Agenda Now Available: IIR's BioRepositories and Sample Management Conference

IIR's 6th Annual Biorepositories and Sample Management Conference is the largest US-event where you come to harness, protect, and grow the value that lies in your samples. We do this through detailed case studies and expert insight into those areas that present the greatest challenges to your business, including how to:

• • Develop harmonized standards to overcome the challenge of sample access
• • Understand current regulatory guidelines - or lack thereof - that affect your day-to-day functions
• • Examine how quality factors in to the evolution of evidence-based Biobanking
• • Determine whether building your own Biorepository or outsourcing to a vendor is the best choice for your company

Download the brochure to view the full agenda.

The Biorepositories and Sample Management Conference will take place September 25-27, 2013 in Boston, MA. Your registration also grants you access to our co-located event, Clinical Collaboration Congress. If you’d like to join us, as a member of this group, you’ll save 15% off the standard rate when you register to join us and mention code XP1898BLOG. This year, we’re also offering a second free delegate pass to a biorepository or biobank participants with the purchase of each pass. For more information on this offer, read here. If you have any questions, feel free to email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Rutgers University completes renovations on largest academic biobank

Rutgers has completed renovations on one of the world's largest university-driven biobanks. As chosen by the NIH, it is one of four institutions that will provide sample processing, analysis, storage, and data management for research projects. A recent Rutgers release states that the biobank features the new Genomics Technology Center. It will serve government agencies, foundations, and private-sector clients worldwide, including major pharmaceutical companies.  The University's biobank is already known for the advances it has made in mental disorders and addictions.

Andrew I. Brooks, Chief Operating Officer, Director of Technology Development and Rutgers associate research professor of genetics stated, "We’ve integrated our operation to make us more efficient, thereby increasing our capacity so we can better serve NIH-funded researchers but also to make our services more available to the private sector. We’ve expanded out infrastructure and doubled our automation analytical capabilities. Our goal is to standardize biosample collection, processing, distribution, and analysis to facilitate and accelerate the disease-discovery process.”

While institutions like Rutgers continue to make strides, the Biorepository industry as a whole is still in need of guidance to push progress forward. Our fall conference, Biorepositories and Sample Management Conference, brings together Industry Standardization Workgroup featuring participants Amelia Wall Warner, Head, Clinical Pharmacogenomics, Merck; Anita Nelsen, Head, R&D Human Sample Repository, GlaxoSmithKline; Helen Moore, Program Director, NCI-BBRB; Lori Ball, COO, Biostorage Technologies; and Katheryn Shea, President, ISBER; VP, Bioservices Operations, Precision Bioservice. During this afternoon session, the panelists and attendees will meet together to discuss Regulatory trends in patient privacy of biospecimens, Bioethical issues, Standardization of samples, Consent and re-consent, Return of research results to patients and more. For more information on this workgroup and the rest of the event, download the agenda here. If you'd like to join us in Boston September 25-27, 2013, a a reader of this blog, when you register to join us and mention code XP1898BLOG, you'll save 15% off the standard rate.

How important is it that we develop industry standards for the biobanking sector?

Share this article with your social network, just click below to share now!

Share |

Just Released: Formulation & Delivery Conference Agenda

We’re pleased to announce the release of IBC’s 13th Annual Formulation & Delivery Strategies for Biologics and Protein Therapeutics taking place this September.

Download the agenda here.

Conference sessions provide predictive methods and innovative technologies for the rational development, production and delivery of next-generation biologics and protein therapeutics:

• - Particle Identification and Characterization for Realizing Stable, Safe and Effective Formulation
• - Analytical Strategies for Determining Formulation Stability
• - Biosimilar Formulation and QbD Considerations for Biologic Development
• - Localized and Targeted Delivery Strategies
• And more!

This event will take place September 17-19, 2013 at the Hynes Convention Center in Boston, Massachusetts. It is co-located with the BioProcess International Conference & Exhibition. As a member of this group, when you register to join us and mention code B13166JP, you’ll save 20% of the standard rate. If you have any questions, feel free to email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Utilizing Design of Experiments (DOE) for Characterizing Assay Robustness during Drug Development

Kyra J. Cowan, Ph.D., Scientist, Genentech, Inc, and presenter at next week's Development, Validation and Maintenance of Biological Assays recently sat down with us to preview her presentation.  For more information on the event, download the agenda.  If you'd like to join us next week in Seattle, as a reader of this blog when you register to join us and mention code IBA13JP, you'll save 20% off the standard rate.

Your abstract states that you identified factors which impacted assay performance utilizing a screening DOE design. Once you have identified these factors do you then utilize the response surface mapping DOE designs to determine appropriate ranges?

