Future of BioPharma

Look Who is Attending the 16th Annual Drug Delivery Partnerships!

noreply@blogger.com (Jennifer) — Wed, 18 Jan 2012 17:11:00 +0000

We call our event Drug Delivery Partnerships for a reason. The networking and partnering opportunities found here every year are unmatched. That’s why companies keep coming back, and new ones join us every year.

In Las Vegas next week, from January 25-27, you will have the opportunity to network with hundreds of companies involved in drug delivery. If you'd like to join these companies, register today and use code XP1778BLOG to receive 25% off the standard rate!

Here is a full list of all the companies attending:

3M Pharmaceuticals * Abbott Laboratories * Accredo Health Incorporation* Activaero * Acura Pharmaceuticals * Aisling Capital * Alkermes Inc * Allergan Incorporation * Amcor Rigid Plastics * Amgen Incorporation * Aparna Biosciences Corporation * Aprecia Pharmaceuticals * Apricus Bio/NexMed USA * Aptalis Pharma Tech Incorporation * Aptar Pharma * Aradigm Corporation * Arecor * ARx LLC * ASLAN Pharmaceuticals * Astellas Pharma US Incorporation * AstraZeneca * Aveva Drug Delivery Systems Incorporation * Banner Pharmacaps Inc * Battelle Product Development Group * Bausch + Stroebel * Baxter Healthcare Corporation * Bayer Healthcare Pharmaceuticals Incorporation * BD Biosciences * Becton Dickinson & Company * Bespak * Biochemics Incorporation * Biocodex Incorporation * Boehringer Ingelheim * Bristol Myers Squibb * Buehler Motor Incorporation * Burrill & Company * Cambrex Corporation * Cambridge Consultants * Camurus AB * Carticept * Catalent Pharma Solutions * Chattem Incorporation * CIMA Labs * Columbia Analytical Services * Corium International Incorporation * Credit Agricole * Critical Pharmaceuticals * CSIRO * CSL Behring * Delpor Inc * Deutsche Bank * Dharma Therapeutics * Dow Corning Corporation * DSM Pharmaceuticals * Durect Corporation * Eisai Incorporation * Elcam Medical * Eli Lilly & Company * EMD Millipore Corp * Emergent Technologies Incorporation * Encompass Pharmaceutical Services Incorporation * Endo Pharmaceuticals Incorporation * Ethypharm USA * Evonik Degussa * Flamel Technologies * Flextronics Medical * Flugen * Galen Partners * Galenix Innovations * Gattefosse * Genentech Incorporationorporated * Genisphere Incorporation * GlaxoSmithKline Pharmaceuticals * Glide Pharma * Grunenthal * Haselmeier * Haynes & Boone Llp * Henkel Corporation * Hospira Incorporation * ICP Consulting * Inhalation * Insulet Corporation * Intec Pharma * Ipsen * Jaleva Pharmaceuticals * Janssen * Jazz Pharmaceuticals Incorporation * Johnson & Johnson * JRX Biotech * KAI Pharmaceuticals Incorporation * Kimberly Clark Corporation * Laboratoires Plasto Sante * Ligand Pharmaceuticals Incorporation * Lipocine Inc * Lux Research * Madeira Therapeutics * Mayne Pharma International * Medimetrics * MedImmune * Medpro Safety Products * Merck & Company Incorporation * Merial * Mikron * Millennium Pharmaceuticals Incorporation * MonoSol Rx * Morgan Lewis & Bockius LLP * NanoSmart Pharmaceuticals * NexMed Inc * Next Breath LLC * Nissen Consulting Group, LLC * Novaliq GmbH * Novartis * Noven Pharmaceuticals * Novo Nordisk * Novozymes Biopharma UK * OctoPlus * Ompi of America * Onconova Therapeutics Incorporation * OraPharma Incorporation * Owen Mumford * P/L Biomedical * Pacira Pharmaceuticals Incorporation * Pantec Solutions * Pantheon Pharmaceutical Service * Par Pharmaceutical Incorporation * Particle Sciences * PCCA * Pfizer * Pierre Fabre Medicament * PII * PL Developments * Plasto Technologies * PLD * PolyPeptide Laboratories Inc * PPI * Precision NanoSystems * Prime Therapeutics * PTM Consulting * Purdue Pharma LP * Q Chip *Ranbaxy Labs * Ratio Incorporation * Roth Capital Partners * Safety Syringes Incorporation * Sandoz Incorporation * SCD PharmaConsulting * SciDose LLC * Senfile Medical * SNBL Europe * Solubest * South University * SPI PHARMA * SteadyMed * Stevanato Group SPA * Supernus Pharmaceuticals Incorporation * Takeda Pharmaceuticals North America Incorporation * Tapemark Medical Products * Taris Biomedical * Teamtechnik Corporation * Technology Catalysts Corporation * Teicos Pharma Incorporation * Teikoku Seiyaku Company * Teva Pharmaceuticals * The Safepoint Trust * Thomas McNerney & Partners * TRL & MTS Business Development * Unigene Laboratories Incorporation * Unilife * University of Coimbra and LaserLeap Tech * University of Colorado * University of Copenhagen * University of Utah * Unomedical AS * UPM Pharmaceuticals * Upsher Smith Laboratories * Valeo Partners * Velocity Consulting * Vetter Pharma International USA * Washington Speakers Bureau * Watson Pharmaceuticals * West Pharmaceutical Services * Wilmington Pharmaceuticals * Wolfe Tory Med Inc * WR Grace * Z Cube SRL * Zogenix * Zydus Noveltech Incorporation

