The journey of a new drug from concept to market is a complex and highly regulated process. At its core lies the New Drug Application (NDA) submission – a critical milestone that paves the way for new medications to reach patients in need. But how do drugs reach this...
No stranger to adversity, Olayiwola (Ola) Kassim was born and raised in Lagos, Nigeria. From an early age he saw doctors as heroes, as personified by his uncle who studied nursing abroad in the UK and his sister who later did the same. He lost his mother at only 3...
Clinical study protocols are conducted according to the International Council for Harmonization guidance on Good Clinical Practice (GCP) which outlines safeguards for the rights, safety and well-being of participants. Protocols “should [also] be designed, conducted...
Unveiling the Canvas: A Maestro's Tale In the heart of BioPharma Services' flourishing ecosystem stands the People and Culture Champion. Functioning as the architect of engagement, a mediator in reducing turnover, and a meticulous curator of our organizational...
505(b)(2) pathway approvals have experienced double-digit growth recently. Many drug companies are electing to pursue 505(b)(2) applications to obtain a new drug approval (NDA). For developers seeking to obtain approval for previously approved drug products in the...
Artificial intelligence (AI) - based technologies are increasingly finding applications in multiple industries, including the pharmaceutical field. AI integration into drug development contributes to the enhancement of testing accuracy and efficiency, expedites the...
