Drug Delivery
collection of samples. Blood samples should be col- lected prior to treatment and following completion of dose administration to assess the presence of systemic anti-drug antibodies should there be any change to the PK/PD relationship during the study. This may be followed up by more detailed investi- gations such as an assessment of the functionality of the ADAs in neutralising antibody (NAb) assays and/or immunohistochemistry (IHC) staining for the presence of immune complexes. However, such in-depth characterisation is not often needed at the preclinical stage, although it should definitely be considered for inclusion in clinical studies.
Conclusion
In the complex field of biopharmaceuticals, inhala- tion-based drug delivery is an exciting and growing segment in modern drug discovery and develop- ment; despite the additional considerations associ- ated with the delivery route and biopharmaceuti- cals, there is considerable early-stage research activity in this market sector. A detailed under- standing of the pharmacology and biology of the biopharmaceutical product moving through dis- covery and development, careful execution of appropriately designed non-clinical safety studies combined with selection of the most appropriate delivery method, can ensure the successful transi- tion from pre-clinical to clinical assessment. This is critical if biopharmaceutical products are to have the prospect of making it all the way through dis- covery, all stages of development and onwards to market entry.
DDW
Association of Inhalation Toxicologists and the British Standard Institution on Nanotechnologies.
Dr Kirsty Harper joined Envigo in June 2013 in her current role to design safety studies and non- clinical development programmes for biologics in response to customer requests as well as to provide scientific support and advice. Prior to this, she was employed as Principal Scientist at Oxford Immunotec Ltd, where she was responsible for pipeline product development projects and the pro- vision of immunological advice and expertise. Dr Harper obtained her PhD in Immunology from the University of Bristol (UK) in 2005, after which she completed a post-doctoral position investigating peptide therapy as potential treatment for autoim- mune disease. Prior to this she obtained her BSc and MSc in Microbiology at Massey University (New Zealand) and worked at the Malaghan Institute (New Zealand) where she conducted basic research in autoimmune disease.
Dr Simon Moore joined Envigo in 1999 and is now the Director of Inhalation Science and Engineering and Toxicology Operations Inhalation Team Leader. In this role, Dr Moore is responsible for all aerosol technology aspects including the overall interpretation and reporting of the inhalation stud- ies, including safety pharmacology and ADME. In addition, he also leads a team of inhalation engi- neers who design, prototype and manufacture cus- tom inhalation equipment for non-clinical safety assessment studies conducted at Envigo. Dr Moore obtained a Chemistry degree from the University of Dundee (UK) in 1996 and gained his PhD in Heterogeneous Catalysis from the University of Glasgow (UK) in 2000 using high-pressure gas flow and chromatography. He lectures at the University of Surrey (UK) as part of the MSc Toxicology course on inhalation dosing, techniques and methodology and is a committee member of the
Drug Discovery World Winter 2017/18
Dr Sylwia Marshall joined F-star Biotechnologies in January 2018 as Principal Scientist. Prior to joining Envigo, Dr Marshall held a director role at Envigo and was responsible for designing safety studies and non-clinical development programmes for biologics, and before that was a senior research position at Novartis, where she lead multi-disci- plinary biologics projects from early discovery through to clinical development working with external collaborators and CROs. Dr Marshall received her undergraduate degree (BSc Biomedical Sciences) from the University of Durham (UK) and completed her PhD at the University of Manchester (UK) in 2005 where she researched peritoneal wound healing and fibrosis. She then took on post-doctoral research positions at University College London and The Lung Institute of Western Australia which investigated biological processes involved in the development of fibrosis and inflammation.
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http://liquidia.com/publications/ Liquidia_Inhalation_Magazine_ August_2012.pdf. 4 Agu, RU et al. The lung as a route for systemic delivery of therapeutic proteins and peptides. Respiratory Research 2001, 2:198-209. 5 Schmierer, T and Malica, C. Inhalation Technology – A breath of fresh air in drug delivery
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http://www.imshealth.com/ deployedfiles/imshealth/global/c ontent/corporate/IMS Health Institute/Reports/Global_use_ of_meds_outlook_2017/biologi cs_market.pdf. 8 Ralf Otto, AS, Ulf, Schrader. Rapid growth in biopharma: Challenges and opportunities. 2014; Available from:
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