assay that allowed us to quantify drug levels in multiple levels of tumor mate- rial collected from punch biopsy specimens following topical administration. This was a challenging method to develop as we were work- ing with a PEGylated molecule being quantified in a tumor biopsy matrix. The method developed was published in Bioanalysis in 2017 and we were delighted to hear that it was one of the most accessed Research Articles in the journal last year [1]. It was successfully utilized for a Phase II
clinical trial in this rare condition, allowing the assessment of drug penetration in individual patients recruited to the study, with the results recently published in the journal, JAMA Dermatology [2].
Q
What new technology would you like to see in the future and how would this improve your work?
One of the challenges I see in the future relates to the accessibility of LC–MS and other analytical equipment. We are increasingly identifying drugs and patient populations whereby therapeutic drug monitoring approaches are being shown to be the most appro- priate approach to treatment. Currently our laboratory in New- castle carry-out the analysis of patient samples for centers treating childhood cancer patients across the UK, but as this area progresses it would be ideal for centers to be able to generate data on drug exposures at the point-of-care. This would realistically require the development of smaller and more cost-effective instruments which can be used more routinely in clinical centers.
Q
What are you excited about working on in the future? In addition to the therapeutic drug monitoring project
mentioned above, an area that we are very keen to progress relates to the development of fully validated LC–MS assays for the quantification of anticancer drug levels from dry blood spot or related micro blood sampling approaches. The development of such approaches to the point of their appropriate utilization for clinical sample analysis could have a significant impact on the clinical trials that we are involved in. In particular, current studies involving neonates and very young children are com- monly limited by the number of blood samples that it is safe to draw within a defined period of time. Micro blood sampling
approaches would not only limit the volume of blood being collected but would also facilitate more intensive sampling strategies, with the potential for collecting samples when the patient is away from the hospital. We also have active collabora- tions with groups in countries, such as India, where the collection of clinical samples for research studies can be limited by the lack of a cold chain currently required to ensure sample integrity. The successful development of assays to provide sound data from samples collected by dry blood spot or micro blood sampling devices could have a really positive impact on the work that we do and we feel is well worth invest- ing the required time and effort to progress.
Financial & competing interests disclosure The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or finan- cial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. No writing assistance was utilized in the production of this
manuscript.
Disclaimer The opinions expressed in this interview are those of the inter- viewee and do not necessarily reflect the views of Future Science Group.
References 1. Zangarini M, Rajan N, Danilenko M, Berry P, Traversa S, Veal GJ. Development and validation of LC–MS/MS with in-source collision-induced dissociation for the quantification of pegcantra- tinib in human skin tumors. Bioanalysis 9(3), 279–288 (2017). 2. Danilenko M, Stamp E, Stocken DD et al. Efficacy of target- ing tropomyosin receptor kinase in cutaneous CYLD defective tumours (TRAC): A randomised placebo-controlled early phase trial with pegcantratinib. JAMA Dermatol. doi:10.1001/jamader- matol.2018.1610 (2018).
www.bioanalysis-zone.com
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