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Fit For Purpose Solutions Fueled by Innovative Technical and Regulatory Strategies

Scientific & Medical Writing 

Prepare & review:
  • Grant applications
  • White papers
  • Manuscripts
  • Meeting abstracts, posters, and presentations
  • Technical Content of Patent applications 
  • Device and Pharmaceutical Clinical Trial Protocols
​

Laboratory Developed Test (LDT) Support

Prepare & review:  
  • Clinical laboratory documentation 
  • Clinical dossiers
Support:
  • Inspection readiness; audit test documentation
Provide:
  • Training on LDT validation   
  • Control and monitoring strategies
  • Reagent supply chain management
  • ASCP-certified Molecular Technologist: direct molecular diagnostics bench testing experience

Assay Development Support

Support clinical trials and commercial assay development:
  • Research Use Only (RUO) assays
  • Clinical Trial Assays (CTAs) 
  • Investigational Use Only (IUO) assays
  • In Vitro Diagnostic (IVD) products 

Provide & review:
  • Analytical and clinical validation studies
  • Protocol & Reports
  • Control strategies
  • Design Control documentation 
  • Failures Modes and Effect Analysis
  • Validation approaches
  • Supply chain risk assessments
  • Product Development Process Training
Knowledgeable in:
  • Clinical & Laboratory Standards Institute (CLSI) guidelines
  • GLP 
  • GCP 
  • ​GMP
Manage:
  • Budgets 
  • Request for proposals (RFPs) 
  • Sample sourcing (access to expansive biospecimen network)
  • IRB/EC submissions 
  • CRO partnerships (access to an expansive network)
  • Diagnostic development vendors (access to an expansive network)
Strategies:
  • Single-site IVD (ssIVD) development in CLIA-certified clinical laboratories
  •  ssIVD and distributed IVD product development strategies
  • Clinical Trial Patient Identification 
Biobanking:
  • Implement ISO 20387:2018 compliance 
  • Support A2LA Accreditation
  • Support IRB/EC submissions 
  • Expert on pre-analytical considerations for development projects

Regulatory Support 

Diagnostics Regulatory Executive for emerging companies 

Prepare, review & publish submissions:
  • De novo requests
  • Investigational Device Exemptions (IDEs)
  • IND amendments for biomarker testing & assay validation data
  • Pre-submissions
  • Breakthrough Device Designation Requests 
  • Pre-market Approval (PMA) applications
  • Study Risk Determinations (SRDs)
  • 510(k)s
 Support:
  • Preparation for regulatory meetings 
  • Answering deficiency responses
​Regulatory Advisory Board (RAB):
  • Panel of regulatory experts 
  • Better prepare for regulatory interactions
  • Share regulatory intelligence to identify risks

On-demand Knowledge Sharing

  • Provide 1:1 consultations  
  • Complete surveys
  • Discuss life science industry trends and challenges for industry so you can stay informed and make better business decisions
  • Provide first hand experience 
  • Provide referrals to experts in the life sciences industry
  • Participate on Scientific Advisory Boards
  • Provide fractional/interim leadership to emerging biotech; previous roles include VP, Clinical Affairs, VP Companion Diagnostics; VP, Diagnostic Development; VP, Regulatory Affairs; VP, Translational Medicine/Science  

Due Diligence 

Evaluate biotech  for investment firms:
  • Audit technical documentation
  • Audit analytical and clinical validation study documentation and strategies
  • Evaluate biomarker development strategies and companion diagnostic plans
  • Participate in deep diligence calls to identify asset & project risks
  • Audit regulatory strategies and documentation 
  • Provide competitive landscape assessments
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