Best-In-Class Precision Medicine Consulting
Hourly Ad Hoc Consulting | Fractional Executives | Mixed Offering (Equity & Cash) | Monthly Retainers | Project-based Engagements
Clinical Biomarkers & Companion Diagnostics
Best-in-class team with combined 50+ years of clinical biomarker development experience & 15+ years of CDx experience (concept > launch)
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- Support clinical biomarker development
- Biomarker prioritization based on sample availability
- Manage CDx co-development
- Execute biomarker feasibility studies
- Grant writing (SBIRs, private funding)
- KOL engagement to generate feasibility and clinical utility data
- Analyze biomarker data (GraphPad PRISM)
- Manage collection of local laboratory testing data & provide molecular data harmonization forms for BLA/NDA/MAA
- Execute TCGA & GENIE (cBioPortal) biomarker analysis to support indication selection & biomarker development
- Manage bioinformatics strategic alliance partners for deeper analytics & novel prognostic & predictive signature development
- Pharmacodynamic biomarkers for dose optimization decision making
- Prepare/review biomarker content in clinical study protocols & reports, non-clinical study reports, Laboratory Manuals, Investigator’s Brochures, etc.
- Review informed consent forms to ensure biomarker testing & CDx is covered
- Support IRB/EC submissions
- Biomarker experience includes AI/ML-informed predictive & prognostic algorithms/signatures, cell biophysical characteristics, circulating tumor cells, digital pathology, fragmentomics, genomics, glycoproteomics, immune signatures, transcriptomics, proteomics, methylation signatures & phosphoproteomics
- Assay experience includes Adeno-associated virus (AAV) antibody assays, heme & solid comprehensive genomic profiling tests, gene expression (RNAseq, RT-PCR) for tumor-specific antigens, immunohistochemistry (singleplex & multiplex), multiplex immunofluorescence, in situ hybridization, early cancer detection assays, cancer recurrence monitoring assays, MRD assays (solid tumor, tumor-naive & tumor-informed), & infectious disease detection (multiplex respiratory viral panels, including COVID-19)
Laboratory Developed Tests
- CLIA LDT and EU in-house testing (validation planning & execution)
- Compliance with EU IVDR for clinical trial testing
- Reimbursement support (MolDX dossiers & Technical Assessments)
- Best-in-class team with 20+ combined years of IVD & LDT experience to support FDA Final LDT rule compliance:
- Technical, quality, & regulatory gap analysis, test menu prioritization, FDA reagent & instrument pivots
- Leveraging existing CLIA Quality System to reduce burden
- Intended use classification support (Class I, II, or III IVD)
- Quality Systems compliance (21 CFR Part 820, ISO13485, & ISO15189)
- Medical Device Reporting (MDR) documentation & training
- Clinical sample sourcing support for supplemental validation
- Small Business Designation Certification support
- FURLS Registration & Listing
- Labeling review & updates
- Investigational requirements training
- Pre-submissions to align with FDA
- LDT Breakthrough Device Designations (BDDs)
- Marketing submissions (HDE, 510k, De Novo, & PMA)
Global In Vitro Diagnostics (IVDs)
- Research Use Only (RUO) promotional labeling review
- US & EU Clinical Trial Assays (CTAs)
- US FDA Investigational Use Only (IUO) assays
- EU IVDR Performance Evaluation Only (PEO) studies if required
- Support CROs with global CTAs
- IVD product development
- Recommend & manage biomarker testing & IVD providers
- Support analytical and clinical validation study plans using recognized consensus standards (CLSI, etc.) & contemporary regulatory intelligence
- Work with biostatisticians on study designs & analysis
- Commercial Strategy
- Implement Design Control & Design and Development Planning
- Quality Compliance Support (21 CFR Part 820, ISO9001, ISO13485, & ISO15189)
- Risk Management Support (ISO 14971)
- IVD training workshops (virtual & on-site)
- Manage sample sourcing strategies (existing relationships with global commercial biobanks)
- Support ISO 20387 compliance for high-quality biobanking for feasibility & analytical validation studies
- Review consent and IRB/EC approval documentation for samples used for IVD development (analytical validation)
- Support IRB submissions for IVD development (feasibility testing, analytical validation & clinical validation)
Audits
- Best-In-Class team available for virtual or on-site audits:
- Quality: ISO 13485:2016 (TPECS) certified with Lean Six Sigma Green and Black Belt
- Regulatory: 25+ years combined team experience
- Technical: PhD-trained & experienced in IVD analytical validation
- Molecular Dx Testing: ASCP-certified Clinical Molecular Technologist
- Available for:
- CDx company audits
- IVD company audits
- CLIA laboratory audits (Final FDA LDT Rule compliance)
- Design History File (DHF) audit for investigational studies
- Supplier audits (GMP for manufacturers, OEM audits)
- Clinical trial (investigational) testing audits (GCP)
- Gap analysis audits (application of 21 CFR Part 820, ISO9001, ISO13485, & ISO15189)
- Software audits (IEC 62304)
- Instrumentation audits (IEC 61010, IEC 61010, & IEC 61326)
- Risk Management audits (ISO 14971)
- FDA pre-approval inspection audits
- FDA Bioresearch Monitoring (BIMO) mock audits
- EU GSPR audits
Global Regulatory
Regulatory Submissions
15+ combined years of US IVD submissions experience:
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- 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
- 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
- 2+ years of EU IVDR experience
- Align on clinical trial assay(s) regulatory path at Scientific Advice Meetings
- Regulatory intelligence from supporting many EU clinical trials
- Leverage CE-IVDs and in-house IVDs when possible
- Support/review EU Performance Evaluation Applications (PEA)
- Support Clinical Trial Application (CTA) biomarker testing documentation
- Support laboratories with analytical validation for in-house tests or PEAs
- Support Technical Documentation for CE-marking
- Support EMA CDx discussions
- Support expert regional consultants & strategic alliance partners with global regulatory documentation for clinical trials & CE-marking of IVD products
- Support Global Ethics Committee (EC) submissions
Regulatory Advisory Boards
- Provide a panel of technical, regulatory, and clinical experts for mock regulatory authority meetings (combined 50+ years of IVD regulatory experience) & to review regulatory submissions to prepare for questions from regulators.
Diligence & Competitive Intelligence
- 100+ clients with multiple biomarkers & projects/client > 9 years consulting > extensive precision medicine competitive intelligence
- 20+ years of precision medicine product development experience
- Technical, quality, regulatory & commercial experts to execute diligence to de-risk investments
- Execute deep diligence to identify commercial, quality, technical & regulatory risks
- Deliver a detailed report covering all elements with recommendations
- Provide competitive landscape assessments
- Placed in companies by investors to support investment
- Support drafting technical content of patent applications