We used a 24-run Plackett-Burman screening design to economically model all main effects and all ten 2-way interactions that may impact the response, and these factors and their corresponding levels that were included in this robustness DOE were selected based on prior knowledge of the assay and the acceptance criteria for the assay (Cowan KJ et al., Bioanalysis 4(17), 2127-39 (2012)). A response surface mapping DOE to determine appropriate ranges could have been used, in particular to further define the optimal coat concentration (for example) for this study, however we chose not to run this because we clearly saw the impact of having an unstable ligand, which was the source of the lack of robustness for this assay, and that only by handling the ligand under specific conditions could we rely on the method.

Assay robustness is a common analytical development step to utilize DOE approaches. Do you use DOE for any other development steps? If so which ones?

We can and have in some instances employed DOE to initiate assessment of reagent conditions and assay parameters at the beginning of the development stages of an assay (eg. for assay optimization), whether it’s a PK or an ATA assay, to efficiently assess the levels of the critical factors (such as coat concentration, minimum dilution of matrix, and detection reagent concentration). Some have found this to be a useful step in accelerating assay development, to assess assay robustness, or in new reagent validation.

 Many of our conference attendees are developing cell-based bioassays. Can you envision using the same DOE approach for a cell-based assay instead of a Ligand Binding Assay and what would be the additional challenges?

 As with all DOEs, the critical step is to determine which factors (and their levels) need to be assessed, since this design was meant to be a fit-for-purpose DOE and the factors will define the effectiveness of the DOE. The factors selected to be analyzed, and in turn the output or response of the DOE, should reflect the experience of the assay developer during development. This particular Plackett-Burman design used in the presentation was originally designed so that it could also incorporate not only coating conditions and substrate development time, but different lots of matrix and detection lots and their concentrations. For a cell-based assay robustness DOE, additional or alternative factors that could be included in the design that may change in small increments over time could be cell seeding density, cell harvest density, cell age, and both assay and detector (eg. Alamar Blue) incubation times, and the 2 levels for each of these factors could be the predicted or potential small variations on the final conditions selected for that cell-based assay. A recent paper by Xinyi C. Chen et al (2012) implemented DOE in the development and validation of a cell-based assay and describes a fractional factorial design to address some of these issues (Chen XC et al., J. Immnunol. Met. 376, 32-45 (2012)).

Share this article with your social network, just click below to share now!

Share |

A deeper look at Flublok - the egg free vaccine

Recently, we invited Manon M.J. Cox, President and CEO, Protein Sciences Corporation to sit down with us before the Vaccines Development and Production Summit to give us a preview of the flu vaccine industry, what challenges their facing and the remarkable technology her company has developed in order to stand apart in the flu vaccine industry.

During the podcast, she discusses the difference between Flublok and other vaccines and the current perception of receiving a flu vaccine by many adults.  She also looks at the current influenza outbrake,t hat of H7N9 and how they've developed a plan to combat it with a vaccine.

Listen to the podcast here.

Manon will be joining us at the Vaccines Development and Production Summit this June 3-5, 2013 in Durham, North Carolina.  For more information on her presentation Flublok®: Developing the World’s First Recombinant, Highly Purified, Egg-Free Influenza Vaccine and the rest of the program, download the agenda. As a reader of this blog when you register to join us and mention B13187SPX32, you'll save 20% off the standard rate. If you have any questiosn, feel free to reach out to Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Vaccines Session Spotlight: Influenza Vaccines for Pandemic Preparedness and the Future and the World’s First Egg-Free Vaccine

Pandemic preparedness is a regulatory and industry effort. Today we feature two of the sessions at Vaccines Development and Production Summit.  You can  hear from the latest U.S. Department of Health and Human Services efforts from Keynote Presenter Robert C. Huebner, Ph.D., Acting Director, Influenza Division, HHS/ASPR/BARDA.  We'll also be joined by Manon M.J. Cox, President and CEO, Protein Sciences Corporation, who developed the  the novel technology Flublok.  It was also  the worlds’ first recombinant, highly purified, egg-free influenza vaccine and it successively navigated the regulatory pathway of the FDA.

The Vaccines Development and Production Summit will take place June 3-5, 2013 in Durham, North Carolina. For more information the featured sessions and the rest of the agenda, download the program.  If you'd like to join us, as a reader of this blog when you register to join us and mention code B13187SPX32, you'll save 20% off the standard rate.

