Lois received her PhD in Biochemistry from the University of Southern California and was a Post-Doctoral Fellow at the Salk Institute for Biological Studies. She is currently Vice President of Product Development for Angionetics Inc. (subsidiary of Gene Biotherapeutics Inc.). Lois was responsible for Chemistry, Manufacturing, and Controls and Quality Control activities and regulatory submissions resulting in FDA 510(k)-clearance of Excellagen® and clinical advancement of gene therapy product candidates for dermal wound healing and therapeutic angiogenesis. Lois established and implemented Gene Biotherapeutics’ Quality Management Systems, which resulted in successful ISO 13485 Certification. In the process, she fostered mutually respectful alliances with Contract Manufacturers and Contract Testing organizations, and worked through technical challenges, achieving validated procedures, and outcomes meeting budget, timeline, and material supply requirements. Lois will be responsible for technical/scientific matters as it relates to the developmental process that created Excellagen. She will also provide guidance on the various stages of production of Excellagen. Lois was awarded the Patent for Excellagen in June 2018. She currently heads R&D at Angionetics and leads the team creating the first gene-based therapy for refractory angina.
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