Nonclinical / Early Phase Development

It is never too early in cell and gene therapy or biologics to begin thinking about the path to regulatory approval, and non-clinical development is the best time to initiate the strategic planning for an IND application.

In early phase development, lead candidates are selected and assessed for efficacy and safety; ensuring these initial assessments are compliant and address potential questions from regulatory authorities will minimize downstream efforts to respond to inquiries and change processes.

Strategically planned non-clinical development will inherently de-risk a program early and enable informed decision-making for process development and clinical study design.

At TKD we focus our non-clinical development on meeting IND specifications. We use early phase studies to address potential questions from regulatory authorities and prescribe IND-enabling studies during the non-clinical development.

We have experience in GLP toxicology and safety pharmacology study design for gene and cell therapies as well as biologics, and we have experience filing INDs and interacting directly with regulatory authorities. We can leverage our experience in advancing early-stage programs to streamline your path to IND approvals.

  • Lead candidate selection and optimization
  • Study design
  • Gap analysis
  • Efficacy, safety, toxicology 
  • Regulatory support

At TKD we have experts who have championed campaigns from the non-clinical to clinical phase. We know the questions that should be addressed in non-clinical study design to seamlessly transition programs to clinical trials.

For cell and gene therapy we take a holistic approach to design an effective therapy that takes into consideration the disease pathobiology, method of delivery, and vector design.

Our team has a strong molecular biology background that can help optimize vector design to ensure design-indication fit, particularly in the neuroscience and rare disease space. We can develop biomarkers that can help demonstrate the activity of the gene therapy in nonclinical and clinical settings.

For biologics, we have expertise developing mechanism of action studies and drug purposing study design. We have direct experience in cell line development as well as the design and validation of bioanalytical assays for product safety testing requirements.

Learn how we can support your nonclinical needs.

Nonclinical / Early Phase Development Process Development Regulatory Affairs Cross-Departmental Support Analytical Development Project Management Manufacturing Science & Technology Nonclinical / Early Phase Development Process Development Manufacturing Science & Technology Analytical Development Project Management Regulatory Affairs Cross-Departmental Support