Featured Sessions:

Development of New Influenza Vaccines for Pandemic Preparedness and the Future
Featured Speaker: Robert C. Huebner, Ph.D., Acting Director Influenza Division, HHS/ASPR/BARDA
About the presentation: Since 2004, BARDA has supported the nation’s pandemic preparedness and the technology use for seasonal and pandemic influenza vaccine production. This talk reviews the progress of the current BARDA programs and discusses future efforts to meet the nation’s needs for seasonal and pandemic influenza vaccines.


Flublok®: Developing the World’s First Recombinant, Highly Purified, Egg-Free Influenza Vaccine
Featured Speaker: Manon M.J. Cox, President and CEO, Protein Sciences Corporation
About the presentation:This presentation explores the novel manufacturing technology and regulatory pathway of Flublok, which the FDA regards as a technological advance in the manufacturing of an influenza vaccine. This keynote examines the departure from using the virus and eggs in production and how the process allows for the rapid production of large quantities of the influenza virus protein, hemagglutinin (HA), using a baculovirus expression system.

Share this article with your social network, just click below to share now!

Share |

BPI China Spotlight: Adjustment of Critical Quality Attribute (CQA) by Multivariate Analysis (MVA) in Biosimilar Media Supplement Development

Recently, we had the opportunity to sit down with H. Fai Poon, M.D., Ph.D., Director of Cell Culture, Hisun Pharmaceutical (Hangzhou) Co., Ltd., China to discuss his background and experience with cell cultures and biosimilar development. During the podcast, he discusses his background, his company, and what he will be addressing at BioProcess International China taking place August 20-21 in Shanghai.

On Tuesday, April 20, Dr. Poon will be presenting the case study Adjustment of Critical Quality Attribute (CQA) by Multivariate Analysis (MVA) in Biosimilar Media Supplement Development.  Quality by Design (QbD) is the approach towards development and commercialization of biologics. In QbD, the process is designed and controlled to deliver critical quality attributes (CQA) consistently. Such process controls are particularly important for biosimilar development since they are required to demonstrate CQA similarity to reference drugs. We present a case study here that we applied multivariate analysis (MVA) to adjust the CQA of a biosimilar drug. CQA of a biosimilar product was adjusted to the reference drug criteria by cell culture media supplement optimization using MVA. Moreover, such optimization resulted in a more robust biomanufacturing process.

For more information on this session and the rest of the program, download the agenda.  If you'd like to join us in Shanghai, as a reader of this blog when you register to join us and mention code BPIC13JP, you'll save 20% off the standard rate.  Have any questions? Email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Human Factors Session Spotlight: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Clinical studies on the drug component of many drug-device combination products are conducted simultaneously, yet independently of the human factors studies. If there is a delay on one of these studies, the market launch of the combination product can be delayed.  This May in Bethesda, Maryland, experts from P/L Biomedical, MannKind Corporation and Hospira gather to discuss the  interface between the clinical drug study and the human factors device study to see where there are opportunities for greater synergy and efficiency.

The Human Factors for Drug-Device Combination Products Summit will take place May 14-15, 2013.  For more information on this session and the rest of the agenda, download the brochure.  If you'd like to join us in Maryland, as a reader of this blog when you register to join us and mention code HFJP13, you'l save 20% off the standard rate!

Featured Session: Linking HF to Clinical Trials – Can Clinical Trials Be a Source of Human Factors Information, or Not?

Participants:
Moderator: Lee H. Leichter, RAC, MBA, President, P/L Biomedical
Panelists: Chad Smutney, Senior Director, Device Technology, MannKind Corporation
Seema Kumbhat, MD., Medical Director, Drug Device Development, Hospira

About the session:
• How are clinical studies affected? Should they be conducted at the same time as when you’re conducting HF usability studies?
• What data can/cannot be collected effectively in a clinical trial?
• Can you link clinical trials to human factors studies to come up with elements during trials to show that you’ve probed patient user usage and that residual error is acceptable?
• Medical / clinical perspective on leading human factors programs at corporations: strengths/pitfalls

Share this article with your social network, just click below to share now!

Share |

Flu vaccines and the egg allergy - is there finally a solution?

The flu vaccine has become a staple in the United States - The Bolus cites several reasons including expanded access and improved awareness and education.  But there is currently a small portion of potential individuals who can't revive the current flu vaccine - those who are allergic to eggs.  However, recently the FDA has approved two types of egg-free vaccines including Flucelvex and Flublok for adults over the age of 18.  These two procedures have found alternative ways that can leave chicken embryo fluid out of the vaccine development process.

