Clinical and Regulatory Challenges with Nanomedicines
Science & Innovation Webinar
Webinar Recorded on Oct. 14, 2021
Sponsored by Vifor Pharma, Inc.
The field of nanomedicine is a complex and rapidly growing scientific domain. Nanomedicine encompasses a large and diverse number of pharmaceutical formulations including liposomes, micelles, nanoparticles and polymer-drug conjugates. Submissions of Investigational New Drugs and New Drug Applications have risen dramatically over the last decade. Currently, there are over 40 FDA approved nanomedicines on the US market. In their draft guidance entitled “Drug Products, Including Biologics, That Contain Nanomaterials” the Food and Drug Administration identify 11 factors that the agency identifies as crucial to making risk-based evaluations of these drug products. These factors are not only applicable to new drug approvals but are also critical for bioequivalence of generic or follow-on products. Currently, many research gaps exist in defining and measuring critical quality attributes for the heterogeneous class of nanomedicines. Pharmacists will be provided with a view of the landscape of nanomedicines and implications for patient safety and therapeutic efficacy.
Following the completion of this webinar, participants will be able to identify and define types of nanomedicines approved for clinical use demonstrate an understanding of the complexities of nanomedicines related to their pharmacokinetics, pharmacokinetics, biodistribution and biodegradation and be able to analyze these issues and their implications regarding the regulatory landscape for nanomedicines and its application to formulary management.
- Tamer Elbayoumi, PhD
Professor, Department of Pharmaceutical Sciences
Co-Director, Nanomedicine Center of Excellence (COE)
Midwestern University, College of Pharmacy-Glendale
- Judith A. Smith, B.S., Pharm.D, BCOP, CPHQ, FCCP, FISOPP, FHOPA
Professor & Director of Women’s Health Integrative Medicine Research Program
McGovern Medical School at UTHealth
Department of Obstetrics, Gynecology and Reproductive Sciences
This webinar is sponsored, developed and presented by the sponsor. The content of this Science & Innovation Theater Webinar and opinions expressed by the presenters are those of the sponsor or presenters and not of AMCP.