Complimentary Web Seminar Thursday: Clinical Trial Outsourcing Dollars and Financial Sense

noreply@blogger.com (Jennifer) — Tue, 17 Jan 2012 16:00:00 +0000

Date: Thursday, January 19, 2012
Time: 2:00-3:00 PM EST
Presented by: Garen Sarafian, Vice President, Citigroup Investment Research & Analysis, Citigroup
Register here (Mention code P1700W1BLOG)

About the web seminar:
The global health care landscape is beset with multiple challenges and opportunities: regulatory, scientific, logistical and financial. This interactive Web seminar will provide a comprehensive overview of clinical trial outsourcing from a financial perspective, with a particular eye toward trends in health care technology, outsourced operations and investment considerations.

What you will learn:
- Get Wall Street’s take on the clinical outsourcing market trajectory
- Probe outsourcing financial strategies in a rapidly changing drug development environment
- Understand how clinical research outsourcing decisions can impact and improve business performance and increase your organization’s value in the eyes of investors
- Examine emerging best practices and new norms in trial outsource spending and financial management
- Explore metrics and instruments to help guide strategic decision making from a practical economic point of view

About the Presenter:
Garen Sarafian is a Vice President within the Healthcare Technology & Distribution sector at Citi Investment Research & Analysis. He has been with the firm since 2007. Most recently, Garen has been named "Best Up and Comer" in Institutional Investor’s 2010 All-America rankings. Prior to his current role, Garen covered the sector as part of a larger team that included the Managed Care sector and ranked top 3 in each of the last 8 yearly Institutional Investor rankings.

Garen also has extensive industry experience. He was a Director at Aetna, a Fortune 100 health care firm, for 5 years where he was a part of the Strategic Marketing Group. This group assessed new opportunities, identified & responded to key business issues, and advised Aetna’s various operating segments on enhancing growth.

Register to join us today!

The 2012 Immunogenicity for Biotherapeutics Agenda is Available for Download

noreply@blogger.com (Jennifer) — Fri, 23 Dec 2011 15:31:00 +0000

We are pleased to announce that the brochure for IIR’s 13th-annual “Immunogenicity for Biotherapeutics” is now available for you to download! The most trusted event for Immunogenicity experts just got even better: guided by your feedback, we’ve changed the format and the flow, and added an all-new lineup of never-before-heard case studies and all-new summits. This year’s program offers something for everyone, from the most highly specialized immunochemists to scientists just starting their assay design and interpretation work. As the largest and longest-running conference devoted to designing safer molecules and reliable assays, no other event provides more cutting edge scientific insights. Immunogenicity for Biotherapeutics will take place April 17-19, 2012, in Baltimore, Maryland.

Over 40 Immunogenicity experts address the four most important challenges facing pharmaceutical scientists today. Their case studies will help you:

• Predict Immunogenicity through a Better Understanding of its Underlying Causes
• Plan and Confirm Improvements in Clinical Assay Design
• Prevent Immunogenicity through Advances in Protein Engineering and Tolerance Induction
• Prepare for Breakthroughs in Immunogenicity Considerations for Biosimilars and Biobetters

Why is IIR’s Immunogenicity Event the Only Event You Need to Attend All Year?
It is the only event to provide:

→ Up-to-the-minute interactive briefings from FDA regulators, which will guide you to avoid mistakes and design consistently worthwhile assay and reporting methods.
→ A major emphasis on predicting and matching the immunogenic profiles of biosimilars and biobetters, which will help you – personally – lead your company to success and safety away from the “patent cliff.”
→ A detailed workshop on setting and understanding cutpoints and outliers to boost your skills and the efficiency and reliability of your results.
→ Multiple sessions and an in-depth workshop devoted to modifying biologics to minimize epitopes, which will prove essential to your de-risking approach.

