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 collaborative ethos, underscored by robust leadership, enables him to balance 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 reviewer at the FDA. 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), AI-enabled technologies, and minimal residual disease (MRD) tests.

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. 

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'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.

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.