Cambridge Healthtech Institute’s 5th Annual Analytical Forum

Accelerating Analytical Development

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

August 15-16, 2018


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.

Topics may include, but are not limited to:

Phase Appropriate Analytical Development

  • The evolution of discovery stage developability analysis; success rates for early stage predictive assays
  • Balancing speed and resource considerations in selection of fit-for-purpose assays at each stage of development
  • Best practices for comparability analysis following method changes, method bridging
  • Using an analytical target profile to prepare assays for GMP and QC use

Optimizing the Speed and Efficiency of Analytical Development

  • Resource, technology and modality considerations in developing the target product profile (TPP)
  • Analytical platforms in an era of novelty and new modalities
  • Automation and high throughput analytical methods
  • New developments in reducing sample size requirements for common assays

Emerging Methods and Instruments to Support Accelerated Development

  • Applying MS MAM (Multi-Attribute Method) in GMP/QC
  • Imaging and microscopy applications in biotherapeutic analytical development
  • New instrument combinations; correlating analytical results from multiple methods
  • Potency assay strategies in an accelerated development environment

Computational Analysis and Data Management

  • Computational biophysics for long term stability prediction
  • Experimental validation of computational predictions
  • Integrating data analysis from different instrument manufacturers and platforms
  • Internal software/data challenges: lab notebooks, standards, sample ID/tracking, databases

Analytical Development Challenges of New Modalities

  • Characterization challenges for combination products
  • Characterization challenges for novel scaffold molecules
  • Characterization techniques for cell and gene therapies
  • Correlation of analytical methods across different bispecific antibody formats

If you would like to submit a proposal to give a presentation at this meeting, please click here here. Please specify the conference in which you would like to speak and remember to provide your full contact information.

Deadline for priority consideration is February 9, 2018.

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are 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

Phone: 207-869-9199

Email: ksimmons@healthtech.com

For exhibit & sponsorship opportunities, please contact:

Companies A-K

Sherry Johnson

Business Development Manager

Phone: 781-972-1359

Email: sjohnson@healthtech.com

Companies L-Z

Carolyn Benton

Business Development Manager

Phone: 781-972-5412

Email: cbenton@healthtech.com

For media partnership opportunities, please contact:

Kaushik Chaudhuri

Director of Product Marketing

Phone: 781-972-5419

Email: kchaudhuri@healthtech.com


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Premier Sponsors:

Millipore Sigma
Unchained Labs