Cem Calışkan | Pharmaceutical Science | Best Researcher Award

Dr. Cem Calışkan | Pharmaceutical Science | Best Researcher Award

R&D Manager from World Medicine, Turkey

Dr. Cem Çalışkan is an accomplished R&D Manager and pharmaceutical researcher with a distinguished background in analytical chemistry, method development, and regulatory compliance. His professional journey is marked by extensive contributions to the pharmaceutical industry, particularly in analytical method validation, formulation development, and laboratory accreditation processes. With over a decade of progressive experience, Dr. Çalışkan has held key roles at leading pharmaceutical organizations including World Medicine and Neutec İlaç, consistently driving innovation and excellence in pharmaceutical R&D. His academic background features a Ph.D. in Analytical Chemistry from Yıldız Technical University, complemented by a Master’s degree in Organic Chemistry and ongoing Executive MBA studies at Istanbul University, reflecting a multidisciplinary approach to science and leadership. Dr. Çalışkan’s portfolio includes several peer-reviewed publications in top scientific journals, where he explores themes such as nitrosamine detection, impurity profiling, stability-indicating methods, and in-vitro drug release. His research not only addresses critical analytical challenges but also aligns with global regulatory standards. With a passion for mentoring, scientific rigor, and innovation, Dr. Çalışkan exemplifies the integration of academic excellence and industrial impact, making him a strong candidate for scientific recognition at the international level.

Professional Profile

Education

Dr. Cem Çalışkan has a comprehensive and interdisciplinary educational background that has shaped his expertise in analytical and organic chemistry as well as pharmaceutical development. He earned his Doctor of Philosophy (Ph.D.) in Analytical Chemistry from Yıldız Technical University between 2018 and 2022, where he focused on advanced analytical techniques and pharmaceutical applications. His doctoral work provided the foundation for several high-impact scientific publications and patents in method validation and impurity analysis. To complement his scientific expertise with managerial insight, Dr. Çalışkan is currently pursuing an Executive MBA at Istanbul University (2024–present), focusing on strategic business management and leadership in the pharmaceutical industry. His academic journey also includes a Master of Science in Organic Chemistry from Sakarya University (2014–2016), where he deepened his understanding of chemical reactions, drug formulation, and molecular mechanisms. He holds a Bachelor of Science in Chemistry from Uludağ University (2003–2009), which laid the initial groundwork for his professional path in R&D. This strong academic progression, spanning both the sciences and management, enables Dr. Çalışkan to bridge the gap between innovative research and strategic decision-making in the pharmaceutical sector.

Professional Experience

Dr. Cem Çalışkan’s professional experience reflects a sustained commitment to innovation and quality in pharmaceutical research and development. Since 2020, he has been serving as the R&D Manager at World Medicine, where he leads cross-functional teams in analytical development, method validation, and compliance with international regulatory standards. In this role, he initiated the patented WMINOLAB analytical service model, exemplifying his vision for high-quality, independent R&D frameworks. Prior to this, from February to August 2020, he held the position of R&D Analytical Development Chief at the same organization, coordinating sustainable business process models, documentation systems, and team development initiatives. Between 2013 and 2020, Dr. Çalışkan worked as an R&D Responsible Specialist, playing a critical role in analytical method development, stability testing, and responding to regulatory queries from global authorities. Earlier in his career, he served as a Process Development Analyst at Neutec İlaç (2011–2013), where he conducted formulation trials, transfer validations, and documentation for CTD Module III. These roles have not only honed his technical capabilities but also highlighted his strategic thinking, regulatory insight, and project management skills in both domestic and international pharmaceutical landscapes.

Research Interests

Dr. Cem Çalışkan’s research interests center on pharmaceutical analytical chemistry, with a special focus on developing novel methods for impurity profiling, drug stability studies, and nitrosamine risk assessment. He is deeply engaged in creating robust and regulatory-compliant analytical methodologies using cutting-edge instruments such as LC-MS/MS, RP-HPLC, and FTIR spectroscopy. His scientific inquiries aim to improve the accuracy, reproducibility, and efficiency of pharmaceutical testing methods, ensuring safer and more effective drug formulations. A key area of his work involves validating stability-indicating methods for various drug compounds, exploring the physicochemical behavior of active pharmaceutical ingredients (APIs) and excipients under stress conditions. He is also involved in studies on in-vitro drug release, polymer membrane permeability, and analytical compatibility of formulation components. In recent years, Dr. Çalışkan has broadened his scope to include the assessment of genotoxic impurities and packaging-related contaminant analysis, which are critical in modern pharmaceutical safety regulations. His interest in bridging laboratory innovation with regulatory frameworks is reflected in his leadership of accredited research labs and method development teams. This intersection of research excellence and industry relevance defines his contribution to the evolving landscape of pharmaceutical sciences.

