Pengfei (Peter) Guo

•• Implement regulatory CMC strategy to the entire organization related to developing new gene therapy candidates. • Responsible for authoring and reviewing eCTD contents for IND submission to US and other regulatory authorities; Established feasible IND submission eCTD template for module 3 as well as drafted two AAV gene therapy products CMC content for clients’ IND submission. • Collaborate with QA and QC team to establish/optimize the QMS to ensure the GMP compliance.

• Provide scientific and strategic insight into the development of 15 biologic pipelines from different stages against technical and scientific challenges to support the decision making. • Collaborating with and guiding regulatory affair team with a BLA filling to China CDE, two INDs filling to FDA (one Biologic and one Biosimilar).

Led the Global Regulatory Compliance Department and ensured regulatory compliance for ongoing projects. Provided strategic regulatory and CMC guidance to support company decision-making. Conducted facility inspections in coordination with the Quality Assurance Unit to ensure GLP compliance; supported Saifu Laboratories in successfully passing OECD and FDA audits. Developed a humanized monoclonal antibody for the treatment of Burkholderia infection; patent in preparation. Served as a member of the China Center for Drug Evaluation (CDE) working group responsible for drafting the guidance on “Chemistry, Manufacturing, and Controls (CMC) Requirements for Biosimilars.” Provided CMC consulting support for biologics, cell therapy, and gene therapy projects across Saifu-affiliated companies and external clients. Delivered scientific and laboratory technical training to Saifu facilities and resolved critical technical challenges; led development of a new PCR-based analytical method for ASO/siRNA products. Supported business development by advancing project negotiations and strengthening international project service capabilities; hosted international client audits. Delivered more than 10 regulatory CMC-related lectures at major conferences, summits, and symposiums.s, and symposiums.

Review: • Assessed >100 Biologic INDs, one BLA, and hundreds of amendments in the Division of Biotechnology Review and Research II, Office of Biotechnology Products (OBP). • Conducted technical risk assessments for BLAs, INDs, DMFs, and biosimilars. • Contributed to policy drafting in biosimilar assessment and immunogenicity evaluation. • Represented the FDA in stakeholder negotiations to ensure adequate demonstration of drug safety and efficacy. • Consulted across multiple FDA offices/divisions on CMC assessments, USAN ballot reviews, immunogenicity assays, naturally derived products, medical devices, and cell-based therapies. • Performed pre-licensure inspections including 704 (a)(4) document evaluation, and on-site inspections. Research: • Principle Investigator for “Therapeutic monoclonal antibodies and bacteriophage therapies against pathogenic Burkholderia”. Meanwhile provided scientific consultations for novel and challenging biologic products. • Investigated the molecular mechanism of anthrax cytotoxicity, focusing on the role of Ubiquitin E3 ligase Cop1 in MAPK-ERK1/2 signaling (Publications in PNAS (2020) and JBC (2017)). • Developed cell-based assays to assess the cytotoxicity of anthrax lethal toxin. • Collaborated with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) to develop peptide-based vaccines targeting capsular polysaccharides and lipopolysaccharides of Burkholderia supporting FDA’s role in preparedness for bioterrorism threats (Publications in Monoclonal Antibodies in Immunodiagnosis and Immunotherapy (2016)) • Investigated lung and blood microbiome from patients with acute fatal pulmonary illnesses. • Investigated a novel antibiotic from Pantoea species

• Investigated host-pathogen interactions between Helicobacter pylori and the innate immune system using macrophages as a model system. Discovered the novel role of H.pylori VacA cytotoxin in disruption of macrophage lysosome maturation. • Expressed and purified recombinant transcription factor from Escherichia coli inclusion bodies • Analyzed Tiling array gene expression profiles of both bacteria and host cells during infection.

• Developed innovation library preparation protocol for DNA and RNA sequencing with SOLiD system. • Worked effectively both independently and in team environment planning, organizing, and conducting genomic sequencing and RNA-seq service and support to research laboratories

Applying genetic, molecular biology and cell biology methods to investigate the mechanism and signaling pathway, which control pathogenic fungal morphology switch (yeast form to hyphae form) to understand how morphogenesis impacts on pathogenesis.