Robert L. Clark, Ph.D.
President, Artemis Pharmaceutical Research
General and Reproductive Toxicology
1758 Allentown Road #205
Lansdale, PA 19446 |
Phone: (215) 715-3117 |
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Fax: (215) 207-9780 |
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E-mail: clarkrl33@hotmail.com |
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Area of Expertise |
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Primary areas of expertise from 27 years experience in pharmaceutical industry are developmental and reproductive toxicology, drug development, general toxicology, and juvenile toxicity studies. Expert in reviewing the literature, preparing regulatory protocols, monitoring studies, interpreting data, writing and reviewing final reports, preparing regulatory submissions and interacting with regulatory agencies. Other areas are fetal anatomy, data analysis, risk assessment, inhalation and dermal administration, and developmental and postnatal studies in monkeys. |
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Lori A. Dostal, Ph.D., DABT
Senior Managing Scientist
Exponent, Inc.
39100 Country Club Drive
Farmington Hills, MI 48331
Phone: (810) 229-9552
Mobile: (810) 299-1876
E-mail: ldostal@exponent.com
Web site: www.exponent.com
Area of Expertise
Dr. Dostal is a board-certified toxicologist with over 22 years of experience in nonclinical pharmaceutical development and consulting for small to large companies in the design and conduct of general and reproductive animal studies, monitoring of GLP animal laboratories, writing protocols and reports, and preparation of regulatory submission documents. She is an active member of the Society of Toxicology, including past President of the Reproductive and Developmental Toxicology Specialty Section, as well as the SOT Program, Nominating and Awards Committees. Dr. Dostal is also a member of the Teratology Society.
In 19 years at Parke-Davis and Pfizer, she served as a study director and project team representative, as well as a specialist in reproductive and developmental toxicology, juvenile animal toxicology, and nonclinical antibacterial drug development. Dr. Dostal has special expertise in fertility and sperm evaluations for rats, dogs, monkeys and rabbits; as well as proficiency in assessing testicular and epididymal toxicity in animals. She has designed, monitored, and interpreted hundreds of regulatory toxicological studies to support development of CNS therapeutics, oncology, anti-inflammation agents, biologicals, and products to improve cardiovascular health (e.g. HMG CoA reductase inhibitors such as Lipitor). Dr. Dostal has reviewed and contributed directly to numerous regulatory documents for IND and NDA submissions, including Investigator Brochures, preIND briefing documents, PIP (Pediatric Investigational Plan) and eCTD submissions. Dr. Dostal assists clients in developing and implementing scientific strategies for nonclinical safety testing of new pharmaceutical candidates, particularly in general toxicology, reproductive toxicology, safety pharmacology studies, impurity evaluation, due diligence, nonclinical study planning, and regulatory submissions.
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Ronald D. Hood, Ph.D., Fellow, ATS
Professor Emeritus
Department of Biological Sciences
The University of Alabama
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Principal, Ronald. D. Hood & Associates
Toxicology Consultants
Box 870344
Tuscaloosa, AL 35487-0344
Phone: (205) 348-1817
Fax: (205) 348-1786
E-mail: rhood@as.ua.edu
Web site: http://www.ToxicologyConsultants.com
Area of Expertise
Ron is Principal, Ronald D. Hood & Associates, Toxicology Consultants; consultant since 1980 to industry, government, and law firms; Special Consultant, Environmental Health Committee, U.S. EPA Science Advisory Board (10 yrs); Professor Emeritus and former Interim Department Chair, Department of Biological Sciences, The University of Alabama; Adjunct Professor, University of Alabama at Birmingham School of Public Health; Birth Defects Causation Expert Witness; thirty-six years toxicology research & teaching; courses taught included Developmental Toxicology, Reproductive Physiology, Teratology, Human Embryology, Principles of Toxicology, Environmental Toxicology, and Endocrinology; training course organizer and presenter to regulatory agencies; advisory panels; editorial boards; many publications; book editor and author: (1) Cacodylic Acid: Agricultural Uses, Biologic Effects, and Environmental Fate, (2) Developmental Toxicology—Risk Assessment & the Future, (3) Handbook of Developmental Toxicology, and (4) Developmental and Reproductive Toxicology, a Practical Approach, 2nd Edition.
Ron’s consulting group has seasoned expertise in:
- Developmental & reproductive toxicology
- Birth defects causation: lab animal, nonhuman primate, and human
- Study report review & data interpretation
- Contract research organization (CRO) selection
- Study placement and monitoring
- Nonclinical protocol design & review
- Literature review and manuscript, expert report, and position paper preparation/critique & editing
- Epidemiology
- Drug interactions and overdose
- Alcohol and drug metabolism, blood levels, and analysis
- Endocrinology, including endocrine disruptors
- Pharmaceuticals, agricultural and industrial chemicals, consumer and household products, dietary supplements, and cosmetics
- Risk assessment
- Environmental toxicology (especially toxicology, metabolism, & environmental fate of arsenic compounds)
- Litigation support/expert witness
- Vivarium design and AAALAC accreditation
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Bruce J. Kelman, Ph.D., DABT, Fellow, ATS, ERT
Principal, VERITOX, INC.
18372 Redmond-Fall City Road
Redmond, WA 98052 |
Phone: (425) 556-5555 |
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Fax: (425) 556-5556 |
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E-mail: bkelman@veritox.com
Web site: www.veritox.com |
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Area of Expertise |
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Dr. Kelman is certified in toxicology by the American Board of Toxicology and the Academy of Toxicological Sciences, and is admitted as a European Registered Toxicologist in both the United Kingdom and EUROTOX registries. He has more than 30 years experience in toxicology, forensic toxicology, teratology, and reproductive toxicology and has served as a consultant and expert in numerous investigations across North America. He has evaluated numerous claims of personal injury and health impacts from many chemicals and drugs, and has presented a variety of health risk concepts to policy makers, government regulators, citizen groups, and individuals. Dr. Kelman has experience with both chemical and physical agents (including asbestos, pesticides, solvents, vapors, metals, microbial agents, and electric and magnetic fields), exposure scenarios (including environmental, occupational, residential, and clinical), and routes of exposure (including inhalation, oral, and percutaneous). |
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Gary W. Wolfe, Ph.D., DABT
Gary Wolfe Toxicology, LLC
1516 Thurber Street
Herndon, VA 20170-2565
Phone: (240) 499-4018
Fax: (703) 437-0405
E-mail: gary@gwtox.com
Web site: www.gwtox.com
Area of Expertise
Dr. Wolfe is a board-certified toxicologist with over 30 years of experience in the design and conduct of general and reproductive animal studies, supervision of GLP animal laboratories, and preparation of regulatory submissions and documents. He is a member of the Society of Toxicology, American College of Toxicology, and Teratology Society. He has worked at Hazleton Laboratories (now Covance) and TherImmune Laboratories (also known as R.O.W. Labs and GeneLogic Labs) where he served as GLP study director on general, developmental and reproductive, and juvenile studies for pharmaceuticals, biologicals, chemicals, metals, endocrine disrupters, and pesticides intended for regulatory submission. He also served as the Principal Investigator/Study Director for the NTP Reproductive Assessment by Continuous Breeding Programs for over 15 years. Dr. Wolfe has extensive experience in the design, placement, and reporting of the developmental and reproductive studies at various domestic and international contract research laboratories. He has also prepared various regulatory documents for submission to the U.S. FDA.
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