Aligning Therapeutic & Diagnostic Programs
TRANSLATION
Aligning therapeutic, biomarker and companion diagnostic development
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Biomarker feasibility and performance
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Diagnostic partner selection
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Operational scorecard
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Track record
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Platform
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Global reach
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Commercialization capability
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Pricing & cost
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IMPLEMENTATION
Comprehensive operational support
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Development and deployment of RFIs and RFPs
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Contracts
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Structure
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Negotiation
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Execution
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Regulatory roadmaps and strategy
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Technical advisory
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Operational logistics
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Program management and oversight
COMMERCIALIZATION
Marketing & messaging
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CDX Life Cycle Management
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Awareness and education
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Medical affairs content and strategy
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Patient insights and voice
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Patient-focused marketing 360
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Inspire
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Facebook
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Instagram
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Advocacy channels
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Reimbursement
Enabling Precision Medicine
INSIGHTS
Customized surveys
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Integrated with market and technology trends
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Research with key stakeholders
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Peers
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Customers
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End Users
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Key opinion leaders
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Subject matter experts
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ASSESSMENTS
Areas of focus
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Competitive landscape analysis
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Therapeutic asset review
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Technology and platform evaluations
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In vitro diagnostic strategy
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Investor diligence
EDUCATION
Seminars for Pharma
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Companion diagnostic bootcamp
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IVD regulatory trends and strategy
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Drug/Diagnostic co-commercialization options
Meet The Partners
Kenna Anderes PhD
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25 years Therapeutic and Diagnostic Development
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Start-up Biotech to Big Pharma
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Hands-on Preclinical to IND, FIH
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Clinical development to LCM
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KOL relationship building and management
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ctDNA/CTC subject matter expert
Joe Monforte PhD
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25 years Life Sciences Entrepreneur
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Company building – 18 years in the CSO role
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Diagnostic product strategy and tactical development
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Drug Diagnostic companion (CDx) codevelopment program support
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Rx/Dx patient messaging and engagement
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Genomics and NGS technology expert
Pia Gargiulo PhD
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20 years Pharma/Dx Product and BD Executive
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Translational & Transactional driver
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Out of the box strategist
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Patient advocate and engagement expert
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Specialized experience in companion diagnostic (CDx) Co-Commercialization
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6 PMA (Her2, EGFR, KRAS) 8 CDx Programs Executed