Q BioMed Takes the Stage in the Expanded Access Debate at European Early and Managed Access Program Conference
Q BioMed Orphan Drug VP, who started the first Expanded Access Program Database asked to Speak on Panels and run Roundtable at the Early and Managed Access Program Conference in the UK from October 22nd to 24th 2018
Q BioMed Inc. (OTCQB: QBIO), a biotechnology acceleration company, is pleased to announce that Robert Derham, a member of the Q BioMed team and founder of CheckOrphan and architect of the world”s first access program database, hosted a roundtable discussion on how companies can compliantly communicate their expanded access program and participated on a panel discussion about how to more effectively work with patients and patient organizations when executing an expanded access program.
Expanded access programs are highly regulated programs that provide people with medicine that has not yet been approved on the market. Expanded access programs are receiving more attention as legislation known as ‘The Right to Try’ bill passed in March of this year in the USA. FDA is responsible for regulating requests for expanded access use and most cases are handled over the phone within 24 hours when it is a matter of life of death.
Denis Corin, CEO of Q BioMed Inc. stated, ‘We live in an exciting time, where talk about gene therapy, stem cells and other cutting edge therapies is becoming reality. Thus we can now treat very difficult diseases that have no current treatment, which makes expanded access programs an avenue of hope for patients and their families. However, it is imperative for companies to plan early and engage regulators, health care professionals and advocates to ensure all stakeholders are prepared and can act in the best interest of the patient.’
The conference also discussed the augmenting role that expanded access programs play in Europe and the rest of the world. In Europe, expanded access programs are regulated by EMA and then approved and governed at the national level by the respective country”s health administrators. Some have governing bodies that regulate an expanded access program, while other countries handle each request on a case by case basis.
About Expanded Access Programs
Expanded access programs are regulated programs put in place to through coordination between regulators and pharmaceutical manufacturers to allow physicians to request access to specific medicines where their patient is unable to access that medicine through clinical trials or via the usual commercial route. The decision to treat a patient as part of an access program is based on the clinical judgment of their physician, and is applicable where there is a genuine unmet medical need and no alternative treatments available.
CheckOrphan Access Program Database
CheckOrphan launched the database in 2015, in collaboration with Idis (now Clinigen), to create a resource for the rare disease community who wish to access a specific medicine, but find that it is currently unavailable to them. The listings include information about the therapeutic areas and specific indications where such access programs have been put in place by pharmaceutical manufacturers. Due to regulations governing unlicensed medicines, entries submitted to CheckOrphan for review and publication will not be mentioning product names. Where product names are mentioned on any detail pages, this information is taken from other publicly available sources.
About Q BioMed Inc.
Q BioMed Inc. ‘Q’ is a biomedical acceleration and development company. We are focused on licensing and acquiring undervalued biomedical assets in the healthcare sector. Q is dedicated to providing these target assets, strategic resources, developmental support, and expansion capital to ensure they meet their developmental potential, enabling them to provide products to patients in need.
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NEW YORK, October 26, 2018 /PRNewswire/ —