Happy Holidays from CTC

We will be taking some much needed time off for the holidays. We'd like to thank you for your readership and we encourage you to check back with us next year for more innovative thought, perspective and news surrounding the world of clinical trials.

We wish you a joyous holiday season!

Hard times leads to more patients for clinical trials

A recent news report from ABC 15 in Phoenix, Arizona reports that the current recession is leading more people to enroll as patients in clinical trials. Patients see this not only as a way to supplement their income, but also as a way to help perfect drugs that could be vital in future of their children.

CTC Best of 2008

As 2008 draws to a close, we'd like to share with you some of the most popular articles from the Clinical Trials Congress in 2008!

Web 2.0 ... Health 2.0 ... Research 2.0?
India Times: Recession not to hit clinical trials: CROs
Irish Medical Times: Cork University Hospital Opens Oncology Clinical Trials Unit
Zagats for Clinical Trial Sponsors and CROs
AHA Meeting 2008

Site Activation is Key for Successful Clinical Trials

PharmaExec.com has a informative article on its site that explains in full detail how site activation can improve and make way for successful clinical trials. Take a couple of minutes to read it, it’s worth it!

Consortia -- Pre-Competitive Is In the Eye of the Beholder

It is hardly news that drug development is high-cost and high-risk. What is relatively new is for pharma to lower their guard and begin to share information that action together that may potentially reduce cost and risk. Enter the era of the pharma industry consortia.

Perhaps the grandparents of this space are groups such as the Biomarkers Consortium and the SAE Consortium. The C-Path Institute was created, in-part, to create consortia to act upon the FDA's Critical Path Initiative. Where there has been a lack of sound business models for creating new tools for drug development, consortia have been a good solution.

The ability for otherwise competitors to suddenly collaborate is based upon what some have called the “pre-competitive space”. At least one group has defined this as “technologies that aren’t really the basis on which they are competing but helps them do their jobs.”

But there is an inherent conflict. By their very design, consortia are meant to be inclusive and bring representatives from various related areas around the table. But what is pre-competitive to one stakeholder is likely a key revenue source, business opportunity, or competitive differentiator to another stakeholder. In most cases, “pre-competitive” is in the eye of the beholder.

Today it seems not a week goes by without another new industry-wide initiative being launched. Each requires an investment of resources and a commitment to see value ultimately generated.

Impact on drug development? Consortia have emerged as important mechanism for improving the clinical development toolbox (biomarkers may be a good example). But each initiative must start with an honest discussion among stakeholders around the table about what is truly pre-competitive, and whether everyone sees the same opportunity in the same light.


Co-posted from www.pharmasherpa.com

Dude Where’s My Bailout: US- and UK-biotech edition

This was going to be a posting a few weeks back when the US automakers were heading (back) to Washington in search of billions. Unlike the Wall Street package, most believed the financial struggles from Detroit were based only in-part on current economic turmoil and largely based on a flawed and unsustainable business model.

And so I penciled a what-if posting about pharma heading to Washington. Sure the largest players in the industry are sitting on billions in cash, but the coming struggles are well-known as some will lose over 40% of their revenue over the next 2 years with key products coming off-patent. Could they get in line for a bailout?

But before I could get back on-line and move from pencil to keyboard, BIO beat me to it.

Despite the headlines, the BIO request is perhaps more a cash-advance than a bail-out. Currently companies can use today’s operating losses to offset future taxes when they are profitable. The request in Washington is to let companies receive money from the government today in exchange for giving up those future tax deductions.

And BIO cites a direct linkage to the financial crisis – lack of access to capital coupled with roughly 25% of publicly-traded biotechs having less than 6 months of cash equals an inability to fund expensive clinical trials (or even stay afloat altogether). As the NY Times article notes, “the change, if Washington approved of it, could enable the industry to receive potentially hundreds of millions or even billions of dollars, on the condition that the money would be used for research and development.”

Meanwhile, a similar story from the UK -- although here perhaps more of a bail-out compared with a tax reshuffle. As proposed, first there would be a £500 million ($740M USD) government fund set-up to support consolidation among smaller biotechs. Then there would be a £100 million ($146M USD) VC-backed fund to enable larger biotechs to pursue acquisitions and fund clinical trials.

Impact on drug development – Increasing the potential for companies and trials to survive the economic chaos...especially as proposals in the US and UK stipulate applying funds toward R&D.

