| TARGA
CONTRACT SERVICES
Targa provides,
through its own resources and its institutional collaborations, all of
the services needed to create and evaluate the use of its Therapeutic
Payloads conjugated or fused to a broad variety of targeting moieties.
Therapeutic Payloading
- Full-service
preparation of Therapeutic Payloads conjugated or fused to targeting
moieties:
-
Chemical conjugates
- Recombinant
fusion constructs
- Expression
vectors and cell lines
Pre-clinical
Studies
- In Vitro
Biochemical Pharmacology:
- Design
and efficient execution of biochemical pharmacology studies including:
- Identification
of mechanism(s) of action
- Determination
of activity against tumor cells in culture
- Design
and performance of in vitro studies to clients' specifications.
- Efficacy
in murine tumor models
-
Evaluation of activity and therapeutic index in conventional, BALB/c
nu:nu, and SCID mouse tumor models, including xenograft models
-
Determination of efficacy against orthotopic and metastatic tumor
models
- Assessment
of dose and schedule-dependency
- Pharmacokinetics
and Absorption, Distribution, Metabolism & Excretion (ADME) Studies
-
Assessment of bioavailability as a function of route of administration
-
Plasma or serum pharmacokinetics analyzed using sophisticated PK
software programs (PCNONLIN, RSTRIP, LAGRAN, PK Analyst)
-
Measurement of tissue disposition
-
Identification and quantification of metabolites
-
Conduct of urinary and fecal excretion studies
- Non-GLP
toxicology
- Identification
of appropriate species, doses and schedules for toxicologic testing
- Design
and conduct of non-GLP toxicology studies including gross and microscopic
anatomic evaluation and measurement of hematologic, serum chemical,
urinary and specialized parameters
- Evaluation
of products containing Therapeutic Payloads in combination with other
biological and conventional therapeutic agents
- Consulting
services to evaluate clients' pre-clinical data
Clinical
Development Planning
- Development
of clinical development plans and regulatory strategy
- Preparation
of Investigational New Drug Applications (INDs)
- Design
of Phase I, II & III trials and preparation of protocols and investigator’s
brochures
- Management
of pre-IND meetings with FDA
- Identification
and recruitment of key investigators.
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