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CHI to Host Roundtable Discussions at Optimizing Bioassays for Biologics Conference

Moderated by Drs. Han Li, Bristol-Myers Squibb; Maura C. Kibbey, United States Pharmacopeia (USP); and Max L. Tejada, Gilead Sciences

Needham, MA, October 10, 2015 --( Cambridge Healthtech Institute (CHI), a leading pharmaceutical and biotechnology conference organizer, today announced it will host three roundtable breakout discussion groups at the Third Annual Optimizing Bioassays for Biologics conference scheduled on November 18-19, 2015, at the Hilton Baltimore in Baltimore, MD. Roundtable discussion groups allow participants to meet potential collaborators, share examples from their work, vet ideas with peers, and be part of a group problem-solving endeavor. The roundtables will take place on Thursday, November 19 from 9:35-10:35 a.m.

Table 1: Incorporating New Technologies into Bioassay Development
Moderator: Han Li, Ph.D., Principal Scientist, Lead Discovery and Optimization, Bristol-Myers Squibb
· Is automation an option for bioassay development?
· High density plates meet precision and accuracy, what is the criteria now?
· Platforms matters---reporter assay, affinity binding assay, HTRF assay, BRET assay, or your thoughts?
· New areas, new requirements---how bioassay meets gene therapy and CAR-T technologies?
· What other technologies can be brought in as a future bioassay platform?

Table 2: Challenges in Assay Bridging
Moderator: Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & Biotechnology, United States Pharmacopeia
· Determining if product-related impurities contribute to potency
· Demonstrating that the method is stability-indicating
· Pros and cons of parallel assays during clinical development versus switching post-licensure

Table 3: Method Transfers
Moderator: Max L. Tejada, Ph.D., Senior Research Scientist II, Analytical Operations, Gilead Sciences
· Approaches to clinical, commercial phases
· Approaches to internal transfers (development to QC lab) and external transfers (different sites, partners and CMOs)
· Challenges, lessons learned

Each moderator will summarize the key findings at the conclusion of the group discussions and share with the delegates. The Bioassays conference is one of the tracks at the Immunogenicity & Bioassay Summit 2015.

“The roundtable discussions serve as an excellent way to brainstorm and exchange ideas,” said Samantha Drinkwater, Sr. Conference Director at CHI. “At the conclusion of the meeting, the insights gained at this event will give biologics researchers a better understanding of bioassays that reflect true MOA, are robust, sensitive and reproducible.”

Learn more at

Members of the media are encouraged to participate. Please contact Lisa Scimemi at to apply for a press pass and to inquire about opportunities for coordinated pre-event interviews with speaking faculty.

About Cambridge Healthtech Institute (

Cambridge Healthtech Institute (CHI), founded in 1992, is the industry leader in providing superior-quality scientific information to eminent researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett Educational Services, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Knowledge Foundation and Cambridge Healthtech Media Group, which includes Bio-IT World, Clinical Informatics News and Diagnostics World.
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