Yuling Li Email & Phone Number

Therapeutic Area and Study Phase: acute myeloid leukemia, multiple myeloma, sickle cell disease; phases 1-3.Product Level Responsibilities (pharmacovigilance and clinical development):• Supported statistical analyses of key messages and/or ad hoc analyses in preparation for NDA submission: • Developed, participated in, and ensured quarterly product level aggregated safety data reviews (including AEs/SAEs, clinical laboratory, VSs, ECGs, and events of interest), signal detection, and review meetings. • Managed and contributed product Development Safety Update Report (DSUR) preparations and submissions. Oversaw outsourced PVG activities to ensure the production of DSUR tables and listings from the safety database system (Oracle Argus).• Authored SAE sections of investigator’s brochure.• Drafted relevant sections for responses to regulatory agency inquiries regarding aggregated safety information.• Supported medical communication activities (e.g., manuscripts, abstracts, etc.) by providing and QC of safety data on company compounds.

Rockville, Md, Us

Study Level Responsibilities (pharmacovigilance and clinical development):• Provided medical support related to review of safety and efficacy data from clinical studies.• Participated in development of relevant safety sections to the protocols, clinical study reports, and other clinical documents.• Performed blinded monthly safety reviews during trial execution a phase 3 pivotal study.• Performed and approved medical coding review of MHs, AEs, and concomitant medications. • Supported data cleaning efforts by initiating queries while conducting safety data review and medical coding.• Prepared summary SAE tables for Data Monitoring Committee (DMC) and Steering Committee meetings.• Reviewed and approved study specific safety management plans (SMPs) and safety reporting plans (SRPs).• Reviewed and approved study specific Oracle Argus safety database configurations.• Reviewed and approved study specific SAE/pregnancy report forms and completion guidelines as well as associated documents.• Reviewed SAE reports and associated medical coding to ensure accuracy, integrity, completeness, and quality standard for submission to regulatory bodies and safety partners.• Perform SAE assessment of causality, expectedness, and regulatory reportability.• Reviewed and approved Suspected Unexpected Serious Adverse Reaction (SUSAR) reports including event narratives. Oversaw timely submission of SUSAR reports to global regulatory agencies and investigators.• Oversaw timely cross reporting of SUSAR reports to global regulatory agencies and investigators.• Authored CSR SAE narratives.• Review/revise/implement safety data exchange agreements (SDEAs) for partner studies.• Contributed to the development, management, generation, and implementation of SOPs and guidelines for pharmacovigilance and drug safety monitoring.

Stamford, Ct, Us

• Was responsible for design and scientific oversight of clinical studies in support of Product Development Plans.• Significantly contributed to FDA’s approval of Hysingla™ ER, for which received major key contributor’s award.• Authored clinical study design documents; authored clinical study protocols; critically reviewed FDA IND correspondences to ensure crucial issues were addressed; critically reviewed Pediatric Proposed Study Request (PPSR), identified issues, and contributed to issue resolution resulting in finalization of updated PPSR FDA submission; conducted protocol training for CRO/vendor; reviewed and provided significant medical/scientific input to protocol training materials for investigator meeting prepared by CRO’s medical monitor; provided medical/scientific input in development of Data Monitoring Committee (DMC) charter; participated in medical/scientific consultations with external key opinion leader in pediatric cardiophysiology to develop pediatric clinical study safety monitoring; reviewed/provided significant input for Safety and Medical Management Plan; provided medical/scientific input in development of SAE reconciliation plan; provided medical/scientific input to Simplified Investigational Medicinal Product Dossier (sIMPD) and Investigators Information Packet; performed literature search and authored literature review summary for pediatric use of a product; provided medical/scientific input to development of database training materials for investigator meeting; provided medical/scientific input in development of Electronic Case Report Form (eCRF) and eDiary; provided input for informed consent/assent forms.

Germantown, Md, Us

• Completely independently developed template for section 2.7.2: Summary of Clinical Pharmacology Studies of Electronic Common Technical Document (eCTD); completely independently authored entire section 2.7.2 based on more than 70 individual clinical study reports. • Authored clinical study reports.• Processed and reviewed individual SAE reports; provided guidance for expedited SAE reporting; reviewed and revised numerous SAE narratives and other significant adverse events; provided medical inputs for multiple functional groups.• Managed phase 2 clinical studies; managed CRAs; interacted with sponsors.

