Biologics and RNA Drug Delivery LinkedIn Group Newsletter

Welcome to the August edition of the Biologics and RNA Drug Delivery LinkedIn Group Newsletter. This month, we’re looking at the latest news in the industry and preparing for the Biologics and RNA Drug Delivery Conference in Boston at the end of September! See the bottom of the newsletter for an exclusive discount for you, the LinkedIn Group members.

We have some exclusive video from last year’s Drug Delivery Partnerships event on the future of drug delivery in the pharmaceutical and biotech industry, and the importance of increased pipeline innovation.

Click here to watch it:

http://bit.ly/tu8I1


We invite you to participate in the following discussion question:

What needle-free biological delivery mechanism do you think holds the most promise for improved patient adherence?

http://bit.ly/1a24pS


We also have Twitter! Be sure to follow us for the latest news in drug delivery

http://www.twitter.com/drugdeliveryiir


There are industry breakthroughs in Biologic & RNA drug delivery every day- and we hope that you use this group to keep on top of them! Read on for some of the latest headlines in the drug delivery space:


Protein therapeutics worth $77bn by 2011, says RNCOS

http://bit.ly/dEAkb


Microneedle patch could boost compliance

http://bit.ly/zjPaB



New liquid protein tech could improve drug delivery

http://bit.ly/Sggh6



RXi presents RNA delivery data

http://bit.ly/ES5Lc



Researchers target siRNA delivery

http://bit.ly/vaHWL



We’re gearing up for the Biologics & RNA Drug Delivery event, taking place September 23-25 in Boston, MA. As a member of this LinkedIn group, we’re offering you an exclusive discount of 20% off when you register for the event using the discount code XP1412LINK. To find out more about the conference, download the brochure here:

http://bit.ly/ezMgy


Cheers,

The Biologics Drug Formulation, Development & Delivery Professionals Team

http://bit.ly/4009b5

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MDRP Summit coming to Chicago this September!

Join us at Wyeth, Procter & Gamble and others at the MDRP Summit! Register by September 4 to Save $100!

The event has had a great response! Take a look at all the great companies who have already signed on to attend: Amgen, AstraZeneca Pharmaceuticals, Baxter International Inc, Eli Lilly & Co, Bayer Healthcare Pharmaceuticals, Sanofi Aventis and many others.

The MDRP Summit provides participants face to face access to CMS representatives who clarify your most pressing operational rebate compliance and policy questions, USDOJ officials who describe lessons learned from current Medicaid fraud litigations, NACDS staff who detail the AMP and AWP litigation, DoD representatives who share the new TriCare pricing schedule, as well as organized dispute resolution meetings facilitated by CMS, and much, much more.


Click below to join us!
Visit the Event webpage: http://bit.ly/kFe5m
Registration: http://bit.ly/ZH8ca

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What is value driven pharma?

Pharmaceutical companies must proactively respond to the changing economics of drug “value” metrics to remain competitive. IIR’s Value Driven Pharma event brings together stakeholders across the healthcare value chain to address the urgent need to develop drugs that deliver true value throughout the healthcare value chain.

In Washington, DC on October 15th the industry convenes for an unprecedented multi-stakeholder event focused on how to improve market share and deliver the right drug to the right patient at the right time in an era a value-based benefit design. As an active audience participant you will have the opportunity to meet with an industry cross section of those adopting a value driven approach from the point of drug discovery through commercialization.

Find out more about the event here.

If you are interested in joining a group of professionals focusing on Value Driven Pharma, follow us on Twitter or join our LinkedIn group.

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Liquid protien could help in drug delivery

According to in-Pharma Technologies, a newly developed liquid protein, which would be the first in the world, and could help with the delivery of therapeutic proteins and high potency drugs.

Professor Stephen Mann who was incharge of the team that developed the protien stated “represents a possible way forward to a novel state of biomolecular matter, and could therefore have a number of important [biomedical] applications.”

Read the full article here.

If you'd like to network with other professionals in the drug delivery field, join our LinkedIn group! Or follow our Drug Delivery Twitter here.

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Biosimiliars 2009 Speaker Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs

Kevin E. Noonan of Patientdoc.org writes that, Professor Henry Grabowski has been cited often in the data exclusivity debate, on the economic justification for a twelve-year data exclusivity period for biologic drugs. Dr. Grabowski (at right), a Professor at The Fuqua School of Business at Duke University, has some credibility (in addition to his academic credentials) for having the only peer-reviewed analysis of the topic (his paper, "Follow-on biologics: data exclusivity and the balance between innovation and competition," was published online in Nature Reviews Drug Discovery on May 12, 2008). Opponents cite his support by the Pharmaceutical Research and Manufacturers of America (PhRMA) as raising issues of impartiality (albeit in the face of frankly partisan contrary opinions that have not faced peer review). Under the circumstances, it is important to the debate that everyone be familiar with the assumptions, analysis, and conclusions presented by Professor Grabowski.

