For nearly three decades Dr. Livingstone has been involved in drug research and development on both the technical and commercial sides. He has nearly 20 years in corporate development and new venture strategy across a wide variety of business types from small privately owned companies to global divisions of large, public corporations.

As a former member of the MIT Venture Mentoring Service and regular participant in the MIT Enterprise Forum, Dr. Livingstone helped to establish several new companies, most notably Xpogen - an early drug development and data AI company, and CyberMedica - a company focused on developing new information platforms for global drug research and collaboration. His most recent role was VP and Head of Unisys’ Global Life Sciences and Healthcare Division, where he was responsible for new commercial product development and oversaw a $200M P&L across 4 regions and 15 countries. During this time Dr. Livingstone clients included the global research divisions of many luminary pharmaceutical companies, inclusive of GSK, Pfizer, Novartis, J&J, and BMS.

Dr. Livingstone received his PhD in Physical Biochemistry from the University of Wisconsin at Madison and his BS in Biochemistry from the University of Missouri at Columbia. He went on to work first at Genentech as part of the Herceptin™ team, then to NCI/FCRCD to work on AIDS HIV protease inhibition. Following his scientific endeavors, Jeff has held various leadership positions in both life sciences business strategy and consulting and health and life sciences IT business development.

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

Steve completed his BS in Biology from Niagara University, Niagara Falls, NY in 1974 and his JD form Seton Hall Law School in 1988. Prior to attending law school Steve acquired experience in basic research, toxicology and regulatory (GLP) requirements.
As an attorney Steve defended pharmaceutical companies in major products liability cases. Since 1996 Steve has worked in drug development and has significant experience in clinical drug development including project management, monitoring, regulatory and document writing and preparation for regulatory submissions, quality assurance auditing and site readiness inspections.
Steve’s experience is summarized below:

Last Position Company Years

Research Associate The University of Arizona, Department of Physiology, Tucson, AZ 1978 -1980

Study Director and GLP Compliance Officer Toxicology Pathology Services, Inc., St. Philips, Indiana 1980 -1984

Paralegal and Law Clerk while in law in school Cole & Dietz, New York, New York 1985-1988

Attorney Dinsmore & Shohl, Cincinnati, OH 1988 -1996

Assistant Director of Regulatory Affairs Kendle International, Inc. Cincinnati, OH 1996 -2000

Attorney Buechel & Conley, 25 Crestview Hills Mall Rd., Suite 104, Crestview Hills, KY 2001 -2002

Vice President LBR Regulatory and Clinical Consulting Services, Inc., Florence, KY 2001 to present

Vice President, Legal and Quality Assurance IGIA Pharmaceuticals, Inc., Florence, KY 2017 to present