See Who's Attending IIR's Bioassay's and Bioanalytical Method Development Event

The 8th Annual Bioassays and Bioanalytical Method Development event is taking place in 3 weeks – October 1-3 in Berkley - and all the leaders in the bioanalytical R&D industry will be there including Vice Presidents, Heads, Directors and Sr. Scientists from:

* Abbott Biotherapeutics * Alexion Pharmaceuticals * Algorithme Pharma * Ambrx * Amgen * Amylin Pharmaceuticals * ATCC * AVEO Pharmaceuticals * Bavarian Nordic GmbH * BioAgilytix Labs * Biogen Idec * BioMonitor A/S * Catalent Pharma Solutions * Charles River Laboratories * Cirion Clinical Trial Services * Crucell * Eli Lilly * EMD Millipore * ENS - Cachan * Epizyme * Eureka Therapeutics * Fresenius Kabi USA * Genentech * Genzyme * GlaxoSmithKline * GSK Biologicals * Healthpoint * Human Genome Sciences * Immunogen * Incyte * Inovio Biomedical * Jennerex * MedImmune * Merck & Company * Merck KGaA * Merz Pharmaceuticals GmbH * OncoMed Pharmaceuticals * Pfizer * Planet Biotechnology * Promega * Regeneron Pharmaceuticals * RMC Pharmaceutical Solutions * Stem CentRx * University of California * Vaxinnate * Visterra *

The 8th annual Bioassays and Bioanalytical Method Development Conference will take place October 1-3, 2012 in Berkley, California. As a reader of this blog, when you register to join us today and mention code XP1768BLOG, you’ll save 15% off the standard rate! If you have any questions, feel free to contact Jennifer Pereira.

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Bioassays & Bioanalytical Method Development Session Spotlight: Elispot Assays to Pinpoint the Quality of T-cell Response

One of the biggest questions in designing and interpreting results from immunoassays is the quality of T-cell response; this is an especially intriguing issue now that newer research has suggested that T-cell and B-cell responses might not be interconnected in the popularly-assumed manner. Though very new, elispot assays are very useful in answering these questions and also for eliminating background variability.  At our upcoming Bioanalytical Method Development & Bioassays event, Medimmune will be sharing results on this topic with a case study.

 For more information on this session and the rest of the event, download the agenda.  As a reader of this blog, when you register to join us this October 1-3 in Berkley, California and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Elispot Assays to Pinpoint the Quality of T-cell Response
Featured Speakers: Lokesh Agrawal, PhD, Project Director, R&D, Translational Medicine, MEDIMMUNE
About the session: Novel cell-based assay designs can allow you to clearly document the decrease in cell signals in neutralizing serum without having to rely on a reporter RSV virus. These techniques will depict GFP expression with the clarity you need to grade vaccine efficacy. Elispot assay techniques, while new, are particularly useful in eliminating background variability and pinpointing the quality of T-cell response.

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Bioassays & Bioanalytical Method Development Session Spotlight: Development of a Novel Set of Release Assays for a Recombinant Influenza Vaccine

Most modern immunoanalysis was inspired by longstanding work in vaccine design - where, of course, an immunogenic result was the goal all along. How simple, effective, and accurate has it been to transition the methods meant to create immunogenic responses into now attempting to prevent them?

This year at the Bioassays and Bioanalytical Method Development Event, Vaxinnate will be on hand to take a closer look at this.  For more information on this session and the rest of the event, download the agenda.  As a reader of this blog, when you register to join us this October 1-3 in Berkley, California and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Development of a Novel Set of Release Assays for a Recombinant Influenza Vaccine

Speaker Scott Umlauf

Featured Speaker: Scott Umlauf, PhD, Director, Immunology and Analytical Testing, VAXINNATE
About the session: Creation of vaccines using recombinant protein technology can involve developing a novel set of release assays, at least some of which are biological in nature. VaxInnate’s technology utilizes a fusion of antigens with an innate immune stimulator.  Qualifying a cell-based assay for Toll-Like Receptor (TLR) activity has presented challenges, while replacing the Single Radial Immune Diffusion Assay (SRID) presents an opportunity to modernize influenza vaccine release assays.

