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

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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