Cambridge Healthtech Institute’s 6th Annual

Accelerating Analytical Development

Optimizing the Speed and Efficiency of Key Analytical Steps in Biotherapeutic Development

August 14-15, 2019


Research for this meeting revealed that industry analytical groups are facing increased pressure to deliver key analytical studies used in candidate selection, process development, clinical development and regulatory submissions faster than ever before – and at lower costs. Accelerating Analytical Development 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 at every stage of development and provide insights on how different organizations are addressing these challenges.

Proposed presentations should offer case studies of strategies, best practices and novel solutions applied in accelerating and optimizing analytical support of biotherapeutic development programs.

Coverage will include, but is not limited to:

Best Practices for Regulatory Filings

  • Analytical support for accelerated development programs (exploratory IND, orphan, first-in-class, etc.)
  • Case study – optimizing your first IND filing (determining essential and optional studies, meetings/dialog with agencies)
  • How to incorporate novel analytical technologies and methods into regulatory filings
  • Phase appropriate characterization steps

Assay Development and Method Lifecycles

  • Accelerating and optimizing analytical method development
  • Identifying assays to align with assessment of product attributes
  • Improving the accuracy of early stage predictive assays
  • Lifecycle considerations in early method development

Emerging Technologies

  • Implementing automation and high throughput solutions for sample handling and analytical studies 
  • MAM Consortium update; new applications, prospects for use in release testing
  • New applications of physical methods in biotherapeutic R&D (chromatography, spectroscopy, NMR, etc.)
  • What will the “lab of the future” look like? (AI, machine learning and multivariate analytical methods)

Analytical Development for New Modalities

  • Attributes testing for PEGylated proteins and peptides
  • Identity tests for proteinaceous vaccines
  • Managing detection limits for low concentration proteins
  • Potency assays for cell and gene therapies

    Analytical Workflow Case Studies

  • Startup with minimal in-house capabilities working primarily through CMOs
  • Mid-size company with significant in-house expertise but limited experience with regulatory filings
  • Established company with multiple regulatory filings and approvals
  • Considering the impact of new and novel modalities on analytical platforms and workflows

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:
Kent Simmons
Senior Conference Director
Cambridge Healthtech Institute
Phone: 207-869-9199
Email: ksimmons@healthtech.com

For partnering and sponsorship information, please contact:

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

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

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