Song Consultancy supports biologics teams preparing the CMC package for IND submission. Frank works on the CMC and upstream workstream, providing senior CMC input where a dedicated CMC function is not in place.
What Frank focuses on
Frank focuses on the upstream and CMC decisions that shape the IND package and the future manufacturability of the program. Early choices in cell line, expression system, media, process development, and CDMO selection can create rework later, so Frank helps make those decisions deliberately and ties them to the IND path, budget, and development timeline.
That includes cell line and expression-system strategy, media and feed strategy, upstream process development, CDMO technical interface, and CMC documentation. His cell line development experience spans 20+ biologics programs across mAbs, bispecifics, and ADCs, supported by hands-on roles across Regeneron, Laureate, Ambrx, and Eminence.
Scope includes
- CMC development plan
- Cell line and expression-system strategy
- Media and feed strategy
- Upstream process development plan
- CDMO technical interface
- CMC documentation for IND preparation
- Investor-facing CMC narrative
Why Song Consultancy
Frank has worked on the bench, led process and cell line development work, and built a biotech company to commercial revenue. That combination matters because CMC decisions are not only technical decisions. They affect burn rate, development timing, CDMO spend, investor confidence, and later transfer risk. He brings technical judgment across cell line development, media formulation, upstream process development, and technology transfer, with operating experience in both the US and China.
Common questions
Is this a full-time role?
No. The engagement is scoped to the work needed. It can be structured as ongoing CMC support, a defined project, or a shorter technical review.
Does Frank own the whole IND?
No. Frank supports the CMC and upstream workstream. Toxicology, clinical, sponsor strategy, and regulatory submission ownership remain with the appropriate internal and external teams.
When should a company hire a full-time CMC executive?
When the workload, funding, and program complexity justify it. Frank's role can include helping the company prepare for that handoff.