There are several key strategic decisions to be made in the rapid development process of COVID-19 vaccines and treatments, including where to target the drug delivery, the appropriate formulation, the correct device and the best regulatory pathway. This webinar discusses these challenges for nasal and pulmonary drug delivery.
Presented by Dr Julie Suman PhD, President, Next Breath, an Aptar Pharma Company, and Dr Jag Shur, CEO, Nanopharm, an Aptar Pharma Company, the webinar discusses how to rapidly formulate, select a device and develop a novel concept for nasal and pulmonary drug delivery.
Over 300 clinical trials worldwide have been initiated as the race to develop therapies to battle SARS-CoV-2 carries on at a frenetic pace. Both novel and repurposed compounds ranging from antivirals to nucleic acids to bacteriophages for prevention and treatment of COVID-19 are in development. One of the key strategic decisions is where to target drug delivery. As SARS-CoV-2 gains a foothold in the body via the ACE2 receptors located in the nose, nasopharynx and lungs, delivery to the respiratory tract could be a key to beating this virus. This presentation highlights the pathophysiologic rationale of drug delivery targets in the upper and lower airways. We differentiate key attributes for classes of therapeutic compounds. Building on this foundation allow selection of the appropriate device platform and drive formulation development.
Our goal is to highlight a pathway to rapidly develop a formulation and device combination to that allows clinical trials to start quickly. We provide insight on a formulation and screening processes to establish stability. Acceleration of lead selection to mitigate risk using novel in vitro deposition studies and regional deposition modeling will be discussed.
Dr. Julie D. Suman
PhD, President, Next Breath, an Aptar Pharma Company
Julie holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). She is a co-editor for Respiratory Drug Delivery Proceedings, an international symposium, and an Affiliate Assistant Professor in the Department of Pharmaceutics, School of Pharmacy, Virginia Commonwealth University. Julie is a Past-Chair of the AAPS Inhalation Technology Focus Group. She is also a licensed Maryland pharmacist. Julie has published her research in peer-reviewed journals, has presented during podium sessions at international meetings such as the FDA Visiting Professor Lecture Series, and has been an invited speaker at ANVISA in Brazil. Dr. Suman’s doctoral research, which focused on the relationship between in vitro tests for nasal sprays and in vivo deposition, has been recognized for excellence by a research award presented at the International Society for Aerosols in Medicine, 2001.
Dr. Jag Shur
CEO, Nanopharm, an Aptar Pharma Company
Jag’s main area of research is investigation of the bioequivalence of orally inhaled and nasal drug products (OINDPs). The key theme of his research has been the development and application of novel tools to understand and quantify the microstructure of OINDPs. He began his career with Profile Drug Delivery (now Philips Respironics) where he developed liquid dose drug delivery systems for cystic fibrosis patients, and later went on to work for GlaxoSmithKline. Jag holds a BSc (Hons) in Chemistry and completed his PhD, entitled ‘Formulated Muco-Regulatory Agents in the Airways of Patients with Cystic Fibrosis’, at Portsmouth School of Pharmacy. Following this, he was a post-doctoral fellow at the London School of Pharmacy, investigating the fabrication of microparticles for vaccine delivery using supercritical fluid technology.