Amy joined NDA in 2020, and has over 18 years experience in the pharmaceutical and regulatory industry, primarily in biologics and cell therapy. She applies her skills & knowledge to a broad range of therapeutic areas and has successfully helped clients prepare & interact with Health Authorities throughout the stages of drug development.
Key Areas Of Expertise
Personalized medicine, gene and cell therapy, oncology, rare disease, infectious disease, biomaterials, implants, medical devices, transport theory, kinetics, immunology, and cell biology
Therapeutic area experience including metabolic disorders, rare diseases, oncology, cell and gene therapy, dermatology and infectious diseases
Planning and development of Clinical Studies, including preparation of protocols, INDs and Final Clinical Study Reports
- Post marketing and life-cycle support of biologic products
- Preparation of technical documents for small molecule, biologic, cell and gene therapy, and combination product submissions to Regulatory Agencies, including for BLAs and NDAs. Preparation of IBs, Meeting Packages, Pediatric Study Plans and INDs
- Experience with recombinant protein, blood fractionation and vaccine manufacturing processes
- Regulatory action plans for post approval commitments and continuous quality improvement
- Coordination of multi-disciplinary activities between clinical, nonclinical and CMC development disciplines
- Thorough knowledge of FDA and ICH Regulations
Amy worked for a vaccine company as Associate Director of Regulatory Affairs working with European and US Regulatory agencies. She has worked for CROs and Biotech companies; primarily with Biologics.