This coming June at the Vaccines Development and Production Event, Manon M.J. Cox, President and CEO, Protein Sciences Corporation, will be on hand to discuss the development of Flublok®.  For more information on Manon's presentation, download the agenda.  If you'd like to join us June 3-5 in Durham, North Carolina, as a reader of this blog when you register to join us and mention code VDPS13JP, you'll save 20% off the standard rate!

Share this article with your social network, just click below to share now!

Share |

Eppendorf develops new single-use bioreactor

Eppendorf has developed the first single-use bioreactor for
microbial applications.

According to BioResearch Online:

The BioBLU 0.3f joins the BioBLU 0.3c which was presented last year and is designed for the cultivation of animal and human cells. Both the BioBLU 0.3c and BioBLU 0.3f are specifically designed for use with the compact DASbox mini bioreactor system. Eppendorf’s DASbox system is a unique mini bioreactor system for parallel operation of 4, 8 or more mini-bioreactors and well suited for Design of Experiment (DoE), bioprocess development screening and for use as a scaledown model. With the new BioBLU 0.3f, Eppendorf is paving the way for users of conventional microbial-based biotechnology to take advantage of, the time and cost benefits of single-use bioreactor technology, such as in pharmaceutical product development.

To learn more about Disposable Probes and Sensors? We'll have Alan Opper, Eastern Regional Manager of Finesse Solutions on hand to present Building Flexibility into Bio-Processing: Turn-Key Bioreactor Control Systems for Both cGMP and Non-GMP Applications and Kamal Rashid, Ph.D., Associate Director, Research Professor of Utah State University to present A Comparative Study of Stirred-Tank Bioreactors: Reusable (Glass) vs. Single-Use (New Brunswick CelliGen® BLU) at the upcoming Single-Use Applications for Biopharmaceutical Manufacturing Summit taking place June 3-5, 2013 in Durham,North Carolina. If you'd like to find out more about these presentations, download the agenda.  If you'd like to join us, as a reader of this blog when you register to join us and mention code SU13JP to save 20% off the standard rate.

Share this article with your social network, just click below to share now!

Share |

Single Use Session Spotlight: Single-Use Process Fit for mAb Production

Applying single-use technology has shown to lower costs and increase yield. How? Merck & Co., Inc. completed an end-to-end process fit using single-used technology for the production of monoclonal antibodies. Gain insights on single-use technology versus traditional stainless steel for process fits and facility designs. Dr. Jeffrey Johnson will be joining us at the Single-Use Applications Summit for Biopharmaceutical Manufacturing to present Single-Use Process Fit for mAb Production this June in Durham, North Carolina.

For more information on this session and the rest of the program, download the agenda. If you'd like to join us June 3-5, 2013, in Durham, North Carolina, as a reader of this blog when you register to join us and mention code SU13JP, you'll save 20% off the standard rate!

Featured Session:  Single-Use Process Fit for mAb Production

Featured Speaker: Jeffrey Johnson, MS, New Technology Lead, Merck & Co

About the session: A complete process fit for end to end single use production of monoclonal antibodies will be presented. The evaluation includes a comparison of stainless steel and SU facilities, with capital estimates and total cost of ownership assessments, and NPV modeling. Sensitivity analysis will be demonstrated using single use equipment evaluated at lab or pilot scale. This in depth evaluation will provide insight into single use vs. traditional stainless steel process fits and facility designs.

Share this article with your social network, just click below to share now!

Share |

Implementing Equivalence Testing for the Evaluation of Parallelism: Insights from Dr. Todd Coffey

In today's blog post, Biological Assays presenter Dr. Todd Coffey, CMC Statistician, Seattle Genetics, share with us a  little about his work in evaluate parallelism for bioassays.  Here's what he had to share.

One of the criticisms of the equivalence approach for assessing similarity is that development teams will inadvertently utilize compromised samples and implement a too-wide “zone of indifference”. How do you protect against this problem?
Compiling a set of historical data that includes the natural variability of parallel curves is not a trivial exercise. I offer three suggestions to protect inadvertently against including compromised samples: 1) Ensure the dataset is large enough to include all sources of assay variation. With an adequately large dataset, patterns can often be identified that may elucidate which samples are compromised and why they should not be included with the other parallel samples. 2) Carefully assess the data for unusual trends and patterns, both visually and with statistical analysis. 3) Compare the parallelism metric for degraded samples that are expected to be non-parallel to parallel samples that are suspected of being compromised.

