Celebrate Columbus Day! Register for Pharma and Healthcare Events Thru Monday and Save $300!

Register for any of the following IIR events and receive a $300 discount*

Mention code COLUMBUSLI when registering for each/any of the following:

-  Register here for IIR’s 15^th Annual Business of Biosimilars event taking place October 20-22, 2014 in Boston, MA, visit the website for full details.

-  Register here for IIR’s 15^th Annual Immunogenicity and Biotherapeutics event taking place October 20-22, 2014 in Boston, MA, visitthe website for full details.

-  Register here for IIR’s 10^th Annual Bioassays and Bioanalytical Method Development event taking place October 20-22, 2014 in Boston, MA, visit the websitefor full details.

Have any questions? E-mail Jennifer Pereira.

*This promotion is only valid October 10^th-13^th 2014. Offer cannot be applied retroactively to confirmed paying registrants and cannot be combined with any other discounts or promotions. All registrants and guests are subject to IIR approval.

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Stay cool this summer with a 30% savings! Register by August 15 and save 30% off the standard rate!

Register now to get your cool savings off IIR’s 10^th Annual Bioassays and Bioanalytical Method Development event with a 30% discount off the standard rate!*

Register here to join us and mention code XP1969Cool to take advantage of this discount.

The Bioassays event will take place October 20-22, 2014 in Boston, MA. Visit the website for full details. Don’t forget this event is co-located with IIR’s 15^th Annual Immunogenicity for Biotherapeutics —learn more here.

Download the agenda here to see what’s on tap.

Have any questions? Email Mike Madarasz.

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Stay cool this summer with a 30% savings! Register by August 15 and save 30% off the standard rate!

Register now to get your cool savings off IIR’s 15^th Annual Immunogenicity for Biotherapeutics with a 30% discount off the standard rate!*

Register here to join us and mention code XP1938Cool to take advantage of this discount.  

The Immuno event will take place October 20-22, 2014 in Boston, MA. Visit the website for full details. Don’t forget this event is co-located with IIR’s 10^th Annual Bioassays and Bioanalytical Method Development event—learn more here.

Have any questions? Email Mike Madarasz.

Follow us on Twitter

Join us on LinkedIn

Don't miss a thing. Sign up for our updates

*This promotion is only valid until August 15, 2014. Discount is not applicable to the Super Pass or Super Pass+

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Delivering Safe, Effective Therapeutics: IIR’s Immunogenicity and Bioassays Conferences

Two events, one goal.

Bring safe and effective therapeutics to the patient faster with IIR’s Immunogenicity and Bioassays conferences. 

The complexity of developing effective biologic therapeutics require adequate analytical methodology to characterize both their physicochemical properties and biological activity. Reducing the risk of triggering unwanted immune responses must be considered early on in drug development. The events focus on the current practice of comprehensive characterization of biotherapeutics from their discovery through all stages of their development.

IIR invites you to join us October 20-22, 2014 in Boston, MA for two co-located events: 15th Annual Immunogenicity for Biotherapeutics and 10th Annual Bioassays and Bioanalytical Method Development.

Download the brochure to find out how to register for one or both events and see for yourself why these are two can't miss events.

Download the Immunogenicity Brochure

Download the Bioassays Brochure

Now, you can save $100 on the current rate for each event. Register here with code XP1938BLOG for the Immunogenicity for Biotherapeutics conference.  Register here with code XP1969BLOG for the Bioassays and Bioanalytical Method Development conference. 

Questions? Comments? Reach out at MMadarasz@iirusa.com. 

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Celebrate America and Bioassays! Register Thursday & Friday and save 30% off the standard rate!

Let freedom ring! Celebrate America’s freedom and YOUR freedom to register for IIR’s 10^th annual Bioassays and Bioanalyitcal Method Development with a 30% discount off the standard rate!*

Register here to join us and mention code XP1969JULY4 to take advantage of this discount.

The Bioassays event will take place October 20-22, 2014 in Boston, MA, visit the website for full details. Don’t forget this event is co-located with IIR’s 15^th Annual Immunogenicity for Biotherapeutics event—find out more here.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid July 3 & 4, 2014.

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Celebrate America and Immuno! Register Thursday & Friday and save 30% off the standard rate!

Let freedom ring! Celebrate America’s freedom and YOUR freedom to register for IIR’s 15^th Annual Immunogenicity for Biotherapeutics with a 30% discount off the standard rate!*

Register here to join us and mention code XP1938JULY4 to take advantage of this discount.

The Immuno event will take place October 20-22, 2014 in Boston, MA, visit the website for full details. Don’t forget this event is co-located with IIR’s 10^th Annual Bioassays and Bioanalyitcal Method Development event—find out more here.

Have any questions? Email Jennifer Pereira.

*This promotion is only valid July 3 & 4, 2014

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13 Steps To Successful Potency Assays

Today, we feature an article from BioProcess International magazine co-authored by Biological Assays event chair. Laureen E. Little, Ph.D., Principal Consultant, Quality Services.

