NEW YORK, October 26, 2018 /PRNewswire/ --
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.
Please visit http://www.qbiomed.com for more information and signup for
regular updates. Also, follow us on Social Media @QbioMed #QbioMed $QBIO
Forward-Looking Statements:
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating
to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking
statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect
our business, operating results, financial condition and stock price. Factors that could cause actual results to differ
materially from those currently anticipated are: risks related to our growth strategy; risks relating to the results of research
and development activities; our ability to obtain, perform under and maintain financing and strategic agreements and
relationships; uncertainties relating to preclinical and clinical testing; our dependence on third-party suppliers; our ability
to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial
additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described
in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any
forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or
circumstances on which any such statement is based, except as required by law.
Contact:
Denis Corin
CEO
Q BioMed Inc.
+1-888-357-2435
SOURCE Q BioMed Inc.