Jeff Song (宋移福，Yifu Song)

Responsibilities and experiences: 1. Design clinical pharmacology related study such as pharmacokinetics and pharmacodynamics studies for clinical trials (including starting dose and dose range selection for FIH studies), review clinical trial study protocol, make sure relevant project milestones achieved from scientific and registrational perspective. Draft clinical pharmacology development plan, RP2D dose selection rationale. Review ICF, eCRF, IB, Module 2. 2. Manage Central lab and Bioanalysis lab and study setup. Review quotation and negotiate with Central lab, review budget, SOW, lab manual, site letters, training materials. Manage Central lab and Bioanalysis lab for PK and PD studies, make sure these studies in compliance with GCP regulations, guideline and SOP. Audit central lab. Select standard curve and help lab to solve any problems during method development and validation, review MV protocol, bioanalysis plan and report. 3. Manage CROs for Clinical Pharmacology Analysis. Review PK, PK/PD analysis plan, TFLs. Review Data transfer agreement. Review and deliver high quality study reports (PK, Pop-PK, ER analysis). 4. Solve problems from agencies and sites. Reply the agencies’ (FDA, CFDA) questions for IND and NDA submission. Communicate with PIs, and CRAs/CRCs on clinical pharmacology study to solve any problems. Training CRA/CRC if necessary, solve any queries from sites. Perform PK NCA analysis and PD data analysis. 5. Modeling and simulation by pharmacometrics method based on the emerged PK and PD data when needed, perform exposure-response analysis, and share the result to the team and in the Safety review committee meeting. 6. Provide effective clinical information and interpretation to the team and SRC members to support safety and efficacy evaluation, dose escalation regimen, as well as clinical development strategy.

1. In charge of preclinical studies (in vitro and in vivo efficacy, ADME/DMPK, TOX studies); in charge of bioanalysis and PK/PD studies of clinical trial. a) Participate in design and dose setting of preclinical studies and bioanalysis and PK/PD studies of clinical trial. b) Make sure scientificity and regulation compliance of preclinical studies and bioanalysis and PK/PD studies of clinical trial. c) Follow up with CROs to make sure all the projects going on with timeline on time and get work orders from CROs. 2. Delivery of excellent quality preclinical research and bioanalysis, PK, PD studies of clinical trial for IND or NDA submission a) Coordinate different CROs to complete the IND enabling studies and support clinical study, draft or update module 2.4 non-clinical overview and 2.6 summaries. b) Follow up with CROs to keep integrity of all data and essential documents. c) Review nonclinical items of IND package submission and bioanalysis, PK, PD studies of clinical trial to make sure these files in accordance with requirement of FDA and CFDA 3. Solve various problems from preclinical studies and bioanalysis, PK and PD studies of clinical trial with CROs and international cooperation partners in compliance with FDA and cFDA regulations. 4. Take part in preclinical studies and clinical trial PK/PD studies analysis and assessment of new projects with BD, propose strategy for projects. 5. Budget and follow up/Team work/Innovation 6. Calculate dose level for First in Human study; calculate safety window; predict human exposure level/Clearance/Volume distribution with animal data (interspecies scaling).

1. Manage project of preclinical GLP studies in CRO. 2. Analyze toxicity and TK tests results as a Toxicologist. 3. Review reports of non-clinical safety evaluation studies 4. Draft summary of preclinical studies for IND enabling file of ADC drug. 5. Solve problems of management and studies and give any support for project. 6. Do research on new targets of ADCs and new small molecular toxins used in ADCs. 7. Do research on Mechanism of Actions of ADCs and internalization of targets by cells. 8. Do research on in vitro models and in vivo xenografts and antigen expression levels; calculate doses for clinical trial phase 1. 1 IND submission approved during the employment.

1. Leading pk and tox team to complete pharmacokinetics and toxicity test, about 60-80 compounds in vivo PK test and 1-4 compounds in vivo sub-acute toxicity test per month. Some of candidate compounds will enter clinical trials, such as 147390. 2. Design doses of toxicity tests in accordance with positive drug’s references, PK and PD tests’ results, write protocols, prepare and carry out tests, analyze raw data and statistics, finally write report. 3. Maintain good communication with the Medicinal Chemistry / Biological / Analysis / Pharmacology departments, complete tests on time. 4. Improved the in vivo BBB test and rat carotid artery surgery. Learned how to detect drug concentration by LC-MS/MS. Wrote relevant SOPs. 5. Assist the other team’s work, complete other tasks assigned by superiors.

Study on the drug safety experiment. According to Chinese Food And Drug Administration toxicity test guideline and good laboratories practice, design and organize a toxicity test, write a protocol, training technician, gather raw data, statistics, analyze result, and finally write a protocol and archive raw data. major study: General Toxicology (Single- and repeated-dose toxicity studies in mice，rats, rabbits, dogs, monkeys and others as required) Special Toxicity (hemolysis test, topical and local toxicity tests) Be familiar with: Genetic Toxicology (Ames, chromosomal aberration and micronucleus assays) Developmental and Reproductive Toxicology (Three segments) Safety Pharmacology (Central Nervous System ,Cardiovascular System)

Major courses: Advanced Biochemistry, Advanced Animal Surgery, Clinical Veterinary Lectures, Principles And Techniques of Genetic Engineering, Biochemistry Laboratory Techniques, Advanced Animal Internal Medicine, Animal Anesthesiology, Senior Animal Obstetrics, Pet Disease Research, Experimental Surgery. Thesis: Measurement of Mammary Blood Flow in Dairy Goat. Use transit time ultra sonic blood flow meter to assess the measurement of mammary blood flow and the accuracy under different conditions, to develop a model, making it as a common technique of animal nutrition.

Major courses: Advanced Biochemistry, Advanced Animal Surgery, Clinical Veterinary Lectures, Principles And Techniques of Genetic Engineering, Biochemistry Laboratory Techniques, Advanced Animal Internal Medicine, Animal Anesthesiology, Senior Animal Obstetrics, Pet Disease Research, Experimental Surgery. Thesis: Measurement of Mammary Blood Flow in Dairy Goat. Use transit time ultra sonic blood flow meter to assess the measurement of mammary blood flow and the accuracy under different conditions, to develop a model, making it as a common technique of animal nutrition.