PPT-Striking the Balance: FDA Oncology’s Regulatory Perspective on Development of Agents

Lynn Howie MD Medical Officer DOP1 Supportive Care is Crucial for Cancer Treatment Antiemetics Growth factors Bone health agents Agents to reduce mucositis Antidiarrheals Supportive care therapies reduce symptoms and side effects allowing for improved delivery of chemotherapy agents many of which are given with curative intent . Phil clin Psych students Elective international student teaching Public Cancer Awareness Programmes Dr Suraj Manjunath Associate Professor Head of Department Dr Shiva Kumar K Assistant Professor Dr Rakesh S R amesh Assistant Professor Dr Tanveer Huss Megan Sheahan and Christopher . B. . Barrett. Presentation for . the workshop . on Structural Transformation in African Agriculture and . Rural Spaces . (STAARS. ). African Development Bank Headquarters, Tunis, . Bruce Ross. , . M.A. M.P.H.. Director, India Office. Agenda. Priorities. Challenges of globalization. cGMP. . deficiencies. Comparison. Post inspection regulatory . actions. 2. Advance Regulatory Science: the science of developing new tools, standards and approaches to assess the safety and effectiveness, quality and performance of FDA-regulated products. Vivid Verbs. From So-So to Striking. Copyright 2014 by . Write Score, LLC. . All Rights Reserved. .. Some Verbs are “So-So”. Linking verbs or state-of-being verbs do little to create meaningful and engaging writing. . Erika Frank. Definition. Hitting an object with a paddle or racket. Complex skill with multiple critical cues . Underarm striking pattern cues:. Slanted paddle, paddle way back, opposite foot, follow through, watch the ball. Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. FDA Modeling and Simulation Working Group. Sponsored by the Office of the Chief . Scientist Fall 2016. Main . Objectives. :. Raise awareness of the successes, challenges and opportunities for modeling and simulation to advance regulatory science at the FDA;. Carolyn Compton, M.D., Ph.D.,. CEO and . President. Critical Path Institute . (. C-Path). IOM Workshop International Regulatory Harmonization. Washington, DC. February 13, 2013. The Global Challenge. precision.fda.gov | precisionFDA@fda.hhs.gov | @precisionFDA. Taha A. Kass-Hout, MD, MS. FDA Chief Health Informatics . Officer. Director, FDA’s Office of Health . Informatics. David . Litwack. , PhD. You . Peter Argenta, MD. Definition. The conditions that result when nerves that carry messages to and from the brain and spinal cord from and to the rest of the body are damaged or diseased.. What does it mean for patients?. John Michael Sauer, PhD. Critical Path Institute’s Predictive Safety Testing Consortium. Tucson, Arizona. jsauer@c-path.org. So you have a biomarker(s) that you want to use for regulatory decision making…now what do you do?. Alzheimers. Therapeutics . (and Diagnostics). Mark Ammann, . Pharm.D. .. President, Catalyst Regulatory Services. September 12, 2017. Pharm.D. . University of Michigan College of Pharmacy. 27 years working in Industry. over 55 years of neuropathic toxicity: . if not now, when do we take . aaacttion. . Joanna M . Brell. , MD. Clinical Associate Professor of medicine. Case Western Reserve University. Associate Director Cancer Center for clinical research. Pamela Horn, MD. Clinical Reviewer. DAAAP. Outline. Patient Perspective from PFDD Public Meeting. Drug Approval Standards. Approved Therapies. Possible CIPN Indications. FDA Review Division Roles. Study Design Issues Raised by Sponsors.