• • Cell-based TLR assays should accurately predict in vivo responses
• • Curve discontinuity complicates mathematical analysis 
• • Replacement of in vivo potency assays with ELISA or SPR desirable

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Bioassays & Bioanalytical Method Development Session Spotlight: Use of Transfected Cells in Cell-Based ADCC Assays

Transfected cells are a type of cell that can make effector cells from serum far more predictable & reliable. Validated purified receptor surrogates are extremely useful in comparing to results from standard cell-based assays.

This year at the Bioassays and Bioanalytical Method Development Event, Pfizer will be on hand to take a closer look at this.  For more information on this session and the rest of the event, download the agenda.  As a reader of this blog, when you register to join us this October 1-3 in Berkley, California and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Use of Transfected Cells in Cell-Based ADCC Assays
Featured Speaker: Poonam Aggarwal, PhD, Senior Principal Scientist, PFIZER
About the session: The biggest challenge you are likely to face in designing robust ADCC assays is the inherent variability across different sources of human blood serum. Yet it is possible for your use of transfected cells to make the effector cells from serum more reliable and predictable. Analyzing the relative comparability of antibodies can shorten your workflow and cut down on some variable and confusing results.

• • Evaluate ADAs to determine whether they are enhancing ADCCs or not
• • Pinpoint the Fc gamma receptor binding signal using surface plasmon resonance
• • Validate your purified receptor surrogates in order to best compare to results from standard cell-based assays

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Immunogenicity University debuts at IIR's Bioassays and Bioanalytical Method Development event

For the first time on the West Coast, the Immunogenicity University full-day summit at Bioassays and Bioanalytical Method Development 2012 will give you the training you need for the design, validation, and smooth transfer of robust immunoassays.

Experts at all career stages will benefit from these in-depth sessions that emphasize troubleshooting, improving result quality and turnover time, and matching the expectations of regulatory reviewers.

Walk away with in-depth knowledge from the leaders in research & development:

• - Fundamentals of Immunogenicity Assessment 
• - Presented by Edwin Golez, Scientist, AMYLIN PHARMACEUTICALS & Valerie Theobald, PhD, Scientific Associate Director, Clinical Assay Development, GENZYME
• - Trusting your Data Chain: Assay Transferability 
• -Presented by Shobha Purushothama, PhD, Principal Scientist, PKDM, BIOGEN IDEC and Shelley Belouski, PhD, Principal Scientist, Clinical Immunology Outsourcing, AMGEN
• - Plan for Challenges in Preclinical and Clinical Development of Anti-Therapeutic Antibody Assays 
• - Presented by Sally Fischer, PhD, Group Leader, Bioanalytical R&D, GENENTECH & Kate Peng, PhD, Scientist, GENENTECH
• - Intensive Skill-Builder for Statistical Analysis 
• - Presented by Martin Kane, PhD, Director of Process Statistics, HUMAN GENOME SCIENCES and Lanju Zhang, PhD, Senior Principal Statistician, MEDIMMUNE

For more information on the Immunogenicity University and the rest of the program, download the agenda.

The 8th annual Bioassays and Bioanalytical Method Development conference will take place October 1-3, 2012 in Berkley, California. As a reader of this blog, when you register to join us today and mention code XP1768LINK, you’ll save 15% off the standard rate! If you have any questions, feel free to contact Jennifer Pereira.

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Bioassays & Bioanalytical Method Development Session Spotlight: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective

Cell-based assays are extremely challenging to use due to their innate uniqueness and the need to interpret them through complex statistical analysis programs. At the same time, FDA regulators often require the use of a NAb assay in order to test immunogenicity and demonstrate product safety – meaning this is a challenge that practitioners in this field cannot avoid. In this session Dr. Martin Lechmann, Associate Director of DMPK at Merck Serono, will provide specific case studies of methods to decrease the development time of these assays, while also increasing robustness, reproducibility, and potential for automation.

