ADVISORY TEAM EXPERTISE

Advisory Board Overview

Scientific & Drug Development Leadership

Preclinical Toxicology & Safety Strategy

• Preclinical strategy and safety assessment
• IND-enabling toxicology programs
• Risk assessment for emerging therapeutics
• Regulatory toxicology strategy

Clinical Pharmacology & Translational Development

• Clinical pharmacology strategy
• IND / NDA development pathways
• Phase I/II clinical design
• Model-informed drug development
• Translational medicine strategy

Pharmaceutical Development & Manufacturing

Sterile Drug Product & Biologics Manufacturing

• Complex drug product development
• Sterile manufacturing strategy
• Biologics and injectable formulation
• Manufacturing scale-up and commercialization

Lyophilization & Biologics Process Engineering

• Lyophilization process design
• Biologics manufacturing scale-up
• Technology transfer
• CMC development risk mitigation

Preclinical Operations & Research Infrastructure

Preclinical Research Operations & Vivarium Strategy

• Preclinical infrastructure strategy
• Vivarium design and operations
• AAALAC / IACUC compliance
• Translational research operations

Quality, Regulatory & Compliance

Global Quality Systems & Regulatory Compliance

• Global GMP compliance strategy
• Regulatory inspection readiness
• Quality system design and remediation
• Pharmaceutical supply chain compliance

FDA Regulatory Law & Policy

• FDA regulatory strategy
• Compliance and enforcement risk
• Federal regulatory policy
• Market authorization frameworks

Quality Operations & Analytical Sciences

Global Quality Control & Analytical Operations

• QC laboratory operations
• Analytical strategy for commercialization
• Stability and release testing programs
• Operational excellence in regulated labs

Validation, CQV & GMP Operations

• GMP manufacturing readiness
• Equipment and facility validation
• Technology transfer
• Quality system optimization

Corporate Strategy & Commercialization

Corporate Strategy, M&A & CDMO Industry

• Corporate strategy and partnerships
• M&A and strategic transactions
• CDMO market strategy
• Commercial expansion

Diagnostics Platform Development & Commercialization

• Diagnostics platform commercialization
• Regulatory approval pathways (FDA / CE-IVD)
• Global diagnostics market strategy
• Operational turnaround of development programs

Brand Strategy & Venture-Stage Growth

• Venture brand strategy
• Product positioning for complex technologies
• Investor communications
• Go-to-market messaging

Healthcare Commercialization & Sales Strategy

• Medtech commercialization
• Hospital market access
• Sales channel development
• Strategic account growth

Number of companies: 6
Number of contacts: 10

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