Authors

Brian Drapeau

Brian Drapeau is founder, GxPFrame and a cell and gene therapy manufacturing and quality systems consultant.
He can be contacted at [email protected] for any consulting or advisory needs. 

Tim Stroud

Tim Stroud is Solutions Consultant Team Leader at Cenevo. He is an experienced life sciences professional with more than 20 years in the pharmaceutical drug discovery industry. Prior to joining Cenevo, he worked as a scientist and lab automation specialist in the pharmaceutical industry at Pfizer and AstraZeneca. He leads Cenevo's team of solutions consultants, who deliver expert support to the sales teams in providing laboratory automation and software solutions to our clients in the academic, biotech, pharma, hospital, and agriscience sectors. www.cenevo.com

Nathan Edwards, PhD, specializes in business development, new product planning, and early brand strategy. He helps companies lay the foundation for successful launches through data-backed strategies spanning indication assessment to portfolio strategy. With a strong background in pricing and market access, Nathan integrates both commercial and access insights into early asset development to maximize market opportunity.

Dr. Thomas Ybert is chief scientific officer and co-founder of DNA Script and leads the company's research and innovation efforts. Thomas is the main inventor of DNA Script's Enzymatic DNASynthesis (EDS) technology. Holding a PhD in molecular biology and yeast genetics from Ecole Polytechnique, his background includes R&D roles at Sanofi and Total/Amyris.

Charlotte McIlvaine is senior manager-North America Pharma Quality at Univar Solutions. Charlotte is an analytical chemist experienced in quality control and quality assurance. Charlotte joined Univar Solutions over 9 years ago to oversee quality in 2 districts focusing on the quality needs for Univar Solutions’ pharmaceutical customers.

Sydney Badger is a Technical Development Manager at IMCD. With over seven years of experience in the pharmaceutical excipient industry, Sydney has a strong background in oral solid dosage forms and formulation development. Leveraging her previous experience as an R&D formulator, she brings application-oriented technical expertise to her current role.

Miguel Fagundes is a Qualified Person eligible and experienced in QA/Operations with 15 years leading pharmaceutical manufacturing, quality assurance, and regulatory compliance across global markets. Proven track record in building state-of-the-art facilities, and implementing quality management systems, overseeing GMP operations and quality, leading tech transfer from R&D to commercial scale. Certified Lean Six Sigma Black Belt with deep knowledge of EMA/FDA regulations and a continuous improvement mindset.

Lily Lin, PhD, is a senior applications scientist at Roquette in the Health and Pharma Solutions Business Unit, specializing in formulation design and excipient innovation. She holds a PhD in polymer chemistry from Texas A&M University and completed postdoctoral training at MIT.