Amanda Szucsik

About Amanda Szucsik

I currently serve as a Veterinary Medical Officer within the Center for Biologics Evaluation and Research at the United States Food and Drug Administration. I have a long employment history conducting in vivo research in diverse species ranging from Standardbred racehorses to Savannah monitor lizards. Veterinary school was the \'second act\' of my career, followed by a residency in Laboratory Animal Medicine and employment as a clinical veterinarian at a global contract research organization. In my current position, I draw on my cumulative experience to evaluate new biologics for safety and activity throughout the product lifecycle.

Experience

1. Veterinary Medical Officer (Vmo), Center for Biologics Evaluation and Research (Cber)

   FDA

   Jan 2023 — Present · Silver Spring, MD, US

   VMO within the Offices of Therapeutic Products (OTP) and Pharmacology/Toxicology (OPT)-Serve as the primary nonclinical (pharmacology/toxicology) reviewer for regulatory submissions on a multidisciplinary team-Evaluate nonclinical data during premarket review of investigational products. Product types include genetically modified cells, viral and non-viral vectors for gene therapy, genome editing products, stem cell-derived products, immunotherapies, therapeutic vaccines, products for xenotransplantation, etc-Provide evidence-based written and verbal feedback to sponsors regarding the design of their nonclinical development program prior to investigational new drug (IND) submissions-Review complex, cutting-edge preclinical programs in IND submissions to determine if there is adequate support for the rationale and safety of product administration in proposed clinical trials-Evaluate the nonclinical sections of Biologics License Applications (BLAs)-Represent the FDA at various scientific and regulatory meetings

Education

• NC State College of Veterinary Medicine

  DVM

  2014 — 2018

• UC Irvine

  MS, Biological Sciences (Comparative Physiology)

  2001 — 2009

• Rutgers University

  Bachelor of Science - BS, Animal Science

  1997 — 2001

• The University of Georgia

  Clinical Residency, Laboratory Animal Medicine

  2018 — 2019

Skills

• Pcr
• Assay Development
• Biochemistry
• Elisa
• Clinical Research
• Pharmaceutical Industry
• Histology
• Animal Models
• Animal Welfare
• Animal Husbandry
• Animal Surgery
• Animal Science
• Veterinary Medicine
• Iacuc
• Laboratory Animal Medicine
• Pre-Clinical Studies
• Drug Safety
• Drug Testing
• Biology
• Life Sciences
• Research
• Science
• Polymerase Chain Reaction (Pcr)
• Biotechnology