Wenzhe Li, PhD, MBA, DABCC

*** ****** **. **********, ** 19709 ■ LinkedIn-Wenzhe-li Profile

acx7ic@r.postjobfree.com ■ 215-***-****

EXECUTIVE – MEDICAL DEVICE & CLINICAL LABORATORY

Business Growth … Clinical Lab Operation… New Assay Commercialization

Collaborative builder and leader of Diagnostic Industry Organizations, with demonstrated track record of creating successful start-ups and corporate growth and innovation initiatives; defining and executing business plans for expansion; and building coalitions of stakeholders and partnerships to accelerate viable market strategy, profitable financial structures, and operational productivity enhancements. Successfully mentors leaders and develops teams to execute innovative and progressive projects and launch new businesses. Deep industry and technical expertise as Board Certified Clinical Laboratory Director with 20+ years’ experience in Medical Device industry and Clinical and Forensic Laboratories. Multilingual fluency in English, Mandarin, and Cantonese, enhancing a complimentary, current, and robust professional network. Targeted qualifications include:

Corporate Growth Business Leadership:

Focused value and mutual interest leverage in negotiation, contracting, collaboration and partnership management within and cross IVD, Healthcare, Biotech and Laboratory industries.

High impact specialization in corporate growth and operational excellence based on new technology and new application investment.

Deep expertise in leading innovation and commercialization of new technologies for IVD, POC, and Clinical Laboratories.

Resilience and flexible style when managing critical culture change and reenergizing underperforming company or sector.

Unparalleled reputation as developer/importer/exporter of key R&D and commercialization opportunities for Chinese and US companies. High profile professional network in global IVD industry and in China at national and local regions.

Replicated success of top leadership roles into non-profit organizations and professional associations.

Certified Clinical Laboratory Director:

Diplomat, American Board of Clinical Chemistry (DABCC).

Successful leader with 10+ years of experience in laboratory operation, safety, quality, and accreditation.

Deep expertise in development and validation of LDT (Laboratory Developed Tests).

Strong rapport and authority with laboratory professionals and technical /clinical experts (KOLs)

Deep IVD Industry Leadership:

CEO and key decision makers’ key advisor in product design and launch strategies.

Saved millions of dollars in resolving strategic and technical enterprise-wide issues for Technical Operations, QC, QA/QS, RA and Customer Support.

Deep expertise in FDA CFR 21 800 through 862 and post market surveillance.

Excellent results with 10+ years of experience with clinical trials and data submissions; Critical review of study protocols and hands-on experience on selections and monitoring of clinical sites.

Success track records in leveraging Six-Sigma methodology to drive alignment for charters and projects.

Key opinion/thought leader for Siemens Dx new technology scouting.

Strong relationship builder understanding the needs/wants of US /Chinese IVD firms in global efforts.

Extensive experience with biotech and CRO regulatory compliance (GLP, PT) and QA systems.

PROFESSIONAL EXPERIENCE

National Medical Services, Inc. (NMS Labs), Philadelphia, PA 2012 – Present

$50 million, tertiary esoteric reference laboratory, specialized in Toxicology & Endocrinology

Executive, VP of R&D and Lab Operation Support

Recruited to head up R&D to optimize operations, resources, and $3.5 million R&D budget while developing long-term strategies. Developed and managed execution across initiatives, collaborations, acquisitions, and vendor partnerships, with some specific focus on in vitro diagnostic or other medical device companies and academic institutions. Developed and managed relationships with clinical key opinion leaders (KOLs).

Profitability enhancements:

Increased annual profits $1 million by reconfiguring staff requirements for validations. Built new laboratory for immunology, eliminated service contract and converted office into a lab.

Saved company $1+ million while establishing research platform with essential chip and reader components. Leveraged emerging technologies.

Generated $5+ million by acquiring 2 major clinical clients. Raised profits to meet historical EBITA criteria mandated by the Board of Directors at 13%, far surpassing industry average of 5%-10%.

Rescued projects with an estimated $200,000/year R&D investment by updating standard operating procedures (SOPs) and validating improved methods. Improved project execution by championing formation of new validation team.

Cut $2 million in instrument maintenance costs by introducing instrument service program.

Obtained $100,000 worth of research products via collaboration with City of Hope, University of Stony Brook-New York, and NIH SBIR research funding.

Additional Results:

Reduced reagent cost from $2.00 to $0.5, saving $1.50 per sample, and $180,000/year. Ended need for solid phase extraction (SPE) unit for every sample by promoting 2D LC-MS technology with mass spectrometry. Saved $60,000 in instrument maintenance expenses and enabled production of cleaner samples.

