The opportunities associated with nasal drug repurposing are not to be sniffed at. This presentation illustrates case studies including the repurposing of an existing lifesaving therapy to ease administration in an emergency situation.
Presented by Guillaume Brouet, Vice-President of Analytical, Regulatory and Scientific Affairs, Aptar Pharma and Dr Julie Suman, President, Next Breath, an Aptar Pharma company, this webinar shows how to accelerate & de-risk programs including COVID-19, to create differentiation and improve patient outcomes.
Development of a New Chemical Entity and its commercialization requires up to 15 years work and can represent a $2.6 billion investment. Utilization of alternative dosage forms is a means to leverage that investment through life cycle management (LCM). In today’s fast changing global pandemic, repurposing a medication can save lives. Repurposing presents other benefits to LCM including, but not limited to, IP creation and increased market share, access to faster, less complex regulatory pathways, patient empowerment and less reliance on HCPs.
This presentation illustrates case studies including the repurposing of an existing lifesaving therapy to ease administration in an emergency situation, and where the core aim has been to enable simplified access, with a more intuitive, user-friendly method of delivery. It also illustrates potential application of nasal and inhalation delivery platforms for COVID-19 treatments. Success of a project through human factors and the selection of the right regulatory pathway are highlighted. In addition, we consider how customization and connected add-ons can enable differentiation and improve patient outcomes.
Vice-President - Analytical, Regulatory and Scientific Affairs, Aptar Pharma
Guillaume Brouet is Vice-President, Analytical, Regulatory and Scientific Affairs for Aptar Pharma. He
has 25 years of experience in the development and qualification of drug delivery systems as well as analytical and formulation development. He has spoken previously at multiple respiratory and nasal drug delivery conferences. Mr. Brouet graduated from Ecole Supérieure de Chimie Organique et Minérale (ESCOM, Paris, France) and earned an Msc in Physical Chemistry, which he obtained at the University of Houston, TX, US.
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.