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Management Quality Assurance

Location:
Belmont, California, 94002, United States
Posted:
June 01, 2010

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******* K. ******, Ph.D., D.A.B.T.

*** ******** ****** *****, *******, CA 94002

Home: 650-***-**** Mobile: 913-***-**** Email: ********@*****.***

SUMMARY OF QUALIFICATIONS

DABT toxicologist/scientist, department head with over 12 years applied

industrial experience, supporting and directing interdisciplinary teams to

both IND and NDA submissions to the FDA and global equivalents.

Management, budgetary and scientific skills include discovery,

investigative, and regulatory toxicity/safety pharmacology with an

excellent foundation in pharmacology, biochemistry and DMPK. Breadth of

work experience includes large pharmaceutical company, CRO, and biotech.

Therapeutic areas supported are anti-infectives, cancer, immune regulation,

diabetes, CNS, prostate enlargement, hepatitis C, and idiopathic pulmonary

fibrosis. Additional professional strengths include:

. Toxicological scientific expert in non-clinical drug development

trained to proactively identify and address issues while designing

programs for better and safer drugs to build company value and lead

to drug commercialization

. Effectively communicates and interacts with scientists, project

leaders and upper-management while sharing technical expertise in the

analysis, application and reporting of research projects and programs.

. Sound scientific judgment and in depth knowledge in designing

toxicology and safety pharm studies to characterize toxicity and to

satisfy regulatory authorities

. Exceptional leadership skills along with an insightful approach to

hiring, supervising, evaluating, motivating, and teaching staff

. Professional evaluation and management of CROs and CRO studies

. Calm but tenacious problem-solving abilities and decision making

allowing for quick and effective strategic planning

. Self-motivated, creative, and goal-oriented, with the capacity to

provide program management in a matrix team environment or operate

independently

. Academic and industrial signal transduction investigations provide a

solid foundation applicable to mechanistic based studies

. Varied professional experience in large pharma, CROs, start-up biotech

and established biotech due to strong recruitment and company

reorganizations

PROFESSIONAL EXPERIENCE

InterMune, Inc. Brisbane, CA

DIRECTOR OF TOXICOLOGY, (Dec) 2007-2010

. Provide leadership and strategic direction for a multidisciplinary

team responsible for discovery, evaluation and development of

potential drugs

. Non-clinical project team leader in charge of toxicology, DMPK, and

pharmacology with Ph.D. and non-Ph.D. reports

. Clearly identify and communicate drug safety priorities and

contingency plans in collaboration with non-clinical safety management

and project team

. Responsible for NDA/MAA non-clinical documentation preparations for

the FDA and EMA including toxicology, pharmacology and

pharmacokinetics

. Trained for meeting with regulatory authorities and defending

submissions

. Current knowledge of NDA/MAA non-clinical requirements including full

EMA environmental risk assessment, abuse liability evaluation and

phototoxicity

. Oral presentation on NCE safety assessment to large pharma partner

company spearheaded multimillion dollar investment and further

opportunities

. Synergistic Roche drug development partnership supported drug

discovery studies of ITMN-191 to clinical trials

. Discovery, DMPK and toxicity posters presentations at national

conferences

. Independently prepared and presented current concepts in drug

development to multidisciplinary team to foster focused understanding

of GLP drug production and state-of-the-art in drug development

programs

Threshold Pharmaceuticals, Redwood City, CA

HEAD TOXICOLOGIST, (Jan) 2006- (Dec) 2007

. Head toxicologist at an aggressive breakthrough discovery and

development biotech company with therapeutic focuses of BPH (prostate

enlargement) and cancer (solid tumor)

. Responsible for CRO selection, negotiations and supervision for

preclinical safety pharmacology and toxicology studies (TH-302) in

addition to pre-NDA chronic toxicity, carcinogenicity and

developmental studies (Glufos, TH-070)

. Coordinate, supervise and manage contract non-GLP and GLP

toxicology and safety pharm studies and successfully achieved

schedule & budgetary goals

. Obtained FDA buy-in on preclinical strategy and prepared pharmacology/

toxicity portion of regulatory submissions for first in man studies

(IND) and support clinical trials for NDA submission

. Designed toxicology studies, interpreted results, and wrote study

summaries

. Saved $200,000 by stopping unnecessary study by regulatory

investigations

. Hired and supervised scientists, support personnel and specialist

consultants while managing toxicology staff for in-house and contract

studies

. Established an investigative toxicology and biomarker program to

identify important mechanisms and markers of toxicity in support of

developing drugs and drug safety profiles

. Performed due-diligence evaluation of investment opportunities and

collaborations

Aptuit, Inc., (Formerly Quintiles, Inc., Preclinical Division) Kansas City,

MO

ASSOCIATE DIRECTOR OF TOXICOLOGY AND HEAD, RODENT SAFETY PHARMACOLOGY, 2004-

2006

. Responsible for the supervision of a highly effective team (8-10) of

scientists and technicians, completing over 30 GLP CNS and 30 GLP

respiratory safety pharmacology studies in a year generating about $2

million in income while contributing to numerous full toxicology IND

packages

. Implemented GLP toxicology and safety pharmacology studies, including:

design, direction and analysis in support of FDA and OECD, ICH

guideline studies for new drug applications (pre-IND, IND, NDA and MAA

Support)

