aldo coppi

* Responsible for sample processing for Transmission Electron Microscope (TEM) evaluation. * Responsible for TEM operation and data collection.

* Provide scientific and project management support on multiple biopharmaceutical programs aimed at the identification and development of novel therapeutics for infectious disease, pain, and autoimmune indications. * Coordinate, plan, and manage preclinical programs, as well as clinical activities to meet corporate goals. * Manage project roles, budgets, and timelines, identify resource requirements, define project deliverables and constraints, identify risks, and ensure quality deliverables. * Prepare draft reports, presentation materials, and program updates for corporate partners and senior management review. * Coordinate, facilitate, and lead multi-disciplinary team meetings, as well as maintain cross-functional logistics, communications, and collaborations. * Provide scientific input on toxicology and safety pharmacology study design and timelines, resulting in a more streamlined process for safety assessment.

* Public Company * 10,001+ employees * AMGN * Biotechnology industry

* Educational Institution * 1001-5000 employees * Higher Education industry

* Served as a toxicology study monitor on outsourced GLP toxicology studies. * Initiated, planned, monitored, and finalized outsourced in vivo GLP toxicology studies. * Contributed to toxicology study design, review and finalization of study protocols and reports, and review of study data. * Calculated drug supply needs and coordinated drug product shipments. * Involved in evaluating potential CRO’s for future study placement, improving CRO selection for upcoming project needs. * Participated in multi-disciplinary team meetings providing critical study updates. * Managed the preparation of the toxicology section of a BLA for FDA submission resulting in FDA approval of ARCALYST® (rilonacept) for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS). * Prepared updates to investigative brochures (IB). * Familiar with FDA, ICH, OECD, and MHLW guidelines and regulations.

* Initiated, planned, and executed GLP pharmacokinetic (PK) studies including single dose PK, bio-availability, dose range finding, drug-drug interaction, and bio-distribution studies which supported several programs in development. * Coordinated and conducted PK and toxicokinetic (TK) sample collection, processing, and analysis using Enzyme-Linked Immunosorbent Assays (ELISA). * Conducted ELISA assay development and validation improving assays and protocols for enhanced test article detection. * Prepared study protocols and Standard Operating Procedures (SOP). * Generated and analyzed PK and TK data and prepared study report. * Maintained and calibrated various instruments. * Periodically monitored GLP toxicology studies to support project toxicologists as needed. * Familiar with FDA and ICH guidelines and regulations.

BS in Biology. Worked as a teaching assistent in the biology lab setting up experiments for first year students. Involved in several extracurricular activities including the Italian Club, DJ for the college radio, on the novice Crew Team, and Biology Club.

Assessing the activation and inhibition of various Protein Kinase C (PKC) isoform’s by lead and calcium. * Utilized an in vitro activity assay to determine the activation or inhibition of PKC isoforms on rodent whole brain homogenate and isolated PKC enzymes following exposure to lead and calcium.