To see the all new agenda, download the brochure here.

Happy Holidays from Future of Biopharma!

noreply@blogger.com (Jennifer) — Fri, 23 Dec 2011 14:00:00 +0000

We're taking some time off from our coverage of biopharma to celebrate the season with our loved ones. We want to sincerely thank you for your readership, your comments and your participation. We look forward to returning to the world of Pharma in 2012! It has truly been the year of the biosimilar at the Future of Biopharma blog.

Here are our top posts from 2010:
A Future for Biosimilars and Biobetters
Large Pharma jumping head first in biosimilars
FDA approves first biosimilar
Podcast: Mark McCamish, Sandoz, on the approval of a generic version of Lovenox
Cell Based Assays: An Interveiw with Xu-Rong Jiang, MedImmune

We wish you Happy Holidays!
-Jennifer Pereira, Future of Biopharma Blog Manager

Amgen & Watson team up to develop oncology biosimilars

noreply@blogger.com (Jennifer) — Wed, 21 Dec 2011 19:24:00 +0000

Source

With the belief that there will be an official FDA ruling on biosimilars soon, many companies are making preparations to join the market. Recently, partnership between Amgen and Watson Pharma to develop oncology biosimilars was announced.

According to Genetic Engineering & Biotechnology News, Amgen will be responsible for developing, manufacturing and commercializing the biosimialrs. Watson will provide $400 million of support for in co-development costs and will also bring their expertise in commercializing and marketing specialty Pharmaceuticals and generics.

What do you believe a partnership like this means for the future of biosimilars?

FDA meets to discuss fee program for biosimilars

noreply@blogger.com (Jennifer) — Mon, 19 Dec 2011 17:30:00 +0000

Last week, the FDA met with the Pharma industry to discuss the fee program for the pathway for biosimialrs, which is expected to be published soon. These fees would go into place October 1, 2012, the Fiscal Year, and last through Fiscal Year 2017.

The four categories discussed during this meeting were:

-Biosimilars Product Development Fees
-Marketing Fees
-Establishment Fees
-Product Fees

In exchange for these fees, the FDA would create a series of goals to meet with both new biosimilars products and resubmitted biosimilars products in order to get them to the market.

They also shared that they have set up a series of desired meetings to establish performance goals and procedures:

- “Type 1” meetings with sponsors trying to revive stalled drug development programs;
- “Type 2” meetings to discuss specific issues such as proposed study design or endpoints or questions where FDA will provide what it calls “targeted advice;”
- “Type 3” in-depth data review and advice meetings; and
- “Type 4” meetings to discuss the format and content of a biosimilar application or supplement.

According to Genetic Engineering and Biotechnology News, these objectives would be sent to Congress by January 15, 2012.

Do you think these fees and meetings will better help companies meet their goals they will have with biosimilars?

DDP Complimentary Web Seminar: Drug Delivery: A Look Forward

noreply@blogger.com (Jennifer) — Tue, 06 Dec 2011 17:36:00 +0000

Drug Delivery Partnerships 2012 keynote speaker G. Steven Burrill, CEO, Burrill Company will be joining us on December 20 at 1:30PM to kick-start your DDP Experience. join us for his complimentary web seminar, then join us in Las Vegas for his keynote presentation, "The Globalization of the Pharmaceutical and Biotechnology Industry: What Does it Mean for Your Bottom Line?"

About the web seminar:
The changing world of healthcare, not just driven by Washington and the healthcare reform dialogue, but by a confluence of technology changing everything from the way drugs/devices/diagnostics are discovered and developed to how they are delivered and paid for has revolutionized the industry. Never in the history of medicine have we seen such dramatic change! This seminar will discuss what these changes mean to the pharma and biotech industries.

