PPT-Understanding Biologics Biologics and Biosimilars

Animation What Are Biologics Production of Biologics Sources of Variation in Biologics Variability Is a Natural and Expected Property of All Biologics Glycosylation Affects Protein Properties Most Biologics Have Undergone Manufacturing Changes. Interchangeability = SubstitutabilityInterchangeable biologics must produce the same result in any given patient, and without negative effects, in terms of safety or efficacy, from switching between t 1. PEG Nanoparticles: . Production . and Drug Delivery. Structure and Function. Principles of the . NanoKit. :. A Laboratory Educational Tool . Syed K. Hasan M.D. . Ph.D. CEO/President. . Arthur . a Virtual Biologics Clinic. Dr Ben Parker PhD, MRCP. Consultant Rheumatologist, Manchester Royal Infirmary. Honorary Senior Lecturer, University of Manchester. To cover. Why the need for innovation in biologics services?. New Opportunities for Universities and Small Biotech Companies: . Is there a role for little New Zealand?. Are we outgunned?. Too small? . Not enough fancy equipment? . Dr Doug Wilson . Biologic Drugs. Presented by . the Alliance for Safe Bioloigic . Medicines & the Global Colon Cancer Association. . . . . Andrew Spiegel, Esquire. . . andrew.spiegel@globalcca.org. THANK YOU! . This program will include a discussion of off-label treatments and investigational agents not approved by the FDA for use in the US, and data that were presented in abstract form. These data should be considered preliminary until published in a peer-reviewed journal.. By. ANSHUL . SHARMA. Graduate Research Scholar. Deptt. Of Biochemical Engg & Biotechnology,. Indian Institute of Technology, Delhi . Biosimilars. Coined by EMA (European Medicine Agency). Bio-betters. 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 . Dr.G.Hima. . Bindu. . MD; PG dip. . diabetology. Asst.Professor. Dept. of Pharmacology. Rajiv Gandhi Institute of Medical Sciences. Ongole. Safety (BEST) Initiative: . Pilot Year. Azadeh Shoaibi, PHD, MHS. CBER Sentinel Lead. FDA Center for Biologics Evaluation and Research. October 12, 2018. Outline. What are Biologics? . BEST Initiative: a component of the CBER Sentinel Program. 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.. Clue: . A biologic product with no clinically meaningful differences from its reference product.  . What is… . A biosimilar. A biosimilar is a biological product that:. 1,2. . Is highly similar to the RP notwithstanding minor differences in clinically inactive components; and. What does personalisation . mean . for you?. Ian N Bruce. Kellgren. Centre for Rheumatology. NIHR . Manchester Biomedical Research . Centre University of Manchester . @. Lupusdoc. Manchester University Hospitals NHS Trust and University of Manchester.