08 Nov Therapeutic Product Development
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Biomedical Innovation Fireside Chats
Session 7: Therapeutic Product Development
Join regional program leaders for virtual “fireside chats” with biomedical entrepreneurs, investors, and industry experts. Conversations are aimed at early-stage academic innovators who need to quickly learn the essentials. Events will be held over Zoom and recorded. Learn more about the series and the rest of the sessions here.
Topics for discussion in this final session of the series will include:
- Target Product Profile
- Preclinical Requirements
- Clinical Study Design
- GMP Manufacturing
About the Host
Lynn Rose, PhD, is an affiliate Associate Professor in the University of Washington School of Pharmacy (SOP), where she maintains faculty positions with the SOP Master in Science in Biomedical Regulatory Affairs and the UW Institute of Translational Health Sciences (ITHS). She has extensive experience in the development of biomedical products, gained in both industry and academic settings. In previous positions she has had direct responsibility for preclinical, clinical, and regulatory programs across multiple therapeutic areas and product types. This experience included participation on multiple drug development teams, four of which resulted in marketed products in the US and EU. She is skilled at critical review of biomedical product concepts, clinical protocols, development of regulatory strategies, and the management of regulatory submissions to federal authorities. In addition to sharing her regulatory experience with students of biomedical regulatory affairs, Dr. Rose is also a founding member of the ITHS Drug and Device Advisory Committee (DDAC), which advises investigators on issues related to the regulatory requirements for product development. This unique combination of experiences is the basis for her role within the ITHS Technology Development Service Center where she advises academic investigators on their regulatory options and strategy.
Dr. Rose’s primary basic and clinical research experience is in the field of immunology, with emphasis on autoimmunity, infectious disease and immune-oncology.
