Welcome to Lighthouse BioSolutions Consulting
We guide biotech and academic innovators in accelerating vaccine, cell and gene therapy, and antibody development across preclinical and clinical stages. Our expertise spans immune monitoring, biomarker validation, and cutting-edge assay implementation. Whether bridging scientific gaps or driving regulatory success, Lighthouse BioSolutions helps life science leaders move smarter, faster, and farther.
Who we advise
Biologics Drug Developers
Contract Research Organizations
Contract Research Organizations
Early and late-stage companies developing vaccines, cell & gene therapies, monoclonal antibodies, and other biologics
Contract Research Organizations
Contract Research Organizations
Contract Research Organizations
Supporting CROs in expanding service offerings through implementation of new platforms and assays
Investors
Contract Research Organizations
Investors
Advising Private Equity Firms and VCs with expert scientific due diligence to de-risk investment decisions
Our Services
Translational Strategies
Translational Strategies
Translational Strategies
Navigate the path from discovery to clinic with strategic gap analysis, IND-enabling studies, streamlined work scopes, regulatory submission assistance, dose establishment, and potency assay development.
Preclinical Development
Translational Strategies
Translational Strategies
Build a solid foundation with target discovery and validation, preclinical study development and execution, strategic biomarker selection, and cutting-edge assay development.
Clinical Development
Translational Strategies
Partnership & Management
Chart your clinical course with comprehensive immunogenicity and safety assessments, identification of immune correlates of protection, and biomarker assay development, qualification, and validation.
Partnership & Management
Quality & Regulatory
Partnership & Management
Navigate partnerships with expert scientific partner identification, seamless CRO oversight, strategic project management, team building, and consensus building in complex collaborations.
Quality & Regulatory
Quality & Regulatory
Quality & Regulatory
Ensure regulatory compliance with comprehensive protocol and report development, assay qualification / validation, clinical protocols, study reports, and GMP/GLP/GCLP compliance guidance.
Immune Monitoring
Quality & Regulatory
Quality & Regulatory
Illuminate immune responses with deep immune profiling, precision immune monitoring, biomarker development, immune correlates of protection, and comprehensive mucosal immunity assessments.
About Lighthouse BioSolutions
Our mission: catalyze smarter science and faster progress
Lighthouse BioSolutions is a scientific and strategic consulting firm led by Franck Lemiale, Pharm.D, Ph.D—an industry veteran with over two decades of hands-on leadership across vaccine, cell and gene therapy, and monoclonal antibody development.
💡 Strategic Consulting for Life Science Innovators
Whether you’re an early-stage startup or academic investigator, we help expedite development through targeted expertise in immunology, biomarkers, and translational strategy.
🧪 CRO Enablement
We guide Contract Research Organizations in expanding their capabilities—implementing robust assay platforms, optimizing protocols, and aligning with regulatory standards.
💰 Investor Support
Partnering with VCs and Private Equity Firms, we deliver rigorous scientific due diligence—de-risking investment decisions and uncovering technical value.
Lighthouse BioSolutions empowers teams to navigate complex biologic development challenges with clarity and confidence.
Areas of expertise
Disease Areas
Cancer Immunotherapy
Infectious diseases
HIV/AIDS
Malaria
Autoimmune Diseases
Rare/Orphan Diseases
Neuromuscular Diseases
Technical Expertise
qPCR/ddPCR
Flow Cytometry
ELISpot/FluoroSpot
Neutralization Assay
ADCC/CDC Assays
Cytokines profiling
Antibody Characterization
Therapeutic Modalities
Therapeutic Modalities
Vaccines
Viral Vectors (LVV, AAV, AdV)
Gene Therapies
Cell Therapies
CAR T/ CAR NK
mAbs / ADCs
Immunotherapies