For more information on Bioassays and Bioanalytical Method Development, download the agenda.  If you'd like to join us in Berkeley, CA this October 1-3, 2012, as a reader of this blog when you register to join us and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Novel Approaches for the Detection of Neutralizing Antibodies
Featured Speaker: Martin Lechmann, PhD,Associate Director, DMPK, MERCK SERONO
About the Session: The development of reliable Nab assays is very challenging and takes a lot of time and resources until a validated NAb assay is up and running. Usually not only the development time is long but also the assay itself can last several days. Thus, cell-based Nab-assays are in general not suitable to analyze high number of samples. In addition, cell-based Nab assays are often susceptible to matrix background and special care has to be taken to assure that the neutralizing effects are attributed to antibodies. Particularly, robustness and reproducibility present major challenges. Therefore, new approaches are needed to decrease the development time and to increase the reproducibility of these assays. We will present different novel approaches with the aim to develop NAb assays that are more robust and have the potential for automation. These approaches include miniaturization of cell cultivation using Lab-on-Chip Technology and ready to assay cells.

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Stop Press: FDA confirms for 8th Annual Bioassays and Bioanalytical Method Development

Your job – and your customers’ lives – depends on your ability to design safe and non-immunogenic biomolecules. The best way for you to meet regulatory expectations and company deadlines is through expert insight straight from the source.

The 8th Annual Bioassays and Bioanalytical Method Development event is pleased to invite you to get your questions answered by one of the FDA’s top bioassay experts. Make sure to register today so you can see this exclusive information:

"Anticipating and Assessing the Immunogenicity of Biologics - A Scientific and Regulatory Perspective" presented by Zuben Sauna, PhD, Principal Investigator, Department of Hematology, CBER, FDA

For more information on this presentation and the rest of the event, download the agenda.

The 8th annual Bioassays and Bioanalytical Method Development conference will take place October 1-3, 2012 in Berkley, California. As a member of this LinkedIn group, when you register to join us today and mention code XP1768BLOG, you’ll save 15% off the standard rate! If you have any questions, feel free to email Jennifer Pereira.

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Who can you meet at Cell Based Assay and Bioanalytical Development next week?

This is your last chance to register for next week's 7th Annual Cell Based Assays and Bioanalytical Method Development event in Berkeley, CA.  Are you registered? Here are the companies can you meet while attending the event:

Abbott BioResearch Center * Ablynx NV * Acceleron Pharmaceuticals Inc * Alexion Pharmaceuticals Inc * Alta Analytical Intertek * Amgen Inc * Amyris * BioAgilytix Labs * Biogen Idec * Boehringer Ingelheim * Covance Laboratories * Crucell Holland B.V. * CSL Limited * Food & Drug Administration * Genentech Inc * Geron Corporation * Grifols Inc * GSK - Domantis Group * Hospira Inc * Human Genome Sciences * Institut Andre Lwoff * KaloBios * Laboratorios Raffo S.A. * LAJ Consultants * MedImmune * Merck & Company * MSD * National Biophotonics & Imaging Platform * Peregrine Pharmaceuticals Inc * Pfizer * PharmaNet Development Group * PPD * Regeneron Pharmaceuticals Inc * Stanford University * Takeda Pharmaceutical * Teva Biopharmaceuticals * UCSF Clinical & Translational Science Institute * University of Buffalo * Wake Forest Univ School of Medicine * ZymoGenetics Inc

For more information about this year's event, visit our webpage.

