Opportunities for Podium, Poster, and Sponsor Presentations at

Cambridge Healthtech Institute’s 2nd Annual

Gene Therapy R&D Analytics

Tools and Technologies for the Preclinical R&D of Gene-Based Therapies

May 5-6, 2022

 

A vast number of mainstream and emerging biotechs are now engaged in the discovery and development of gene therapies, but significant advances in analytical and process technologies are required to support preclinical and clinical development, quality control strategies and progression through the regulatory steps needed to reach the market. The Gene Therapy R&D Analytics meeting offers an opportunity for leading scientists to share their experiences with new tools, lessons and learned – and what works and doesn’t work – to move efficiently in this explosive new field of pharmaceutical science.

 

Coverage will include, but is not limited to:

 

Discovery Stage Evaluations

  • Delivery method, route of administration considerations
  • iscovery stage developability assessment
  • Molecular design, developing an attributes profile

 

Analytical Issues for Second Generation Gene Therapies

  • Epigenetic regulators
  • Gene editing therapies
  • Non-viral nanoparticles for gene delivery

 

Development of Essential Assays

  • Aggregation, particle characterization
  • Biomarker studies
  • Bioassay/potency assay strategy, selection and development
  • Characterization of impurities
  • Empty/full ratio
  • Functional assays
  • Safety and immunogenicity

 

Drug Product Development

  • Device development
  • Formulation development
  • Stability studies

 

Problems and Solutions

  • Analytical methods for small samples
  • Identification of critical quality attributes
  • Process characterization, control strategies and in-process analytics to support PD

 

Regulatory and Standards Issues

  • Comparability analysis
  • Experiences with agency interactions
  • Impact of accelerated review timelines

 

The deadline for priority consideration is October 22, 2021.

 

All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s 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.

 

Opportunities for Participation:

 

 

For more details on the conference, please contact:

Kent Simmons

Senior Conference Director

Cambridge Healthtech Institute

Phone: 207-329-2964

Email: ksimmons@healthtech.com

 

For sponsorship information, please contact:

Companies A-K

Jason Gerardi

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: 781-972-5452

Email: jgerardi@healthtech.com

 

Companies L-Z

Ashley Parsons

Manager, Business Development

Cambridge Healthtech Institute

Phone: 781-972-1340

Email: ashleyparsons@healthtech.com