February Edition of Partnerships with CROs LinkedIn RoundUp now available!

Here's the February edition of the newsletter we regularly send out to our Partnerships with CROs LinkedIn group members. Remember to join our Partnerships with CROs LinkedIn group if you haven't so already in order to receive these communications on a monthly basis. Enjoy!

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Unethical Clinical Trial Outsourcing

This article on Outsource Portfolio details that the growing numbers of companies outsourcing to India is a good thing, so as long as it does not cut the need to protect patients’ rights.

To ensure that patients’ rights are protected overseas India has created an online registry for all trials being conducted in India. This registry allows data to be integrated with data from the World Health Organization further ensuring that all global standards are met. Will this truly help ensure the ethical conduct of clinical trials in India?

New regulations from the Indian government

BNet is reporting that the Indian government may soon impose new regulations on clinical research outsourcing to its country, as well as create a Central Drug Authority to monitor clinical trials that are outsourced by North American and European Countries. It would look to protect patients in CROs in regions such as India, China and Africa. For more, read the article here.

Raising alarms, study sees trials migrating abroad

John Carroll at FierceBiotech.com reports that the U.S. drug industry has shifted most of its clinical trials to overseas sites in a trend that experts warn raises serious ethical concerns. According to a study in the New England Journal of Medicine, 13,521 of 24,206 trial sites being sponsored by the top 20 U.S. drug companies in late 2007 were taking place beyond our borders, where data can be harvested cheaper and faster than the data gathered inside the U.S. And the study adds that the number of countries hosting trials has doubled in 10 years. Most of the countries hosting clinical trials may be using individuals who could never afford the medications and approval for these trials has been less than half. What are your thoughts?

Is Outsourcing of Clinical Trials Faulty?

A recent article in the NY Times raises the question about the ethics of conducting clinical trials outside the US when these studies are meant to gather evidence for drug approval in the country.

The article which was written by several Duke University researchers and was published in the New England Journal of Medicine discusses how medication that is intended for the wealthy should not be tested on people in developing countries. The report questions whether or not testing drugs in developing countries is even relevant to American patients.

What are your thoughts?

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.

Pfizer Plans to Disclose Payments Made to Clinical Investigators

According to Clinical Trials Today, Pfizer plans to publicly report payments made to clinical investigators, physicians and other health care professionals by early next year, making it the first pharmaceutical company to commit to disclosing payments it makes for conducting clinical trials, speaking and consulting. It seems that Pfizer wants to aim for transparency of their practices, perhaps providing an easier system of due diligence within the pharmaceutical and CRO/Clinical Trials arenas. What do you think of this move by Pfizer?

Quintiles opens up Phase I Unit in India

Quintiles will be opening up a the first Phase I unit in India. In conjunction with India's largest hospital group, the Apollo Hospital Group.

Eddie Caffrey, Quintiles’ senior vice president, global phase I, had this to say about the new project:

“They really are very forward thinking. They are very involved in technology, they’re very involved in IT, telemedicine and things like that. We began negotiations and discussions with them, and it was agreed that it would be the ideal opportunity for a joint venture.”

For more on the Phase I Trial, read here.

Microdosing could be a win/win for pharma, CROs

According to Peter Mansell of Pharma Times, a new study by Frost & Sullivan, Strategic Analysis of Opportunities in the CRO Market – Phase 0, notes the increasing acceptance of microdosing and suggests it may be the antidote to industry’s much-discussed problems with drug productivity. Consolidation among CROs has raised concerns about quality of service and attention to detail in the sector, Frost & Sullivan points out. Mansell points out that companies need to ensure these elements are in place if they are to maintain their bargaining power with the pharmaceutical industry. For more information on the study or Peter Mansell's thoughts, check out the original article, here.

PPD Extends its Reach to Eastern and Central Europe

We recently posted that Covance was planning on opening up several offices across Eastern Europe, and now according to this article in novinite.com PPD is set to buy AbCRO, which is Bulgarian based CRO, in order to expand its drug testing businesses in Eastern and Central Europe.

The purchase which is expected to be completed in March will add Romania, Bulgaria, Serbia and Croatia to PPD’s operations in Europe and also help bolster its already existing operations in Poland, Russia and the Ukraine. What other clinical trials companies are investing heavily in Eastern and Central Europe?

NIH Awards University of Texas $1.8M in Research Grants

According to their Press Release, The National Institutes of Health (NIH) awarded Chlamydia researchers at The South Texas Center for Emerging Infectious Diseases (STCEID) at The University of Texas at San Antonio (UTSA) a $1.8 million grant over the next five years to study the pathogenesis of Chlamydia trachomatis, the bacterium that causes human genital Chlamydia.

By studying this sexually transmitted disease, UTSA can better serve the pharmaceutical industry and work together to eradicate Chlamydia from the world's population.

Do you think this was a proper use of NIH funds? What other research are you seeing in this arena?

Covance Opens Offices in Ukraine, Slovakia and Israel

Earlier today I came across this post on the Future of Biopharma blog that highlighted an article on ClinicalTrialsToday that details the recent expansion of three new clinical development offices Covance has opened in Central and Eastern Europe and the Middle East.

The purpose of the new offices is to speed clinical trials and develop strategic relationships in those areas. The new offices will be located in Kiev, Ukraine; Bratislava, Slovakia; and Tel Aviv, Israel. Covance has been providing services already in these parts for quite some time, but now these locations will support staff and the CRO’s regional network of field-based clinical research associates.

Covance expands into Eastern Europe and Middle East

Covance has opened up new offices in Kiev, Ukraine; Bratislava, Slovakia; and Tel Aviv, Israel. The Ukraine and Slovakia offices will be in support of the CROs regional network and field based CRAs. The new office located in Tel Aviv will be a center to support staff for operations in Greece, Turkey and the Middle East.

For more information, read here.

India to Conduct 5% Global Clinical Trials by 2012

A few weeks ago we discussed the report released by RNCOs that discussed India's prominence in the global clinical trails arena. Today, another aspect of the report came in that claims India will be conducting 5% of global clinical trials by 2012. This claim is partly due to India's large patient pool, the recruitment of these patients is also among the fastest in the world. As most of the healthcare costs in India are paid “out of pocket”, a large patient population continues to have unmet medical needs. As a result, they readily volunteer to participate in clinical trials to get free treatment. So we ask you again, what do you think? Are other nations going to rise above India's prominence?

Executives are on the Move in the Outsourcing Industry

I came across this periodic round up of executive appointments on the outsourcing-pharma.com blog and I thought I’d share it with you. Some of the big names that stand out immediately is Allen Rosenston who has been named the new vice president of business development for Halo Pharmaceutical and Terry Ladd who has rejoined US CRO Calvert Labs as vice president of business development. Take some time to read the rest of the executive officers who have recently moved up in their positions.

PRA International expands into southwest Asia

PRA International has partnered with LSK Global Pharma Services of South Korea and Mediscience Planning in Japan to reach further into the clinical research in southwest Asia. They've been working with the region since 2004, in countries such as Australia, New Zealand, Singapore, Hong Kong and Taiwan.

Edward Ian, the senior director of clinical operations for PRA Asia Pacific had this to say about expanding into Japan:

“It really depends on the needs of the Japanese pharma. If they need a clinical program to be done in three countries only—Japan, Korea and Taiwan—that’s great. If they have needs to take the projects to China or Singapore, then PRA’s regional help in Asia-Pacific will be able to come in. It’s a global level of clinical trial management services for those Japanese companies that may have more than regional study needs.”

Source: Clinical Trials Today