What you will learn:
· What is happening now that’s causing dramatic change in the industry
· What is currently changing in the industry
· How the industry is adapting to this change
· What the future looks like

Presented by: G. Steven Burrill, CEO, BURRILL & COMPANY
When: Tuesdsay, December 20, 2011, 1:30PM

Click here to register today! Mention Priority Code XP1778W1BLOG

EMA Updating Biosimilars Gudielines

noreply@blogger.com (Jennifer) — Thu, 01 Dec 2011 17:27:00 +0000

Image Source

The European Medical Association is updating their guidelines they set in place for biosimilars in 2005. The concept paper has been released for consultation and that period will conclude in February 2012.

According to PM Live, a few of the things to be addressed in guideline CHMP/437/04 are:

- Determining whether or not a definition for "biosimilar"is necessary
- Should select biological products follow the legal basis for generics?
- Additional sections that need refinement since the initial realease of the guideline

The revised copy of CHMP/437/04 should be in the first half of 2012.

Oncologists weigh in on biosimilars

noreply@blogger.com (Jennifer) — Wed, 30 Nov 2011 19:16:00 +0000

In a recent article at ASCO, a group of oncologists have weighed in on the prospect of biosimalrs and what they could do for treating cancer. A recent white paper released by The National Comprehensive Cancer Network (NCCN) has stated they will support the use of biosimilars as it will be a critical cost saver for both the patients and society as a whole.

With the promised guidelines from the FDA, many oncologists believe that it is important for the biosimilars to go through clinical trials as the manufacturing process will be different, as that does cause difference to come about in the body's response to the medication. They may exercise caution should they believe biosimilars have not gone through the right approval process.

Dr. Gary Lyman believes that companies need to show complete interchangeability between biosimilars and biologics before the drugs are used, though:
“Whether companies will be required to show comparability or true interchangeability remains to be seen,” Dr. Lyman said. Pharmacokinetic equivalence does not ensure comparability, and interchangeability is an even more stringent requirement, mandating that the new agent provide the same clinical result in any given patient. “Clearly,” he noted, “this is a high bar.”

Do you think doctors will fully embrace biosimilars once they have an approval process from the FDA? What are some of the things that could cause setbacks in their use from those in the medical field?

Emerging markets in emerging countries growing more competitive

noreply@blogger.com (Jennifer) — Tue, 22 Nov 2011 15:38:00 +0000

The United States, Europe and Japan continue to be the headquarters for Pharma companies. The cost of hosting innovation headquarters is high, but worth the price due to the innovation and research that comes out of the areas. However many companies are seeing the importance of expanding into regions with growing markets balancing traditional headquarters with emerging markets. May of the countries seeing an increased interest from Pharma are Brazil, India, China, Asia and Latin America. According to Lab Manager Magazine, these countries in emerging markets are encountering growing economies, large populations, rising personal income levels and progressive political policies. These conditions make these countries rip for investment, manufacturing being one of the key focuses.

The need for brand name Pharma products is also fueling the growth according to David Wilton, Regional Director, Corporate Solutions for Jones Lang LaSalle in Asia Pacific. He says “In most emerging markets, local consumers seek affordable drugs from known, trusted makers so early establishment in population-dense countries like China, India and Indonesia is vital to capture market share. Demand for drugs within these markets is increasing due to the shift in lifestyle created by the rise in personal income and purchasing power. This has resulted in a heightened awareness of traditionally Western diseases and associated treatments.”

This lends itself to the growing amount of clinical trials taking place in emerging markets. Many companies expanding to Latin America and Asia to reach new populations of potential clinical trial participants. The Partnerships in Clinical Trials conference series looks at many of these markets through their growing portfolio of global events - Partnerships in Clinical Trials, Partnerships in Clinical Trials Latin America and Partnerships in Clinical Trials Asia.

What are the benefits from a company expanding its resources and relocating parts/expanding of its business to emerging countries?

Tuscaloosa biorepository to play into long term study on genes and health

noreply@blogger.com (Jennifer) — Mon, 21 Nov 2011 14:30:00 +0000

Tuscaloosa, Alabama's biorepository, hosted at the Tuscaloosa Veteran Affairs Medical Center, has been chosen to as a host to one of the largest studies relating genes to long-term health. The report comes from Tuscaloosa News.

The largest biorepository in the United States will collect two teaspoon blood samples from over one million veterans. There they will be coded and stored. To relate genes to long term health. According to Dr. Lori Davis, associate chief of staff research and development at the Tuscaloosa VA., “The research will study how genes contribute to risk for disease, including common health risks like heart disease, diabetes and cancer. Also, it will look into how we react to certain kinds of medications and who might respond to a certain treatment or who might have a certain side effect.”

