• Regulatory Roundup - foundational steps on your repurposing path

    Dr. Mitchell Seymour, September 26, 2013

    Seymour head shotBefore a clinical trial can begin, an Institutional Review Board (IRB) reviews and approves a proposed study with the goal to protect human subjects and to support Good Clinical Practice.  Cures Within Reach supports research involving off-label use of Food and Drug Administration (FDA)-approved drugs, also known as “repurposing”. Repurposed drug studies can differ in many ways from the FDA-approved, “on-label” use of said pharmaceuticals. These differences require special scrutiny by IRBs during their review of the clinical protocol. Differences can include:

    Patient population - gender, age group, concurrent disease or organ function

    Drug dose or dosing schedule - drug dose and/or frequency, duration or schedule of treatment

    Drug formulation - drug delivery method, different excipients, different release properties

  • Regulatory Roundup - Is it clinical research, or innovative clinical care?

    Dr. Mitchell Seymour, October 24th, 2013

    Dr. Mitchell SeymourWhen current medical options are limited or insufficient, doctors often leverage their knowledge and professional experiences to think and act outside the box. Off-label use is a critical tool in this innovative clinical care. 

    A recent article in the Washington Post provokes interesting considerations regarding drug repurposing. doctor prescription The article suggests that off-label prescribing is inherently suspect or dangerous, and further supports this through commentary from prominent bioethicist Alexander Capron.  Capron believes that when physician finds a helpful off-label use for a drug, he/she is ethically obliged to publish a research article on the findings.

  • Regulatory Roundup – repurposing research is NOT “off-label promotion"

    Dr. Mitchell Seymour, November 20, 2013

    Seymour head shotWhen I mention off-label drug use to my non-clinical colleagues or to the public, I often face confusion, winces, or leery looks. “Isn't that dangerous?” “How can that be allowed?” Misperceptions exist that off-label use is risky and deceptive. One goal of Cures Within Reach is to educate on the prevalence, impact, and value of repurposing “old” or approved drugs for new uses. Our audience is broad, but we accept that challenge with both passion and purpose.

  • Regulatory Roundup – The Investigational New Drug (IND) application in repurposing research

    Dr. Mitchell Seymour, January 2, 2014

    Dr. Mitchell Seymour While much of drug repurposing is physician-initiated and occurs as part of innovative clinical care, clinical research is an important tool to objectively and systematically evaluate the safety and efficacy of an old drug for new uses. Before a clinical trial can begin, an Institutional Review Board (IRB) reviews and approves a proposed study; its goal is to protect human subjects and to support Good Clinical Practice. As such, IRB approval is a regulatory hurdle in repurposing research - but there may be another, like the Food and Drug Administration (FDA) or other regulatory agencies worldwide.  

  • Regulatory Roundup – Varied Paths to the Patient for Repurposed Drugs

    Dr. Mitchell Seymour, February 17th, 2014

    Dr. Mitchell Seymour The most common approach for the new use of an "old" drug is off-label prescribing by doctors, often considered "innovative clinical care". Doctors get their motivation to prescribe off-label from sources like evidence in medical literature, presentations at professional conferences, and medical professional word-of-mouth. One challenge of off-label use is that insurance companies may not reimburse, leaving the patient to carry the financial burden of this innovative clinical care. However, insurance companies periodically review the value of off-label use through guided review of the medical literature and through a detailed risk-benefit analysis. If the story is good – that the new use for an old drug reduces health care costs – then off-label use can be included in the insurer's drug formulary, and the prescription gets covered. 

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