End-User Forum*

Tuesday, January 25

The Forum is open to end-users only and all participants are subject to approval by the conference organizers. The facilitated discussion format of the Forum aims to provide the end-users with an informal atmosphere to brainstorm key issues and solutions to common problems in implementing high-content analysis technology. The Forum is designed both for “advanced users” and new technology adopters.

* Separate registration fee required. Participation is limited to end-users only and subject to approval by conference organizers. Please see registration page for additional information.

Implementing HCA: Overcoming Technical Challenges

10:00-10:45    Registration and Coffee

10:45-11:00    Welcoming Remarks from Conference Director
Julia Boguslavsky, Cambridge Healthtech Institute

11:00-11:45    Instrumentation
Chairperson: Dr. Paul A. Johnston, Research Advisor, Eli Lilly and Co.

Panelists (Additional Panelists to be Announced):
• Dr. Flora Tang, Associate Director, Molecular Pharmacology, Amgen, Inc.
• Dr. Paul Elvin, Principal Scientist, Cancer Bioscience, AstraZeneca

Discussion Questions Include:
• Where in the drug discovery process do you want to position your instrument (target validation, lead generation, lead optimization, or drug development)? What types of biology would you like to address? 
• What hardware features and capabilities are required (throughput, capacity, confocality, live cell kinetic/fixed endpoint assays with on board pipetting)? 
• Manually fed on fully integrated automation? 
• Cost: what is your capital budget? 
• How user-friendly is the software in setting up the instrument and analyzing the data? 
• Beginner or a power user: do you want a turnkey system or do you want flexibility/control? Do you want canned algorithms or customized algorithms, or do you want to develop/build your own algorithms? 
• Customer Service: installation with acceptance/performance testing? Routine diagnostic testing to ensure the instrument is calibrated and fully functional? Response times for software and hardware issues? Educational/training program provided? 
• Policy for upgrades to instrument, software and image analysis algorithms? 

11:45-12:30    Assays, Reagents, and Cells
Chairperson: Dr. Jonathan Lee, Research Advisor, Lead Optimization Biology, Eli Lilly and Co.

Panelists:
• Dr. Paul Elvin, Principal Scientist, Cancer Bioscience, AstraZeneca
• Dr. Ralph Garippa, Research Leader, Roche Discovery Technologies, Hoffmann-La Roche, Inc. 
• Dr. Julie (Zhuyin) Li, Head of Assay Development and Screening, Lead Identification Technology, sanofi-aventis
• Dr. Carmel Nanthakumar, Senior Research Scientist, Automated Imaging, Merck Sharp & Dohme

Discussion Questions Include:
• What is the “value” of high-content assays?
• How do the performance requirements vary for HCA assays at various stages in drug discovery (including lead generation and optimization, tertiary screening, pathway biology, toxicology, etc.)?
• What are the biggest bottlenecks, technical challenges, or unmet needs in reagents?
• What are the pros/cons to developing the assays in-house vs. buying off-the-shelf kits?
• What are good sources of antibodies?
• What cellular technologies are most appropriate for HCA assays (including cell lines, automation, plateware, etc.)? Is cell drift an issue?
• What assay development strategies ensure best cell behavior for imaging (including distribution in the well, adherence, morphology, etc.)?
• End-point vs. kinetic HCA assays?
• What are the “lessons learned” in developing various types of HCA assays (all participants welcome to share their experiences)? 

12:30-1:45    Networking Luncheon

1:45-2:30    Data Interpretation and Management
Chairperson: Ms. Ann Hoffman, Senior Principal Scientist, Roche Discovery Technologies, Hoffmann-La Roche, Inc.

Panelists:
• Dr. Flora Tang, Associate Director, Molecular Pharmacology, Amgen, Inc.
• Dr. Miroslav Cik, Principal Scientist, Department of AD&HTS, Johnson & Johnson Pharmaceutical Research & Development
• Dr. O. Joseph Trask, Jr., Associate Senior Biochemist, Eli Lilly and Co.
• Mr. Leon S. Garfinkel, Director, Informatics & Infrastructure, Preclinical Discovery Research, Hoffmann-La Roche, Inc.

