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Translational Safety Biomarkers in Early Safety Assessment

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Translational Safety Biomarkers in Early Safety Assessment  


translational biomarkersThe Drug Safety Executive CouncilTM(DSEC) hosted a webinar last month entitled Translational Safety Biomarkers in Early Safety Assessment. The recording is available here. During the webinar we presented some findings from a recent research study, conducted by Cambridge Healthtech AssociatesTM (CHA), on issues pertaining to the use of translational biomarkers in early drug safety assessment. In addition, panelists addressed the following questions: 





• What is the current state of pharmaceutical and biotech companies employing biomarkers in early drug development?
• How close is the industry from regularly applying in vitro and/or in vivo biomarkers to assess early-stage safety and efficacy?
• What translational safety biomarkers are most commonly used and trusted today?
• What emerging technologies are showing promise?
• What is the shortest path to adoption of these technologies?
• What hurdles currently exist that impede regular use of these tools?


Audience poll questions during the webinar yielded some interesting results… 

Q1: When you refer to a biomarker, do you most often mean? 


A1: Gene expression up/down regulation – 17%
Protein or peptide – 66%
Metabolite – 17%

Q2: How often do you employ non-FDA certified/validated biomarkers to assess the safety of therapeutics in early development? 


A2: Never – 13%
Sometimes – 33%
Only for target assessment – 15%
It depends – 40%

Q3: Which tests does your company regularly run in early development? 


A3: Prediction software (e.g. DEREK) – 20%
High-Content Cell Health parameters – 25%
Off-target screening (e.g. CEREP) – 55%

Q4: How many new biomarker-type technologies (safety/efficacy) has your company evaluated in the past 12 months? 


A4: 1-2 – 48%
3-4 – 27%
5 or more – 25%


If you are working with biomarkers and would like to learn how Cambridge Healthtech Associates (CHA) can help, please contact Dawn Van Dam (General Manager, CHA).