Fit-For-Purpose Solutions Fueled by Innovative
Technical and Regulatory Strategies & Unequaled Insights
Scientific & Medical Writing
Prepare & review:
- Assay technical documentation
- Feasibility reports, verification & validation plans, protocols, reports
- Investigator’s Brochure
- Instructions For Use
- Assay clinical protocols, reports, performance evaluation study documentation
- Biomarker testing content in Biopharma clinical protocols
- Grant applications
- White papers
- Manuscripts
- Meeting abstracts, posters, & presentations
- Technical Content of Patent applications
Laboratory Developed Test (LDT) Support
Prepare & review:
- Clinical laboratory documentation
- Marketing materials (labeling review)
- Validation plans & reports
- Clinical dossiers
- Clinical utility publications
Support:
- Biopharma audit preparation for clinical trial testing
- CAP audit preparation
- FDA compliance (FDA Final Rule, 05/06/24, effective 07/05/24)
- Gap Analysis, Test Prioritization, & Compliance Timeline
- Sample sourcing support if needed to support supplemental validation
- Small Business Designation Certification if appropriate
- Review of available technical & clinical performance/validation data
- Medical Device Reporting (MDR) Compliance
- Registration & Listing
- Labelling review
- Investigational Device Exemption (IDE) requirements compliance
- Quality Systems (QS) compliance
- Pre-submissions
- Breakthrough device designation requests
- HUD/HDE requests for rare disease
- Marketing submissions (510[k], De Novo, PMA)
Provide:
- Training on analytical & clinical validation
- Control and monitoring strategies
- Reagent, consumable & instrumentation supply chain management
- ASCP-certified Molecular Technologist: direct molecular diagnostics bench testing experience
- Support clinical molecular laboratory build-outs & manual to automation workflow conversions
- Audit molecular diagnostics laboratories for Biopharma
- Identify areas for improving testing throughput & turnaround times
Assay Development Support
Support clinical trials and commercial assay development:
- Research Use Only (RUO) assays for exploratory biomarker analysis
- Review product labeling to ensure appropriate for RUO use
- Clinical Trial Assays (CTAs) for eligibility decisions
- Review clinical trial plans & identify regulatory & technical requirements
- Identify global regulatory requirements
- US FDA Investigational Use Only (IUO) assays
- Determine if likely to be IDE-exempt, Non-significant Risk (NSR), or Significant Risk (IDE required)
- Support study risk determinations (SRDs)
- EU IVDR Device for Performance Evaluation
- Determine if a performance evaluation notification or application is required
- Determine if in-house laboratory testing is an option to reduce cost & timelines (successfully used for tumor antigen IHC test and NGS-based tumor profiling assays)
- In Vitro Diagnostic (IVD) products
- Determine the appropriate global regulatory marketing pathways
- Proactively engage FDA on CDx reclassification
Provide & review:
- Analytical and clinical validation study plans
- Provide insights based on development experience & regulatory authority feedback
- Sample sourcing strategies (relationships with commercial biobanks, using contrived/surrogate samples)
- Analytical Validation Protocol & Reports
- Extensive experience designing & executing accuracy, precision & robustness performance studies
- Control strategies
- Provide insights based on development experience & regulatory authority feedback
- Design Control documentation for assays
- Fit-for-purpose & stage appropriate
- Risk Management
- Failures Modes and Effect Analysis (FMEA)
- Supply chain risk assessments
- EU IVDR General Safety & Performance Requirements (GSPR)
- Product Development Process Training & Workshops
Knowledgeable in:
- Clinical & Laboratory Standards Institute (CLSI) guidelines for test validation approaches
- GLP for non-clinical analytical studies
- GCP for clinical trial sample testing
- IVD GMP requirements
- ISO 13485
- ISO 14971
- ISO15189
Manage:
- Clinical trial biomarker testing & investigational assay budgets
- CDx Request for proposals (RFPs)
- Collection of Local Laboratory Testing information to support eligibility testing in accordance with FDA requirements (molecular pathology test report review & collation of biomarker information)
- Biospecimen sourcing (access to expansive biospecimen network)
- IRB/EC submissions
- CRO partnerships (access to an expansive network)
- Diagnostic development vendors (access to an expansive network)
- IVD developer audits
Strategies:
- Single-site IVD (ssIVD) development in CLIA-certified clinical laboratories
- Navigating EU IVDR (in-house & performance evaluation solutions)
- Global ssIVD and distributed IVD product development strategies
- Proactive engagement with US FDA on CDx reclassification
- CLIA Laboratory FDA readiness (Proposed LDT enforcement rule)
- Clinical Trial Patient Identification
- Successfully negotiated CDx post-market commitments (PMCs)
Biobanking:
- Implement ISO 20387:2018 compliance for high-quality biobanking
- Support A2LA Accreditation
- Support IRB/EC submissions for research projects utilizing biospecimens
- Expert on pre-analytical considerations for development projects (sample stability, tumor purity, etc.)
