Cambridge Healthtech Institute’s 8th Annual

Accelerating Analytical Development

August 18-19, 2021


Industry analytical groups are facing increased pressure to deliver key studies faster than ever before – and at lower costs. Cambridge Healthtech Institute’s 8th Annual Accelerating Analytical Development conference offers a best practices forum in which industry scientists and managers can exchange ideas on strategies, new technologies, and the integration of analytical methods in support of these goals. The conference will address the most important roles of the analytical function from early development through release testing and provide insights on how different organizations are addressing these challenges.

 

Coverage will include, but is not limited to:

 

Automation and Miniaturization

  • Method development for automation
  • New technologies for multiplexing sample analysis
  • Overcoming analytical bottlenecks with HT cell culture, bioprocess and purification technologies

Challenges and Solutions

  • Characterization challenges for cell and gene therapies
  • Characterization for combination products (purity, release, formulation development)
  • Design space approach for analytical method development

Management of Critical Reagents

  • Consistency issues with internal and external supply chains
  • Lifecycle management for critical release assay reagents
  • Measuring reagent comparability

Process Analytics

  • Best practices for developing a control strategy
  • Method development for in-process analytics
  • New technologies for at-line, on-line and in-line process monitoring

Regulatory and Standards Issues

  • EMA and FDA agency perspectives on method changes and bridging exercises
  • Implementing ICH Q12 (Technical and Regulatory Considerations for Lifecycle Management)
  • Update from USP MS working group

Risk Assessment for Accelerated Timelines

  • Risk assessment in small R&D organizations with resource constraints
  • Takeaways from COVID-19-related accelerated development programs; reconsidering risk
  • The benefits and risks of running characterization steps in parallel to accelerate development

 

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

 

The deadline for priority consideration is January 29, 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 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:

Kent Simmons

Senior Conference Director

Cambridge Healthtech Institute

Phone: (+1) 207-329-2964       Email: ksimmons@healthtech.com

 

For partnering and sponsorship information, please contact:

Companies A-K

Sherry Johnson

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-972-1359

Email: sjohnson@healthtech.com

 

Companies L-Z

Jon Stroup

Senior Manager, Business Development

Cambridge Healthtech Institute

Phone: (+1) 781-972-5483

Email: jstroup@healthtech.com


Speaker Proposal