A successful GSK SWTICH program candidate is looking for Clinical Investigator Leader role for the next-step opportunity. Medically trained with a broad scientific background, including Human biology and Pathophysiology, making me adaptable to any therapeutic area/indication. Experienced and skilled in design, execution, result analysis, interpretation and reporting of clinical studies.
Extensive knowledge in IIIb-IV drug development process, regulatory requirements, good clinical practices and human pathophysiology & diseases (e.g., inflammatory/immune-mediated, metabolic and ocular diseases).
Experienced in clinical study design, protocol development and execution.
Participated in oversight study performance. Strong leadership and excellent communication/presentation skills.
Successfully established and led a new functional group of 25 people, responsible for clinical immunogenicity assessments of more than 25 biopharm projects; Served as a Clinical matrix team member for Clinical Immunology, strategy decision maker/leader and educator in the area of clinical immunogenicity assessment, attended meetings with regulatory agencies;
Invited speaker in the immunogenicity-related topics worldwide.
Expert in analyzing scientific medical data including interpretation and summarizing for regulatory submissions and publications (5 INDs, 3 BLAs and over 15 publications).
Proven track-record in conducting scientific advisory board, primary GSK contact for identifying and networking with external scientific experts.
Act as a local expert for scientific engagement initiative Experienced in outsourcing study related tasks to contract research organization including selecting, contracting, budgeting and oversight deliverables.
Strong learning agility and selected into the very competitive SWTICH program (50 out of ~500 applicants).
Clinical Scientist January 2014 to CurrentGSK － King of Prussia, PA
Clinical Development Late Stage, Metabolic Pathway and Cardiovascular (MPC)
As a CIL, accountable for the design and planning clinical trial; lead clinical protocol development process; provide medical/scientific aspects and expertise to clinical trial design, Participations in review of full study protocol and regulatory submission documents
Independently led and oversight a device comparability study (design and execution) and presented the study results at American Diabetes Association conference.
Develop effective working relationship with key health providers (HCPs) and investigators to optimize scientific quality/innovation of clinical study design and execution; make sure all scientific engagement activities and events are compliant with the Corporate Integrity Agreement (CIA) and other Scientific engagement GSK policies
Assisted in developing clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties
Sr. Manager October 2004 to December 2013GSK － King of Prussia, PA
Increased responsibilities on the establishment and management of Clinical Immunology at Biopharm R&D.
Strategy decision maker/leader and educator in the area of clinical immunogenicity assessment internally and externally.
Invited speaker domestically and internationally for the immunogenicity-related topics Acted as a recognized leader/expert in the area of immunogenicity internally and externally.
Provide scientific advice to all the biotherapeutic drug development teams.
Be involved in drafting and reviewing clinical study protocols, study reference manuals, clinical study reports and regulatory submissions as well as addressing global regulatory questions (e.g.
PMDA, SFDA, EMA and FDA), and attending meetings with US FDA.
Strategically led laboratory staff and was fully responsible for clinical biomarker and immunogenicity assay development/validation to support clinical trials in a regulated environment (GcLP) accordingly in a timely and quality manner.
Communicated with and monitor external vendors for assay development/validation and sample testing.
Participate in internal and external inspections and audits, including preparation and execution of corrective actions for observations noted Consistently was involved in the in-licensing and due-dillencies for identifying CROs and potential new drug candidates Had been a great mentor and coach of people development Domestic and international speaker for immunogenicity-related topics Department of pharmaceutical development.
Scientist II May 2002 to October 2004Cardinal Health CRO － RTP, NC
Designed, conducted and documented experiments under GLP/GMP compliance including authoring technical protocols and SOP's for method development/validation, performing data analysis and interpretation, and writing study reports.
Developed, qualified and validated several GLP or non-CLP/CMP cell based assays for biological potency assessment, IGF-1 and Insulin induced proliferation assays, a fluorescence based antibody dependent cellular cytotoxicity (ADCC) assay.
Oversee projects and supervise technicians.
Communicated study results and issues with vendors/partners.
Academic Research on inflammatory diseases at Tulane University Medical Center and Duke Medical School (details upon request).
Identification and characterization of matrix interference in an ADA assay" at 13th IIR Annual Immunogenicity for Biotherapeutics. Baltimore, Maryland; 2012, April 17-19.
