Getting The Right Drug To The Right Patient At The Right Time

By Ed Miseta, Chief Editor, Clinical Leader

It’s no secret that there are patients across the globe with a high degree of unmet medical needs. These patients are desperate for access to new and innovative medicines that are either still in clinical development or not available commercially in their country. “The primary way for them to access those medicines is via a clinical trial,” says Mark Corbett, SVP of Clinigen Group’s Global Access Program. “Unfortunately, if they are in a situation where they don’t live near a clinical trial site, or the trial is not available in their country, there are mechanisms that exist outside of clinical trials to allow patients with a high unmet medical need to access these medicines. We work within these mechanisms to provide global access programs on behalf of pharma and biotech companies, providing access to their innovative new medicines to patients in dire need.”

“Per definitions set by the FDA, global access programs tend to apply to serious or life-threatening diseases where patients have no suitable alternative therapy available to them,” says Corbett. “That means physicians have tried all available therapies and the results were not satisfactory. They have run out of options and have no alternative other than to try a drug that is not commercially approved in that country.”