Two regulatory systems.
One filing pathway.
DDFC bridges FDA- and NIH-trained regulatory judgment with NMPA filing strategy and on-the-ground China execution — so a single development plan holds up in both systems, not just one.
Beyond Consulting. Development Leadership. Global Value Creation.
Most biotech failures are translational failures.
Breakdowns between biology, clinical strategy, CMC, regulatory strategy, and financing destroy billions of dollars of value every year — because most organizations operate in partially isolated scientific and business silos. Biology doesn't talk to regulatory strategy. CMC is divorced from clinical realities. Financing strategy gets structured without technical risk alignment.
The Silo Bottleneck
- CROs and CDMOs execute — they aren't built to lead strategy, judgment, or risk design
- Biology validated in isolation from regulatory reality
- CMC planned without clinical-stage context
- Financing structured without technical risk alignment
- Design risk surfaces late, often post-filing
DDFC Integrated Strategy
- Scientific assessment & translational validation
- Regulatory strategy in both the U.S. & China
- Clinical strategy execution and design
- CMC & clinical supply management
- Venture capital and partnering development
The USA · China · Israel cross-border bridge.
DDFC systematically bridges global innovation with cost-effective and fast execution — propelling molecules from Discovery through Translational Validation, IND Readiness, and Strategic Value Creation.
Strategic Hub for Strategy & Approvals
- FDA regulatory pathways and expertise
- NIH collaboration networks
- Top-tier global pharmaceutical ecosystem and biotech investments
Development & Execution Powerhouse
- NMPA regulatory filings and expertise
- Capital-efficient development and rapid clinical trial execution
- CMC production capability and strong manufacturing networks
Cutting-Edge Science & Innovation
- Advanced academic biology and immunology
- Vibrant startup and entrepreneurial ecosystem
- Highly active global translational science development
The DDFC Model: de-risking prior to large capital deployment.
Asset Evaluation
Biology validation through rigorous review of mechanism, pathway and preclinical assays; translation into concrete human indications; positioning against the global competitive landscape.
Development Plan
Regulatory pathways tailored for U.S. FDA & China NMPA; clinical strategy including protocol design, PI and site selection, and endpoints; CMC and production readiness.
Strategic Positioning
Financing readiness on strong, de-risked data; high-value global in-licensing and out-licensing partnering attraction; coordinated international execution strategy.
Goal of the model: to dramatically improve the probability of technical, clinical, regulatory, and commercial success before large capital deployment.
Two tracks. Run in parallel, not in sequence.
Programs rarely move cleanly from "U.S. strategy" to "China execution." DDFC runs both tracks at once, so decisions made for one filing don't quietly create problems for the other.
Clinical IIT / PoC in China
- IIT/IND regulatory communication & submissions
- Clinical trial strategy & KOL communication
- Clinical operations & data analysis
- Nonclinical / toxicology studies
- CMC development across modalities, incl. new biomedical technologies
- Clinical supplies & cross-border logistics
Regulatory Services, Both Markets
- Nonclinical, CMC, clinical & regulatory strategy for drug development
- IND / NDA / BLA regulatory document writing & submissions
- FIH dose selection, clinical pharmacology study design
- Nonclinical pharmacology & toxicology — drugs, biologics & CGTs
- Pharmacometrics & strategic MIDD for dose selection
- CMC for chemicals, peptides, biologics & CGTs
U.S. & China coordinated regulatory pathway.
Strategy
Preclinical and early CMC, pharmacology & tox, clinical development plans.
Writing
IND/NDA/BLA regulatory document compilation.
Dose
FIH dose selection, clinical trial protocol design.
Modeling
Pharmacometrics, MIDD, clinical pharmacology.
CMC
CMC development for chemicals, peptides, biologics & CGTs.
Pre-IND and IND coordinated submissions: we align CMC development standards, tox profiles, and dose models simultaneously for both FDA and NMPA filing — accelerating overall IND approval timelines by up to 40%.
Helping stakeholders maximize development judgment.
Biotech Companies
We act as trusted virtual development partners, providing comprehensive, multi-disciplinary guidance.
- Translational de-risking & PoC
- IND and pre-IND strategy planning
- CMC, clinical protocols & supply
- Out-licensing & financing prep
Venture Capital
We serve as specialized diligence advisors, ensuring your investment decisions are scientifically sound.
- Deep scientific and tech diligence
- Translational risk mapping
- Asset / pipeline prioritization
- Platform feasibility assessment
Pharmaceuticals
We support BD & licensing teams in assessing and integrating high-potential external innovations.
- External pipeline assessment
- In-licensing / due diligence
- Cross-border development plans
- Translational optimization
The China IIT Accelerator
Assessment
Regulatory pathway determination under Order No. 818.
Site Match
Qualified Tier 3 hospital sites & PI engagement.
Ethics / CRO
CRO/CDMO coordination & ethics/NHC filing.
Activation
Site activation, patient screening & enrollment.
First Dose
First patient dosed & interim data readout.
