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Abstract Details

NeuroREACH™ Platform for Expanded Access Program (EAP) Trials as the Foundation for Clinical Research of the Future
Neuromuscular and Clinical Neurophysiology (EMG)
S56 - Neuromuscular Therapeutics (4:42 PM-4:54 PM)
007

Expanded Access Programs  provide investigational therapies to patients who are not eligible or able to participate in clinical trials but have serious or life-threatening diseases, for which their physician has determined there are no appropriate treatment options.

Many pharma/biotech offer investigational products and many investigators agreeing or insisting upon running multiple EAP trials for the benefit of their patient population who fail eligibility criteria of "regular" clinical trials.

Introduction of a regulatory-compliant platform to execute EAPs became a necessity.

The Center for Innovation and Bioinformatics (CIB) introduced the NeuroREACH™ platform to facilitate:

  •  - Rapid deployment of EAP trials
  •  - Capture of clinical and safety data from patients
  •  - Data Management
  •  - Real-time secure and controlled access to data visualization and reports
Develop a platform for rapid deployment of neurological EAP clinical trials to test investigational therapies and aggregate safety data in a compliant regulatory setting

Any investigator with an IRB-approved EAP protocol and open enrollment of patients may capture and store phenotypical, safety, and biomarker data utilizing the NeuroREACH EDC platform. The CIB acts as the Data Coordination Center and its program management team will oversee the addition of new studies, data curation, visualization, and reporting.  

The NeuroREACH platform has been deployed at CIB and available to investigators and sponsors around the world.  Currently FOUR EAP trials utilize NeuroREACH. 

As patients may participate in multiple EAPs, NeuroGUIDs/NeuroSTAmPs are used to uniquely identify EAP participants across studies. Study sponsors and drug manufacturers have access to reports and dashboards to track enrollment data in real time.

As EAPs become more and more prevalent method to test investigational products for safety and even efficacy, the investigators and study sponsors may use NeuroREACH to rapidly deploy trials. The captured EAP information utilized by  pharma/biotech for new indications, safety analyses, and in negotiations with the FDA and insurance companies

Authors/Disclosures
Alexander Sherman (Massachusetts General Hospital)
PRESENTER
The institution of Mr. Sherman has received research support from The ALS Association. The institution of Mr. Sherman has received research support from NIH. The institution of Mr. Sherman has received research support from FDA. The institution of Mr. Sherman has received research support from Biogen. The institution of Mr. Sherman has received research support from Amylyx Pharmaceuticals. The institution of Mr. Sherman has received research support from Mitsubishi-Tanabe Pharma America. Mr. Sherman has a non-compensated relationship as a Member, Board of Directors with ALD Connect that is relevant to AAN interests or activities.
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
Sarah Luppino, NP No disclosure on file
Jennifer Scalia, NP (MGH) No disclosure on file
Sabrina Paganoni, MD, PhD Dr. Paganoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Cytokinetics. Dr. Paganoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Jannsen. Dr. Paganoni has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Arrowhead. Dr. Paganoni has received personal compensation in the range of $0-$499 for serving as a Consultant for Sola. Dr. Paganoni has received personal compensation in the range of $0-$499 for serving as a Consultant for Frequency Therapeutics. The institution of Dr. Paganoni has received research support from Amylyx. The institution of Dr. Paganoni has received research support from Revalesio. The institution of Dr. Paganoni has received research support from Alector. The institution of Dr. Paganoni has received research support from UCB. The institution of Dr. Paganoni has received research support from Biohaven. The institution of Dr. Paganoni has received research support from Clene. The institution of Dr. Paganoni has received research support from Prilenia. The institution of Dr. Paganoni has received research support from Seelos. The institution of Dr. Paganoni has received research support from Calico. The institution of Dr. Paganoni has received research support from Denali. The institution of Dr. Paganoni has received research support from Anelixis. The institution of Dr. Paganoni has received research support from Cytokinetics.
Merit E. Cudkowicz, MD, MSC, FAAN (Massachusetts General Hospital) Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for biogen. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for cytokinetics. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for immunitypharm. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for transposon. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Quralis. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Regeneron. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for vectorY. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for inflectis. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for novartis. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ono. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for otsuka. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for coya. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for ac immune. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for pontifax. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Inflectis. Dr. Cudkowicz has received personal compensation in the range of $0-$499 for serving as a Consultant for ab science. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving as a Consultant for aclipse. Dr. Cudkowicz has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Locust Walk. Dr. Cudkowicz has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pasithea. Dr. Cudkowicz has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Praxis Precision Medicine. Dr. Cudkowicz has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Annals of Neurology . The institution of Dr. Cudkowicz has received research support from NINDS. The institution of Dr. Cudkowicz has received research support from ALSFAC. The institution of Dr. Cudkowicz has received research support from UCB ra. The institution of Dr. Cudkowicz has received research support from Biohaven. The institution of Dr. Cudkowicz has received research support from Clene nanomedicine. The institution of Dr. Cudkowicz has received research support from prilenia. The institution of Dr. Cudkowicz has received research support from ALS one. The institution of Dr. Cudkowicz has received research support from Seelos. The institution of Dr. Cudkowicz has received research support from Calico. The institution of Dr. Cudkowicz has received research support from denali. The institution of Dr. Cudkowicz has received research support from ITB. The institution of Dr. Cudkowicz has received research support from PharmAust. The institution of Dr. Cudkowicz has received research support from woolsley. Dr. Cudkowicz has received research support from lilly. The institution of Dr. Cudkowicz has received research support from J& J. Dr. Cudkowicz has received publishing royalties from a publication relating to health care.