7th Annual Project Management for the Drug and Device Industry

Over the past year, life sciences organizations have been experiencing unprecedented challenges. Our industries have seen an uptick in company consolidations, greater regulatory hurdles, and debates on healthcare reform. It is likely that this will continue well into 2010 and beyond. How is the Project Manager impacted by these internal and external factors? We are continually impelled to drive our teams towards critical goals, and the success or failure of these projects is directly related to our flexibility and innovation.

The 7th Annual Project Management for the Drug and Device Industry event has been designed to provide cutting-edge tools and techniques to help you lead your team confidently and walk away with clear strategies for achieving project, program and portfolio success.

Find out more about this event here.

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Outsourcing Pharmaceutical Project Management

According to an article found on Article Dashboard, the pharmaceutical industry is facing challenges in product discovery, development and subsequent manufacturing of drugs. This is where efficient project management provided by outsourced firms comes into the picture. The article touts outsourcing of project management to countries like India; however, does outsourcing really provide a feasible and cost-effective way to secure a product's success? Take a moment a read the article, we'd like to hear your thoughts.




Visit the webpage here.
Download the brochure here.

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Biotech is still Lagging in Social Media Use

Here's an interesting news clip from NECN Business in which they discuss that although many companies have found ways to advance their products through social media, the biotech industry is still lagging way behind. The problem seems to be the FDA and the strong hold on regulations that they have on pharma advertising. Make sure to watch the 3 minute video below. Enjoy!

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Roche looking to expand oncology

At their recent investor conference Roche announced that they plan to increase their presence in oncology. They're currently the leading player in the oncology sector, as 53% of their 2009 sales came from that sector. Their current pipeline for oncology includes: several new drugs such as pertuzumab and T–DM1 for HER2-positive breast cancer, RG7204 for the treatment of malignant melanoma, GA101/RG7159 for chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, and RG3616 for the treatment of advanced basal cell carcinoma and potentially other cancers such as colorectal cancer.

Read the full article here.

This post is brought to you by:


Target Clinical Trial Series: The Optimal Approaches to Oncology Clinical Trial Design and Analysis brings together colleagues in biostatistics, oncology clinical trials, clinical R&D, adaptive trials, oncology drugs and diagnostics, and translational research in an exciting and engaging environment to deliver and develop solutions, industry standards and practical applications for clinical trial design and analysis.

This event, along with the entire Target Clinical Trials Series is FREE to clinical research professionals from a pharmaceutical or biotech company.

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Immunogenicity for Biotherapeutics 2010: Hear Case Studies from Amgen, Eli Lilly, & Pfizer

The 11th Annual Immunogenicity for Biotherapeutics convenes the industry’s leading experts and scientists to discuss updates on emerging regulatory updates, new assay development and validation strategies, novel and advanced case studies, and more to help your company conserve time and money so you weather the storm in today’s economy. Join 100+ colleagues to hear the latest immunogenicity techniques and learn how to accelerate approvals through the adoption of innovative scientific methods that deliver validated immunogenicity data.

→ Are you confident you are managing drug interference effectively?
Many consider drug interference as one of the toughest challenges in immunogenicity testing. Hear case studies from Amgen, Merrimack Pharmaceuticals, and Human Genome Sciences as these scientists share method validation techniques and lessons learned for handling drug interference with the diversity of therapeutic products in development.

→ Can you accurately evaluate the downstream impact of your immunogenicity data and establish clinical relevance for overall study interpretation?
Hear case studies from Eli Lilly and Biogen Idec on how to handle complicated immunogenicity assessments and the overall impact of these results upon clinical studies. Be ready to share your own lessons learned and ask questions of industry colleagues regarding strategies and solutions for data interpretation and establishing clinical relevance.

→ Do you need clarity on the induction of immunological tolerance to proteins?
To achieve the full potential of biologicals as therapeutic products, alternative approaches for eliminating immunogenicity are essential. Spend an afternoon with experts from Pfizer, State University of NY at Buffalo, Genzyme, and the University School of Medicine to discuss the details and challenges for tolerance induction to therapeutic proteins.

Join these sessions and many more at the longest running and the largest Immunogenicity event of the year. Visit our website to view the finalized agenda and to place your registration.

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How will healthcare reform affect Pharma?

Kaiser Health News recently wrote an article detailing the new healthcare bill and how it will affect those involved including Pharma, hospitals, insurers and doctors.

Even though the industry will face $84.8 billion in new taxes, they will receive:

-- The drug industry will put up $84.8 billion to help fund the legislation. Part of that goes to making brand-name drugs more affordable for seniors who hit the Medicare coverage gap - the "doughnut hole." But pharmaceutical firms stand to make much more in return. With more Americans insured, more can buy brand-name drugs.

-- Expensive biologic drugs would get 12 years of exclusivity protection from generics. Obama, AARP and the generic drug industry were calling for a 5- or 7-year limit. While biologic drugs are only a small portion of industry sales, they represent the fastest-growing segment of the market.

-- The legislation, despite the pleas of some lawmakers, doesn't make it easier for Americans to buy less expensive drugs from abroad. Nor does it allow the government to negotiate lower drug prices for Medicare.


To find out more about the effect this healthcare bill will have on biosimilars at IIR’s Generic Drug Summit: Business of Biosimilars. In 2009, the event was expanded to deliver brand and generic companies innovative tools to compete in the business of biosimilars and biogenerics. The event is well positioned to become the leading business meeting for executives looking to profit in the emerging market of biosimilars and biogenerics. Visit the webpage here.

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Biorepositories 2010 – Registration Open & Event Overview Ready for Review

BIOREPOSITORIES 2010 - SAVE THE DATE

September 27-29, 2010

Hyatt Harborside, Boston, MA

Now in its 3rd year, IIR’s Biorepositories event convenes the most innovative and strategic minds to the premier event designed by and for the biobanking community.

