PERSONAL

Address: 1541 Ferrell Road
Chapel Hill, NC USA 27517
Contacts:
  +01 (919) 967-5199 (office)
  +01 (919) 618-4738 (mobile)
  TGrizzle@toxicologyservices.net
Birthplace: Chapel Hill, NC
Married, 3 children

EDUCATION

• Diplomate, American Board of Toxicology, 2003, 2009
• M. S., Physiology/Biochemistry, 1986
  North Carolina State University, Raleigh, NC
• B. S., Natural Science, 1982
  Campbell University, Buies Creek, NC
  

PROFESSIONAL EXPERIENCE

Toxicology Services, Inc., Chapel Hill, NC. President and Founder of an independent contract toxicology corporation.  On- or off-site contracted nonclinical drug safety assessment services, primarily for small to mid-sized pharmaceutical companies and clinical research organizations. 2002 - present.

Icagen, Inc., Research Triangle Park, NC. Senior Toxicologist in the New Product Development group of a small pharmaceutical company. Design, plan, monitor, and insure accurate reporting and interpretation of all contracted preclinical toxicology studies and bioanalysis for sickle-cell anemia, epilepsy, and glaucoma drug candidates and other projects in discovery. Includes genetic toxicity, acute, multi-dose subchronic and chronic, reproductive, and PK/ADME studies. Manage laboratory animal facility, conduct PK studies and analyses, chair IACUC, design and write protocols. Prepare regulatory documents including amendments and annual updates to IND, toxicology and TK/PK reports, and toxicology/PK-ADME sections of Investigational Drug Brochure. 2001-2002.

Triangle Pharamceuticals, Inc., Durham, NC: Senior Toxicologist in the Toxicology and Preclinical Pharmacology group of a small pharmaceutical company. Design and write protocols, coordinate and monitor the completion of a wide variety of safety evaluation studies with a primary focus on antiviral (HIV and HBV) drug development. Also gained experience with anti-cancer, psoriasis, and herpes drug development. Member of several Project Teams and committees; prepare abstracts and manuscripts for publication, write SOPs and TK reports, prepare regulatory documents including INDs, NDAs, and the pharmacology/toxicology section of Investigator's Brochures. 1997-2001.

Research Triangle Institute, RTP, NC: Research Toxicologist, Study Director in the Center for Life Sciences and Toxicology at a contract research organization (CRO). Directed, scheduled, and conducted contract PK and reproductive toxicology studies. Duties included writing GLP-compliant and IACUC protocols, final reports and SOPs; conducting pharmacokinetic analyses, monitoring studies, training and supervising staff of up to 5 technicians, and authoring abstracts and manuscripts. 1987 - 1997.

Fisher Scientific Company, Raleigh, NC: Account Representative for a laboratory products company. Managed territory containing pharmaceutical, educational, industrial, municipal, and state accounts. Visited customers, solved service problems, wrote sales contracts, and promoted new and existing products including chemicals, equipment, and lab apparatus. 1986 - 1987.

Northrop Services, Inc., RTP, NC: Associate Scientist, Neurotoxicology laboratory, US Environmental Protection Agency. Administered drugs, performed necropsy or surgery on rats and chickens, completed enzyme kinetic assays and axonal transport assays, prepared rat liver microsomes for bioactivation experiments. 1984 - 1986.

North Carolina State University, Raleigh, NC: Graduate Research Assistant, in a reproductive physiology research laboratory. Participated in embryology, endocrinology, and biotechnology research of cattle, pigs, and mice. Developed radioimmunoassay of protein and steroid hormones, completed embryo recovery, culture and transfer to bovine, swine and murine surrogate mothers. Gained skills in electron microscopy, paraffin histology and microinjection. 1983 - 1984.

University of North Carolina-Chapel Hill, Chapel Hill, NC: Clerk III, Lipid Research Clinics, Department of Biostatistics. Compiled case histories for review by a team of cardiologists in a clinical trial testing the cholesterol-lowering drug Questran. 1982.

