Xinwen James Yu, MD, PhD

*** *** ****** *****

Thousand Oaks, California 91360

Cell: 805-***-****; Home: 805-***-****

abif02@r.postjobfree.com

SUMMARY

Senior Scientist with 8-year R&D working experience in biopharma industry

following PhD in the area of Pharmacology & Toxicology. Successful in

completion of nonclinical section of IND & NDA filing. Built up excellent

working relationship with CRO & FDA. Designed & finished 40+ PK/PD/ADME/Tox

studies for drug development as Study Director & Study Monitor. Authored

study protocols, reports, departmental SOPs & IACUC protocols. Provided

leadership & management to scientific staff. Hands-on experience in PK/PD

modeling, WinNonlin, JMP, EDMS, eCTD, ELISA, IHC, Watson LIMS, cell culture

& animal handling. Record of scientific accomplishments as reflected by 10

papers published in peer-reviewed journals & 14 conference abstracts &

presentations.

PROFESSIONAL EXPERIENCE

MannKind Biopharma, Valencia, CA. 2007-present

Senior Scientist, Department of Pharmacology & Toxicology

Represent the department on a number of Project Teams, contributing to

the setting of technical objectives and regulatory submissions.

Participate in the preparation and review of regulatory submissions

(IND, IB, NDA etc) and responses to regulatory comments.

Perform PK modeling and simulations (including interspecies scaling)

as well as statistical analysis in support of dose selection for first

in human studies, and design of the toxicokinetic aspects in drug

safety studies, as well as assist in the design, conduct and analysis

of specialized PK or PK/PD biomarker experiments.

Serve as Study Director on assigned projects and is responsible for

design and implementation of non-clinical PK and TK experiments,

including protocol design, in-life conduct, data analysis,

interpretation of results and writing of final report.

Analyze bioanalytical data to obtain pharmacokinetic parameters,

interpret study results and prepare technical reports for regulatory

submissions. Assist Bioanalytical R&D and Drug Safety staff members in

the interpretation of PK and TK data.

Provide supervisory guidance to staff members in the non-clinical PK

group, typically a combination of direct and indirect reports,

including coordinating of work flow, prioritization of study

assignment and professional development, as well as review of study

reports, PK/TK memos and consultation on scientific issues.

Serve as Study Monitor in 10+ PK/PD/ADME/Tox CRO studies (GLP and non-

GLP) in support of 3 drug-development projects. Built up relationships

with CROs to ensure compliance with protocol & regulatory guidelines.

Coordinated with regulatory, QA, analytics and CRO to finalize study

reports.

Amgen Inc., Thousand Oaks, CA. 2004-

2007

Research Scientist, Department of Pharmacokinetics & Drug Metabolism

. Played an integral role in the development of the overall strategy for

the pharmacokinetic components of drug candidates in various stages of

development and the design, execution and interpretation of PK-related

studies in support of regulatory submissions (IND, IB, BLA etc).

Responsible for the PK and PK/PD component of study protocols,

reports, project summaries and development plans.

. Participated in multiple Globe Project Teams, responsible for

conducting pharmacokinetic and statistical data analyses of

development compounds and was the lead pharmacokineticist and

department representative on project teams, provided expert advice on

issues related to pharmacokinetics and pharmacodynamics.

. Designed & completed 10+ in-house PK/PD/Tox studies (GLP & non-GLP)

using WinNonlin software for oncology & inflammatory diseases.

Developed & validated 5 novel ELISA assays.

Pfizer Inc., Ann Arbor, MI. 2002-

2004

Post-Doctoral Scientist, Department of Drug Safety Evaluation

. Clarified mechanisms of drug-induced vasculitis in rats and dogs.

Published 3 papers & 3 abstracts. Identified biomarkers for early

diagnosis of vasculitis in cardiovascular drug development.

University of Arkansas for Medical Sciences, Little Rock, AR.

1995-2002

Research Assistant, Department of Pathology, Pharmacology & Toxicology

. Clarified signal transduction of IL-6-induced inotropic effect in

hearts. Identified molecules expressed by follicular dendritic cells

in regulating human T lymphocyte response. Published 5 papers & 7

abstracts.

