Tox Clarity advances the development of your drug in three arenas.

Create strategic vision specific to novel product modality, therapeutic area, and stage of development

Modalities:

• Small molecules, recombinant proteins, antibodies, oligonucleotides, cell therapies, gene therapies

Therapeutic Areas:

• Neurology, ophthalmology, oncology, wound healing, hematology, metabolic diseases, dermatology
• Rare, severe and life threatening

Stage of Clinical Development:

• pre-IND (to inform selection of safe starting dose, maximum escalation dose, dose regimen, patient population, monitoring criteria)
• pre-Phase 3 Clinical-stage (to inform inclusion of WOCBP, addition of pediatric cohorts, assessment in large populations)
• pre-NDA/BLA (to inform labeling)
• Post-marketing (to inform regulatory commitments, label expansion, market expansion)

Stage of Business Development:

• To defined inflection points (spending cap, Proof-of-Concept)
• To defined milestones (First-in-human, clinical Phase 3, marketing registration)

Identify opportunities for streamlined development and/or Accelerated Approval

Define the ‘when’ and ‘with what data’ as well as probability of award

• Carcinogenicity, chronic toxicity, developmental and reproductive toxicity waivers
• Orphan Drug Designation applications
• Fast Track, Breakthrough Designation applications
• 505(b)1 or 505(b)2 pathways

Confirm scientific studies meet regulatory requirements and sufficiently address drug product risks

Review study protocols, findings, interpretations, and reports

• Toxicology, safety pharmacology, secondary pharmacology, and in vitro drug-drug interaction studies
• non-GLP, GLP standards

Contextualize findings in regulatory submissions

Communicate import for clinical development and marketing

• Define target organs, critical toxicities, reversibility, monitorability, and margins of safety
• Address relevance for patients
• Profile similarities and differences relative to drug class or standard of care
• Provide appropriate emphasis in Investigator Brochures and Drug Safety Update Reports
• Draft label language

Compose or revise regulatory documents

Prepare and maintain eCTD INDs/CTAs and NDAs/BLAs

• Module 1: Meeting background materials and correspondence, special protocol assessment requests, pediatric study plans, information amendments, annual reports, post-marketing commitments
• Module 2: Nonclinical overview, written summaries, tabulated summaries
• Module 3: Novel excipient and impurities qualification

Develop global Investigator Brochures

• Structure content to align across multiple regulatory regions

Represent nonclinical affairs in health authority meetings

Judiciously utilize time to obtain actionable feedback and generate goodwill

Acquisitions:

Evaluate nonclinical data and package completeness, assess risks, and construct a gap analysis relative to the next critical milestone

Divestitures:

Organize and present the data package to facilitate easy, clear review by potential partners