The Need for Biosimilars

“Last year, Americans and their insurers spent $307.4 billion on prescription medicines, according to IMS Health, which tracks data for the health care industry.” The constant rise in the price of pharmaceuticals has caught the eye of elective officials, and they’re looking to for ways to contain costs.

Members of the House of Representatives have established a committee to produce legislation to lead to a wider use of generic drugs and biosimilars as a way to reduce national health spending growth. Although cost containment is a driving factor, their goal is not solely to reduce the cost of medication, but also influence lawmakers to actively solve these ongoing issues. They also hope to expand the size of the FDA office that’s in charge of approving biosimilars and biobetters.

“Rising drug costs and limited health care budgets across the world, coupled with the fact that many biotechnology drugs will soon lose their patent protection, means that there is a huge opportunity for biosimilar manufacturers.” As more blockbuster biologics approach expiry, interest in biosimilars and biobetters is sure to expand.

This year’s Business of Biosimilars and Biobetters provides you with the opportunity to learn about biosimilar prospects around the world, with speakers from Korea, India, Australia and more. You will also be able to network with other attendees from the UK, Switzerland, Japan, Hungary, India, Canada, the Netherlands and more.

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The 15th Annual eClinical Integration Summit Agenda Now Available!

Do you want to effectively connect data and clinical technology through real-time integration? Are you prepared to align your eclinical technologies with the latest industry standards?

Gain insight into these challenges and more at the 15th Annual eClinical Integration Summit, September 19-21, 2011 in Boston, MA. Download the complete conference brochure to check out the speaker line-up and full program details where you will find out how to:

• • Integrate multiple eclinical systems to drive end to end life cycle efficiencies
• • Examine future trends in Patient-Centered Clinical Trials through home-based participation and ePro
• • Implement CDISC standardization initiatives for operational success
• • Comply with FDA guidelines for EDM submission standards and eTMF to improve processes
• • Understand how the changing Mobile landscape affects clinical trial data and its full potential
• • Optimize safety and health outcomes by integrating Electronic Health Records
• • Gain insights into site preferences to improve partnerships
• • Assess, track, and share performance metrics and data analytics

For more on this year’s agenda, download the brochure.

Visit the eClinical Integration Summit webpage  for more information.

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Download the 2011 Biorepositories Brochure

The 2011 Biorepositories agenda is tailored to solve your most pressing sample management needs. Over 3 days, you will learn how to detect and overcome threats to your samples through best practices from your colleagues. You will also learn how to take the next step from purely operational to generating revenue from existing samples. We are excited to have over 25 of the industry’s leading experts as they divulge their techniques and tricks to maintaining a productive biorepository.

To learn more, visit us online to download the 2011 Biorepositories Brochure.  Biorepositories 2011 will be taking place a the Clinical Business Expo this September 19-21, 2011 in Boston, MA.

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White Paper: The Global Use of Medicines: Outlook Through 2015

Spending is slow on medicines world wide for medicines within the next years due to the increased reliance on generic options in the United States.  Other causes for the decreased growth are sustained growth in emerging regions and government policies changing in various nations around the world.  The IMS Institute has a new white paper out looking at the effects of how spending worldwide will increase.

An excerpt from the white paper:
Spending on medicines will reach nearly $1,100Bn in 2015, reflecting a slowing growth rate of 3-6% over the five year period compared to 6.2% annual growth over the past five years.  Absolute global spending growth is expected to be $210-240Bn, compared to $251Bn since 2005.  The U.S. share of global spending will decline from 41% in 2005 to 31% in 2015, while the share of spending from the top 5 European countries will decline from 20% to 13% over the same period. Meanwhile, 17 high growth emerging markets led by China, will contribute 28% of total spending by 2015, up from only 12% in 2005.  The next five years will also see an accelerating shift in spending toward generics, rising to 39% of spending in 2015, up from 20% in 2005.

Download the white paper here.

Do you think this is true?  What role will specialized medicines for rarer diseases play in the coming years for medicine sales?

