BEGIN:VCALENDAR VERSION:2.0 METHOD:PUBLISH PRODID:-//Telerik Inc.//Sitefinity CMS 15.4//EN BEGIN:VTIMEZONE TZID:W. Europe Standard Time BEGIN:STANDARD DTSTART:20251002T030000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=3;BYMINUTE=0;BYMONTH=10 TZNAME:W. Europe Standard Time TZOFFSETFROM:+0200 TZOFFSETTO:+0100 END:STANDARD BEGIN:DAYLIGHT DTSTART:20250301T020000 RRULE:FREQ=YEARLY;BYDAY=-1SU;BYHOUR=2;BYMINUTE=0;BYMONTH=3 TZNAME:W. Europe Daylight Time TZOFFSETFROM:+0100 TZOFFSETTO:+0200 END:DAYLIGHT END:VTIMEZONE BEGIN:VEVENT DESCRIPTION:Time: \;14:00 - 15:00 (UK Time)\nChair: \;Dr. Bernd-Wol fgang Igl \;(Boehringer Ingelheim Pharma GmbH &\; Co. KG)\n\n\nPubl ished in: Regulatory Toxicology and Pharmacology 96 (2018) 94&ndash\;105\; https://doi.org/10.1016/j.yrtph.2018.04.018)\nAuthors:\n Matthew Clark\, Scientific Services\, R&\;D Solutions\, Elsevier\, Philadelphia\, USA & amp\; Thomas Steger-Hartmann\, Investigational Toxicology\, Bayer AG\, Ber lin\, Germany\nAbstract:\n Attrition of drug candidates in clinical trials due to safety issues still contributes to a significant part of project c losures besides other reasons such as the lack of efficacy\, PK issues or strategic reasons. While failure of a candidate during preclinical develop ment is a reflection of the primary task of the functions involved in this phase (i.e. toxicology\, safety pharmacology and DMPK)\, failures during the later clinical phases often raise the question whether the preclinical safety studies are sufficiently predictive for the human outcome. Due to the fact that the First-in-Man study requires pivotal animal studies norma lly performed in two species\, the focus of analysis of the debated predic tivity centers around these animal studies. After the seminal study from O lson et al. (2000) numerous publications have shown that animal toxicity s tudies are predictive to a certain extent and that the predictivity varies among endpoints\, some of them such as hematological\, gastrointestinal\, and cardiovascular events being better predicted than others (e.g. cutane ous adverse events). Most of these analyses compared the preclinical &ndas h\; clinical correlation for a rather limited set of compounds (<\;150) or for specific field of indications. The authors will present the results of this purely statistical approach based on data available for 3290 comp ounds in the commercial database Pharmapendium. The work provides answers to the implication of an observation in an animal for human risk and more specifically to the question whether concordance\, i.e. the translatabilit y of an observation from animal to human is dependent on the animal specie s. The statistical methods and procedures will be described in detail.\n\n \nRegistration:\nRegistration has now closed. DTEND:20181211T140000Z DTSTAMP:20260608T171130Z DTSTART:20181211T130000Z LOCATION: SEQUENCE:0 SUMMARY:How Well do Toxicology Studies Predict Clinical Safety Outcome? – A Translational Safety Big Data Analysis UID:RFCALITEM639165354900071826 X-ALT-DESC;FMTTYPE=text/html:Time: \;14:00 - 15:00 (UK Time)\n

Chair: \;Dr. Bernd-Wolfgang Igl \;(Boehringer Inge lheim Pharma GmbH &\; Co. KG)
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Published in : Regulatory Toxicology and Pharmacology 96 (2018) 94&ndash\;105\; https://doi.org/10.1016/j.y rtph.2018.04.018)

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Authors:

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Matthew Clark\, Scie ntific Services\, R&\;D Solutions\, Elsevier\, Philadelphia\, USA &\; Thomas Steger-Hartmann\, Investigational Toxicology\, Bayer AG\ , Berlin\, Germany

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Abstract:

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Attrition of drug can didates in clinical trials due to safety issues still contributes to a sig nificant part of project closures besides other reasons such as the lack o f efficacy\, PK issues or strategic reasons. While failure of a candidate during preclinical development is a reflection of the primary task of the functions involved in this phase (i.e. toxicology\, safety pharmacology an d DMPK)\, failures during the later clinical phases often raise the questi on whether the preclinical safety studies are sufficiently predictive for the human outcome. Due to the fact that the First-in-Man study requires pi votal animal studies normally performed in two species\, the focus of anal ysis of the debated predictivity centers around these animal studies. Afte r the seminal study from Olson et al. (2000) numerous publications have sh own that animal toxicity studies are predictive to a certain extent and th at the predictivity varies among endpoints\, some of them such as hematolo gical\, gastrointestinal\, and cardiovascular events being better predicte d than others (e.g. cutaneous adverse events). Most of these analyses comp ared the preclinical &ndash\; clinical correlation for a rather limited se t of compounds (<\;150) or for specific field of indications. The author s will present the results of this purely statistical approach based on da ta available for 3290 compounds in the commercial database Pharmapendium. The work provides answers to the implication of an observation in an anima l for human risk and more specifically to the question whether concordance \, i.e. the translatability of an observation from animal to human is depe ndent on the animal species. The statistical methods and procedures will b e described in detail.
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Registration:

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Registration has now closed.

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