating, getting dressed, or using a phone or computer difficult or frustrating. It is not known why these cells die, but current research indicates that the processes that lead to dopamine deficit start much earlier (decades), making it a pressing need to increase the understanding of the condition’s progression. The main symptoms of Parkinson’s are tremor, muscle stiffness, and slowness of movement. But not everyone will experience all of these. As well as the symptoms that affect movement, other issues, such as tiredness, pain, and depression impact daily life. Parkinson’s doesn’t directly cause people to die, but symptoms do get worse over time, which greatly impacts the ability of individuals to function, leading to a severe decrease in quality of life.

ABOUT PARKINSON’S UK:

Every hour, someone in the UK is told they have Parkinson’s.

It affects 127,000 people in the UK, which is around one in 500 of the population.

Parkinson’s is a degenerative neurological condition, for which there currently is no cure. The main symptoms of the condition are tremor, slowness of movement and rigidity.

Parkinson’s UK is the UK’s leading charity supporting those with the condition. Its mission is to find a cure and improve life for everyone affected by Parkinson’s through cutting edge research, information, support and campaigning.

For advice, information and support, visit www.parkinsons.org.uk.

ABOUT CRITICAL PATH INSTITUTE (C-Path):

Established in 2005 as a nonprofit organization, C-Path was formed to deliver on the vision of FDA’s Critical Path Initiative. C-Path is committed to improving human health and well-being by developing new technologies and methods to accelerate the development and review of medical products. An international leader in forming collaborations around this mission, C-Path has established twelve global, public-private partnerships that include more than 1,000 scientists from regulatory and other government agencies, academia, patient advocacy organizations, and 41 major pharmaceutical companies. C-Path has headquarters in Tucson, AZ, and has been funded by public and private philanthropic support from the University of Arizona, Science Foundation Arizona (SFAz), the US Food and Drug Administration (FDA), and the Tucson community. For more information, visit www.c-path.org.

C-Path Contact:
 Kissy Black
+1.615.298.1144
kissyblack@lotosnile.com