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
Announcement: July 10, 2025

Announcement: November 19, 2024
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More Sites, More Patients, More Data

The Leader in Pragmatic Expanded Access Trials

Expanded Access trials sponsored by us, in partnership with manufacturers

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A source of real world treatment outcomes data in your targeted population(s)

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Experts in site feasibility and full cost recovery

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A complete solution to the increasing expectations of wider engagement and access

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How WideTrial Works

Expanded Access programs are “Treatment-Use” clinical trials for patients who cannot take part in research trials for the particular therapeutic or diagnostic in serious unsolved disease areas. We take over the burden of sponsoring and managing these programs, because (a) we have specialist knowledge and experience, and (b) manufacturers must spend their resources on the controlled studies required for marketing approval.

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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.

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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.

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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

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Expanded Access Summit

  • calendar iconPast meetings: 2017, 2019, and 2020
  • location iconNational 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
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. 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 earned the Chartered Financial Analyst designation in 2004.

Lee Allen
Lee Allen | Head of Business Operations

Lee brings 15 years of operational expertise in healthcare and community development programs. A former Peace Corps volunteer and graduate with a Master’s of Public Health from the University of Arizona, Lee’s professional background includes developing and managing large scale public health and quality assurance programs for multiple independent physician networks. Lee brings a background in reducing clinical administrative burden, navigating and building relationships with both commercial and public insurance payers, along with effectively managing and adhering to federal and state-level health program initiatives.

Francis Greenleaf
Nadia Sheibani | Director, Clinical Operations

Nadia started her career as a bench scientist, converting into clinical operations later in her career. Nadia has more than 30 years of experience in the Biotechnology & Pharmaceutical industries, including 15 in clinical program management. Nadia has excelled at designing and implementing solutions to significantly simplify processes for participating sites and patients.

Mitchell Hilbe
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.

Shona Allen
Shona Allen | Associate Director of Clinical Programs

Shona Allen has built a career as a clinical scientist with a focus on patient-centered drug development. With several years of experience in therapeutic innovation and neuroscience research, she has led efforts to advance treatments for rare and neurological diseases. Trained at Stanford’s School of Medicine, she specialized in designing patient-centric clinical trials and developing meaningful outcome measures through her Master of Science in Translational Research and Applied Medicine. Shona is dedicated to advancing clinical research and care that advocates for patients without treatment options.

Shona Allen
Laurie Anstine-Anderson | Head of Commercial Relations

Laurie Anstine-Anderson brings over 25 years of clinical research experience, with a unique blend of expertise in project management, contracts, budgeting, and vendor and stakeholder engagement. Known for her collaborative approach, Laurie excels at building strong relationships with sites, sponsors, vendors, and cross-functional teams to ensure the successful execution of clinical programs. She holds a Master’s degree in Public Administration with a focus on Health Services from the University of San Francisco. Laurie is particularly passionate about advancing treatment options in rare and autoimmune diseases, and is committed to driving high-quality, patient-focused healthcare.

Shona Allen
Alfonso Suarez | Senior Scientist, Oncology Programs

Dr. Ildefonso Vicente-Suarez is a specialist in immunology and oncology with over 20 years of experience in academia and industry. He earned his Ph.D. at the Moffitt Cancer Center and has since led the development of multiple antibody and cell-based therapeutics from early discovery through IND submission.

With a strong publication record and multiple patents in immunomodulatory therapies, Dr. Vicente-Suarez brings deep scientific insight and a proven ability to identify translational opportunities. His focus is to expand patient access to promising treatments for cancer and autoimmune diseases.

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