BOSTON, May 31, 2018 /PRNewswire/ -- Jess Rabourn, CEO of WideTrial Inc. and founder of The Expanded Access Summit, has announced that this year's conference will be held on September 6th and 7th at the Mandarin Oriental Hotel in Boston.
Expanded Access, sometimes called pre-approval access, is the FDA-authorized treatment use of an investigational medical product by groups of patients who do not meet the enrollment criteria for traditional clinical trials.
Co-located with Biotech Week Boston, the Summit focuses on integrating Expanded Access into the overall drug development process for new products in serious, unsolved diseases.
Conference sessions will analyze the case history of Expanded Access with twenty of the most experienced regulators and practitioners in the space, including: Richard Klein, Former Director of FDA's Patient Liaison Program; Amy Barone MD, Medical Officer at FDA Office of Hematology and Oncology Products; Richard Moscicki MD, EVP at PhRMA; and Paul Aliu PharmD, Global Head of Medical Governance at Novartis.
Panelists will also explore how modern Expanded Access programs are strengthening the clinical development process with large cohorts of patients, consented outcomes data, and new tools to enable clinical discovery of responder subgroups, wide ranging safety, and other real-world insights.
"The Summit is about improving the clinical development process in difficult, breakthrough diseases-- improving it through greater involvement of the vast numbers patients who don't meet the inclusion/exclusion criteria of research trials," said Jess Rabourn, The Summit Chairman. "How do we make these programs more attractive to our industry? What keeps exploratory treatment options from patients isn't the regulation or the ethics of unproven medicine; it's the business challenge of running meaningfully sized access programs in ways that are feasible for manufacturers and care providers," he added. "We launched the Summit to work through these issues. It's time for solutions."
"The Expanded Access Summit provides attendees a front row seat for a lively exchange of views presented by distinguished key opinion leaders addressing the ethical and logistical challenges in providing marginalized patients with access to experimental therapies," noted Maria Hardin, Patient Assistance Fund Consultant.
To register for the conference, click here. Special pricing is extended through July 31st. For sponsor and partnership information, email [email protected].
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Expanded Access, sometimes called pre-approval access, is the FDA-authorized treatment use of an investigational medical product by groups of patients who do not meet the enrollment criteria for traditional clinical trials.
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Co-located with Biotech Week Boston, the Summit focuses on integrating Expanded Access into the overall drug development process for new products in serious, unsolved diseases.
Conference sessions will analyze the case history of Expanded Access with twenty of the most experienced regulators and practitioners in the space, including: Richard Klein, Former Director of FDA's Patient Liaison Program; Amy Barone MD, Medical Officer at FDA Office of Hematology and Oncology Products; Richard Moscicki MD, EVP at PhRMA; and Paul Aliu PharmD, Global Head of Medical Governance at Novartis.
Panelists will also explore how modern Expanded Access programs are strengthening the clinical development process with large cohorts of patients, consented outcomes data, and new tools to enable clinical discovery of responder subgroups, wide ranging safety, and other real-world insights.
"The Summit is about improving the clinical development process in difficult, breakthrough diseases-- improving it through greater involvement of the vast numbers patients who don't meet the inclusion/exclusion criteria of research trials," said Jess Rabourn, The Summit Chairman. "How do we make these programs more attractive to our industry? What keeps exploratory treatment options from patients isn't the regulation or the ethics of unproven medicine; it's the business challenge of running meaningfully sized access programs in ways that are feasible for manufacturers and care providers," he added. "We launched the Summit to work through these issues. It's time for solutions."
"The Expanded Access Summit provides attendees a front row seat for a lively exchange of views presented by distinguished key opinion leaders addressing the ethical and logistical challenges in providing marginalized patients with access to experimental therapies," noted Maria Hardin, Patient Assistance Fund Consultant.
To register for the conference, click here. Special pricing is extended through July 31st. For sponsor and partnership information, email [email protected].
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SOURCE The Expanded Access Summit
