Cambridge Healthtech Institute’s 3rd Annual

Gene Therapy CMC and Analytics

Regulation and Analysis of Vector-Based Gene Therapies

August 14-15, 2019


Gene therapy is an extremely promising technique for the treatment of incurable diseases such as cancer and genetic disorders such as hemophilia. However, the analysis, characterization and delivery of these unique products remain a key issue.

Cambridge Healthtech Institute’s Gene Therapy CMC and Analytics meeting uncovers the practical challenges facing vector-based gene therapy analytics, assay development, quality control, vector development and delivery.

Coverage will include, but is not limited to:

  • CMC and analytics
  • CMC requirements from Phase I-Phase III
  • Potency assay development and validation
  • Gene therapy analysis and characterization – MS, NMR, HPLC
  • Particle sizing
  • Plasmid production, aggregation and purity
  • Stability testing – ancillary materials, lipids, carbon source of producer
  • Comparability following process change
  • CMO sourcing and management
  • Formulation, stability and delivery
  • Gene editing/CRISPR techniques in gene therapy
  • Gene editing and delivery
  • Vector design, selection and development
  • Delivery strategies for gene therapies – viral and non-viral delivery systems
  • Determining whether the vector is full or empty
  • Molecular biology – RNA, DNA, synthetic, peptide
  • Nanoparticles     

If you would like to submit a proposal to give a presentation at this meeting, please click here.

The deadline for priority consideration is February 11, 2019.

All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.


For more details on the conference, please contact:
Daniel Barry
Senior Conference Director
Cambridge Healthtech Institute
Phone: 781-247-6266
Email: dbarry@healthtech.com

For partnering and sponsorship information, please contact:

Companies A-K
Sherry Johnson
Senior Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-1359
Email: sjohnson@healthtech.com

Companies L-Z
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5412
Email: cbenton@healthtech.com