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.

Pushing past the placebo: Legislating for a new kind of clinical trials

From amednews.com:

In January, a study published in the Journal of the American Medical Association on the first two commercially available drug-eluting stents found no significant differences in clinical outcomes.

In August, a report in the New England Journal of Medicine concluded that patients with stable angina who underwent percutaneous coronary intervention showed slightly more improvement over those treated with medication. But that added benefit disappeared by 36 months.

Then in September, a study in the NEJM found that arthroscopic surgery for osteoarthritis of the knee provided no additional benefit over physical and drug therapy.

What these very different studies have in common is that they compare the effectiveness of one treatment option with another instead of on its own. Although more of this type of research is being conducted than ever before, physicians, insurers and consumer groups widely agree that not enough comparative-effectiveness data exist on pharmaceuticals, medical devices and procedures.

For the rest of this article, please click here.

Zagats for Clinical Trial Sponsors and CROs

Living in Manhattan years ago, Zagats defined how we found restaurants. This was Web 2.0 before the Internet -- relying on feedback from other diners to find the "best" restaurant.

Today the spirit of user ranking and feedback defines Web 2.0 -- TripAdvisor tells us which hotel is best, Epinions which product is best, etc.

We are also seeing the Zagat spirit in healthcare. Enter your doctor's name in Google and the first matches are likely all physician and hospital rating sites -- HealthGrades, Vitals, RateMDs. Even Zagats has entered the fray of rating doctors.

So how far could we be from sites where investigators and patients can post reviews and rankings for clinical trial sponsors?

Some groups such as CenterWatch have a history of surveying sites to identify top rated CROs and sponsors. But moving from a controlled survey to the "wild west" of Internet reviews and postings will be a different world. Same too for inviting feedback from patients.

If this seems unrealistic, that is probably what the venture capital community used to believe. No entrepreneur would ever dare to post ratings and reviews of interactions with VCs while seeking funding? And then came TheFunded.com, disrupting and nudging a long-standing power balance.

Today many are addressing the shortfall in number of investigators by looking for sites around the world, and addressing the challenges in patient recruitment by increasing trial-related advertising spend. Perhaps such a review website would be good for drug development -- a site where investigators and patients were posting their feedback and ratings may force the industry to identify and address the roots behind the problems.

Co-posted from www.pharmasherpa.com

Freakonomics of Drug Development

In their best-selling book Freakonomics, Levitt and Dubner look at the world through the lens of economics and demonstrate how incentives (how people get what they want or need) are the root of most everything around us.

So what are the Freakonomics of drug development? Where are the incentives?

Here is a good starting question -- If you work at a "sponsor" is the goal of your company to make medicine or to sell medicine?

I would argue that if you are at a start-up biotech, you are there to make medicines. Your company likely aspires to get a drug into clinical trials, but it is unlikely they would still own the drug by the time of registration and equally unlikely the company would transform into sales & marketing.

If you are at a large pharma, I would argue your company is there to sell medicine. To confirm this, look no further than the revenue cliff ahead for most pharma as patents expire. The anticipated drop in sales is what drives most current decision-making.

So where are the incentives for those in development? Does your company reward for new project starts (regardless of ultimate project value)? Does it reward for killing a project early? Does it reward for innovation and risk-taking?

If your company is ultimately seeking to bring new approved medicines to patients and the marketplace as quickly and safely as possible, it would seem most of these incentives are misaligned.

Co-posted from www.pharmasherpa.com

Continued Growth in India's Clinical Trials

We've been frequently updating you on the rise in Clinical Trials in India, another news story on this growth has come up today that we wanted you to be aware of.

From Press Trust of India:

Clinical trials in India to test the safety and efficacy of newly invented drugs or medical devices have shown a huge growth and registered nearly a five-fold increase in the last four years, a top official said today."In 2005, around 100 clinical trials had been approved in the country by the Drugs Controller of India (DCI). In 2006, it increased to around 150 and to 240 in 2007. In the current year, around 450 have already been approved," Joint Drugs Controller of India, A B Ramteke, told reporters on the sidelines of a conference here today.

What do you make of this rise in Indian Clinical Trials? We'd love to hear your thoughts.