Alzheimer’s Disease Data Initiative Launches, Critical Path for Alzheimer’s Disease Consortium to Partner

 

CPAD will partner with ADDI to build better tools for researchers around the world to access, use and share dementia-related data to accelerate the development of new and more effective treatments for Alzheimer’s disease

TUCSON, Ariz., November 17, 2020 — The Critical Path Institute’s (C-Path) Critical Path for Alzheimer’s Disease (CPAD) Consortium today announced its participation as a Partner with the Alzheimer’s Disease Data Initiative (ADDI), a 501(c)(3) medical research organization which launched today. ADDI is dedicated to advancing scientific breakthroughs in the treatment of Alzheimer’s disease (AD) and related dementias.

“ADDI will be a game-changing collaboration to provide the necessary data accessibility to advance data-driven solutions to accelerate Alzheimer’s disease drug development,” said C-Path’s Chief Science Officer Klaus Romero, M.D., M.S., F.C.P. “C-Path is honored to be a key Partner with ADDI, through CPAD, and contribute our data science, model-informed drug development and regulatory science expertise to ensure the success of ADDI.”

CPAD’s integrated and standardized patient-level database comprised of randomized clinical trials from industry, which is currently available to qualified researchers across the globe, will be a relevant and crucial component of ADDI’s Alzheimer’s Disease Workbench. This will enable researchers in AD and related dementias around the world to interact with relevant data resources more efficiently and accelerate the generation of actionable scientific insights leading to innovative solutions, diagnostic tools and therapies in AD.

Emphasizing the expected impact of ADDI, CPAD’s Executive Director Sudhir Sivakumaran, Ph.D., said, “ADDI is uniquely positioned to maximize the value of each data point contributed by individuals living with AD, who participate in clinical trials, observational studies, patient registries and other research efforts.”

CPAD’s Industry Co-Director and Vice President, Clinical Research, Neurology Business Group, Eisai, Inc. Michael C. Irizarry, M.D., M.P.H., added, “In this important initiative, the CPAD partnership with ADDI aims to facilitate increased aggregation and robust analysis of high-quality AD clinical research data, to model disease progression and help accelerate the development of biomarkers and therapeutics.”

For more information, visit: https://c-path.org/programs/cpad/; https://codr.c-path.org/main/applyDatabaseSelection.html; https://www.alzheimersdata.org/; https://www.alzheimersdata.org/ad-workbench.

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 62% funded by FDA/HHS, totaling $14,448,917, and 38% percent funded by non-government source(s), totaling $8,669,646. 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.

 


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 US 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 www.c-path.org and  c-path.eu.

 

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

C-Path and Lundbeck Announce a Data Sharing Collaboration to Enable Development of Advanced Drug Development Tools in Alzheimer’s Disease

 

 

TUCSON, Ariz., March 18, 2020 — The Critical Path Institute (C-Path) and H. Lundbeck A/S (Lundbeck) are proud to announce that they will work together to significantly improve the scientific community’s insight in Alzheimer’s disease (AD) through Lundbeck’s contribution of a unique set of clinical trial data from more than 2,500 AD patients to the Critical Path for Alzheimer’s Disease (CPAD) consortium’s integrated database for qualified researchers across the globe to access.

The Data Contribution Agreement (DCA) between Lundbeck and C-Path, with support from Gates Ventures, will allow for these clinical data to be integrated and managed by CPAD, with support from C-Path’s Data Collaboration Center (DCC) adding to the CPAD patient-level database in AD, which presently contains data from more than 14,500 patients. CPAD is currently exploring acquisition of contemporary datasets from other sources with an expected growth of the CPAD database to include more than 40,000 patient-level records in the coming months.

This contribution of patient-level data from Lundbeck embodies Lundbeck’s continued support to increase pre-competitive collaborations between pharmaceutical companies and academia, and to advance effective public-private partnerships. Generous contributions such as these ensure that CPAD can continue its mission to develop innovative quantitative tools and methods to de-risk and speed up the drug development process in AD.

These data stem from Lundbeck’s Phase II and III studies that evaluated the compound idalopirdine in AD and include relevant information about disease progression, drug effects and clinical trial design. The shared data are highly valuable and the contribution of this type of data is vitally important to CPAD’s work in developing a disease progression model across the entire continuum of AD, from the earliest to late stages of the disease. CPAD aims to provide advanced drug development tools that will aid in optimizing clinical trial designs and execution and facilitating the regulatory review process.

“Lundbeck and C-Path recognize the hard work to generate these data and contributions of the many patients with Alzheimer disease, their relatives and caregivers, and the investigators who took part in these trials,” said C-Path President and CEO Joseph Scheeren, Pharm.D. “We look forward to continuing to work together to advance and expedite the development of new therapies.”

“We are delighted with this opportunity to share data with CPAD, ensuring that researchers can get the most out of them in advancing the understanding of Alzheimer’s and how to best develop new treatments. We are proud to contribute to this work, not only through our own drug development activities, but also in this unique collaboration,” said Mads Dalsgaard, Senior Vice President, Experimental Medicine & Clinical Development at Lundbeck.

 


 

About Critical Path Institute
C-Path is an independent, nonprofit organization established in 2005 as a public-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’s US headquarters is located 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.