Discussion Questions Include:
• Which software packages handle the multiparameter readouts of imaging platforms in “user friendly” fashion?
• What additional query tools are available to data mine large scale HCS collections? 
• What are the options for the first time purchaser of a data management solution for HCS? 
• Are there platform independent solutions to automated image analysis? 
• How are machine learning, artificial intelligence and neural networks being applied to HCS? 
• Is there ready-to-use image analysis software? 
• How can Information Technologies/ Information Management teams interact with HCS scientists more effectively? 
• What is the rate-limiting steps in accessing HCS data? How can data be shared and synchronized between multiple sites?
• How can all the images and data be saved in a cost effective manner? 
• Is there a need for standardized image formats?
• How long should the images be saved, is it really necessary to save them indefinitely? 

2:30-3:15    What Standards are Needed for HCA?
Chairperson: Dr. Kurt Langenbach, Research Biologist, Cell and Tissue Measurements Group, Biotechnology Division, National Institute of Standards and Technology

Panelists:
• Dr. O. Joseph Trask, Jr., Associate Senior Biochemist, Eli Lilly and Co.
• Ms. Ann Hoffman, Senior Principal Scientist, Roche Discovery Technologies, Hoffmann-La Roche, Inc.
• Dr. Robert F. Murphy, Professor of Biological Sciences and Biomedical Engineering; and Director, Merck Computational Biology and Chemistry Program, Carnegie Mellon University

Discussion Questions Include:
• What impact would standards (or a lack thereof) have on HCA?
• What are the working “gold standards” for assay validation? Are new standards prepared every time an assay is run?
• What are the sources of potential measurement errors and how can we quantify these errors (including cells, assay conditions, fluorescent probes, image acquisition, image analysis, etc.)? 
• How accurate and precise are each of the HCA measurements? What is the variability within an assay? How repeatable are the assays (will you get identical data from the same samples run later in the day)? How reproducible are the assays (do you get the same information on different days or in different labs)?
• How rugged and robust are HCA assays? How long can cells be used? How does cryopreservation influence cellular behavior? How does variability in culture media and serum influence cellular behavior? Does the source of plasticware introduce variability into the system? 
• What are the limits of detection and quantitation? How many cells do we need to measure to adequately describe a population? How does system miniaturization influence sensitivity to inherent variations? How do we clearly describe/delineate a change in a population?

3:15-3:45    Networking Refreshment Break

3:45-4:30    ROI Analysis on HCA 
Chairperson: Dr. Ralph Garippa, Research Leader, Roche Discovery Technologies, Hoffmann-La Roche, Inc. 

Panelists (Additional Panelists to be Announced):
• Dr. John Dunlop, Associate Director, Discovery Neuroscience, Wyeth Research
• Dr. Paul A. Johnston, Research Advisor, Eli Lilly and Co.

Discussion Questions Include:
• What is the investment in implementing HCA technology, including capital investment in instrumentation, assay development and reagent costs, 
IT infrastructure, maintenance and upgrades, down-time and technical support?
• What are the typical costs/assay for various assay types?
• Cost/benefit analysis on alternatives to HCA. What are the alternatives to HCA (including cell-based and non-cell-based assay formats, as well as 
target-specific vs. assay-specific applications)? What is the increased “value” of HCA data? Is this worth the investment?
• What avenues are currently under-exploited in HCA and what applications would dramatically increase the ROI (such as ADME/Tox, systems 
biology, etc.)?

4:30-5:15    Consensus Statement for the Vendors

End-User Task Force:
• Dr. John Dunlop, Associate Director, Discovery Neuroscience, Wyeth Research
• Dr. Paul Elvin, Principal Scientist, Cancer Bioscience, AstraZeneca
• Dr. Ralph Garippa, Research Leader, Roche Discovery Technologies, Hoffmann-La Roche, Inc. 
• Dr. Paul A. Johnston, Research Advisor, RTP Laboratories, Eli Lilly and Co.
• Dr. Flora Tang, Associate Director, Molecular Pharmacology, Amgen, Inc.

Discussion Questions to be provided by the Vendor Task Force before the meeting.

5:15 Close of End-User Forum