Showing posts with label Pharma Event. Show all posts
Showing posts with label Pharma Event. Show all posts

Thursday, November 8, 2012

Announcing the ALL NEW BDPWeek Experience


IBC's Biopharmaceutical Development & Production Week provides updates on current and emerging Methods to improve your bioproduction capabilities and delivers strategies to help you overcome the challenges and accelerate production of the biopharma industry's most exciting new Molecules.

The 2013 BDP Week program with MORE presentations and MORE networking than ever before!
  • - 175+ Presentations 
  • - 48 Presentations with Unpublished Data 
  • - Interactive Q&A Sessions
  • - Networking with 800+ Peers 
  • - BDP Week Beach Party
  • - 65+ Exhibitors
  • - 50+ Scientific Posters


Methods …
  • - Process Validation and Continuous Verification
  • - Contract Manufacturing & Technology Transfer
  • - Analytical Technologies
  • - Raw Materials
  • - Viral Safety Download Program to See for Yourself:
Molecules…
  • - Upstream Processes
  • - Downstream Processes
  • - Biosimilars
  • - Manufacturing & Lifecycle Management
  • - Antibody Drug Conjugates
  • - Bispecific Antibodies
Biopharmaceutical Development and Production Week will take place February 25-March 1 in Huntington Beach, California.  As a reader of this blog, register today and mention code B13155blog .  We hope to see you there!




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Thursday, September 13, 2012

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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Thursday, August 2, 2012

Bioassays & Bioanalytical Method Development Session Spotlight: Use of Transfected Cells in Cell-Based ADCC Assays

Transfected cells are a type of cell that can make effector cells from serum far more predictable & reliable. Validated purified receptor surrogates are extremely useful in comparing to results from standard cell-based assays.

This year at the Bioassays and Bioanalytical Method Development Event, Pfizer will be on hand to take a closer look at this.  For more information on this session and the rest of the event, download the agenda.  As a reader of this blog, when you register to join us this October 1-3 in Berkley, California and mention code XP1768BLOG, you'll save 15% off the standard rate!

Featured Session: Use of Transfected Cells in Cell-Based ADCC Assays
Featured Speaker: Poonam Aggarwal, PhD, Senior Principal Scientist, PFIZER
About the session: The biggest challenge you are likely to face in designing robust ADCC assays is the inherent variability across different sources of human blood serum. Yet it is possible for your use of transfected cells to make the effector cells from serum more reliable and predictable. Analyzing the relative comparability of antibodies can shorten your workflow and cut down on some variable and confusing results.
  • • Evaluate ADAs to determine whether they are enhancing ADCCs or not
  • • Pinpoint the Fc gamma receptor binding signal using surface plasmon resonance
  • • Validate your purified receptor surrogates in order to best compare to results from standard cell-based assays



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Wednesday, July 25, 2012

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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Thursday, June 14, 2012

Business of Biosimilars & Generic Drugs International Session Spotlight: Overview of Biosimilar Trends in BRIC Countries

As global demand for advanced therapeutics increases and more markets are newly becoming able to reimburse at least part of the costs, what commercialization, outreach, and research initiatives are you planning in order to make truly global product rollouts possible? This session will compare and contrast case studies of biosimilar sales in many different international markets, including Turkey, Mexico, Thailand, and Vietnam, in order to paint the fullest picture of the techniques you will need for global success.

This September at Business of Biosimilars and Generic Drugs, Alex Kudrin, Medical Director, Takeda Pharmaceuticals will be on hand to examine this topic in his presentation "Overview of Biosimilar Trends in BRIC Countries" on Tuesday, September 11.  For more on this presentation and this year's event, download the brochure. If you'd  like to join us in Boston, register and mention code XP1786BLOG to save 25% off the standard rate.