The USP states that one can use the absolute difference of slopes or a ratio of slopes when using the equivalency approach for similarity. Do you have a preference and why?
Using ratios has the advantage of being generalizable across assays. However, calculating confidence intervals on the ratios is not always straight-forward because the ratio of two normally distributed variables is not normally distributed. Thus special care has to be used to correctly calculate confidence intervals on ratios. While not as generalizable across assays, calculating differences between standard and test is more straight-forward statistically and is also interpretable. For these reasons, I prefer to set equivalence limits using differences

How many reference vs. reference runs do you recommend using to establish a “zone of indifference”?
There are at least three issues to consider when discussing sample size. First, to be representative, the number of runs needs to include all sources of variation. Second, the sources of variation have a great impact on the relative value of measurements and the sample size is dependent on getting the right data. For example, if most of the assay variation comes from factors that vary between runs, then many measurements in the same run are of much less value than measurements from different assays. In this case, the sample size is dependent more on the number of times the assay is run after varying the factors that cause the variation. Finally, to provide accurate estimates of tolerance intervals, the sample size of independent measurements generally needs to be several dozen. When that sample size is not attainable, I recommend setting initial limits, monitoring the assay, and then modifying limits as new data emerge.

Many companies start with a difference approach to similarity during early product development when they have a small number of lots and the assay is still being developed. At what stage of development is it reasonable to implement an equivalency approach for similarity?
I recommend using the equivalence approach when there is an adequate set of representative historical data that contains all sources of variation. Sometimes this dataset is available during qualification or before the IND is submitted. If it is not available then, the next potential milestone may be when process characterization activities begin.

Dr. Coffey will be presenting Tips and Tricks for Implementing Equivalence Testing for the Evaluation of Parallelism this May 14-16, 2013 in Seattle, Washington at the Development, Validation and Maintenance of Biological Assays event.  For more information on his session and the rest of the program, download the agenda.  If you'd like to join him, as a reader of this blog when you register to join us and mention code IBA13JP and save 20% off the standard rate.  Have any questions?  Feel free to email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

The Analyzation of SPC Data

Stanley Deming, Ph.D., President, Statistical Designs recently sat down with us to go over some of the topics he'll be presenting on during the Development, Validation and Maintenance of Biological Assays event taking place this coming May.

Today, Dr. Deming answers the question:
Are there differences in how SPC data should be analyzed if one is interested in spotting emerging trends rather than determining the acceptability of a particular assay?

This is, in part, a trick question: SPC data should never be used to determine the acceptability of a particular assay. Concepts like “system suitability criteria” and “assay acceptance criteria” are essentially “specifications” (whether we call them that or not), and it is a commonplace that “specifications should be based on fitness for use”, not on the behavior of the assay. 

Statistical process control limits can be thought of as a visualization of the voice of the process (assay) talking to us and telling us how it is behaving. Specification limits can be thought of as a visualization of our voice talking to the process and trying to tell it how we want it to behave. Unfortunately, the process could care less about what we want – it is not going to listen to us, it is just going to do what it does. 

Setting specifications based on statistical process control limits is misguided thinking – control limits and specification limits are totally separate concepts. For example, a process can be out of statistical control and still be within specifications (i.e. fit for use). Statistical process control limits should never be used to set specification limits – specification limits should be based on fitness for use. 

Getting back to the first part of the question: The “rule of eight” (or, as I prefer, the “rule of ten”) states that if eight (or ten) or more consecutive data points fall on the same side of the center line on either the x-bar or r chart, then the process is out of control in the sense that it is drifting off in one direction. This indicates an ‘emerging trend” and should be brought to the attention of the assayist. 

As a final point, sometimes “emerging trends” are not necessarily bad. As an example, if the r-chart has eight (or ten) or more consecutive data points below the centerline, this is an indication of improved precision. This suggests that there is an opportunity to discover why the precision has improved, and to then implement that discovery so the precision can remain improved in the future.

Dr. Deming will be leading the workshop Process Capability and Variance Components Analysis on May 14, 2013.  For more information on this session and the rest of the program, download the Bioassays agenda. If you'd like to join us May 14-16, 2013 in Seattle, as a reader of this blog, when you register to join us and mention code IBA13JP, you'll save 20% off the standard rate! Have any questions? Feel free to email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Dr. Stanley Deming on Process Capability and Variance Components Analysis

Stanley Deming, Ph.D., President, Statistical Designs recently sat down with us to go over some of the topics he'll be presenting on during the Development, Validation and Maintenance of Biological Assays event taking place this coming May.  

Today, he answers the question:

Some characteristics of an assay are not normally distributed, often because there is a physical barrier – such as %RSD which is limited by 0. How do we set these SPC limits? If we need to transform the data to get a normal distribution, what in your experience is the best transformation?

