Laurie is an expert in clinical development and regulatory strategy supporting all NDA’s service lines to address most critical needs by the biopharma industry. She advises companies on their regulatory and clinical strategies to support product approvals, assessing gaps and opportunities for accelerated development in the US and Europe.
Over the last 8 years, Laurie has either worked on directly or overseen more than 70 different rare disease indications, including oncology indications.
Key Areas Of Expertise
- Rare genetic disorders
- Infectious diseases – bacterial and viral
- Immunologic disorders
- Neurodegenerative disorders
- Advisory committee, oral explanation and key milestone meeting strategies
Laurie served as President of PharmApprove; and President and CEO of Phytomedics, focusing on inflammatory disorders. She spent over 20 years at Bristol Myers Squibb in leadership roles of increasing responsibility in clinical development in cancer and infectious diseases/antivirals.
As Senior VP Global Regulatory Science at Bristol Myers Squibb she created and led corporate Business Risk Management.
Laurie was trained in Internal Medicine and Medical Oncology at the Yale School of Medicine.
Dr Laurie Smaldone Alsup