In this episode of the Drug Solutions Podcast, Feliza Mirasol, science editor, discusses the changing parameters for oral solid dosage forms as driven by APIs and new chemical entities with Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione.
Oral solid dosage forms are a dynamic, ever-changing landscape, driven primarily by more highly potent new chemical entities (NCEs) that require particularly specific formulations. In this Drug Solutions Podcast episode, Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, and Marco Gil, senior vice-president of Sales & Marketing, Hovione, discuss how, in addition to NCEs, older, more established APIs are finding renewed life because these APIs are continually enhanced to have higher potency at lower doses, changing the way their formulation is handled. Looking toward the future, the bio/pharma industry is also tackling the issue of converting large-molecule (biologic) drugs into orally administered dosage, rather than parenteral administration, for increased patient compliance. Among the issues discussed are:
Deepak Thassu, vice-president R&D and Regulatory Submission, LGM Pharma, joined LGM in 2020 to lead the company’s integrated R&D and regulatory submissions teams for CDMO clients. He has launched commercial products with several US and EU patents and handled submissions for NDAs, ANDAs, BLAs, and medical devices. Prior to joining Nexgen in 2015 to lead the R&D and Regulatory groups, Deepak was managing director at Actavis, chief scientific officer and vice-president of pharmaceutical development at PharmaNova, chief scientific officer and senior vice-president of pharma development at Holopack International, and associate director of Global Pharmaceutical Development and Technology at UCB Pharma. He earned his master’s in Pharmaceutics from Saugor University and his PhD and post-doctoral training from the University of Cincinnati in Pharmaceutical Sciences. He earned MBAs from Cornell University—in general business administration and finance—and Queen’s University.
Marco Gil, senior vice-president of Sales & Marketing, Hovione, graduated from the Chemical Engineering department at the Technical University of Lisbon, where he also obtained a PhD in chemistry in 2006. In 2007 he joined the Hovione R&D department as a scientist in the particle design discipline. The focus of his work was the application of particle engineering technologies to improve bioavailability of poorly water-soluble drugs. In May 2011 he was appointed the director of R&D Process Chemistry and was responsible for a group of dedicated scientists focused on the development and scale-up of chemical processes for the production of active ingredients. He has held several management responsibilities, including site general manager of Hovione operations in the United States and commercial-related functions. He is author of more than 15 scientific papers in peer-reviewed journals and book chapters, co-author in two patents, and an invited speaker in more than 10 international conferences.
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