Pre-Clinical

The following services are offered as either stand-alone activities or as part of a more extensive development effort:

Synthetic Organic Chemistry / API:

• Route Selection
• Evaluation of existing routes to leads, scaffolds and development candidates, from point of view of safety and practicality
• Troubleshooting and adaptation of synthetic routes for scale-up
• Development of new synthetic routes or steps, as warranted

Chemical Process Development:

• Scale-up and production of leads and candidates for preclinical R&D, including IND-enabling tox batch
• Selection of appropriate API physical form
• Pharmaceutical salt screening, evaluation, selection and development
• GMP manufacture to provide clinical API supply
• Chemical process R&D – process optimization, process discovery, asymmetric synthesis
• Critical process impurity tracking and control

Radiosynthesis:

• Design of routes to radiolabeled leads and APIs for nonclinical research (non-GMP synthesis) and clinical studies (GMP synthesis)

Analytical Support / Material Characterization:

• Development of fit-for-purpose methods for reaction monitoring, intermediate and product purity
• Selection/development of release tests for IND-enabling nonclinical and clinical GMP API lots produced/manufactured
• Characterization
• Structure verification
• Physicochemical/solid state properties crystallinity, polymorphism, solubility
• Critical impurity detection, quantification and identification
• Potential Genotoxic Impurities (PGIs) – prediction, identification, quantification and control
• Stability – supporting non-regulated preclinical evaluations and formal (GMP) studies

Formulation:

• Development of nonclinical toxicology formulations
• Preformulation studies
• Development, selection and production/manufacture of clinical formulations

Regulatory CMC:

• Preparation and execution of strategies for transition of lead molecules, from late discovery through candidate nomination, preclinical R&D and clinical trials
• Selection and justification of API regulatory starting materials for GMP manufacture
• Authorship and review of new chemical entity (NCE) investigative new drug (IND) CMC sections

The pharmaceutical sciences team utilise a wide network of established service providers to deliver support in the following areas to optimise the quality, cost and speed of collaborative research.

Pre-formulation

• Strategic sourcing of vendors to provide pre-formulation, formulation development and analytical solutions for pre-clinical, toxicological and clinical studies
• Technical evaluation of early lead molecules to risk assess pharmaceutical delivery and development options
• Project and relationship management
• Developing and ensuring execution of work plans to deliver high quality results

Program Management

• Application of expertise in the discovery and development new medicines
• Developing program strategy options, which efficiently address needs and capitalise on opportunities
• Building and delivering on effective plans, in line with individual client and compound needs
• Facilitation of problem solving, decision analyses and stakeholder management
• Risk identification and development of mitigation strategies
• Harmonising services to deliver key milestones

The TRN ADME/DMPK team utilise a wide network of established service providers to deliver support in the following areas to optimise the quality, cost and speed of collaborative research:

• Access to a wide range of non-GLP and GLP ADME assays
• Vendor identification/selection.
• Service agreement/work order generation
• Negotiating competitive quotes, scheduling, prioritisation and deliverables (timelines and output required)
• Study design expertise
• Study placement support – from compound shipment to data upload
• Information transfer (study, methods, compound)
• Watson study generation
• Scientific troubleshooting
• Data transfer, review & storage (online services, Secure email, etc)
• Timeline tracking
• Market scan/research
• Vendor audits and assessment (scientific and business)
• Relationship management