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SUMMARY:Preclinical Development of Orally Inhaled Drug Products (OIDPs) - 
 Are Animal Models Predictive Or Shall We Move Towards In Vitro Non-Animal 
 Models? by Dr Dania Movia - Dr Dania Movia\, Laboratory for Biological Cha
 racterisation of Advanced Materials (LBCAM)\, Department of Clinical Medic
 ine\, Trinity Translational Medicine Institute\, Trinity College Dublin\, 
 Dublin\, Ireland 
DTSTART:20210611T100000Z
DTEND:20210611T110000Z
UID:TALK160969@talks.cam.ac.uk
CONTACT:Kirsty Shepherd
DESCRIPTION:Affiliation: Laboratory for Biological Characterisation of Adv
 anced Materials (LBCAM)\, Department of Clinical Medicine\, Trinity Transl
 ational Medicine Institute\, Trinity College Dublin\, Dublin\, Ireland \n\
 nRespiratory diseases such as chronic obstructive pulmonary disease (COPD)
 \, cystic fibrosis or lung cancer constitute a huge burden in our society\
 , and the global respiratory drug market currently grows at an annual rate
  between 4% and 6%. Oral inhalation is the preferred administration method
  for treating respiratory diseases\, as it: (i) delivers the drug directly
  at the site of action\, resulting in a rapid onset\; (ii) is painless\, t
 hus improving patients’ compliance\; and (iii) avoids first-pass metabol
 ism reducing systemic side effects. In the most recent years\, orally inha
 led drug products (OIDPs) have found application also in the treatment of 
 systemic diseases. OIDPs development\, however\, currently suffers of an o
 verall attrition rate of around 70%\, meaning that seven out of 10 new dru
 g candidates fail to reach the clinic. During my presentation I will discu
 ss some of the reasons behind the poor OIDPs translation into clinical pro
 ducts for the treatment of respiratory diseases\, with particular emphasis
  on the parameters affecting the predictive value of animal preclinical te
 sts. The key question that I will try to address in this presentation is w
 hether there is value in using and refining current animal models for OIDP
  preclinical testing\, or whether these should be relinquished in favour o
 f new\, more human-relevant non-animal methods. The preclinical methods cu
 rrently available to test the efficacy [1] and safety [2] of new OIDPs for
  the treatment of uncurable respiratory diseases will be discussed\, toget
 her with their limitations. The current advances in overcoming such limita
 tions will be also reviewed\, focusing on the adoption of in vitro\, cell-
 based new approach methodologies (NAMs)\, such as the multilayered culture
  model of non-small-cell lung cancer we developed in our group [3\,4]. \n\
 nReferences: \n1. Movia D. et al.\, Animals\, 2020\, 10\, 1259\; doi:10.33
 90/ani10081259 \n2. Movia D. et al.\, Frontiers in Bioengineering and Biot
 echnology\, 2020\, 8\, 549\; doi.org/10.3389/fbioe.2020.00549 \n3. Movia D
 . et al.\, BMC Cancer 19 (1)\, 1-21\; doi.org/10.1186/s12885-019-6038-x \n
 4. Movia D. et al.\, Nature Scientific Reports 8 (1)\, 1-19\; doi.org/10.1
 038/s41598-018-31332-6\n 
LOCATION:Meeting ID: 842 1922 6854  Passcode: 116894
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