Leadership

LBR is committed to staffing every project with the most qualified and experienced personnel available.

• PhD in Biochemical Pharmacology, SUNY Buffalo School of Pharmacy

• Postdoctoral Fellow, University of Arizona at the Schools of Pharmacology and Medicine

• Co-Founder and owner of LBR since 2001

• CRO experience from 1996 (Kendle International) including VP of Global Regulatory and QA

• 16 years of experience in the pharmaceutical industry (Mead Johnson, Hoffman La Roche, Merrill Dow (aka Marion-Merrill Dow), Procter & Gamble, Medisorb) including hands-on research and management experience in preclinical and regulatory management of global projects

• JD, Seton Hall Law School

• BS Biology, Niagra University

• The University of Arizona: 2 years of basic research

• Co-Founder and owner of LBR since 2001

• CRO experience from 1996 (Kendle International and LBR Regulatory)

• Toxicology and Pathology Services, Inc: 3 years of toxicology experience conducting studies and 1 year as GLP officer

• 8 years’ experience in defense of drug product liability litigation involving drugs and devices

• PhD in Physical Biochemistry, University of Wisconsin, Madison

• Postdoctoral Fellow, Protein Engineering Department, Genentech

• Senior Scientist, National Cancer Institute

• Senior level pharmaceutical experience since 2001

• Seasoned global senior executive with experience as CEO IGIA Pharma, VP & Global Head, Unisys Life Sciences and Healthcare, Exec VP Seracare Life Sciences, and VP Fisher Scientific – Pierce Milwaukee

• PhD in Pharmacology, University of Cincinnati College of Medicine

• Postdoctoral Fellow, University of Cincinnati College of Medicine

• With LBR since 2005

• 6 years of experience in the pharmaceutical Industry (Procter & Gamble, ICOS Corp, and Elan Pharmaceuticals) including Regulatory project management of small molecule and biologic programs

• CMC Regulatory expertise in drugs and biologics

• Experience writing IND, NDA/BLA, sections (preclinical, CMC, package insert); Complete ANDAs; Orphan drug applications; and Clinical reports

• FDA liaison with various Divisions within CDER and CBER; Authorized representative for small companies

• Experience in Pre-IND, End of Phase 2, and Pre-NDA Meeting Preparation and Lead