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Mapping Pre-Clinical and Clinical Timelines to CMC and CMC Regulatory Strategies

November 14-15, 2018
  • Washington, DC

Cell and gene therapies often address unmet needs for incurable and fatal disease. As a result, there’s a strong push for regulators to expedite applications, and with that speed comes questions, and risk, for biotheraputic manufacturers.

CBI’s Regulatory Congress for Cell & Gene-Based Therapy focuses on examining and mapping expedited regulatory pathways for next generation therapeutics. Join your peers and colleagues to learn how to expedite regulatory approval without compromising CMC integrity.

A Dialogue-Driven Forum on Existing Regulatory Pathways and Draft Guidances

  • Understand the Linkages Between CMC and Pre-Clinical Work
  • Learn To Quickly Scale Up CMC Operations Without Compromising Regulatory Success
  • Learn to Select Alternative Endpoints for Clinical Trial Success
  • Learn to Manage Unique Post-Approval Commitments for Cell and Gene-Based Therapies
  • Benchmark Expedited Pathway Strategies for Accelerated Approval

Regulatory Congress for Cell and Gene-Based Therapy

Mapping Pre-Clinical and Clinical Timelines to CMC and CMC Regulatory Strategies

Cell and gene therapies often address unmet needs for incurable and fatal disease. As a result, there’s a strong push for regulators to expedite applications, and with that speed comes questions, and risk, for biotheraputic manufacturers.

CBI’s Regulatory Congress for Cell & Gene-Based Therapy focuses on examining and mapping expedited regulatory pathways for next generation therapeutics. Join your peers and colleagues to learn how to expedite regulatory approval without compromising CMC integrity.

A Dialogue-Driven Forum on Existing Regulatory Pathways and Draft Guidances

  • Understand the Linkages Between CMC and Pre-Clinical Work
  • Learn To Quickly Scale Up CMC Operations Without Compromising Regulatory Success
  • Learn to Select Alternative Endpoints for Clinical Trial Success
  • Learn to Manage Unique Post-Approval Commitments for Cell and Gene-Based Therapies
  • Benchmark Expedited Pathway Strategies for Accelerated Approval