DC Discussion Group

With the origins of CASSS in mind, the DC Area Scientific Discussion Group offers an opportunity for CASSS members to meet others who understand what they do in an informal setting and exchange new ideas. They have been bringing people in the field of biotechnology and biopharmaceutical development together since 2014. This group’s mission is "Bringing Together Industrial Challenges in the Development of Biologics with Advances in Science and Technology." Anyone in the greater DC/Maryland area (or for virtual meetings, anyone around the world) affiliated with biotechnology, or interested in learning more about the scientific and technological applications to biotechnology is invited to attend.

Click on the sections below for detailed information:
Attend

ICH Q12 | April 9 15:00 EDT | Rockville, MD

Join us in-person on April 9 for a focused discussion on ICH Q12 featuring panelists from government and industry and to network with DC-area CASSS members. Registration for this free opportunity and more information will be available soon.

Location:
IBBR (University of Maryland - Institute for Bioscience and Biotechnology Research)
9600 Gudelsky Dr
Rockville, MD 20850

Attendance and Substitution Policy

CASSS reserves the right to withdraw, replace, add, or substitute presenters, speakers, and other guests without notice. Entry into the conference is at the sole discretion of CASSS and CASSS reserves the right to refuse entry to anyone for any reason.

Abstract
Despite ICH Q12’s promise of science-based lifecycle flexibility, adoption remains limited, often due to perceived industry hesitancy. In reality, organizations are actively exploring Q12, but progress is slowed by internal constraints, the need for a mindset shift, and the challenge of integrating Q12 into quality systems. Defining and justifying non-Established Conditions (non-ECs) is particularly complex, with inconsistent recognition of benefits and resource-intensive cross-functional evaluation. This session brings together industry and agency perspectives to share practical strategies for credible and feasible Q12 implementation. Discussion will focus on building risk-proportionate ECs and defensible non-ECs, leveraging prior knowledge—especially for platforms like monoclonal antibodies and delivery devices.

Promote Your Participation

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Here are some ways you can share your message:

  1. Follow CASSS on Facebook, X, and LinkedIn. Stay up-to-date on the latest Discussion Group announcements and opportunities. Links can be found in the right column or at the bottom of this page.
  2. Share your participation via your personal Facebook, X, and LinkedIn accounts. Whether you are a recurring presenter or this is your first time attending, we are grateful to have you join us this year.
  3. Share the news with your colleagues who run your organization's official social media channels. We are proud to show our community your participation - let your community convey their support too.
  4. Personalize your email signature. Add an image or short message to your default email signature to let your colleagues know you will be attending the Discussion Group. 
  5. Remember to tag CASSS on all social media posts.

If you have any questions about this media kit, please reach out to Renee Olson.

Save the Date

Mark your calendars for the DC Discussion Group on April 9, 2026. Registration for this free opportunity and more information will be available soon.

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