Douglas K. Fuhrer, Ph.D., D.A.B.T.
*** ******** ****** *****, *******, CA 94002
Home: 650-***-**** Mobile: 913-***-**** Email: abmqhf@r.postjobfree.com
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. Fuhrer, 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. Fuhrer, 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. Fuhrer, B. Buckman, L. Pan, and S. Seiwert
PEER REVIEWED PUBLICATIONS
Douglas K. Fuhrer, 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.
Douglas K. Fuhrer 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.
Douglas K. Fuhrer 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, Douglas K. Fuhrer, 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.
Douglas K. Fuhrer, 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, 270:248**-*****.
Douglas K. Fuhrer. Over-expression, purification, and phosphorylation
of the Bacillus subtilis CheA protein. (1995) Biochemistry and
Molecular Biology International, 37:89-99.
Xin-Yuan Wang, Douglas K. Fuhrer, Mark S. Marshall and Yu-Chung Yang.
Interleukin-11 induces complex formation of Grb2, Fyn and JAK2
(1995) Journal of Biological Chemistry, 270:279**-*****.
Douglas K. Fuhrer 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