. Collaborated with toxicologists and pharmacologists from major

pharmaceutical and biotech companies in addition to consulting on

scientific, pharmacological, and regulatory subjects

. Successfully synergized with Senior Management and Departments of

Quality Assurance, Document Management, and Laboratory Animal

Resources for timely project completions

. Study director for general toxicology and ICH S7A safety pharmacology

studies. Review and support of ICH S7B cardiovascular telemetry

studies, DMPK, and general formulation analysis studies in rodents,

canines, and non-human primates

. Championed department by optimizing pricing for maximum budget and

salary applications in addition to department funding, organization,

collaborations, and working space

. Energized staff through performance reviews, personal goal setting,

rewards, and developmental directions to support the highest

performance and efficiency levels

. Budgeting, cost control, contract negotiation, profit and loss

expertise

AstraZeneca Pharmaceuticals LP, Wilmington, DE

SENIOR SCIENTIST/ TOXICOLOGIST, 2001-2003

. Provided significant toxicological direction of drug discovery and

development teams in anti-infectives, cancer, and CNS therapeutic

areas at a global pharmaceutical company

. Participated on multiple teams of drug discovery, investigative, and

developmental projects leading to practical experience with acute and

sub-acute rat and dog studies in addition to ICH guidelines for

requirements for IND exemption for clinical trials

. Supplied significant design and input to global safety assessment

initiatives on hepatocyte and blood lineage toxicity and delivered

new predictive assays suitable for screening all potential drugs

early in the drug discovery process

. Directed study team to validate new rapid and high throughput

technology to characterize hemotoxicity, hematopoiesis, and

apoptosis

. Determined metabolism/toxicity drug characteristics and specific

CYP involvement by cellular expression of cloned human CYPs with

compounds to improve drug design

. Personally proposed and initiated new technology to analyze novel

functional and toxicity mechanisms, for advancing drug discovery

projects

Astellas Pharmaceuticals (Formerly Fujisawa Healthcare, Inc.), Deerfield,

IL

SCIENTIST/ SENIOR SCIENTIST, 1998-2001

. Promoted to senior scientist after first year of published scientific

accomplishments

. Designed, directed and carried out in vitro and in vivo experiments

and analyzed results from sub-acute rat studies of new drug

combinations to study immunosuppression and reduction of secondary

drug target effects

. Established molecular, cellular and animal diabetes models in addition

to immunoregulatory models for the extended characterization of the

transplant drug FK506/Prograf

. Identified meaningful signaling pathway targets leading to new drug

combinations that had no drug toxicity at levels allowing a

significant therapeutic index

. Discovered and demonstrated in vitro and in vivo rescue of post-

transplant diabetes by determined mechanisms that prompted company to

increase resources and support

. Collaborated with clinical research and development teams to evaluate

new drugs and drug combinations in cellular and animal models of

disease

Washington University, St. Louis, MO

RESEARCH FELLOW, 1996-1997

. Aggressively identified the roles of chemokines in human osteoclast

and osteoblast regulation in the control of bone regulation

Indiana University, Indianapolis, IN

POST-DOCTORAL FELLOW, 1992-1996

. Successfully discovered and characterized ten novel IL-11 (Oprevelkin

approved drug, trade name Neumega ) interactions (see publications).

Proteins studied include Src-family kinases, phosphatidylinositol 3-

kinase, Janus kinases, gp130 (beta-receptor), SHP-2 tyrosine

phosphatase, PP2A (phosphatase), GRB2, and the Ras oncogene

University of Illinois at Urbana, Champaign, IL

GRADUATE ASSISTANT, 1986-1992

. Cloned, sequenced, over-expressed, purified, and mutated CheA of

Bacillus subtilis. Characterized CheA mutants and showed

autophosphorylation for the first time. First to find and identify the

two-component phosphorylation-signaling pathway in the Bacillus

subtilis chemotaxis mechanism

EDUCATION

. Diplomate American Board of Toxicology (DABT)

. Post-Doctoral Training, Indiana University, Indianapolis, IN

. Ph.D., Biochemistry, University of Illinois at Urbana - Champaign, IL,

1992

. M.S., Biological Sciences, Northern Illinois University, DeKalb, IL

. B.S., Biological Sciences, Northern Illinois University, DeKalb, IL

HONORS, CERTIFICATIONS AND SOCIETY MEMBERSHIPS

Board Certified Toxicologist by the American Board of Toxicologists

(ABT), Reviewer: Pharmacology and Toxicology, Bone Regulation Grant

Fellow Award, AAPS Member, AAPS Abstract Committee, Society of

Toxicology-Full Member, Safety Pharmacology Society-Full Member, SPS

Abstract Review Committee, Invited Speaker: Washington University,

Wayne State University, Beckman Institute, and University of Illinois.

