A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Ali Said Faqi, DVM, PhD, DABT, ATS, is a Senior Director of Developmental and Reproductive Toxicology, a Senior Principal Scientist at MPI Research and an Adjunct Associate Professor at Wayne State University, School of Medicine, Department of OBGYN in Detroit, MI. He received his Ph.D. from the University of Leipzig in Germany in 1995 and D.V.M. from Somali National University. Dr. Faqi earned a diploma of specialization in Experimental Pharmacology from the University of Milan in Italy. He was a postdoctoral fellow at the Institute of Clinical Pharmacology and Toxicology at the Free University of Berlin-Germany from 1996 till 1998. He worked as a Research Associate at Morehouse School of Medicine in Atlanta, Georgia and at Thomas Jefferson University in Philadelphia, Pennsylvania. Before joining MPI Research, Dr. Faqi was a Senior Scientist at Allergan Pharmaceuticals in Irvine, California and a Research Toxicologist at IIT Research Institute in Chicago, Illinois. He is a Diplomate of American Board of Toxicology (D.A.B.T.) and a Fellow of Academy of Toxicological Sciences (A.T.S.). Dr. Faqi is a member of the Editorial Board of Reproductive Toxicology Journal and ISRN Toxicology. He served as a Board of Scientific Counselors (BOSC) Computational Toxicology at the United States Environmental Protection Agency (US EPA) from September, 2009-September, 2010. He is also a member of Scientific Advisory Board of the Alzheimer's Art Quilt Initiative (AAQI). Dr. Ali Faqi is ad-hoc scientific reviewer for the scientific journals (Regulatory Pharmacology and Toxicology, Toxicology Journal, System Biology in Reproductive Medicine, Pesticide Biochemistry and Physiology, PLoS ONE and Birth Defects Research Part B: Developmental & Reproductive Toxicology). He is a Visiting Professor at the University of Palermo, Italy. In 2009, Dr. Faqi was a guest speaker at King Fahd Medical Research Center in King Abdiaziz University, Jeddah (Saudi Arabia) where he lectured on Preclinical Toxicology. He is a past chairman of the membership committee of the Teratology Society and a past President of Michigan Society of Toxicology. Currently, he is the chairman of the Education Committee of the Teratology Society (2012-2013) and the Vice President of Toxicologists of African Origin (2012-2013). He has published over 100 technical and scientific papers and authored and co-authored 7 book chapters.

1. Introduction

Section I. Drug Discovery, Metabolism, and Pharmacokinetics 2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls 3. ADME in Drug Discovery 4. Pharmacokinetics and Toxicokinetics

Section II. Toxicological Studies and Ind Application, and First In-Human Clinical Trial 5. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development 6. Genetic Toxicology Testing 7. Contemporary Practices in Core Safety Pharmacology Assessments 8. Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial 9. Developmental and Reproductive Toxicology 10. Immunotoxicology Assessment in Drug Development 11. Juvenile Testing to Support Clinical Trials in Pediatric Population 12. Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models 13. Current Strategies for Abuse Liability Assessment of New Chemical Entities

Section III. Clinical Pathology, Histopathology, and Biomarkers 14. Clinical Pathology 15. Best Practice in Toxicological Pathology 16. Molecular Pathology: Applications in Nonclinical Drug Development 17. Biomarkers in Nonclinical Drug Development

IV. Biostatistics, Regulatory Toxicology, and Role of Study Directors 18. Biostatistics for Toxicologists 19. Regulatory Toxicology 20. Role of Study Director and Study Monitor in Drug Development Safety Studies

Section V. Specialty Route of Administration 21. Infusion Toxicology and Techniques 22. Photosafety Assessment

Section VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines 23. Preclinical Development of Monoclonal Antibodies 24. Nonclinical Safety Assessment of Cell-Based Therapies 25. Preclinical Development of Nononcogenic Drugs (Small and Large Molecules) 26. Preclinical Development of Oncology Drugs 27. Preclinical Toxicology of Vaccines 28. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based Therapeutics

Section VII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices 29. Safety Evaluation of Ocular Drugs 30. Nonclinical Safety Assessment of Botanical Products 31. Biocompatibility Evaluation of Medical Devices

Section VIII. Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging 32. Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment 33. Toxicometabolomics: Technology and Applications 34. Toxicogenomics in Preclinical Development 35. Use of Imaging for Preclinical Evaluation