Research Skills

Dr. Cem Çalışkan possesses a broad and advanced skill set in pharmaceutical R&D, particularly in the analytical domain. His technical proficiency includes the use of LC-MS/MS, RP-HPLC, FTIR, UV-Vis spectroscopy, and gravimetric analysis for method development, validation, and impurity determination. He is well-versed in Good Laboratory Practice (GLP) and has led numerous method validation studies, including for high-risk pharmaceutical substances like nitrosamines and complex impurities. His skills extend to process optimization, formulation compatibility testing, and the analytical transfer of drug products across laboratories and regulatory environments. Dr. Çalışkan also excels in scientific documentation, protocol writing, and preparation of CTD Module III files for regulatory submission. Beyond technical expertise, he has notable experience in project management, cross-departmental coordination, and team training, equipping him to lead dynamic research teams. His communication skills support effective regulatory correspondence with ministries and international partners, while his analytical thinking aids in critical decision-making across all stages of pharmaceutical development. Combined, these research skills make him not only a technically sound researcher but also an effective scientific leader.

Awards and Honors

While specific awards and honors are not listed in his current profile, Dr. Cem Çalışkan’s career accomplishments reflect a reputation for research excellence and industrial innovation. His leadership in the development and implementation of WMINOLAB, a patented analytical service platform within World Medicine, stands as a testament to his ability to deliver novel, scalable solutions to industry-wide challenges. His publications in reputable journals such as the Journal of Pharmaceutical Sciences, European Journal of Mass Spectrometry, and Journal of AOAC International showcase his academic influence and contributions to pharmaceutical quality control and safety. Additionally, Dr. Çalışkan has played a crucial role in securing and maintaining laboratory accreditations, further evidencing his standing in the professional R&D community. With continued recognition through publications, cross-functional leadership roles, and innovation in analytical techniques, it is evident that he is well-positioned for formal accolades in both industrial and academic circles. Nomination for a Best Researcher Award would be a fitting acknowledgment of his significant impact on pharmaceutical research and method validation at both national and international levels.

Conclusion

Dr. Cem Çalışkan represents a compelling candidate for the Best Researcher Award, bringing together scientific rigor, innovative thinking, and impactful leadership in the pharmaceutical sector. His multi-tiered education, from chemistry through analytical science to business management, empowers him to operate effectively at the intersection of research, industry, and regulation. His extensive experience with analytical method development, impurity profiling, and compliance documentation, along with his proactive approach to laboratory innovation, positions him as a distinguished researcher. His publication record reinforces his scientific credibility, while his managerial roles highlight his ability to lead R&D initiatives with strategic foresight. What sets Dr. Çalışkan apart is not only his technical excellence but also his drive to elevate pharmaceutical research standards in Turkey and beyond. As the industry faces increasing regulatory scrutiny and demands for innovation, his skill set is more relevant than ever. Recognizing his achievements through a Best Researcher Award would honor a career dedicated to advancing analytical science and fostering pharmaceutical innovation, while inspiring emerging researchers to pursue excellence in both academia and industry.

Publications Top Notes

1. Comparison of permeability of topical Cream drug through polymer synthetic membranes of different structures using Franz Cell diffusion test

  • Authors: Cihan Torlak, Müge Güleli, Şevki Kızılok, Remziye Azra Kartop, et al.

