Base to Base Biotech
This week, we have a conversation 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 [https://www.diaglobal.org/] (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. [https://medicuspharma.com/] 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. To get in touch with guest suggestions, or to sponsor or advertise on the podcast, please email jim@deeptechdigest.com [jim@deeptechdigest.com]
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