A Novel Bioluminescent Assay to Measure ADCC & CDC with the use of Automation

Cell Technology, partners of the Bioassays and Bioanalytical Method Development Event this October, recently published a poster about the novel bioluminescent assay titled: A Novel Bioluminescent Assay to Measure ADCC & CDC with the use of Automation.

Highlights of the poster include:

The success of biologic therapeutics has begun to reshape today’s pharmaceutical market. The first and most successful of these antibody therapies, Rituximab (Rituxan®; Roche/Genentech), showed worldwide sales in 2009 of $5.6 billion (GEN News Highlights, 2011). This, among others including Trastuzumab (Herceptin®; Hoffman-La Roche), have shown great promise for treatment of patients with leukemia, lymphomas, breast, and other cancer types due to their specificity and reduced side effects (Zhou, 2007). One of the mechanisms which play a central role in the response to clinical antibody therapy is Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) (Wang, 2008). This involves the response of natural killer (NK) cells to bind to specific antibody-coated target cells, such as CD20 and HER2 expressing cells, to promote the death of the target cell.

Read the full poster here.

Bioassays and Bioanalytical Method Development Conference this October 1-3, 2012 in Berkley, California.  For more information on this event, download the agenda. To join Cell Technology at the event,register today and mention code XP1768BLOG to save 15% off the standard rate.  If you have any questions about the event, email Jennifer Pereira.

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India unveils Draft of Biosimilar Guidelines

The government of India made a surprising announcement during the Biotechnology Industry Organization (BIO) international meeting June 18-21, 2012 in Boston MA.  BIO is the annual meeting of biotechnology leaders from across the globe.  With the Supreme Court upholding the Affordable Care Act (ACA) of 2010 just days after the convention it was appropriate that India unveil its guidelines for biosimilar development at BIO 2012. The ACA included the Biologics Price Competition and Innovation Act that allow the development of biosimilars.

The guidance document released by India is entitled “Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India” and outlines the biosimilar development procedures for Indian biopharma and global players. Here is a link to the guidance documents. India is now open for business in terms of international development and commercialization of biosimilars. The guidelines allow for India to be a part of the regulated global market currently developing biosimilars. Many hope that when the US FDA finalizes the guidances for biosimilars the market will begin to grow and develop. These guidances also assure global biopharma companies that India is developing standards similar to those already established in biotherapeutic development.

What are your opinions of the guidelines as the have been released?  How do you think these guidelines will affect global biopharma development?  Do you think India will be view as potential partners or competitors to the more established biotherapeutic markets?

For more information on this topic, check out the presentation by ShinJae Chang, VP, R&D, Celltrio titled "The Strategy and Case Study of Global Biosimilar Development" at the 13^th Annual Business of Biosimilars and Generic Drugs.  For more information on this session and the rest of the program, download the brochure.  If you'd like to join us in Boston for the event, register today and mention code XP1786BLOG to save 25% off the standard rate!

Do you see reglation of biosimilars coming soon to the US market? Why or why not?

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Business of Biosimilars & Generic Drugs Session Spotlight: When Being the Same is Good Enough: Building Public Confidence and Interest in Biosimilars

There’s an enormous amount of public confusion and misconceptions about the efficacy and safety of biosimilars, even in markets such as Europe where these products are already available. By anticipating and countering the public’s fears you can assure better product uptake.  Today we feature the session "When Being the Same is Good Enough: Building Public Confidence and Interest in Biosimilars," presented by Alex Bruni, VP for Commercial Operations, Merz Pharmaceuticals.

Alex Bruni

The Business of Biosimilars and Generic Drugs will take place September 10-12, 2012 in Boston, MA.  For more information on the rest of the program, download the agenda.  If you'd like to join us in Boston, register today and mention code XP1786BLOG to save 25% off the standard rate!

Featured Session: When Being the Same is Good Enough: Building Public Confidence and Interest in Biosimilars
Featured Speaker: Alex Bruni, VP for Commercial Operations, Merz Pharmaceuticals
About the Session: Even as small-molecule generics have grown to take the majority of the prescription market, there are still widespread misconceptions and apprehensions about their quality and effectiveness. Biosimilars have yet to prove themselves in the U.S. market, but they will surely face the same public scrutiny and “urban legends.” How can you best confront counter-messaging and position your product as the best in its class?

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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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Exclusive Interview - Dr. Mark McCamish, Global Head of Biopharmaceutical Development, Sandoz

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The 13th Annual Business of Biosimilars & Generic Drugs offers you access to an exclusive interview with Dr. Mark McCamish, Global Head of Biopharmaceutical Development at Sandoz.

Dr. McCamish’s remarks cover such key topics as:

• • The critical role biosimilars can play in increasing access and lowering healthcare costs
• • Key takeaway points in the current FDA Draft Guidelines on biosimilar development.
• • Implications of using unique names to identify biosimilars
• • Importance of communication in building acceptance and understanding of biosimilars

Download download the interview.

The 13th Annual Business of Biosimilars and Generic Drugs Event will take place September 10-12, 2012 in Boston, MA. As a reader of the Future of Biopharma blog, you receive an exclusive discount of 25% off of the standard price when you register to join us and use priority code XP1786BLOG.  For more information on this year's program, download the brochure here.  Have any questions about the event? Feel free to contact Jennifer Pereira.

