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. IntroductionSection I. Drug Discovery, Metabolism, and Pharmacokinetics2. Critical Aspects of Integrated Nonclinical Drug Development: Concepts, Strategies, and Potential Pitfalls3. ADME in Drug Discovery4. Pharmacokinetics and Toxicokinetics5. Secondary Pharmacology Screening in Drug DiscoverySection II. Toxicological Studies and Ind Application, and First In-Human Clinical Trial6. Acute, Subacute, Subchronic, and Chronic General Toxicity Testing for Preclinical Drug Development7. Genetic Toxicology Testing8. Contemporary Practices in Core Safety Pharmacology Assessments9. Preparation of a Preclinical Dossier to Support an Investigational New Drug (IND) Application and First-In-Human Clinical Trial10. Developmental and Reproductive Toxicology11. Juvenile Testing to Support Clinical Trials in Pediatric Population12. Preclinical Evaluation of Carcinogenicity Using Standard-Bred and Genetically Engineered Rodent Models13. Current Strategies for Abuse Liability Assessment of New Chemical EntitiesSection III. Clinical Pathology, Histopathology, and Biomarkers14. Clinical Pathology15. Best Practice in Toxicological Pathology16. Molecular Pathology: Applications in Nonclinical Drug Development17. Biomarkers in Nonclinical Drug DevelopmentIV. Biostatistics, Regulatory Toxicology, and Role of Study Directors18. Biostatistics for Toxicologists19. Regulatory Toxicology20. Role of Study Director and Study Monitor in Drug Development Safety StudiesSection V. Specialty Route of Administration21. Infusion Toxicology and Techniques22. Photosafety AssessmentSection VI. Nonclinical Development of Monoclonal Antibodies, Stem Cells, Oncogenic and Non-Oncogenic Drugs, Oligonucleotides, and Vaccines23. Preclinical Development of Monoclonal Antibodies24. Nonclinical Safety Assessment of Cell-Based Therapies25. Nonclinical Development of Antiviral Drugs26. Nonclinical Assessment of Anti-diabetic drugs27. Safety Assessments of Cancer Immunotherapy Drugs28. Application of Micro-physiological systems to enhance drug safety assessment29. Use of Humanized mice in Safety Assessment30. Safety Assessment of Cell and Gene Therapy31. Preclinical Development of Oncology Drugs32. Preclinical Toxicology of Vaccines33. Overview of the Nonclinical Development Strategies and Class-Effects of Oligonucleotide-Based TherapeuticsSection VII. Safety Evaluation of Ocular Drugs, Botanical Products, and Medicinal Devices34. Safety Evaluation of Ocular Drugs35. Safety Assessment of Targeted Protein Degraders (TBD)36. Biocompatibility Evaluation of Medical DevicesSection VIII. Predictive Toxicology, Toxicometabolomics, Toxicogenomics, and Imaging37. Application of Evolving Computational and Biological Platforms for Chemical Safety Assessment38. Use of Imaging for Preclinical Evaluation39. Drug Development Challenges and Opportunities Post-Pandemic