Services
Each engagement is scoped as a set of work packages, each with an hour ceiling, a timing window, and a named owner for the work that falls outside it. The ceilings hold where the sponsor and its partners meet their obligations; where they do not, the practice seeks written authorization rather than absorbing the overrun or diminishing quality without notice.
What Crawling Stone does
The services apply across cell therapy, gene therapy, and in vivo and ex vivo genome editing. Programs advised to date span inducible CAR-T, TCR T cell, TIL, and nonviral CRISPR and base editing delivered by lipid nanoparticle.
Regulatory strategy and FDA engagement
For sponsors preparing for INTERACT, Pre-IND, or IND submission
Crawling Stone formulates the regulatory strategy for a cell or gene therapy program and carries it into the relationship with the Agency: authoring the briefing documents for INTERACT, Pre-IND, and Type C meetings, chairing those meetings on the sponsor's behalf, and partnering with the sponsor's scientific and manufacturing teams to develop the IND Module 3 and Module 4 content and the Target Product Profile that follow from them.
- INTERACT, Pre-IND, and Type C meeting requests and briefing documents
- Meeting preparation, chairing, and sponsor response to Agency feedback
- IND Module 3 and Module 4 development in partnership with the sponsor's authors, or critical review of sponsor-drafted modules
- Target Product Profiles and integrated development plans
- Rare-disease evidence pathways and expedited-designation strategy
- U.S. Agent services for academic and ex-U.S. sponsors
CMC and manufacturing strategy
For programs defining a process, selecting a CDMO, or scaling toward clinical manufacture
The practice defines the control strategy and directs process development, scale-up, and technology transfer. Having served as the sole client-side point of contact for CDMO manufacture of clinical drug product, Crawling Stone brings that oversight model to sponsors that lack a manufacturing organization of their own.
- Control strategy: critical quality attributes, critical process parameters, and in-process controls
- Release specifications, potency assurance strategy and assay qualification, and stability protocols
- CDMO selection, technology transfer, Quality Agreement scope, and master batch record review
- Comparative assessment of manufacturing platforms: viral vector, transposon, CRISPR-mediated knock-in, nonviral mRNA, and automated closed systems
- Person-in-plant oversight of process qualification and clinical manufacturing runs
- Deviation management, change control, and comparability strategy
Preclinical and IND-enabling development
For programs advancing from proof of concept to a submission-ready nonclinical package
Crawling Stone designs and executes the IND-enabling study program as Study Director and, with the sponsor's scientific team, develops the Module 4 reports that carry it into the submission. Where no animal model of the disease exists, the practice has secured Agency alignment on patient-derived cellular models as the basis for proof of concept.
- Nonclinical package scope and study design
- Pharmacology, biodistribution, toxicology, and off-target assessment planning
- Animal model selection and new approach methodologies
- Module 4 reports and the nonclinical overview, developed with the sponsor's authors
- Study Director responsibilities and contract research organization oversight
Program leadership through the discovery-to-clinic transition
For teams requiring a single accountable owner across the laboratory, the manufacturer, and the clinic
The practice leads the program, represents CMC on the executive asset team, and directs the cross-functional work that carries a candidate from discovery research into clinical investigation, serving as the interface between manufacturing and clinical operations, including IRB communication and site readiness for drug product administration.
- Program and portfolio leadership, risk projection, and timeline development
- Standards for the discovery-to-process-development handoff
- Executive asset team and CMC sub-team representation
- Clinical site manufacturing readiness and starting-material logistics
- Scoped, capped engagements with a named owner for every deliverable
Institutional portfolio strategy
For technology transfer offices, academic medical centers, and institutional investors
Academic commercialization functions are constituted to generate inventions, fund validation, and form companies. What they characteristically lack is independent sponsor-side judgment: the integration of product definition, indication, CMC, regulatory, nonclinical, clinical, cost, and financing considerations into a single decision before translational capital is committed.
- Asset and indication selection against a financeable product thesis
- Integrated development planning to the next value inflection
- Stage-gate governance yielding explicit advance, reposition, partner, hold, or terminate recommendations
- Regulatory and CMC due diligence in support of spin-out and investment decisions
- Design of translational institutes and sponsor-side development functions
How engagements run
- Scope first. A written scope states what the engagement includes, what it excludes, and who owns what lies outside it. Scope terminates at a defined event: a meeting, a submission, or a decision.
- Work packages with ceilings. Each package is authorized individually and is not billed unless requested. Unused hours do not transfer between packages.
- Decisions precede the activities that depend on them. The first deliverable is typically an enumeration of what must be settled before the next gating event, and the consequence of its being late.
- Written findings. Reviews yield documented findings the sponsor can act upon and file, rather than verbal comment.
Begin with a program, a question, or a portfolio.
Most engagements begin with a short call to establish where the program stands and which decision comes next, whether it concerns regulatory strategy, manufacturing, nonclinical development, clinical readiness, intellectual property, or the disposition of a portfolio.