A Day in the Life of an Associate Director
Dr. Nikolov’s duties involve overseeing the rheumatology team of 10 medical officers in his division, serving as a resource for staff, helping manage the OND’s structural transition and “launching efforts to modernize the FDA as a champion of change within the division and across OND,” he says.
For the past decade Dr. Nikolov has been involved in the regulatory review of immunomodulatory therapies, including small molecules, biologics and biosimilars for the treatment of pediatric and adult rheumatologic diseases at the FDA. He also participates in the development of the agency’s policies in these areas.
In addition to his other duties as lead for the division, Dr. Nikolov provides advice to the division director and other center leaders on questions related to rheumatologic diseases, maintains personal contacts with thought leaders inside and outside the agency through his regulatory and academic activities, and he represents the division and the agency as a rheumatology subject matter expert at a variety of working groups and meetings that include advisory committees, professional societies, patient-focused drug development groups and patient-advocacy groups.
“While we are very active in our external stakeholder engagement efforts, which include participation in professional society meetings, advocacy group meetings, research fora, workshops, advisory committee meetings,” Dr. Nikolov says, “we would need more human resources to be able to organize and attend more such meetings.”
Dr. Nikolov is also the lead in an interdisciplinary team of scientists evaluating new products for rheumatologic indications, ensuring their safety and effectiveness as well as establishing appropriate safeguards for testing experimental rheumatology products in humans, He also participates in the review of product labeling and advertising, post-market surveillance, improvement of research and evaluation practices, and the development of regulations regarding rheumatology product development and marketing.
“The FDA is a dynamic, purpose-driven organization dedicated to the review of new drug applications, interactions with all stakeholders, and ultimately deciding whether the benefits of a drug outweigh the known risks,” he says. Dr. Nikolov views the need for better outcome measures particularly in the rare rheumatologic diseases as one of the impediments of drug development. But in more prevalent rheumatic diseases, such as rheumatoid arthritis and psoriatic arthritis, he says the success in drug development has resulted in changing the treatment paradigm from symptomatic management to potentially inducing long-term disease control and remission, which presents new opportunities for drug development.
Biosimilars
As division lead for biosimilars, Dr. Nikolov is also very active in the development of these drugs, providing advice and overseeing the review of biosimilar development programs, leading collaborative reviews of cross-division biosimilar applications, developing policy on biosimilars and interchangeables through intercenter and cross-division collaborations and leading the agency’s outreach efforts on education of rheumatology stakeholders about biosimilars and interchangeables.
“We get to see the cutting-edge science and drug development not available to anyone else, which makes this job so unique and exciting,” he says.
