Accelerate & de-risk programs including COVID-19, create differentiation & 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. Aptar Pharma Services will present our platform that facilitates LCM via formulation development, device selection and regulatory-ready packages.
This presentation will illustrate 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. We will also illustrate 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 will be highlighted. In addition, we will consider how customization and connected add-ons can enable differentiation and improve patient outcomes.
The opportunities associated with nasal drug repurposing are not to be sniffed at.
Vice-President – Analytical, Regulatory and Scientific Affairs
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.
Julie D. Suman,
President, Next Breath, an Aptar Pharma company
Julie D. Suman, R.Ph., Ph.D is the Founder of Next Breath, an Aptar Pharma company, and serves as its President. Dr. Suman holds a B.S. in Pharmacy from Duquesne University (1996) and a Ph.D. in Pharmaceutical Sciences from the University of Maryland, Baltimore (2002). Dr. Suman is 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. She is also a licensed Maryland pharmacist. Dr. Suman has published her research in peer-reviewed journals and has been presented during podium sessions at international meetings at the FDA Topics in Bioequivalence Seminar Series and has been an invited speaker at ANVISA in Brazil. Dr. Suman is also a member of the Parental Drug Association Visible Particulate Taskforce.