Professor Grabowski's Economic Analysis of Data Exclusivity for Follow-on Biologic Drugs

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

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Array Biopharma Stays Ahead

According to this article in Forbes a combination of good study data results and effective partnerships should drive Array Biopharma's stock higher over the course of the next year. Just recently an analyst Ian Somaiya cited positive early-stage data for their type 2 Diabetes treatment, the drug met all safety goals.

Although it is still limited data, it provides support that their treatment is progressing. According to Somaiya, he has a price target on Array's share at $15, which is more than three times its current value. Will we see Array Biopharma skyrocket?

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Official Call For Papers: Oncology Clinical Trials

From: Courtney Leonard, Conference Producer
Re: Call for Speakers & Presentations
Event Date: February 3 - 5, 2010
Event Venue: San Francisco

INDUSTRY ALERT: OFFICIAL CALL FOR PAPERS
The Institute for International Research (IIR) is currently seeking presenters for the 2010 Oncology Clinical Trials event. This event will take place February 3-5, 2010 in San Francisco. We invite you to submit a proposal for a speaking opportunity directly to Courtney Leonard, by September 1, 2009. Please send to cleonard@iirusa.com.
________________________________________
Submission Guidelines & Details
CUSTOMIZE YOUR CONFERENCE AGENDA!

We are currently recruiting biopharmaceutical professionals who can share NEW DATA through detailed case studies on what has worked (and what hasn't worked) for oncology clinical trials. This two day event will focus on current challenges the industry sees today and provide a forum for experts to come together and share knowledge and expertise.

Some of the topics to be addressed at the 2010 event are:

• Patient accrual for oncology trials
• Biomarkers in cancer drug development
• Imaging in oncology trial design
• Translational oncology
• Drug development strategies and trial design
• Non-paper solutions for data capture
• Implementation of adaptive strategies in clinical trials
• Designing studies to better target toxicity levels
• Coordination of multiple vendors
• Phase I/II study designs for cytostatic agents

MAKE SURE YOUR BIGGEST ISSUES ARE ADDRESSED!

Are your biggest issues not addressed here?
Contact Courtney Leonard to ensure that your pressing issue gets the attention it deserves! cleonard@iirusa.com or 919.518.8294.
________________________________________
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 e-mail dborrok@iirusa.com.
Sessions will be 30-45 minutes including Q & A.

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Cloud Services for Biopharma R&D

Fierce Biotech reports today that Biopharma research and development organzations need to be mindful when purchasing a cloud computing service.

Cloud computing--a data-crunching force multiplier that allows companies to draw on resources across the Internet, either on the fly or as a dedicated service--is potentially disruptive to companies because it changes the dynamic of who owns the capital assets, turning traditional IT infrastructure models on their heads.

Be cautious, but be open-minded," says Rick Franckowiak, director for systems engineering at the Pharmaceutical Research & Development IT organization of Johnson & Johnson. Likewise: "Be careful," says Brian Boruff, vice president for cloud computing at systems integration consultancy Computer Sciences Corp., a cloud service provider.

Read more: Fierce Cloud Services for Biopharma R&D

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MONOVISC Approved for Canadian Market

Chris Reidy of Boston.com reports that Anika Therapeutics Inc. said it has received regulatory approval to distribute a treatment for osteoarthritis of the knee in Canada.

The treatment is MONOVISC, a single injection viscosupplement for the treatment of osteoarthritis of the knee, Bedford-based Anika said in a press release.

"MONOVISC has been broadly available in the European Union since the second quarter of 2008," said the Anika press release, which noted that the company is moving forward on its goal to receive approval for MONOVISC in the United States.

How long until the United States has MONOVISC available to patients?

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Biopharma is on the move this week

This recent post on CNBC discusses how there has many major moves in the Biopharma industry this week and this has been good for many that hold biopharma stocks. Some of the major moves in the biopharma space include the following:


Human Genome Sciences and Orexigen showed their Lupus and diet drug data.

Onyx Pharmaceuticals was a surprise guest with its mid-stage breast cancer results on Wednesday.

Celgene announced it had stopped a multiple myeloma study early because the drug appears to be working so well.

