Spotlight: Selection Committee Member
A Chat with iSelect BioTech Selection Committee Member, Melissa Walker
A Brief Background:
Melissa is a regulatory professional with over 27 years of experience in the medical products industry. She currently serves as Founder, President and CTO at Graematter, Inc., a regulatory intelligence firm. A self proclaimed computer nerd, Melissa patented the Graematter database which collects regulatory data and makes it available as a SaaS product for those navigating the FDA regulatory process. Melissa holds the position of Senior VP Regulatory at Topera, Inc which was acquired by Abbott Laboratories in 2014. Her specialties include regulatory intelligence research and reporting, due diligence audits and evaluations for acquisitions, product approvals and clinical trials. Melissa previously served as the industry representative for the FDA Medical Device Dispute Advisory Panel and is currently an adjunct Instructor at Washington University teaching courses within the Clinical Research Management degree program. Melissa is also involved as a mentor for Pipeline, the midwestern entrepreneurial community.
Tells us about your involvement in the entrepreneurial scene and what you like about it.
What I really like about startups is the broad exposure to so many different aspects of a company. If you work in a large company you only end up seeing that small piece, whatever your job description says. But if you’re in startup companies you do everything from make the first pot of coffee to pitching to investors.
There’s something different everyday. I love to put puzzles together and there’s nothing more like a puzzle than putting a strategy together to get through the regulatory process. It all depends on the nature of the product and the pieces that you have to work with. Every startup is a little different so each regulatory strategy has to be carefully tailored.
It’s a soup to nuts sort of activity when you’re in a startup.
Thank you Melissa !
