Laurie Iciek, PhD, RAC

Laurie Iciek, PhD, RAC

Senior Consultant

Laurie has over 17 years of experience as a Toxicologist, with a current role as Sr. Nonclinical Consultant for Biologics Consulting, and previous roles as a Lead Toxicologist in the pharmaceutical industry. Her academic training in cellular and molecular immunology has served as a strong foundation for Laurie’s work in biologic drug development, including issues that arise during the development of monoclonal antibodies (mAbs), fusion proteins, vaccines, and immuno-oncology therapeutics. Her industry experience includes the development of biologics and small molecules for MedImmune, Abbott Laboratories (currently AbbVie), and Bristol-Myers Squibb (BMS). She has received numerous industry awards including Bronze and Silver awards from MedImmune, a CEO team award from AstraZeneca, a 3Rs Honorable Mention award from AstraZeneca, and a President’s award from Abbott. Laurie’s experience as a Lead Toxicologist includes: 1) conducting target safety risk assessments (literature reviews) for potential targets in multiple therapeutic areas; 2) designing, executing, and defending preclinical safety assessment packages to support the worldwide development of both biologics and small molecule drugs for oncology, immunology, and infectious disease indications; 3) authoring toxicology and pharmacokinetics sections for discovery transition documents/co-development packages, clinical documents, and worldwide regulatory submissions (e.g., IND, IMPD, BLA, MAA. 505(b) 2 NDA); 4) Study Director, Study Monitor, and/or Study Sponsor for GLP toxicity studies in multiple species; 5) authoring Standard Operating Procedures and IACUC protocols; 6) training/mentoring direct reports and students; and 7) educating others through internal and external seminars and mentorship programs. Laurie’s biologics experience includes mAbs, bi-specifics, combinations, antibody drug conjugates (ADCs), immuno-oncology drugs, fusion proteins, vaccines, and immunotherapeutics. Laurie also has experience in the development of safety risk assessment strategies for process impurities, extractables and leachables, and excipients. To broaden her knowledge of the entire drug development process, Laurie obtained her Regulatory Affairs Certification (RAC, USA) in 2014.


Education

PhD, Immunology, Michigan State University, East Lansing, MI (1994)

BS, Biology, Central Michigan University, Mount Pleasant, MI (1988)