Shulin Wang

Leading clinical development program in oncology, metabolic diseases, anti-inflammatory diseases, gastroenterology, and CNS with microbiome products. Play a key role in communication with regulatory agency in US and China on IND filing with investigational microbiome product. Oversee donor program to ensure the donor selection, maintenance, and quality control process meeting the national and international standards. Innovatively designed donor ranking program to guide FMT (fecal microbiome transplantation) clinical practice. Provide medical, clinical, and scientific advice to drug development of LBP (live biopharmaceutics product). Build relationship with KOLs in the field.

Lead clinical development program for a leading LBP biotech company in China. Built and trained a clinical team to managing clinical trials for sponsored trials and investigator initiated trials. Authored clinical development plan and guided strategic planning medically and clinically for microbiome products. Authored and reviewed full range of clinical documents for all trials conducted by company. Played a key role on FDA IND filing of microbiome products, and participated communication with China regulatory agency on microbiome product. Established relationship with KOLs to build a network of drug development of microbiome product. Supervised donor selection process and donor maintenance program. Performed gut microbiome profiling of the donor and categorized donors via bioinformatic analysis. Provide medical guidance and advice to the team that promotes and applies new technology to clinical practice. Collaborated with KOLs for clinical research in treating diseases with microbiome products.

My responsibility includes leading protocol development from drafting the protocol to protocol approval; leading protocol specific training at the start up phase of the study; authoring key documents at the study startup, such as ICF and monitoring plan. perform medical monitoring during the study; supporting the study with medical, scientific, and clinical input.

Managing phase I-III clinical studies of cross multiple therapeutic areas such as neurology, psychiatry, and oncology. Support business development department.

• Involved in early clinical development including clinical development planning and clinical development plan execution; designing studies from first in human to proof of concept. • Lead clinical program from strategic planning, study design, protocol execution, to data presentation; • Managed phase I/II studies from drafting protocol to final study report (both scientific and clinical leadership for clinical trials and detailed operation of executing study protocols, project management and clinical study management) • Managed vendors for outsourced projects; perform vendor qualification visit when necessary. • Authored and reviewed SOPs for clinical research related processes.

A core member of the management team, providing input in strategic directions, guarding corporate intellectual assets and values, expanding business development, and ensuring achievement of organizational goals and objectives. Building a clinical team that has the ability to execute all phases of clinical study, outcome research and population based public health research with operational excellency.

successfully initiated and managed global clinical trials in Phases 2 through 4; especially experienced with managing large post-marketing trials and working with research-naïve sites. Managed investigator-sponsored trials (Phases 1 through 4) with on-time start, on budget execution, and well published at close of the study.

Medical affairs support such as clinical research concept review, research grant review, advisory board meeting plan, preparation and participation, sale force training, and investigator initiated clinical research management.

Worked at Assay Development Group, Immunology and CV/Met department during this period of time. Supported marketed drug by discovery of mechanism of adverse reaction.

Worked in Molecular Biology Department under Dr. Ihor Lemishka with stem cell research and under Albert for gene knockout research.

Completed residency training and practiced as a Radiologist in this best hospital in China.

Study in Biology