Rates and proportions (such as %RSD) are different because the measured quantities are bounded, usually by 0 and 1, or by 0 and 100%. Thus, the statistics required to construct confidence intervals about point estimates (and thus to make statistical decisions involving uncertainty) must take these usually asymmetrical bounds into account.

An excellent introduction to the statistics required for dealing with rates and proportions is a chapter in the text by Stanton a. Glantz, Primer of Biostatistics, McGraw-Hill, New York, NY, 2002. A more complete text is J. L. Fliess, B. Levin, and M. C. Paik, Statistical Methods for Rates and Proportions, 3rd ed., John Wiley & Sons, New York, NY, 2003.

Methods described in these references can be used to set SPC limits on rates and proportions. The use of p-charts (instead of the usual x-bar and r charts) is one example where proportions are used to set SPC limits.

There are other situations where non-normal data are encountered. In bioassay work, these are usually log-normal distributions that can be “normalized” by simply working with the logarithm of the measured quantities instead of working with the measured quantities themselves. A familiar example is relative potency – it is usually the logarithms of the relative potencies that are normally distributed, not the relative potencies themselves. Plotting the logarithm of the relative potencies on the usual x-bar and r charts often works well for setting statistical process control limits for bioassay results.

Dr. Deming will be leading the workshop Process Capability and Variance Components Analysis on May 14, 2013.  For more information on this session and the rest of the program, download the Bioassays agenda. If you'd like to join us May 14-16, 2013 in Seattle, as a reader of this blog, when you register to join us and mention code IBA13JP, you'll save 20% off the standard rate! Have any questions? Feel free to email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Event Update: FDA confirms for 8th Annual Next Generation Protein Therapeutics Summit

IBC Life Sciences’ is pleased to announce Kathleen A. Clouse, Ph.D., Division of Monoclonal Antibodies Director at OBP, CDER, US FDA will deliver a keynote presentation FDA Perspective on Novel Monoclonal Antibody Development Pathways on Friday, June 28 at the 8th annual Next Generation Protein Therapeutics Summit in San Diego, CA.

This is a rare and valuable opportunity to hear first-hand from the FDA about their perspectives on the development of novel antibody-based molecules and scaffolds. Gain new ideas to help you engineer novel molecules and formats to meet regulatory expectations.

Dr. Clouse joins our faculty of over 30 international industry and academic experts in protein therapeutics design and development whose presentations will give you new ideas and practical strategies you can apply right away in your own laboratory.

For full program details, download the agenda.  As a reader of this blog, when you register to join us and mention code NGPT13JP, you'll save 20% off the standard rate.  This event is co-located with Bioconjugates: From Targets to Therapies, so you'll have access to sessions from both events!

Have any questions?  Feel free to email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Antibodies could be key to development of vaccines for AIDS

Researchers from Los Alamos National Laboratory, Duke University School of Medicine, Boston University, the National Institutes of Health and others collaborated on a study to see how AIDS spread through the body.  According to R&D Magazine, they found a broadly cross-reactive neutralizing antibody and  the founder virus to understand how this virus spreads through the body could be the key to determining what kind of vaccine could be developed.

Through developing an atom-by-atom picture of how the virus spread, they found:

...induces the body to create antibodies that can neutralize more than one strain of the virus is crucial to creating a vaccine that can stay ahead of the virus as it mutates in the body. The intensely focused X-rays of the APS were used to hone in on a small portion of the epitope protein in the HIV virus that is recognized by the body’s immune system and the broadly neutralizing antibody it triggers to develop

This June at the Vaccine Development and Production Summit, we look at the development and innovation you need to stay ahead of the game in the vaccine development market. Presentations from Matrivax Research and Development Corporation and CureVac GmbH will be looking at how to develop new vaccines and the innovative processes for developing them. For more information on these sessions and the rest of the program, download the agenda. If you'd like to join us at Vaccine Development and Production Summit, as a reader of this blog when you register to join us and mention code VDPS13JP, you'll save 20% off the standard rate!

Share this article with your social network, just click below to share now!

Share |

A look at Antisense Technologies

One of the greatest technologies to determine how to specifically treat diseases in humans, animals and plants is with antisense technologies.  These technologies, which manipulate DNA or RNA, end up interrupting the normal cellular processing to a gene and we can therefore discover what the gene functions as.  Integrated Gene Technologies recently released a white paper examining this issue.

