Your Invitation to IIR's Business of Biosimilars

Building upon your technical improvements in molecular safety and immunoprofiling, we invite you to join the upcoming 14th Annual Business of Biosimilars on October 15-17 in Boston. The overall characterization of biologics can determine the success of a Biosimilar product, making this is the only event that provides a unique multidisciplinary approach comprising of competitive intelligence, regulatory strategy, bioanalytical comparability, clinical development and more. You will learn from market leaders including Teva, Mylan, Hospira, Sandoz, Momenta, and Boehringer Ingelheim to:

• Navigate the EMEA approval pathway for monoclonal antibodies
• Conduct structural and PK/PD comparability assessments
• Overcome the science and complexity of indication extrapolation
• Define the role of higher order structure in fingerprinting
• Analyze current biosimilar market trends and future challenges

Want to learn more? Download our full agenda.

The 14th Annual Business of Biosimilars and Generic Drugs will take place October 15-17, 2012 in Boston, MA. As a member of the Business of Biosimilars LinkedIn Group, you’ll receive 15% off when you use code XP1886BLOG to register. Have any questions about the event? Feel free to contact Kate Devery at kdevery@iirusa.com or visit the webpage.

Cheers,
The Business of Biosimilars Team

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

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

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

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

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FDA Votes to Broaden User Fee System

Yesterday, the Senate voted to support a new bill  that increases the fees Pharma pays to see their products through the review process.  Over the next four years, they are expected to pay $4 billion, which is an increase of 6%.  Biosimilars have a rate of $128 million locked in through 2017 and generic drug companies will pay $1.5 billion.  Also included in the legislation is a requirement for drug companies to share problems in the drug supply, as this helps the overall rate of drug shortages drop.  The FDA will also increase it's inspections in international drug manufacturing sites and drop investigations of US manufactures to inspections once every two years.  For more on this story, visit First World Pharma.

This September at the Business of Biosimilars and Generic Drugs Summit in Boston, we'll have the latest updates of the FDA's biosimilars guidelines.  For more information on the event, download the brochure.  As a reader of this blog, if you'd like to join us, register today and mention code XP1786BLOG and save 25% off the standard rate!

How do you think this new bill will help the generics industry?

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Business of Biosimilars & Generic Drugs Session Spotlight: The World is Flat—Make Sure Your Sales Are Not—Commercializing Generics in Global and Emerging Markets

The United States and European markets are redically different when it comes to the approval and use of biosimilars.  New guidelines from the FDA in the United States should make could soon make it easier to bridge the gap and identify the market.  Not only will there be an emerging market for biosimilars in the United States, but around the world.  At Business of Biosimilars and Generic Drugs, we will help you identify emerging markets for your follow-on products: both in developing countries with populations that have just gained the capacity to purchase pharmaceuticals, and the U.S. and Europe where you can capitalize on new opportunities for generic / biosimilar versions of established drugs. It will give you the skills to match the needs of each unique market segment while answering any of their concerns about product effectiveness, quality, or point of origin.

For more information about The Business of Biosimilars and Generic Drugs taking place September 10-12, 2012 in Boston, MA, download the brochure.  As a reader of this blog, when you regsiter to join us today and mention code XP1786BLOG, you'll receive a discount of 25% off the standard rate!

Featured Session: The World is Flat—Make Sure Your Sales Are Not—Commercializing Generics in Global and Emerging Markets

Featured Speaker: Andrew Shaw, Senior Director, PKDM, MYLAN

About the session: Identify growing markets (with a particular emphasis on Latin America, Asia, and MENA) to which your business plans can adapt fastest:

• - Tactics for reassuring new audiences about the suitability and acceptability of your product
• - Choosing and training regional partners required for formulation, manufacturing, and distribution
• - The U.S. as an ‘emerging’ market – focus on new methods for branded generics and facilitated reimbursement that can find new profit sources

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Would you like to guest blog from Drug Delivery Partnerships?

That’s right, we’re offering a few exclusive all-access complimentary passes to Drug Delivery Partnerships – January 25-27, 2010 in Orlando, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in drug delivery innovation to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Sanofi Aventis, GlaxoSmithKline, Merck and Company, CIGNA and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, January 13, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us January in Orlando.

For more information about the event, please follow the links below:

For more on the Drug Delivery Partnerships event, visit the website:
http://bit.ly/6chdrj

Download the 2010 Drug Delivery Partnerships Brochure:

http://bit.ly/8DRnHv

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Would you like to guest blog from Drug Delivery Partnerships?

That’s right, we’re offering a few exclusive all-access complimentary passes to Drug Delivery Partnerships – January 25-27, 2010 in Orlando, and you could attend the conference – on us ($3,000+ value). We’re looking for experienced bloggers who are well-versed in drug delivery innovation to begin blogging now and also at this year’s event. In return for your posts, you’ll be able to attend educational sessions and training seminars delivered by industry thought-leaders and Pharma professionals through in-depth case studies featuring the industry experts from leading pharmaceutical companies Sanofi Aventis, GlaxoSmithKline, Merck and Company, CIGNA and more.

To apply to be a guest blogger, simply send your name, title, company and a few writing samples (a link to your blog is recommended) to Jennifer Pereira at jpereira@iirusa.com no later than Wednesday, January 13, 2010. We will review the submissions and contact all winners directly with more details. This opportunity doesn’t come often and we encourage you to apply and join us January in Orlando.

For more information about the event, please follow the links below:

For more on the Drug Delivery Partnerships event, visit the website:
http://bit.ly/6chdrj

Download the 2010 Drug Delivery Partnerships Brochure:

http://bit.ly/8DRnHv

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