Specialist support for organisations building the future of osteoarthritis treatment.

Biotechnology companies & start-ups

We support founders and management teams when internal resources are limited but the decisions are complex. We can add experienced osteoarthritis leadership without requiring the company to build every capability in-house.

Typical needs

• Asset and indication strategy
• Translational planning
• First clinical development plan
• Phase II design
• Biomarker and imaging strategy
• Regulatory preparation
• Scientific advisory board formation
• Investor and partnering readiness
• Fractional CMO or clinical development support

Pharmaceutical companies

We provide independent, disease-specific expertise to complement internal development, medical, biomarker, regulatory and business development teams.

Typical needs

• Independent programme review
• External challenge of development assumptions
• Biomarker strategy
• Endpoint and imaging review
• Advisory board leadership
• Pipeline prioritisation
• Asset acquisition or licensing review
• Rescue of programmes with ambiguous results

Advanced-therapy developers

Cell and gene therapies introduce additional questions concerning product biology, local delivery, durability, immunogenicity, manufacturing, long-term safety and regulatory classification. We integrate these considerations with the clinical realities of osteoarthritis.

Typical needs

• ATMP or gene-therapy strategy
• Dose and administration rationale
• Local versus systemic exposure
• Long-term follow-up
• Safety monitoring
• Translational biomarkers
• Clinical population selection
• Regulatory interactions

Biomarker, imaging & diagnostic companies

A technically strong biomarker does not automatically have a viable role in drug development. We help define the context of use, evidence requirements, customer problem and pathway to adoption.

Typical needs

• Context-of-use definition
• Analytical and clinical validation strategy
• Regulatory qualification planning
• Integration into trial designs
• Industry value proposition
• Pharmaceutical partnership strategy

Investors & transaction teams

We provide independent scientific, clinical, regulatory and commercial assessment of osteoarthritis assets and companies.

Typical needs

• Technical due diligence
• Probability-of-success assessment
• Competitive landscape
• Development-cost and timeline review
• Regulatory risk
• Differentiation and market potential
• Critical-value-inflection analysis
• Expert committee support

Academic spin-outs

We help translate academic discovery into a development proposition that can be evaluated by regulators, investors and industry partners.

Typical needs

• Translational gap analysis
• Target product profile
• Initial indication
• Biomarker plan
• Development roadmap
• Company-building support
• Advisory board creation
• Investor materials