Name
Marshall Scicchitano
Educational Degrees
BS, MS
Education
BS Biology from Mansfield University
MS Biology from Shippensburg University
Expertise
Cardiovascular Toxicology, Clinical Trials (Phases I- II- III- IV), Drug/Pharmaceutical Development, Genetic Toxicology and Cytogenetics, GLP Study Auditing, Hepatic Toxicology, In Vitro Toxicology, Medical Devices, Pharmacokinetics/Toxicokinetics, Product Safety Assessment, Regulatory Toxicology, Renal Toxicology, Risk Assessment, Safety Pharmacology, Toxicologic Pathology, Training and Training Courses
Specialties
Toxicology * Regulatory * IND * Discovery Toxicology * Exploratory Toxicology * Biomarkers * Mechanism of Toxicology * Investigative Toxicology * Due Diligence * ADME* Pharmacology * Small Molecules * Antisense Oligonucleotides * Biologics
Experience
I have been involved in the field of toxicology for 20+ years within the pharmaceutical industry. I have experience with toxicology study designs, dose selection, including interpreting toxicology data, generating toxicology study reports and experience with regulatory authority submissions and interactions. I have many years of experience on cross-functional clinical/preclinical teams where I successfully managed and lead all toxicology activities and effectively collaborated with clinical team members regarding the clinical plan, regulatory documents, and departmental timelines. I lead the selection of CROs, solicit and evaluate quotes, negotiate timelines, and liaise with CRO staff. I have a solid background and experience in both drug discovery and development and understand the requirements and processes needed to advance drugs from target selection/validation, lead ID/optimization through regulatory toxicology studies and into clinical development. I have a strong molecular biology background with experience developing assays to support a variety of discovery/preclinical/clinical projects, development and application of molecular profiling capabilities in the areas of predictive and mechanistic toxicology, including biomarker studies. I have provided scientific and technical leadership related to nonclinical development using in silico, in vitro and in vivo toxicology methods to investigative molecular and cellular mechanisms of toxicity.
Address
501 Pleasant View Drive
City
Douglassville
State
PA
Zip Code
19518
Country
USA
Telephone
610-905-1146
Fax
610-689-4646
Mobile Number
610-905-1146