Announcing Exclusive Updates to the Biorepositories Event

We're excited to share with you exclusive updates to the 4th Annual Biorepositories conference featuring these updates:

New Sessions including:
Regulatory Keynote - Setting New Biorepository Performance Standards
Dr. Helen Moore, Biospecimen Research Program Coordinator, NIH’s Office of Biorepositories and Biospecimen Research

Strategies to Create Quality Attributes and Streamline Searches of Biorepository Specimens
Renu Vora, Senior Associate Scientist, Centocor

Case Study Spotlights on Incorporating Next-Generation Technology into your Biospecimen Management:  


Innovative Systems Pathology for Functional Interrogation of Biospecimens
Michael Roehrl, PhD, Assistant Professor of Pathology and Laboratory Medicine, BOSTON UNIVERSITY

High-Throughput Techniques for Diagnostic Testing and Blood-Banking, and Use of Excess and Discarded Materials in a CLIA Lab 
Lynn Bry, MD, PhD, Associate Director, PARTNERS HEALTHCARE

Coupling Biorepositories with Informatics and Mining of EMR Data for Future Use
Wendy Wolf, PhD, Executive Director – Biorepositories, CHILDREN’S HOSPITAL BOSTON

Technical Advances in Frozen Sample Aliquotting to Boost Sample Homogeneity and Renewability
Dale Larson, Director, Biomedical Systems Group, DRAPER LABORATORY

Testing the Effects of Anhydrobiosis and Ambient Storage on RNA Sequencing
Kristin Ardlie, PhD, Director, Biological Samples Platform, BROAD INSTITUTE

For more information on these updates and the complete agenda, download the brochure here.  Biorepositories 2011 is taking place September 19-21, 2011 in Boston, MA as a part of the Clinical Business Expo.

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Innovative Stem Cell Trial in Cleveland

The current multiple sclerosis clinical trial at Cleveland Clinic, University Hospitals Seidman Cancer Center and Case Western Reserve University is working to treat and possible reverse the damage that patients suffering the disease are facing using the patient’s own Mesenchymal stem cells. The goal of the study is to examine if it is possible that stem cells can be a way to strengthen the immune system. his clinical study has already had two patients undergo the procedure and plan to have 24 patients enter the study over the next 2-3 years. According to Cleveland.com, there are clinical studies in Spain, Iran and China examining the same type of procedure.

The scientists collect the patients stem cells, then nurture them in a lab until they are grown and then inject them into the patients arm. The first patient saw his condition ease within a matter of weeks. This video examines the study further:


This fall at the Cell Therapy Commercialization Summit, there will be a full track examining clinical development strategies with speakers from Bioheart, Aldagen, Cytograft Tissue Engineering and more. For more information about the event, download the brochure.

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FDA realigns to support possible biosimilars change

Image Source: FDA

On August 15, the generics industry stuck a deal with the FDA that could expedite the approval process of generic drugs after fees are paid.  It is believed that first year fees could reach up to $299 million to speed up the review process which typically takes 2 1/2 years currently for approval.

The FDA Office of Generic Drugs has reported they are adding a second Division of Bioequivilance and a fourth Division of Chemistry.  Director Helen Winkle released the plans in a memo from the Office of Pharmaceutical Science.  According to Cutting Edge Information, they believe that the addition of a second Division of Bioequivilence could indicate that there has been an agreement reached after the initial Biologics Price Competition and Innovation Act passed Congress in 2009.

The Business of Biosimilars and Biobetters Conference will be addressing the abbreviated pathway  head on, with a panel of experts examining the pros and cons of paying for expediting the process of the approval of generics.

How do you feel about paying to expedite the review process?

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Pharma and biotech deals in 2011 flow steadily

The year of 2011 is on track to to have as many or more Pharma and Biotech deals and transactions for the first time since before the recession began.  So far this year, 31 deals have been struck with a value of $51.6 billion, and 18 of those deals have been worth at least $20 million.