Achieved 100% success in getting 15 New York State Department of Health (DOH) submissions approved between 2013 and 2015 after company faced major issues with past failures.

Harmonized technical operations/personnel after major corporate reorganization. Inspired best work out of R&D scientists by introducing project scoring system. Tied bonuses to merits and promotions to achievements.

Ensured successful results by launching new innovation program that is guided by a steering committee, strategy team, and R&D to determine best practices and ROI, which is confirmed by hard data.

Introduced several new product lines and platforms with 300% ROI; each product represented $1-$5 million investment.

Siemens Healthcare Diagnostics, Newark, DE / Los Angeles, CA 2007 – 2012

$4.2 billion, world leading company in the entire in vitro diagnostic industry

Medical Officer, Global Medical Affairs

Provided clinical utility consultations in premarket and postmarket phases for all products. Supported regulatory approval and commercial success of the products and brand (e.g., marketing studies). Represented the company to communicate with regulatory agencies and/or key opinion leaders (KOLs).

Tapped by multiple stakeholders to provide critical clinical perspectives on business development opportunities, panel expert on company’s Dx new technology scouting team. Relied upon to make corporate key decisions regarding global technologies and strategic positioning.

Developed clinical assessment on assay as well as instrument and software issues, reviewed and approved Field Safety Notice and Technical Bulletins, provided critical guidance at various customer service supporting levels.

Guided integration of quality and regulatory assurance activities in postmarket surveillance (MDR, Recall), domestically and internationally. Contributed to the integration in multiple acquisitions of Siemens Dx.

Member of expert review panel in product development and market readiness reviews.

Directed the design of clinical trials, reviewed and approved study clinical trial protocols, and addressed issues for FDA during Pre-IDE, FDA and LRQA submission reviews (for CE marks); Hands-on experience with selection and monitoring of sites.

Highlighted Results:

Established system that has become standard industry practice for FDA inspections. Inspired production of Clinical Assessment document adopted throughout industry.

Maximized product safety by developing method to efficiently assess impact of product issues on clinical applications; evaluated up to 3% of 600 products at any given time.

Protected company from 50%-80% cost hikes associated with failing FDA inspections. Effectively mitigated clinical assessment deficiencies.

Established high-impact business functions and systems for Global Medical Affairs; developed and trained staff on SOPs, and instituted guidelines for all manufacturing sites.

Rated as Top Talent Manager in 2011 among 150+ mid-level managers, founded and ran a successful Six Sigma charter, the Design Input Requirement Charter leading multiple task forces to solve critical product issues while improving operations across R&D, Quality Assurance (QA), and Regulatory Affairs (RA).

oStreamlined communications and expertly resolved product development disputes among 3 newly-merged companies.

oSaved $100,000/year in costs associated with monthly meetings by launching DIR workshop. Attracted 25 participants from 5 different countries to define product needs throughout the lifecycle of development.

Paul Merage School of Business, Irvine, CA 2007- 2009

Ranked among top 10 Healthcare MBA programs in US

Business Practice Leader

Winner of Polaris Investment Competition, 2008-2009, Team Captain, leading a team of 6 MBA students to invest $300K real money sponsored by Mont Pelerin Capital LLC.

2nd place in Merge & Acquisition ACG Cup, 2009, Team Captain, leading a team of 3 MBA students to compete for proposals for a M&A case using the Merrill-Lynch database. Finished 2nd among 8 teams.

Provided consultation with start-ups: Pricing of lab tests for an IVD Company; Marketing and finance strategy for a Fashion Company; Design of capital and stock structure for a Laboratory Services Company.

Reputational consulting in providing critical development advice for 10+ companies including 6 start-ups:

oBuilt business plans for chain clinics on sleeping disorders, a chain of 20 outpatient clinics, and a rehab hospital

oDesigned capital and stock structure for several startup clinical laboratories and in vitro diagnostic companies

oExecuted successful marketing and finance strategies for a fashion company and a cosmetic product company

oEstablished progressive pricing of lab tests for an IVD Company

Diagnostic Product Corporation, Los Angeles, CA 2001 – 2007

$600 million, high-growth IVD company in the automated immunoassay global market, employed 2,300 people in 3 international locations. Acquired by Siemens Dx in 2007.

Director, Clinical Applications

Maintained the highest levels of customer service, operational efficiency, and product quality while working across business units to determine best practices. Influenced critical decisions regarding manufacturing, quality control, customer relations, and product recalls by providing in-depth clinical assessments. Investigated trends and customer complaints. Directed highly productive team of 4 PhD scientists and 5 technicians, overseeing work of indirectly-reporting laboratory technicians. Enabled team to successfully support 150+ products during rapid growth period, when business expanded from $250 million to $600 million in annual revenue.

