Anna Sedello, PhD, Rac Drugs
About Anna Sedello, PhD, Rac Drugs
Anna Sedello, PhD, serves as the Executive Director of Regulatory Affairs at Alpine Immune Sciences, Inc. She specializes in regulatory strategies for various therapeutic areas and has extensive experience in managing submissions and liaising with regulatory agencies.
Work at Alpine Immune Sciences
Anna Sedello serves as the Executive Director of Regulatory Affairs at Alpine Immune Sciences, Inc. since 2023. In this role, she oversees regulatory strategies and compliance activities related to the development of therapeutic products. Her responsibilities include managing submissions, protocols, and annual reports, ensuring adherence to regulatory standards. Sedello's expertise in regulatory affairs supports the company's mission to advance innovative therapies.
Previous Experience at Eiger BioPharmaceuticals
Prior to her current position, Anna Sedello held multiple roles at Eiger BioPharmaceuticals. She served as Executive Director of Regulatory Affairs for 7 months in 2023 and as Senior Director of Regulatory Affairs from 2022 to 2023. Additionally, she was the Director of Regulatory Affairs from 2019 to 2021. In these roles, she was responsible for obtaining product designations and managing regulatory submissions, demonstrating her proficiency in regulatory strategies.
Education and Expertise
Anna Sedello has a strong academic background in the life sciences. She earned her Doctor of Philosophy (PhD) in Cell and Molecular Biology from the Max Planck Institute for Molecular Cell Biology and Genetics from 2005 to 2009. She also holds a Diploma in Biochemistry from Leipzig University, completed from 2002 to 2005. Her education is complemented by studies in Molecular Biology and Genetics at Universidad de los Andes and Biochemistry at the University of Tübingen.
Regulatory Affairs Skills
Sedello is skilled in regulatory affairs, with expertise in obtaining product designations such as Breakthrough Therapy Designation (BTD) and PRIority MEdicines (PRIME). She is proficient in handling original Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), and Emergency Use Authorizations (EUAs). Her specialization includes regulatory strategies for rare diseases, oncology, and advanced therapy medicinal products (ATMP), among others.
Management of Regulatory Submissions
In her roles, Anna Sedello has managed various regulatory submissions and documentation, including protocols, investigator brochures (IBs), informed consent forms (ICFs), and annual reports such as Development Safety Update Reports (DSUR) and Periodic Adverse Drug Experience Reports (PADER). Her experience includes liaising with regulatory agencies like the FDA and EMA, ensuring compliance throughout the clinical development process.