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Call for Speakers / Abstracts: Cell Based Assays and Bioanalytical Method Development Conference

The 7th Annual Cell Based Assays and Bioanalytical Method Development Conference will be held October 3-5, 2011 at The Claremont Hotel Club & Spa in Berkeley, CA. You are invited to submit speaking and/or poster proposals for consideration. The deadline for speaking proposal submissions is June 17.

Designed by leaders in the bioassay and bioanalytical industry, this meeting is the only place to connect with fellow scientists who are discovering new approaches and solutions to the assay development challenges you face every day. It will feature key updates on the latest regulatory developments, analysis of new whitepapers, and case studies of novel techniques. Networking and sharing solutions with your scientific colleagues will help you understand best practice in assay design and validation, which in turn will streamline your preclinical and clinical pipelines and facilitate drug discovery and safety maintenance.

Please direct all inquiries and suggestions to the Conference Producer, Matt Greenbaum at mgreenbaum@iirusa.com or (646) 895-7310.

To discuss sponsorship and exhibitor opportunities, contact Business Development Manager David Borrok at dborrok@iirusa.com or (646) 895-7485.

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The 3rd Annual Business of Biosimilars & Biobetters final agenda is now available for download!

Business of Biosimilars and Biobetters is the three day event has expanded to order to better address the needs of our audience and reflect the changes in the biopharmaceutical industry, including global biosimilar and biobetter commercialization opportunities with in-depth analysis of scientific and business development considerations.

The agenda is now available for download here.

New for 2011, this event allows you to focus on what matters most:

• • Identify strategies and tools to prepare you for what you need to ensure profitability for your biosimilars and biobetters through two customized tracks focused on development and commercialization
• • Collaborate with your peers and discuss current hot topics and industry trends through specialized roundtable discussions
• • Overcome scientific challenges and streamline biosimilar development using lessons learned from the expanded full day scientific symposium
• • Gain insight into biosimilar and biobetter opportunities around the world with regional spotlights on Asia, the EU and the US
• • Network with 200+ leading experts, 600+ participants and 50+ exhibitors across the clinical development continuum in the brand new Clinical Business Expo exhibit hall

As a member of the reader of the Future of Biopharma blog, if you register before May 31st using code XP1686BLOG, you'll receive $600 off the standard rate!

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FDA could approve increased number of drugs in 2011

In a recent article at Reuters, Dr. Janet Woodcock, head of the FDA's drugs center recently stated that she sees an increase in the number of drugs approved this year by the FDA. At the current time, twelve novel drugs have been approved in 2011. There were 21 drugs total approved in 2011. Woodcock points to the number of solid drugs being delivered for approval by many of the smaller Pharma companies. The number of drugs in one year peaked at 53 in 1996. Any number of factors could result in fewer drugs being approved, from higher scrutiny by the FDA to large Pharma companies greatly reducing the funding to their research.

WORLDx Congress involves developing biomarkers that guide the creation of new drugs, and a lot of pharma have complained that creating new personalized medicines gets slowed down significantly by FDA. WORLDx Congress takes place this July 18-20, 2011 in Baltimore, Maryland.

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Save the Date for the 4th Annual Biorepositories Event!

Save the date for the 4th Annual Biorepositories conference, taking place September 19-21 in Boston at the Sheraton Hotel and World Trade Center. Learn advanced strategies to take your biorepository from operational to profitable.

You will gain crucial insights into how to:

• -Guarantee full life-cycle specimen quality control
• -Uncover the balance between on-site and outsourced operations ideal for your business model
• -Master state-of-the-art techniques in specimen storage, management, and transportation
• -Implement surefire added value strategies for your collection
• -Maximize biospecimen renewability and stability
• -Develop and comprehensively track the most useful informed consent
• -Harmonize biospecimen research techniques with input from the physician and patient communities to improve treatment outcomes
• -Target opportunities and avoid obstacles in domestic and international partnerships and expansions

Find out more about the 2011 Biorepositories Event.

