Wednesday, September 30, 2009

New Multi-Marketing Channel Strategies for Pharma

The future of Pharma marketing lies in using new marketing channels such as social media intertwined with traditional marketing practices to create a multi-channel marketing mix. However, online brand promotion through social media is more effective for targeting patients than physicians, indicating direct marketing tactics to physicians through social media should be limited. Datamonitor’s report, New Multi-Marketing Channel Strategies provides an overview of the reasons behind the need for new marketing channels and explores the different channel mixes used to reach the pharma industry’s diverse customer base (focusing on patients and doctors). The report also examines the use of online technology, especially social media and uses in-depth case study analysis to examine the pros and cons of each method, while providing actionable recommendations on the appropriateness of the respective targeted audiences.




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Tuesday, September 29, 2009

Keryx Biopharmceuticals Announce Phase 2 Study of Single-Agent Cancer Treatment

RTTnews.com announced today that Keryx Biopharmaceuticals Inc. has announced updated clinical results from a Phase 2 study of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, as a single-agent treatment for advanced metastatic renal cell carcinoma or RCC.


Keryx Biopharma Announces Updated Clinical Results From Phase 2 Study Of KRX-0401 - Quick Facts


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Monday, September 28, 2009

New Drug Delivery System Uses Magnetism to Release Medication

This article in Cnet highlights an effective new approach to delivering intermittent doses of medication that can not be taken orally. Research led by Daniel Kohane at Children's Hospital Boston has uncovered a tiny implantable device that releases the medication through a membrane by switching on an off a magnetic field.

This is a novel approach to delivering drugs and hopefully we should see this come to hospitals soon. What are some other examples of innovative drug delivery systems that are being researched?

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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Friday, September 25, 2009

Partnerships APAC looks at clinical trials in the Asia region

Due to the rapid growth and increasing interest in the Asia Pacific clinical trial market, we are happy to announce that in a few short months, we will debut Partnerships in Clinical Trials Asia Pacific – our first program specifically tailored for conducting clinical trials in this region.

Partnerships APAC represents a time and cost-effective way to evaluate CROs without visiting each region one by one. From local, regional specialists to well-known global partners – this is your chance to figure out which partners match up with your trials’ needs. Our diverse speaking faculty represent experts from most of the region’s key areas for clinical development, saving your time and travel budget with just ONE meeting for the complete picture of conducting clinical trials in the APAC region.

In addition to key industry speakers from India, China, Japan, Singapore, Vietnam and more, the event also features US counterparts talking about proven strategies that they’ve implemented in conducting trials overseas. Combine this with the local regulatory insight you will gain and you’re not just buying a pass to a conference – you’re investing in future clinical trials by preventing delays and determining how to best navigate in this region.


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Tuesday, September 22, 2009

We invite you to join us tomorrow in Boston!

Coming up this week in Boston, September 23 - 25, we have three events that will bring professionals together to network, collaborate and learn about three of the most pressing topics in biopharma today: Vaccines, Biologics and Drug Delivery and Biosimilars.

We hope to see you there!

* * * *

The Vaccines Development Forum

The Vaccines Development Forum has added all new content to address rapid vaccine product in response to the world’s current pandemic. Explore the most mission critical updates and advances in the H1N1 flu vaccine rapid development with case studies and expertise from The National Institute of Health, GlaxoSmithKline, Vical, and CSL Limited.

Visit the Vaccines Development Forum Homepage


Visit the Vaccines Development Forum Agenda

* * * *

Biologics Drug Delivery & Beyond

Discover the latest scientific advances in biologics and RNA formulation and delivery at the Biologics Drug Delivery & Beyond event, coming up next month in Boston. Attending the event gives you exclusive access to experts from pharma, biotech, specialty pharma, and drug delivery companies and 15 + case studies for a clearer picture of where the opportunities and pain points lie, helping you to inject increased scientific strategies into your business decisions.

Visit the Biologics Drug Delivery & Beyond Homepage


Visit the Biologics Drug Delivery & Beyond Agenda


* * *

Business of Biosimilars

With US legislation for a biosimilars approval pathway making significant headway, many questions still remain for biotech, pharma and generic companies alike. Knowing this, The Business of Biosmilars Event is designed to address your key challenges and prepare you to compete in this dynamic new market.

