2nd Annual Business of Biosimilars: New Dates & Venue Announced for 2010

September 20-22, 2010

Hyatt Regency Boston • Boston, MA

The biopharmaceutical market is at a crossroads. Some of the biggest-selling biologics are losing their patent protection, opening up a global market estimated at over $19 billion for biosimilars, otherwise known as “follow-on biologics” or “biogenerics”. Already we are seeing changing business models as a whole new set of global competitors emerges. As the industry moves forward, it asks itself:

*What will the new biosimilars market look like?
*How do you navigate regulatory challenges?
*Who can you partner with to leverage your company?
*What product launch and marketing strategies should you use?
*How do you ensure your economic success?

IIR’s 2nd Annual Business of Biosimilars conference delivers the tools you need to succeed in the biosimilar arena. Exchange ideas and best practices surrounding innovation, regulatory change, IP protection and patent litigation strategies, and commercial management.

Join leaders and industry experts to develop effective strategies to navigate scientific, regulatory, economic, and legal challenges to remain competitive in commercializing your biosimilar portfolio in the United States and abroad.

Do You Want Your Message To Reach Top Level Decision Makers?
To learn about how you can position your company as a leader and innovator through a custom sponsorship package, please contact Andrew Sinetar at 646.895.7472 or email asinetar@iirusa.com.

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New report out for biosimilars in use

Dr. David Goldsmith of Guy's Hospital in the UK reports of the new report out looking at some of the first biosimilar technology to have ever been successfully implemented and credited for treating patients.

This article charts a brief history of their use in clinical medicine, mainly dealing with chronic kidney disease, paying special attention to how these agents were introduced into clinical medicine and what has happened subsequently; in 2009, there were several developments that could be regarded as a "perfect storm" in terms of the long-term use of these compounds in chronic kidney disease and oncology and, likely, elsewhere. We are now very much at a "crossroads," where mature reflection is required, because with the latest trials and meta-analyses, these therapies seem not only expensive but also very much a clinical tradeoff (increased risk of adverse effects versus a small gain in fatigue scores).

Read the full article here.

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Doctors face a challenge with electronic medical records

The New York Times recently published an article looking at a challenge many individuals never think of when it comes to electronic medical records. While they may provide an edge when it comes to collecting superior data, many doctors are finding it challenging use electronic medical records while in the exam room with the patient.

As the doctor in the article descried:
The new computer was perched atop a desk in one corner of the room; the patient sat on the exam table on the other side of the room. In order to use the computer, I had to turn my back to the patient as I spoke to him.

The author of the article goes on to say that a compensation can be found in collecting great data with EMR and collecting the little details that come from the patient-doctor relationship. A fine balance must be found, though.

What do you think? Can many doctors overcome the challenge that having a computer in the exam room?

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Concerns beyond FDA Approval for Biosimilars

In a recent article at the Association of Corporate Council, they look at a few of the facts beyond the FDA's jurisdiction for decisions.

Their key aspects:
-the availability of biosimilars will put pressure on biologic drug manufacturers
-which have not had to grapple with the same limited marketing exclusivity periods
-patent cliffs for biologics that small molecule drugs have been subject to for two decades.

What do you think about these three issues? While the FDA has the key to bring biologics to market, what about the limited marketing exclusivity periods? Are these the things you are most concerned about? What other concerns does your company face with biologics?

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See who is attending Immunogenicity for Biotherapeutics 2010

Time is running out. You have less than one week to join the 11th Annual Immunogenicity for Biotherapeutics - the longest running event in the business with senior industry thought leaders on the Advisory Board and speaking faculty, covering THE top issues in the industry.

Over 1500 senior scientists have attended this event over the last 10 years. Join the countless others who have benefited from IIR’s Immunogenicity event and learn everything you need to know about assay development, validation, regulatory initiatives and novel technologies in immunogenicity testing in today’s changing regulatory environment.

Don't miss this opportunity to meet with global leading scientists at the
2010 Immunogenicity for Biotherapeutics.

