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Message from ACT Corporate Partner—Altasciences

By Karen Cook posted 10-23-2024 03:32 PM

  
ACT Corporate Partner Message


Altasciences―A Different Kind of CRO/CDMO 

Key Considerations for Nonclinical Gene Therapy Studies
It is estimated that there are over 6,000 monogenic diseases, affecting over 350 million people worldwide. For these diseases, cell and gene therapies may provide hope for a cure by terminating the disease process at the cellular or genetic level.
However, there are significant challenges associated with the successful development of these complex, leading-edge therapies. The in vivo nonclinical study of cell and gene therapies includes a thorough understanding of on-and-off-target activity, immune responses, and other adverse events just to name a few―all of which require careful monitoring, and rigorous assessments.
In this issue of The Altascientist, we take a deep dive into the essential factors in the development of nonclinical cell and gene therapies—including insights into mitigating complex challenges and maximizing translational opportunities to first-in-human trials. 

This scientific publication covers the following: 

  • ICH S-12 guideline on biodistribution studies
  • species selection
  • choosing the right vector for your cell and gene therapy studies
  • the importance of germline mitigation
  • exaggerated on-target effects
  • immunogenicity
  • nonclinical study planning
  • case studies from Altasciences
Read the issue here or come chat with our experts at Booth #400.
For more information, visit altasciences.com.
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