SELECTED TRAINING COURSES / CERTIFICATIONS

Management Orientation, Performance Management System, Quality

Management, Interactive Management Essentials, Situational Leadership,

GLP Training, ERES Part 11 Awareness, Salary Planning, Performance

Review Evaluations, Privacy Awareness, Laboratory Animal Care,

Customer Focus Training (1, 2 and 3), GLP for Managers, Maintaining a

Respectful Workplace, Notocord Applications, and Mid-American

Toxicology Course; Certificates of Training in GLP, Study Direction,

Animal Handling, Radioactivity Usage, Laboratory Safety, Affymetrix,

Cellomics, Digital Imaging, CELISA, GEL Electronic Documentation,

Biomek FX Robotics Core System, and Effective Communication

SELECTED WORKSHOPS ATTENDED

"Cardiovascular Assessment: the Preceding, Contemporary and

Prospective Viewpoint"

"Concepts, Methods and Applications of Discovery, and Investigative

Toxicology"

"Current Regulatory Requirements and Trends for Developmental,

Reproductive, and Neonatal Non-clinical Safety Testing and Risk

Communication"

"Targeted Therapeutic Approach to Anti-Cancer Drug Development"

"An Overview of Idiosyncratic Drug Reactions"

"Perspectives in Drug Development"

"Toxicogenomics in the Pharma Pipeline"

"Improved Strategies for Preclinical Cardiac Safety Testing"

"Target Organ Toxicity"

"Cellular Dynamics: Stem Cell Cardiomyocytes"

" New Frontiers in Safety Pharmacology"

RECENT ABSTRACTS/POSTERS

AASLD 2008 - Identification of Novel Non-Macrocyclic Inhibitors of HCV

NS3/4A Serine Protease Activity: B. Buckman, L. Pan, L. Huang, K.

Kossen, P.T. Rajagopalan, S. Misialek, S. Stevens, H. Tan, D.

Ruhrmund, V. Serebryany, J. Matulic-Adamic, A. Stoycheva, S. Ammons,

D. ******, L. Blatt, L. Beigelman, and S. Seiwert

AAPS 2009 - Preclinical Properties of a Second Generation Anti-fibrotic

Agent,

ITMN-520: L. Pan, S. Park, D. ******, C. Schaefer, L. Huang, V.

Serebryany, L.

Beigelman, J. Liu, S. Srikonda, N. Snarskaya, D. Ruhrmund, S. Seiwert,

and K. Kossen

ACT 2009 - Seven-Day Repeat Dose Exploratory Toxicity Study of a

Targeted

Hepatitis-C Drug: D. ******, B. Buckman, L. Pan, and S. Seiwert

PEER REVIEWED PUBLICATIONS

******* K. ******, M. Kobayashi, and H. Jiang. Insulin induction and

suppression by FK506, cyclosporin A, and rapamycin is through

regulation of the ATP-sensitive potassium channel. (2001) Diabetes,

Obesity, and Metabolism, 3:393-402.

******* K. ****** and Yu-Chung Yang. Activation of Src-family protein

tyrosine kinases and phosphatidylinositol 3-kinase by interleukin-11

in mouse preadipocyte 3T3-L1 cells. (1996) Experimental Hematology,

24:195-203.

******* K. ****** and Yu-Chung Yang. Complex formation of JAK2 to

PP2A, PI3K, and Yes in response to the hematopoietic cytokine

interleukin-11 (1996) Biochemical and Biophysical Research

Communications, 224:289-296.

Liu Yang, C. Nicklaus Steussy, ******* K. ******, Jean Hamilton and Yu-

Chung Yang. IL-11 mRNA stabilization in phorbal ester stimulated

primate bone marrow stromal cells (1996) Molecular and Cellular

Biology, 16:3300-3307.

******* K. ******, Gen-Sheng Feng and Yu-Chung Yang. Syp associates

with gp130 and Janus kinase 2 in response to interleukin-11

stimulation in 3T3-L1 mouse preadipocytes. (1995) Journal of

Biological Chemistry, 270:24826-24830.

******* K. ******. Over-expression, purification, and phosphorylation

of the Bacillus subtilis CheA protein. (1995) Biochemistry and

Molecular Biology International, 37:89-99.

Xin-Yuan Wang, ******* K. ******, Mark S. Marshall and Yu-Chung Yang.

Interleukin-11 induces complex formation of Grb2, Fyn and JAK2

(1995) Journal of Biological Chemistry, 270:27999-28002.

******* K. ****** and George W. Ordal. Bacillus subtilis CheN, a

homolog of CheA, the central regulator of chemotaxis in Escherichia

coli (1991) Journal of Bacteriology, 173:7443-7448.

ADDITIONAL RESEARCH STUDIES AND EXPERTISE

Renal toxicity and renal protection from novel targeted cytotoxic anti-

cancer agents.

A primary rat hepatocyte extended viability screening assay applicable

to toxicity and toxic metabolite screening that is comparable with

clinically proven toxicity.

Apoptotic mechanism of chloramphenicol toxicity in EPO dependent and

independent erythroblast cell lines progresses through the BCL-2

pathway.

Rescue of tacrolimus induced diabetes by regulation of cAMP levels

in a rat -model system with increased immunosuppression.

References are available upon request



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