DDP Keynote Marc Koska talks to us about Drug Delivery’s role in Global Health

noreply@blogger.com (Jennifer) — Fri, 18 Nov 2011 20:53:00 +0000

One of this year’s keynotes at the Drug Delivery Partnerships event is Marc Koska. He is the inventor of the first non-reusable syringe credited with saving over 10 million lives. In this DDP Exclusive Podcast, Mark Koska discusses how important the drug delivery community is for global health, as well as how Drug Delivery Partnerships facilitates not only forward-thinking business development, but also the betterment of health conditions worldwide.

Download the “Importance of Safe Drug Delivery in the Developing World” Podcast here.

During the podcast, Marc answers this question:
Has anyone from the pharmaceutical side of things ever reached out to you to partner directly? Or are they very much removed because, obviously, you are the technology as opposed to the drug?

His answer:

No, no one has ever reached out and it is a shame because we’ve always tried to pick up on that wave length. You know, if someone was selling, for instance, a Hepatitis vaccine, that they would want that safely delivered in the developing world (especially since it is where we focus most of our attention). And it seems a shame and it seems like a missed opportunity just simply because if a drug company/vaccine company wants to deliver a product with kudos, if you like, so that this one is as pure as it could possibly be, it seems like a great opportunity. But, we’ve never really picked that up and joined the two dots together. But I can understand why and that is because until you get the market reaching a tipping point, you can understand why people wouldn’t want to pioneer and put effort into putting another new item, another variable into the market. So, I can understand the reticence, but it seems like the time is really becoming now that we should be having those conversations.

As a reader of the The Drug Delivery Blog, you get a 25% discount off the standard rate when using code XP1778BLOG to register for Drug Delivery Partnerships 2012. The Event is taking place January 25-27, 2012, in Las Vegas. If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com.

Pharma Friday Roundup: This week's stories

noreply@blogger.com (Jennifer) — Fri, 28 Oct 2011 16:03:00 +0000

Each Friday, we're going to share with you some of the big news from the past week in Pharma. If you see a story that isn't covered and you'd like to see it on the Future of Biopharma blog, feel free to email jpereira@iirusa.com and share your story!

This week's big news:
Genetic Engineering and Biotech News: Repligen Buys Novozymes Biopharma Sweden for $22.7M
AFP: Pharma giants open up drug patents in new collaboration
Physorg.com: How biological capsules respond under stress
The Pharma Letter: EuropaBio sets out views on biosimilars, saying they should not be treated like generics

The 2012 Drug Delivery Partnerships Brochure Is Ready for Download

noreply@blogger.com (Jennifer) — Mon, 24 Oct 2011 16:23:00 +0000

Drug Delivery Partnerships is the meeting place to discover innovative products, anticipate and take advantage of trends in the partnering landscape and implement best practices to ensure your company stays ahead of the curve. We invite you to download the exciting 2012 Drug Delivery Partnerships agenda!

By joining us January 25-27, 2012, in Las Vegas, you’ll have the opportunity to:

Be a Part of the New Drug Delivery Partnerships Experience:
10+ Hours of Networking with 500+ Industry Professionals before, during and after the conference with our expanded partnering tool and at the conference in the DDP Hall
6 New Symposia, featuring Three Full Day Events including, “Manage Macromolecule Challenges to Deliver a Robust Biologic Product” and “Maximize the Potential of your Drug Delivery System through Drug Delivery Device Combination Products"
80 + Speakers including 40 New DDP speakers
40 + Technology Presenters with the latest drug delivery technology innovations

Click here to download the 2012 Drug Delivery Partnerships brochure today!

And, as a reader of the The Drug Delivery Blog, you get a 25% discount off the standard rate when using code XP1778BLOG! If you have any questions about the agenda or event, please contact Jennifer Pereira at jpereira@iirusa.com.

Should the exclusivity period for biosimilars shorten?

noreply@blogger.com (Jennifer) — Thu, 20 Oct 2011 14:43:00 +0000

This week, 51 of the members of the House of Representatives asked President Obama not to shorten the exclusivity period of biosimilars from 12 years to seven as a part of the Affordable Care Act. His latest plan for economic growth and debt reduction, branded biosimilars producers would face the shortened exclusivity time. The House of Representatives believes that biosimilars can be a great asset to the market and patients who face the high prices of biologic drugs. Patient Docs believes that the ultimate losers in this potential situation are the patients. Many companies would look to move abroad where they were in an atmosphere that supported and acknowledged the importance of innovation, leaving America because of no incentive to develop these cheaper drugs.

