Haydar Celik, PhD

As a strategic consultant in the clinical laboratory and diagnostics industry, Dr. Celik provides invaluable guidance to companies and investors looking to navigate the complex regulatory landscape and stay ahead in a highly competitive market. With a deep understanding of the industry's unique challenges and opportunities, Haydar delivers critical executive advice to C-suite leaders and cross-functional teams, helping them differentiate their business through strategic navigation of regulatory requirements, proactively manage regulatory risks and uncertainties and position their company for success in the dynamic diagnostics field. For investors, Haydar offers expert assessments of target companies, analyzing potential regulatory risks and evaluating technological capabilities to help stakeholders make informed investment decisions and maximize returns.

Haydar's collaborations with industry leaders, government policymakers, FDA regulators, academia, payers, advocacy organizations, trade associations, diagnostic companies, clinical labs, and pharmaceutical partners have enriched his dedication and comprehensive insights into the complexities of driving broader access and the adoption of transformative technologies within biomarker testing and personalized medicine.

Haydar's collaborative ethos, underscored by robust leadership, enables him to manage multiple projects effectively, balancing innovation with strategic business objectives. With his roots in research and academia, Haydar's passion and focus are firmly set on driving commercial success, propelling precision medicine forward. He is dedicated to ensuring that cutting-edge, precisely tailored diagnostic solutions reach the market, benefiting the patients and providers who depend on them.

Haydar is a highly accomplished professional with a strong background in regulatory affairs, having served as a senior-level reviewer at the FDA. During his tenure at the FDA, Haydar demonstrated exceptional skills in building and guiding cross-functional teams to deliver decisions and memos to industry on tissue and liquid biopsy-based IVDs. Throughout his career at the FDA, Haydar gained a deep understanding of the regulatory landscape by assessing a wide range of industry submissions. His primary focus as FDA regulator was on molecular diagnostics, including tissue and liquid biopsy-based NGS and PCR tests for companion diagnostic (CDx) use, tumor-gene profiling, cancer screening, multi-cancer early detection (MCED), and minimal residual disease (MRD) tests.

As the FDA's primary liaison, Haydar collaborated closely with the Clinical and Laboratory Standards Institute (CLSI) on the development of standards for molecular diagnostic tests. He continues to serve as a committee member for CLSI, further contributing to the advancement of standards in the field.

Haydar's contributions were recognized with the prestigious FDA/CDRH/OPEQ Group Recognition Award in 2022. This award acknowledged his exemplary performance in approving multiple PMAs for rare biomarkers in lung cancer during staffing shortages resulting from the COVID-19 pandemic. 

In the molecular diagnostics industry, Haydar gained valuable hands-on experience with technologies specializing in tissue and liquid NGS-based oncology IVDs for CDx, MRD testing, and MCED uses. His work involved leading cross-functional efforts to guide technology development in alignment with global regulatory requirements, including US and EU markets. Haydar's industry responsibilities also included playing a pivotal role in the implementation of Quality Management Systems (QMS) for diagnostic laboratories in compliance with 21 CFR 820 and ISO 13485.

As a strategic consultant, Haydar has made significant contributions to the diagnostics and clinical lab industry by providing expert guidance and regulatory leadership to numerous companies. His deep understanding of the regulatory landscape, combined with his strong clinical and technical background, industry experience and his role as a former FDA regulator, has enabled him to navigate complex regulatory pathways and develop effective strategies for his clients.

Haydar's approach to risk management in regulatory practice has been a cornerstone of his consulting practice. By leading client services in regulatory risk analysis and de-risking strategies, he has applied least burdensome approaches to minimize compliance hurdles and expedite market entry for his clients. His strategic advice has guided companies through complex regulatory pathways, optimizing product compliance and market success. He assisted clients with the development of regulatory strategies that align with business goals, focus on enhancing potential revenue, and aim to reduce product failure rates. 

Haydar has extensive academic and laboratory research experience and is a published author of scientific research. He was invited by Georgetown University Medical Center to conduct his post-doctoral studies within the drug discovery and development field for molecularly targeted therapies of pediatric cancers. His experience extends into small molecule drug discovery, contributing to all phases of preclinical development for molecularly targeted therapies. After completing his post-doctoral research, Haydar continued working in the same University as the Assistant Professor of Molecular Oncology. Later, he joined the laboratory of myeloid malignancies at NIH/NHLBI, where he studied translational human immunology to find ways to detect, prevent and treat AML relapse. Haydar has published 21 peer-reviewed papers with 11 papers as the first or corresponding author. Haydar earned his Ph.D. and M.S. in Biochemistry from METU in Turkiye, where he also worked as a faculty member and currently holds an Associate Professor degree.

Haydar's expertise spans the entire lifecycle of IVD and CDx development—from biomarker strategy and analytical validation to clinical evidence generation and commercialization in the field of precision medicine.

In the dynamic field of life science, Haydar offers extensive expertise and a proven track record of success in regulatory strategy and clinical diagnostics. He is broadly experienced with multiple diagnostic technologies and applications including genomics, proteomics, and molecular, cellular, and protein-based assays, as well as digital health technologies, AI/ML enabled diagnostics, and SaMD.

Haydar is adept at navigating various intended use settings, including OTC/DTC tests, at-home testing and sample collection, and both single-site and distributed kit models for decentralized testing, adapting strategies to diverse market segments.

In his free time, Haydar enjoys gardening, traveling, and hiking with his wife, two kids and their Labrador Retriever, Pasha. He and his family enjoy spending time with friends, going to the beach, and state/national parks. Haydar is passionate reading about philosophy and for a better understanding of the meaning of human existence and the nature of our universe.