Anova Enterprises, Inc. (Anova), an organization dedicated to accelerating promising treatments to market with its transformative AnovaOS™ technology platform, and the industry’s first collaborative ‘learning system’, today announced a partnership with the Korea Orphan & Essential Drug Center (KODC) to develop a legislative framework for compassionate use of investigational product, to help increase access to investigational treatments for patients in need across South Korea.
“A primary focus of Anova is improving access to promising new treatments for patients in need. Our team are delighted to partner with KODC. It demonstrates our recognized leadership in the area of compassionate use which is an important part of our work to increase access,’ said Chris Beardmore, CEO at Anova. ‘Partnering with KODC has the potential of increasing access to investigational treatments for thousands, if not tens of thousands of patients across South Korea.’
Compassionate use is a treatment option that allows the use of promising new treatments still under development. Under strict conditions, investigational products can be made available to individual or groups of patients who have a serious and/or life-threatening disease with no satisfactory therapies available and who cannot enter a clinical trial.
These programs are only put in place if the treatment(s) is expected to help patients with life-threatening, long-lasting or seriously debilitating illnesses, which cannot be treated satisfactorily with currently available treatments.
Compassionate use of investigational treatments for patients with severe and/or debilitating diseases are known by many names, including expanded access, right-to-try, managed access, named patient access, special access, pre-approval access, and others. Anova works with both biopharmaceutical companies and physicians in dozens of countries on compassionate use programs, supporting manufacturers to generate important data as part of these cases to inform development efforts, and supporting sites and physicians secure access to investigational treatments using these pathways.
