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:
Potency Assay for Complex Biologics (Including Cell and Gene Therapies) – Holistic and Phase Appropriate Approach | Rockville, MD | NEW DATE June 17, 2025 15:00 - 17:00 EDT
Join us in person at the IBBR campus where you can network with DC-area CASSS members. The June Discussion Group will be fully in-person. Don’t miss your chance to participate in this panel discussion on potency assays for complex biologics. Register by June 13, 2025.
Location:
Institute for Bioscience and Biotechnology Research
9600 Gudelsky Dr.
Rockville, MD, USA 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.
Potency Assay for Complex Biologics (Including Cell and Gene Therapies) – Holistic and Phase Appropriate Approach | Rockville, MD | NEW DATE June 17, 2025 15:00 - 17:00 EDT
Potency assays play a critical role in controlling product manufacturing consistency, monitoring product stability, and ensuring therapeutic efficacy. They are even more important for complex biologics such as CGT than for traditional protein/antibody therapeutics for which extensive knowledge has been accumulated and comprehensive biochemistry and biophysical characterization tools exist. For CGT products, the biology of manufacturing and the mode of action (MOA) in vivo are typically not thoroughly understood, and the characterization toolbox selection is still limited. A fit-for-purpose, phase appropriate potency assay at different stages of drug development is expected by regulatory agencies, and a robust, MOA reflecting potency/functionality assay is essential for final marketing approval.
This DCDG will discuss and exchange ideas on how the new FDA potency draft guideline changes or does not change the way companies design and develop potency assays, control strategies, and typical questions/challenges faced by the industry in potency/functionality assay development.
Shihua Lin
TopAlliance Biosciences
Shihua Lin joined TopAlliance Biosciences in 2022 and currently serves as Vice President, CMC Analytical and Quality Control; bringing over 20 years of experience in the pharmaceutical industry, spanning drug discovery and development from pre-IND through BLA and commercialization. He is responsible for developing bioassays and analytical strategies to support CMC, Quality Control, and regulatory filings; also serves as Test Site Manager for the GLP lab. Previously, Shihua served as the Director and team lead of Bioassay Development at AstraZeneca, and is the former Senior Manager and team lead at Otsuka Maryland Medicinal Laboratories. He earned a BS and MS in biology, as well as a PhD in neuroscience/cell biology, all from Kyoto Institute of Technology, Kyoto, Japan.
Nadine Ritter
Global Biotech Experts, LLC
Dr. Nadine M. Ritter is a highly accomplished professional with extensive experience in the fields of cell and molecular biology, analytical R&D, and biopharmaceutical consulting. With a background in academic research and industry work, she has contributed significantly to the development and validation of test methods, compliance remediation efforts, and quality and compliance activities. Ritter has also been involved in training, consulting, and advisory roles for biotech and biosimilar products, and has played a key role in numerous international filings and post-approval change protocols. Additionally, she has been instrumental in co-founding industry forums and has served in leadership positions in professional organizations, including a past president of CASSS.
John Yu
Arcellx, Inc.
Dr. John Yu is an accomplished scientific leader with extensive experience in lentiviral vector, gene editing reagent, and cell therapy product development and manufacturing. He currently serves as Director of Analytical Development at Arcellx, where he leads cross-functional efforts supporting IND filings, drug product development, and potency strategy for advanced cell therapy programs. Previously, Yu held leadership roles at Sana Biotechnology, where he directed critical analytical and CMC initiatives for hypoimmune CAR-T therapies. His contributions included developing and transferring potency assays, leading comparability studies, and spearheading gene editing CMC activities.
Yu began his career making key contributions to iPSC-based disease modeling and gene editing platforms at Amgen and Applied StemCell Inc. He earned his PhD in cell biology from the Chinese Academy of Sciences and completed postdoctoral training at UCSF, where he focused on mitochondrial genome dynamics. A published author and recognized speaker, Yu has contributed to the fields of CRISPR editing, epigenetics, and cell signaling. A passionate advocate for scientific innovation, Yu brings deep technical expertise, strong leadership, and a collaborative spirit to the advancement of next-generation cellular therapeutics.
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Here are some ways you can share your message:
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- Join our CASSS LinkedIn Group to help create additional discussion before the Discussion Group and beyond about topics of interest with like-minded people. https://www.linkedin.com/groups/2361040/
- 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.
- Remember to tag CASSS on all social media posts.
If you have any questions about this media kit, please reach out to Renee Olson.
Register Now
Save your spot for the DC Discussion Group on June 17, 2025 (originally April 23, 2025) in Rockville, MD. Register by June 13, 2025.