EDUCATION

PhD in Pharmacology and Toxicology

2002

University of Arkansas for Medical Sciences. Little Rock. AR

MS in Pathology

1997

University of Arkansas for Medical Sciences. Little Rock. AR

MD in Clinical Medicine

1993

Shanghai Medical University, Shanghai, China

AWARDS:

2006 Amgen Quality Award

2003 Scientific Merit Award, Michigan Society of Toxicology

1999-2001 Pre-Doctorate Fellowship, American Heart Association

1998 Travel Awards, National Center for Toxicological Research

1995-2002 Graduate Research Award & Scholarship, University of Arkansas

1987-1993 National Scholarship, Shanghai Medical University

PROFESSIONAL AFFILIATIONS

Society of Toxicology

American Association of Pharmaceutical Scientists

PROFESSIONAL EDUCATION ACTIVITIES/RELEVANT TRAINING

Principle and Applications of Toxicokinetics. SOT, Baltimore, MD 2009.

Study Director Training, American College of Toxicology, AZ. 2008

Training for outsourced preclinical studies. Marra & Associates, CA. 2007

Principles of PK/TK for industrial scientists. University of Arizona, AZ.

2005

GLP for preclinical testing, compliance, QA & audit. CfPIE, PA. 2004

PUBLICATION

Selected Articles:

1. Eric McDuffie, Xinwen Yu & Mudher Albassam. Endothelin-A-Receptor

Antagonist CI-1034-Evoked Mesenteric Artery Injury in Rats. (in press)

2. Eric McDuffie, Xinwen Yu, Gregg Sobocinski, Yunling Song & Mudher

Albassam. Acute Coronary Artery Injury in Dogs Following

Administration of CI-1034, an Endothelin A Receptor Antagonist.

Cardiovascular Toxicology, 6 (1): 25-38, 2006

3. Xinwen Yu, Meei-Yueh G Liu, Richard H. Kennedy & Shi J. Liu. Both cGMP

& Peroxynitrite Mediate Chronic Interleukin-6-induced Negative

Inotropy in Adult Rat Ventricular Myocytes. The Journal of Physiology,

566 (2): 341-353, 2005

4. Xinwen Yu, Qian Chen, Richard H. Kennedy & Shi J. Liu. Inhibition of

Sarcoplasmic Reticulum Function by Chronic Interleukin-6 Exposure via

iNOS in Adult Ventricular Myocytes. The Journal of Physiology, 566

(2): 327-340, 2005

5. Michael Dame, Xinwen Yu, Eric McDuffie, Mudher Albassam & James

Varani. A stepwise Method for the Isolation of Endothelial Cells &

Smooth Muscle Cells from Individual Canine Coronary Arteries. In Vitro

Cellular & Developmental Biology-Animal, 39 (10): 402-406, 2003

6. Xinwen Yu, Richard H. Kennedy & Shi J. Liu. JAK2/STAT3, Not ERK1/2,

Pathway Mediates Interleukin-6-Elicited Induced NOS Activation &

Decreases in Contractility in Adult Ventricular Myocytes. Journal of

Biological Chemistry, 278 (18): 163**-*****, 2003

7. Xinwen Yu. PhD Dissertation: Signal Transduction & Cellular Mechanisms

underlying Interleukin-6-induced Negative Inotropic Effect in

Ventricular Myocytes. 2002

8. Anthony W. Butch, Kathleen A. Kelly, Michael.S. Willbanks & Xinwen Yu.

Human Follicular Dendritic Cells Inhibit Superantigen-Induced T-cell

Proliferation by Distinct Mechanisms. Blood 94(1): 216-224, 1999

9. Xinwen Yu, S. Zohair, G. Newport, W. Slikker Jr., S.F. Ali. Role of

Ibogaine in Methamphetamine-induced Hyperthermia & Expression of Heat-

shock Protein. Brain Research, 823 (1-2): 213-6, 1999

10. Xinwen Yu. Molecules Produced/Expressed by Human Follicular Dendritic

Cells That Regulate Antigen-driven T Cell Response. OCLC's

Experimental Thesis Catalog (US), 1997

Selected Conference Abstracts / Presentations:

