She is active in several external organizations which have helped her to build a strong network and knowledge base, including being a speaker and committee member for ISPE, California Separation Science Society (CASSS), Product Quality Research Institute (PQRI), American Association of Pharma-ceutical Scientists (AAPS), International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), and Drug Information Association (DIA). In addition to serving as the ISPE PQLI® Co-Chair and a member of the Regulatory Steering Council (RSC), she has been a member of the ISPE International Board of Directors (2020-2024), the PhRMA Global Quality and Manufacturing group, and the ICH Q2(R2)/Q14 Expert Working Group. She has a PhD from Purdue University School of Pharmacy and has over 25 years of industry experience.
How Did Your Career Journey Unfold?
My first job was at Warner-Lambert/Parke-Davis in Morris Plains, NJ, as an analytical chemist, then I moved to California and worked at a small start-up in Santa Barbara, before joining Amgen in 1998 where I started out in analytical development supporting pharmaceutics and process development. About 12 years ago, I joined Regulatory Affairs- CMC. Because I had worked on filings and submissions to regulators as part of my technical role, I thought it would be interesting to see it from the other side.
My current role in advocacy and external engagement involves a lot of outreach and one of the first organizations that I got involved with was ISPE. I joined the PQLI® accelerating product development team and was very impressed because of how the group worked together to write articles and was really trying to create useful information to educate people around the world. It’s really great to see the global outreach of ISPE and that sense of a common purpose and mission to help patients around the world.
What Do You See Next for the Industry?
The pace of change is so fast these days and with the amount of knowledge in the world growing exponentially, it can be hard to keep up. I think that regulators around the world have recognized the value of collaboration and reliance mechanisms as a means to gain efficiency. There is more work-sharing and collaboration using IT platforms where different regulators can view the same submission and collaborate on what their responses are going to be back to the sponsors. Not only is it more useful for regulator assessments, but it also has the advantage of being able to speed up those approvals for sponsors. It can also foster harmonization and innovation through building a common understanding of the requirements for the Quality/CMC sections of a regulatory submission. Together with these common platforms, automation of regulatory submissions using structured data and AI will free up scientists and product teams to really concentrate more on what the data is telling us, as it will enable reuse of information across sections without the manual labor of cutting and pasting.
What Do You Enjoy About Being a Member of ISPE?
The pharmaceutical industry is rapidly evolving, driven by technological advancements, regulatory trends, and global considerations. ISPE is well-positioned to assist its members in this changing landscape. ISPE’s PQLI® initiative serves drug manufacturers and health authorities by providing tools and education to bridge the gap between regulations and implementation to achieve quality throughout the product lifecycle for the benefit of patients. It is at the nexus of science and regulation where scientific innovation meets regulatory expectations. We share strategies for translating regulations into practice, including detailed interactive training sessions for regulators. The teams have developed webinars, conference sessions, workshops, publications, and blog articles illustrating the practical implementation of new technology and regulatory approaches based on sound scientific, engineering, and business principles.
Join a Communities of Practice
Are you an ISPE Member looking for a better way to connect with your colleagues from around the globe? Or are you a Member seeking information on new trends, issues or concerns affecting your profession and your day-to-day work life? Join an ISPE Community of Practice (CoP). CoPs are groups of ISPE Members with a common interest and similar job functions who collaborate on topic-specific discussions using the ISPE networking forum, ISPE Engage.