What do you think about the exclusivity period? Should it be seven or twelve years, and how does each scenario affect the American people?

The growing importance of generic branding strategies

noreply@blogger.com (Jennifer) — Thu, 13 Oct 2011 15:32:00 +0000

In the most recent edition of Beyond Borders, Glen Giovannetti who is renowned globally in the life sciences and an accounting consultant ant Earnest and Young, reveals that he believes that branded strategies for generics are now more important than ever. LiveMint.com states that with Pharma companies struggling with successful research and development (largely due to the large organizations where innovation through bureaucracy), it is critical that they capitalize on the generic industry, as the patent cliff is quickly approaching. Giovannetti believes one of the places to make up for the lost revenue is to go into emerging markets and develop a brand strategy to get the drugs to those countries, however, this is contingent on how they can successfully enter the country's market:

In order to get a higher growth level, they know they need an emerging market strategy and so that often falls in the brand of generics, either through acquisitions or partnerships and other arrangements. A lot of them are realizing that they have large portfolios which are effectively branded generics that they already own and can market in a different way for different markets. So it has become an important part of the commercial strategy for many Big Pharma firms.

He also takes an interesting spin on the growth and future of biosimilars. Since it is so complicated to produce a working biosimlar, there will only be a few Pharma companies on the market who will be able to succeed. However, for those who do, it will be very profitable.

What is your take on the growing importance of generics? Do you believe that only a few will truly succeed in the biosimilars market? Why or why not?

Who can you meet at Cell Based Assay and Bioanalytical Development next week?

noreply@blogger.com (Jennifer) — Tue, 27 Sep 2011 19:29:00 +0000

This is your last chance to register for next week's 7th Annual Cell Based Assays and Bioanalytical Method Development event in Berkeley, CA. Are you registered? Here are the companies can you meet while attending the event:

Abbott BioResearch Center * Ablynx NV * Acceleron Pharmaceuticals Inc * Alexion Pharmaceuticals Inc * Alta Analytical Intertek * Amgen Inc * Amyris * BioAgilytix Labs * Biogen Idec * Boehringer Ingelheim * Covance Laboratories * Crucell Holland B.V. * CSL Limited * Food & Drug Administration * Genentech Inc * Geron Corporation * Grifols Inc * GSK - Domantis Group * Hospira Inc * Human Genome Sciences * Institut Andre Lwoff * KaloBios * Laboratorios Raffo S.A. * LAJ Consultants * MedImmune * Merck & Company * MSD * National Biophotonics & Imaging Platform * Peregrine Pharmaceuticals Inc * Pfizer * PharmaNet Development Group * PPD * Regeneron Pharmaceuticals Inc * Stanford University * Takeda Pharmaceutical * Teva Biopharmaceuticals * UCSF Clinical & Translational Science Institute * University of Buffalo * Wake Forest Univ School of Medicine * ZymoGenetics Inc

For more information about this year's event, visit our webpage.

Woodcock reports release of biosimilars is imminent

noreply@blogger.com (Jennifer) — Tue, 27 Sep 2011 14:39:00 +0000

While the release of guidance for biosimilars have been long awaited by the Pharmaceutical industry, Janet Woodcock has stated it could come as early as next week, but definitely before the end of the year. Reuters reports that Pharma representatives and the FDA have come to an agreement on how fees would be collected to support the biosimilars process and a pathway. While biosimilars are a generic version of biologics, which are used to treat such diseases as diabetes and multiple sclerosis.

What do you anticipate to see from the long-awaited biosimilars draft guidance?

Generics and their availability to poorer nations

noreply@blogger.com (Jennifer) — Wed, 21 Sep 2011 15:11:00 +0000

The New York Times recently looked at the availability of drugs to treat cancer, diabetes and heart disease in poorer nations. While 80% of the drugs produced in the world are produced in China and India, it's found that the population doesn't have access to these drugs because of cost. However, if generic versions of the drugs produced at these plants were available to the citizens of poorer countries, many lives would be saved. Non communicable diseases are responsible for 2/3rds of the death today. So how do these drugs, readily available in developed nations, find their way to aid others? Many of the generic drug companies in these countries are trying to find ways to get these drugs to the poorer nations, including selling them at discounted rates

Generic drugs is often the answer, however the drugs that provide treatment are often a large source of revenue for the companies producing them. According to the New York Times:
Obama administration has been trying to stop an effort by poorer nations to strike a new international bargain that would allow them to get around patent rights and import cheaper Indian and Chinese knock-off drugs for cancer and other diseases.

