Regulatory Intelligence & Development Strategy

Helping seed to late-stage teams turn complex science into approvable labels.

• End-to-end regulatory pathways (IND/CTA → NDA/BLA/MAA → commercialization and lifecycle management).

• Integrated nonclinical, CMC, and clinical strategies for first-in-class and high-complexity assets.

• Global roadmaps across the US, EU, UK, Canada, Japan, Latin America, and key APAC markets.

• Alignment with evolving ICH guidance to reduce region-by-region rework.

• Clear, board- and investor-ready framing of regulatory risk, timelines, and value inflection points.

• Coordinated FDA, EMA, and DEA strategies for controlled-substance and high-scrutiny programs.

Psychedelic & Neuroplastogen Trial Design

For teams advancing MDMA-derived compounds, ibogaine, psilocybin, DMT, ketamine, and next-generation neuroplastogens, including programs in substance abuse and addiction.

• IND/CTA strategies for psychedelic and Schedule I programs across multiple regions.

• DEA and controlled-substance strategy: research registrations, site licensing, quotas, import/export permits, diversion-control plans.

• Trial architectures addressing durability, expectancy and bias control, psychotherapy separation, rater training, and functional outcomes.

• Design support for PTSD, treatment-resistant depression, anxiety, suicidality, trauma-related disorders, and substance use and addiction (AUD, OUD, polysubstance use).

• Integration of AI/ML-enabled endpoints and digital measures into credible regulatory narratives.

• Documentation and operations calibrated to FDA/EMA/MHRA/PMDA review, DEA inspection, and investor diligence.

Rare Disease, Orphan & Pediatric Strategy

For high-need, complex, and underserved populations.

• Orphan designation strategy and applications (US, EU, UK, Canada, Japan, Latin America, key APAC markets).

• Development strategies for rare and ultra-rare programs with small, fragile, or dispersed populations.

• Pediatric strategies, including PSPs and PIPs, aligned with long-term lifecycle and access goals.

• Harmonized rare and pediatric plans that respect local requirements while maintaining a coherent global path.

• Risk–benefit narratives grounded in clinical practice, ethics, and desired labeling outcomes.

Expedited Programs & Health Authority Engagement

For teams looking to accelerate timelines without losing credibility.

• Strategy and dossiers for expedited and advanced pathways:

  • Breakthrough Therapy, RMAT, Fast Track

  • PRIME

  • Accelerated Approval

  • Priority Review and Priority Review Vouchers

• Health authority meetings and communications with:

  • FDA (including meeting packages, questions, and written responses)

  • EMA (Scientific Advice)

  • MHRA, PMDA, Health Canada, and other global agencies

• Agency interfaces for controlled substances, including:

  • DEA registrations, quotas, and inspections

  • Alignment of FDA and DEA expectations for psychedelic, CNS, and addiction programs

• Briefing documents and follow-up designed to yield actionable guidance and support cross-regional harmonization.

• Planning for an AI-enabled regulatory future (e.g., Elsa, Agentic AI, and similar tools), including:

  • “AI-ready” documentation, governance, and data structures

  • Strategies to mitigate confidentiality, trade secret, and due-process risk.

Therapeutic Focus

Odette’s work centers on high-scrutiny, high-impact therapeutic areas where regulatory architecture materially shapes patient access.

Psychedelic psychiatry & trauma

• PTSD and trauma-related disorders

• Treatment-resistant depression and complex mood disorders

• Anxiety, suicidality, and complex psychiatric comorbidities

Substance abuse and addiction

• Alcohol use disorder, opioid use disorder, and polysubstance use

• Stimulant and emerging behavioral addictions in overlap with trauma and mood disorders

• Programs targeting craving, relapse prevention, and functional recovery

Neuroplastogens & next-generation CNS therapeutics

• Novel neuroplasticity-modulating agents (psychedelic and non-psychedelic)

• Programs with complex, partially subjective endpoints and functional outcomes

Rare immune-mediated and metabolic disease

• Immune-mediated kidney disease (e.g., FSGS, IgA nephropathy)

• Inborn errors of metabolism (e.g., HCU)

Oncology, immuno-oncology & pediatric oncology

• Adult and pediatric oncology programs

• Translational and immunology-adjacent trials with high regulatory and ethical complexity

Autoimmune & inflammatory disorders

• Systemic and organ-specific autoimmune disease

• Overlap with CNS, kidney, and complex multi-system involvement