Gui S.

1. Medical Device Regulatory Approval in China I lead a team to prepare high-quality regulatory clinical evaluation reports (CERs) contributing to and speeding up the successful regulatory approvals of more than 100 medical devices in diverse disease areas in China, such as orthopedics implants, cardiac surgery devices (cardiopulmonary bypass devices, ECMO devices, and valvuloplasty rings/bands), transcatheter aortic valve replacement devices, neurovascular devices, peripheral vascular devices, and orthopedic robotic and navigation system. All the CERs received ZERO or minimal number of deficiency questions from reviewers of China regulatory authority- National Medical Products Administration. 2. EU MDR CE mark I develop cost-effective clinical evaluation strategies and lead a team to prepare high-quality EU MDR clinical documents contributing to the successful MDR CE marking of more than 8 Orthopedic devices, including one Class III implant, six Class IIb implants, one Class IIa devices, and several Class I instruments. 3. Peer Reviewed Scientific Journal Publications 19 first- or second- or corresponding authored articles published in peer reviewed clinical/medical journals with a high impact. 4. Clinical Experience Papers for Product Adoption and Market Penetration 20 Clinical Experience Papers on customers’ experiences in and opinions on using products.

As a Senior Manager of Medical Writing/Clinical Evaluation/Evidence Strategy in a global medical device company, I manage a 10-member team to provide clinical/medical support for medical devices’ whole product lifecycle, including developing regulatory clinical evaluation strategy, writing regulatory clinical documents (clinical evaluation plan/report, post-market clinical follow-up plan/report, and summary of safety and clinical performance), developing clinical evidence strategy for post-approval devices, and writing clinical experience papers for post-approval devices. Before becoming a people manager, I was a senior (3 years) and then principal (3 years) medical writer in medical device industry responsible for writing clinical study documents (CIP, CSR), regulatory clinical documents (CER, CEP, PMCF plan/Report, and SSCP), scientific manuscripts, and commercial medical/clinical documents (e.g. Clinical Experience Papers). Prior to my medical device industry jobs, I had been a research scientist in University of Wisconsin Madison for more than 10 years. The highlights of my experiences are: 1) high-quality regulatory clinical evaluation reports contributing to the successful regulatory approvals of medical devices in diverse disease areas, such as orthopedics implants, cardiac surgery devices (cardiopulmonary bypass devices, valvuloplasty rings/bands), transcatheter aortic valve replacement devices, neurovascular devices, peripheral vascular devices, and orthopedic robotic and navigation system in China. 2) high-quality EU MDR clinical documents contributing to the successful CE marking of Orthopedic implants and instruments. 3) 15 first- or second-authored articles published in peer reviewed clinical/medical journals with a high impact.

As a principal medical writer in medical device industry, I was responsible for writing clinical study documents (CIP, CSR), regulatory clinical documents (CER, CEP, PMCF plan/Report, and SSCP), scientific manuscripts, and commercial medical/clinical documents (e.g. Clinical Experience Papers).

1) Write English and Chinese biomedical or clinical documents for global pharmaceutical companies. 2) Teach how to write biomedical or clinical research papers to Chinese medical students and healthcare professional

Write English and Chinese scientific manuscript and medical documents for global pharmaceutical and medical device companies, including Roche, Sanofi, Amgen, and Covidien.

Translate Chinese biomedical or clinical documents into English.