Research Triangle Institute, RTP, NC: Laboratory Animal Technician. Responsible for daily care and maintenance of mice, rats, hamsters, guinea pigs, chickens and dogs. Conducted experiments, including dosing animals, performing small animal surgery, and collecting various biological samples. 1976 - 1978.

PROFESSIONAL ACTIVITIES

• Society of Toxicology
• NC Society of Toxicology
• American College of Toxicology
• Middle Atlantic Reproduction and Teratology Association (MARTA)
• Roundtable of Toxicology Consultants
  

PUBLICATIONS

BJ Collins, TB Grizzle, and JK Dunnick. Toxicokinetics of phenolphthalein in male and female rats and mice. Toxicol. Sci. 56, 271-281 (2000).

GM Szczech, P Furman, GR Painter, DW Barry, K. Borroto-Esoda, TB Grizzle, MR Blum, J-P Sommadossi, R Endoh, T Niwa, M Yamamoto, and C Moxham. Safety assessment, in vitro and in vivo, and pharmacokinetics of MKC-442, a potent and selective non-nucleoside reverse transcriptase inhibitor of HIV-1. Antimicrob. Agents Chemother. 44, 123-130 (2000).

PA Fail, JD George, TB Grizzle, and JJ Heindel. Formamide and dimethylformamide: Reproductive assessment by continuous breeding in mice. Reprod. Toxicol. 12, 317-332 (1998). 

JD George, PA Fail, TB Grizzle, and JJ Heindel. Nitrofurazone: Reproductive assessment by continuous breeding in Swiss mice. Fund. Appl. Toxicol 34, 56-66 (1996).

TB Grizzle, JD George, PA Fail, and JJ Heindel. Carisoprodol: Reproductive assessment by continuous breeding in Swiss mice. Fundam Appl. Toxicol. 24, 132-139 (1995).

RE Chapin, PA Fail, JD George, TB Grizzle, JJ Heindel, GJ Harry, BJ Collins, and JT Teague. The reproductive and neural toxicities of acrylamide and three analogues in Swiss mice, evaluated using the Continuous Breeding Protocol. Fundam. Appl. Toxicol. 27, 9-24 (1995).

TB Grizzle, JD George, PA Fail, JC Seely, and JJ Heindel. Reproductive effects of 4-vinylcyclohexene in Swiss (CD-1) mice assessed by a continuous breeding protocol. Fundam. Appl. Toxicol. 22, 122-129 (1994).

JJ Heindel, RE Chapin, DK Gulati, JD George, CJ Price, MC Marr, CB Myers, LH Barnes, PA Fail, TB Grizzle, BA Schwetz, and RSH Yang. Assessmant of the reproductive and developmental toxicity of pesticide/fertilizer mixtures based on confirmed pesticide contamination in California and Iowa groundwater. Fundam. Appl. Toxicol. 22, 605-621 (1994).

RE Chapin, DK Gulati, PA Fail, E Hope, SR Russell, JJ Heindel, JD George, TB Grizzle, and JT Teague. The effects of feed restriction on reproductive function in Swiss CD-1 mice. Fundam. Appl. Toxicol. 20, 15-22 (1993).

PA Fail, JD George, JC Seely, TB Grizzle, and JJ Heindel. Reproductive toxicity of boric acid in Swiss (CD-1) mice: Assessment using the Continuous Breeding Protocol. Fundam. Appl. Toxicol. 17, 225-239 (1991).

TB Grizzle, BH Johnson, and KL Esbenshade. Active immunization of boars against gonadotropin releasing hormone. I. Effects on reproductive parameters. Theriogenology 27, 571-580 (1987).

S Padilla, TB Grizzle, and D Lyerly. Triphenyl phosphite: A comparison of in vivo and in vitro effects on rat neurotoxic esterase. Tox. and Appl. Pharm. 87, 249-256 (1987).

TB Grizzle. The effects of active immunization against gonadotropin-releasing hormone on steroidogenesis and spermatogenic function in mature boars. North Carolina State University (Thesis), 1986.