  • Year: 2024

  • Journal: Journal of Dispersion Science and Technology

2. Evaluation of a Novel LC‑MS/MS Based Analytical Method for the Risk Assessment of Nitrosamines in Pharmaceutical Products and Packaging Materials

  • Authors: Remziye Azra Kartop, Cihan Torlak, et al. (study led by Kartop and colleagues)

  • Year: 2024

  • Journal: Journal of Pharmaceutical Sciences

3. Simultaneous quantification of tiotropium bromide impurities G + H in capsule formulation by LC‑MS/MS

  • Authors: Not specified in preview

  • Year: 2023

  • Journal: European Journal of Mass Spectrometry

 

 

Niclas Nikolai Stephanson | Pharmaceutical Science | Best Researcher Award

Mr. Niclas Nikolai Stephanson | Pharmaceutical Science | Best Researcher Award

Scientist from Karolinska University Hospital, Sweden

Niclas Nikolai Stephanson is a seasoned clinical pharmacologist and forensic chemist based at the Karolinska University Hospital in Stockholm, Sweden. With a career spanning over three decades, he has carved out a notable reputation in the scientific community, particularly in the analysis of drugs of abuse. Holding a PhD in Medicine from the prestigious Karolinska Institutet, he combines academic rigor with practical experience. Niclas is a licensed pharmacist, senior chemist, and prolific researcher whose contributions include over 35 peer-reviewed scientific publications. His research focus lies at the intersection of pharmacology and toxicology, with a specialization in mass spectrometry and method development for detecting drugs in biological materials. He plays a pivotal role in improving clinical and forensic diagnostics through enhanced analytical techniques. Niclas’s work has contributed to better accuracy in detecting and quantifying illicit and therapeutic drugs, ultimately supporting public health and justice systems. His long-standing association with one of Europe’s most reputable hospitals is a testament to his dedication, expertise, and continuous contribution to the advancement of clinical pharmacology. Stephanson stands out not only for his technical skills but also for his impactful research that bridges laboratory science with real-world applications in healthcare and law enforcement.

Professional Profile

Education

Niclas Nikolai Stephanson received his academic training at the renowned Karolinska Institutet in Stockholm, Sweden, where he earned his PhD in Medicine in 2007. His doctoral work was rooted in the Department of Medicine and focused on the interdisciplinary field of clinical pharmacology, an area combining pharmacokinetics, pharmacodynamics, and toxicology. Prior to his doctoral studies, Niclas qualified as a licensed pharmacist, which provided him with a strong foundation in pharmaceutical sciences, drug interactions, and patient-centered pharmacotherapy. His dual academic background in pharmacy and medicine positions him at the nexus of research and clinical practice. This educational pathway has enabled him to integrate principles of chemistry, biology, and medicine in his professional work. Niclas’s academic experience at Karolinska Institutet—a globally respected institution known for its role in awarding the Nobel Prize in Physiology or Medicine—further highlights the high standards and intellectual rigor of his training. The comprehensive and multidisciplinary nature of his education has empowered him to design and conduct advanced analytical research while maintaining a deep understanding of clinical implications. Overall, his educational background has significantly influenced his ability to carry out complex method development and toxicological investigations with precision and clinical relevance.

Professional Experience

Niclas Nikolai Stephanson has been professionally affiliated with Karolinska University Hospital in Stockholm since August 1992, where he currently holds the position of Senior Chemist in the Department of Clinical Pharmacology. Over the span of more than three decades, he has contributed significantly to the hospital’s mission of delivering cutting-edge clinical diagnostics and therapeutic monitoring. As a licensed pharmacist and senior forensic chemist, Niclas has specialized in the analysis of drugs of abuse, playing a key role in the development and implementation of advanced analytical techniques for routine and investigational use. His daily responsibilities involve overseeing laboratory operations, mentoring junior staff, and collaborating with clinicians to interpret toxicological results. His long tenure reflects not only technical proficiency but also institutional trust in his expertise and leadership. Working within a hospital setting, he has consistently ensured that his research aligns with real-world clinical demands, particularly in the identification and quantification of illicit substances and medications in complex biological matrices. Stephanson’s role at Karolinska University Hospital also supports legal and forensic proceedings, as accurate drug analysis is crucial for both medical and judicial outcomes. His professional experience highlights a unique blend of scientific inquiry, clinical application, and public health impact.

Research Interests

Niclas Nikolai Stephanson’s research interests are centered on clinical pharmacology, forensic toxicology, and analytical chemistry, with a particular focus on the detection and analysis of drugs of abuse. He is especially committed to method development in toxicological screening, applying advanced techniques such as mass spectrometry to improve the precision and sensitivity of drug detection. His work often explores various biological matrices—ranging from blood and urine to less conventional materials like hair or oral fluid—to assess the presence and metabolism of illicit and therapeutic substances. Niclas’s interest in mass spectrometry enables the high-resolution identification of complex compounds, which is critical for timely and accurate diagnoses in both clinical and forensic settings. He is also interested in validating new protocols for routine use in healthcare facilities, aiming to bridge the gap between research and clinical practice. Additionally, his work contributes to public safety by improving methodologies used in legal and judicial drug testing. Through collaborations and internal projects at Karolinska University Hospital, his research continues to evolve in response to emerging substances and new analytical challenges. Overall, his interests reflect a strong alignment with societal needs in healthcare and law enforcement, emphasizing both scientific innovation and practical application.

