White Paper: What can the cloud do to improve clinical trials?

Can drug development and clinical trials to bring those drugs to market be done faster with the right technology?   The National Cancer Institute and Bristol-Myers Squibb recently partnered to see how using cloud technology along with digital signatures and digital identities could do this.

According to the white paper Research collaboration in the cloud: How NCI and Research Partners are using Interoperable Digital Identities, Digital Signatures and Cloud Computing to Accelerate Drug Development:

The researchers were provisioned with interoperable digital identity credentials, a form of software installed on a computer, cell phone or other device, which establishes a close link with the user’s  proven identity and allows for the application of digital signatures to electronic documents. Unlike their  simple electronic counterparts, digital signatures cryptographically guarantee the integrity of documents to which they are affixed. In the pilot study, the electronic documents were placed in the cloud, where the researchers were able to access and sign them immediately. Prior to the study, the signature process was delayed by use of courier service, fax, travel, etc. 

So what did this case study find out about using the cloud and other digital services to track the progress of the clinical trial? There was immense amounts of cost savings because there was no need to overnight documents to where they needed to be, time was saved due to the immediate ability to process documents, document loss was eliminated due to the fact that everything was digital, and the the carbon footprint created by the study was minimized.

Read the full paper here.

This March at the Cloud Computing for Life Sciences event, the NCI and Bristol Meyers Squibb will be on hand to present "Innovative research Collaboration in the Cloud" to present a more in-depth look at this case study.  They will expand on understand what interoperable digital identities are, and why they were central to the success of this study.  For more information on this session and the rest of the event, download the agenda.  If you'd like to join us, register today and mention code XP1808BLOG to save 15% off the standard rate.

Do you think that the cloud could have a significant impact on clinical trials?  How and why?

This blog is co-posted with the Clinical Trial Partnerships blog.

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

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!

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Emerging markets in emerging countries growing more competitive

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?

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Pfizer buying King Pharmaceuticals

Pfizer recently announced it's purchase of King Pharmaceuticals for #3.6 billion. Big pharma continues to buy small Pharma firms looking to acquire new products to their pipelines.

King's main products include, pain drugs, including painkillers designed to be resistant to abuse, and EpiPen, a pre-filled injection to treat allergic reactions. Pfizer has stated that they will cut $200 million in costs. News Observer has the full story.

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What's next for the Pharma industry?

The Atlantic has a very interesting article looking at the future of the Pharma industry. With most of the patents set to expire at the end of next year, many companies are also facing pipelines with few products and low approval rates from the FDA. With the clinical trials being the most expensive parts medical development, in addition to the targets of new drugs being very small portions of the population, many drugs are shelved or are out of financial reach for many of the patients who need to use them.

Pharmaceutical companies are blamed for focusing on marketing at the expense of innovation: they allegedly kill promising compounds because of fears of small markets, then concentrate on “me too” drugs that aren’t really any better than their competition’s. Or they tweak existing drugs in ways that don’t necessarily make the drugs any more effective, but do give companies a new patented drug for which they can charge the Earth.

Read the article here.

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Live from Partnerships in Clinical Trials Next Week!

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

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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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Web Seminar: Realizing Multidimensional Performance Metrics for Improved Clinical Trial Management

Next Tuesday, February 23, 2010 2:00 PM - 3:00 PM EST

Sign up here.

Performance metrics need to be reviewed with respect to the end goals of the study they are being measured on. They should be looked at in context with those goals and with an understanding of their effect on other aspects of the study. Status reports should accurately report the Key Performance Metrics and provide insight into their implications if they remain unchanged. This would allow for strategy to be focused on what needs to be done to enhance performance. Status reports with metrics can be a vehicle to consistent communication between upper and lower level management.

What you will learn:
• How to use metrics to enable discussions with upper management
• How to focus results / goals
• Using metrics to guide strategy
• Understand that metrics should not be viewed in a silo

Presented by:
John C. Burnett, PMP
Founder / CEO
JaPa Associates, Inc.

John is a seasoned Clinical Research Professional with nearly 15 years experience working in Clinical Trials, including 8 years in senior level management roles. John has worked for major pharma and biotech companies such as Vivus, Pfizer, Amgen, Scios under Sr. CRA, Clinical Project Manager and Clinical Trial Manager positions.

Sign up for this complimentary web seminar here:
http://bit.ly/7BFIvH

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Central Labs Spotlight: Peter Colbourne

Over at the Partnerships in Clinical Trials blog, we've begun a podcast series with the speakers of Central Labs West. Taking place this February, Central Labs West brings together the operational team responsible for the execution of safe and efficient clinical trials research.

Our current featured podcast is with Peter Colbourne. During this podcast, he answers the following questions:

-A look at Logistics standardization
-A preview of the Logistics Taskforce
-Some Logistics advice



Download Peter Colbourne's podcast here.
Download a transcript of Peter Colbourne's podcast here.

Central Labs West will be taking place February 3-5, 2010, and before then, we're going to highlight some of the speakers who will be joining us. We invite you to join our Central Labs LinkedIn group to network and communicate with others before and during the event!

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