According to a report released earlier this month by HBM Partners AG, "Even though several important M&A transactions were announced in July, it is difficult to provide an outlook on biopharma M&A due to the recent turbulences on the financial markets. If biotech stocks fall further, some public companies could become attractive takeover targets. For venture and private equity investors, trade sales will remain the preferred and possibly the only exit route for the next 6 to 12 months. Cash-strapped companies with ongoing clinical development programs will thus face a buyers' market."

As reported by The Deal Pipeline, while this will be a considerable number of transactions, it will probably not beat the total amount for transactions, which was $177.7 billion in 2009, largely because of Pfizer acquiring Merck.

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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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Requests for no discussion of biosimilars in the Trans-Pacific Partnership meeting

The House Democrats have written President Obama a letter that encourages him to leave all biosimilars discussions out any discussions that will take place.If the discussions were to take place it would conflict with the Fiscal Year 2012 budget proposal.

The Pharma Times stated:
The TTP is a multilateral free trade agreement which the US is currently negotiating with Australia, Brunei, Chile, Malaysia, New Zealand, Peru, Singapore and Vietnam. If the finally-agreed version deal were to include 12 years' exclusivity for biologics, this "would impede the ability of Congress to achieve the Administration's proposed seven-year change without running afoul of US trade obligations," the Democrats warn the President, adding: "we see no reason for the United States to agree to such a provision, much less to propose it."


This September at Business of Biosimilars and Biobetters, representatives from Momenta Pharmaceuticals, Inc., Schiff Hardin LLP and Fish & Richardson will be conducting the workshop Biosimilar IP Protection and Patent Litigation Strategies for Development in the US and Abroad which will examine regulatory and legal affairs, legal counsel and IP/Patent litigation within biosimilar and originator biopharmaceutical and biotech companies. For more information, download the brochure.


Do you believe it is best for Obama to leave biosimilars out of these discussions?  Why or why not?

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Is the cell therapy industry poised for a breakthrough?

Dr. Arnold Caplan, Director, Skeletal Research at Case Western Reserve University, recently sat down with the Cell Therapy Commercialization team to look at the current state and future of the cell therapy industry.

He answered questions including:
- What are the current hot topics in cell therapy?
- Where is the cell therapy industry in terms of advanced products?
- Is the cell therapy industry poised for a breakthrough?
- Is big Pharma taking more steps to partner with smaller firms/non-profits/governments working on cell therapy?

To hear Dr. Caplan's responses to these questions, download the Cell Therapy Commercialization Summit podcast here.

Dr Caplan will be presenting Industry Overview – The Current Status of the Cell Therapy Business on Tuesday, September 20 at the Cell Therapy Commercialization Summit.  To find out more about his presentation, and the rest of the program featuring Anthony Atala, Institute for Regenerative Medicine, Brock Reeve, Harvard Stem Cell Institute, Ian Harris, Stem Cell Org. of Johnson and Johnson, download the brochure here.

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Biorepositories Podcast: Lisa Miranda, Biobusiness Consulting

Download the pre-event Podcast from biobanking expert Lisa Miranda, President of Biobusiness Consulting, who will be speaking at the 4th Annual Biorepositories event. She will be speaking on at Biorepositories 2011 participating in both: “Manage Your Biorepository to Guarantee Full Life-Cycle Specimen Quality - Learn how to do more with less!” and “Integrating Technology Transfer Offices for Strategic Breakthroughs in IP and Data Management”.

Download her podcast here.

In addition to Lisa Miranda, our speaking faculty includes industry thought leaders from Merck, Pfizer, Genentech, Biogen Idec, Infinity, Astrazeneca, Roche, Dow Agrosciences, Centocor, Boston University, Rutgers University, and Harvard Partners Healthcare, plus a not-to-be-missed regulatory keynote from Dr. Helen Moore of NIH’s Office of Biorepositories and Biospecimen Research. To learn more, download the conference brochure.

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Biosimilars FDA Approval won't be "One Size Fits All"

As the FDA comes closer to releasing guidance on biosimilars, they've found that a "One Size Fits All" guidance won't work in this case.  They will find a way so that the evidence of the performance of the drug is weighted in order to assess whether or not the drug is safe for the market.  With the huge market that is sure to come from these drugs as soon as they are approved for use in the United States, expected to be a compound annual growth rate of 89.1% from 2009-2014 in the United States, many producers are waiting on ruling from the FDA.  Mass High Tech even goes as far as to say that that Americans will dominate the market by the end of that time frame in 2014.

