PPT-A Roadmap to Innovation in Drug Development – Stories About the FDA New Biomarker Qualification

John Michael Sauer PhD Critical Path Institutes Predictive Safety Testing Consortium Tucson Arizona jsauercpathorg So you have a biomarkers that you want to use for regulatory decision makingnow what do you do. 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. Worldwide Trends . 2014. What is a Biomarker?. Worldwide Trends. 2014. What is a Biomarker?. A biological marker, better known as a “biomarker”, is a characteristic . that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacological responses to a therapeutic . Not Quite Ready . for Prime Time. Scott Kopetz, MD, PhD. . Department of GI Medical Oncology. MD Anderson Cancer Center. NOT YET. YES. Individual Biomarkers versus . Molecular Subtypes. Individual biomarkers:. At . the end of this module, you will be . able to recall . FDA regulations . related to pharmaceutical . advertising . with 100% . accuracy. MODULE OBJECTIVE. Pharmaceutical companies spend millions of dollars on drug advertising . James D. McKean, DVM, JD. Associate Director, Iowa Pork Industry Center, . Iowa State University. x2mckean@iastate.edu. Future of . Antimicrobials. Disclaimer. - My “CRYSTAL BALL” . may be . cracked !!!. David W Feigal, Jr MD MPH. Adjunct Professor, O’Connor College of Law, ASU. January 16, 2016. Workshop: . Pharmaceutical Pricing and Marketing: Markets versus Regulation. “When I use a word” Humpty Dumpty said in a rather scornful tone, “it means just what I chose it to mean – neither more nor less.”. New . findings and methods for feed engineering to face present and future challenges in salmon . aquaculture. Presenter:. Albert . Caballero Solares, . Ph.D. Collaborators:. X. Xue. 1. , J.R. Hall. 2. James D. McKean, DVM, JD. Associate Director, Iowa Pork Industry Center, . Iowa State University. x2mckean@iastate.edu. Future of . Antimicrobials. Disclaimer. - My “CRYSTAL BALL” . may be . cracked !!!. 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. PhUSE 2014 Paper SP06 Renuka Chinthapally, Cytel Statistical Software & Services Pvt. Ltd., Hyderabad, India ABSTRACT Biomarkers play an important role in the clinical development due to their ability patent brand-name medicines. Low-cost generic drugs—Food and Drug Administration (FDA)-approved, interchangeable versions of the same products made by different manufacturers—were considered . Submit written comments to the Dockets ManagementStaff(HFA305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket physIQ. TEAM. Gary . Conkright. , CEO. Dr. Steve . Steinhubl. , CMO. Stephan . Wegerich. , CSO. Chris . Economos. , CCO. John . Varaklis. , . physIQ. Advisor. physIQ. : Extracting Insight from Biosensor Data. When They Work – When They Don’t . And Why. Steven Walker. Co-Founder, Volunteer. Abigail Alliance for Better Access . to Developmental Drugs. Kakkis. . Everylife. Foundation Panel – March 27, 2014.