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Cell Based Assays & Bioanalytical Method Development helps Arm Your Assay Development with Critical Workshops

This October at Cell Based Assays and Bioanalytical Method Development, we are pleased to announce four intimate critical topic workshops that feature troubleshooting examples and group feedback on your most pressing issues. Don't miss out on this year's offerings:

2011 Critical Topic Workshops:

• - Method Development for Liquid Chromatrography - Mass Spectrometry Applications in the Clinical Laboratory Setting
• - Fundamentals of CBA — Tactics & Troubleshooting
• - Using Design Of Experiment to your Greatest Advantage in Reducing Variance and Guaranteeing Translational Success
• - Minimize Error Potential through Firm Establishment of Acceptance Criteria, Baselines, Cutpoints, and Outliers

This event will take take place October 3-5, 2011, in Berkeley, California. For more information on these workshops and their leaders, and the rest of the program, visit the Cell Based Assays & Bioanalytical Method Development webpage.

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Cell Based Assays and Bioanalytical Method Development Podcast: Chandra Dixit, National Biophotonics & Imaging Platform of Ireland

Chandra Dixit, Researcher, National Biophotonics & Imaging Platform of Ireland recently sat down with the Cell Based Assays and Bioanalytical Method Development team to discuss various methods of improving assay sensitivity and signal-to-noise ratios, in the context of his own work in developing high-sensitivity surface plasmon resonance immunoassays and nanoparticle-based imaging platforms.

Here's a excerpt from the podcast:

Could you describe your own work in bioanalytical method development?

Dixit: I am working on developing different platforms, like if you’re working assay development, you might have heard about developing immunoassays for phased plasmon resonance on focal imaging. So, what I’m trying to do is I’m trying to build a bioassay that is highly sensitive. When we are talking about enzyme immunoassays, then I’m trying to improve the sensitivity so that we can go far below the thresholds and that could be used to – that have huge applications in industry and diagnostics. And when I’m talking about SPL immunoassays and imaging platforms, then we certainly can go and make visualization of various particles. So, what I am doing is I’m developing a platform that could detect viruses or bacteria or cellular components down below that threshold that’s in our bodies. So, I will go one by one what exactly I am doing.

First of all, I was working with Bristol-Meyers Squibb. With them, what I did – they have bioprocess technologies going on. They develop different pharmaceutical products. So, they expected me to develop immunoassays that can detect impurities in their bioprocess systems. So, I developed five immunoassays, which are now translated and the technologies are transferred to them. So, in other cases I have developed few Surface Plasmon Resonance assays and currently I’m working on developing different high-sensitivity nanoparticle-based imaging systems, which uses silicone nanoparticle and which is, of course, high dose. These dyes are near infrared dye, which comes into the range of – the fluorescence comes into the range of near infrared region. So, this is all about my work.


To read the entire transcript and listen to the podcast, download it here.

Cell Based Assays and Bioanalytical Method Development event is taking place October 3-5 in Berkeley, CA. For more information on Dixit's presentation and the rest of the program, download the brochure. As a reader of the Future of Biopharma Blog, register for this event with the special Priority Code XP1668Blog, to receive 25% off the standard rate! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com.

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Overcoming Hurdles in Mass Spectrometry-based mAb Quantification with Xiaotao Duan

Cell Based Assays Speaker Spotlight:
Xiaotao Duan, Assistant Professor, State University of New York – Buffalo
Presenting: Overcoming Hurdles in Mass Spectrometry-based mAb Quantification
For more on Xiaotao Duan's presentation, download the Cell Based Assays  Bioanalytical Method Development Brochure here.

What are you currently working on at University of Buffalo. What impact does this research have on the future of pharmaceutical / medical development?
My research in SUNY Buffalo has been focused on:
a) developing bioanalytical methods for characterization, identification and quantification of therapeutic proteins/peptides
b) the application of mass spectrometry to the quantitative and structural analysis of endogenous markers and small‐molecule drugs/metabolites.
These analytical efforts have contributed greatly to a variety of PK/PD studies and clinical investigations.


What interested you in this line of work in the first place?
LC/MS based targeted protein quantification, which has shown great potential in the development of protein therapeutics.


