Cambridge Healthtech Institute’s Fifth Annual

Optimizing Bioassays for Biologics

Merging Biology and Statistical Methods for Successful Biological Assay Development

October 25-26, 2017 | The Westin Alexandria | Washington, DC


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. The biological aspect is based on finding or creating a living system that responds to the compound with most development effort focused on how to make the response larger, more consistent, and more selective. The statistical aspects involve the design of the assay system, techniques for constructing measures of the relative activity (or potency) of preparations of the stimulant, tools for improving the assay system, and methods for demonstrating the properties of potency estimates. 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. At Cambridge Healthtech Institute's Fifth 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. Health authorities will weigh in on new guidelines as well as provide insight into what they consider a well-characterized and well-controlled bioassay. Finally, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.


Who should attend: Members of bioanalytical R&D, those who work in quality control or CMC for biological products, statisticians and biologists who are new to biological assays, and members of industry regulatory groups that support biological products.

STRATEGIC BIOASSAY DESIGN

KEYNOTE: Essentials in Bioassay Design

Thomas Little, Ph.D., President, Bioassay Sciences, Thomas A. Little Consulting

Setting Realistic Product Specifications to Avoid OOS

David Lansky, Ph.D., President, Precision Bioassay, Inc.

SETTING EQUIVALENCE BOUNDS FOR SIMILARITY

Defining Equivalence Criteria for a Parallelism Experiment: A Case Study

Anne Benoit, Ph.D., Expert Biostatistician, Biostatistics and Statistical Programming, Non-Clinical R&D Statistics – CLS, Clinical Evidence Generation, GSK Vaccines

PARALLEL LINE ANALYSIS TO DETERMINE RELATIVE POTENCY

Parallelism and Constraining Curves: The 4-Parameter Logistic Function

Martin Kane, MS, CRE, Managing Data Scientist, Statistical and Data Sciences Practice, Exponent

Extensive Comparison of Parallelism Tests for Potency Bioassays

Perceval Sondag, Principal Statistician, Non-Clinical Statistics, Arlenda

AUTOMATION TECHNOLOGIES

Shrinking Potency Assays: Development of an Automated Low Volume Dispensing System

Robyn Beckwith, Ph.D., Associate Scientist, Analytical Development and Quality Control, Product Technical Development, Genentech

A Unique Automation Approach to Product Potency Assay Execution Using Acoustic Droplet Ejection (ADE) Technology

Sandra Thiemann, Ph.D., Scientist, Bio-Immunoassay Group, Attribute Sciences, Amgen



For more details on the conference, please contact:
Samantha Drinkwater
Senior Conference Director
Cambridge Healthtech Institute
Tel: 781-972-5461
Email: sdrinkwater@healthtech.com
For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5412
Email: cbenton@healthtech.com

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Celebrating 25 years