Chi-Wei Lu

Phone: 617-319-6763Email: cw_lu@hotmail.com

1 Cranston Rd,Kendall Park NJ08824

Summary An effective research manager leading multiple projects in a clinical academic

department Managing a diverse team of clinical personnel for executing clinical/translational

research Key contact person between academic administrative units and CRO, clinical trial

sponsors and external regulatory agency Possesses robust experiences in research, data analysis, presentation and

communication A Harvard-MIT-Rutgers trained basic biomedical scientist with a strong background in

oncology/hematopoiesis/virology/stem cell biology.

Director of Research (Jan. 2015 – present) andDirector of Embryology Cryopreservation Laboratory (April 2011-present) Women’s Health Institute and Embryo cryopreservation laboratoryDepartment of Obstetrics, Gynecology and Reproductive Sciences, Rutgers Robert Wood Johnson Medical School

Job responsibility:

Coordinating center function: site assessment visits, site budget review/negotiation, protocol/ICF review, site selection.

Research design and protocol development: Serentrix, Common sense, Edgewell.

Clinical trial management: Bayer 15788; TherapeuticsMD TVX-014; Bayer 16803; Edgewell Edg-1501 and Edg-1502; GSK EVA16301; Astellas 178-MA-1005; NIH10280607; GSK201580; Elagolix M12-815 and M12-817; Estetra SPRL MIT-Es0001-C302; Common Sense F-7-32.4-3- Site initiation: complete site feasibility inquiries, CDA/CTA execution; IND/IDE documentation review; IB/1572 and review; contract/budget negotiation; write protocol synopsis and research protocol; write informed consent, review PI eligibility, IRB preparation and submission; site feasibility and initiation visits. - Activation of trials: source document preparation, trial-related trainings (PHS, GCP, HIPAA), writing protocol/ICF amendments and updates. - Study Implementation: personnel (PI, CRC and clerks) management, data entry and validation, eCRF entry, EDC validation, IVRS/IWRS, iMedidata, Trialmax), invoicing, managing SAE (severe adverse event) and safety updates, patient recruitment, medication storage/dispense; laboratory processing, shipment and report review; coordinate site monitoring visits; IRB continuing review submission.

- Trial completion: prepare close-out reports, coordinate site close-out visits, drug accountability, response to data query, managing early termination, maintenance of site regulatory files.- Financial oversight: budget preparation, expenditure management, invoicing, quarterly billing report and year end analysis/income projection. - Serve as the point of contact between CRO/sponsor and the study site.

Research project management: Rutgers Chancellor’s seed grant ( Bachmann), Rutgers GAIA grant (Bachmann), New Jersey Health Foundation (Bachmann, Phillips and Lu); Pfizer IGLA initiative (Hutchinson-Colas); Rutgers Community collaborative grant (Hutchinson-Colas); Rutgers Benefunder Competition ( Bachmann, Rosen, Molyer); Feldstein Medical Foundation (Segal, Duzyj).

- Research project design and grant writing - Literature review and data analysis.- Reporting: preparation of posters, manuscripts and abstracts.- Attending scientific conferences.

Personnel management (7 MDs, 4 Ph.D.s, 4 study coordinators and 10 research intern students)- Allocate efforts for research coordinators, clerk and volunteers in different

projects;- Conduct weekly research meetings for progress report and

discussing/resolving emerging issues - Identify and allocate sub-investigators for research studies; - Cross-team coordination for university approvals between different offices.- Managing communication between IRB, sponsor, CRO and study

personnel. - Prepare year end-reports for division activity and achievements.- Goal setting for team members and advising on career paths.- Performance evaluation and recommendation for improvements.- Mentoring and advising on student term papers and reports.

Patient contact, billing, billing dispute management and service referral:

embryo cryopreservation laboratory.

Achievement highlight: Works in a matrix environment to enable translational and clinical research. Significantly improving research quality and numbers: increasing number of active clinical trials (from 2 to 10), research funding submissions (from 0 to 11), and all IRB protocol management (20) within one year. Established an organizational structure for the overall operation of the research team for the Women’s Health Institute.

Clinical Science Consultant, (Jan 2016- present)OMI innovation consulting, Princeton, NJ

Job responsibility: Research protocol design, budget analysis, time/cost estimation, pre-study site assessment, site selection and star-up.

Resident Scientist and Assistant Professor (2011-present)Child Health Institute of New JerseyDepartment of Obstetrics, Gynecology and Reproductive Sciences

Job responsibility: Managing a human induced pluripotent stem cell (iPSC) research laboratory : Design research projects, grant application, executing research activities, molecular/cellular biology experiments, grant reporting, expenditure management, manuscript preparation, teaching, lecture preparation, student advising, regulatory: biosafety, human subject research, animal research, chemical safety.