How do you use LC‐MS applications in your own work?
Our lab is equipped with a variety of state-of-the-art LC/MS instruments. We have a high resolution / mass accuracy platform (e.g. LTQ/Orbitrap XL with ETD) which is largely engaged in large-scale proteome profiling and PTM identification. We also have several triple-quadruple MS dedicated for targeted protein quantification, as well as sensitive measurement of small- molecule biomarkers/drugs.


How much of your protein characterization and quantification work for monoclonal antibodies depends on use of MS techniques, and how much depends on ligand‐binding assays (or other assay designs)? Do you find that these approaches compliment one another? Or is one strictly better than the other?
For mAb quantification, in most cases we prefer MS techniques, because the specific reagents for ligand-binding assays (LBA) are usually not available and the MS method development is faster and more cost-effective. Moreover, MS methods often provide superior sensitivity and specificity as well as reproducibility. Nonetheless, I would by no means conclude that MS is strictly better than LBA. In fact, a decent LBA, once successfully developed, can be run at higher throughput and offers even better sensitivity in specific applications.


Have you come across any surprising or unusual results?
With regards to mAb quantification using LC/SRM-MS, we did observe several “hidden risks” that are often overlooked by others. For example, in most applications for protein drug/biomarker quantification, synthesized signature peptides are typically used as the reference standards to prepare both calibration solutions and quality control samples. Nevertheless, our finding suggests this peptide-referenced calibration may introduce significant biases for mAb quantification, as a complete digestion of mAb is unachievable most of the time. Therefore, pure protein standards are always preferable to enable an accurate quantification of mAb


What are some of the biggest challenges that you face in your work, and how do you manage to address them?
When you pave the road to a more refined LC/MS analysis, challenges are always there. A recent case occurred in the context of tissue mAb quantification. A big concern of this work was how to ensure assay accuracy, which is often compromised by nonquantitative sample preparation, unforeseeable instability of signature peptides, and potential pre-analytical variations (e.g. dissociation of light and heavy chains). To address these challenges, we put a lot of efforts to optimize the extraction/digestion protocol, and to evaluate peptide stability in targeted tissues. We also monitored more than one peptide for each mAb to strengthen our confidence on the quantification results.


What would you consider to be the most exciting news or recent developments in LCMS applications? Are there new discoveries in particular that you’ve heard of and tried to incorporate into your own work—and if so, how did that turn out?
There have been tremendous technical advances in LC/MS analysis over the last few years. A significant one is the implementation of ETD on high-resolution / mass accuracy hybrid instrumentation such as the Orbitrap. We have successfully applied this strategy to improve the characterization of therapeutic proteins/peptides and the identification of important PTMs.


What will you be discussing at the CBA‐BAMD conference? Who do you think would benefit the most from hearing you speak?
While LC/MS holds great promise for therapeutic protein quantification, developing a sensitive and specific LC/SRM-MS method for mAb quantification in complex matrix remains challenging. In the upcoming CBA-BAMD conference, I will discuss in detail the critical issues in the implementation of MS / MS-based mAb quantification, including signature peptide selection and SRM optimization. I will also introduce a novel, on-the-fly optimization approach to facilitate method development. Demonstrative applications to mAb PK/PD studies will be reported as well. I believe this topic will be of great interest to the audience—in particular, to anyone working directly on MS-based targeted protein quantification.


What are you most looking forward to learning at the CBA‐BAMD conference?
I will be especially interested in the latest applications of novel immunoaffinity approaches combined with mass spectrometry.

Now in its 7th year, the Cell Based Assay and Bioanalytical Method Development event is taking place October 3-5 in Berkeley, CA. For more information, visit our website. As a reader of the Future of Biopharma Blog, register for this event with the special Priority Code XP1668Blog, to receive 25% off the standard rate! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com. Register here.

