Wenzhe Li, PhD, MBA, DABCC

■ *** Estate Dr. Middletown, DE 19709 ■ E-mail: acve09@r.postjobfree.com ■ 215-***-**** EXECUTIVE SUMMARY

Business Executive & Board Certified Clinical Laboratory Director with 15 years’ experience in Medical Diagnostics Industry and Tertiary Reference Clinical and Forensic Laboratories. SKILLS

Innovation; IP licensing and technology transfer; IVD R&D platforms, assays and methods; Point of Care Device; project management, pre- and post- market product support; FDA submission; clinical trials, FDA CFR 21 800 through 862; GMP, GLP; CLIA lab operations; QA/QS and QC

QUALIFICATIONS

Business leadership and executive experience in

large companies, Fortune 500 equivalent

Business development and effective R&D

project execution

Collaboration and partnership management with

clear demonstration of viable business options

Effective communication with key stakeholders

Strong rapport and authority with internal and

external technical /clinical experts (KOLs)

In-depth knowledge and consultation experience with new projects and start-ups

Provided for 10+ companies including 6 start-ups: Business plan for chain clinics on sleeping

disorders;

Business plan for a chain of 20 clinics; Business plan for a rehabilitation hospital;

Design of capital and stock structure for several laboratory services and in vitro diagnostic

companies;

Pricing of lab tests for an IVD Company;

Marketing and finance strategy for a fashion

company and a cosmetic product company.

In-depth knowledge and experience in IVD industry

Guided product design and product launch

strategies

Strategic and technical problem solving for

Technical Operations, QC, QA/QS, RA and

Customer Support

Familiarity and working knowledge of FDA CFR

21 800 through 862; Expertise in post market

surveillance

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.

Hands-on experience with Six-Sigma Projects

Certified Clinical Laboratory Director

Diplomat, American Board of Clinical Chemistry

10+ years of experience in management of

laboratory safety, quality, and accreditation.

Extensive working experience with clinical

laboratories on regulatory compliance (GLP,

PT)

Expertise in development and validation of LDT

(Laboratory Developed Tests).

Additional Leadership and Strategic Perspectives

Managing culture change to reenergize an old

/tired company

Key opinion/thought leader for Siemens Dx new

technology scouting

Leadership and experience in non-profit

organizations

Held positions of President, Secretary, and VP in professional societies and Toastmasters.

PROFESSIONAL EXPERIENCE

Executive, VP of R&D and Business Development Nov 2012 – Present Philadelphia, PA National Medical Services, Inc. (NMS Labs)

$45 million, esoteric reference laboratory, specialized in Toxicology & Endocrinology Major Duties:

Head of R&D, develop and manage the execution of R&D projects

Collaborations and partnership with vendors, in vitro diagnostic or other medical device companies, and academic institutions

Develop and manage relationships with clinical key opinion leaders (KOLs) Achievements in two years:

Launched a new innovation program that is guided by a Steering Committee and vigorous reviewed by a R&D Governance on ROI and strategic fitting; It requires active investigation and preparation by Strategy Team using tools such as ROI calculation and business decision packages; The program replaced the previous anecdote decision making based on “gut” feelings by C- suit without involvement or foot work by scientists and marketing team.

Identified and successfully completed feasibility studies on three larger projects that involve extensive collaboration with outside entities (a medical device company and two medical centers). The investment each is approximately $ 0.5 to 1.5 million in two years and the projected revenue is $15 to $20 million each by the 4th year.

Established an investment and product profile that steer the innovation program to leverage the company’s core competency in toxicology and extend its technical capability in other clinical areas.

Built a new laboratory and enabled the company to add specialty in Point-of-Care drug testing, MicroRNA molecular diagnostics, cell based immunoassays in merely two years.

Implemented a valid Clinical Report and other essential measures for clinical business without losing any high level personnel. This is a culture shock /change for a company that only passionate for and historically focused on forensic applications.

Steered R&D to deliver cost competitive clinical assays. Due to this change in philosophy and execution, NMS LABS is finally able to offer a price that is competitive with LabCorp and QUEST to earn larger clinical business deals ($0.5 million to $2.0 million vs. the previous $5K to $100K deals per account). Medical Officer, Global Medical Affairs May 2007 – July 2010 Los Angeles, CA Siemens Healthcare Diagnostics July 2010 – Nov 2012 Newark, DE

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

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). Achievements:

Provided critical clinical perspectives on business development opportunities, panel expert on Siemens Dx new technology scouting team.

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

Provided guidance on 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.

Lead ad hoc teams composed of directors and senior scientists to success in tackling critical technical and operational issues across Siemens Healthcare Diagnostics.

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. Business Practice Sept 2007-Sept 2009

Paul Merage School of Business Irvine, CA

Ranked among top 10 Healthcare MBA programs in US

Major Achievements

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. Director, Clinical Applications Mar 2001 – Aug 2007 Diagnostic Product Corporation Los Angeles, CA

$600 million, world leading company in RIA and chemiluminecent immunoassays Major duties

Department Head, 9 reports, 4 PhD or MD senior scientists and 5 technicians.

Investigated trends in post-market surveillance including customer complaints.

Provided consultation to company executives across pre- and post- market phases.

