Cancer: Pathophysiology, Current Therapies, Clinical Trials and Drug Development One Washington Circle Hotel, Washington, DC October 19-21, 2016

Transcription

1 Cancer: Pathophysiology, Current Therapies, Clinical Trials and Drug Development One Washington Circle Hotel, Washington, DC October 19-21, 2016 Wednesday, October 19, :30 8:30 AM Registration and Continental Breakfast 8:30 8:45 AM PERI Welcome and Course Overview Lauren Kirk, Course Manager The Pharmaceutical Education and Research Institute, Inc. 8:45 10:00 AM Clinical Pharmacology - Dose Selection Julie Bullock, PhD Senior Director of Clinical Pharmacology & Regulatory Science d3 Medicine 1 10:00 10:15 AM Morning Break 10:15 11:30 AM Protocol Designs and Statistical Issues Malini Iyengar, PhD Director, Biostatistics Adaptimmune US 2 Overview of Phase 2-3 Trial Designs Approaches without or with predictive biomarkers Clinically meaningful endpoints, PFS, OS, and the ASCO Recommendations to Raise the Bar for Clinical Trials Foreign data; Regional differences in standard care 11:30 AM 12:30 PM Overview of US FDA Regulatory Guidance in Oncology Development Leigh Marcus, MD Medical Officer, Division of Oncology Products 2 Office of Hematology and Oncology Products Office of New Drugs, CDER U.S. Food and Drug Administration 3 Safety and Efficacy requirements for approval Clinical Trial Endpoints, trial designs, types of approval Expedited Trials 12:30 PM 1:30 PM Lunch Break 1:30 2:30 PM Lung Cancer Shakun M. Malik, MD, Head, Thoracic and Head & Neck Cancer Therapeutics Clinical Investigational Branch, Cancer Therapy Evaluation Program Division of Cancer Therapy and Diagnosis 4 Overview of molecular pathogenesis of lung cancer Staging and treatment of lung cancer

2 Wednesday, October 19, 2016 (continued) 2:30 3:30 PM Managing Radiologic Imaging for Oncology Phase II-III Studies Robert Ford, MD Founder & Principal Clinical Trials Imaging Consulting, LLC 5 Imaging Endpoints and RECIST Challenges for imaging with emerging therapies Global Registration Trials 3:30 3:45 PM Afternoon Break 3:45 5:00 PM Clinical Pharmacology Neeraj Gupta, PhD Director, Clinical Pharmacology (Oncology) Takeda Oncology 6 Thursday, October 20, :30 8:00 AM Continental Breakfast 8:00 9:00 AM Prostate Cancer Clinical Update Ravi Madan, MD Clinical Director, Genitourinary Malignancies Branch Center for Cancer Research 7 9:00 10:00 AM Emerging Concepts in Immunotherapy Ravi Madan, MD 8 Immune Checkpoint Inhibition Update on therapeutic cancer vaccines Biomarker development Developing immune combinations and the next generation of immunotherapy 10:00 10:15 AM Morning Break 10:15 11:15 AM Upper Gastrointestinal Malignancies: An Overview of Therapy M. Naomi Horiba, MD MPH Medical Officer, GI team Scientific Liaison for Gastroesophageal Cancers CDER/OND/OHOP/DOP2 US Food and Drug Administration 9 Pancreatic cancer Stomach cancer Hepatocelluar carcinoma 2

3 Thursday, October 20, 2016 (continued) 11:15 AM 12:15 PM Melanoma Sekwon Jang, MD Hematology Oncology, Inova Medical Group Director, Melanoma and Cutaneous Oncology Therapeutics and Research Inova Melanoma and Skin Cancer Center, Inova Schar Cancer Institute Associate Professor of Medicine, Virginia Commonwealth University 10 Background & Staging of disease Risk factors and screening Overview of Current treatment standard of care pros/cons Recent approvals Overview of future treatment horizons 12:15 1:15 PM Lunch Break 1:15 2:00 PM Leukemias Braddock Oncology Associates Western Maryland Health System Regional Cancer Center 11 Acute leukemias Chronic leukemias 2:00 2:15 PM Afternoon Break 2:15 3:15 PM Lymphoid Malignancies 12 Lymphoid malignancies overview Hodgkin s disease and non-hodgkin s lymphoma Burkitt s lymphoma 3:15 4:15 PM Breast Cancer 13 Risk factors and screening Local treatment options for adjuvant therapies Hormonal therapy options for early stage breast cancer Adjuvant chemotherapy options Goals of treatment Therapies: supportive, endocrine, chemotherapy 4:15 4:30 PM End of Day Discussion 3

4 Friday, October 21, :30 8:15 AM Continental Breakfast 8:15 9:15 AM Overview of Oncology Targets and Emerging Therapies Senior Medical Director, Clinical Intelligence, Takeda Pharmaceuticals and Industry Representative to the FDA Oncology Drugs Advisory Committee (ODAC) 14 9:15 9:30 AM Morning Break : Fundamentals of early drug development Molecular Underpinnings of Oncology Pathways to Clinical Development 9:30 10:45 AM New Perspectives in Colorectal Cancer Mohamed Salem, MD GI Oncologist Assistant Professor of Clinical Medicine Associate Fellowship Program Director Division of Hematology and Oncology Lombardi Comprehensive Cancer Center, Georgetown University 15 General trends in gastrointestinal cancer Etiology Current effective treatment modalities Experimental horizons 10:45 AM 12:00 PM Ovarian and Renal Cancers 16 12:00 1:00 PM Lunch Break Background & Risk factors Emerging therapeutics Learnings from recent registration programs 1:00 2:15 PM Pediatric Regulations and FDASIA: Operational Approaches to New FDA Initiatives Supporting Development for Pediatrics Margaret Thompson, MD Medical Officer, Division of Oncology Products 2 Office of Hematology and Oncology Products US Food and Drug Administration 17 2:15 2:30 PM Afternoon Break 2:30 3:15 PM Learnings from the FDA Oncology Drugs Advisory Committee (ODAC) 18 3:15 4:00 PM How to Apply the Information Learned 4:00 PM Adjournment PERI reserves the right to change agenda items and instructors without notice to accommodate situations beyond its control. 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 the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit. Continuing Pharmacy Education 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 continuing education units (CEUs) are available for this program. Initial Release Date: 10/19/16. This is a knowledge based CPE Activity. Continuing Medical Education 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 20.25AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity. 5