Our Mission
DDFC BIO bridges scientific innovation and clinical reality in both China and the US for biotech companies, venture capital firms, and pharmaceutical companies, while maintaining global regulatory credibility, including FDA acceptance.
Regulatory and Clinical Services
Clinical IIT/PoC in China
- IIT/IND Regulatory Communication & Submissions
- Clinical Trial Strategy and KOL Communication
- Clinical Operation and Data Analysis
- Nonclinical/Tox Studies
- CMC Development for different modalities, including New Biomedical Technologies
- Clinical Supplies
Regulatory Services in both the US and China
- Nonclinical, CMC, Clinical, and Regulatory Strategy for Drug Development
- IND/NDA/BLA Regulatory Document Writing & Submissions
- FIH Dose Selection, Clinical Pharmacology Study Planning and Design
- Nonclinical pharmacology and toxicology for drugs, biologics & CGTs
- Pharmacometrics Supporting Dose Selection and Strategic MIDD
- CMC Development for Chemicals, Peptides, Biologics & CGTs
Modalities
- Chemicals
- Peptides
- Biologics, ADCs, bispecific Antibodies
- Cell and Gene Therapies
- RNAs
- Long-acting formulations and Nanomedicine
- Drug-device combinations
Core Capabilities
- Translational medicine
- Clinical strategy
- Regulatory strategy (US FDA & China NMPA)
- CMC and clinical supply
- IND and/or IIT planning
- Scientific diligence
- Strategic partnering
Leadership Team
Hong Wen, PhD
Co-Founder, CEO
- Former FDA Scientific Lead and Senior Reviewer
- Former Project Leader & Fellow, Novartis
- Former Senior Scientist, Pfizer (legacy of Wyeth Research)
- Former CSO, Livzon Pharmaceutical Group
- Former Partner (Founding and Managing Partner of VC Group), Shanghai Healthcare Capital
Jing Bao, MD, PhD
Co-Founder, President
- Former NIH Medical Officer
- Global Clinical Development Leader
- Former CMO, Livzon Pharmaceutical Group
- Partner, Shanghai Healthcare Capital
- Co-founder of China-Israel Health & Longevity Consortium
- Member of the Society of Physician Entrepreneurs
- PhD from the Weizmann Institute of Science in Israel
Xueming Liu, PhD
CTO
- Former CMC VP & Head of Production of Haihe Biopharma
- Former CMC Head of Livzon & Executive Director, and Head of Analytical Chemistry of BeOne Medicines
- 12 Years in global pharma R&D at AbbVie, Abbott Labs and J&J
- 7 NDA approvals
Get in touch
We’re here to answer your questions and listen to your suggestions.
USA
Jing Bao, MD PhD
jing.bao@ddfcbio.com
Mobile: (240) 907-8264
China
1st Floor, Building4, No.69, Jiepu Road, Jiangsu Industrial Park, Suzhou, China