SEANOBI-ALS

An Expanded Access Program (EAP) for MN-166 in ALS

WideTrial is pleased to support the NIH-funded Expanded Access Program to provide treatment-use of MN-166 (ibudilast) for people with ALS who cannot enroll in the drug’s ongoing research trial. In partnership with a leading academic medical center, WideTrial is establishing an open network of healthcare providers who seek to bring this investigational treatment option to their patients. If you would like to learn more about participating in this EAP, please register your interest here.

For Physicians For Patients

Read our recent announcement

A nurse and a patient look at a tablet device

About Expanded Access

Group-level Expanded Access clinical trials (not to be confused with single-patient “compassionate use”) allow meaningful numbers of patients and their physicians to explore a new investigational treatment with a well designed protocol and supply-chain to work in harmony with the continued clinical development of the particular treatment.

When integrated into the drug development cycle, Expanded Access trials bring many benefits to the drug company, including wider patient engagement, increased chances of discovering response-predictive biomarkers, and information that leads to more-highly targeted pivotal trials in historically difficult diseases.

WideTrial sponsors both large group and small to medium sized group EAPs. The allowable size and timing of the program depends on many factors, including the degree of medical need, the safety profile of the product, and the quality of existing clinical data. We have seen every kind of case in the 30 year history of U.S. Expanded Access. We’ll devise the right access strategy for your product.

It's great to see WideTrial emerging to tackle such a critical issue with such a comprehensive solution.

John Carney

Traditional clinical trials are expensive, but these wide access trials may allow us to bring more patients into the drug development process at very little cost, and that helps everyone.

Jon Katz, MD

WideTrial may be the solution we've all been seeking for responsible early access to new treatments.

Alison Bateman-House, PhD

Expanded Access Summit

Past meetings: 2017, 2019, and 2020
National Press Club, Washington D.C.

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About Us

WideTrial is an integrated service and technology platform that delivers scalable, group-level Expanded Access programs (EAPs) that are easy to participate in. The primary objective of any EAP is to provide pre-approval treatment options in situations of unmet medical need. For us, the secondary objective is to generate clinical data from a larger and more representative set of patients within the target indication. Many patients do not meet the enrollment criteria of traditional research trials, and bringing them into the drug development process can be a win for all parties.

Jess Rabourn | Chief Executive Officer

Jess Rabourn is the founder and CEO of WideTrial, the culmination of several projects aimed at improving the treatment landscape for unsolved serious diseases. Since 2010 he has been a nationally recognized speaker on pre-approval access and the economics of breakthrough clinical development. He is executive producer of the Expanded Access Summit, the annual forum on integrating well-designed Expanded Access trials into the modern drug development process. Through his consulting firm, Jess has guided several pharmaceutical companies and disease organizations on regulation and strategy in this area. He was lead author of the Expanded Access section of the submitted draft for FDA’s Guidance on ALS Drug Development. Prior to his life sciences career, Jess spent 15 years in the investment management industry at firms in San Francisco and New York. He learned the Chartered Financial Analyst designation in 2004.

Mylea Charvat, PhD | Chief Medical Officer

Mylea Charvat is a trained neuroscientist with a background in neurodegenerative disease and clinical neurology. She has been involved in several successful digital medicine companies, including Savonix, in which she developed novel diagnostics for early detection of dementia in Alzheimer’s disease and other progressive CNS disorders. Mylea has authored several peer review publications in mental health & neuroimaging. She completed her fellowship in clinical neuroscience at Stanford & has been a lecturer at Stanford. She has also taught at The University of San Francisco & San Francisco State University. She has been a monthly contributor with Psychology Today, written for Tech Crunch & Stat News & appeared as a subject matter expert at many conferences including AAIC, ADPA, CTAD, The Atlantic Council, the NIH & NIA & with the Duke Leadership Program.

Francis Greenleaf | Head of Business Operations

Francis Greenleaf’s career has focused on leveraging technology for a positive impact on Healthcare. He brings 8 years of health tech startup experience from Medical Devices to AI & Machine Learning diagnostics and has self-published a book about American Healthcare.

Mitchell Hilbe | Head of Site Relations

Mitchell Hilbe is in charge of User Experience in WideTrial’s network of trial sites and participating treatment centers. He has 20 years experience in clinical research support, with focus in oncology, autoimmune, infectious disease, and rare genetic disorders. Mitchell studied Emergency Medical Care and began his healthcare career as a paramedic and, later, an EMS instructor at Central Arizona College, eventually earning awards for management of cardiac arrest patients and serving in the Incident Command center for mass casualty events. He is a co-founder of the Clinical Research Justice League and speaks regularly on innovation in site management and shared investigator platforms.

Widening the Reach of Drug Development

More Sites, More Patients, More Data

The Leader in Pragmatic Expanded Access Trials

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