Lead authoring and strategy for regulatory dossiers including DMFs, INDs, ANDAs, NDAs, BLAs, MAAs, NDS
Provide risk-based approach in the areas of submission content and strategy
Lifecycle management of global dossiers for biologics and small molecule-based products
Facilitation of meetings with regulatory authorities on behalf of sponsors
Collaboration with nonclinical and clinical teams on regulatory dossiers
Interim Chief Financial Officer
JAMES A. MCNULTY, CPA
Mr. McNulty was CFO of MIRA Pharmaceuticals, Inc., until shortly before its IPO in August 2023. He was CEO of MYMD Pharmaceuticals, Inc. from its inception in 2014 until it became public in early 2020.
After leaving public accounting in 1998 after a 26-year career in Tampa as founder of three CPA firms, he served as CFO in the biopharmaceutical industry, including 3 years with Star Scientific, Inc. (NASDAQ: STSI) and 15 years with BioDelivery Sciences International, Inc. (NASDAQ: BDSI). He served five years on the board as Lead Director/Audit Committee Chair of CV Sciences, Inc (OTC: CVSI). He has extensive experience in privately held companies, including five years as a Director of Quantum Technology Sciences, Inc. until its acquisition by a public company, and since 2000 as CFO of Hopkins Capital Group, an affiliation of limited liability companies which engage in venture activities primarily in the development of pharmaceuticals, including 6 years as CFO of Defender Pharmaceuticals, Inc. He is a partner in Perfect Golf Event, LLC, an online organizer of over 5,000 charity golf events.
Accounting and consulting services includes expert testimony as a Certified Public Accountant, primarily in construction litigation and personal injury cases. He is a 1972 graduate of University of South Florida.