Highlighted results:

•Successfully redesigned 5 solutions, repositioning them to become signature products. Developed new manufacturing/formulation processes, reagent chamber construction methods, and automation protocols for IMMULITE Progesterone, Testosterone, Estradiol, hCG, and IMMULITE /2000 IGF-1.

•Played key role during $4.2 billion acquisition of Bayer Diagnostics; guided reorganization of Product Support, Customer Support, and Medical Affairs Departments.

•Boosted efficiency 30%, cutting $1.5 million in annual expenses, by streamlining escalation process for product customer support. New processes minimized troubleshooting cycles and maximized customer satisfaction.

•Eliminated $2 million in potential losses by proactively solving severe negative bias for testosterone assay and progesterone assay stability issue; reduced deterioration from 12 to 3 months by splitting reagents into 2 chambers.

•Relieved 4-week product back order while spotlighting dated recordkeeping processes to senior management. Prompted introduction of electronic raw material tracking system.

•Led testing of tube effects to become standard assay testing procedure industry-wide. Spearheaded major investigation across IVD industry during major Becton Dickenson (BD) tube issues.

•Delivered comprehensive training to internal organizations and affiliated agencies/distributors nationwide. Provided quarterly training to 45+ managers in order to mitigate product performance issues/risks.

•Expertly resolved issues regarding IGF-1 reformulation and E2 discordant issues in IVF application. Reformulated/re-established reference ranges with WBC folate. Developed agreement between multiple PSA assays. Provided CRP recalibration, cardiac claim, and QC specification.

•Spurred market growth and improved sales by an estimated $1.5 million. Made significant contributions to clinical protocol designs that enabled 510 K FDA clearance of cardiac, tumor, thyroid, and fertility product lines.

•Earned fast-track promotions from initial Operational Senior Scientist and Technical Director positions.

Early Career: 1996 – 2001

Los Angeles, CA & Seattle, WA

Senior Operation Scientist at Diagnostic Product Corporation (DPC)

Acting Director at Clinical Laboratory, Harborview Medical Center

Clinical Chemistry Resident Fellow at Laboratory Medicine, University of Washington Medical Center

Acting Director June 1997-Jan 1999

Clinical Laboratory, Harborview Medical Center Seattle, WA

600 beds hospital clinical laboratory, affiliated with UWMC (Univ. Washington Medical Center)

Achievement and major duties:

Provided support and consultation for client and physician inquiries.

Conducted teaching and training for UWMC MedTech program.

Evaluated, recommended, and implemented discontinuation of infrequently ordered tests.

Obtained certification as a CAP inspector for clinical laboratories.

Provided daily problem solving for general chemistry lab and associated satellite labs and POC.

Developed and implemented home brew assays:

oDeveloped HPLC assays for HIV protease inhibitors.

oAutomated existing manual VB1 and VB6 assays on Cobas-Fara system.

Conducted staff education and training.

Reviewed QC data for Specialty Chemistry section.

Clinical Chemistry Resident Fellow Feb 1996-June 1997 Laboratory Medicine, Univ. of Washington Medical Center Seattle, WA

Teaching hospital and medical center ranked among the nation’s top hospitals

Achievement and duties:

On call for reports of critical values, laboratory operational issues, and test ordering issues

Conducted state-of-art research on mechanisms of apoptosis and published original articles.

Developed and implemented molecular diagnostic assays: hemochromatosis and prothrombin gene II, PCR.

Resolved technical problems: e.g., bilirubin inconsistency between Paramax and Dimension.

EDUCATION

M.B.A. Paul Merage School of Business, University of California-Irvine (UCI), Irvine, CA.

DABCC (Diplomate, American Board of Clinical Chemistry), University of Washington, Seattle, WA.

Ph.D. Molecular Biology, University of Nebraska-Lincoln, Lincoln, NE

BS, Biology, Peking University

TECHNICAL / CLINICAL SKILLS

Innovation IP licensing and technology transfer IVD R&D platforms

Assays and method development Point of Care Device FDA CFR 21 800 through 862

Pre- and post-market surveillance and product support FDA submission Clinical trials

Project management GMP, GLP CLIA lab operations Six Sigma and Lean QA/QS and QC

INDUSTRY LEADERSHIP and AFFILIATIONS

•Chair of Industry Division, Member, and Former President, American Association of Clinical Chemistry (AACC)

•Member and Former President, North American Chinese Clinical Chemistry (NACCCA)

•Former Secretary, AACC Southern California Section

•Founder and Former President, Siemens Glasgow Toastmasters Club

•Former Member, Society for Endocrinology

•Former Member, American Society for Clinical Laboratory Science (ASCLS)

•Former Member, American Chemistry Society (ACS)

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