Dr. David Schodin, PhD JD
Industry expert with 30+ years of experience guiding diagnostics, laboratory-developed tests (LDTs), and molecular technologies through high-stakes regulatory, transactional, and commercialization decision points.
Dr. David Schodin brings deep expertise at the intersection of FDA regulatory strategy, molecular diagnostics commercialization, and complex life sciences transactions. He has advised executive teams on regulatory positioning, intellectual property strategy, partnering, and market access; particularly for novel diagnostic technologies where regulatory pathways, reimbursement, and deal structures must be aligned early to mitigate risk.
Areas of Focus / Expertise
- FDA regulatory strategy for diagnostics, ASRs, and LDTs
- Commercialization strategy for FISH, microarray, NGS, and mass spectrometry platforms
- Regulatory and business positioning for cloud-based and data-driven diagnostic technologies
- Intellectual property strategy, licensing, and freedom-to-operate analysis
- Complex biotech transactions, partnering, and M&A execution
- Business development and licensing negotiations
- Investment diligence and transaction advisory
Selected Experience & Impact
Over the course of his career, Dr. Schodin has led business development and licensing for FISH and microarray-based diagnostic products, including numerous ASRs used in LDTs and multiple FDA-approved oncology and autism-related diagnostics. He has also led commercialization strategy for proprietary molecular tests based on next-generation sequencing, mass spectrometry, and cloud-based analytics. As a biotech attorney, he has negotiated hundreds of commercial agreements, executed scores of IP licenses and strategic partnerships, and led at least six complex transactions valued at over $50M. He has directly supported the launch of two LDTs within small business environments and serves as Senior Advisor to Evergreen M&A and Convergence Health.
Background & Credentials
Prior to FDA Partners, Dr. Schodin held leadership roles in business development for molecular diagnostics companies and practiced as a patent, IP, biotech, and M&A attorney focused exclusively on medical products. He holds a PhD in Molecular Biology and earned his JD with high honors from Chicago-Kent College of Law.
Dr. Schodin approaches regulatory and transactional strategy with a scientist’s rigor and a dealmaker’s focus on execution, helping clients align technical innovation with durable commercial outcomes.