Laurie is an expert in clinical development and regulatory strategy with focus on benefit/risk 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 10 years, Laurie has led teams to success on more than 70 disease indications, including hematology/oncology and rare diseases.
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 an early-stage company focused on inflammatory disorders. She spent over 20 years at Bristol Myers Squibb in leadership roles of increasing responsibility in clinical development in cancer and HIV/infectious diseases.
As Senior VP Global Regulatory Science she was responsible for the regulatory approval process across all phases of development for the portfolio. She also created the system, governance and led Business Risk Management for the corporation.
Laurie was trained in Internal Medicine and Medical Oncology at the Yale School of Medicine.
Dr Laurie Smaldone Alsup