Skills: research proposal writing and presentation, manuscript writing, data analysis (Microsoft office), molecular analysis (real-time PCR, cDNA array/RNA sequencing analysis, Mass Spec proteomics analysis, ELISA assays, protein/DNA gels), cellular analysis (flow cytometry, immunohistochemistry, immunofluorescence, single cell gene expression analysis (fluidium), tissue analysis (chamber slide cell culture, laser-capture microscopy analysis, frozen section microtom, parafilm-embedded tissue analysis), tumor growth assay, tumor endpoint, leukemia mouse models, cell biology assays (human/mouse iPSC and ESC stem cell culture, CRISPR/Cas9 genome editing, lentiviral transgene/shRNA expression, reprogramming, differentiation to blood and placental cells, functional analysis),

Achievement highlight: obtained research funding from federal (NIH), state, and private sources, established and managed stem cell core facility laboratory; selected presentations in national conferences ( Ellison Medical Foundation on Biology of Aging; Keystone symposium on Reproduction; Best poster ISSCR 2006); built extensive collaboration between research teams.

Education and Training Rutgers University, Piscataway, New Jersey Ph.D. 1996-2002

Biochemistry/Molecular Virology, ref: Monica Roth National Taiwan University, Taipei, Taiwan B.S. 1990-1994

Professional Experience Assistant Professor, Robert Wood Johnson Medical School 2008-present Director, Human Embryonic Stem Cell Laboratory,

Robert Wood Johnson Medical School 2008-2011 Assistant Scientist, McKnight Brain Institute, University of Florida 2007-2008

Neural stem cell/induced pluripotent stem cell, ref: Dennis Steindler Research Fellow, Harvard Medical School, Boston, Massachusetts 2003-2007

Oncogenesis, stem cell biologu, ref: George Daley Research Fellow, Whitehead Institute for Biomedical Research 2002-2003

Hematopoiesis, leukemogenesis, ref: George Daley Research Assistant, Academia Sinica, Taipei, Taiwan 1994-1996

Awards and HonorsEllison Medical Foundation New Scholar Award, 2009Living Free for Research Foundation Young Investigator Award, 2008Keystone Symposia Educational Fund Scholarship, 2007 Best Poster Award, International Society for Stem Cell Research Meeting 2006Georgeanna Seegar Jones Young Investigator Award, 2006

Publications •Woodward MJ, Lu CW, Levandowski R, Kostis J and Bachmann G. The exercise prescription for enhancing overall health of midlife and older women. (2015) Maturitas 82(1) 65-71, PMID:

25963099•Lu CW, Seita Y, Treff N and Roth MJ Ethnic disparity in stem cell availability and research. Book Chapter in Ethnic Differences in Fertility and Assisted Reproduction, in press 2013 •Lan Yi, Chi-Wei Lu, Wen-Wei Hu and Arnold Levin, Multiple roles of p53 related pathways in somatic cell reprogramming and stem cell differentiation. (2012) Cancer Research 72(21) 5625-45 PMID: 22964580•Wu DT, Seita Y, Zhang X, Lu CW and Roth MJ Antibody-directed lentiviral gene transduction for live-cell monitoring and selection of human iPS and hES cells (2012). •Yasunari Seita, Jing Su, Nathan Treff and Chi-Wei Lu, CDX2 marks trophoblast progenitor during human pluripotent stem cell differentiation. (2012) submitted •Chen LY, Yabuuchi A, Eminli S, Takeuchi A, Lu CW, Hochelinger K and Daley GO (2009) Cross-regulation of Nanog and Cdx2. Cell Research, 19(9), 1052-61• Viswanathan SR, Mermel CH, Lu J, Lu CW, Golub TR and Daley GQ (2009) MicroRNA expression during trophectoderm specification. PLoS One, 4(7) e6143• Chi-Wei Lu, Lingyi Chen, Akiko Yabuuchi, Srinivas Viswanathan, Kitai Kim and George Q. Daley (2008) Ras-Mitogen Activated Protein Kinase Signaling Promotes Trophectoderm Lineage Establishment. Nature Genetics Jul; 40(7)921-6• Kyba M, Perlingeiro RC, Hoover RR, Lu CW, Pierce J, Daley GQ. (2003) Enhanced hematopoietic differentiation embryonic stem cells conditionally expressing Stat5. PNAS 100 Suppl. 1 11904-11910• Lu CW and Roth MJ (2003) The Role of Q252R in activating membrane fusion in the murine leukemia virus surface envelope protein. J.Virol. 2003, Oct; 77(20): 10841-9.• Lu CW and Roth MJ (2003) Functional Interaction between the N- and C-terminal domains of murine leukemia virus surface envelope protein. Virology 310(1):130-40• Lu CW, O’Reilly and Roth MJ (2003) G100R mutation within 4070A murine leukemia virus Env increases virus receptor binding, kinetics of entry, and viral transduction efficiency. J Virol. 77(1):739-43.• Lu CW and Roth MJ (2001) Functional characterization of the N termini of murine leukemia virus envelope proteins. J Virol. (9):4357-66.• Lin JS, Lu CW, Huang CJ, Wu PF, Robinson D, Kung HJ, Chi CW, Wu CW, Yang WK, Whang-Peng JJ, Lin WC. (1998) Protein-tyrosine kinase and protein-serine/threonine kinase expression in human gastric cancer cell lines. J Biomed Sci. 5(2):101-10.