Featured International Session: Overview of Biosimilar Trends in BRIC Countries
Featured Speaker: Alex Kudrin, Medical Director, Takeda Pharmaceuticals
About the session: In this session, you'll learn to:
  • •Anticipate how the economic growth and demand for new therapies will shape markets for biosimilars in these key new regions
  • • Plan for creative and adaptable techniques to protect your IP in markets with different legal traditions and baselines
  • • Design a multi-pronged approach for successful reimbursement based on government, insurance, and individual priorities and capabilities
  • • Establish local partnerships to capitalize on vital trends and resources


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Wednesday, June 13, 2012

The 8th Annual Bioassays & Bioanalytical Method Development Agenda is ready for Download!

In the face of industry cost-cutting and consolidation pressures, every day that you get inconclusive results is a day when your job is on the line, and a day that the sick spend further away from a cure. Whether your greatest challenges focus on identifying critical reagents, successfully transferring assays among work sites and partners, or statistical analysis of complex cell-based assays, the 8th annual Bioassays & Bioanalytical Method Development conference is the one event you must attend to maximize the accuracy, stability, efficiency, and transferability of your workstream.


Assembled specifically to meet the needs of the bioanalytical R&D community, this conference will allow you to maximize ROI on your analytical methods through crucial knowledge-sharing on latest industry regulations, troubleshooting, and intricate but necessary methods for cross-referencing the results of multiple different assays.

This year’s agenda will build your bioanalytical skills through:
  • • Two unique co-located full-day summits: “Immunogenicity University” and “Cell Based Assay Academy,” which will get scientists at all career stages equally comfortable with basic foundational techniques and prepared for the more detailed state-of-the-art case studies to follow
  • • Critical guidance on how to sequence and interpret multiple bioanalytical methods in your workstream
  • • Answers to your most pressing development challenges on assays for vaccines and virology
  • • Over 15 never-before-heard case studies presented by an international faculty of leaders in the bioanalytical R&D industry!
The 8th annual Bioassays and Bioanalytical Method Development Conference will take place October 1-3, 2012 in Berkeley, California. As a member of this LinkedIn group, 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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Thursday, June 7, 2012

Could the fate of biosimilars in the USA rest on the healthcare reform ruling?

US Supreme Court
June 2007 was the first bill leading to the approval of biosimilars to be passed in the United States. Senator Edward Kennedy of Massachusetts first introduced the Biologics Price Competition and Innovation Act.  However, it wasn't until 2010 that the Affordable Care Act gave an actual, legal pathway for biosimilars to be approved in the United States.  With the market on biosimilars growing at such a rapid pace, $112.93 billion in 2011 which was up 4.6% from 2010, there is a severe, cost controlled need from the public.  Many drug companies are seeing this need and forming partnerships to bring biosimilars to the market.  Biosimilars were not specific to the case against the Affordable Care Act presented to the Supreme Court according to Medill Reports in Chicago.  Hospira, who is currently working to bring biosimilars to the market, believe that if the healthcare reform  law is overturned, they believe they can take their biosimilars through the approval process by way of the biologics application. They intend, along with many other companies, to continue the development of this needed treatment whether or not this pathway is overturned.

This fall at the Business of Biosimilars and Generic Drugs Conference, Pfizer and Shire will be on hand to present "Outlook and Strategic Impact of U.S. Biosimilar Approval Pathway," a presentation covering the full spectrum of where biosimialrs are in the process of approval from the government, interchangeability with biologics and more.  For more on this session and the rest of the event, download the brochure.  If you'd like to join us this September in Boston, as a reader of this blog you save 25% off the standard rate when you register and mention code XP1786BLOG.  


Do you think the Supreme Court will overturn the part of the Affordable Care Act and set back the approval process for biosimilars?  What effect would this have on the development process?


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Thursday, May 31, 2012

Business of Biosimilars & Generic Drugs Session Spotlight: Reimbursement Strategies for Generics & Biosimilars Around the World

Reimbursement is one of the cornerstone aspects of successful market penetration for a follow-on product. Drug and biologic sponsors must be fully aware of who the major payors are, their priorities and criteria. While the biosimilar product class is still new in North America, there is a tremendous amount that they can learn from the successful establishment of reimbursement guarantees enjoyed by small-molecule generics. What business relationships must you set up with healthplans, pharmacies, PBMs, employers, and other major players in this space to guarantee good ROI?