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A Special Message from the Cell Based Assays & Bioanalytical Method Development Chairperson

A message from Shan Chung, PhD; Scientist, Bioanalytical Sciences, Genentech; Co-Chair, Cell Based Assays and BioAnalytical Method Development 2011:

Dear Colleague,

We all face similar challenges in designing and validating assays and bioprocesses. Whether trying to secure cell sources that reliably present conditions of interest, determining criteria to identify and eliminate outlier results, or designing assays sensitive enough to track ultra low-abundance proteins, each step involves performance trade-offs that must be carefully considered and accounted for. And ultimately we all seek to design methods with proven transferability and clinical utility.

That is why I would like to invite you to attend IIR’s 7th Annual Cell Based Assays and BioAnalytical Method Development conference, to be held October 3-5, 2011 at the Claremont Hotel Club & Spa in Berkeley, CA. This year’s event will feature nearly 40 speakers, and will continue to offer the small-format discussions and troubleshooting sessions you have come to expect. To learn more, download the latest conference brochure.

Some of the topics we will cover include:
• Strategies for control and assessment of Fc effector functions of therapeutic antibodies
• A rapid approach to developing reporter cell lines for bioassays
• Bioanalytical test elements that facilitate comparability studies for the development of biosimilars
• Virus neutralization assays using multiple image-based technology platforms

For more information, download the event brochure.

Thank you very much, and I look forward to welcoming you to this event in October.

Sincerely,
Shan Chung, PhD
Scientist, Bioanalytical Sciences, Genentech
Co-Chair, Cell Based Assays and BioAnalytical Method Development 2011

As a reader of the Future of Biopharma Blog, register for this event with the special Priority Code XP1668Blog, to receive 25% off the standard rate! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com. Register by emailing register@iirusa.com.

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Call for Speakers / Abstracts: Cell Based Assays and Bioanalytical Method Development Conference

The 7th Annual Cell Based Assays and Bioanalytical Method Development Conference will be held October 3-5, 2011 at The Claremont Hotel Club & Spa in Berkeley, CA. You are invited to submit speaking and/or poster proposals for consideration. The deadline for speaking proposal submissions is June 17.

Designed by leaders in the bioassay and bioanalytical industry, this meeting is the only place to connect with fellow scientists who are discovering new approaches and solutions to the assay development challenges you face every day. It will feature key updates on the latest regulatory developments, analysis of new whitepapers, and case studies of novel techniques. Networking and sharing solutions with your scientific colleagues will help you understand best practice in assay design and validation, which in turn will streamline your preclinical and clinical pipelines and facilitate drug discovery and safety maintenance.

Please direct all inquiries and suggestions to the Conference Producer, Matt Greenbaum at mgreenbaum@iirusa.com or (646) 895-7310.

To discuss sponsorship and exhibitor opportunities, contact Business Development Manager David Borrok at dborrok@iirusa.com or (646) 895-7485.

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Who can you meet at Cell Based Assays & Bioanalytical Method Development 2010?

Over the past 5 years, the Cell Based Assays and Bioanalytical Method Development Conference has been the only place to learn from the scientists at the forefront of new approaches and solutions to the assay development obstacles you face everyday.

This year, hear the latest regulatory requirements, white paper authors and most recent case studies on new approaches to troubleshooting bioassay and bioanalytical challenges.

These companies will be there, will yours?

AAI Pharma Inc. * Alder BioPharmaceuticals * Allergan Inc. * Amgen Inc. * Biogen Idec * Bristol Myers Squibb * CBER FDA * Center for Molecular Medicine & Immunology * Cephalon Australia Pty Ltd * Charles River Laboratories * Facet Biotech * Food & Drug Administration * Genentech Inc. * Gregory Maschek * Human Genome Sciences Inc. * ImClone Systems * Immunogen Inc. * IRX Therapeutics * KaloBios * Laboratory of Cellular & Gene Therapy * Macrogenics Inc. * MedImmune Inc. * Pfizer * PPD Inc. * Process Confidence * Promega Corporation * Roche Diagnostics GmbH * SafeBridge Consultants Inc. * Sanofi Pasteur * Shire Human Genetic Therapies * TOLERX * Trion Pharma GmbH * University of Louisville James Graham Brown Cancer * US Pharmacopeia * Willem Oosterveen * Wyeth Pharmaceuticals