1. Xinwen Yu, Judith Stern, Stephanie Greene and Peter Richardson (2010)

Synergy of Technosphere Insulin with other Diabetic Drugs in Zucker

Diabetic Fatty Rats. ADA 70th Scientific Sessions

2. Stephanie Greene, Xinwen Yu, Anthony Smithson & Peter Richardson

(2010) GLP-1: Superior Systemic Pharmacokinetics after Pulmonary

Delivery as MKC253 (Technosphere Particles) Compared to Intravenous

and Subcutaneous Routes in SD Rats. ADA 70th Scientific Sessions

3. Stephanie Greene, Xinwen Yu, Anthony Smithson & Peter Richardson

(2010) Oxyntomodulin and Peptide YY Pulmonary Delivery by Technosphere

Particles: Decreased Food Intake in Normal and Diabetic Rats. ADA 70th

Scientific Sessions

4. Baley Fong, Xinwen Yu, George Doellgast & Carmine Lanni (2006).

Comparison of Absorbance, Time-Resolved Fluorescence & Luminometric

Detection Methods for a Monoclonal Antibody in Human Serum. AAPS

Journal 8(S1) T2020.

5. Xinwen Yu, Yunling Song, Eric McDuffie & Mudher Albassam (2004).

Potential Markers of Coronary Artery Injury in Dogs Following

Administration of CI-1034, an Endothelin A Receptor Antagonist. The

Toxicologist #1820

6. Xinwen Yu, Michael Dame, Eric McDuffie, Mudher Albassam & James Varani

(2004). Isolation & Characterization of Canine Coronary Smooth Muscle

& Endothelial Cells. The Toxicologist #1818

7. Xinwen Yu, Michael D. Reily, Eric McDuffie, Donald Robertson & Mudher

Albassam (2003). NMR-based Metabonomics as a Tool for Investigating CI-

1034-evoked Acute Coronary Artery Injury in Dogs. Best Poster Award,

Michigan Society of Toxicology #8

8. Xinwen Yu (2003). Cellular Mechanism & Signal Transduction Pathways

Underlying Interleukin-6-induced Negative Inotropic Effect in Adult

Ventricular Myocytes. Journal of Interferon & Cytokine Research 23

(9): 549-550

9. Xinwen Yu, R.H. Kennedy & Jesse Liu (2002). Involvement of JAK/STAT

Pathway in Interleukin-6-induced Nitric Oxide Production & Negative

Inotropic Effects in Adult Rat Ventricular Myocytes. Best Poster

Award, FASEB Journal 16 (4) 6344

10. Xinwen Yu, R.H. Kennedy & Jesse Liu (2000). Nitric Oxide Synthase

Pathway Involved in Suppression of Cardiac Contractility During

Chronic Exposure to IL-6. Journal of Molecular & Cellular Cardiology.

32 (5): A72

11. Xinwen Yu, R.H. Kennedy & Jesse Liu (1999). IL-6 Decreases Post Rest

Potentiation & Ca++ Responsiveness in Adult Rat Ventricular Myocytes:

Role of NOS. American Heart Association 72nd Scientific Sessions

12. Xinwen Yu, S. Imam, G. Newport, A. Scarlet, W. Slikker Jr., S.F. Ali

(1998). Ibogaine Blocked Methamphetamine-induced Hyperthermia but

Potentiate Dopaminergic Neurotoxicity in Mice. Society For

Neurosciences 855.7

13. Xinwen Yu, W. Slikker Jr., S.F. Ali (1998). Role of Ibogaine in

Methamphetamine-induced Hyperthermia & Expression of Heat-shock

Protein. South Central Chapter, Society of Toxicology #16

14. Xinwen Yu, J. Griffin, N. Pumford (1997). Induction of Heat-shock-

protein Synthesis by Trichloroethylene in the Autoimmune Prone MRL+/+

Mice. South Central Chapter, Society of Toxicology #18

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