Translational Science Consulting
Biomarker Assay Development | Biomarker Clinical Operations | Companion Diagnostics | Complementary Diagnostics | Data Analysis | Drug Development Tools | Grant Support | Technical Writing
- Guide biomarker strategy benchtop-to-bedside and bedside-to-benchtop
- Manage companion diagnostic co-development from concept to commercial launch
- Write grants (SBIR, STTR, EIC & private funding)
- Fractional advisor appointments for grants
- Company is registered in the US federal government’s System for Award Management
- Write technical content for patent applications
- Engage KOLs to support feasibility, clinical validity & clinical utility studies
- Analyze biomarker data (GraphPad PRISM expertise)
- Manage collection of testing data
- Provide molecular data harmonization forms for BLA & NDA therapy submissions
- Execute TCGA & GENIE (cBioPortal) biomarker analysis to support indication selection & biomarker approach
- Manage bioinformatics strategic partners for deeper biomarker analytics
- Guide pharmacodynamic biomarker development for dose decision making
- Prepare & manage documentation for Drug Development Tool (DDT) submissions
- Prepare & review biomarker content in Pharma non-clinical & clinical study documentation
- Review Informed Consent Forms for biomarker testing & companion diagnostic testing
- Prepare & submit IRB submissions for clinical research studies
US Clinical Laboratory Testing Consulting
Laboratory Developed Tests (LDTs)
- US CLIA LDT development & commercialization
- CLIA, CAP & NYS-CLEP LDTs (clinical trials & commercial testing)
- Support bringing CLIA LDTs through US FDA single-site IVD process
- Reimbursement support (MolDX dossiers & Technical Assessments)
- ASCP-certified Clinical Laboratory Scientist & Molecular Technologist to support testing inquiries
- Partnerships with Fractional Laboratory Directors
US FDA Product Development Consulting
Clinical Diagnostics | Companion Diagnostics | Complementary Diagnostics | Diagnostic Imaging | Digital Health Tools | Digital Pathology | Drug Development Tools | In Vitro Diagnostics | Medical Devices
- Research Use Only (RUO) product promotional labeling reviews
- Investigational Use Only (IUO) assays & Medical Devices
- In Vitro Diagnostics (IVDs) & Medical Devices
- Drug Development Tools (DDTs)
- Novel digital health technologies (DHTs), clinical decision support tools (CDSTs) & Software as a Medical Device (SaMD) products
- Guide regulated product development:
- Recommend & manage testing, CROs & IVD partners/providers
- Support analytical and clinical validation planning & execution
- Partnerships with biostatisticians to collaborate on study designs & statistical analysis plans
- Manage intended use clinical sample sourcing strategies (biobank relationships)
- Commercialization & Reimbursement Strategies
- Design Control
- Design and Development Planning
- Quality Compliance
- Risk Management
- Training workshops (virtual/on-site)
- Support ISO 20387 compliance for high-quality biobanking
- Review Informed Consent Forms
- Generate & submit IRB submissions for analytical & clinical validation studies (WCG IRB Connexus account)
US Audit Team:
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- Quality Auditor: ISO 13485:2016 (TPECS) certified with Lean Six Sigma Green & Black Belt
- Regulatory Auditor: 25+ years combined team experience
- Technical Auditor: PhD-trained scientist experienced in analytical & clinical validation studies
- Audit:
- CDx companies
- CROs
- IVD companies
- CLIA laboratories (Final FDA LDT Rule compliance)
- Design History File (DHF)
- Suppliers (GMP for manufacturers, OEM audits)
- Clinical trial testing (GCP)
- Gap analysis (QMSR, ISO 9001, ISO 13485, & ISO 15189)
- Software (ISO 27001, ISO 42001, IEC 62304)
- Instrumentation audits (IEC 61010, IEC 61010, & IEC 61326)
- Risk Management audits (ISO 14971)
- FDA pre-approval inspection audits
- FDA Bioresearch Monitoring (BIMO)
- GLP & GCP
US FDA Regulatory Consulting
Operations | Strategy | Submissions
- US FDA Regulatory Agent Service
- 513(g) requests for information
- Study Risk Determinations (SRDs)
- Investigational Device Exemptions (IDEs)
- Humanitarian Device Exemptions (HDEs)
- IND amendments with biomarker assay validation data & modifications
- IND non-clinical reports (e.g., algorithm development, cut-off determination, validation summaries, assay modifications, etc.)
- Pre-submissions
- Information Meetings
- Breakthrough Device Designation (BDD) Requests
- Safer Technologies Program (SteP) Requests
- Pre-market Approval (PMA) applications
- 510(k)s
- De Novo Requests
- Regulatory insights & intelligence from consulting for 9+ years with 100+ clients with multiple projects/client
- Provide Regulatory Advisory Boards with clinical, quality, regulatory, & technical experts for mock regulatory authority meetings & to review regulatory submissions to prepare for questions from regulators.
Global Regulatory Consulting
Operations | Strategy | Submissions
Experience
- Brazil ANVISA
- UK MHRA
- Health Canada ITAs
- New Zealand MEDSAFE
- Korea MFDS
- China NMPA CMDE
- Japan PMDA
- Australia TGA
- Extensive experience with global clinical performance & clinical bridging studies
Competitive Intelligence & Investment Diligence
- Unparalleled competitive intelligence from 20+ years of precision medicine product development experience
- Clinical, commercial, quality, regulatory & technical diligence to de-risk multi-million $ investments
- Commercial insights from both diagnostic & therapeutic viewpoints
- Provide competitive landscape assessments to support commercial viability
- Placed in companies by investors to support their multi-million $ investments