1) Establish primary breast cancer cells and primary fibroblasts to investigate the interaction between the tumor microenvironment and breast cancer cells 2) Created micro 3-dimensional collagen gel co-culture model to investigate the heterogeneity of stroma-carcinoma interactions in breast cancer 3) Created 3-dimensional collagen gel co-culture model to study the molecular mechanism of Syndecan-1 mediated stromal fibroblast-carcinoma interaction Publication: [1] Su G, Sung KE, Beebe DJ, and Friedl A. Functional screen of paracrine signals in breast carcinoma fibroblasts. PLoS One, 7:e46685, 2012. [2] Bauer M, Su G, Beebe DJ, and Friedl A. 3D microchannel co-culture: method and biological validation. Integrative Biology, 2: 371-8, 2010. [3] Bauer M*, Su G*, Casper C, He R, Rehrauer W, and Friedl A, Heterogeneity of gene expression in stromal fibroblasts of human breast carcinomas and normal Breast. Oncogene, 29: 1732-40, 2010. * These authors contributed equally to this work. [4] Sung KE, Su G, Pehlke C, Trier SM, Eliceiri KW, Keely PJ, Friedl A, and Beebe DJ, Control of 3-dimensional collagen matrix polymerization for reproducible Human Mammary Fibroblast cell culture in microfluidic devices. Biomaterials, 30:4833-41, 2009. [5] Su G, Blaine SA, Qiao D, and Friedl A, Membrane type 1 matrix metalloproteinase-mediated stromal syndecan-1 shedding stimulates breast carcinoma cell proliferation. Cancer Research, 68:9558-65, 2008. [6] Su G, Blaine S, Qiao D, and Friedl A, Shedding of syndecan-1 by stromal fibroblasts stimulates human breast cancer cell proliferation via FGF2 activation. Journal of Biological Chemistry, 282: 14906-15, 2007. [7] Su G, Meyer K, Nandini CD, Qiao D, Salamat S, and Friedl A, Glypican-1 is frequently overexpressed in human gliomas and enhances FGF-2 signaling in glioma cells. American Journal of Pathology, 168: 2014-2026, 2006.

Studied the function of heparin sulfate proteoglycan in glioma proliferation and invasion. Publication: Su, G., Meyer, K., Nandini C.D., Qiao, D., Salamat, S., and Friedl, A., Glypican-1 is frequently overexpressed in human gliomas and enhances FGF-2 signaling in glioma cells. Am J Pathol., 168: 2014-2026, 2006.

Established primary astrocyte and neuronal culture to investigate the contribution of Na-K-Cl cotransporter activity to brain damage caused by ischemia. Publications: 1) Kintner, D.B., Su, G., Lenart, B.J., Ballard, A.J., Meyer, J.W., NgLL, Shull, G.E. and Sun, D., Increased Tolerance to Oxygen and Glucose Deprivation in Astrocytes from Na+/H+ Exchanger Isoform 1 Null Mice. Am J Physiol Cell Physiol., 287: C12-C21, 2004. 2) Schomberg, S.L., Bauer, J., Kintner, D.B., Su, G., Flemmer, A., Forbush, B. and Sun, D., Cross talk between the GABAA receptor and the Na-K-Cl cotransporter is mediated by intracellular Cl-. J Neurophysiol., 89: 159-167, 2003. 3) Su, G., Kintner, D.B. and Sun, D., Contribution of Na+-K+-Cl- cotransporter to high [K+]o-induced swelling and EAA release in astrocytes. Am J Physiol Cell Physiol., 282: C1136-C1146, 2002. 4) Su, G., Kintner, D.B., Flagella, M., Shull, G.E. and Sun, D., Astrocytes from Na+-K+-Cl- cotransporter-null mice exhibit absence of swelling and decrease in EAA release. Am J Physiol Cell Physiol., 282: C1147-C1160, 2002. 5) Schomberg, S.L., Su, G., Haworth, R.A. and Sun, D., Stimulation of Na-K-2Cl cotransporter in neurons by activation of non-NMDA ionotropic receptor and Group-I mGluRs. J Neurophysiol. 85: 2563-2575, 2001. 6) Su, G., Haworth, R.A., Dempsey, R.J. and Sun, D., Regulation of Na+-K+-Cl- cotransporter in primary astrocytes by dibutyryl camp and high [K+]o. Am J Physiol Cell Physiol., 279: C1710-C1721, 2000.

Ph.D. thesis is "The role of Na-K-Cl cotransporter in ischemic damage in brain".