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Cell Based Assays: An Interveiw with Xu-Rong Jiang, MedImmune

Speaker and Cell Based Assays Track Chair Xu-Rong Jiang, PhD, MD, Associate Director, Analytical Biochemistry, MedImmune, recently commented on the case study he'll be presenting at this year's conference taking place October 4-6, 2010, in San Francisco, California.

Download the MP3 here. Download the transcript here.
Visit the Cell Based Assays & Bioanalyitical Method Development agenda here.

First of all, can you tell us a little bit about your background?
Xu-Rong: I started cell based assay development back to 1998 at Geron for the early drug discovery. I have further developed cell based potency assays at Amgen since 2002. I was leading a group of scientists responsible for the development, qualification, validation of potency assays used for clinical and commercial biologic development. During the past 3 years, I have increasing responsibilities leading a large bioassay group responsible for development of cell based assays for low release biological characterization of biologics at MedImmune, a Biologic Subdivision of AstraZeneca. It has been my great pleasure working with Anne Reel, your program director, to present and co-chair at the Cell Based Assay Development conferences during the past 4 years. It is a very enriching experience for me.

Can you give us a preview of the case study you’ll be presenting this year? Xu-Rong: I have observed an increased level of interests and attendants of the conference during the past few years. Attendance of this conference really covers a great deal from the biopharmaceutical industry, especially for scientists the industrial leaders such as Genentech, Amgen, Biogen Idec, as well as for scientists from new emerging companies who wish to learn more from the industrial leaders and discuss their concerns. The case study I will present at this conference focuses more on a platform technology approach that will facilitate the development of homogeneous, fast and robust bioassays more effectively and efficiently. Specifically, this case study concerning the utilization of engineered cells for the development of cell based assays that could assess both Fab and Fc functionalities in a development- and QC-friendly manner.

What are you looking forward to at this year’s event?
Xu-Rong: I think this year there are a couple of aspects that really have advanced from the past few years. Firstly, this year’s Cell Based Assays will be combined with Bioanalytical Method Development. So they are going to cover a broader range of topics, from cell based assays for potency, Fc effector function assessment, Nabs assays for immunogenicity, and assays utilized for PK/PD purpose.
Secondly, while I am serving on the advisory panel for the meeting organizers that we realized it would be great to attract regulators to present at the conference. This year,
2 Cell Based Assays & Bioanalytical Method Development Podcast: Xu-Rong Jiang, PhD
the conference has indeed attracted broader attendance, especially speakers from the FDA.
Last but not least, this year will held a Fc effector function session and a strategy white paper for the assessment of effector functions of therapeutic antibodies will be presented by An Song, PhD, Senior Scientist, Associate Director, BioAnalytical R&D, GENENTECH. I worked closely with her to co-author the manuscript that was submitted one month ago. All these aspects I believe will make this combined conference very unique.

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New White Paper: Helpful Hints for Better Aseptic Technique

Jill Mariano, MD of the Cell Based Assays LinkedIn group recently shared the white paper Helpful Hints for Better Aseptic Technique. You can see the white paper here.


In 2010, we are combining the Cell Based Assays and Bioanalytical Development Conferences to provide one comprehensive event that encompasses both areas, yet leaving time to dive deeply into the content of each one using separate track sessions. For more information on this event, please visit the webpage.

