IGIA - Key Persons

Job Titles:

• Member of the Scientific Advisory Board

Job Titles:

• Member of the Executive Management Team
• Vice President, Program Management

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.

Job Titles:

• Member of the Scientific Advisory Board

Job Titles:

• Member of the Scientific Advisory Board

Job Titles:

• Associate Director, Regulatory Affairs

Job Titles:

• Member of the Executive Management Team
• Vice President, Regulatory Affairs

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:

Job Titles:

• CEO
• Member of the Executive Management Team
• 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.

Job Titles:

• COO
• Member of the Executive Management Team

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:

Job Titles:

• Member of the Executive Management Team
• Vice President, Legal and Quality Assurance

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.

Job Titles:

• Member of the Scientific Advisory Board