Visit the Biosimilars webpage

Visit the Biosimilars Agenda


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Thursday, September 17, 2009

Biosimilars could help healthcare costs

Sam Taylor, the president of the North Carolina Biosciences Organization and James C. Greenwood, President and CEO, Biotechnology Industry Organization recently wrote an opinion piece about how the approval of a pathway for biosimlars, which could help tremendously when it comes to healthcare and reducing the costs of both medicine and care.

The letter states:
Done correctly, an approval process for biosimilars will protect patient safety, expand competition to reduce costs for consumers, and provide fair incentives for continued biomedical innovation.

As well as:
In considering biosimilars legislation, Congress must maintain incentives for continued investment in order to realize the full potential of this sector to provide new therapies and even cures to patients.

Read the full article here.

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


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Wednesday, September 16, 2009

FAB Pharma, A Biopharma Company Developing Drugs To Treat Severe Bacterial Infections

Medical News Today reports that, FAB Pharma has acquired assets in the treatment of methicillin-resistant Staphylococcus aureus (MRSA) from Mutabilis S.A. Severe infections caused by MRSA is a growing issue, especially in the hospital where it is one of the main causes of nosocomial infections. By definition, MRSA is resistant to a broad group of antibiotics. FAB Pharma's approach consists in developing a new class of low-molecular-weight antibacterial molecules which target a specific, essential enzyme in MRSA called Fatty Acid Biosynthesis I (FAB I).

There is a growing medical need for anti-MRSA drugs. Nosocomial infections constitute a major health problem, with 4 million cases reported each year in Europe and 2 million a year in the USA.

Will the anti-MSRA drug that FAB Pharma is developing work to help this millions of infected persons? Are there other companies working on a similar drug?


FAB Pharma, A Biopharma Company Developing Drugs To Treat Severe Bacterial Infections


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Tuesday, September 15, 2009

Self-administration drug delivery evolving the industry

According to zikkir, the future of drug delivery is increasingly turning towards self-administration. With medical advances, patients are increasingly able to give themselves their prescriptions. Because these devices that are already pre-filled and easier to use, they're leading to more patient compliance. Read more about the increase in self-administration drug delivery devices here.

What do you think? With the growing number of patient-administered drug delivery devices, do you think this will contribute to a patient's compliance to continually and regularly take their medication?


If you'd like to network with other professionals in the drug delivery field, join our LinkedIn group! Or follow us on Twitter at http://www.twitter.com/drugdeliveryiir!


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Monday, September 14, 2009

IIR's Genotoxic Impurities Brochure Ready to Download

IIR’s Genotoxic Impurities is the US event presenting New Toxicology and Analytical Chemistry Approaches for Managing Genotoxic Impurities (GTIs) in Compliance with EU and FDA Guidance. Click here to download the conference brochure.

IIR’s Genotoxic Impurities event is the only US intensive day and a half event that brings together industry thought leaders, white paper and FDA guidance authors to define regulatory concerns to build industry best practices to reduce the need for individual judgment calls. This intensive format designed to deliver everything you need to know about GTIs through regulatory case studies, interactive panel discussions and in depth round tables to build industry best practices.

Answers to Your Current GTI Questions
  • Identify what constitutes an Serious Adverse Reaction (SAR) alert
  • Strategies to assessing and handling degradation products
  • Discover sensitive analytical techniques that can provide accurate measurements of the genotoxic impurities in presence of the difficult matrices (API, lipid formulations and etc.)
  • Understand how other companies are handling issues such as related substances and degradation products
  • Define the appropriate scenario for running in silico and test in Ames
  • Determine how much and when to perform potential genotoxic impurities (PGI) fate mapping
  • Discussion on approaches to cumulative control of multiple impurities
Featured Sessions
  • FDA's Guidance for Industry Genotoxic and Carcinogenic Impurities in Drug Substances and Products
Chris Riley, President, RILEY AND RABEL CONSULTING SERVICES
  • PhRMA ATG GTI Working Group Update & Industry Survey Results!
Nancy Benz Project Leader, Process Analytical Chemistry, GPRD ABBOTT
PhRMA ATG GTI Working Group

We look forward to seeing you in Princeton, NJ.

P.S. Register and Save $200 off the standard registration by using VIP Code: 0TB3WA


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Friday, September 11, 2009

Did you miss last year’s Patient Assistance Programs?

Did you miss last year’s Patient Assistance Programs?

