CMC strategy
Development planning, risk framing, phase-appropriate decision support and program structure.
Executive advisory for biotech programs
Technical and strategic judgment for companies building complex therapeutics
Eight Crest Strategies advises biologics, cell and gene therapy and gene editing teams across CMC, technical development, quality systems and regulatory strategy. The work is designed for executives who need clear priorities, disciplined execution and technical decisions that support the business as well as the science.
Services
Focused support where technical execution and company priorities need to align
The advisory model is intentionally lean: direct, senior and tailored to the decisions founders and executives need to make.
Technical development
Process and analytical strategy, technology transfer planning and operational problem-solving.
Quality systems
Quality structures that are credible, practical and suited to emerging-company realities.
Regulatory positioning
Technical narratives and planning that support filings, agency engagement and internal alignment.
CRO and CMO management
Oversight, scope review, relationship support and alignment between vendors and company goals.
Founder and leadership advisory
Senior input on tradeoffs, readiness, investor-facing issues and critical program choices.
Approach
Measured, discreet and execution-oriented
Assess the program
Clarify stage, constraints, operating model and the specific technical issues that will influence the next milestone.
Define the decision path
Convert complexity into a clear sequence of priorities, owners and tradeoffs relevant to leadership.
Support execution
Stay engaged enough to keep teams moving while preserving the senior perspective required for executive decision-making.
Eight Crest Strategies is especially well suited to moments when technical decisions carry outsized implications for capital efficiency, external credibility, or development timing. The emphasis is on substance, clarity and progress.
Speaking & publications
Selected thought leadership that supports technical and strategic decision-making
Representative invited talks and a selected publication across CMC, gene editing, advanced therapeutics, quality systems and regulatory strategy.
Publication
Guide RNAs in CRISPR-based therapeutics: addressing CMC and analytical challenges to improve clinical translation
Nucleic Acid Insights (Jan 2026) Vol. 3, 11-18.
Invited talk
Impurity Characterization and Control During mRNA Production
mRNA Conference 2026, Boston, Massachusetts, USA, Apr 27-28, 2026.
Invited talk
Mechanisms, Measurements and Mitigation of dsRNA in In Vitro Transcription
3rd DNA Process Development & Manufacturing Summit, Boston, Massachusetts, Mar 24-26, 2026.
Invited talk
Advancing Viral Vector Manufacturing: NGS-driven Solutions for Manufacturing Robustness, Product Safety and Regulatory Compliance
4th Viral Vector Process Development & Manufacturing Summit, Boston, Massachusetts, Feb 23-25, 2026.
Invited talk
Accelerating Cell Therapy Development: Challenges and Opportunities
RAPS Convergence, Pittsburgh, Pennsylvania, Oct 7-9, 2025.
Invited talk
Establishing Platform Approaches in Cell and Gene Therapy: CMC and Analytical Frameworks
USP-Northeastern University Workshop on CMC Considerations for Biotechnology and Advanced Therapy Products, Seoul, South Korea, Oct 1-2, 2025.
Contact