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CHING H. (ROBERT) CHANG 609-448-7845 cc5d4a32@westpost.

net Summary Twenty plus years of experience at a Fortune 100 pharmaceutical company. Has pro ven abilities to design and execute study activities, hire and mentor direct rep orts and coordinate project activities through working with internal team member s as well as external experts. Can effectively convey key pre-clinical pharmacol ogy and toxicology study results to various task teams (drug discovery to NDA fi ling), upper management and for external publications. Had served as an ad hoc r eviewer for FASEB Journal. Core Competencies a Knowledge of GCP, FDA/ICH regulations and guidelines, and regulatory complianc e for INDs, NDAs and ANDAs. a Had designed a Phase III Clinical Trial Protocol and Synopsis in a team settin g; involved in a mock clinical trial with emphasis on the conduct of patient Inf ormed Consent and Internal Review Board functions. a Had experience in the design of Case Report Form and in validating statistical data table against a summarized data table from Case Report Forms. a Can design, execute, and convey results of non-clinical efficacy and toxicity assessment studies to support regulatory filings. a Can determine non-clinical biomarkers by gene, protein and lipid profiling, an d by using bio-chemistry, histology, telemetry, and imaging tools. a Have experience in evaluating technical capabilities of selected CROs and cond ucting studies through off-site study directors. Degrees and Certifications Certificate, Drug Development and Clinical Research, Mercer County Community Col lege, West Windsor, NJ. September 16, 2009 to June 23, 2010. Certificate, Overview and Management of 21-CFR-11 Compliance, EDM Systems, and E lectronic Submission to FDA of Clinical Trials, Raritan Valley Community College , May 2 and 9, 2009. Postdoctoral Fellow; Biochemical Endocrinology, Department of Cell Biology, Baylor College of Medicine, Houston, TX Ph.D., Nutrition; Minors: Endocrinology/Physiology, Clemson University, Clemson, SC M.S., Animal Genetics; Minor: Statistics, Kansas State University, Manhattan, KS Diploma, Major: Animal Science; Minor: Chemistry, National Ping-Tung Institute o f Agriculture, Ping-Tung, Taiwan Experience Merck Research Laboratories, Rahway, NJ (Retired as Senior Research Fellow; 20+ years) a Established murine atherosclerosis models (apoE null, LDLR null, and [CETP]TgLDLR null mice) for the evaluation of multiple therapeutic targets. Earned a Mer ck Award in 2008 for the conduct and write-up of pharmacological studies that we re included as key basic data to support the product concept and safety of larop iprant/niacin (CordaptiveTM, TredaptiveTM, and associated Trade names) for NDA f ilings to FDA and marketing application filing to EU Regulatory Agencies, respec tively. a Collaborated with in-house basic biologists and off-site Peptide Center of Exc ellence staff to perform target validation and proof of concept studies of Apo A 1 mimetic peptides in a mouse model of atherosclerosis that resulted in the co-a uthorship of one published paper and one patent application. a Demonstrated the feasibility of utilizing MRI and 3D-HFUS (high frequency ultr asound) to evaluate novel anti-atherosclerotic compounds that reduced plaque vol ume in apoE null mice. MRI measurements were confirmed by the aortic cholesterol content, aortic en face stained neutral lipid area, and aortic root histology. a Demonstrated efficacy (improved insulin sensitivity) and reduced cardiovascula r side effects (cardiac hypertrophy and plasma volume expansion) of specific PPA

R receptor modulators in SD rats, Zucker fa/fa rats, and db/db mice. Received MR L Key R&D Award in 2007 and the work was a Ching H. (Robert) Chang Page 2 609-448-7845 published in Eur J Pharm 2008, 584:192. a Performed critical studies to determine the reason why MK-0767, a PPAR alpha/g amma dual agonist, caused hemangiosarcoma in subcutaneous white adipose tissue i n a 2-year carcinogenicity study in CD-1 mice. Based on our study results, we hy pothesized that full activation of PPARgamma may be necessary but not sufficient for generation of the proliferative vascular lesions. A second ahita could be r equired to induce overt neoplastic lesions in fat-associated vascular cells. a Investigated the effect of a non-peptidyl GH secretagogue L-163255 in Mongrel dogs chronically treated with an anti-inflammatory steroid dexamethasone - a model for Cu shingas Syndrome. a Established flea-bite dermatitis model in beagles for the evaluation of potent ial drugs for the treatment of flea allergy dermatitis in dogs and cats. Predni sone was the only compound found to be effective in reducing flea allergen-induc ed immediate and delayed skin responses. Eastman Chemicals Division, Kingsport, TN. (Title at departure- Senior Research Bioscientist; 4+ years) a Responsible for the biological evaluation of growth hormone releasing peptides in collaboration with Dr. Cy Bowers of Tulane University and was a co-inventors of four published patents. a Evaluated, established and monitored several external research projects with m ajor universities; evaluated and monitored research projects under joint venture agreements with Triton Technology, Inc. and Molecular Genetics, Inc using compl ementary DNA technology. a Conducted ex vivo and in vivo studies to determine the effects of IsoPlusTM co mponent isoacids on milk production and on metabolic status of lactating dairy c ows. Baylor College of Medicine, Houston, TX. (Title at departure- Research Instructo r; 1.5 years). a Performed physicochemical characterization of the androgen receptors in normal rat prostate and hyperplasic human prostate including photoaffinity labeling of the androgen receptors. Professional Development and Training a Earned a Certificate in Drug Development and Clinical Research (Foundations in Clinical Research and Protocols, Clinical Data Management, and Regulatory Affai rs and Legal Issues), Mercer County Community College, September 16, 2009 to Jun e 23, 2010 at West Windsor, NJ. a Attended the Symposium on Regulatory Affairs, May 22, 2010 at Piscataway, NJ. a Attended the Biologics Drug Development Conference, March 6, 2010 at Fort Wash ington, PA a Attended the Workshop on Non-Clinical Drug Safety Evaluation, December 12, 200 9 at Pincecrest Country Club, Lansdale, PA. a Earned a Certificate in Overview and Management of 21-CFR-11 Compliance, EDM S ystems, and Electronic Submission to FDA of Clinical Trials, Raritan Valley Comm unity College, May 2 and 9, 2009. a Attended the Workshop on US FDA Generic Drug Regulations and Approval Process, March 28, 2009 at Gaithersburg, MD. a Attended Conferences on Clinical Trials and Innovative Drug Development, March 14, 2009 at Princeton, NJ and March 21, 2009 at King of Prussia, PA. a Attended a Pharmacokinetics/Pharmacodynamics Training Course, 1989. University of California at San Francisco, CA.

Computer skillsMicrosoft Word Processing, Excel Spreadsheet/graph, Prism Graph, Adobe PD F file, Adobe Photoshop, PowerPoint, QuickBooks, and Microsoft Access Linkedin Profile and References