During her 39 years in the pharmaceutical industry Lois has developed an in-depth knowledge of the clinical drug development process including drug discovery, non-clinical research, IP manufacturing and compliance, quality assurance, strategic regulatory affairs (IND through NDA/BLA/NADA process including meetings with the FDA and working with FDA on audits for NDAs), and managing the conduct of Phase 2 and Phase 3 clinical development programs. Lois brings many years of experience in auditing and inspection readiness for regulatory agency audits.
Lois founded LBR Regulatory in January 2001 to provide regulatory strategic consulting and clinical project management for small to mid-sized pharmaceutical companies. At present LBR Regulatory has 40 full time employees. Since 2001 LBR regulatory has successfully conducted Phase 3 clinical protocols for 5 drugs that received FDA approval based on the clinical trials conducted by LBR Regulatory for the sponsor pharmaceutical company. LBR Regulatory has also prepared INDs and NDAs for submission to the FDA and has represented pharmaceutical companies at the FDA.
Lois’s experience is summarized below:
Position Company Years
Senior Scientist, Cardiovascular Research Mead Johnson Pharmaceutical Division, Evansville, IN 1980 - 1984
Manager, Cardiovascular Ischemic Drug Discovery Team Bristol Myers Pharmaceutical Division, Evansville, IN 1984
Associate Director, Cardiovascular and Atherosclerosis Research Hoffman-LaRoche, Inc, Nutley, NJ 1984 -1988
Manager, Regulatory Affairs Marion Merrell Dow, Cincinnati, OH 1988 - 1991
Section Head, Regulatory Affairs Procter & Gamble, Co, Cincinnati, OH 1991 -1994
Director, Regulatory Affairs/Safety and Compliance for Manufacturing Drug and Devices Medisorb Technologies International, L.P, OH 1994 - 1996
President Comprehensive Regulatory Compliance, Inc, KY 4-1996 to 8 1996
Global Vice President, Regulatory Affairs and Quality Assurance Kendle International Inc, Cincinnati, OH 1996 - 2000
President LBR Regulatory and Clinical Consulting Services, Inc, Florence, KY 2001 to present
Acting CEO, Vice President Clinical Operations IGIA Pharmaceuticals, Inc., Florence, KY 2017 to present