She is responsible for a two-way exchange of CMC policy information between the external environment and internal stakeholders, monitoring trends to identify potential impact on products and processes to support planning and compliance, as well as developing policy proposals to share with regulators and industry groups to shape future guidelines. Lamm holds a bachelor’s degree in chemistry and biology from Greenville University, and a doctorate in pharmaceutical chemistry from the University of Kansas. She currently serves as Co-Chair of the ISPE Product Quality Lifecycle Implementation (PQLI®) committee, is a member of the PQLI® Transportable/Point of Care and PQLI® Patient Centric Specifications/ICHQ6 technical teams, the Regulatory & Quality Harmonization Committee (RQHC) APAC Regional Focus Group, and the ISPE Regulatory Steering Council.
How Did Your Career Journey Unfold?
I started my career as an analytical scientist. As part of my role, I helped submit the specifications we had developed. When we received pushback from the regulators, I wanted to engage more closely with them and share my perspective of why I thought these were appropriate specifications and wanted to understand from their perspective why they had concerns. I transitioned into a regulatory role because it was something I was passionate about. And then I took on a more external role so that I could converse with regulators on a more regular basis.
What Do You Enjoy Most About Your Work?
I love the people I get to work with, and the fact that the department I work in is global. Outside of my company I enjoy working with regulators and people in the pharmaceutical industry. It’s powerful to be able to pull together the different perspectives and find solutions. A key component of policy work is identifying a problem; in my case, a gap or barrier to product innovation in a guideline and working with others to fix it. It is wonderful to have the opportunity to hear diverse opinions and perspectives.
What Is a Project You’re Proud Of?
Recently I worked with a group of scientists from ISPE’s PQLI® team to deliver training to Health Canada on ICH Q13. In addition to Health Canada, we had attendees from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and Singapore’s Health Sciences Authority (HSA). It took a lot of work and a lot of coordination across different companies, but it was rewarding in multiple ways.
The training was well received. We had breakout sessions where we talked with regulators and inspectors, allowing us to hear their questions and share how we envision implementing Q13 within our companies, including our use modeling for continuous manufacturing. What was unique about this training was that we had the chance to share the information with a large number of regulators, as opposed to just a small team.
What Do You Enjoy About Being a Member of ISPE?
Engaging with the people. I think that ISPE brings together so many brilliant minds, which has strengthened me as a CMC scientist and policy lead. I’ve had the opportunity to learn from so many people across many walks within the pharmaceutical industry—that has been the greatest benefit.
Currently, I’m working on a platform paper with several different members, bringing together diverse viewpoints from across the industry. There are a lot of questions about platform technology and how it can be applied, and it’s been rewarding to collaborate with these individuals and hear their ideas.
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.
