2015 BPD Header

Cambridge Healthtech Institute’s 2nd Annual
Early Analytical Development for Biotherapeutics
Optimizing the Selection and Performance of Preclinical Analytical Studies
August 5-6, 2015
Part of CHI's 7th Annual The Bioprocessing Summit

August 3-7, 2015 | Westin Copley Place Hotel | Boston, Massachusetts


Overview Description:
The analytical steps conducted in preclinical development following the handoff of a lead candidate are vital on many levels in determining the fate of that program. This complex effort shapes the optimization of the new product, requires the use of expensive and scarce resources and supports the voluminous regulatory filing that is the early IND application. It is imperative that companies reach this important milestone as quickly and efficiently as possible, while positioning the organization to move rapidly into the GMP production needed for early phase clinical trials.

Early Analytical Development for Biotherapeutics will present best practice case studies of how industry companies have approached the most important analytical studies occurring during this stage, focusing on the development and optimization of key assays, the application of automation and the challenges of analytical development for novel modalities. Proposed presentations should focus on case studies of lessons learned in preclinical development, and special consideration will be given to those addressing next generation therapeutic modalities.

Topics will include, but are not limited to:

Preclinical and Discovery Stage Analytics 

  • Discovery stage molecular assessment
  • Fitting new programs to existing analytical platforms
  • How much how soon? The extent of assay qualification in early development
  • Impacts of FDA’s 2014 “Analytical Procedures” guidance on early development
  • IND analytical requirements and expectations for different regulatory jurisdictions
  • Research-stage analytics: miniaturization; potency and PK assay development

Assay Development and Troubleshooting 

  • Application of DOE for development of analytical methods and testing of robustness
  • Applications of mass spectrometry in early development
  • Assay development for characterizing effector functions
  • Best practices and troubleshooting for cell-based potency assays
  • Biophysical assays for aggregation and subvisible particles
  • Challenges with setting specifications based on unvalidated early development assays
  • Emerging methods and technologies for ligand binding assays
  • Troubleshooting identity, potency, purity and safety/immunogenicity assays

Early Analytical Development for Novel Biotherapeutics 

  • Antibody conjugates
  • Bispecific antibodies
  • Cell-based therapeutics
  • Fusion proteins
  • Gene therapy
  • Nucleic acid therapeutics
  • PEGylated proteins
  • Vaccines and adjuvants

Automation and Emerging Technologies 

  • Application of DOE to optimize product and process parameters
  • Improving the throughput of early stage method development
  • New high throughput analytical methods and instrumentation
  • Qualifying automation systems based on autosamplers and robotics
  • Translating manual workflows to automated systems

The deadline for submission is January 30, 2015. Click here to submit a proposal. Please specify the conference in which you would like to speak and remember to provide your full contact information.

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
Conference Director
Phone: 207-869-9199
Email: ksimmons@healthtech.com 

For exhibit & sponsorship opportunities,
please contact:

Jason Gerardi
Manager, Business Development
Phone: 781-972-5452
Email: jgerardi@healthtech.com 

For media partnership opportunities,
please contact:

Kaushik Chaudhuri
Director of Product Marketing
Phone: 781-972-5419
Email: kchaudhuri@healthtech.com