When the AIDS epidemic was was plaguing the African continent, patent rights were waived to treat those citizens. But this article asks if the AIDS Epidemic is different from the non-communicable diseases plaguing many nations today.

Are AIDS and diseases such as breast cancer and diabetes parallel in developing nations? What impact could generic drug companies distributing copies of these drugs in poorer countries have? Can big Pharma find a way to help meet the needs of those patients?

Cell Based Assays & Bioanalytical Method Development helps Arm Your Assay Development with Critical Workshops

noreply@blogger.com (Jennifer) — Mon, 19 Sep 2011 17:24:00 +0000

This October at Cell Based Assays and Bioanalytical Method Development, we are pleased to announce four intimate critical topic workshops that feature troubleshooting examples and group feedback on your most pressing issues. Don't miss out on this year's offerings:

2011 Critical Topic Workshops:

- Method Development for Liquid Chromatrography - Mass Spectrometry Applications in the Clinical Laboratory Setting
- Fundamentals of CBA — Tactics & Troubleshooting
- Using Design Of Experiment to your Greatest Advantage in Reducing Variance and Guaranteeing Translational Success
- Minimize Error Potential through Firm Establishment of Acceptance Criteria, Baselines, Cutpoints, and Outliers

This event will take take place October 3-5, 2011, in Berkeley, California. For more information on these workshops and their leaders, and the rest of the program, visit the Cell Based Assays & Bioanalytical Method Development webpage.

The Cell Therapy Commercialization Summit is next week!

noreply@blogger.com (Jennifer) — Wed, 14 Sep 2011 17:47:00 +0000

The Cell Therapy Commercialization Summit is only one week away!

Are you confident that your current clinical development plan will take your product from approval to successful commercialization?

Are you looking for a roadmap to ensure financial solvency throughout clinical development?

Do you want to maximize your valuable time away from the office at a minimum of expense?

In three days you will learn strategies to:
1. Manage Costs to Control the Spending Burn and Remain Self-Sustaining
2. Choose the Right Design Parameters for Trial Efficiency and Sustainability
3. Minimize Waste, Maximize Efficiencies, and Speed Up Timelines During the Clinical Trial Transition
4. Optimize Cell Product Quality of Ancillary Materials
5. Incorporate the Concepts of Pharmaceutical Quality Systems into Cell Therapy Product Development
6. Leverage Manufacturing Process Technologies to Maximize Capacity and Minimize Cost-of-Goods

For more information on the event, download the brochure. We hope to see you next week at the Clinical Business Expo!

Which companies will be at the 3rd Annual Business of Biosimilars & Biobetters Event?

noreply@blogger.com (Jennifer) — Tue, 06 Sep 2011 19:00:00 +0000

The 3rd Annual Business of Biosimilars & Biobetters event is taking place this month! Register now before it’s too late and join these industry leaders:

AET * Amgen Inc * Arecor Ltd * Biogen Idec * Boehringer Ingelheim Pharmaceutical * Bristol Myers Squibb * Celestial Biologicals * Celltrion Inc * Center for Medicine in the Public Interest * CEVEC Pharmaceuticals GmbH * Decision Resources * Dr Swamys Lab * Eden Biodesign Inc * EMD Millipore * Engel & Novitt * Express Scripts Inc * Fish & Richardson * Fuld & Company * Greenblum & Bernstein PLC * Hospira Australia * Johnson & Johnson * KBI Biopharma * Ken Pang * Makovsky & Co Inc * Merck & Co Inc * Momenta Pharmaceuticals Inc * Montclair Bioequivalence Services LLC * MPM Capital * NIST National Institiute of Standards and Technology * Novartis Pharmaceuticals * Panacea Pharmaceuticals * Percivia LLC * Pfizer * PPD Inc * Quintiles * Ropes & Gray LLP * Sandoz Inc * Sanofi Aventis * Schiff Hardin LLP * Smithers Group * SpringLeaf Therapeutics Inc * STC Biologics Inc * Synthon Pharmaceuticals Inc * Technology Catalysts Corporation * Teva Neuroscience * The Texas A&M University System * Valin Technologies * Vital HealthPoint *
Wolters Kluwer

IIR's 3rd Annual Business of Biosimilars & Biobetters, taking place September 19-21 in Boston, is designed to help you 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.

