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November 11-13, 2019
Hyatt Regency Reston,
Reston, VA

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

Industry Leaders Share Best Practices for Accelerating Novel and Complex Modules Towards CMC Success

Hear unpublished, new data from leading biologics drug developers, gain practical advice from multiple case studies to apply to your own projects, and accelerate your molecule development by finding new analytical or bioassay technology applications.

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 will consist of two 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. We will also be hosting Post-Conference Workshops on November 13. 

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

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Present a Scientific Poster

Highlight your company's latest research findings by presenting a scientific poster, which will be displayed in the Exhibit & Poster Hall during the event. The deadline to have your poster presentation included in the event guide is October 11.

Benefits of presenting a poster:

  1. FOCUSED DISCUSSIONS: Posters offer the opportunity to engage with others also interested in the same subject and application as yourself which could potentially lead to future collaboration.
  2. RECEIVE IMPARTIAL CRITIQUES: An insightful, impartial discussion of your work by a peer can often provide ideas for improving your work downstream.
  3. SHARPEN YOUR PRESENTATION SKILLS: Presenting a poster enables you to explain a concept in different ways to see which method is most well received and practice your visual and oral presentations.
  4. HONE YOUR IDEAS: A poster is ideal for early stages of the research, when you may not have much more than an idea, and you stand to benefit a lot from discussing your idea with other researchers from the same field.


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: Bshuka@knect365lifesciences.com |  +1-857-504-6684