ABSTRACTS

TB Grizzle. Exposure Assessments in Nonclinical Reproductive Toxicology Studies using Toxicokinetics, Including a Novel Approach for Monitoring Pre-/Postnatal Study Exposures. Toxicology Letters 189S (abstr. J02), 2009.

TB Grizzle, GC Rigdon, JW Stocker, GA McNaughton-Smith, and MM Yuschak. Nonclinical evaluations of ICA-17043: an Investigational Drug for Treatment of Sickle Cell Disease (SCD). Toxicol. Sci. 2006. 

TB Grizzle, JW Stocker, GA McNaughton-Smith, and GC Rigdon. Nonclinical evaluations of ICA-17043: A potent and selective drug candidate for treatment of sickle cell disease (SCD). 30th Anniversary Combined Meeting of the National Sickle Cell Disease Program and the Sickle Cell Disease Association of America (abstr. 42), 2002.

TB Grizzle, LH Wang, JP Walsh, N Song, and GM Szczech. Absorption, distribution, metabolism and excretion (ADME) studies of 14C-emtricitabine (CoviracilÒ; FTC) in monkeys and rats. Toxicol. Sci. 2001.

TB Grizzle, LH Wang, JP Walsh, RW Hart, JA Begley, and GM Szczech. Emtricitabine: Summary of Toxicology and Nonclinical Pharmacology Evaluations. 40th Interscience Conference on Antimicrobial Agents and Chemotherapy, Toronto, Canada, Abstr. 1631 (2000).

TB Grizzle, J Delehanty, LH Wang, FS Rousseau, and GM Szczech. Preclinical safety evaluation of emtricitabine (CoviracilÒ). XIII Intl. AIDS 2000, Durban, South Africa, Abstr. WePeA4058, (2000).

TB Grizzle, LH Wang, MR Blum, CP Moxham, FS Rousseau, CT Whalen, DG Halverson, and GM Szczech. Tissue distribution and excretion studies of emivirine in monkeys and rats. Toxicol. Sci. 54 (1-S), 256 (2000).

TB Grizzle, FS Rousseau, JT Delehanty, RW Hart, LH Wang, JP Walsh, JL Schardein, DG Stump, RW Tyl, and GE Szczech. Preclinical reproductive and developmental safety profile of CoviracilTM (emtricitabine, FTC), an oxathiolane nucleoside analog for the treatment of HIV and HBV infection. Abstracts of the Infectious Disease Society of America 37th Annual Meeting, Abstr. 337, p. 98 (1999).

TB Grizzle, FS Rousseau, J Delehanty, MR Almond, JP Walsh, JA Begley, and GM Szczech. (-)-FTC (emtricitabine), a nucleoside analog for the treatment of HIV and HBV infection, does not produce adverse effects in reproductive and developmental toxicity tests. Toxicol. Sci. 48 (1-S), 1827 (1999).

TB Grizzle, FS Rousseau, CP Moxham, and GM Szczech. Favorable reproductive and developmental safety profile of MKC-442, a new non-nucleoside reverse transcriptase inhibitor (NNRTI). 38th Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstr. 49-I.I-12 (1998).

KJ Dix, TB Grizzle, SA Anderson, DR Brine, RW Handy, and BJ Collins. Toxicokinetics and metabolism of tamoxifen (TAM) in rats after single and multiple administration. Toxicol. Sci. 42 (1-S), 1065 (1998).

BJ Collins, SA Anderson, TB Grizzle, DR Brine, RW Handy, and KJ Dix. Effect of rifampicin (RIF) on the single and multiple dose toxicokinetics and metabolism of 3’-azido-3’-deoxythymidine (AZT) in B6C3F1 mice. Toxicol. Sci. 42 (1-S), 1067 (1998).

TB Grizzle, KJ Dix, BJ Collins, DR Brine, and RW Handy. The toxicokinetics (TK) and metabolism of 2-hydroxy-4-methoxybenzophenone (HMBP) in rats and mice. The Toxicologist 36:1, part 2, 718 (1997).