For more information on the speakers and the presentation at the event, download the brochure here.

As a reader of the Future of Biopharma blog, if you register before September 9 using code XP1686BLOG, you'll receive 1 complimentary workshop of your choice! If you have any questions about the event, please feel free to contact Jennifer Pereira at jpereira@iirusa.com.

Announcing Exclusive Updates to the Biorepositories Event

noreply@blogger.com (Jennifer) — Mon, 29 Aug 2011 16:12:00 +0000

We're excited to share with you exclusive updates to the 4th Annual Biorepositories conference featuring these updates:

New Sessions including:
Regulatory Keynote - Setting New Biorepository Performance Standards
Dr. Helen Moore, Biospecimen Research Program Coordinator, NIH’s Office of Biorepositories and Biospecimen Research

Strategies to Create Quality Attributes and Streamline Searches of Biorepository Specimens
Renu Vora, Senior Associate Scientist, Centocor

Case Study Spotlights on Incorporating Next-Generation Technology into your Biospecimen Management:

Innovative Systems Pathology for Functional Interrogation of Biospecimens
Michael Roehrl, PhD, Assistant Professor of Pathology and Laboratory Medicine, BOSTON UNIVERSITY

High-Throughput Techniques for Diagnostic Testing and Blood-Banking, and Use of Excess and Discarded Materials in a CLIA Lab
Lynn Bry, MD, PhD, Associate Director, PARTNERS HEALTHCARE

Coupling Biorepositories with Informatics and Mining of EMR Data for Future Use
Wendy Wolf, PhD, Executive Director – Biorepositories, CHILDREN’S HOSPITAL BOSTON

Technical Advances in Frozen Sample Aliquotting to Boost Sample Homogeneity and Renewability
Dale Larson, Director, Biomedical Systems Group, DRAPER LABORATORY

Testing the Effects of Anhydrobiosis and Ambient Storage on RNA Sequencing
Kristin Ardlie, PhD, Director, Biological Samples Platform, BROAD INSTITUTE

For more information on these updates and the complete agenda, download the brochure here. Biorepositories 2011 is taking place September 19-21, 2011 in Boston, MA as a part of the Clinical Business Expo.

Innovative Stem Cell Trial in Cleveland

noreply@blogger.com (Jennifer) — Fri, 26 Aug 2011 10:00:00 +0000

The current multiple sclerosis clinical trial at Cleveland Clinic, University Hospitals Seidman Cancer Center and Case Western Reserve University is working to treat and possible reverse the damage that patients suffering the disease are facing using the patient’s own Mesenchymal stem cells. The goal of the study is to examine if it is possible that stem cells can be a way to strengthen the immune system. his clinical study has already had two patients undergo the procedure and plan to have 24 patients enter the study over the next 2-3 years. According to Cleveland.com, there are clinical studies in Spain, Iran and China examining the same type of procedure.

The scientists collect the patients stem cells, then nurture them in a lab until they are grown and then inject them into the patients arm. The first patient saw his condition ease within a matter of weeks. This video examines the study further:

This fall at the Cell Therapy Commercialization Summit, there will be a full track examining clinical development strategies with speakers from Bioheart, Aldagen, Cytograft Tissue Engineering and more. For more information about the event, download the brochure.

FDA realigns to support possible biosimilars change

noreply@blogger.com (Jennifer) — Thu, 25 Aug 2011 15:40:00 +0000

Image Source: FDA

On August 15, the generics industry stuck a deal with the FDA that could expedite the approval process of generic drugs after fees are paid. It is believed that first year fees could reach up to $299 million to speed up the review process which typically takes 2 1/2 years currently for approval.

The FDA Office of Generic Drugs has reported they are adding a second Division of Bioequivilance and a fourth Division of Chemistry. Director Helen Winkle released the plans in a memo from the Office of Pharmaceutical Science. According to Cutting Edge Information, they believe that the addition of a second Division of Bioequivilence could indicate that there has been an agreement reached after the initial Biologics Price Competition and Innovation Act passed Congress in 2009.

The Business of Biosimilars and Biobetters Conference will be addressing the abbreviated pathway head on, with a panel of experts examining the pros and cons of paying for expediting the process of the approval of generics.

How do you feel about paying to expedite the review process?