Auditing:
- Assess CDx partners Quality Compliance (ISO13485), Technical Capabilities (validation documentation), & Regulatory Capabilities (US IUO, US IDE, US IVD, EU IVDR, etc.)
- Assess US CLIA laboratories for IUO/IDE/Clinical Trial testing readiness
- CLIA LDTs > FDA-authorized single-site IVD
- Assess clinical testing in-house laboratories & diagnostic developers for EU IVDR compliance (e.g., GSPR documentation, ISO13485, ISO15189, Technical Documentation, Performance evaluation study documentation, etc.)
Regulatory Support
Fractional/Interim Diagnostics Regulatory Executive for emerging start-up/stealth companies; develop strategy & transfer to a full-time regulatory executive when the time is right
Prepare, review & publish submissions:
- CDx reclassification support
- Biomarker testing & CDx content in Biopharma Briefing Books to enable co-development alignment
- Study Risk Determinations (SRDs)
- Investigational Device Exemptions (IDEs)
- IND amendments for biomarker testing & assay validation data
- Pre-submissions
- Breakthrough Device Designation Requests
- Safer Technologies Program (SteP) Requests
- Pre-market Approval (PMA) applications
- 510(k)s
- De novo requests
- EU IVDR Performance Evaluation Documentation
- Review global regulatory documentation from expert regional consultants (Japan, China, Canada, Australia….)
Support:
- Preparation for regulatory meetings; lead meetings & serve as a mock regulatory reviewer
- Predict deficiencies & identify paths forward
- Answer deficiency responses
Regulatory Advisory Board (RAB):
- Lead a panel of regulatory experts for mock regulatory authority meetings (combined 50+ years of experience) to prep teams for regulatory interactions
- Prepare technical development teams for regulatory interactions to interrogate validation approaches
- Better prepare personnel for effective regulatory interactions
- Share regulatory intelligence from a combined 82 years to identify risks and regulatory authority alignment areas
On-demand Knowledge Sharing
- Provide 1:1 ad hoc consultations or retainers available if sustained support is needed
- Complete voice of customer surveys that can be used for design goals
- Discuss life science industry trends & challenges for industry to keep clients informed and be able to make better business decisions
- Provide first hand technical & regulatory experience
- Provide referrals to experts in the life sciences industry (Biostats, Quality, etc.) if more support is needed
- Participate on Scientific Advisory Boards providing product development guidance
- Provide fractional/interim leadership to small emerging start-up/stealth biotech; previous roles include VP, Clinical Affairs; VP/Executive Director, Companion Diagnostics; VP, Diagnostic Development; VP, Regulatory Affairs; VP, Translational Medicine
Due Diligence
Evaluate Biotech for Investors:
- Review technical documentation
- Review analytical and clinical validation study documentation and strategies
- Evaluate biomarker development strategies and CDx plans
- Participate in deep diligence calls to identify asset & project risks
- Assess regulatory strategies and documentation
- Provide competitive landscape assessments