Are you interested in speaking? We currently have a limited number of speaking spots available. To learn more, please contact Matthew Greenbaum at MGreenbaum@iirusa.com.

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Stem Cell research will continue to be funded by tax dollars

It’s been a rocky road for stem cell researchers in the United States, with both Presidential administrations and the courts going back and forth on whether federal funding can be used to support embryonic stem cell research. According to a recent Reuters report, the latest round went in favor of supporters of the use of ESCs, as an appeals court ruled that the Obama administration can continue to use federal tax dollars for this research.

NIH Director Francis Collins stated, "This is a momentous day -- not only for science, but for the hopes of thousands of patients and their families who are relying on NIH-funded scientists to pursue life-saving discoveries and therapies that could come from stem cell research.”

Executives at the Cell Therapy Commercialization Summit look to rulings such as these to know the barometer for where support is for cell therapy research, and particularly research using ESCs. With this recent victory under their belts, they can continue move forward with their R&D, preclinical and clinical efforts at producing viable cell therapy products, capable of mass commercialization in the coming years.

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Save the Date for the 2011 Cell Therapy Commercialization Summit!

The Cell Therapy Commercialization Summit is the only event where business executives, along with clinical operations stakeholders, learn cutting-edge strategies towards production and commercialization of viable therapeutic products, enabling you to turn scientific business challenges into money-making solutions.

Highlights of the Summit include:
Operational Strategies
• Identify Therapeutic Opportunities to Develop the Most Robust Pipelines.
• Manage Big Pharma Alliances To Ensure Effective Partnering of Cell Therapy Platforms
• Implement Your Partnership to Meet Pipeline Development Goals
• Determine What Pipelines Will Attract Investors in an Unstable Economy
• Ensure your Investments Have Enforceable Intellectual Property
• Outsourcing Your Clinical Trials to Minimize Cost and Streamline the Clinical Process
• Maintaining Quality & Maximizing Efficiencies in Post-Production Logistics
• Sail Through the Murky Waters of Reimbursement For Cell Therapies

Business Strategies
• Choose the Right Design Parameters for Trial Efficiency and Sustainability
• Minimize Waste, Maximize Efficiencies, and Speed Up Timelines During the Clinical Trial Transition
• Maintain the Quality of Cell Therapy Products and Ancillary Materials
• Overcome Cold Chain Inefficiencies to Deliver a Fully Potent, Commercially Viable Cell Therapy Product
• Identify and Establish Optimal Delivery Systems for Your Cell Therapy Product
• Running a Bioprocessing Mechanism that Will Give You a Viable Cost to Goods Model

Visit the Cell Therapy Commercialization Summit webpage.

Collocated alongside 5 industry events at the Clinical Business Expo, it is the one cell therapy conference where you will meet 200+ experts, 600+ attendees, 50+ exhibitors and have 10+ hours of incomparable networking time with invested peers in all areas of clinical development. Find out more about the Clinical Business Expo.

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A Future for Biosimilars and Biobetters

With growing concern for rising healthcare cost comes a growing demand for more affordable drugs, and a market for developing them. Biobetters and biosimilars are gaining the attention of both small and large pharma companies as an area of opportunity to deliver more cost-effective treatments. As the patents for many originator pharmaceuticals are approaching expiry, now, more than ever, biosimilars are becoming an opportunity for profit growth.

Many companies are already planning for the future of biosimilars and biobetters, whether that be in stocks, research and development for new drugs, or international expansion – biosimilars will become an intricate part of our healthcare system, similar to their role in the EU.

So will pharmaceutical companies choose to develop biosimilars or biobetters? Furthermore, how does one even define a biobetter, seeing as there is no legal or regulatory definition currently in place? Outsourcing-pharma.com states, “A biobetter improves on the original biologic by, for example, reducing the side-effect profile.” The site also discusses how biobetters will produce a need for clinical trials, which opens new business opportunities for CROs.

The Third Annual Business of Biosimilars and Biobetters event provides you with the opportunity to hear industry experts share the development and commercialization strategies that matter most.

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