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Save the Date & Call for Presenters: Cell Based Assays & BioAnalytical Method Development 2010

In 2010, we are combining the Cell Based Assays and Bioanalytical Development Conferences to provide one comprehensive event that encompasses both areas, yet leaving time to dive deeply into the content of each one using separate track sessions. It will take place October 4-6, 2010 in San Francisco, California

Visit the Cell Based Assays website for further updates!
http://bit.ly/dc8frZ

Would you like to be a presenter at Cell Based Assays or Bioanalytical Development?
We invite you to submit a proposal for a speaking opportunity directly to Anne Reel, Senior Conference Director, by April 23rd, 2010 at the very latest. Send to areel@iirusa.com or call 919-676-0306.

Submission Guidelines & Details

We expect that the conference will attract between 75-125 attendees. For consideration, please e-mail areel@iirusa.com with the following information by April 23, 2010

• Proposed speaker name(s), job title(s), and company name(s)
• Contact information including address, telephone number, and e-mail
• Title and objective of presentation
• Please indicate which topic you plan to address.
• Short Summary of the talk

We are also interested in proposals for one day and half day workshops. These workshops should be focused on specific techniques and skill building topics.

All speakers receive FREE admission to the conference as well as any pre-conference activities

General Areas
• Potency
• Immunogenicity
• Characterization
• In Vitro Toxicology
• Immunotoxicolgy
• Fc Functionality
• ADCC Assays

Case Studies Suggestions:
• Fc gamma binding ADCC, FC effecter binding and function, Assessment of FC functionality and F binding ADCC
• Alternative assays to using ADCC to measure FC/FCR binding
• ADC matrix interference
• QA Assays development & QC assay qualification
• Antiviral reporter assay
• Cell based functional assays
• Technical Platform qualification and evaluate long term usefulness of new technologies
• How to rapidly develop assays for new indication where there is no established systems
• Determine limit of detection of assay and complexity of MoA
• Case studies on cell based potency assays, methodology selection cellular mechanisms
• Strategies for characterizing new therapeutics for efficacy
• Improvements in innovation and automation
• Surrogate for NK cells –example NK cell line
• Antibody drug conjugate case studies
• Total and bound assays-free vs total drug assays examples
• Technologies to measure drug target interactions

Why should you attend?
• To learn from other in industry how they overcome issues
• To update recent research analysis and methods development
• To gain insight into the state of the art bioanalytical methods
• To learn where BA field in respect to measuring total vs free drug target in pre clinical and clinical studies

Is your number one challenge not addressed here?
Contact Anne Reel to ensure it is on the final program! AReel@iirusa.com

Do you want to reach this audience?
We have a limited number of slots available for solution providers/consultants.
People who wish to become part of the program should contact Dave Borrok, Sponsorship Manager, at 646.895.7485 or dborrok@iirusa.com.

This year, BioAnalytical Method Development be co-located with Cell Based Assays. To find out more about BioAnalytical Method Development, visit the webpage: http://bit.ly/dc8frZ

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2nd Annual Bioanalytical Method Development

What’s new in 2009 for Bioanalytical Method Development?
• Tackle biomarker assay issues with Biomarin, Human Genome Sciences, and Genentech – bring back to your lab new approaches for including biomarkers in your PK/tox program, using biomarker assays as a trigger for treatment, and strategies to resolve heterophilic interference
• Half-day dedicated to all new Fc Functionality data
• Improve your developmental strategies for free and/or total antibody drug at the half-day workshop dedicated to case studies and open dialogue on the challenges, pros, and cons of developing free and total assays with Eli Lilly and Amgen
• Industry experts share strategies to generate meaningful data on molecular interactions to support biotherapeutic development
• Pfizer presents data on interference generated in different assay formats, using modeling as a predictive tool, and how to generate significant savings by reducing the number of assays requiring GLP validation.

Why IIR’s BAMD?
• Shorten development timelines to improve speed to market
• Network with colleagues to solve your biggest challenges
• Reduce costs by improving efficiencies in your lab

This is a unique opportunity to mingle with such an esteemed group of scientists all focusing on the advancement of bioanalytical method development! Register now and save $400 when mentioning code FVFVSBF.

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