Pharmaceutical Toxicology: Toxicology in the Nonclinical Development of Drugs and Biologics. December 3-4, 2012 PERI Training Facility ~ Arlington, VA

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1 Pharmceutical Toxicology: Tentative Agenda Pharmaceutical Toxicology: Toxicology in the Nonclinical Development of Drugs and Biologics December 3-4, 2012 PERI Training Facility ~ Arlington, VA Monday, December 3, :30 8:00 AM Registration and Continental Breakfast PERI Welcome Address Jan Horner, Course Manager Pharmaceutical Education and Research Institute, Inc. (PERI) 8:00 9:00 AM An Introduction to Designing Nonclinical Toxicity Studies in Relationship to the Rest of the Project Plan 4 Dependence of toxicology on CMC, pharmacology, pharmacokinetic data, and the clinical plan Execution of a nonclinical plan by a project team 9:00 10:30AM Pharmacokinetic Concepts for Pharmaceutical Development 5 10:30-10:45 AM Refreshment Break Key concepts in metabolism and pharmacokinetics The basis and consequences of interspecies differences Dealing with the uncertainties and expectations of pharmaceutical development 10:45 AM 11:45 AM Safety Pharmacology and Genotoxicity 6 12:15 1:15 PM Lunch on Your Own 1:15 2:15 PM Dose Range-Finding and Repeated-Dose Toxicity Studies 7

2 Monday, December 3, 2012 continued... 2:15 3:30 PM Reproductive Toxicology Invited - Benjamin Fisher, PhD 8 3:30 3:45 PM Refreshment Break ICH test guidelines and their scientific basis Toxicokinetics in reproductive toxicology Timing of studies relative to clinical trials Risk Assessment 3:45 5:00 PM Pharmaceutical Development in High Risk Disease: The Case of Cancer Whitney Helms, PhD Division of Hematology Oncology Toxicology 9 Description of ICH S9 Differences between ICH S9 and ICH M3 Points to consider during drug development Case study of the oncology drug review process 4:45-5:00 Daily Wrap up/questions 2

3 Tuesday, December 4, :30 8:00 AM Continental Breakfast 8:00 9:00 AM Nonclinical Safety Testing for Reformulated Drug Products and Novel Excipients: Teaching Old Drugs New Tricks Dan Mellon, PhD Supervisory Division of Anesthesia, Analgesia, and Addiction Products 10 Overview Published FDA Draft Guidance Document for Reformulations Discuss nonclinical bridging existing nonclinical information to support reformulated drug product Overview of FDA Guidance to Industry: Nonclinical Safety of Excipients Defining what is a new/novel excipient and what must be done to characterize safety of novel excipient. What drug developers should do; what they frequently do, why it does not work and how to avoid hold issues. Overview of caveats in the Regulatory Pathways and common misconceptions about what can and cannot be used to support a new drug application. 9:00 10:00 AM Toxicology Considerations for Ophthalmic Drug Development Maria I. Rivera, PhD Division of Anti-Infective and Ophthalmology Products Office of Antimicrobial Products 11 Ocular route studies Systemic route studies 10:30 10:45 AM Refreshment Break 10:45 AM 11:45 AM Immunotoxicological Evaluation of Investigational New Drugs: Regulatory Aspects Richard Houghtling, PhD Division of Neurology Products CDER Immunotoxicology Subcommittee Chair 12 12:15 1:15 PM Lunch on Your Own Regulations and guidances FDA/CDER Guidance for Industry: Immunotoxicology Evaluation of Investigational New Drugs 3

4 Tuesday, December 4, 2012 continued 1:15 2:15 PM Workshop :15 3:15 PM Nonclinical Development of Biotechnology-Derived Products Barbara Wilcox, PhD Division of Neurology Products 14 Distinguishing characteristics Studies unique to biologics Preclinical safety studies Regulatory review process 3:15 3:30 Refreshment Break 3:30 5:00 PM Carcinogenicity Studies Adam Wasserman, PhD Supervisory Division of Anesthesia, Analgesia, and Addiction Products 15 Regulatory requirements Types of studies and issues with design and selection FDA review process, and the Carcinogenicity Assessment Committee (CAC) and Executive CAC 5:00 PM Course Wrap-up, Adjournment, and Questions 4

5 CONTINUING EDUCATION CREDIT Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit both the Continuing Education Application form and the program evaluation directly to a PERI on-site coordinator. A continuing education certificate or Statement of Credit will be distributed to you within three weeks of this program. Pharmaceutical Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number is L01-P 1.4 continuing education units (CEUs) are available for this program. Initial Release Date: 12/03/2012. This is a knowledge based CPE Activity. Medical PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this live activity for a maximum of 14 AMA PRA Category 1 Credits TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity Pharmaceutical Education & Research Institute, Inc. (PERI) All Rights Reserved 5