IIR’s Patient Assistance Programs event is back this October, and in its third year the quality of speakers has been raised and the topics delve deeper to tackle the most important challenges in running an effective and strategic program.


Is your program facing higher enrollment than ever before?

Turbulent economic times have increased the need for assistance and biopharmaceutical companies are feeling the effects. Now more than ever before, there is a tremendous opportunity for patient assistance program administrators to leverage, improve and optimize these programs by increasing access and enrollment. Join this year’s event to develop strategies for expediting enrollment and approval processes and implementing program changes to effectively handle the higher volume of patients.


Would you like to expand your outreach?

The 2009 event is designed to help you cultivate low-cost outreach strategies to increase program transparency to reach people most in need. Gain insights into the role manufacturers can play while interacting with copayment foundations who are currently handling increased demands and record enrollment.


Do you want an A+ Patient Assistance Program?

With increasing restrictions on sales rep access to healthcare providers, patient assistance programs are continuing to become an even more integral component of biopharmaceutical’s customer centricity. Join the 2009 Patient Assistance Programs event to gain clarity on specific program attributes that drive perceptions of a company’s commitment to patient access.
Sincerely,

Courtney Leonard,
PAP Conference Director
IIR

P.S. Register by September 18 and save up to $200! Mention code 0TN797


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Thursday, September 10, 2009

Overcome contract approach and development challenges

In the highly regulated pharma sector, understanding the key points of negotiation and drafting a proper contract can be challenging. As Clinical Outsourcing managers are leading negotiations, drafting and managing key contracts on a daily basis, it is essential to have a firm grasp of the basic terms and tactics for creating effective contracts.

The 16th Annual Clinical Trial Cost & Contract Management event will tackle these challenges with a BIOGEN IDEC led workshop dedicated to key terms and negotiating strategies for contract approach and development. This interactive workshop delves deep into:

• Determining the terms and conditions
• Regulatory, financial and legal considerations
• Creating timelines
• Utilizing strategic sourcing concepts and tools
• Grasping contract language and legal terms
• Financial review, profit margins, cost savings
• Understanding payment and business terms
• Master Agreements, rate cards, discount/penalties

Just using one of the strategies from this workshop to get the upper hand in negotiation covers the cost of the entire conference.

Download the brochure to see how this year’s event will empower you with core strategies to significantly reduce cost and risk while working with sponsors, sites and CROs.

We look forward to seeing you in Boston in October!



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Wednesday, September 9, 2009

Are you getting ready for Biologics Drug Delivery & Beyond?

Biologics and RNA Drug Delivery is the groundbreaking conference showcasing cutting edge drug delivery technologies and advances in integrating them with biologic formulations to expand product pipelines.

We are pleased to bring this event to Boston, the hub of the east coast Biotech industry, making it easier and more affordable for you to attend than ever before. Attending the event requires no travel costs or investments.

• Gain competitive advantages by developing your biologic with needle-free delivery: discover the latest in needle-free delivery of biologics and learn how to reformulate your products for needle-free delivery
• Establish what technologies hold the most promise for advancing your biologics, RNAi, SiRNA, and DNAi pipelines to determine where investments should be made and resources should be allocated to
• Discover the latest scientific advances in biologics delivery and formulation for a clearer picture of where the opportunities and pain points lie, so you can inject a strategic POV into business decisions
• Address these development challenges and business opportunities with regards to how to overcome the challenges and formulate your drugs for different drug delivery methods

Visit our website for the comprehensive speaking faculty and complete agenda details.

So join us today and walk away with the technologies that will hold the most promise for needle-free delivery of biologics.

If you'd like to network with other professionals in the drug delivery field, join our LinkedIn group! Or follow us on Twitter at http://www.twitter.com/drugdeliveryiir!


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Tuesday, September 8, 2009

Can-Fite Announces Positive Results from its Psoriasis Phase II Trial with CF101

Reuters reports that those who suffer from Psoriasis may soon have relief. Can-Fite BioPharma, a biotechnology company traded on the Tel Aviv Stock Exchange, an Israeli Biopharmaceutical company, announced today that its 75-patient Phase II clinical study with CF101 to treat patients with moderate to severe Psoriasis has successfully met its primary objectives.

Patients in this double-blind study were randomly assigned to 1, 2 or 4 mg of
CF101 or placebo twice daily. The drug was taken orally as a monotherapy for 12
weeks.

