The TRND program supports a world-class, in-house team of drug development experts and project managers with experience and knowledge across the spectrum of drug discovery and development.
TRND staff are capable of providing any and all of the following expertise, as needed:
- Medicinal chemistry optimization
- Evaluation of functional activity, potency, pharmacokinetics, pharmacodynamics and efficacy
- Biomarker development
- Definition or optimization of dose and schedule for in vivo activity
- Development of pharmacology assays
- Conduct of pharmacology studies with pre-determined assays
- Acquisition of bulk substance (Good Manufacturing Practice [GMP] and non-GMP)
- Development of suitable formulations
- Development of analytical methods for bulk substances
- Production of dosage forms
- Stability assurance for dosage forms
- Range-finding initial toxicity
- IND-directed Good Laboratory Practice toxicology, with correlative pharmacology and histopathology
- Planning of clinical trials
- Regulatory support to increase the likelihood of satisfying Food and Drug Administration requirements
- IND filing support