Cambridge Healthtech Institute’s 7th Annual

Optimizing Bioassays for Biologics  

Merging Science and Statistical Methods for Successful Biological Assay Development 

October 24-25, 2018

 

Bioassays, at their core, spring from a fusion of biological and statistical sciences, and are used to measure activity or function of a compound or group of compounds in samples. As the field evolves, new technologies and software are changing the way scientists view experimental design and data analysis. The health authorities and USP have provided guidance for the design and validation of a bioassay; however, they do not discuss solutions to common problems springing from this revolution in technology. At Cambridge Healthtech Institute's seventh annual Optimizing Bioassays for Biologics, leaders working in bioanalytical and bioassay development will come together to provide case studies and best practices for handling the most common issues in biological assay development, validation, transfer, and maintenance. There will also be a focus on lifecycle management and design of experiments methods. In addition, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.

LIFECYCLE MANAGEMENT

KEYNOTE PRESENTATION: A Lifecycle Approach to Bioassay Validation
Timothy Schofield, Senior Advisor, Technical Research & Development, GSK

A Quality Approach to Stage One Bioassay Optimization
Steven Novick, PhD, Director, Statistical Sciences, MedImmune

Assay Performance Qualification: A Fit for Purpose Approach
Perceval Sondag, Senior Manager, Statistics, PharmaLex

CPV Application in Bioassays – Strategies to Maintain Lot to Lot Consistency & Prevent Assay Drift
Mitra Azadeh, PhD, Principal Scientist, Bioanalytical & Biomarker Development, Nonclinical Development, R&D, Shire

PANEL DISCUSSION: Design of Experiments in Bioassay Development
Moderator: Perceval Sondag, Senior Manager, Statistics, PharmaLex

STATISTICAL CONSIDERATIONS IN SIMILARITY

Near-Universal Equivalence Bounds for Similarity in Bioassays
David Lansky, PhD, President, Precision Bioassay, Inc.

Analytic Similarity: A Review of the FDA Draft Guidance on Evaluating Analytic Similarity
Martin Kane, MS, CRE, Managing Data Scientist, Statistical and Data Sciences Practice, Exponent

BIOASSAY VALIDATION STRATEGIES

FEATURED PRESENTATION: Strategic BioAssay Design, Beginning with the End in Mind
Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting

Assessing Bioassay Validation Acceptance Criteria in Relation to Study Design
Keith M. Bower, Principal CMC Statistician, Process Sciences, Seattle Genetics

The Rush to Validate Bioassay: The Good, the Bad and the Ugly
Brian R. Peterson, MSc, President, Bioassay Solutions LLC

STRATEGIC AND NOVEL BIOASSAY DEVELOPMENT

Preliminary Title: Strategies for a Successful Bioassay
Stephen Hartman, PhD, Senior Scientist III, AbbVie

Straight to Automation! The Benefits of Early Implementation in Bioassay Development and Optimization
Robyn Beckwith, PhD, Associate Scientist, Analytical Development and Quality Control, Product Technical Development, Genentech

Development of a Cell-Based Potency Assay for New Modality of ADC Product
Mingfang Shen, Principal Development Associate, Translational Research, ImmunoGen, Inc.


For more details on the conference, please contact:
Kaitlyn Barago
Associate Conference Producer
Cambridge Healthtech Institute
Phone: (+1) 781-247-6282
Email: kbarago@healthtech.com

For partnering and sponsorship information, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Phone: (+1) 781-972-5412
Email: cbenton@healthtech.com