KJ Dix, TB Grizzle, RW Handy, and BJ Collins. Toxicokinetics of benzophenone (BPH) in male and female rats and mice. The Toxicologist 36:1, part 2, 720 (1997).

CM Sparacino, BJ Collins, JC Blake, TB Grizzle, and KJ Dix. The toxicokinetics of intravenously and dermally administered d,l-camphor (CAM) in rats and mice. The Toxicologist 36:1, part 2, 719 (1997).

BJ Collins, KJ Dix, TB Grizzle, DR Brine, and RW Handy. Toxicokinetics of phenolphthalein (PTH) in male and female rats and mice. The Toxicologist 36:1, part 2, 710 (1997).
TB Grizzle, RW Handy, BJ Collins, GN Rao, SR Morehead, DR Brine, and L Buckley Kedderis. The pharmacokinetics (PK) of 3’-azido-3’-deoxythymidine (AZT) and its metabolites in B6C3F1 mice. The Toxicologist 15, 188 (1995).

TB Grizzle, L Buckley Kedderis, BJ Collins, TJ Goehl, RW Handy, and DS Marsman. Toxicokinetics (TK) of 2,4-dichlorophenoxyacetic acid (2,4-D) in rats, mice, and hamsters. The International Toxicologist 7, 47-P-9 (1995).

BJ Collins, L Buckley Kedderis, TB Grizzle, TJ Goehl, RW Handy, and DS Marsman. Toxicokinetics (TK) of di-n-butylphthalate (DBP) in rats, mice, and hamsters. The International Toxicologist 7, 47-P-13 (1995).

JR Buchanan, TB Grizzle, L Buckley Kedderis, BJ Collins, TJ Goehl, RW Handy, and DS Marsman. Toxicokinetics (TK) of gemfibrozil in rats, mice, and hamsters. The International Toxicologist 7, 47-P-14 (1995).

DS Marsman, L Buckley Kedderis, TB Grizzle, BJ Collins, RW Handy, and TJ Goehl. Toxicokinetics (TK) of the peroxisome proliferator WY-14,643 in rats, mice, and hamsters. The International Toxicologist 7, 47-P-11 (1995).

TB Grizzle, BJ Collins, GN Rao, JM Hill, NF Gaudette, and RW Handy. Effect of stomach pH on absolute bioavailability (F) of 2’,3’-dideoxyinosine (ddI) in female CD-1 Swiss mice. The Toxicologist 14, 379 (1994).

JD George, PA Fail, TB Grizzle, RSH Yang, and JJ Heindel. Reproductive toxicity evaluation of a pesticide/fertilizer mixture administered in the drinking water to mice. The Toxicologist 13, 77 (1993).

PA Fail, JD George, TB Grizzle, and JJ Heindel. Potential reproductive toxicity of formamide (FORM) as evaluated by the continuous breeding protocol. The Toxicologist 13, 76 (1993).

PA Fail, JD George, TB Grizzle, J Bishop, and JJ Heindel. Dominant lethality of acrylamide and three of it’s congeners after chronic exposure in Swiss mice. Env. Molec. Mutagenesis 21 (Suppl. 22): 19 (1993).

TB Grizzle, PA Fail, JD George, RE Chapin, and JJ Heindel. Reproductive effects of feed restriction in Swiss (CD-1) mice. Tri. Consortium for Reprod. Biol. Program, (Jan. 1992).

TB Grizzle, PA Fail, JD George, RE Chapin, and JJ Heindel. Feed restriction affects the reproductive competence of Swiss (CD-1) mice. Biol. Reprod. 46 (suppl. 1), 478 (1992).

TB Grizzle, JD George, PA Fail, and JJ Heindel. Reproductive toxicity of carisoprodol (CARI) as evaluated by the continuous breeding protocol. The Toxicologist 12, 197 (1992).

MK Izard, PA Fail, JD George, TB Grizzle, and JJ Heindel. Reproductive toxicity of cresol isomers administered in feed to mouse breeding pairs. The Toxicologist 12, 198 (1992).