Here is an excerpt:

Antisense Oligonucleotides

Oligonucleotide-based antisense techniques represent the most common and, to date, the most successful approach to achieving suppression or elimination of a genetic message. The antisense effect of a synthetic oligonucleotide sequence was first demonstrated in the late 1970s by Zamecnik and Stephenson [1]. Using nucleotide sequences from the 5’ and 3’ ends of the 35S RNA of Rous sarcoma virus (RSV), Zamecnik and Stephenson identified a repeated sequence of 21 nucleotides (nt) that appeared to be crucial to viral integration. They synthesized a 13-mer oligonucleotide, d(AATGGTAAAATGG), complement to a portion of this viral sequence. When this synthetic oligonucleotide sequence was introduced into cultured fibroblast cells infected with RSV, viral production was significantly inhibited. They correctly concluded that the oligonucleotide was inhibiting viral integration by hybridizing to the crucial sequences and blocking them. The term they introduced to describe such oligonucleotides was “hybridon.”

At the same time as this work was being done, other groups, notably Tennant et al. [2] and Miller et al. [3], were reporting similar effects for synthetic oligonucleotides in other systems. These results stimulated a rash of studies focusing on the ability of synthetic oligonucleotides to interfere with genetic processes. Many of theses studies failed to achieve the desired effect and it quickly became clear that there were a number of issues that needed to be addressed if synthetic oligonucleotides were to become generally useful reagents for these studies. The most immediately important of these issues was what can be called “persistence.” Synthetic oligonucleotides are foreign to the cells into which they are introduced and they immediately become prey for endogenous nucleases. If synthetic oligonucleotides were to attain the level of persistence in the cell that would be needed for them to accomplish their tasks, they would have to be protected from those endogenous nucleases. Following Kurreck [4], there are three possible sites on a nucleotide where protective modifications could be introduced (Figure 1). In both DNA and RNA nucleotides the base can be altered or changes can be effectedin the phosphate backbone. In RNA nucleotides the 2’ hydroxyl group, missing in DNA nucleotides, can also be modified. The “trick” involved in protective modifications of nucleotides is to introduce an alteration that is protective against nuclease degradation that does not, at the same time, eliminate the desired effect of the oligonucleotide sequence by blocking complementary hybridization or harming the cell. 

Read the full white paper here.

This May at the TIDES Event,we will be looking at antisense technologies in a number of presentations including Antisense Development Portfolio Advances with Richard S. Geary, Ph.D., Senior Vice President, Development, Isis Pharmaceuticals, Inc. and Characterization of Oligonucleotide Biotherapeutics by LC/MS/MS with Pfizer. For more information on these sessions, download the agenda. If you'd like to join us at the TIDES event taking place May 12-15, 2013 in Boston, as a reader of this blog when you register to join us and mention code TIDES12JP, you'll save 20% off the standard rate!

Share this article with your social network, just click below to share now!

Share |

Want to get involved with Biorepositories 2013?

The Institute for International Research is looking for interested speakers for our upcoming 6th Annual Biorepositories and Sample Management Conference. Biorepositories has the largest concentration of pharma, biotech, and innovators sharing proven strategies for specimen preservation, stability, quality, and accessibility.

We invite you to submit a proposal for a speaking opportunity directly to Heather King by April 11, 2013. We are currently recruiting pharmaceutical and biotech executives working in biorepositories, biobanking and sample management, and industry insiders who can share NEW DATA through detailed case studies related to:

• • Standardization
• • Country-specific challenges
• • Industry Academia partnerships
• • Quality concerns
• • Biorepository management and implementation

Please feel free to suggest other timely and relevant topics.

Submission Guidelines & Details

In your abstract, please provide the following:

• • Proposed Title of Session: Objective and purpose
• • Background Information: A descriptive paragraph of 3-4 sentences describing what is unique or special about the information you plan to share
• • Key Takeaways: 3-4 benefit/bullet points highlighting the strategies, tools and techniques attendees will walk away with

For more information about the 6th Annual Biorepositories and Sample Management Conference, visit please visit the website.

P.S. Two events for the price of one! This event is co-located with the Clinical Collaboration Congress. Your registration grants you access to both of these events — which means double the content and double the networking, too.

Share this article with your social network, just click below to share now!

Share |

Save the Date for the 6th Annual Biorepositories

Biorepositories is back!

Back by popular demand, IIR is proud to present the all-new 6th Annual Biorepositories & Sample Management Conference, taking place September 25-27 in Boston, MA. This one-of-a-kind event is designed exclusively for executives working in biorepositories, biobanking, and sample management.

Weaved throughout the program are workshops and sessions that focus attention on the growing need—and inherent challenges—of self-regulation and process standardization, domestically and abroad.

Moreover, this year’s event will be co-located with the all-new Clinical Collaboration Congress where participants will have dedicated time to meet clinical operations professionals as well as labs, logistics, and technology vendors to grow revenue opportunities and increase efficiencies.

