Clinical Trial Cost & Contract Management Agenda Finalized

Greater scrutiny of financial ties to clinical investigators coupled with increased accountability and drug safety puts more pressure on contracting executives to clearly outline responsibilities from the start.

Attend Clinical Trial Cost & Contract Management West this November 9-10 and take back to the office the necessary tools to streamline processes and better define accountability and responsibilities:

∙ Gain the upper hand in your contract with a workshop dedicated to contract approach and development
∙ Avoid embarrassing and costly violations regarding financial ties to clinical investigators with a firm grasp on Fair Market Value (FMV)
∙ Bring your drug to market before your competitors by fine tuning your strategy for handling Intellectual Property (IP)
∙ Improve the quality of you’re 3rd party clinical research data with warning signals and outline methods direct from an FDA representative
∙ Improve ROI by defining best practices for handling site payment disputes with your CRO

To view the full agenda click here!

Visit the website here to place your registration.

Clinical trial shows hope for no more insulin injections

According to The Medical News, an Australian clinical trial will commence for the treatment of type I diabetes that will not require daily insulin injections. The trial will now move on to Auckland, New Zealand in Middlemore Hospital.

Prof. Bob Elliott, Founder of LCT and diabetes specialist, said: "We have great hopes for these trials. We already have two patients in the Russian trials that are now off insulin and we are planning to use much higher doses of our product Diabecell in these trials."

Find out more here.

How to rescue a clinical trial

At ClinPage, they recently posted an article about the keys to resuming a clinical trial if you've taken over it midway through the process. So what should you do if you're asked to resume a project after everything's been started?

They suggest:
1) Assess and plan
2) No rushing
3) Create trust
4) Initial Visits
5) Ongoing oversight

For an in-depth look at the steps, read the article here.

Insurance and clinical trials

In a recent article at Pharma Exec, they look at the growing trend of making sure patients around the world are insured should they become injured during a clinical trial. Although regulations are different from country to country, those countries with no regulation for insurance for a clinical trial patient are limiting what a CRO can do. There have been a number of attempts to standardize clinical trial regulations across the globe, including the Good Clinical Practice Standards.

For an in-depth look at this story, read the article here.

CRO PharmaNet Development Group Explores Strategic Alternatives

ClinicalTrialsToday reports that PharmaNet Development Group, which is a troubled CRO, is working alongside UBS to explore alternatives, including the potential sale of the company.

The company’s share price has plunged from $39.19 in January to $1.01 in early morning trading Friday. The company has also received some letters of interest regarding the sale, but PharmaNet will not comment any further until a decision is made.

Clinical Trials Market Expected to Grow in India Despite Economic Crisis

Outsourcing-pharma discusses in this post that even though the country is going through a rough economic crisis, the Indian clinical trial market is predicted to continue its growth. This information comes from a partner at Ernst & Young, and he also states that biotechs increasingly turning to India will help drive growth from its current $200m a year to $600m a year in 2010, which is what KPMG predicted.

Are companies budgeting less towards their outsourcing?

In an article at International Business Times, they say that companies have reduced their spending when it comes to outlays in outsourcing as a percentage of their clinical budget. In the study, the found that an average of 20% of the budget was reduced after each phase of the trial in research performed in 2006.

David Richardson, the lead author of the report, had this to say:
"Companies are now realizing that outsourcing does not necessarily make things easier, cheaper, or remove a burden from their plate. Research has appeared arguing against the cost-saving effects of outsourcing. Also, companies are being more frugal. Keeping things in-house grants easier oversight because of institutional proximity, ensuring efficient and competent work, instead of spending the same time managing a CRO."

Do you agree with his statement? Is this is what's happening with your clinical trial?

New report focusing on outsourcing in central Europe

Centerwatch has published a new report focusing on outsourcing in Central and Eastern Europe. It focuses on the strategies that CROs and biotech companies need to focus on to succeed in these regions.

The author of the report, Sara Gambrill, had this to say about the report and the benefits of researching in Central and Eastern Europe:
“Industry experience and expertise in some countries, such as Poland and The Czech Republic, rival the West’s. Russia and Ukraine, with their very large populations and increasing experience, offer enormous growth potential.”

Find out more here.

Clinical Trials in an Emerging Brazilian Market

China and India have taken advantage of the need for outsourced clinical trials through contract research organizations, but a new study published by Frost & Sullivan shows that the Brazilian market is emerging as the future of clinical trials.

Daniela Putti, Industry Analyst at Frost & Sullivan mentions

“Higher costs, competition from generics, and lack of productivity from R&D have been challenging pharmaceutical companies worldwide to better manage R&D costs and deadlines as well as improve quality of the whole drug discovery process. To responsibly address these issues, pharmaceutical and biotech companies are seeking for more accessible and efficient clinical trial locations such as emerging countries like Brazil. Here these companies and Contract Research Organizations (CROs) may likely find promising market features and growth opportunities for clinical trials.”

How will this affect current outsourced clinical trials in other countries?

inVentiv Clinical Solutions expands into Europe

In a recent news release by Globe Newswire, it was announced that Fernando Martinez, PhD, was appointed to be the director of clinical operations at inVentiv Clinical Solutions at their new office in Madrid. They plan to expand beyond Madrid into other regions of Europe including the emerging market countries of eastern Europe.

Kendle International

Earlier this week, Smart Cap Investor took a look at the CRO Kendle International. It's one of the leading CROs in the world. Based in Cincinnati, Ohio this CRO employs over 4,000 people in 48 locations in 28 countries. It has reached its $724.7 market cap by strategically placing itself where the future opportunities lie. Ithas locations in Australia, China, India, Singapore and Latin America and benefits from the current of outsourcing clinical trials. For more information, read Small Cap Investor's article here.

