Technical judgment for the decisions that shape a program
Eight Crest Strategies advises biologics, cell and gene therapy and gene editing teams across CMC, technical development, quality systems and regulatory strategy — so leadership can make fast, defensible decisions under real capital and timeline constraints.
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 actually need to make.
CMC strategy
Development planning, risk framing, phase-appropriate decision support and program structure.
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 & leadership advisory
Senior input on tradeoffs, readiness, investor-facing issues and critical program choices.
CMC & technical due diligence
Independent, investment-relevant assessment of a target's drug development, CMC, analytical and manufacturing readiness for investors and their advisors — translating technical risk into the terms that inform capital decisions.
Every engagement is accepted with clear independence and confidentiality safeguards and screened for conflicts before work begins.
Who you'd be working with
Senior advisory means the person you hire is the person doing the work. Every engagement is led directly by the founder.
Kok Seong Lim, PhD
Founder & PrincipalKok Seong Lim is a pharmaceutical leader with over 20 years in biologics research and development, specializing in CMC, analytical sciences, quality control and regulatory strategy for advanced therapies.
He has held leadership positions at Metagenomi, Aura Biosciences, Editas Medicine and Thermo Fisher Scientific, helping advance more than 15 programs across gene therapy, cell therapy and gene editing — spanning rare disease and oncology indications such as hemophilia, retinal and skin disorders and lysosomal storage disorders. His work covers the full range of modalities, from viral vectors (AAV, retrovirus and adenovirus) to mRNA and guide RNA, lipid nanoparticles, Cas enzymes and oligonucleotides.
Along the way he has built and led analytical and quality organizations of 15 to 20 scientists, stood up GMP-compliant manufacturing facilities and analytical infrastructures, carried programs from early development through late-stage clinical, managed multimillion-dollar portfolios and led regulatory submissions and health-authority interactions across the U.S. and Europe.
He currently serves as Chair of the Regulatory Affairs Professional Society (RAPS) San Francisco Chapter and on the U.S. Pharmacopeia (USP) Biologics — Cell and Gene Therapy Expert Committee.
- Postdoctoral research — Massachusetts Institute of Technology (MIT) and University of California, San Diego (UCSD)
- PhD, Biochemistry — National University of Singapore
- BSc, Pharmacy — University of Strathclyde, Scotland
- Regulatory Affairs Certification (RAC), RAPS
- Passed CFA Level I and II Exams (CFA Institute)
- USP Biologics Expert Committee (Cell & Gene Therapies) · ISO/TC 276 U.S. TAG · RAPS SF Chapter Chair
- 15+ advanced therapy programs supported across gene therapy, cell therapy and gene editing
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.
Representative engagements
Illustrative examples of the work this advisory practice supports, drawn from prior CMC, analytical and regulatory leadership roles across rare bleeding, ocular, skin, neurometabolic and oncology indications. Company names and figures are withheld for confidentiality.
Selected thought leadership
Representative invited talks and a selected publication across CMC, gene editing, advanced therapeutics, quality systems and regulatory strategy.
Guide RNAs in CRISPR-based therapeutics: addressing CMC and analytical challenges to improve clinical translation
Impurity Characterization and Control During mRNA Production
Mechanisms, Measurements and Mitigation of dsRNA in In Vitro Transcription
Gene Editing Therapy Development: Platform Design and Manufacturing Readiness
Advancing Viral Vector Manufacturing: NGS-driven Solutions for Manufacturing Robustness, Product Safety and Regulatory Compliance
Accelerating Cell Therapy Development: Challenges and Opportunities
Establishing Platform Approaches in Cell and Gene Therapy: CMC and Analytical Frameworks
Active in the standards and regulatory community
This service reflects a deep, current understanding of how compendial, ISO and regulatory expectations for advanced therapies are developing — perspective that informs sound CMC and regulatory decisions.
U.S. Pharmacopeia (USP)
ISO / TC 276 Biotechnology
RAPS — SF Bay Area Chapter