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Overview

Innovations in the development of advanced therapies have yielded new and dynamic solutions for the prevention and treatment of diseases where none existed previously. However, compared to traditional small molecules, advanced therapies present unique CMC challenges that may complicate development. Effective CMC strategies are crucial to the successful development and lifecycle management of these products. Leveraging advances in technology as well as accelerations in development due to the pandemic will enable us to bring even more products to market.

The DIA Advanced Therapies: Innovations in CMC conference will explore common CMC challenges posed by the development of these increasingly complex products. The use of multi-stakeholder perspectives and relevant case studies will provide solutions to enable regulatory compliance, shorter review timelines, and support post-approval maintenance.



Who should attend?

Professionals involved in the following areas of advanced therapy development:
  • CMC Regulatory Affairs
  • CMC Writing
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • Development and Manufacturing
  • CMC Project Management
  • Rare, Orphan Diseases
  • CMC Lifecycle Management
  • Biotechnology

Program Committee

  • Kirsten  Messmer, PhD, RAC
    Kirsten Messmer, PhD, RAC Senior Research Analyst
    POLITICO's Agency IQ, United States
  • Judy  Chou, PhD
    Judy Chou, PhD President and CEO
    AltruBio, Inc., United States
  • Eliana  Clark
    Eliana Clark Senior Vice President Technical Operations and Quality
    Intellia Therapeutics, Inc., United States
  • M. Scott  Furness, PhD
    M. Scott Furness, PhD Deputy Director, Office of New Drug Products, OPQ, CDER
    FDA, United States
  • Anthony  Bevivino
    Anthony Bevivino Associate Principal Scientist
    Merck & Co., Inc., United States
  • Sofia Håkansson  Buch
    Sofia Håkansson Buch Vice President for Stem Cell CMC & Manufacturing
    Novo Nordisk A/S, Denmark
  • Mia  Kiistala
    Mia Kiistala Owner, Principal Consultant
    Aurora CMC Consulting, Finland
  • Cynthia  Schnedar, JD
    Cynthia Schnedar, JD Principal, Regulatory Compliance
    Greenleaf Health Inc., United States
  • Cortney  Lawrence
    Cortney Lawrence Consultant Scientist, Global Regulatory Affairs CMC Biotechnology
    Eli Lilly and Company, United States
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