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PK and ADA Assays for Biologics (US)
PK and ADA Assays for Biologics (US)

Course Description

Biologics continue to be a steadily growing component of the pharmaceutical industry. Large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This webinar is designed to offer both a broad overview and detailed discussion of specific issues to address when developing and validating PK and ADA assays for biologics. We will speak to changes in regulatory agency expectations with specific key analysis of assay variability, considerations for disease specific matrices, and using design of experiments in early development. Troubleshooting assays in production will also be discussed. The format of the webinar offers an examination of current best practices as well as time to dissect attendee-specific questions in an interactive manner.

  • Regulatory guidance
  • PK methods
  • Immunogenicity methods
  • Troubleshooting assay failures
  • Understanding current regulatory expectations
  • Designing, developing, optimizing, and validating
    key methods
  • Preclinical method qualification/validation vs.  clinical method validation
  • Use of DOE and statistical analysis
  • Handling of critical materials
  • Process monitoring concepts
  • Overcoming impact of the matrix and comedications
  • Assessing readiness for validation
  • Defining the validation protocol with real-time
    capture of data analysis
  • Maintaining quality through documentation
  • Identify potential challenges to ADA methods
  • Practical consideration for development of positive controls
  • Understanding the complexity of potential
    interference
  • Gain knowledge of new technologies to overcome
    assay interference
  • Implementing a strategy to overcome challenging
    methods
  • Designing ADA methods for modified drugs
  • Understanding and targeting domain specificity

PK and ADA Assays for Biologics (US)

12 - 14 June 2024, Live Online Training
Regular price €1.850,00
Unit price
per 
Dr. Gwen Wise-Blackman

Dr. Wise-Blackman is a consultant and project lead at BioData Solutions, with over 24 years of experience. Her attention is devoted to providing guidance to small and large biotechnology and pharmaceutical companies in support of drug development. Her work includes supporting regulatory approval of large molecule therapeutics.

START TIMES

8:00 AM Los Angeles time

11:00 AM New York time

4:00 PM London time

5:00 PM Vienna time

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Course Description

Biologics continue to be a steadily growing component of the pharmaceutical industry. Large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical testing. This webinar is designed to offer both a broad overview and detailed discussion of specific issues to address when developing and validating PK and ADA assays for biologics. We will speak to changes in regulatory agency expectations with specific key analysis of assay variability, considerations for disease specific matrices, and using design of experiments in early development. Troubleshooting assays in production will also be discussed. The format of the webinar offers an examination of current best practices as well as time to dissect attendee-specific questions in an interactive manner.

  • Regulatory guidance
  • PK methods
  • Immunogenicity methods
  • Troubleshooting assay failures
  • Understanding current regulatory expectations
  • Designing, developing, optimizing, and validating
    key methods
  • Preclinical method qualification/validation vs.  clinical method validation
  • Use of DOE and statistical analysis
  • Handling of critical materials
  • Process monitoring concepts
  • Overcoming impact of the matrix and comedications
  • Assessing readiness for validation
  • Defining the validation protocol with real-time
    capture of data analysis
  • Maintaining quality through documentation
  • Identify potential challenges to ADA methods
  • Practical consideration for development of positive controls
  • Understanding the complexity of potential
    interference
  • Gain knowledge of new technologies to overcome
    assay interference
  • Implementing a strategy to overcome challenging
    methods
  • Designing ADA methods for modified drugs
  • Understanding and targeting domain specificity

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

PK and ADA Assays for Biologics (US)

Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.

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