November 11-13, 2019
Hyatt Regency Reston,
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 & Regulatory Leaders To Accelerate Your Biologics & Novel Modalities/Molecules to Market
Industry Leaders and Academics Share Their Secrets to Success
You will be able to hear unpublished, new data from leading biologics drug developers, gain practical advice from multiple case studies to apply to your own projects, and accelerate your molecule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
FDA will be onsite with a big presence again this year. 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
Cross-Fertilize Ideas and Discuss Common Challenges with CMC, Analytical, and Biological Assay Colleagues
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
- Build Robust Bioassays which can cope with
Analytical Method Transfer between Research and
- Case studies around tried and tested technology
- Overcome challenges with CROs and Critical
- Case studies for the latest assay developments for
novel and complex molecules
- 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
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 submit your poster is Friday, October 11, 2019.
Benefits of presenting a poster
- 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.
- RECEIVE IMPARTIAL CRITIQUES: An insightful, impartial discussion of your work by a peer can often provide ideas for improving your work downstream.
- 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.
- 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.
Sponsorship & Exhibition Opportunities
- Connect one-on-one with the scientists who implement your tools to generate interest and gain insight
- Showcase your expertise and demonstrate thought leadership to industry leaders and decision makers
- Learn about the latest developments in the industry so you can better anticipate future needs of the market
- Uncover new potential clients and partnership opportunities to grow your business
- Highlight your company as a member of the life sciences community in an intimate setting to grow relationships
For more details, contact Blake Shuka at Bshuka@knect365lifesciences.com or 857-504-6684.
“The Well Characterized Biologics and Biological Assays conference has a long history of attracting scientists and regulatory professionals with a profound interest in developing best practices for analytical strategies. The opportunities to attend talks, focused short courses, and networking sessions, are second only to the experience of discussion and debate with the highest caliber of professionals in the Industry.”
Brian Peterson, MSc.
President, Analytical Consulting
Bioassay Solutions LLC
“I am looking forward to discussions of common challenges, strategies, and solutions for biological characterization and bioassay development. Especially looking for industry peers and HA/ regulatory feedback on approached to bioassay lifecycle management.”
Petra Bennington, MSc.
Associate Principal Scientist, Bioprocess Development
Merck Research Laboratories
“More and more novel gene therapy drugs are coming to the market. The discussion on potency assessment of these drugs between different companies and regulators is necessary.”
Marina Feschenko, Ph.D.
Principal Scientist, Analytical Development - Biologics and Gene Therapy
“With the rapid development of technologies that have application to both the design of novel biological products and alternative bioassays for product characterization, new technical and regulatory issues will continue to emerge. This conference offers an excellent opportunity for participants to learn from the experiences of regulators, industry leaders and experienced scientists, including statisticians, who have played a part in the successful development of a wide array of well-characterized biologics and biological assays, and to engage in open discussions about the current challenges faced by numerous stakeholders.”
Nancy Sajjadi, MSc.
“All will share and discuss relevant data and lessons learned so common challenges can be addressed with bioassay colleagues providing practical advice supplemented with case studies.”
Michael Sadick, Ph.D.
Catalent Pharma Solutions