Cambridge Healthtech Institute’s 5th Annual
Early Analytical Development for Biotherapeutics
Optimizing Preclinical Analytical Development for Emerging Biotherapeutics
Part of CHI's Ninth Annual The Bioprocessing Summit
August 23-24, 2017 | Westin Copley Place | Boston, MA
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 biotherapeutic formats.
Topics may include, but are not limited to:
Optimizing the Speed and Efficiency of Analytical Development
- Analytical strategies for accelerated/aspirational programs
- Best practices for analytical lifecycle management
- Development and adaptation of platformed analytical approaches
- Analytical development for acquired, partnered and in-licensed programs
- Risk assessment and decision metrics in early development
Methods and Instruments
- Automation and robotics
- Emerging instruments and technologies
- High throughput biophysical analysis
- Mass spec in combination with other instruments
- Multiple-attribute monitoring (MAM)
Early Analytical Challenges
- Application of statistics and DOE in early development
- Host cell proteins
- Material constraints and accelerated timelines
- Regulatory responses to novelty (delivery technologies, excipients, molecule/product formats, presentations)
- Timeline for use of transient material
- Biosimilars: establishing analytical similarity, support of control strategies
- Developability evaluation and predictive assays for novel modalities
- Fusion proteins
- Immuno-Oncology: new targets, combinations
- New bispecific and ADC formats
Please click here to submit an abstract. Remember to specify the conference that you are interested in and please provide your full contact information.
The deadline for submission is February 17, 2017.
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:
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