Christine Chirdo has worked in the pharmaceutical industry since junior in college where she began her career as a bench scientist which continued upon graduation at Merck & Co., Inc. in molecular immunology and inflammation research. During the years spent in discovery, she led fermentation screening for vector candidates and analytical assay development in vaccines as well as the optimization of bioprocess scale-up manufacturing efforts for at that time a first-in-class HIV treatment later known as Crixivan. In pursuit of experience along the R&D continuum, she thought to try regulatory affairs where she has been for 25 years and counting.
In her words, she has been privileged to have diversified working knowledge in therapeutic areas in drugs and biologics with an emphasis on small molecules. Her experience in progressive roles of leadership as both a US strategist and GRL spans CMC and Clinical aspects of drug development with emphasis on the latter which has prevailed in OTC and Rx segments of pharma. Whether it’s novel (technology) or the pursuit of a repurposed molecule, Christine’s strategic philosophy is one of innovation. With expertise in late-stage advancements, she has also extensive experience in FIH trials (IND) as well as observational, quality of life, and behavioral (patient experience) studies to inform the evolution of the label. In recent years, her focus has been rare disease and oncology as well as pediatrics, securing expedited pathways and regulatory designations. Among her industry peers, she is esteemed for trust equity within the context of excellence in FDA engagement (milestone meetings and everywhere in between) and places significant weight on the establishment of credibility leading to the cultivation of a highly collaborative dynamic between the sponsor and Agency. Her approach is one of transparency and expansive thought leadership which has proven successful in IND clearances and NDA approvals including Pfizer’s first Rx-to-OTC switch of Nexium. Proudly, she has earned a reputation within FDA review divisions for providing the highest quality applications that have been recognized to have a limited in number of Information Requests and no deficiencies resulting in any Refusal to File, Complete Response, or Clinical Hold. She attributes her success to the intentionality of investing in the cross-functional team of data contributors, educating them according to the standards and expectations of scientific reviewers.
Rutgers University, Bachelor of Science, Biochemistry, Bachelor of Science Nutritional Science