Robert Lee
Executive Vice President Particle Sciences, USA
Title: Formulation technologies supporting patient centric drug product design to address the needs of special patient populations
Biography:
Dr. Lee is Executive Vice President of Pharmaceutical Development Services at Particle Sciences, a Lubrizol Advanced Materials, Inc. company, a pharmaceutical contract development and manufacturing organization (www.particlesciences.com). He provides direction and is involved with product and business development. Before joining Particle Sciences, Rob held senior management positions at Novavax, Inc., Lyotropic Therapeutics, Inc., and Imcor Pharmaceutical Co. He holds BSs in Biology and Chemistry from the University of Washington and a PhD in Physical Bioorganic Chemistry from the University of California, Santa Barbara. Rob has published articles in numerous peer-reviewed journals and five book chapters plus holds over two dozen issued patents or provisional patent applications.
Abstract:
Many active pharmaceutical ingredients are poorly water soluble and may suffer from low oral bioavailability, if formulated in unmodified form. These compounds are also challenging to formulate for other routes of administration, especially parenteral. The prevalence of low solubility compounds has led to intensive research and has generated many technologies to address formulation. For BCS II molecules, there are other drug delivery approaches besides nanoparticulate suspensions (NSs) used for oral administration but many feel the higher value of this technology is for parenteral delivery. This technology has been used for several marketed products including oral tablets, oral liquid NSs, and parenteral liquid NSs. There continues to be a strong interest in employing NS formulations, particularly for parenteral dosage forms. An overview of the history and product development of NSs with an emphasis on sterile products will be presented
I look forward to the meeting. It looks like my talk may be appropriate for tracks 1, 5, 6, and 9 – probably track 6 may be the best fit. Please get back to me as soon as possible on what session, date, and time my presentation is scheduled for along with when I need to be there to chair my session (and what session). Let me know if you need any additional information. Once I know what date my session is, I’ll make my hotel reservations.
Nélio Drumond
Takeda, Germany
Title: Formulation technologies supporting patient centric drug product design to address the needs of special patient populations
Biography:
Nélio Drumond is a PharmD by training with a PhD in Patient Centric Drug Product Design. He shares several years of experience in the Pharmaceutical Industry, providing scientific leadership to govern the formulation and manufacturing strategies for drug product development programs during clinical stages, including their scalability and validation for commercial use. Currently, Dr. Drumond is responsible for the technical management and leadership of commercial manufacturing activities at different Contract Manufacturing Organizations (CMOs) for an established portfolio of Takeda products within the EMEA region.
Abstract:
Oral drug administration provided as solid oral dosage forms (SODF) remains the major route of drug therapy in primary and secondary care. There is clear evidence for a growing number of clinically relevant swallowing issues (e.g., dysphagia) in the older patient population, especially when considering the multimorbid, frail, and polymedicated patients. Swallowing impairments have a negative impact on SODF administration, which leads to poor adherence and inappropriate alterations (e.g., crushing, splitting). Different strategies have been proposed over the years in order to enhance the swallowing experience with SODF, by using conventional administration techniques or applying swallowing aids and devices. Nevertheless, new formulation designs must be considered by implementing a patient centric approach in order to efficiently improve SODF administration by older patient populations. Together with appropriate SODF size reductions, innovative film coating materials that can be applied to SODF and provide swallowing safety and efficacy with little effort being required by the patients are still needed. Scientific evidence demonstrating the benefits of given SODF coating materials in the concerned patient populations are still very limited. Consequently, the availability for safe, effective, and clinically proven solutions to address the increasing prevalence of swallowing issues in the older patient population are still limited.