There is one important part to the approval.  The law firm Ropes & Gray of Boston believes under the totality of evidence approach, animal and clinical studies will be required for the foreseeable future for approval of protein biosimilars, but the scope and extent of such studies may be reduced where detailed fingerprint-like characterization is used.  Much of this is due to the fact that the biosimilars aren't exact genetic copies of the drugs.

Suzanne Sensabaugh, MS, MBA, Founder and Member, HartmannWillner LLC will be joining Business of Biosimilars and Biobetters to look at the regulatory update for biosimilars. The event will take place September 19-21, 2011, in Boston, MA as a part of the Clinical Business Expo. For more information on the event and it speakers, download the brochure here.


Do you agree?  Should biosimlars approval be weighted on the findings from the manufacturer on a case by case basis?

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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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University of Michigan secures adult stem cell lines

According to The Detroit News, The University of Michigan has secured three new adult stem cell lines donated from the skin of adults with bipolar disorder, as well as two more lines of genetically normal cells from a tissue back. These will join the three lines of embryotic cells UM already has to study hemophilia, and Marie-Charcot-Tooth disease and a control line of genetically normal cells. These studies, coming from universities, form the basis for dozens of cell therapies that are moving to the clinic. At the Cell Therapy Commercialization Summit, Brock Reeve, Executive Director of the Harvard Stem Cell Institute, will discuss how cell therapy products are moving from the bench to the boardroom.

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Hear from Industry Leaders from Baxter Healthcare, Merck & More at the Project Management for Drug and Device Event!

Are you looking for proven strategies to deliver advanced time saving and silo busting strategies to bring drugs and devices to market on time and on budget? Do you want to learn to effectively transition from PM to Portfolio Manager?

Then the Project and Portfolio Management for the Drug and Device industry event is a can’t miss for you and your company.

In two days you will hear from industry leaders from companies like Baxter Healthcare, Johnson & Johnson and Merck who will share tried and true methods for managing their projects and portfolios.
Practice case studies will show you how your peers have successfully implemented their projects.

Learn how they did it in these sessions:

• • Build a Service and Value-Driven PMO
• • Make Project and Portfolio Management Support Scientific Innovation

Download the brochure to find out more about this year’s program.

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India's biosimilars growth expected to grow exponentially

Biosimilars market share is expected to grow exponentially over the next few years at a rate of 52% between 2010 and 2015.  Two of the factors leading to this are patent expirations on biologics and the rising cost of drugs. India is also a leader in biosimilars production, with 40 of the biologics marketed in India, 25 of the biologics are manufactured there.  They've also embraced the manufacturing of the drugs due to the cost advantage of development, which reduces the appeal of importing them.  Learn more about the stats above in the Global Biosimilars Market Analysis, which was recently released.

At the Business of Biosimilars and Biobetters Conference taking place September 19-21, 2011 in Boston, MA, Subir Basak, PhD, MBA, Chief Executive Officer, Celestial Biologicals, Chief Commercial Officer, Intas Biopharmaceuticals, will examine how the biosimilars market is expected to evolve in India and the IP and tax implications of their future development.  For more information on this presentation and the others at the Business of Biosimilars and Biobetters Conference, download the brochure here.

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Exclusive Biorepositories Video from Genentech

As a valued reader of the Future of Biopharma blog, we would like to offer you a free sneak preview of the learning opportunities available at the upcoming Biorepositories Event with an exclusive video from Genentech’s Jamieson Sheffield, Head of the SSF Sample Repository.

In this installment of our Biorepositories Video Series, Jamieson shares his insights into biobanking and the value of centralized sample collection, transport, and protection.

For your first chance to download the video before everyone else, please visit the website.

The Fourth Annual Biorepositories Event will be taking place this September 19-21, 2011, in Boston, MA with the Clinical Business Expo.  For more information on the speakers and sessions at this year's event, download the brochure here.

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