Technical judgment for the decisions that shape a program
Eight Crest Strategies helps biologics, cell and gene therapy and gene-editing teams work through the CMC, technical and regulatory decisions that move a program forward — the ones where getting it wrong is expensive and slow to fix.
Where senior technical judgment earns its keep
The model is deliberately small. You work with one senior person, not a team of associates learning on your program.
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 & PrincipalA 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. The indications ranged widely — hemophilia, retinal and skin disorders, lysosomal storage disease — and so did the modalities: viral vectors (AAV, retrovirus and adenovirus), mRNA and guide RNA, lipid nanoparticles, Cas enzymes and oligonucleotides.
He has built analytical and quality organizations of 15 to 20 scientists and stood up GMP manufacturing and analytical infrastructure from the ground up. That work has taken programs from early development into late-stage clinical, alongside multimillion-dollar portfolios and regulatory submissions and health-authority interactions across the U.S. and Europe.
He currently serves as Chair of the Regulatory Affairs Professionals 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), Regulatory Affairs Professionals Society (RAPS)
- Passed CFA Level I and II Exams (CFA Institute)
How the work actually goes
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.
This tends to matter most when a technical call carries real weight for the timeline, the budget or the way a program reads to the people funding it. The work stays quiet and keeps its focus on getting you to the next decision.
Representative engagements
A few examples of the kind of work involved, drawn from prior roles across rare bleeding, ocular, skin, neurometabolic and oncology programs. Names and figures are left out for confidentiality.
Talks and writing
A selection of recent talks and one publication, mostly on the CMC and analytical side of gene editing and advanced therapies.
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)
International Organization for Standardization (ISO)
Regulatory Affairs Professionals Society (RAPS)