Your actions today to preserve and correctly store precious biological samples will significantly impact your future drug development and revenue.

Are you looking to build your own biorepository from the ground up?

Is your biorepository adhering to current FDA and EMEA guidelines?

Are you prepared for the unexpected and preventing sample loss in the event of a natural disaster?

Do you have the best automation equipment for optimal sample storage practices?

Can you turn your biobank into a strategic asset?

Are you ready to realize the future scientific opportunities proffered by optimal biospecimen storage?

If so, join the hundreds of life science executives who benefit from sessions led by the industry’s foremost experts as they deliver the nuts and bolts of biorepository operations, discover the scientific possibilities, and operationalize the strategic vision of optimal sample storage all under one roof.


Do You Want To Join the 2010 Speaking Faculty?
IIR is currently accepting abstracts for the 2010 event. We invite you to submit a proposal for a speaking opportunity directly to Courtney Leonard at cleonard@iirusa.com by March 22, 2010.

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 Sarah Scarry at 646.895.7472 or sscarry@iirusa.com.

Do You Want to Protect Your Samples Now?
Click here to register www.biorepositoriesevent.com

Do You Want to Be Informed When the Event Program is Ready for Download? Click here.

Join the Community

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Immunogenicity shown in Prevenar 13 studies

According to RTT News, in a Phase III safety and immunogenicity study, Prevenar 13 showed that the vaccine was immunogenic and generally well tolerated in healthy young children who had received at least three prior doses of Prevenar. This proved that there was a prevention of pneumonia and Streptococcus pneumoniae in children under five years old. Read the whole article here.

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Clayton Christensen on small market versus blockbuster

Last year, Clayton Christensen, a keynote presenter at the 18th Annual Partnerships with CROs, focused on disruptive innovation in the Pharma industry as he discussed how it is on the precipice of major change where strategic sourcing/partnering approaches that provoke or complement disruptive change could be an important solution. In this portion of his speech, he looks at how blockbuster and small market drugs have changed over the past few decades.

Watch Part 3 of the presentation in the Multimedia box at the bottom of the page under “Video”:


This year, we’re excited to have , Jason Hwang, MD, MBA, Executive Director of Healthcare, Innosight Institute, who was the co-author of The Innovator’s Prescription: A Disruptive Solution for Health Care. He will be presenting the keynote speech, “Value Creation through strategic sourcing and new business Models, “ on Wednesday, April 14 at Partnerships in Clinical Trials. For more information on his presentation and others at Partnerships in Clinical Trials, download the brochure here.

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Top Reasons to Attend Project Management for the Drug & Device Industry

Have you considered joining us for the 7th Annual Project Management for the Drug & Device Industry event? It will be taking place Orlando, April 12-14, 2010 in Orlando.

Consider all you can gain from joining us in:
→ Understand and Apply Project Management Leadership Models in the Workplace
→ Master Lean Development and Management
→ Hear the Results of an Exclusive PM Benchmarking Survey
→ Boost Communication and Idea Exchange Using Social Media Tools
→ Succeed in Emerging Markets and with International Project Teams
→ Uncover New Opportunities for PM’s as Consultants or Contractors
→ Build a Successful PMO and Resource Management Function
→ Reduce Cycle Times in the Pharma R&D Process
→ Network and Collaborate With Hundreds of Your Industry Peers and access over 600 companies and nearly 2,000 clinical professionals
→ Understand the Impact of Healthcare Reform on the Industry with Insights from Senator Daschle
→ Earn up to 17.6 PDUs

Register before Friday, March 19 to save $200 and help lead your team confidently with clear strategies for achieving project, program and portfolio success in the evolving pharmaceutical and device industry.

Visit the webpage here.
Download the brochure here.

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Archimedes Gets a Dose of Green

Reuters reports that European pharmaceutical giant, Archimedes has raised had raised 65 million pounds ($97,892,414.29 USD) in the largest funding round by a private European biopharma company in the last 15 years. The money will be used to establish Archimedes' operations in the United State, expand its business in Europe and support the global launch of its novel nasal spray for cancer pain PecFent.

Learn more:

• Drug Firm Archimedes Raises £65 Mln
• Archimedes gets $100M bankroll and names a new CEO

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The Meaningful Use Regulation of Healthcare Project Management

Recently, PM Boulevard looked at how American Recovery and Reinvestment Act (ARRA) is changing the way project management in healthcare organizations must change by 2015. In order to accomplish this, PMs must establish clear project management practices for their healthcare IT project managers.

The Meaningful Use regulations were defined, and we're currently in a 60 day comment period, as it was introduced on December 30, 2009, where:
It offers a 3 stage approach, offering incentive payments to eligible professionals and hospitals of up to $44,000. However, the real incentive is not to receive the reduction in Medicare/Medicaid payments beginning in 2016 that non-compliance will warrant.

Read the rest of the article here.

The 7th Annual Project Management for the Drug and Device Industry event has been designed to provide cutting-edge tools and techniques to help you lead your team confidently and walk away with clear strategies for achieving project, program and portfolio success.

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New Production Plant in Slovenia is Constructed to Produce Epoetin Alfa

According to this article in in-Pharma Technologists Lek has opened up a manufacturing facility in Slovenia to produce epoetin alfa drug for biosimilars which is marketed by its parent company Sandoz. The addition of the new facility will help boost production of the drug which was originally marketed by Johnson & Johnson.

The huge investment have been used to uild a 430m² production plant that will become a global supply point for Sandoz modified proteins. Zvonko Bogdanovski, a member of the Lek board of management mentions “Our endeavours in biopharmaceuticals will have an important impact on health systems going forward.”

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