Current Practices in Clinical Immunogenicity Assessment" at International Antibody Conference. 2011, March 18-21, Beijing
Current Practices in Clinical Immunogenicity Assessment" at Drug Discovery Development of Innovation therapeutic. 2009, Jun 1-3, Tokyo, Japan Round table coordinator PEGS-Immunogenicity, 2007 May 17-21 2nd Annual Biologics
Clinical and Regulatory Conference, Feb 22-23, Baltimore, 2010 Next Generation Protein Therapeutics Summit, Jun 21-23, San Francisco, 2010
Immunogenicity of Therapeutic Proteins, (DIA), Bethesda, Maryland, 2008 IIR Immunogenicity, DC, May 19-21, 2008 Poster
Presentation A Randomized Crossover Comparison of Preference and Usability between 2 Once-Weekly Glucagon-Like Peptide-1 Receptor Agonist Pen Injectors (Albiglutide and Exenatide Extended-Release) in Adults with Type 2 Diabetes Mellitus. 75th ADA. Boston, 2015
Chen KC, Page JG, Schwartz A, Lee TN, DeWall SL, Sikkema D and Wang C. False-positive immunogenicity responses are caused by CD20+ cell membrane fragments in an anti-ofatumumab antibody bridging assay. J. Immuno Method. 2013, 394 (1-2):22-31
Liao K, Sikkema D, Wang C, Lee TL. Development of an enzymatic assay for the detection of neutralizing antibodies against therapeutic angiotensin-converting enzyme 2 (ACE2). J Immuno Method. 2013, 389:52-60.
Liao K, Sikkema D, Chen KC, DeWall SL, Wang C and Lee TL. Development and validation of a cell-based SEAP reporter assay for the detection of neutralizing antibodies against an anti-IL-13 therapeutic antibody. J. Immuno Method. 2012; 375:258-263
Timothy G. Hammond TG, Saban, Bost KL, Harris HW, Kaysen J, Fatime H, Goda O, Wang XC, Lewis FC, Bjorling, DE, Saban MR, and Zeidel ML. Substance P dependence of endosomal fusion during bladder inflammation. Am. J. Physiol. 278:F440-F451, 2000.
Wang XC, Saban R., Kaysen JH, Saban M., Hammond TG. Nuclear factor kappaB mediates lipopolysaccharide-induced inflammation in urinary bladder. J. Urol. 1999.163:993-998.
Wang XC, Jaffe GJ, Jobin C, Allen JB. Suppression of NF-kappaB-dependent proinflammatory cytokines in cultured human retinal epithelial cells (hRPE) by a proteasome inhibitor. Invest. Ophthalmology. Vis. Sci. 1999;40: 477-486
Jaffe GJ, CS Yang, Wang XC, Cousins SW, Gallemore RP, Ashton P. Intravitreal sustained-release cyclosporine A in the treatment of experimental uveitis. Ophthalmology. 1998;105: 46-56.
Ohta K, Norose K, Wang XC, Ito S, Yoshimura N. Abnormal naive and memory T lymphocyte subsets in the peripheral blood of patients with uveitis. Curr. Eye Res. 1997:16 (7): 650-655.
Ohta K, Norose K, Wang XC, Ito S, Yano A, Segawa K. Apotosis-related fas antigen on memory T cells in aqueous humor of uveitis patients. Curr. Eye Res. 1996:15(3): 299-306.
Wang XC, Norose K, Kiyosawa K, Segawa K. Ocular findings in a patient with Prader-Willi-willi syndrome. Jpn. J. Ophthalmol. 1995;39: 284-289.
Wang XC, Norose K, Yano K, Ohta K, Segawa K. Two-color flow cytometric analysis of activated T lymphocytes in aqueous humor of patients with endogenous and exogenous uveitis. Curr. Eye Res. 1995;14: 425-433.
Ohta K, Norose K, Wang XC, Nohara M, Segawa K, Tokushima T, Yoneyama J, Nakayama J. Malignant choroidal melanoma associated with nevus of Ota. Jpn. J. Clin. Ophthalmol. 1994; 48(6): 1285-1290.
Norose K, Yano A, Wang XC, Tokushima T, Umihira J, Seki A, Nohara M, Segawa K. Domininace of activated T cells and interlukin-6 in aqeous humor in Vogt-Koyanagi-Harada disease. Invest. Ophthalmol. Vis. Sci. 1994; 35:33-39.
Aoyagi M, Norose K, Ohta K, Wang XC, Nagata S, Segawa K. HLA-B 27 positive uveitis with ankylosing spondylitis. Folia. Ophthalmol. Jpn. 1994; 45:770-774.
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Companies Worked For:
Cardinal Health CRO
Hebei Medical University
Job Titles Held:
Ph.D : Immunology M.D.
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