At the Business of Biosimilars and Generic  Drugs taking place September 10-12, 2012 in Boston, MA, Steven Goldberg, Chief of Medical Affairs, Express Scripts and Michael Castagna, Executive Director of Immunoscience, Bristol-Myers Squibb will be presenting "Reimbursement Strategies for Generics & Biosimilars Around the World," examining this topic.  For more on this year's event, download the brochure. If you'd  like to join us in Boston, register and mention code XP1786BLOG to save 25% off the standard rate.

Speaker Michael Castagna,
BRISTOL-MYERS SQUIBB
 
Featured Session: Reimbursement Strategies for Generics & Biosimilars Around the World

Featured Speakers: Steven Goldberg, Chief of Medical Affairs, EXPRESS SCRIPTS
Michael Castagna, Executive Director of Immunoscience, BRISTOL-MYERS SQUIBB

About the session:
Global rollouts of new biopharma products require an in-depth understanding of the reimbursement mechanisms in every market. In parts of Latin America drugs are purely paid by the consumers, which will narrow your potential audience pool and require a more focused marketing theme. Reimbursement in China is handled by the government—but fi rst you must clear the extensive obstacles for the authorization of sale of new biosimilars or supergenerics. Meanwhile, in the U.S. your commercialization efforts will succeed or fail depending on your interactions and relationships with payers at the federal, state, and local level—an “alphabet soup” of potential partners, all of whom you must be able to work with.
  • • Improve uptake and reimbursement through collaborations with hospitals, healthplans, and pharmacies
  • • Focus on the priorities and informational needs of pharmacies and PBMs to boost the likelihood of reimbursement
  • • What does the Avastin decision mean for the biologics and biosimilars approval mechanism and reimbursement?


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Tuesday, May 29, 2012

Don't miss the most diverse array of global case studies for the marketing of biosimilars!

Your business depends on your ability to construct a firm pathway to market-access for follow-on biopharmaceuticals - and every hour counts. With that in mind we are pleased to invite you to attend the 13th annual Business of Biosimilars and Generic Drugs – the only conference in the United States devoted entirely to giving you the tools you need for successful commercialization of biosimilars!

Our expert faculty will provide you with senior executive-level expert insight on all of your critical success factors, including regulatory approval, IP challenges, and planning and coordinating an international product rollout strategy attuned to the needs of each market.

Featured Speakers include:
  • - G. Steven Burrill, CEO, Burrill & Company presenting “Think Different - Navigating the Brave New Globalized Life Science Industry”
  • - Alex Kudrin, Medical Director, Takeda Pharmaceuticals presenting “Access the Emerging BRIC Markets for Biosimilars”
  • - Bassil Dahiyat, CEO, Xencor presenting “Learn How to Design Profitable Strategic Partnerships for Follow-On Biopharmaceutical Development”
For more information on these case studies and the rest of the event, download the brochure here. 

The 13th Annual Business of Biosimilars and Generic Drugs will take place September 10-12, 2012 in Boston, MA. As a member of the Business of Biosimilars LinkedIn Group, you receive an exclusive discount of 25% off of the standard price when you register to join us. Simply use priority code XP1786LINK. Have any questions about the event? Feel free to contact Jennifer Pereira.


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Friday, May 25, 2012

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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Wednesday, May 23, 2012

Business of Biosimilars & Generic Drugs Session Spotlight: The New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development

Earlier this month, Biocon announced that it's partnership with Mylan to develop biosimilars could be worth $33 billion.  According to the Economic Times, their partnership was formed in order to develop five biosimilars drugs related to cancer an pain.  This is a similar trend emerging throughout the industry.  At the Business of Biosimilars and Generic Drugs Summit, we'll be looking at the evolving partnerships that are evolving in order to discover and develop biosimilars. For more information about the event, taking place September 10-12 in Boston, MA, download the brochure here.  If you'd like to join us, as a reader of this blog, register and mention code XP1786BLOG to save an exclusive 25% off the standard rate.

