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      MATTER Workshop: Defining a CMC Strategy — How and Where to Begin in Chicago

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      October 25, 2018

      Thursday   9:30 AM

      222 West Merchandise Mart Plaza
      Chicago, Illinois 60654

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      MATTER Workshop: Defining a CMC Strategy — How and Where to Begin

      MATTER members and partners: use your discount code for 100% off the registration price. If you don't know your code, please email for assistance. ABOUT THIS WORKSHOP Chemistry, Manufacturing and Controls (CMC) exist to protect both patients and drug manufacturers and is important for maintaining the consistency of drug products as well as the ability to prove safety and efficacy in clinical studies. Regulatory requirements for clinical drug supplies vary by geographic region, so when planning clinical studies, the drug supply must meet the criteria for each country in which the study will be conducted.Join this workshop to learn how to: Develop a CMC strategy that provides a phased approach to selection of analytical methods, manufacturing procedures and validation to meet regulatory requirements Minimize expenditures and resources throughout the clinical process Develop a detailed description of how your product is manufactured and tested under GMP Define product specifications, a Certificate of Analysis for each product lot and a stability protocol Develop an understanding of FDA and ICH guidelines as well as the unique regional requirements of individual regulatory agencies and quality groups Can't attend in person? Join us in our virtual classroom. To join this workshop virtually via Webex, select the "Virtual classroom" ticket type at checkout - access instructions will be included in your email receipt. ABOUT THE INSTRUCTOR Richard Johnson, Ph.D., of BioPhia Consulting, is a protein biochemist with extensive experience in biologics and medical device development. He has lead teams in the development of anti-inflammatory biologics (both protein and nucleic acid based) and is a complement biochemistry expert with extensive experience in hemocompatibility applications (from novel coating technologies to regulatory testing requirements (ISO10993 Part 4)). He is proficient in protein isolation, characterization, modification, and structure-function analysis, including ligand-receptor interactions, forced degradation studies and immunogenicitym as well as cell isolation, cell culture and analysis, including flow cytometry, working with WBC subsets and CD34+ human stem cells. Prior to BioPhia, Richard headed research/development departments at Baxter and started a biotech company based on complement-inhibiting peptides. He is currently and Adjunct Professor at Rosalind Franklin University.

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