Will next week be just as exciting in the biopharma industry/

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Hear from leading experts in biotech and biosimilar legislation

This fall, the Business of Biosimilars event addresses the key legal issues surrounding this new marketplace with insight into:

* Data and market exclusivity periods
* IP/Patent protection for biologics and next generation biologics
* Methods for resolving disputes between innovator and imitator applicants
* Global case studies highlighting the outcome of patent settlements
* Analysis of the current competitive landscape

Don’t miss your opportunity to collaborate with the leading experts in biotech and biosimilar legislation:
Michael S. Wroblewski, Bureau of Competition, The Federal Trade Commission
Bruce Leicher, SVP and General Council, Momenta Pharmaceuticals, Inc.
Mark Bowditch, Patent Attorney, Sandoz
Naomi Pearce, Director, Biosimilars IP, Hospira
Aaron F. Barkoff, PhD, Author, The Orange Book Blog, Patent Attorney, MBHB

And that’s just the beginning. To view the complete speaker line-up and event program click here!

Register today and secure your spot at the biosimilars event of the year.

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

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Biopharma IPO Is a Healthy Sign

The Wall Street Journal reports today that Cumberland Pharmaceuticals had, by traditional standards, a poor initial public offering last week but a closer look at the offering shows success.

Cumberland's revenue grew 25% in 2008. It has another product coming to market soon that could redouble that growth. But 70 times earnings is a dizzying valuation all the same.

Cumberland's product portfolio makes the rich multiple all the more impressive. Its biggest current product, Acetadote, is an intravenous version of a drug treating Tylenol overdoses. The oral form of the drug is generically available. According to the prospectus, protection from competition comes not from patents, but from "trade secrets and proprietary know-how" as well as marketing exclusivity, granted by the U.S. Food and Drug Administration, that expires in 2011.

Will we see Cumberland's offerings pick up for the remainder of 2009 and early 2010?

Biopharma IPO Is a Healthy Sign

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Biopharma in India is Surging

According to this article in FierceBiotech a weakened economy and the need for cutbacks is pushing big pharma companies to drive drug development and manufacturing in India. One thing though, many Indian developers are having a hard time transitioning from manufacturing generic drugs to devising new therapies. This is certainly a huge opportunity for Indian firms to thrive if they can ease the transition somehow. It will be interesting to see how things will play out over the course of the next couple of years.

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Stanford Spinout Eiger Biopharma Licenses Hep C Drug Targets from School

Genomeweb.com reports that Eiger Biopharmaceuticals, a recent spinout of Stanford University, said last week that it has licensed the exclusive rights to a hepatitis C virus technology from the university.

"Disrupting the interaction between NS4B and HCV-RNA may be a promising new method to treat HCV infection and help combat drug resistance to HCV polymerase and protease inhibitors," David Cory, president and CEO of Eiger, said in a statement.

"We are rapidly advancing novel small-molecule inhibitors of NS4B-RNA binding into the clinic for the benefit of clinicians and HCV patients," Cory added.

With the exclusive rights from Eiger Biopharmaceuticals, will we see others clamoring to come up with hepititis biopharmaceuticals?

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

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Top Ten Reasons to Attend Value Driven Pharma

Top Ten Reasons to Attend Value Driven Pharma

1. The first & only conference focusing specifically on the paradigm shift in payors’ criteria in determining value of drugs.
2. Develop necessary outcomes-based pricing strategies to remain competitive.
3. Must-have innovation strategies that support the ultimate goal of cost-reduction. Learn how to align all of your incentives behind improving the health of individuals.
4. Attending is a cost-effective way to acquire and evaluate strategies toward payor market demands.
5. Strategies to foster the sought after payor/manufacturer relationship. Performance based contracts between both parties as evidenced by Merck & CIGNA is making the relationship model a reality.
6. Maximize market share in an era of value-based design. Pharma can no longer realy on contracting negotiations alone to gain a strategic reimbursement advantage.
7. Extend your company’s reach – attending Value Driven Pharma will give you access to industry influencers and motivators.
8. Obtain imperative information on the value based paradigm shift in a concentrated environment with industry front runners.
9. With the end of the “blockbuster drug,” don’t be left behind by not differentiating your product at R&D based on market need.
10. Encouraging Patient Adherence? Companies who implement strategies to increase adherence and persistence with their products more easily increase their share of profit.

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Medtronic Biotech Dispute with AGA Medical is Over

According to this article in Patent Docs a recent hearing in the US District Court ruled in favor Medtronic stating that AGA Medical Corp infringed on their patents for blood vessel occlusion devices. AGA Medical is required to pay Medtronic $57 million in restitution.

The suit originated in 2007, and the result of the calculation is due to past damages and an 11 percent royalty for future sales of the product up until 2018. The case will now go in front of the US District Court again for other issues of invalidity and unenforceability.

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Illinois researchers have developed new cancer drug delivery method

University of Illinois researchers have developed a new drug delivery system to treat cancer. In trying to only kill tumor cells and allow the healthy cells to live, as well as allow the side effects of the procedure to be reversed in order to cut down the length of time for side effects. Read the full article here.


This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today on LinkedIn!