ABC Laboratories * Advion BioServices * Aerovance Inc * Affymax Inc * Agensys Inc * Alder BioPharmaceuticals * Alexion Pharmaceuticals Inc * Allergan Inc * Alta Analytical Intertek * Ambrx Inc * Amgen Inc * Amylin Pharmaceuticals * Astellas Pharma Global Development * Biocon Limited * Biogen Idec Inc * BioMarin Pharmaceutical Inc * BioMimetic Therapeutics Inc * BioMonitor A/S * Bristol Myers Squibb Co * BRT Burleson Research Technologies Inc * Centocor Research & Development Inc * YOUR COMPANY NAME HERE * Charles River Laboratories * CNRS Cultures Langues Textes * Covance Laboratories * CSL Ltd * Eli Lilly & Company * Enobia Pharma Inc * EpiVax Inc * Facet Biotech Inc * Ferring Pharmaceuticals AS * Food & Drug Administration (FDA) * Fujifilms Medical Systems * Genentech Inc * Genzyme Corporation * GlaxoSmithKline * Gyros US Inc * Hanmi Pharm Company Ltd * Hematech Inc * Hospira Inc * Human Genome Sciences Inc * Huntingdon Life Sciences * IBT Laboratories * ImClone Systems (a wholly-owned subsidiary of Eli Lilly and Company) * Intarcia Therapeutics Inc * Ipal GmbH * KAI Pharmaceuticals Inc * Luminex Corporation * MedImmune Inc * Merrimack Pharmaceuticals * Meso Scale Discovery * NIBSC * Novartis Pharma AG * Pacific Biometrics Inc * PerkinElmer BioSignal Inc * Perseid Therapeutics * Phadia AB * PharmaNet Development Group * PPD Inc * Regeneron Pharmaceuticals Inc * Sanofi Pasteur * Shanghai Kanghong Weichi Biotechnologies Inc * SUNY University at Buffalo * Takeda * Talecris Biotherapeutics * Taligen Therapeutics * Tandem Labs * Univ of Maryland School of Medicine Center for Vascular & Inflammatory * Viracor IBT Laboratories * Wyeth Pharmaceuticals * Xoma Ltd * ZymoGenetics Inc

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Biosimilars could help costs of the healthcare bill

In an article at AIS Health, they look at how the approval of biosimilars would lead to the saving of millions of dollars in the future healthcare bill.

The article stated:
Also known as follow-on biologics or follow-on protein products, these drugs represent a way to bring down health plans’ spend on biologic therapies, which can run tens and even hundreds of thousands of dollars per patient per year. Potential 10-year savings estimates vary significantly, but all range in the billions of dollars. Health plans should start keeping tabs on these drugs now so they can take advantage of them when they hit the U.S. market soon. Plans also should consider a variety of ways — including modifying existing formulary tiers — to incentivize patients and physicians to use these drugs.

What do you think? How much of an impact could the approval process of biosimilars have on the current healthcare bill? Read the full article here.

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Partnerships 2010: Special Guest Keynote Address: Ethan Zohn, Winner SURVIVOR: AFRICA

This past week at Partnerships in Clinical Trials, Ethan Zohn, winner of Survivor: Africa shared his patient perspective on the Pharma industry and what that industry has done for him. This is co-posted with the Partnerships in Clinical Trials blog. There, you can also find session write ups from many of the Partnerships in Clinical Trials sessions.

Special Guest Keynote Address: Ethan Zohn, Winner SURVIVOR: AFRICA

One in two men and one in two women will be diagnosed with cancer. While it is pressing lives, it is encouraging strength in the nation.

At one time, the word Survivor meant something completely different. Survivor is just a game, but since then, he has been able to show new insights into madness. Ethan wanted to use his money to make a difference in the life of others, so he co-founded Grassroots Soccer to combat AIDS. A moment that changed Ethan’s life was taking goats to children in a village who turned out to be HIV positive. He gave his one possession, a small hacky sack, to a child. The character, values and essence of human spirit is what Ethan was left with when he went to Africa. A lot of this was had to do what helped him win Survivor and beat cancer.

He was diagnosed Hodgkin's Lymphoma , which he discovered while training for the New York Marathon. He went through two types of chemotherapy, both of which were resistant to the chemo.

Science and medicine were on Zohn’s side. He had to have trust in something larger than himself. While on Plan C, he was in a clinical trial that was showing great results. The clinical trial involved radiation, chemotherapy and ended in a stemcell transplant. He wants to let all of Pharma know that they are making a difference. Ethan Zohn is an example of Pharma’s work. He is able to continue living because of this work.

