Dr. Erik Flahive

Biography

Erik is an independent CMC-API consultant, and brings over 18 years of API manufacturing, CMC and process R&D experience from his prior roles at Pfizer-La Jolla, Ardea Biosciences and Trius Therapeutics.  In his roles at the latter two companies, he successfully delivered the commercial API manufacturing route used for new, FDA-approved medicines for treatment of gout (Zurampic®) and MRSA skin infections (Sivextro®).  At Pfizer, he led research teams that delivered projects in oncology (Inlyta® (axitinib), pelitrexol), anti-viral and ophthalmology disease areas.  Before Pfizer, Erik was a faculty research associate at the Cancer Research Institute (Arizona State University), where he obtained his Ph.D. in Organic Chemistry, and worked on the synthesis of several anti-cancer, marine natural products.  He received a B.S. in Chemistry (Biology minor) from Georgetown University.  Since 2014, Erik has successfully operated a San Diego-based consultant business, and has worked with more than eight clients on projects ranging from pre-IND programs to NDA-stage programs, including support of route registration/validation/launch activities, on-site manufacturing technical oversight, and regulatory filing support.     

Research Interest

Pharmaceutical Analysis and Quality Assurance  Industrial Pharmacy Clinical Pharmacy  Pharmaceutical Administration Medicinal Chemistry  Drug Discovery and Development