About Lisa

Lisa earned a Masters Degree in Business Administration HealthCare Management in 2004. She then began her career in clinical research working for the Office of Protocol Research at MD Anderson Cancer Center. She now has Clinical 18 years of experience in various positions including, academia, regulatory, clinical operations and project management. She has many career accomplishments throughout her career in academia and small biotech including successful NDA/BLA/MMA filings and regulatory inspections as well as successful completion of small and large programs starting from IND submissions through database lock.  

• Successfully completed NDA and MAA submissions for Type 1 Diabetes program which lead to a successful FDA inspection. The inspection was so successful that the inspector shorten her review time from 2 weeks to 1 week and we had zero findings. This lead to EMA approval.
• Successful CRO oversight, which lead to successful outcomes during regulatory inspections, at the CRO, with no 483s.