Cancer: Pathophysiology, Current Therapies, Clinical Trials and Drug Development MicroTek Training Center Washington, DC October 17 19, 2018

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1 Cancer: Pathophysiology, Current Therapies, Clinical Trials and Drug Development MicroTek Training Center Washington, DC October 17 19, 2018 Wednesday, October 17, :00 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 9:30 AM Clinical Overview 1 Evolution of Targets Development Phases Companion Diagnostic Development Timeline Clinical Team Members 9:30 AM 10:30 AM Considerations for Clinical Trial Design and Endpoints Toward U.S. Drug Approval Lorraine Pelosof, MD PhD Medical Officer, Gastrointestinal Oncology Team Office of Hematology and Oncology Products U.S. Food and Drug Administration 2 10:30 10:45 AM Morning Break Safety and Efficacy requirements for approval Clinical Trial Endpoints, trial designs, types of approval Expedited Trials 10:45 11:45 AM Upper Gastrointestinal Malignancies: An Overview of Therapy Lorraine Pelosof, MD PhD 3 Pancreatic cancer Stomach cancer Hepatocelluar carcinoma PERI, Inc

2 Wednesday, October 17, 2018 continued 11:45 AM 1:00 PM Improved Strategies for Selecting Recommended Phase 2 Dosing: Moving Beyond Maximum Tolerated Dose Lanre Okusanya, PharmD, MS Clinical Pharmacologist. Division of Clinical Pharmacology V Office of Clinical Pharmacology U.S. Food and Drug Administration 4 1:00 PM 1:45 PM Lunch Break Learnings from toxic examples Clinical Pharmacology driven decision making - Dose-response and exposure-response Non-oncology learnings Dose Selection - Importance and process - Alternatives to toxicity driving RP2D - Pharmacodynamic endpoints in early drug development 1:45 2:45 PM Analysis of Time to Event Data Malini Iyengar, PhD Director, Biostatistics & Programming Adaptimmune US 5 Define Time to event data Methods used to analyze these data Designing studies with TTE data 2:45 3:45 PM Emerging Concepts in Cancer Immunotherapy Julius Strauss, MD Assistant Research Physician, Laboratory of Tumor Immunology and Biology Co-Director, Clinical Trials Group Center for Cancer Research National Cancer Institute 6 3:45 4:00 PM Afternoon Break Immune Checkpoint Inhibition Update on therapeutic cancer vaccines Biomarker development Developing immune combinations and the next generation of immunotherapy 4:00 5:00 PM Malignant 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 7 Background & Staging of disease Risk factors and screening PERI, Inc

3 Overview of Current treatment standard of care pros/cons Recent approvals Overview of future treatment horizons Thursday, October 18, :00 8:30 AM Continental Breakfast 8:30 9:30 AM Pediatric Regulations and FDASIA: Operational Approaches to New FDA Initiatives Supporting Development for Pediatrics 8 9:30 9:45 AM Morning Break 9:45 10:45 AM Prostate Cancer Clinical Update Marijo Bilusic, MD, PhD Associate Research Physician, Genitourinary Malignancies Branch Program Direct, NIG Hematology Oncology Fellowship National Cancer Institute 9 10:45 AM - 12:00 PM Regulatory Actions and Outcomes for NDAs and BLAs Florence Houn, MD, MPH, FACP VP, Global Regulatory Science Celgene Corporation 10 12:00 12:45 PM Lunch Break Refuse to file, filing over protest, withdrawal PDUFA VI Interactions Complete Response, Approval, Appeals PMR/PMC, REMS 12:45 1:45 PM Leukemias Blanche H. Mavromatis, MD Medical Oncologist Western Maryland Health System Schwab Family Cancer Center Acute leukemias Chronic leukemias 1:45 2:45 PM Lymphoid Malignancies Blanche H. Mavromatis, MD Medical Oncologist Western Maryland Health System Schwab Family Cancer Center :45 3:00 PM Afternoon Break Lymphoid malignancies overview Hodgkin s disease and non-hodgkin s lymphoma Burkitt s lymphoma PERI, Inc

4 3:00 4:00 PM Lung Cancer Clinical Update Shakun Malik, MD Head, Thoracic Cancer Therapeutics Cancer Therapy Evaluation Program National Cancer Institute Draft Course Agenda v3 September Overview of molecular pathogenesis of lung cancer Staging and treatment of lung cancer Thursday, October 18, 2018 continued 4:00 5:00 PM Breast Cancer Blanche H. Mavromatis, MD Medical Oncologist Western Maryland Health System Schwab Family Cancer Center 14 Friday, October 19, :00 8:30 AM Continental Breakfast 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 8:30 9:30 AM Colorectal Cancer Clinical Update Benjamin A. Weinberg, MD Assistant Professor of Medicine, Division of Hematology and Oncology Gastrointestinal Medical Oncologist, Lombardi Comprehensive Cancer Center Georgetown University Medical Center 15 9:30 10:45 AM Pancreatic Cancer Clinical Update Benjamin A. Weinberg, MD 16 10:45 11:00 AM Morning Break 11:00 AM 12:00 PM Renal Cell Cancer Chana Weinstock, MD Medical Officer, Genitourinary Group Division of Oncology Products 1 Office of Hematology and Oncology Products U.S. Food and Drug Administration 17 : Background Current treatment landscape Ongoing trials and future directions PERI, Inc

5 12:00 1:00 PM Oncologic Imaging in Drug Development: Past, Present and Future 18 Trial Mechanics Imaging Modalities Regulatory Issues 1:00 PM Adjournment PERI, Inc

6 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 L01-P continuing education units (CEUs) are available for this program. Initial Release Date: 10/17/18. 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 18.5 AMA PRA Category 1 Credits. Physicians should claim only the credit commensurate with the extent of their participation in the activity. PERI, Inc