Regulatory Head of Regenerative Medicine & Advanced Therapy & Interim Lead of GRA Data Science
Why I'm a JPAL
Support of novel ideas is fundamental to bringing much needed solutions to health issues globally. I am a JPAL to foster collaboration and help bring novel ideas forward.
Katherine has 30 years of progressive global regulatory experience in small and large sized Pharma companies. She has worked on products at various stages of development, from early through to filing, approval and commercialization. Katherine is the Janssen Regulatory Head of Regenerative Medicine & Advanced Therapy (RMAT). In this role, she ensures global regulatory policy strategies contribute to and support development plans for RMAT products across several therapeutic areas and facilitates J&J enterprise wide efforts to enhance awareness and connectivity for the development of processes that enable assessing, partnering, and developing safe and effective advanced therapies globally. Externally, she is the co-chair of the National Academy Science Engineering Medicine Regenerative Medicine Forum, and Advanced Therapy Industry Liaison of the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee. Additionally, Katherine is the Interim Lead of GRA Data Science including: RWE, Digital, Clinical Trial Innovation, and Data Modeling. She leads the team focused on the use of Data Science in regulatory decision making and represents global regulatory on the cross-functional Leadership teams. Katherine is an adjunct professor at Syracuse University College of Engineering and Computer Science teaching Introduction to Global Regulatory Affairs. She received her Bachelor of Science Biology from Temple University, Juris Doctorate from Widener University Law School, and is admitted to the practice of law in Pennsylvania and New Jersey.
"Unless someone like you cares a whole awful lot. Nothing is going to get better. It's not."
- Dr. Seuss
My family owns a motocross track.