To sign up to receive updates on the upcoming event and to receive the agenda when it is released, sign up for email updates.

As a reader of this blog, when you register to join us by May 17 and mention code XP1898BLOG, you can save $800 off the standard registration rate!  If you have any questions, feel free to email Jennifer Pereira.

Share this article with your social network, just click below to share now!

Share |

Why did Mirna Therapeutics choose miR-34 for your lead development program?

Recently, we sat down with TIDES speaker Dr. David Brown, the Director of Discovery at Mirna Therapeutics.  He discussed at length Mi-RNAs and pre-clinical development programming.  Today's featured question is:

Why did Mirna Therapeutics choose miR-34 for your lead development program?

David's response: miR-34 was one of about 15 or 20 microRNAs that we identified in studies about 10 years ago that functioned as tumor suppressors. So, we had done work at a company that I was working for to identify microRNAs that played roles in human health. We were doing a collection of studies looking at microRNA expression in cancer patients. We identified a number of microRNAs that were either down-regulated or up-regulated consistently in tumors in cancer patients. We were also, at the same time, doing studies trying to understand the functional roles of microRNAs. For those studies we were introducing microRNA mimics into cancer cells or inhibiting microRNA function in specific cells. Those studies led us to this 15 or 20 microRNAs that were commonly down-regulated in cancer patient tumors that also had the capacity to affect apoptosis or reduce cell proliferation or viability or affect cell cycle progression in cancer cells. miR-34 was one of those micro RNAs and it turns out that as we began to study the role and function of miR-34 and its biological activity, we noted that miR-34 was a microRNA that probably had the broadest range of activity. That is, it had the capacity to induce apoptosis and reduce cell proliferation and cell viability in a very broad range of cancer cells. That led us to study it further. 

Among the most interesting features of miR-34 was the capacity to actually cause the complete loss of viable cancer cells. If you gave cancer cells several doses of miR-34 in culture, you’d essentially wipe out all viable cancer cells. There is also some work that we did with cancer stem cells. We noted that the down-regulation of miR-34 was vital for the development of cancer stem cell characteristics. In fact, if you introduced miR-34 back into cancer stem cell populations, they lost their stem-like characteristics and qualities. It also significantly reduced their capacity to form tumors in mice. So that, for us, was pretty compelling evidence that miR-34 was a very strong tumor suppressor. 

However, when we started studying it in animal models of cancer is really where we got very excited. We noted that among the microRNAs that we were testing for therapeutic development that miR-34 had this amazing capacity to inhibit tumor growth. We were using models of lung cancer and prostate cancer and multiple myeloma and leukemia. In all cases we saw that an introduction of a mimic of miR-34 had the ability to significantly inhibit tumor development. We then went on and married the miR-34 mimic, to a delivery technology that was developed originally by a company called Novosom and then ultimately purchased by a company called Marina Biotech. We’ve noted that the combination of a mimic of miR-34 with this delivery technology provided us with a very strong accumulation of miR-34 in solid tumors, especially those solid tumors that were in the liver. In two different models of liver cancer we noted that miR-34 that had been formulated with this delivery technology caused complete tumor regression. So, for us, this is pretty compelling evidence that miR-34 functions as a tumor suppressor and has the ability to cause a therapeutic response. 

At this point we’ve continued to study miR-34 and its ability to affect tumor growth and, in fact, cause tumor regression. What we’ve noted is that the introduction of miR-34 into liver cancer cells has effects on the genes within the beta catenin pathway and wnt pathway. It has the ability to affect genes in the c-Met pathway, the MYC pathway, the MAP kinase pathway, and the vegf pathway. It also stimulates expression of genes, tumor suppressor genes within the p53 pathway. So, you begin to get this understanding of the fact that this single microRNA functions as a tumor suppressor based on its ability to co-regulate many oncogenes and tumor suppressors. This kind of power provides a potency that we are able to observe in these animal models and we certainly hope that is going to now translate as we move into the clinic.

Listen to David's full podcast here.
Read the full transcript here.

You can find out more from David at the TIDES Summit, taking place May 12-15, 2013 in Boston, MA. He will be presenting Efficacy, PK and Tox Data Supporting the Move to IND for Mirna Therapeutics on Wednesday, May 15. For more information on this session and the rest of the program, download the agenda. If you'd like to join David in Boston, as a reader of this blog when you register to join us and mention the code TIDES13JP, you'll save 20% off the standard rate! Stay tuned for more excerpts from David's podcast.

Share this article with your social network, just click below to share now!

Share |