13 Steps To Successful Potency Assays

1. 1. Acquire as broad and in-depth as possible an understanding of the biological and other properties and actions of the cellular therapy product(s) for which you wish to develop potency methods. You should collect sufficient product characterization data (molecular, biochemical, immunologic, phenotypic, hysical, and biological properties) throughout preclinical and clinical development to inform and refine your approach to measuring potency.
2. 2. Acquire broad and in-depth knowledge of the process by which your cellular product is manufactured.
3. 3. Familiarize yourself with the way in which the product is administered and the events that follow administration.
4. 4. Start designing and developing two (or possibly more) potency assays early — as early as during preclinical development is desirable. Developing at least two different methods increases your chances that one of them will be suitable for both your company and the regulators.
5. 5. Realize that biological potency assay design and development for GMP use requires considerable, specialized, and varied knowledge and experience. If you are not already an expert, either become one (for suggestions, see box, Gaining Expertise in Biological Potency Method Development”), find and apprentice yourself to one in your organization, hire one, or engage the services of an expert consultant. Be sure to confirm that any prospective employee or consultant has specific knowledge and experience in developing and validating biological potency assays.
6. 6. Initiate and maintain a discussion with your CBER Reviewers so that you have agency feedback to assist in your development decision making.
7. 7. Familiarize yourself with all relevant regulations and guidance and get current and stay current with the technical literature.
8. 8. Thoroughly characterize all rare and other reagents, reference materials, standards, and controls.
9. 9. Thoroughly characterize and qualify your potency assay(s).
10. 10. Give regular technical presentations to gain input from your colleagues.
11. 11. Be diligent in creating a formal Method Development Plan and in keeping a Development Report and refer to them often.
12. 12. Determine the robustness of, and validate your potency method(s) before your end of phase 2/pre-pivotal trial meeting with FDA
13. 13. If you outsource development of your potency assay(s), always have a knowledgeable and experienced employee or consultant, whose services your company has engaged, guide and manage the product development.

Would you like to meet with Dr. Little?  Dr. Little will be hosting the workshop A Practical Guide to the Development of Assays for Evaluation of Biologics and Biotherapeutics – a Systematic Approach to Supporting Product Development in the Regulatory Environment on Monday, May 5 in Berkeley, California at Biological Assays.  For more information on her workshop and the rest of the event, which takes place May 5-7, download the agenda. As a reader of this blog, you are eligible save 20% off the standard rate when you register to join us and mention code B14177JT.

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Toward Three-Dimensional Liver Bioassays

Today, we present a spotlight from BioProcess International Magazine, looking closer at three-dimensional assays.  Read the full report here.

The Hamner Institutes for Health Sciences of Research Triangle Park, NC, has formed a research initiative to develop more realistic 3D tissue bioassays for in vitro toxicity testing. With support from the American Chemistry Council, this program should produce better human tissue surrogates than are currently available by implementing the vision of a 2007 National Academies of Sciences (NAS) report. Toxicity Testing in the 21st Century advocated new in vitro approaches to chemical safety sciences. These new technologies could enhance human relevance of test results and significantly improve product stewardship and responsible care efforts. The research program also could have implications on improving drug safety through a collaborative effort with scientists at The Hamner-UNC Institute for Drug Safety Sciences, a Hamner collaborative program with the University of North Carolina.

Current 2D liver cell cultures are viable in vitro for only about one week, making them suitable for studying acute conditions. But 3D cultures are viable for four to eight weeks, which enables studies of more prolonged exposure to chemicals. Researchers will use multiple cell types to replicate the architecture of a human liver in their laboratory. As this program matures, they will consider similar approaches for other tissues: e.g., lung, kidney, and heart. For the program’s initial phase, novel cell culture systems will be developed and evaluated. The most promising technologies will move forward to validation for more routine use in toxicity testing.

“We are very pleased to have Dr. Edward LeCluyse join us to lead this new program,” said Melvin Andersen, director of the Institute for Chemical Safety Sciences. “Ed is a world-renowned specialist in this area, and we feel extremely fortunate to have someone with his track record and ability to work collaboratively. His expertise will help accelerate the efforts toward establishing better, human-relevant approaches to risk assessments and the acceptance of the approaches outlined in Toxicity Testing in the 21st Century.”

The NAS report envisions a major effort to advance the science of toxicity testing and foster implementation into everyday practice. The new paradigm should generate improved data on potential risks to humans posed by exposure to various agents and assess chemicals more efficiently than ever before. A stronger scientific foundation offers the prospect of improved risk-based regulatory decisions and greater public confidence in the decisions. Andersen is a coauthor of the report.

LeCluyse previously served as scientific director for HepaShear, part of HemoShear LLC, where he helped develop an advanced human surrogate model of the liver to be used as a tool for drug discovery and the study of liver disease. The Hamner Institutes for Health Sciences is a nonprofit research organization building on 35 years of research in toxicology and human health research to develop and validate new cutting-edge tools for safety assessment. Novel technologies currently being developed include in silico models for predictive toxicology, in vitro models that use human cells or cell lines to evaluate perturbations of cellular responses, and in vivo models to elucidate genes that play a role in susceptibility to drug-induced toxicities. 