Us

• For clinical trials of monoclonal antibody in neonatal sepsis, performed first medical review of clinical study data including both emergent safety data and ongoing study endpoint data; participated in Safety Monitoring Committee and Data Safety Monitoring Board meetings; oversaw safety reporting process by pharmacovigilance group of CRO; reviewed/provided medical input for numerous MedWatch reports.• For clinical trials of monoclonal antibody in neonatal sepsis, actively contributed to clinical study protocol design; authored clinical study protocol; authored clinical study report; actively contributed to an in-house supplemental statistical analyses of an early phase 1/2 study; authored IND annual reports, orphan drug annual reports, and IND amendment cover letters; authored abstracts and manuscripts based on phase 1/2 and phase 2 clinical studies; authored clinical study slide presentations for multiple venues; contributed greatly to other written documents including multiple documents in support of the clinical and regulatory processes.• Ensured documents were prepared with the highest quality in regard to scientific content, regulatory requirements, and internal guidelines. • Under direction of Director of Clinical Operations, managed CRO activities and performed audits of clinical study trial master files in preparation of FDA audit for clinical trials of monoclonal antibody in neonatal sepsis.

• Managed multiple national/international oncology studies (in leukemia, breast cancer, colorectal cancer, non-small cell lung cancer, head & neck cancer, and testicular cancer).• Developed, maintained, and tracked detailed clinical study timelines, deliverables, milestones, and budgets; proactively alerted Project Leader to potential timeline and budget issues; managed cooperation of inter-functional groups; identified and provided resolutions for operational problems; developed contingency plans; provided key data to Project Leader and upper management; contributed to development and maintenance of standard templates; conducted project team meetings; managed all aspects of CRO performance; managed other vendors such as central laboratory and central image management provider; interacted with investigators and site staff regarding site recruitment, subject recruitment, site study conduct, resolutions of protocol questions, and site informed consent form development; negotiated and approved vendor proposals; developed, reviewed, and approved site study contract in collaboration with legal department; reviewed and approved vendor and site invoices and payments. • Served as an author of phase 3 oncology clinical study protocols, protocol amendments, and template informed consent forms; assisted in development of statistical analysis plans (SAP); actively contributed to development of Case Report Forms (CRFs) and CRF completion instructions, subject diaries, monitoring guidelines, study coordinator guidelines, data validation specifications, study procedure manuals, and interactive voice response (IVR) system specifications; managed and reviewed study data listings, tables, and figures; performed medical reviews of study data; supervised QA/QC of clinical data; reviewed sNDA study reports.

• Managed multiple clinical studies in oncology and infectious diseases; managed clinical research associates (CRAs); interacted with sponsors; completed Project Management Academy Training.• Trained CRAs on protocols, CRF source data verifications, and site management; reviewed site monitoring reports; performed medical review of study data.

• Managed clinical studies for community acquired pneumonia and nosocomial pneumonia; identified and evaluated potential investigators; performed medical/scientific data review including evaluability assessments for efficacy; contributed to preparation of protocol amendment.

• Managed study sites for a clinical study in gastroesophageal reflux disease; performed interim monitoring visits; performed thorough medical review of medical records and case report form source data verifications; managed study sites’ IRB submissions and approvals.

• Managed multiple study sites and multiple phase 3 clinical studies simultaneously; performed thorough medical review of study subjects’ medical records and case report form source data verifications for clinical studies in complex therapeutic areas such as subarachnoid hemorrhage, multiple sclerosis, stroke, Parkinson’s disease, schizophrenia, and myelodysplastic syndrome; performed pre-study visits, interim monitoring visits, and closeout visits; managed study sites’ IRB submissions and approvals; completed comprehensive training of ICH GCPs.

Edmonton, Ab, Ca

• Conducted a phase 3, randomized, double-blind, multi-center acute stroke study as study coordinator.• Conducted a study of global brain ischemic damage for correlations of clinical outcome, MRI spectroscopy measurements of a specific amino acid in neurons, and neuronal volume measurements.

Doctor Of Medicine - Md, Medicine

Doctor Of Medicine - Md, Medicine

M.S., Pathology/Experimental Pathology