 

About H. Lundbeck A/S
H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.

Our approximately 5,500 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several R&D programs and our products are available in more than 100 countries. We have research centres in Denmark and California and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18,1 billion in 2018 (EUR 2,4 billion; USD 2,8 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.

 

Contact:

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

C-Path Selects Experienced Neuroscientist to Lead Alzheimer’s Consortium

 

 

TUCSON, Ariz., March 12, 2020 — The Critical Path Institute (C-Path) today announced it has named Sudhir Sivakumaran, Ph.D., as Executive Director of its Critical Path for Alzheimer’s Disease (CPAD) consortium effective immediately. Dr. Sivakumaran, a neuroscientist and research and development professional, has nearly 20 years combined experience in academic, pre-clinical and early clinical research and development, phase 1 and phase 2 clinical study design, data analysis and diligence and business development. He has been with C-Path since July 2019 as Associate Director for CPAD.

As Executive Director of CPAD, Dr. Sivakumaran will guide all operational and scientific input for the CPAD Consortium and develop and implement the strategic plan and priorities for individual working groups within CPAD. He will work with key individuals at global regulatory agencies including the U.S. Food and Drug Administration, European Medicines Agency and the Pharmaceuticals and Medical Devices Agency. Dr. Sivakumaran will also provide scientific leadership and oversee projects dealing with neuroscience, biomarker qualification, clinical outcome assessment development, data sharing and aggregation related to utility of modeling and simulation in Alzheimer’s disease (AD).

“We are thrilled that Sudhir has accepted the role of Executive Director of our long-standing Alzheimer’s consortium, CPAD,” said C-Path President and CEO Joseph Scheeren, Pharm. D. “He brings a wealth of experience to the program and in the short time Sudhir has been with C-Path, he has stepped up to continue to drive CPAD’s initiatives to create new tools and methods to increase the efficiency in the development process of new treatments for AD and related neurodegenerative disorders. With Sudhir leading CPAD, I know we’ll continue to enhance our already ample collaborative efforts with our agency, industry and patient organization partners in this area.”

Dr. Sivakumaran previously held positions as Associate Director, Research Management at Aptinyx, Inc. in Greater Chicago and Senior Manager, External Partnerships & Alliances, Neuroscience at Pfizer, Inc. in Cambridge, Mass. He has published more than a dozen peer-reviewed publications and was the recipient of multiple research grants and awards including the Epilepsy Foundation & American Epilepsy Society Post-doctoral Training Fellowship, Integrated Pilot Award from BU-CTSI, Academy of Finland Research Grant and the CURE Young Investigator Travel Award among others. He speaks English, Tamil, and Italian and his interests include traveling the world, long road trips and exploring and enjoying world cuisine. Dr. Sivakumaran holds a doctorate in neuroscience from SISSA/ISAS in Trieste, Italy and an M.Sc. and B.Sc. in microbiology from Univ. of Madras in India.

“I am very excited to be at C-Path and for the opportunity to lead the CPAD consortium,” said Dr. Sivakumaran. “Alzheimer’s disease is globally one of the most devastating diseases for millions of people and their loved ones. We are at a game changing moment in finding meaningful and effective therapeutic options in AD. An organization like C-Path, and its consortium CPAD, provides a great opportunity for us to come together within a neutral, pre-competitive environment in partnership with industry experts, regulatory agencies and patient organizations and work towards finding effective solutions for the most pressing needs and de-risk the drug development process in AD. I look forward to continuing to work with everyone at C-Path and beyond, towards refining and redefining our future course of action in AD drug development.”

Reporting directly to Scheeren, Dr. Sivakumaran will serve on C-Path’s leadership team, which is responsible for the overall strategic direction of the Institute.


 

About CPAD
CPAD’s mission is to accelerate the drug development process for patients with chronic neurodegenerative disease leading to dementia. Its primary focus is on AD. CPAD works with industry, regulatory authorities, and patient advocacy organizations to advance Drug Development Tools for evaluating drug efficacy and safety, to optimize novel clinical trial designs, and aggregating anonymized patient-level data using CDISC consensus standards to facilitate the regulatory review process.

CPAD has the following areas of pre-competitive focus: (1) regulatory qualification of biomarkers (2) development of CDISC data standards for AD endpoint assessments, (3) creation of integrated databases for observational and clinical trials data, and (4) development of quantitative model-based tools for drug development.

 

About Critical Path Institute
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 US 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.

 

Contact:

Kissy Black
615.310.1894
kissyblack@c-path.org

European Medicines Agency Deems Imaging Biomarker a Qualified Measure to Select Patients with Early Stages of Cognitive Impairment for Alzheimer’s Disease Clinical Trials

Based on a request for regulatory review by Critical Path Institute’s (C-Path) Coalition Against Major Diseases (CAMD), the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use has issued a positive opinion on the use of magnetic resonance imaging (MRI) to measure hippocampal volume as a tool to enrich recruitment into regulated clinical trials in the pre-dementia stage of Alzheimer’s disease (AD). This is the first imaging-based biomarker for AD to be granted a positive opinion by a regulatory agency.

MRI.pdf