PPT-JMP for Biosimilars : Tools for Analytical Similarity

Sept 16 2015 W Heath Rushing Adsurgo LLC Andrew Karl Adsurgo LLC Richard Burdick Elion Labs Outline 2 Introduction Current FDA ThinkingApproach Demonstration Statistical Equivalence using Sample Size and Variance Adjustment Method. Presented by . the Alliance for Safe Bioloigic . Medicines & the Global Colon Cancer Association. . . . . Andrew Spiegel, Esquire. . . andrew.spiegel@globalcca.org. THANK YOU! . Knowledge Connect Slide Resource. This slide deck has been designed to be used as a central resource from which pertinent slides can be extracted as needed . and is not intended for use in its entirety. Introduction/Overview . What Is a Biosimilar?. Differences Between Development of Generics and Biosimilar Medications. Clinical Development Program: Biosimilars. Biosimilar Outliers:. "Biomimics" and "Biobetters". Practical Legal/Regulatory Considerations Arising In The Course Of The Pathway’s Implementation. John M. Engel, Esq.. Managing Partner. Engel & Novitt, . l. lp. The Law Firm That Knows Its Science. Introduction/Overview . PLANETRA Extension Study: . ACR50 Response Rate. Etanercept vs SB4 (Etanercept Biosimilar): ACR20 Response Rates. Typical Study Design for Biosimilar Switching Studies in Rheumatology. OMICS Group Biosimilars 2015 Birmingham, UK. 10-11 Aug 2015. Hazel Gorham . GorhamHazel@prahs.com. Topics. What is a Biosimilar and Why?. Demonstrating Similarity . Quality attributes. Non-clinical animal. Mia Stephens – . mia.stephens@jmp.com. What is JMP (and JMP Pro)?. Statistical Discovery Software from SAS. Developed in 1989. For teaching and doing. Comprehensive. Basic. Advanced. Extendible. powerful scripting language. Alice DOMINIQUE - M2 AREIPS. 1. Content. 2. Definitions. 3. What. . is. a . biological. . medicine. ?. Biological medicine = Biologic medical product . . . . = Biological . . . Key Issues and Challenges.  . Introduction. Differences Between Generics and Biosimilars. Clinical Development Program: . Biosimilars. Differences Between Development of New Generics and New Biosimilar Medications. Dr Chris Deighton. Consultant Rheumatologist . Conflicts of interest. Advisory boards for . Hospira. and . Napp. Work with Pfizer, Janssen, . Abbvie. , Roche . Arguments for. We have been using . biosimilars. Richard . Dolinar. , MD. Endocrinologist, Chairman of the Alliance for Safe Biologic Medicines. Presented at the . Colorado . Biosimilars. . Educational Forum  . December . 6, . 2012. 2. The differences between Chemical Drugs and Biotech Medicines you . ®. to Enhance Traditional Taguchi Methods. 2015 JMP Discovery Summit, San Diego. Author: Steve Olsen, Sr. Principal Reliability Engineer, Ogden Tech Center. Why robust optimization?. SN and Mean calculated from spread in results across noise factors. Quiz. Which pair of words exhibits the greatest similarity?. 1. Deer-elk. 2. Deer-horse. 3. Deer-mouse. 4. Deer-roof. Quiz Answer. Which pair of words exhibits the greatest similarity?. 1. Deer-elk. 2. Deer-horse. Disclaimer. This panel is moderated by Dr. Delphine Courmier, Executive Director Global Head of Pricing. & Biosimilars Market Access at Organon. The views expressed are those of the speakers and do not necessarily represent the views of ISPOR or Organon..