He discovered that it’s not about how we leave this world, what matters is what is given you to you and then you share with others. Zohn has decided to spend the rest of his life this way. He is going to spend his life making sure people don’t go through the what he went through. This is why he battled cancer publically. He chose to share is story through People Magazine. Generosity from others has helped Ethan get through these tough times.

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Live from Partnerships in Clinical Trials Next Week!

Next week, the Partnerships in Clinical Trials blog will have live coverage from the 19th Annual Partnerships in Clinical Trials event! Be sure to look for blog posts covering many of the sessions as well as following @PartnershipCROs on Twitter for live coverage from the event. If you're unable to join us, but still want to join the online conversation, be sure to mark your tweets #CROs.

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Ranbaxy and Pfenex team up for biosimilars agreement

According to the Press Times of India, Ranbaxy Labs is teaming up with Pfenex to develop biosimilars. They are partnering in order to develop production strains and commercial making of biosimilars. A statement from Ranbaxy Labs claimed, "Under the terms of the agreement Pfenex is eligible to receive maintenance fees, milestone payments as well as royalty payments on any product sales derived from the agreement." Read the full article here.

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Save the Date & Call for Presenters: Cell Based Assays & BioAnalytical Method Development 2010

In 2010, we are combining the Cell Based Assays and Bioanalytical Development Conferences to provide one comprehensive event that encompasses both areas, yet leaving time to dive deeply into the content of each one using separate track sessions. It will take place October 4-6, 2010 in San Francisco, California

Visit the Cell Based Assays website for further updates!
http://bit.ly/dc8frZ

Would you like to be a presenter at Cell Based Assays or Bioanalytical Development?
We invite you to submit a proposal for a speaking opportunity directly to Anne Reel, Senior Conference Director, by April 23rd, 2010 at the very latest. Send to areel@iirusa.com or call 919-676-0306.

Submission Guidelines & Details

We expect that the conference will attract between 75-125 attendees. For consideration, please e-mail areel@iirusa.com with the following information by April 23, 2010

• Proposed speaker name(s), job title(s), and company name(s)
• Contact information including address, telephone number, and e-mail
• Title and objective of presentation
• Please indicate which topic you plan to address.
• Short Summary of the talk

We are also interested in proposals for one day and half day workshops. These workshops should be focused on specific techniques and skill building topics.

All speakers receive FREE admission to the conference as well as any pre-conference activities

General Areas
• Potency
• Immunogenicity
• Characterization
• In Vitro Toxicology
• Immunotoxicolgy
• Fc Functionality
• ADCC Assays

Case Studies Suggestions:
• Fc gamma binding ADCC, FC effecter binding and function, Assessment of FC functionality and F binding ADCC
• Alternative assays to using ADCC to measure FC/FCR binding
• ADC matrix interference
• QA Assays development & QC assay qualification
• Antiviral reporter assay
• Cell based functional assays
• Technical Platform qualification and evaluate long term usefulness of new technologies
• How to rapidly develop assays for new indication where there is no established systems
• Determine limit of detection of assay and complexity of MoA
• Case studies on cell based potency assays, methodology selection cellular mechanisms
• Strategies for characterizing new therapeutics for efficacy
• Improvements in innovation and automation
• Surrogate for NK cells –example NK cell line
• Antibody drug conjugate case studies
• Total and bound assays-free vs total drug assays examples
• Technologies to measure drug target interactions

Why should you attend?
• To learn from other in industry how they overcome issues
• To update recent research analysis and methods development
• To gain insight into the state of the art bioanalytical methods
• To learn where BA field in respect to measuring total vs free drug target in pre clinical and clinical studies

Is your number one challenge not addressed here?
Contact Anne Reel to ensure it is on the final program! AReel@iirusa.com

Do you want to reach this audience?
We have a limited number of slots available for solution providers/consultants.
People who wish to become part of the program should contact Dave Borrok, Sponsorship Manager, at 646.895.7485 or dborrok@iirusa.com.

This year, BioAnalytical Method Development be co-located with Cell Based Assays. To find out more about BioAnalytical Method Development, visit the webpage: http://bit.ly/dc8frZ

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