Team

Executive Management

Jeff Livingstone, PhD, CEO
Lois Rosenberger, PhD, COO
Stephen Rosenberger, BS, JD, Vice President, Legal and Quality Assurance
Greg Kelso, PhD, Vice President, Regulatory Affairs
Ann Flandermeyer, PhD, RN, PMP, Vice President, Program Management

Scientific Advisory Board

Anton Bennett, PhD
Steve Colan, MD
Dominic Abrams, MD
Amy Roberts, MD
Alexander Vinks, PharmD, PhD, FCP

CEO

Jeff Livingstone, PhD

Executive Leader driving business growth through innovative life sciences product development.

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.

COO

Lois Rosenberger, PhD

Lois completed her PhD in Biochemical Pharmacology from the State University of New York, Buffalo, NY in 1978 and completed a two-year Post-Doctoral NIH Fellow in the Departments of Medicine and Pharmacology at The University of Arizona, Tucson, AZ in 1980.

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

Vice President, Legal and Quality Assurance

Stephen Rosenberger, BS, JD

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.

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

Vice President, Regulatory Affairs

Greg Kelso, PhD

Greg completed his PhD in Pharmacology from the University of Cincinnati College of Medicine, Cincinnati, OH in 1993 and completed a four-year Postdoctoral Fellow at the University of Cincinnati College of Medicine, Cincinnati, OH in 1997.

During his 20 years in the pharmaceutical industry Greg has developed an in-depth knowledge of the clinical drug development process with a focus on regulatory and expertise in CMC to ensure appropriate manufacturing documentation is in place for IP. Greg has been responsible for the strategic regulatory consulting, preparation and submission of INDs, NDA, CMC submission, ongoing regulatory updates to the FDA, foreign applications and regulatory filings for a range of clinical indications. Greg is also experienced in vendor qualification audits, QA audits and inspection readiness audits.
Greg’s experience is summarized below:
Position Company Years

Postdoctoral Fellow University of Cincinnati College for Medicine, Cincinnati, OH 1993 -1997

Senior Regulatory Specialist Kendle International, Inc. Cincinnati, OH 1997 -1999

CMC Regulatory Scientist Procter & Gamble Pharmaceuticals, Mason, OH 1999 -2001

Sr. Manager, Regulatory Affairs ICOS Corporation, Bothell, WA 2001 -2003

Associate Director, Regulatory Affairs Elan Pharmaceuticals, San Diego, CA 2003 -2005

Director of Regulatory LBR Regulatory and Clinical Consulting Services, Inc, Florence, KY 2005 to present

Vice President, Regulatory IGIA Pharmaceuticals, Inc., Florence, KY 2017 to present

Vice President, Program Management

Ann Flandermeyer, PhD, RN, PMP

Ann completed her RN at Lake Superior State University, Sault Ste. Marie, MI in 1976 and her PhD in Nursing Research from the University of Cincinnati, Cincinnati, OH in 1996 and received her PMI certification as a Project Management Professional in 2009.

Ann completed her RN at Lake Superior State University, Sault Ste. Marie, MI in 1976 and her PhD in Nursing Research from the University of Cincinnati, Cincinnati, OH in 1996 and received her PMI certification as a Project Management Professional in 2009.
During her 22 years in the pharmaceutical industry Ann has developed an in-depth knowledge of the clinical trial process with a focus on overall management of the execution and management of timelines and budgets for large global clinical trial programs for major pharmaceutical companies. Ann has managed large groups of departments and worked internally to ensure projects were delivered on time and within budget. Ann also has 20 years of experience in various nursing positions and as an instructor and professor in the nursing field.
Ann’s experience is summarized below:

Position Company Years
Nursing and Nursing Instructor Positions Various hospitals and College of Mount St. Joseph, Cincinnati, OH 1976 - 1991

Assistant Professor/ Research Assistant University of Cincinnati, College of Nursing and Health, Cincinnati, OH 1991 -1996

Senior Project Manager Kendle International, Inc. Cincinnati, OH 1996 -2002

Sr. Project Director Omnicare Clinical Research, King of Prussia, PA 2002 -2006

Executive Director, Early Clinical Development Covance Clinical Development Services, Princeton, NJ 2006 -2012

VP Operations LBR Regulatory and Clinical Consulting Services, Inc., Florence, KY 2012 to present

Vice President, Project Management IGIA Pharmaceuticals, Inc., Florence, KY 2017 to present