IND-enabling Programs for Gene and Cell Therapies [Virtual]

Advanced therapies, including cell and gene-based products, are transforming precision medicine through potential cures for a variety of genetic diseases and cancers, with several approved therapies to date and many more expected going forward. In this webinar, we’ll focus on aspects of a gene and cell therapy preclinical program that are central to an IND submission –namely, in vivo pharmacology, toxicology and pharmacokinetics (PK) assessments using the appropriate models & test systems. Together, these studies help to guide determination of clinically safe and biologically relevant dose levels, establish safety endpoints for clinical study monitoring and elucidate the biological disposition of administered product.

In this webinar, attendees will learn about:

• Animal model selection in preclinical studies
• Routes of administration, including ocular and neural/brain tissue
• Safety study designs to guide determination of biologically relevant and clinically safe dose levels (e.g. dorsal root ganglion analyses and others)
• Pharmacokinetic endpoints including biodistribution, cell or gene product analysis including, engraftment, and persistence, viral shedding, transgene and anti-transgene analyses.

There will also be an opportunity for Q&A following the presentation. Please note that we plan to record the webinar presentation and will remind attendees at the onset of the event.

Register here.
 

Presenters:

• Brian E. McIntosh, Ph.D.
  Cell and Gene Therapy Lead | Study Director | Safety Assessment | Toxicology
  Covance Laboratories Inc. | Madison, Wisconsin

• Jay Herman, Ph.D.
  Study Director │Project Team Leader │ Safety Assessment │Toxicology
  Covance Laboratories Inc. | Madison, Wisconsin