Daniel Aleksandrowicz

Manage the timing, design and execution of Preclinical Pharmacotoxicology Studies for multiple programs, from transition throughout marketing. Responsible for all operational aspects of the Toxicology Studies run within Development Programs; these include liaising with CROs, managing internal clients, document tracking and timing management. Fully involved in Protocol Development and Study Design based on relative Guidances (FDA, OECD, MHLW, ICH) for the following types of studies; Screening Assays, Gene Toxicology, IND-enabling, Chronic and Safety Pharmacology studies (CV Safety, CNS Safety and Respiratory Safety Studies). Participate in the Development and Quality Control of IND, IB, BLA and Annual Review Documents to assure compliance with FDA guidances. Monitor CROs to ensure technical conduct of Toxicology studies

Conducted a variety of oncology focused studies including Maximum Tolerated Dose and Efficacy Studies for the Pharmacology department. Independently calculated drug formulations, coordinated schedule of multiple team members to ensure dosing, blood collection, necropsy, tumor measurements, and cell injections of oncology projects were performed efficiently and accurately. Assisted in piloting new techniques and screening models for various Programs. Worked exclusively with the development of a Polycythemia Model in mice as well as ran all the surgical models for the Neurobehavioral group in Lenti-viral injections utilizing the stereotaxic equipment in rodents. Conducted rodent and canine PK studies for the DMPK department. Worked both independently and within a team setting to ensure PK studies were performed timely and accurately. Determined drug dose calculations. Adeptly dosed animals via catheters, intraperitoneal injection, subcutaneous injection, and oral gavage. Provided meaningful data to DMPK department by quality sample collection (urine, blood, feces, bile), necropsy, data capture and entry. Member of a Project Core Team; .responsibilities included attending regular meetings to collaborate with team members to guide the direction of the project, contributed to the development of the study design by providing knowledge of in-vivo studies. Performed husbandry and facility duties for all animals and animal areas which includes familiarity with all aspects of facility operations (cage wash, writing/reviewing SOP's). Utilized programs such as BioBook to accurately recorded and analyze data.

Conducted biocompatibility testing under appropriate guidelines (FDA, EPA, GLP, ISO, AALAS) on various species'. Assisted in the preparation and review of data packages. Performed both large and small animal surgery (Rats, Mice, Dogs, Pigs, Goats, Rabbits, Guinea Pigs) for both Biocompatability Testing and Surgical Modeling. Provided training to new employees including test article preparation, animal handling and restraint, dosing methods (IV, IP, PO, IM, ID, SC), sampling methods, surgery techniques, necropsy and GLP Guidelines.