Co-posted from www.pharmasherpa.com

Setting up Successful Meetings for Clinical Trials Investigators

According to this article on ClinicalTrialsToday, participation from investors in global clinical trials conducted in the Central and Eastern European region was up 25% over the prior year’s. A reason why this is happening is because there has been a slight change in setting up investigator meetings.

One aspect is that meetings should be set in “nice” locations outside of Eastern Europe. Investigators from Eastern Europe like to travel and so that would produce higher numbers. Also, give the investigators some time for sightseeing as they rarely step foot outside of the office. This will take away the bitter feelings of having to sit within four walls and then return home immediately. Take a look at the article to see the rest of the aspects highlighted.

Free Webinar: Project Management in the Life Sciences

Don’t miss your chance to view the free webinar Project Management in the Life Sciences: Results from a 2008 Survey and Comparison with Previous Surveys over the Last Decade with presenter Jann Nielsen on Wednesday January 22nd from 2:00 PM – 3:00 PM Est. Here’s a brief description of the webinar:

The seminar will describe the most interesting data from the 2008 survey and how it compares to previous surveys. For example, there will be a comparison of how project management occurs in large pharma, small pharma and biotech. Differences in how project management is performed in the US vs. EU vs. Canada will be shown. Comparisons between virtual and defined project management groups will be explored. Single vs. multiple function project management groups will be contrasted.

- How project management occurs in large pharma, small pharma, and biotech
- Differences in how project management is performed in the US, EU and Canada
- Contrasts between virtual and defined project management group’s practices
- Comparisons between single and multiple function project management practices

Register here:
https://www1.gotomeeting.com/register/403770168
Mention priority code: G1M2140W1BLOG

Clinical Trials and Unfavorable Results

This post on Chilmark Research discusses how the pharmaceutical industry has an uncharacteristic practice of sequestering less than favorable results. According to the post, approximately 75 percent of research never sees the light of day due to unfavorable results. Read the full article here.

Ex-Lilly executives open 'trials' clinic

From Applied Clinical Trials Online:

A new clinic that is on the cusp of conducting human trials in Indianapolis could distinguish itself as a key player in drug development, not only within the state, but nationally as well.Centurion Clinical Research LLC serves pharmaceutical companies and medical-device makers that need to test their products before they can be approved for widespread use. That first phase, in which healthy people are paid to participate in the overnight studies, is critical in determining the safety and success of a treatment.

"Without people volunteering, there won't be cures for these diseases," Centurion CEO William McGinnis said.
McGinnis and company President Michael Smiricky, both former Eli Lilly and Co. executives, are part of a group of 10 investors who raised more than $2 million to launch Centurion. It is the only commercial clinic in the city and just the second in the state that hosts Phase I trials.

For the rest of the article, click here.

People in the Move in the Clinical Trials Industry

This latest article one outsourcing-pharma.com reports some very important changes in personnel within the clinical trials industry. Some changes include GVK Biosciences appointing Dr. Shoibal Mukherjee to the post of senior vice president, clinical development, and The appointment of Joerg Reinhardt as chief operating officer of Novartis. There are plenty more changes, you can read the full article here.

Chinese CRO Cuts Manufacturing Positions in US

Clinical Trials Today reports that WuXi Pharma Tech, which is a Chinese contract research organization, is discontiunuing its U.S. biologics manufacturing operations as of December 31st, and as a result of this the company will be cutting nearly 100 manufacturing positions across its Philadelphia facility.

The restructuring of the CRO will cost the company between $2.5 million and $3.5 million within the next couple of months. WuXi CFO Benson Tsang recently mentioned:

“Given the depressed demand and the high cost structure of our biologics manufacturing services, we will focus on expanding our biologics testing, cell banking and cell therapy services in our Philadelphia site instead.”

Open Source for Clinical Trials

Matt Asay recently posted on cnet that the clinical trial open source project OpenClinica has finally broken through. TMCnet gives a great profile of the open source project:

“Since its debut in 2005, OpenClinica [developed by Akaza Research] has quickly become the most popular open source clinical trials software in the world. Akaza Research previously announced that it had experienced 2,000 OpenClinica downloads as of August 2006. Today's announcement represents a growth of 700 percent since that time....Akaza Research takes the position that its professional open source approach is key to helping to facilitate widespread adoption.”

This is a very interesting concept for the clinical trials industry, but I’m eager to see if this concept will catch on with big pharma execs.