Our Mission
Drug Development and Filing Consulting, LLC (DDFC) helps innovative biotech and pharmaceutical companies to achieve clinical proof of concept (PoC) by offering one-stop integrated, efficient, and cost-saving services in China, while maintaining global regulatory credibility, including FDA acceptance.
Our Key Services
Integrated Services for Clinical PoC in China
- Nonclinical/Tox Studies
- Clinical Supplies
- China IND Regulatory Communication & Submissions
- Medical KoL/PI Collaboration & Clinical Trial Design
- Clinical Operation and Data Analysis
- CMC Development for Chemicals, Peptides, Biologics, CGTs & RNAs
Regulatory Services in the US
- 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
Clinical Resources in China
- Medical KoLs/PIs: Oncology, Autoimmune, CVM, musculoskeletal, renal, rare diseases, etc.
- CROs: ~100 focused on clinical services
Clinical Supplies in China – Modalities
- Chemicals
- Peptides
- Biologics
- CGTs
- RNAs
US Regulatory Teams
- Clinical Consultant Team
- Clinical Pharmacology/PKPD modeling Consultant Team
- Nonclinical/Tox Consultant Team
- CMC Consultant Team
- Regulatory Document Writing and Submissions
Leadership Team
Hong Wen, PhD
CEO & CSO
- Former CSO of Livzon, overseeing R&D and strategy
- 15 years in global pharma R&D at Novartis and Pfizer; 9 NDA approvals
- Former FDA Scientific Lead, directing regulatory science and post-marketing programs
- Former Founding and Managing Partner at Shanghai Healthcare Capital
Jing Bao, MD, PhD
President, CMO
- Former NIH Medical/Scientific Officer & CMO of Livzon in China
- Partner of a VC in Shanghai
- Co-founder of China-Israel Health & Longevity Consortium
- Member of SoEP. PhD from the Weizman 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
Room 302, No. 8, Lane 111
Qilianshan Road
Shanghai, China