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October 27-29, 2020
College Park Marriott Hotel & Conference Center,
Hyattsville, MD

Ensure CMC Success and Expedite Your Product’s Path To Market By Optimising Characterization Strategies and Robust Bioassay Development

Gain Practical Advice From Case Studies, FDA & Regulatory Leaders To Accelerate Your Biologics & Novel Modalities/Molecules to Market

COVID-19 Update - Book with Total Confidence

As our event is still 6 months out, we are still planning on holding this year’s Well Characterized Biologics & Biological Assays meeting on its scheduled dates of October 27-29 in Maryland. It's business as usual for now, and our team continues to closely monitor regulations from local and global health authorities. 

As the COVID-19 situation is changing daily, we want you to feel totally confident about booking onto our events.

  • If Informa needs to reschedule the event, we will simply roll over your booking to the new dates
  • If Informa is unable to run the event again in the next 12 months, you will be entitled to a full refund

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Meet Directly with the FDA and Regulatory Speakers

Each year, this meeting brings in 5+ FDA speaker's from CBER/CDER that are onsite with a big presence. They’ll be able to answer all of your regulatory questions and present on some key topic areas of interest. We’re finalizing the representatives that are coming. In the meantime, here are some potential topic areas that will be addressed:

Most Problematic Areas of Submissions for Analytical Characterization and Bioassay Development
Regulatory Updates and Insights on Emerging Technologies for Analytical and Bioassay Development
Regulatory Guidelines on Analytical Procedure Validation vs. Qualification
FDA Town Hall - Open Forum Q&A with Multiple FDA Reviewers


Is the cost of a typical drug -- Can you afford to be wasting time?
1/10 DRUGS
That enter Phase 1 reach a patient -- Are you staying up-to-date on the latest regulatory guidelines?
of the top 100 drugs by 2021 will be biologics -- how are you preparing to stay ahead of competition?

Accelerate your product timelimes and overcome development and submission challenges

The 2019 program covered two main tracks, each featuring case studies with practical advice you can apply in your CMC programs and new data and lessons learned all within an open information-sharing environment.  The last of the event featured three specialized workshops allowing attendees to discuss their specifical challenges in a expert-led classroom style setting.

Track 1: Well Characterized Biologics Track
  • Sessions will feature case studies on analytical methods and strategies for novel modalities (bispecifics, fusion proteins, cell and gene therapies and more)
  • Hear from experts on accelerating analytical preparation methods and timelines
  • Learn from case studies on successful CMC packages and Regulatory Perspectives
  • Get an overview on emerging technologies for characterization and hear new case studies on these novel approaches
Track 2: Biological Assays Track
  • Learn how to accelerate timelines for assay development
  • Build Robust Bioassays which can cope with Analytical Method Transfer between Research and
    QC Environments
  • Case studies around tried and tested technology approaches
  • Overcome challenges with CROs and Critical Reagent variability
  • Case studies for the latest assay developments for novel and complex molecules
Post-Conference Workshops
  • The Evolution of Monoclonal Antibodies - Analytical Methods, Technologies, Best Practices and Lessons Learned 30+ Years in the Making
  • DoE Based Approaches in Bioassay Development
  • Bioassays for Beginners


Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.  

Contact Blake Shuka: |  +1-857-504-6684