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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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Ranbaxy announces plans for future biosimilars

Yesterday, Ranbaxy Laboratories announced it's plans to have three biosimilars on the market in India by 2015. The drugs will mainly be used to treat cancer. Their goal is to become serious competitors of Sandoz and Teva, and plan to do that by gaining biosimilars experience with approval of their biosimilars in India then expanding to the United States and Europe. They currently have one approved biosimilar on the market - a copy of Neupogen, an Amgen drug.Find out more at Reuters.

At the Business of Biosimilars and Generic Drugs this September 10-12 in Boston, Volker Schellenberger, CSO, AMUNIX will be on hand to present "Improve and Approve: Boost the Safety and Convenience of Biobetters, and Navigate the New Regulatory Environment." In this discussion, Schellenberger will look at the current pathway to biosimilar approval, which will be required for the drugs to enter the market. For more information on this year's program, download the agenda. If you'd like to join us in Boston, register today and mention code XP1786BLOG to save 10% off the standard rate.

Do you think that gaining biosimilars knowledge in India before moving into the US Market will benefit companies like Ranbaxy? Why or why not?

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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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Business of Biosimilars & Generic Drugs Session Spotlight: Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet

Amidst all the focus on the Affordable Care Act, it is important to remember that there were other important new codes taking effect this year regarding the reimbursement and user fees for generic drugs. Candis Edwards, Senior Director for Regulatory Affairs and Compliance at Amneal Pharmaceuticals, will detail the best ways to account for new generic drug user fees in your business plan, as well as providing a timely update on factors that had changed concerning REMS agreements between branded and generic pharma companies.

Today, we highlight the session Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet presented by Candis Edwards, Senior Director, Regulatory Affairs & Compliance, Amneal Pharmaceuticals.  Business of Biosimilars and Generic Drugs will take place September 10-12, 2012, in Boston, MA.   For more information on the rest of the program, download the agenda.  If you'd like to join us in Boston, as a reader of this blog, register to join us and mention code XP1786BLOG and save 25% off the standard rate!

Featured Session: Analyze the Regulatory Criteria that your Generic Drug Candidate Must Meet
Featured Speaker: Candis Edwards, Senior Director, Regulatory Affairs & Compliance, Amneal Pharmaceuticals
About the Session: 2012 saw the installation of a new regime of user fees for sponsors of generic drug candidates. This timely session will analyze the impact that these changes will have on your business model and appropriate methods for making the best use of your regulatory interactions.

• • Anticipate and account for new user fees in your business plan
• • Itemize the differences between new user fee structure and earlier payment systems
• • Update on important factors concerning REMS agreements between generic and brand companies

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Biosimilar Development and the Affordable Care Act: What Next?

On June 28, 2012 the Supreme Court upheld the Affordable Care Act (ACA) in a vote of 5/4 in favor of taxation for individual health care costs.  The original bill required Americans to obtain health insurance or face penalties.  The ACA was signed by President Obama in March 2010 and was immediately challenged by twenty-six states, individuals and the National Federation of Independent Business in Federal District Court to challenge the individual mandate. Included in the ACA, was the Biologics Price Competition and Innovation (BPCI) Act that authorizes an abbreviated pathway for the development of biosimilars of FDA-approved biologic reference products.  Basically, biosimilars are versions of biologic drugs that have been shown to have similar safety, purity, and efficacy as the FDA approved product.  The biologics market is estimated to be worth over 100 billion dollars worldwide.

Since biologics therapies are expensive, biosimilars will be a relief to the US healthcare system offering a 30-40% decrease in cost. In an effort to minimise profit loss of their own lucrative biologics therapies, several multinational drug firms have partnered with successful small molecule generics manufacturers to develop biosimilars.  Companies such as Merck are partnering with Dr. Reddy, Amgen has partnered with Watson Pharmaceuticals, and surprisingly the technology company Samsung partnered with biotech giant Biogen Idec.  These multi-billion dollar partnerships signal a new era in therapeutic development.  It appears that the biosimilars business model, at least for now, is “ If you can’t beat them, join them”. 

For companies that want to learn more about the strategic frameworks necessary to optimize success in this rising therapeutic area make sure to attend the 13^th Annual Business of Biolsimilars and Generic Drugs meeting held at the Hilton Boston Back Bay in Boston, MA September 10-12, 2012.  Companies can plan on gaining invaluable insight into partnering, global biosimilar development and approval.  Here are a few of the key presentations: Stanley Hong, SVP,Celltrion presenting The Strategy and Case Study of Global Biosimilar Development, Suzanne Sensabaugh, CEO, HARTMANN WILLNER, LLC presenting Adapt to New Regulatory Requirements for Biosimilar Approval and Success and Brian Harvey, Vice President, U.S. Regulatory Strategy, PFIZER and Carrie Burke, Director of Government Affairs, SHIRE presenting Outlook and Strategic Impact of U.S. Bosimilar Approval Pathway.  For more information on these sessions and the rest of the program, download the agenda.  If you'd like to join me in Boston for the Business of Biosimilars and Generic Drugs, register today and mention code XP1786BLOG and save 25% off the standard rate!

So, what hurdles do you foresee for biosimilar manufacturers? Do you think biosimilars will live up to the hype and offer the 30-40% savings over innovator therapies that analysts are predicting? How long do you think it will take for biosimilars to enter the US market? Do you think physicians and patients will accept these new therapies?

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