Dr. Michael David, Head of the Department of Dermatology, Rabin Medical Center,
the study principal investigator said: "The study data is impressive and
promising. CF101 is a unique small molecule orally bioavailable drug with an
impressive safety profile based on accumulated experience in more than 700
patients. There is a market need in Psoriasis for small molecule drugs and I am
confident that Can Fite should progress with the clinical development of CF101
based on the study data."

For more information, please visit the original article.



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Friday, September 4, 2009

US Biotech companies missing R&D mark

According to Med Page Today, US biotech companies aren't getting as much out of their R&D dollars as European biotech companies. From 1993-2003, European biotech companies developed more "First-in-class"drugs than American biotech after spending for research and development was adjusted. In addition, Europe has pulled ahead, although by very little, of the research dollars spent per number of new products introduced. Read the full article here.


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Thursday, September 3, 2009

When Is Revenue Not Revenue for Biotech Firms?

Nicolas Morgan of Genengnews.com writes that newly proposed changes to accounting rules may help public biotech and pharmaceutical companies and others avoid the nightmare scenario suffered by Impax Laboratories last year when the SEC revoked the registration of its common stock, essentially eliminating the public market for the company’s securities.

The SEC has designated the Financial Accounting Standards Board (FASB) as a private organization responsible for setting accounting standards for U.S. public companies. One arm of FASB, the Emerging Issues Task Force (EITF), holds public meetings to identify and resolve accounting issues occurring in the financial world.

For more information, please see Morgan's article it is entirety.

When Is Revenue Not Revenue for Biotech Firms?




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Wednesday, September 2, 2009

Biopharma Updates Across the World

This recent post on Biopharmatoday sheds some light on recent biopharma developments from around the world including India, China, Japan, and around the Pacific. Some of the highlights from the article include President Gloria Macapagal-Arroyo from the Philippines signing a new legislation that will transform the nation's top regulatory group. Under the new Act the Bureau of Food and Drugs will replace the Food and Drug Administration. In Europe, Roche became the first multinational pharma company to establish a research and development center in China.

Make sure to take a look at the post for the rest of the updates.


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Tuesday, September 1, 2009

Web Seminar: Leveraging Health: Improving Health Status and Bending the Financial Trend through Value-Based Designs

Title: Leveraging Health: improving health status and bending the financial trend through value-based designs.
Date: Thursday, September 24, 2009
Time: 12:00 PM - 1:00 PM EDT

Reserve your Webinar seat now at:
https://www1.gotomeeting.com/register/478763376

About the web seminar:
Health cost inflation and the economic downturn are unique challenges, but they are also the unique opportunities. The tension that exists in managing health care costs at this time is exactly the spotlight that was needed to change the dialogue on health care. In fact, even the questions we’ve been asking should be changed.

Instead of asking “How much will this cost?” the road to real, sustainable change lies in the question, “How much health will this dollar buy?” Value-based designs have consistently shown the results in improved health status and reduced financial strain. This seminar showcases the learnings, the levers, and the dividends that accrue when a total health management approach is used to create sustainable results through aligned risks and rewards.

You will learn:
- The definition and process of a value-based design, including the categories for improvement
- The metrics of success and the time to achieve them
- The data required to begin the shift to investing in value
- The case studies of others who have implemented over 100 levers to drive change and improved health and economic outcomes

About the presenters:
Cyndy Nayer, MA
Cyndy Nayer is the President and Chief Executive Officer of the Center for Health Value Innovation, a community of employers and payers building evidence, tools and competency in value-based design for improved health and reduced cost trends . She is on of the five equal founders of the Center; Jack Mahoney MD, Global Health Strategy consultant for Pitney Bowes, is another of the founders, and he serves as Chief Medical Officer for the Center.

John J. (Jack) Mahoney, M.D.
John J. (Jack) Mahoney, M.D., is a founder of the Center for Health Value Innovation and serves as its Chief Medical Officer. In 2008, Dr. Mahoney was named as a Fellow of the Center, along with other prominent health benefits executives and thought leaders who are committed to advancing value-based health design.

Jan Berger, M.D., M.J.
Jan Berger works closely with Jack Mahoney, M.D. and Cyndy Nayer as member of the Board of Strategic Advisors for the Center for Health Value Innovation. Her depth and breadth of knowledge in value-based design and provider engagement serve as the foundation for for her role in the Center.

This Web Seminar is brought to you by:



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