Chengjun Deng Email & Phone Number

Beijing City, China

• Overseeing Medical, Scientific and Drug Safety Functions of Medical Affairs Department• Responsible for development and approval of trial design, synopsis, protocols, medical monitoring plans and CSRs.• Responsible for reviewing and approving CRF, ICF, IB and related study documents of all clinical studies awarded to QM Pharma.• Responsible for leading the discussion and interpretation of study results and resolution of issues from clinical trials.• Interacting with KOL and investigators of related therapeutic areas for assigned clinical studies.• Responsible for analyzing safety information from clinical trials and providing guidance for documentation and reporting of SAEs to IRB/IEC and regulatory agencies, • Provide strategic and technical support for all business activities of the company• Responsible for communications with regulatory agencies regarding fillings of INDs or (A)NDAs to NMPA/FDA/EMA.

• Leading the preclinical development of LSD1 inhibitors for AML, lung and breast cancers.• Responsible for strategic planning of the optimized molecules and selection of indications based on preclinical efficacy and safety data and thorough literature analysis.• Initiating and establishing scientific collaboration with academic KOLs of national research institutes for selection, designing and conduction of key efficacy studies to support further clinical development.• Development of synopsis, draft clinical protocols for an early phase AML study.• Drafting and reviewing manuscripts for publications of the efficacy data generated from the planned studies as the co-corresponding author on two international scientific journals. • Leading the activities of fund raising and government fund applications, participating road shows and other business activities to gain support for the drug development programs.• Leading the preclinical development of AMPK agonists for cirrhosis and portal hypertension.• Initiating and organizing the AMPK agonist program by collaborating with CADD expert and medicinal chemists to design, test and optimize the potential compounds.

• Leading the clinical study design and marketing application of the diagnostic kits for cirrhosis and liver cancer.• Developing and approving study protocol, synopsis, CRF/ICF/IB and related clinical study documents.• Responsible for interacting with regulatory agencies along with regulatory colleagues for the implementation of the clinical studies.

• Led the study design, protocol review, IND filing for a phase 1 study for a stroke drug candidate.• Led a phase 1 study design for an EGFR inhibitor by exploring various solid tumor types for target therapy by pre-selecting patients based on relevant biomarker analyses. • Identified and led business development activities in neurology, cardiovascular and metabolic diseases.

Hampton, Nj, Us

• Led development plan, study design, drafting study protocols and IND filings for indications of AMI, ARDS, sepsis and organ transplantations, incorporating relevant biomarkers into each of the study protocols. • Led a translational science team to direct the consorted efforts of pharmacology, toxicology, PK and CMC to support the clinical development in critical care therapeutic area.• Assist the filling of INDs and NDAs of the company by evaluating essential study data.

Served as Medical Lead for Phase 1 and 2 clinical trials in the areas of Alzheimer’s Disease, Schizophrenia, Bipolar Disorder and Asthma.As Drug Safety Officer, reporting to the Chief Medical Officer, reviewed all individual safety reports and managed all safety monitoring required for 6 different Phase 1 and Phase 2 clinical trials.• Played key roles in the design or implementation of clinical studies for Alzheimer’s disease, schizophrenia, bipolar disorder and asthma• Played key roles in the approval of 5 Investigational New Drug Applications (IND) or Clinical Trial Applications (CTA). • Organized advisory review board meeting for phase 2 result analyses• Reviewed and approved 5 Clinical Study Reports.• Successfully monitored safety for 600 subjects and patients across 6 different trials.• Reviewed and approved all individual safety reports.• Determined seriousness, drug relatedness and reportability of all adverse events.• Managed SAE database and reporting system. • Filed Annual Report and Periodic Safety Reports for 3 Phase 2 clinical studies.

Md, Medicine

Education record