JD George, PA Fail, TB Grizzle, and JJ Heindel. Reproductive toxicity of nitrofurazone (NTFZ) administered in the feed to mouse breeding pairs. The Toxicologist 12, 199 (1992).

PA Fail, JD George, TB Grizzle, JC Seely, and JJ Heindel. Reproductive toxicity of 4-vinylcyclohexene (VCH) in mice as evaluated by the continuous breeding protocol. The Toxicologist 11, 113 (1991).

JB Bishop, RE Chapin, PA Fail, JD George, TB Grizzle, BM Sadler, and JJ Heindel. Acrylamide induced dominant lethality in mice following low dose chronic administration in drinking water. Envir. Mol. Mut. 17 (Suppl. 19), 11 (1991).

JJ Heindel, JD George, PA Fail, and TB Grizzle. Reproductive toxicity of a chemical mixture (MIX) administered in the drinking water to Swiss mice. The Toxicologist 11, 113 (1991).

TB Grizzle, HR Sauls, SW Dennis, and PA Fail. Response of testis to hCG in swiss mice (CD-1) following chronic exposure to boric acid (BORA). Biol. Reprod. 40 (Suppl. 1), 153 (1989).

PA Fail, JD George, JC Seely, TB Grizzle, and JJ Heindel. Reproductive toxicity of boric acid (BORA) in male mice. J. Androl. (Suppl.) 10, 45 (1989).

PA Fail, JD George, TB Grizzle, and JJ Heindel. Reproductive toxicity of boric acid (BORA) in the feed as evaluated by the continuous breeding protocol. The Toxicologist 9, 266 (1989).

S. Padilla, TB Grizzle, and D Lyerly. A comparison of in vitro and in vivo neurotoxic esterase inhibition by triphenyl phosphite (TPP). The Toxicologist 6, 19 (1986).

BH Johnson, TB Grizzle, and KL Esbenshade. Testicular changes in mature boars actively immunized against GnRH. J. Anim. Sci. (Suppl.) 61, 396 (1985).

CONTINUING EDUCATION COURSES ATTENDED (SINCE 2000)

Stress as a Confounding Factor in Toxicology Studies.  Society of Toxicology (SOT) Course, March 2009.

Introduction to Pathology for Toxicologists and Study Directors. SOT Course, March 2008.

Concepts, Methods and Applications of Discovery and Investigative Toxicology.  SOT Course, March 2007.

Reproductive Toxicity Testing: Study Designs, Evaluation, Interpretation and Risk Assessment. SOT Course, March 2006

Practical Strategies for Evaluation of Immunosuppression in Pharmaceutical Development.  SOT Course, March 2006.

ICH Requirements for Conducting Non-clinical Safety Studies of Human Pharmaceuticals: Guidelines, Case Studies and Challenges.  SOT Course, March 2005.

Clinical Pathology - The Granddaddy of Biomarkers.  SOT Course, March 2005.

19th Annual Genetic and Molecular Toxicology Workshop. BioReliance Course, June 2005

Adrenal Gland: Mechanisms of Toxicity and Carcinogenisis. SOT Course, March 2004.

Toxicology Studies in Juvenile Animals: Why, When and How? ACT Course, November 2004.

Genetic Toxicology Principles, Practices and Emerging Challenges.  American College of Toxicology (ACT) Course, November 2004.

Mid-America Toxicology Course. Klaassen Course, April 2003 

Non-clinical Safety Assessment of Vaccines Regulated by CBER. ACT Course, November 2003.

WinNonlin Professional Hands-on Training Course.  Pharsight Course, February 2002.

Prediction of Human Toxicity and Metabolic Fate of Drugs Using In Vitro Systems. SOT Course, March 2001.

Liver Toxicology. SOT Course, March 2001.

Practical Approaches to Applying the Immunotoxicology Guidelines to Safety Assessment.  ACT Course, November 2001.

Regulatory Update. ACT Course, November 2001.

Safety Pharmacology and Risk Assessment. SOT Course, March 2000.

______________________________
Contact: TGrizzle@toxicologyservices.net