Featured Session: The New Paradigm in Strategic Partnerships for Follow-on Biopharmaceutical Development

Featured Speaker: Bassil Dahiyat, President and CEO, XENCOR

About the session: What does the recent trend of giant partnerships among biologics and generics companies foretell about the future of the industry? Is this soon to become a standard, and if so, what does your follow-on biologic company need to know and prioritize in order to choose the best partner and structure the strongest, most enduring, and most profi table coalition?
  • • Applications for strategic entry into non-U.S. markets
  • • Re-envisioning partnerships as a source of process patents to strengthen your product’s life cycle
  • • Predict how your patent portfolio can be better protected through market consolidation


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Monday, May 21, 2012

Get the most detailed up-to-date strategies for moving your products into pharmerging markets!

Suzanne Munck, FTC
At past IIR “Generic Drug Summits”, our expert speaking faculty has always provided the most valuable event of the year in terms of sharing crucial and exclusive knowledge about the compliance and commercialization hurdles that you faced on a day-to-day basis. Now more than ever, the insight that we offer in our 13th annual Business of Biosimilars and Generic Drugs conference can help your company stay on top of the latest regulatory developments while capitalizing on new and untapped markets.

Our unequaled speaking faculty this year will provide you with the market-specific case studies and commercialization tactics that you need in order to expand your product portfolio and capitalize on growing global demand! Featured speakers include:

  • - Andrew Shaw, Senior Director, PKDM, Mylan presenting “Establish R&D Methods and Timetables that will Streamline your Expansion into New Markets”
  • - Abdullah Baaj, CEO, Boston Oncology presenting “Getting Global Manufacturing Processes Prepared for Product Rollouts”
  • - Suzanne Munck, Chief Counsel for Intellectual Property, FTC presenting "Turn Antitrust Laws to Your Advantage in the Generics and Biosimilars Marketplace"

For more about these presentations and the rest of the program, download the brochure here.

The 13th Annual Business of Biosimilars and Generic Drugs will take place September 10-12, 2012 in Boston, MA. As a reader of this blog, you receive an exclusive discount of 25% off of the standard price when you register to join us. Simply use priority code XP1786LINK. Have any questions about the event? Feel free to contact Jennifer Pereira.


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Wednesday, May 16, 2012

Current State of Biosimilars in the United States

The FDA has had the regulations to approve biosimilars in place for two years.  Yet, as Pharmalot points out, it is yet to receive an application for approval. Gillian Woollett, a vice president at Avalere Health, a healthcare consulting firm, took some time to share her views on the current state of biosimilars.  She points out that there are 149 biologics approved for use in the United States and over 900 are in clinical development.  Those who take the biologics on a daily basis pay about $22 a day.  The market is expected to reach $150 billion by 2016.  It costs $250 million to develop a biosimialr.  So does this open the door for biologics in the US?

In Europe, there are already 14 biosimilars approved and on the market, many out sell their originator biologics.  However, Woollett is quick to point out that in the EU, the EMA doesn't give complete interchangeability to biologics and biosimilars.  The United States FDA does have this ability.  But at the end of the article, Woollet points out that the approval is ultimately about the patient, and many things will be determined by how much the biosimilars will cost who will be paying for it.

At the Business of Biosimilars & Generic Drugs this September, Hoss Dowlat, Vice President, Regulatory Affairs, PHARMA-BIO CONSULTING will be on hand to present "Experiences from Developing Biosimilars for EMA: Unique Perspectives from Growth Hormones to Monoclonal Antibodies,"looking at how the US and European markets may differ and how to coordinate a roll out between the two markets.  To find out more about this session and the program, download the brochure here. If you'd like to join us this September 10-12 in Boston, register today and mention code XP1786BLOG to save 25% off the standard rate.

Do you believe we'll see a biosimilars presented for approval in the US in the next year? Why or why not?


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