Communicated with key opinion leaders (KOLs) to drive evidence and influence practical applications of product Achievements

Established new department, wrote SOPs, and managed budgeting, hiring, firing and performance evaluation of the personnel; Supervised operation of the laboratory.

Conducted root-cause investigation for RIA and automated immunoassays on all IMMULITE Platforms, including endocrine hormones, oncology markers, TDM markers, and cardiac markers. o Defined product issues and provided technical solutions; Made significant contributions in directing the company’s focus for resolutions on difficult long-term issues: a. BD tube issue

b. IGF-1 reformulation

c. E2 discordant issues in IVF application

d. Reformulation and re-establishing reference ranges with WBC folate e. Agreement between multiple PSA assays

f. CRP recalibration, cardiac claim and QC specification o Provided impact assessment on clinical applications. o Directed strategies and implementations for customer handling and assay development or improvement. o Recommended and developed new clinical applications based on new findings indicated in clinical research or recommended by professional societies.

Provided technical and clinical supervision to Technical Service. o Reviewed and approved specialists’ responses to international distributors and domestic clients. o Provided consultation for field supportive personnel and marketing managers on escalated issues. o Closely involved in customer management of National Accounts. o Took full responsibility or significant roles in communications with domestic or international regulatory agencies, PT

(Proficiency Testing) survey programs, and professional key opinion leaders (KOLs).

Coordinated internal and external communications and managed product changes. o Provided updates to international distributors and customers on status of major product issues, release of new instrument software or new assays, and technical information on new products or changes made on existing products.

o Coordinated product changes involving multiple departments including Inventory Controls, QC, Product Support, R&D, and Technical Services. Drafted and finalized Technical Bulletins. o Guided filing of MDR (Medical Device Report), product recall, revision of QC specifications, update of expected ranges and assay characteristics or limitation statements in package inserts.

Provided consultation to DPC customers.

o Guided clinical laboratories to meet quality compliance requirements, e.g., GLP, CLIA, CAP and PT. o Provided consultation for technical troubleshooting and clinical interpretation of patient results such as issues with patient population, sample types, sample handling, interference substance, cross reactivity to drugs, or assays performance.

Provided seminars or training sessions internally and externally for audiences including both domestic and international clinical professionals, researchers, and bench technologists. Senior Operation Scientist Jan 1999- Feb 2001

Diagnostic Product Corporation (DPC) Los Angeles, CA

$300-400 million, world leading company in RIA and chemiluminecent immunoassays Achievements and major duties:

Provided technical solutions to product performance issues through changes in reagents, raw materials, and manufacturing process. Projects with significant financial impact included: o Testosterone: identified root cause of a significant (-3SD) low bias and released the product that had been on backorder for 2 months.

o Progesterone: split the reagents into two chambers to resolve a stability issue and extended the reagent shelf life from 3 months to 12 months.

Actively involved in root cause identification of product issues: o Identified issues during manufacturing of products working with Processing or QC. o Investigated issues associated with field operation of instruments working with Technical Services. 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:

o Developed HPLC assays for HIV protease inhibitors. o Automated 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 2009. Paul Merage School of Business, University of California-Irvine (UCI), Irvine, CA.

DABCC 2002. (Diplomate, American Board of Clinical Chemistry), University of Washington, Seattle, WA.

Ph.D. 1996. Molecular Biology, University of Nebraska-Lincoln, Lincoln, NE. ADDITIONAL EXPERIENCE

Professional Associations

President, AACC Southern California Section, 2009.

President, NACCCA (The North American Chinese Clinical Chemists Association), 2005.

Secretary, AACC Southern California Section, 2003 and 2007

Founder and President, Siemens Glasgow Toastmasters Club, 2012

Member, American Association for Clinical Chemistry (AACC), 1996-2009.

Member, Society for Endocrinology, 2005-2009.

Member, American Society for Clinical Laboratory Science (ASCLS), 1996-1999.

Member, American Chemistry Society (ACS), 1997-2000. Leadership Skills

Task and goal oriented, well-balanced “driver” and “amiable” style.

High level of learning skills and self awareness and self management skills.

Strong rapport with R&D senior scientists, mid-level managers and non-technical staff.

Believing in recognizing and developing subordinates.

Completed corporate training sessions on sales, communication and leadership.

Lead Siemens Dx to charter a new Toastmaster Club in Glasgow, DE.

Lead Siemens Dx to revive the SWAN program (a Siemens women’s leadership network) in Glasgow, DE

Taught Tai Chi class in Siemens Dx Los Angeles

Healthcare MBA in University of California-Irvine: o Understanding of government operations and policy making: Close-up internal perspectives and analysis of Capital Hill operations in Washington DC.

o In-dept understanding of issues in Healthcare IT: Extensive research and case study of current issues. o Extensive training on competitive intelligence (CI) including establishment of CI system and study of real cases with War Game modeling.

Communication Skills

Extensive written communication experience including drafting and editing mass communications (e.g., Safety Notice and Technical Bulletins), editing of marketing materials and formal communications with regulatory authorities and/or agencies.

Effective oral communication skills including presentations in top-level executive meetings, internal or external conference calls, training for both business or technical, domestic, or international audiences.

Continued enhancement in public speaking with Toastmasters clubs, held key officer positions.

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