Phase I Trial Outsourcing in India by 2010?

Outsourcing-pharma reports that Phase I outsourcing of trials to India may be allowed in 2010. Currently Phase I trials are not allowed in India, but the Central Drugs Standard Control Organisation (CDSCO) is considering changes stances.

Allowing Phase I trials to be outsourced to India would boost India’s thriving clinical outsourcing industry as well as offer pharma companies a cost-cutting route. These are some of the areas that the CDSCO will be focusing in on: fixed timelines of 2-6 weeks for each application, internet based new drug application (NDA) status and the recruiting subject experts and reviewers.

Will the recent new of infant deaths in India change the progress of this proposal?

Clinical trial for autoimmune drug halts

Recently, the Birmingham Business Journal reported that a clinical trial for BioCryst Pharmaceuticals found that tested drug BCX-4208 was shelved due to the trial showing that it had no effect on psoriasis. The test included 66 patients who suffered from severe psoriasis.

The drug did prove to meet this objective:
The study showed the drug met another objective by suppressing the number of immune T-cells which act as gatekeepers for the body in determining whether to accept transplanted organ.

Finding patients is the lengthy part of a clinical trial

According to a new report from Cutting Edge Information, detailed here at FDA Drug Daily Bulletin, it takes more time to recruit and enroll a patient for a clinical trial than it does to provide them medical care. There are a few things causing these problems, including competition for the same group of patients who are candidates for popular trials. The study cited the best way to find patients was through physician referrals, patient referrals, and newspaper and television ad.

BioMS Will Give $10m to MS Drug Testing

A clinical study for secondary progressive multiple scleroses will be being conducted by BioMS Medical Corp will receive $10 million from Eli Lilly and Co. BioMS Medical Corp is a leader in developing treatments for MS, and Eli Lilly will contribute their money towards the licensing and collaboration agreements. They signed on to the study after an independent drug safety company gave the treatment an OK. This was reported by FDA News.

Encorium Group Announces $3.5 Million of New Contracts for Clinical Trials for Vaccines

MarketWatch reports that Encorium Group, Inc, which is a multi-national contract research organization, has announced the signing of $3.5 million of new business contracts with a global biopharmaceutical company.

This contract will cover clinical trials in the field of vaccines for infectious diseases in multiple European countries. Kenneth M. Borow, M.D., Encorium Group's President mentions:

"With the signing of these contracts, Encorium has announced approximately $13.5 million of new business during the past three weeks. In aggregate, these new contracts represent both repeat and new client business and cover a wide array of therapeutic areas for multiple small as well as large biopharmaceutical companies. Encorium will provide clinical trial services for these studies on three continents including North America, Europe, and South America. We are very encouraged about our company's ability to win new business, especially as we move forward with our globalization efforts."

New Reports proposed by the FDA to monitor safety

The FDA is now proposing a change to the way safety is reported on in respect to clinical trials. The FDA is proposing that clinical trial sponsors submit an annual Development Safety Update Report (DSuR), as reported by FDA News. This would replace current reports that deliver the status of the safety of drugs in clinical trials such as the IND Annual Report.

In this new DSUR, trial sponsors would be responsible for:

--updating the trial’s status

-- summarizing their understanding and management of identified and potential risks

--describing new safety concerns that could affect the protection of trial subjects

--examining whether the information collected during the previous year fits with knowledge about the product’s safety, the draft says.

India’s Clinical Trials

India is known for their acceptance of outsourcing in their country. Due to the low costs of financing trials here, big Pharma has also started to look to India for outsourcing clinical trials. Time recently took a look at the business of CROs in India. Typically, it costs $1 billion to bring any particular drug to the market, and most of that money is devoted to the part of testing on humans. In India, not only is it cheaper to conduct the human trial, but there are also less strict regulations when testing the drugs. There are currently 400 clinical trials taking place in India. Although there are numerous doctors who are proficient in English to support the effort, few of those doctors have graduated from world class institutes, and even fewer of the people working on the clinical trials have been properly trained.

One of the allures of participating in clinical trials for Indian citizens is the healthcare that’s involved. Since India has no public health care system, the care given during a clinical trial is often better than not receiving any at all. Sadly, most of the citizens who sign up for the clinical trials are illiterate. And with Pharma pushing for trials to go faster, often times health standards are not the highest. The booming business will lead to medical breakthrough for India, but how will it affect their citizens in the long term?

Costs Are Too Much for a Drug Trial Center in Indianapolis

This article in the Indy Star reports that the Lilly Center for Medical Science will end clinical trials in Indianapolis later on this year. Many drugs that treat diabetes and depression grew out of research from the Lilly Center, but now early stage – Phase 1 trials in the United States are no longer cost-effective, and so most companies have begun to outsource their clinical trials.

Lilly is not getting out of early-stage drug trials altogether, but it has created a partnership with Covance in which they will conduct majority of the trials elsewhere. Covance already does preclinical toxicology testing for Lilly, but now it will conduct several more clinical trials. Working more closely with Covance will allow Lilly to get drugs out to the market faster and cheaper than before.

CRO Revenues are Expected to Increase

According to this article in in-PharmaTechnologist.com a recent study conducted by Turner Investment Partners reveals that while CROs are in demand across the whole pharma sector, they will be particularly important to smaller scale bio-pharmaceutical companies as they invest in new drug testing.

The article also details that 30% of CROs revenue come from biotech firms, which indicates that there will be heavy competition from the estimated 500 CROs around the world. Turner Investment Partners estimates that CROs will become part of up to 50% of all drug development projects at the clinical stage and pre-clinical stage within the next couple of years.