DABT Toxicologist and Scientist with Applied Industrial Experience Specific to IND and NDA Submissions to the FDA and Global Equivalents.

Expertise

• DABT Toxicologist and 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 drug safety assessment with an excellent foundation in toxicology, pharmacology, physiology, biochemistry and DMPK.
• Therapeutic areas supported are anti-infectives, cancer, immune regulation, diabetes, CNS, prostate enlargement, hepatitis C, and pulmonary fibrosis (IPF).
• Discovered and characterized ten novel inflammatory cytokine protein-protein interactions (IL-11, biologic drug Neumega%uFFFF).
• Large pharmaceutical, experience: CRO, start-up biotech and established biotech due to company acquisitions and reorganizations.
• Broad background in applied drug discovery, drug toxicology, biochemistry, protein interactions, pharmacokinetics, GLP/OECD, cell biology, comparative physiology and assay development.
• Pre-clinical work with FDA approved and in process drug applications in the therapeutic areas of metabolic diseases, immunoregulation, neuroscience, and anti-infectives.
• Design and implementation of studies to characterize complex mechanism or satisfy regulatory guidelines leading to product registration.
• Developing in vivo validated, highly predictive in vitro toxicity assays/models with cell lines and primary cells suitable for structure-activity analysis or high throughput screening.
• Expert in exploratory drug investigative and IND and NDA/MAA supporting pharmaceutical studies and strategies.
• INDs and NDA/MAAs submissions.
• Laboratory performance management systems based on quality management, interactive management essentials, situation leadership, GLP Training and Educational Resources in Environmental Science (ERES) Awareness.
• Laboratory animal care.

Experience

Undisclosed Company, Director of Toxicology - Consultant, 2007 - Present

• Non-clinical project team leader in charge of toxicology, DMPK, and pharmacology with Ph.D. and non-Ph.D. reports.
• Provided leadership and strategic direction for a multidisciplinary team responsible for discovery, evaluation and development of potential drugs.
• Clearly identified and communicated 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.
• Synergistic Roche drug development partnership supported drug discovery studies of ITMN-191 and others to Phase I and II clinical trials.
• Discovery, DMPK and toxicity poster presentations at national conferences.
• Proactively presented internal seminar on current concepts in drug development to multidisciplinary team to foster focused understanding of GLP drug production and state-of-the-art skills in drug development programs.

Independent Consultant, 2004 - Present

• Member of a team of consultants selected for experience in their fields (cell biologist, biochemist, physiologists and toxicologist) critical to pharmaceutical discovery, development, safety assessment and regulatory compliance.
• Project experience with CRO based in vivo toxicity and safety pharmacology protocols and FDA contact in support of drug development.

Threshold Pharmaceuticals, Redwood City, CA, Head Toxicologist, 2006 - 2008

• 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 nonclinical safety pharmacology and toxicology studies in addition to pre-NDA chronic toxicity, carcinogenicity and developmental studies.
• Successfully achieved all schedule and 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 rabbit developmental study.
• 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.

Quintiles, Inc., Kansas City, MO, 2004 - 2006

Associate Director of Toxicology and Head, Rodent Safety Pharmacology

• 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 developmental teams in anti-infectives, cancer, and CNS therapeutic areas at a global pharmaceutical company.
• Participated on multiple teams of drug discovery, investigative, and regulatory projects leading to practical experience with rat and dog studies.
• 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.

Astellas Pharmaceuticals, (Formerly Fujisawa Healthcare, Inc.), Senior Scientist, 1998 - 2001

• Promoted to Senior Scientist after first year of published scientific accomplishments.
• Established molecular, cellular and animal diabetes models in addition to immunoregulatory models for the extended characterization of the transplant drug FK506/Prograf.
• 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 characterized osteoblast mechanisms in the control of bone regulation.

Indiana University, Indianapolis, IN, Post-Doctoral Fellow, 1992 - 1996

• Successfully discover and characterize ten novel IL-11 (Oprevelkin approved drug, trade name Neumega) interactions.
• Proteins studied include Src-family kinases, phosphatidylinositol 3-kinase, Janus kinases, gp130

Honors & Publications

Credentials

• Diplomat American Board of Toxicology (DABT)
• Certificates of training in GLP
• Study Director, Animal Handling
• Radioactivity Usage
• Effective Communication
• Laboratory Safety, Affymetrix, Cellomics, Digital Imaging, CELISA, GEL Electronic Documentation, Bomek FX Robotics Core System
• Reviewer: Pharmacology and Toxicology
• Digital Imaging, CELISA, GEL Electronic Documentation, Biomek FX Robotics Core

Academic and Professional Affiliations

• American Association for the Advancement of Science - AAAS
• American Diabetes Association - Professional Division
• Society of Toxicology Member Candidate
• Safety Pharmacology Society-Full Member, SPS Abstract Review Committee

Awards

• Pharmacology and Toxicology, Bone Regulation Grant Fellow Award
• Bone Regulation Grant Fellow Award

Education

• Ph.D. Biochemistry, University of Illinois, Urbana, Champaign, IL
• M.S. Biological Sciences, Northern Illinois University, DeKalb, IL
• B.S. Biological Sciences, Northern Illinois University, DeKalb, IL