This week, we have conversations with DIA chief science and regulatory officer, Maria Vassileva, and Medicus Pharma CEO, Raza Bokhari.
Times:
02:53 Medicus Pharma
29:13 DIA
DIA
DIA (Drug Information Association) is a global organisation that assists life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow.
Starting with the controversy over the drug Thalidomide, DIA’s founders – a group of 30 pharmaceutical professionals, medical writers, and academics – came together to create a platform for necessary global communication and collaboration to solve a healthcare threat to unborn children worldwide.
Today, professionals from 80 countries engage with DIA through its membership network, educational offerings, and professional development opportunities.
Medicus Pharma
Medicus Pharma Ltd. has submitted an Orphan Drug Designation (ODD) application to the U.S. Food and Drug Administration for SkinJect (D-MNA) for the treatment of basal cell carcinoma (BCC) in patients with Gorlin syndrome, a rare genetic disorder characterised by the development of multiple, recurrent skin cancers. There are no FDA-approved therapies specifically for BCC in Gorlin Syndrome.
The submission represents a strategic expansion of the SkinJect programme into a high unmet need orphan indication, where current treatment options are limited and often involve repeated surgical procedures associated with cumulative morbidity and disfigurement.
Medicus believes SkinJect can address this through a localised, repeatable, non-surgical treatment approach. It is a doxorubicin-containing dissolvable microneedle array designed for direct intradermal delivery into BCC lesions.
SkinJect has been evaluated in phase 1 and 2 clinical studies in patients with basal cell carcinoma.
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