Title: Founder and Principal
Company: Bioconsulting PRO
Location: Rockville, Maryland, United States
Antonina G. Nikolova, PhD, founder and principal at Bioconsulting PRO, has been recognized by Marquis Who’s Who Top Executives for dedication, achievements, and leadership in bio consulting.
With two decades of experience, Dr. Nikolova has built a successful career in bio consulting, specializing in pharmaceutical and biotech company consultancy. Since 2023, she has served as a partner at Barragán Bioconsulting, founder and principal at Bioconsulting PRO, and vice president at Allucent. In these roles, he manages early morning meetings with clients in Asia, particularly in Korea, China, and Japan, due to the time difference. Her responsibilities include reviewing documents, providing strategic advice on the next steps for drug development, conducting inspections and audits, and preparing drug submissions for the U.S. Food and Drug Administration (FDA) and the European Medicines Agency. His experience also includes serving as senior director of chemistry, manufacturing, and controls (CMC) regulatory affairs at Allucent from 2022 to 2023 and as a senior regulatory scientist at Allucent from 2021 to 2022. Prior to that, she was a principal CMC consultant at Parexel International Corporation from 2019 to 2021, a regulatory CMC advisor at Novartis AG from 2017 to 2019, and a senior staff fellow, and a product quality reviewer at the FDA from 2004 to 2017.
Dr. Nikolova has made significant contributions to scientific research and publications. She has contributed to works such as “A de novo (C755T; Ser252Phe) in exon 6 of the proteolipid protein gene responsible for Pelizaeus-Merzbacher disease,” “Characterization of the protein phosphatase 1 catalytic subunit in endothelium: involvement in contractile responses,” and “Different mutations in the same codon of the proteolipid protein gene, PLP, may help in correlating genotype with phenotype in Pelizaeus-Merzbacher disease/X-linked spastic paraplegia (PMD/SPG2).” Other notable contributions include her work on “Diversity of the antibody response to tetanus toxoid: comparison of hybridoma library to phage display library,” “FDA Approval: Gemtuzumab Ozogamicin for the Treatment of Adults with Newly Diagnosed CD33-Positive Acute Myeloid Leukemia,” “Genetic relatedness of selected clinical and environmental non-O1/O139 Vibrio cholerae,” and “Genetic diversity of O-antigen biosynthesis regions in Vibrio cholerae.” He has also contributed to research on “Molecular epidemiology of O139 Vibrio cholerae: mutation, lateral gene transfer, and founder flush,” “Multiple factors influence the contribution of individual immunoglobulin light chain genes to the naïve antibody repertoire,” and “X-linked spastic paraplegia due to a mutation (C506T; Ser169Phe) in exon 4 of the proteolipid protein gene (PLP).” In addition to co-authoring 10 peer-reviewed scientific publications, she has been a speaker at numerous scientific and regulatory conferences, including the World Vaccine Congress in Washington, DC, and the Regulatory Affairs Professionals Society in Montreal, Canada.
Laying a solid educational foundation, Dr. Nikolova earned a bachelor’s degree in biotechnology in Bulgaria before pursuing a PhD in human genetics from the School of Medicine at the University of Maryland, Baltimore, in 2004, and completed a postdoctoral fellowship at the Laboratory of Molecular and Developmental Immunology with the U.S. FDA. She holds memberships with the Parenteral Drug Association and is certified in Regulatory Affairs. Reflecting on her path, she has always had a deep love for science, particularly biology and chemistry. Her personal journey was further shaped by the loss of her mother to cancer, inspiring her to work in the pharmaceutical industry. She takes great pride in her participation in the approval of several drugs, driven by her passion for work that she believes has a significant impact on people’s health. In the coming years, she hopes her two companies will continue to grow, with plans to expand their business and hire more staff. She is also intrigued by the growing potential of gene and cell therapy, which she sees as an increasingly exciting area in the market.
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