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A look at the Green Pharma Summit

The Green Pharma Sumit LinkedIn newsletter came out this week. Click here to read it. If you haven't joined our LinkedIn Green Pharma Summit Group, join today. You'll receive more updates and network with others who strive to make Pharma a more sustainable and eco-friendly industry.

If you were unable to attend the Green Pharma Summit, we have notes on the discussions during event’s roundtables, networking breaks and panels focusing on Pharma’s opportunities, challenges and actions going forwards. See what they discussed here:
http://bit.ly/GPPres

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Wyeth and the Medical Ghostwriters

The New York Times takes a look at the recent news out of Wyeth. According to the article, hidden industry influence on medical journals may be greater than previously expected. From 1998-2005, a journal article stated that taking hormones would increase the benefits and reduce the risks of skin cancer, heart disease and dementia. However, a federal study was stopped when the results were the opposite. There was a detailed paper train found that showed that Wyeth contracted with a medical publication company and wrote the information then had doctors sign their names with little or no contribution to the article. This is particular dangerous because these medical articles could change the way doctors persrcibe the medication. For a full look at the current ghostwriter claim against Wyeth, read the New York Times article here.

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Tuesday's H1N1 Summit Webcast

Press release from The Department of Health and Human Services.

Department of Homeland Security (DHS) Secretary Janet Napolitano, Department of Health and Human Services Secretary Kathleen Sebelius and Department of Education Secretary Arne Duncan joined on Tuesday with Centers for Disease Control and Prevention Director for Immunization and Respiratory Diseases Dr. Anne Schuchat to discuss H1N1 preparedness and answer questions from the public.

Dr. Schuchat and Secretary Sebelius outlined the four pillars of President Obama’s “National Framework for Response”—surveillance, community mitigation, vaccination, and communication—and detailed planning and preparedness efforts used by the federal government to facilitate these goals.

Secretary Napolitano highlighted the role DHS plays as federal coordinator during public health emergencies, particularly by working closely and communicating clearly with state and local first responders and emergency communicators during a health emergency.

Secretary Duncan and Secretary Sebelius stressed the federal government’s ongoing commitment to reach out to parents and the education community to help them prepare for the upcoming school year.

Press Release

For more information about vaccines and to attend The Vaccines Development conference, please click here.

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The state of the art targeted delivery options for your macromolecule

Targeted macromolecular drugs have been touted as the treatment of the future for cancer and cardiovascular disease. To achieve this promise, safe and efficient drug delivery strategies must be realized. While formulation strategies have progressed significantly over the past several years, the industry still faces challenges in advancing delivery of biologics.

Join us in Boston this September 23-25 at the Biologics Drug Delivery & Beyond event, where you will uncover the latest technologies for effectively delivering your macromolecule, including a featured session entitled “The Magic Bullets of the Shots Heard Round the World: Targeted Macromolecule Delivery”, which provides insight on how to:

* Deliver biologics to target
* Use advanced drug delivery formulation for targeting
* Enable macromolecules targeting to treat

In addition, participants hear from David Cipolla of Aradigm on local and systemic lung delivery of peptides, oligos and proteins using solution inhalers. No other event brings the scientific leaders at the forefront of biologic drug delivery under one roof.

Visit our website for complete agenda details, as well as access to presentations from the 2009 Drug Delivery Partnerships event.

Join us on Twitter!

This is the global drug delivery partnerships meeting place, focusing on bringing together professionals seeking the latest strategies, industry updates, and networking opportunities to help position your company for a successful partnership/collaboration. Join us today!

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US House Votes on Protection for Biologic Drugs

According to this article in Pharma Times the US House Panel is voted 47-11 in favor of the 12 year exclusivity amendment that protects branded biologic drugs from generic competition. President Obama, which supported the 7 year exclusive plan, commented that this will keep important drugs off the market and also drive up those costs further.

Billy Tauzin, CEO of PhRMA, and Jim Greenwood, CEO of BIO, are some of the pharma representatives that agree with the House decision. Others like the Generic Pharmaceutical Association are “sincerely disappointed that some members of the House Energy and Commerce Committee have decided to put brand pharmaceutical profits before patient needs.” This will be an up and down battle between both parties for quite some time still.

If you're interested in networking with other professionals in the field of Biosimilars, join our LinkedIn Group here.

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New software designed to help in clinical trials

Laboratory Networks has a new article about the about the new software from Thermo Fisher Scientific about the newly re-designed software Nautilus LIMS designed specifically to serve the needs of the biobanking industry. It's designed to meet the challenges of sample collection, as well as banking for pharma discovery with clinical operations. The software can help accellerate sample analysis. Read more about the new software specifically for Biorepositories and sample collection here.

If you're interested in networking with other professionals in the biorepository field, join us here at the Biorepositories LinkedIn Group!

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