Professional AffiliationsInternational Society for Stem Cell Research (ISSCR)American Association for Cancer Research (AACR)

Invited Presentations:National Taiwan University Hospital, Department of Obstetrics and Gynecology, June 2014New Jersey Medical School Department of Biochemistry April 2013New Jersey Stem Cell Symposium September 2012Doctor for a day program for high school students, UMDNJ 2012Cancer Institute of New Jersey Stem Cell Colloquium 2012 Division of Biological Science, Institute for Advanced Studies, 2010New Jersey Stem Cell Symposium September 2010Keystone Symposium on Reproduction: Advances and Challenges, New Mexico, 2007 Center for Regenerative Medicine, University of Connecticut, Oct 2006 Department of Biochemistry and Molecular Pharmacology, Harvard Medical School, MA, June 2006Center for Genomic Research, Academia Sinica, Taipei, Taiwan, June, 2006Division of Medical Research, Chang-Gang memorial Hospital, Kaohsiung, Taiwan 2006The Activated Egg Symposium, Bedford Research Foundation, Newton, MA, Oct 2005Harvard Stem Cell Institute Meetings; Boston, MA Sep. 2005Sun-Tien Pharmaceuticals; Taipei, Taiwan May 2004

Advising and Educational Activities: Lectures: Molecular Basis of Pharmacology (UMDNJ) (2009-present), Advancement in

Regenerative Medicine ( Capstone Master Program, 2013-present), Genetically Engineered Drug Delivery Systems (Rutgers April 2013), Stem cells in Bioengineering (Rutgers) (2009-10), Molecular and Cellular Physiology (2010), Rutgers Stem Cell Training Course (2009-2010).

Medical fellow research advising: Revital Foro (2012-2013), Monica Tschirhart (2012-2013),

Caroline Lynch (2013-2014), Vivek Gupta ( 2014) Medical Student Research Advising: Danielle Wald (Class 2018); Catherine Manuelli ( Class

2016) Postdoctoral fellow mentoring: Yasunari Seita (2009-2014), Percy Luk Yeung (2011-2015),

Bradley Phelan (2014), Jian-Ling Zhuan (2011). Master students: Danielle Wald, Jonathan Harmon (2012-2013), Janice Hejirika (2014-2015);

Grace Atalia (2015-2016) Thesis Committee: Peter Mazari (2010), Dai-Tze Wu (2014), Biochemistry, Yi Liao

(2013),Department of Pharmacology; Smithri Prem (2016), Department of Neuroscience. Proposition exam committee: Jonathan Brezezinski (2011), Department of Biochemistry Undergraduate Students: RiSE Program: Amber Fairley (2012); Emma Hsu (2013-15) Work Study Program: Tesia McKinze (2009), Cavan Bailey (2010), Alex Persona (2015).

Service: Graduate School of Biomedical Sciences graduate student recruitment committee. (2013-

present) Journal Review : Stem Cell, Cell Death and Diseases, Human Reproduction, Grant Review : Wellcome Trust

Active Research Support: NIH R21 HD081682-01A1 Alternative cleavage and polyadenylation during human trophoblast

development. PI: Tian Bin Role: co-PI 7/31/2015-6/30/2017 NIH R21 Transcription control of human NK cell function. PI Derek San’t Angelo Role: co-PI

4/01/2015-6/30/2017. New Jersey Center for Excellence in Autism Research at Robert Wood Johnson Medical

School. Role: co-PI 12/20/2012-12/30 2015

Completed Research Support: New Jersey Commission on Science and Technology Stem Cell Initiative: Bioengineering

Human ES Stem Cells, Program project P.I: Monica Roth: Project 2 “Bioengineering hES cells into oligodendrocytes”, role: P.I. (effective 10/2008) Total cost (project 2), $137,000, 07/01/07-06/30/10.

New Jersey Health Foundation: Transcription control for Human Natural Killer Cell Function (2014-2015), role : Co-PI, $25,000.

Ellison Medical Foundation New Scholar Award: oncognetic transformation in stem cells : cellular model of aging, role: P.I., $400,000, 07/01/2009-06/30/2013

NIEHS Center for Environmental Exposure and Disease Pilot application Award, role: P.I. $20,000)7/01/2013-06/30/2014

Community, Outreach and Volunteering: Women’s Health Institute Facebook page editor Host of the Robert Wood Johnson Medical School Women’s Health Lecture Series

2015 (6 lectures) and Rutgers Day outreach program. Secretary, American Women In Science central NJ chapter Steering committee, Taiwanese American Association of New Jersey