Research Skills

Niclas Nikolai Stephanson possesses a robust set of research skills that underscore his success as a senior clinical chemist and academic contributor. One of his core strengths lies in advanced method development, particularly in the field of forensic toxicology, where he designs, tests, and refines techniques for detecting drugs of abuse in biological matrices. His proficiency in mass spectrometry—including LC-MS/MS and GC-MS systems—is central to his work, enabling precise identification and quantification of substances even in trace amounts. Niclas is also skilled in biological sample preparation, including extraction and purification techniques that are critical for ensuring reliable analytical results. He demonstrates strong data analysis and validation abilities, ensuring that his methods meet rigorous standards for reproducibility, sensitivity, and specificity. In addition, he has experience in regulatory compliance and quality assurance, ensuring that laboratory practices align with healthcare and forensic standards. His skill set extends to scientific writing and publication, as evidenced by his record of more than 35 peer-reviewed articles. These competencies, combined with his practical knowledge of clinical workflows, empower him to translate complex research into diagnostic and therapeutic tools. His research skills are not only technical but also strategic, aiming to meet real-world challenges with innovative scientific solutions.

Awards and Honors

Although specific awards or honors for Niclas Nikolai Stephanson are not explicitly listed, his sustained position at Karolinska University Hospital and the volume of his peer-reviewed publications are indicative of high professional recognition and esteem. Holding a senior chemist position at one of Europe’s leading medical institutions is a reflection of both his expertise and institutional trust in his abilities. His role in the department of Clinical Pharmacology implies consistent recognition through internal appointments, research responsibilities, and possibly departmental accolades for contributions to method development and toxicological analysis. Publishing over 35 scientific articles in peer-reviewed journals also suggests peer recognition and validation of his work within the scientific community. It is not uncommon in the medical sciences for researchers with such a track record to be involved in national and international working groups or to serve as peer reviewers or advisors in forensic and clinical pharmacology. His continued association with the Karolinska Institutet—home to Nobel-level research—implies a professional standing that exceeds routine recognition. While specific honors may not be documented publicly, his contributions and career longevity highlight a professional trajectory marked by consistent achievement and expert-level contribution to clinical science.

Conclusion

Niclas Nikolai Stephanson stands as a highly accomplished clinical pharmacologist and forensic chemist whose contributions span research, diagnostics, and public health. His work at Karolinska University Hospital since 1992, combined with a PhD from Karolinska Institutet, demonstrates a career dedicated to scientific excellence and societal impact. He has specialized in the development of analytical methods using mass spectrometry to detect drugs of abuse, contributing to over 35 peer-reviewed publications. His research not only enhances clinical decision-making but also supports forensic and legal systems by ensuring accurate and timely drug testing. While his achievements are impressive, expanding his international collaborations and diversifying his research themes could further amplify his academic influence. Nonetheless, his sustained excellence and deep specialization in clinical pharmacology make him a valuable asset to the scientific and medical community. Stephanson’s profile exemplifies the rare blend of research depth, clinical utility, and long-term dedication, positioning him as a strong candidate for prestigious honors such as the Best Researcher Award. His work bridges the gap between bench science and bedside application, marking him as a leader in toxicological innovation and a model for aspiring researchers in the field.

Publications Top Notes

  1. Title: Application of liquid chromatography combined with high resolution mass spectrometry for urine drug testing
    Authors: O.M.L. Beck (Olof M.L.), A. Rylski (Alexia), N.N. Stephanson (Nikolai N.)
    Citations: 4

  2. Title: Use of LC–HRMS in full scan-XIC mode for multi-analyte urine drug testing – a step towards a ‘black-box’ solution?
    Authors: N.N. Stephanson (Nikolai N.), P. Signell (Patrick), A. Helander (Anders), O.M.L. Beck (Olof M.L.)
    Year: 2017
    Citations: 19