This year at the Bioassays Event, Abhishek Mathur, Ph.D., Senior Scientist, Function Biocharacterization of Amgen Inc will on hand to present a similar perspective on in-vitro bioassays testing during his presentation Impact of Aggregates on In-Vitro Bioassays.  For more information on his session and the rest of the program, download the agenda.  If you'd like to join us May 5-7, 2014, as a reader of this blog, when you register to join us and mention code B14177JT, you are eligible to save 20% off the standard rate.

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BioProcess International Poster Preview: Near-universal Similarity Bounds for Bioassays

Leading up to the BioProcess International Event, we'll be highlighting many of the posters you'll be able to find in the hall at the event taking place September 16-19, 2013 in Boston, MA. If you'd like to join us at the event, as a reader of this blog, when you register to join us and mention code BLOG13JP, you'll save 20% off the standard rate!

Poster: Near-universal Similarity Bounds for Bioassays

Presenter: David Lansky, Precision Bioassay, Inc

About: Several versions of composite and parameter-specific measures of non-similarity will be described and compared. Two approaches to sensitivity analyses yield new ways to examine the potential impact of various amounts of non-similarity and offer a good rationale for universal similarity equivalence acceptance limits. Factorial combinations of various amounts of parametric non-similarity are used in simulations to compare different candidate measures of non-similarity. Comparisons include the properties of each measure of non-similarity (i.e.; bias) and the performance of potency (i.e.; bias). A recommended modification of parameter-specific equivalence bounds for non-similarity yields nearly universally applicable good control of important non-similarity.

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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: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective

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. We are pleased to invite you to get your questions answered by one of the FDA’s top bioassay experts.  Today we spotlight the presentation "Bioassays: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective," from Zuben Sauna, PhD, Principal Investigator, Department of Hematology, CBER, FDA.

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: Anticipating and Assessing the Immunogenicity of Biologics—A Scientific and Regulatory Perspective
Presented by: Zuben Sauna, PhD, Principal Investigator, Department of Hematology, CBER, FDA 
About the session: Your drug development pipeline and submission testing procedures depend upon your sound understanding of the underlying risks and causes of immune response, and your ability to engineer biomolecules that are less immunogenic. You must also understand the preferred reporting thresholds and procedures of domestic and international regulatory agencies.

• • Status of newest regulatory guidelines
• • Expectations for cell-based NAb test validation
• • Preferred methods for following up after positive immunogenic results>
• • Desired drug tolerance levels across multiple phenotypes

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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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Industry Alert: Official Call For Presenters 12th Annual Immunogenicity For Biotherapeutics

From: Anne Reel, Senior Conference Producer
Re: Call for Speakers & Presentations
Event Date: April 2010
Event Venue: Washington DC
SUBMIT YOUR PROPOSAL NOW!

The Institute for International Research (IIR) is currently seeking presenters for the 2011 12th Annual Immunogenicity for Biotherapeutics event. This 3-day event will take place April 2011 in Washington DC. We invite you to submit a proposal for a speaking opportunity directly to Anne Reel, by September 10, 2010. Please send to AReel@iirusa.com.

Submission Guidelines & Details

CUSTOMIZE YOUR CONFERENCE AGENDA!
We are currently recruiting biopharmaceutical scientists who can share NEW DATA through detailed case studies on what has worked (and what hasn't worked) for Immunogenicity related to development and validation of Immunoassays, outsourcing, technology, and more. This three day event will focus on current challenges the industry sees today and provide a forum for experts to come together and share knowledge and expertise.

Who will attend the leading industry conference on Immunogenicity? Attendees will be both new and experienced biopharmaceutical scientists working in Immunogenicity such as neutralizing assay development and validation, technology, regulatory issues, and more. We expect that the conference will attract between 150-200 attendees. We are looking for novel approaches to handling nonclinical and clinical issues including:

• Regulatory considerations
• Cell-based and ligand-binding neutralizing antibody assays
• Methods to overcome drug interference
• Development and validation of Immuno and bioassays
• Demonstration of applying PK/PD/ADA/AE to interpretation of nonclinical safety studies
• Presence of ADA in nonclinical species with no PD marker available
• Cell line changes and comparability issues - animal models?
• Patient populations with high pre-existing antibody "interference"
• Interference due to increased drug target with treatment
• Standardization of statistical analysis - confirmation cut-point
• Oligonucleotides, small peptides
• Drug conjugates
• Comparison of technologies

MAKE SURE YOUR BIGGEST ISSUES ARE ADDRESSED!
Are your biggest concerns not addressed here?
Contact Anne Reel to ensure that your pressing issue gets the attention it deserves! AReel@iirusa.com or 919-676-0306.


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 e-mail dborrok@iirusa.com.
Sessions will be 30-45 minutes including Q & A.

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