Fixed scope, two ways to fund it: a single 12-month engagement from regulatory pathway to first-dose data — priced as a fixed fee for funded companies, or structured through equity/territorial rights for capital-constrained teams. No milestone billing, no open-ended retainer.
Resolving what other advisors could not.
Anonymized to protect client confidentiality — sourced from the current DDFC service deck, which has already cleared internal review for external distribution.
Ex-FDA Regulatory Lead
Direct scientific lead and senior reviewer oversight on US FDA filings, ensuring highly accurate filing expectations.
Advanced Modality Mastery
Deep domain expertise in cell/gene therapies (CGT), RNAs, long-acting formulations, and ADC technologies.
China-US Bridge Strategy
A fully integrated clinical, regulatory, and CMC strategy utilizing the cost and speed advantages of the Chinese ecosystem.
Cell Therapy Client
A clinical-stage cell therapy company faced an unresolved NMPA classification ambiguity — after multiple specialist consultations and a formal NMPA submission failed to settle it.
- Resolved the NMPA review pathway where prior specialists and a formal submission could not
- Gave the client a defensible basis to brief its board and investors
- Completed within the originally proposed timeframe
- Client's venture investor independently confirmed strong satisfaction
Healthcare VC Client
A healthcare-focused VC firm engaged DDFC for scientific diligence on a prospective portfolio investment, then referred the resulting portfolio company for a dedicated China regulatory engagement.
- Independent scientific diligence delivered prior to the firm's investment decision
- Diligence and portfolio-company engagements kept cleanly separate and billed independently
- Portfolio company engagement resolved a significant cross-border regulatory ambiguity
- Firm expressed interest in expanding DDFC's role across its broader portfolio
Additional anonymized case studies available on request — documented outcomes, not just credentials.
What sits underneath both tracks.
Translational Medicine
Mapping preclinical biology models directly to human clinical applications.
Clinical Strategy
Indication mapping, protocol design, study endpoints, and trial structures.
Regulatory Strategy
Coordinated filing plans with both US FDA & China NMPA.
CMC & Supply
API process development, formulation, scale-up, and clinical supply management.
Pre-Clinical Due Diligence
Deep scientific evaluation of third-party assets for venture funds and licensing.
Flexible models tailored to your stage.
Project-Based
Fixed Scope & FeeDefined deliverable, timeline, and cost. Ideal for discrete workstreams: IND strategy, regulatory gap analysis, CMC readiness review, or clinical protocol design.
Best for: Early-stage biotechs with a specific near-term needRetainer
Monthly / AnnualOngoing strategic partnership — DDFC functions as your embedded development team, providing continuous guidance across regulatory, clinical, and CMC workstreams.
Best for: Biotechs in active development needing ongoing strategic supportEquity / Co-Dev
Aligned IncentivesFor capital-constrained teams, DDFC can fund the China IIT Accelerator directly in exchange for equity and/or China territorial rights — under a defined valuation, IP, and exit framework.
Best for: Pre-Series A teams with a strong asset but limited runway to self-fund ChinaSuccess Fee
Milestone-BasedStructured around key value inflection points: IND clearance, first-in-human data, out-licensing. Fees tied to outcomes, minimizing upfront cash burden.
Best for: Pre-Series A teams optimizing cash while advancing clinical milestonesEngagements are tailored to your stage and goals — reach out to discuss the right model for your pipeline.
Built by the people who reviewed these filings from the inside.
Hong Wen, PhD
Co-Founder, Executive Chairman & Chief Development Officer- Directed 32+ clinical-stage assets resulting in 9 NDA approvals, incl. Signifor LAR and Entresto
- Former FDA Scientific Lead & Senior Reviewer
- Former Project Director, Novartis; Former Senior Scientist, Pfizer/Wyeth
- Former CSO, Livzon Pharmaceutical Group
- Former Venture Partner (previously Founding & Managing Partner, VC Group), Shanghai Healthcare Capital
- Chief Scientist (Scientific Advisor), YuanBio
- Novartis Leading Scientist Award; trained in chemistry, biochemistry & pharmaceutics at Fudan, U. Tennessee & Purdue
Jing Bao, MD, PhD
Co-Founder, President & Chief Medical Officer- Former CMO, Livzon Pharmaceutical Group; Medical/Scientific Lead, U.S. NIH
- Managed & directed 20+ global clinical trials
- Venture Partner, Shanghai Healthcare Capital; board director for several international companies
- Co-Founder, China–Israel Health & Longevity Consortium
- NIH Director's Merit Award recipient
- MD, Southeastern Medical School; PhD, Weizmann Institute of Science, Israel; adjunct professor at HKUST and Fudan University
Xueming Liu, PhD
Chief CMC Officer- Former CMC VP & Head of Production, Haihe Biopharma
- Former CMC Head, Livzon; Executive Director & Head of Analytical Chemistry, BeOne Medicines
- 12 years in global pharma R&D — AbbVie, Abbott Labs, J&J
- 7 NDA approvals
Start with the filing you're worried about.
Tell us where the program is headed and which regulator you're most concerned about disappointing. We'll tell you, plainly, what we can and can't help with.
Jiangsu Industrial Park, Suzhou, China