Julie Lieb

I have over 30 years experience in GLP CRO/Biotechnology/Pharmaceutical industry. I have skills and expertise to make an immediate impact for your Drug Development Program. I can serve as your point of contact/monitor for the placement/conduct of outsourced nonclinical (GLP and non-GLP) in vitro and in vivo toxicology, ADME and pharmacology studies for preclinical development. Manage day to day interactions with CRO’s and research collaborators. CRO site selection, site qualification inspections, negotiates best cost for study design and project timelines. In-process monitoring of CRO’s for protocol, facility SOP’s and ensuring studies are conducted within defined timelines. Coordinate the preparation and review of data and relevant study documents including protocols and interim and final reports. Experience with both large and small molecules.

C.A.P.T.S. is a non-profit organization which is staffed and managed by volunteers. Dedicated to sending care packages to US troops. Capt's goal is to provide our soldiers with comforts of home. Our boxes contain food products, undergarments, personal care items, books, magazines and other comforts from home. We try to make these boxes to have a personal connection to someone back home. C.A.P.T.S. coordinates all its efforts with local schools, VFW’s, working families and other organizations to involve the community in informing them about the needs of our US military personnel.

Purchased by Shire Pharmaceuticals

Purchased By Shire

•Qualify contract laboratories for preclinical studies. •Initiate and monitor toxicology, pharmacology and drug metabolism studies. •Develop protocols, cost comparisons and “fast tracking” strategies for drug development programs. •Monitor all phases of in vivo and in vitro studies to ensure compliance with the protocol, facility SOP’s and FDA, ICH compliance. •Summarize and present data at internal Drug Development program meetings. •Assist clinical development in dose selection for human trials.for Intravitreal injection, IV and SQ dose routes. •Prepare summary/abstracts for toxicology studies. •Develop and manage a master schedule for the company’s toxicology, pharmacology and drug metabolism groups. •Perform audits (GLP) according to worldwide regulations (FDA, etc.). •Collect data and analyze, for in-process reviews.

Formerly Arthur D. Little - Life Sciences Division

•Coordinated the conduct of studies for a wide range of dermal, oral, IV bolus and infusion, ophthalmologic, photocarcinogenicity and phototoxicity/photosensitization studies. •Managed study conduct, scheduling, and data review. •Monitored technical activities related to the studies. •Trained and guided junior staff in proper procedures regarding regulatory agencies and lab techniques. •Collected and analyzed data and wrote final reports. •Developed a repeated intravenous infusion program utilizing an ambulatory infusion pump. •Coordinated and reconciled sample analysis with external subcontracts.