Ms. Ablashi has been working in the biotech industry since 1990 and joined Biologics Consulting in 2005. As a CMC Technical Writer at Biologics Consulting, Ms. Ablashi utilizes her GMP manufacturing, quality, and project management experience to assist clients with the preparation of CMC portions of their regulatory submissions to the FDA, EMA, and other regulatory bodies. Specifically, Ms. Ablashi writes and reviews the Quality Overall Summary (QOS, CTD Section 2.3) and CTD Module 3 sections of pre-IND, IND, BLA, NDA, PAS, and Master Files in accordance with ICH M4Q. To do this, she interacts directly with each client's SMEs and regulatory experts. Ms. Ablashi also prepares and reviews worksheets, white papers, and SOPs. Since joining Biologics Consulting, Ms. Ablashi has also reviewed completed batch records and laboratory notebooks, assisted with the preparation of an Investigator's Brochure for an early-phase clinical project, performed review of the Tables, Listings, and Figures of clinical data for an MAA / BLA submission, mapped the contents of a traditional "Section 7" CMC Section to a CTD Module 3 section. She has also served as a regulatory project manager for Biologics Consulting clients, which involves coordinating the preparation of regulatory submissions and serving as the point of contact with FDA Regulatory Project Managers. Her clients range from academia to industry, with projects in all phases of clinical development, from Pre-IND to post-marketing.
Ms. Ablashi received a BS in General Biological Sciences at the University of Maryland, College Park, in 1989 and earned a MS in Environmental Biology from Hood College in 2000. After completing her undergraduate education, she went on to work with HIV and other infectious viruses at Universal Biotechnologies (1990 – 1991) and then at Microbiological Associates (now BioReliance) (1991 – 2001). At BioReliance, she worked first in a GLP testing environment and then in the cGMP manufacturing facility, producing and supervising the production of gene therapy and cell-associated products for clinical use. She also supervised the cGMP Cell Banking suite before moving into technology transfer / process development group. In 2000, Ms. Ablashi became a Project Manager specializing in GMP Manufacturing. From there, she moved to become a Project Manager handling the CROs and CTOs for manufacturing and preclinical testing at Biosynexus Incorporated, a biopharmaceutical company specializing in anti-staphylococcal agents.
MS, Environmental Biology, Hood College, Frederick, MD (2000)
BS, General Biological Science, Emphasis in Zoology, The University of Maryland, College Park, MD (1989)