United Arab Emirates is Set to Rise in Clinical Trials

According to this post in outsourcing-pharma.com the United Arab Emirates is set to grow in the CRO industry due to the attractive of cost effectiveness there. Kermani, author of A quick guide to healthcare and biotechnology in the Middle East, predicts that with big pharma companies like Pfizer, Amgen and AstraZeneca establishing offices in UAE, many more CROs will follow.

What are some other companies that you have caught wind up that are trying to locate to UAE?

Innovation needed for biotechs

An article in the San Francisco Chronicle believes that Biotech is in need of innovation, and points to diagnostics testing and biofuel production as the next possible chance, as it takes many many years to develop blockbuster drugs. Innovation was possible before because of the fact that investors were willing to risk time and money to come up with the next blockbuster drug. Innovation is critical in these few fields. What do you think? Where will innovation and production in teh biotech industry go next?

Sigma-Alpha Moves Differently from Classic CROs Offerings

Last week, Tony Fong of Genomeweb reported that, Sigma-Aldrich, hoping to grab a bigger slice of the biopharma industry's expanding appetite for outsourcing, (last) week expanded its services business to include mass spectrometry-based protein characterization, protein expression, and protein purification.

The idea is not for Sigma-Aldrich to collaborate with biopharmas on large-scale projects and manage them; "that's what a classic CRO does, and this is definitely not a classic CRO offering." Rather, what the company is offering is the chance for customers to choose individual services from a menu without fear of jeopardizing their intellectual property, she said.

In fact, the executive of one CRO said that because of the limited offering of services by Sigma-Aldrich, the two are not competing for the same business.

Sigma-Aldrich Debuts New Protein Services to Meet Biopharma's Growing Outsourcing Trend

Shifting Clinical Trial Environment

Earlier today, I came across this great interactive treemap in this post in outsourcing-pharma.com that presents a unique visual analysis of the globalization of clinical trials and rise in CROs in the past 20 years. Take a couple of minutes to view this informative map.

View the interactive map

Centralized patient recruitment

In a recent article at Pharma Live, they take a look at the challenge when it comes to recruiting patients and keeping clinical trials running on time. This article focuses on the three different case studies looking at the size of the study, the number of patients sourced from a central campaign, the timing of the recruitment activity, and importantly, the effect of the patient recruitment on the time needed to complete enrollment.

Read the case studies here.

Full Details are Required for Indian Clinical Trials

According to this article in outsourcing-pharma.com CROS and drug companies that are conducting clinical trials in India will now be required to record full details of all their research including the funding source.

Up until now, registration on Indian Council of Medical Research (ICMR) website was done voluntarily, but now that will all change come this June. Last summer 49 infants died in clinical trials in India, and an infant that died in October should have never been part of the trial because the baby had existing heart problems. As a result of this, the committee wants to be able to regulate and monitor all patients before they are enrolled.

CardioNet Expands into CRO Industry by Acquring Biotel

According to this article in Outsourcing-pharma.com CardioNet, a US company that specializes in cardiac monitoring devices, has broken into the CRO sector by purchasing Biotel for $14million.

CardioNet sees a lot of potential in the CRO industry, especially in monitoring its current product portfolio. Biotel will provide provides event, Holter and electrocardiogram (ECG) monitoring services for CardioNet. This is just the first step CardioNet is taking to expand to the clinical research sector.

The Political Economy of Pharmaceutical Clinical Trials

Metapsychology has a review on a new book following 20 clinical trials from around the US analyzing for profit clinical trials.

Medical research for hire combines indeed ethnography and ethics. The former prevails: the book is rich in quotations from the many interviews conducted by the author and we get to know how the participants in the private clinical trials studied perceive themselves. However, the author only visited a minor fraction of the many organizations conducting trials in the USA and had unequal access to the different types of participants.

Read the full review of the book here.
Buy the book here.

March Partnerships with CROs LinkedIn Roundup

The March Partnerships with CROs LinkedIn Roundup is here! Read the newsletter here. If you haven't had a chance to join our Partnerships with CROs LinkedIn Group, join now!

We also had a special message from Lesly Atlas, the Partnerships with CROs Event Director, about what benefits you'll find at Partnerships with CROs as a LinkedIn member.

Premier Acquires Pivotal Research Centers

According to this article in Clinical Trials Today Premier Research, a CRO based in the UK, has finalized its deal with Pioneer to acquire Pivotal Research Centers, which is a site management organization that specializes in phase II and phase IIa clinical trials.

Pioneer’s president and CEO Bruce Shear recently mentioned, “The completed sale of Pivotal advances our plan to focus on our faster growing core business of delivering behavioral health care.”

Omnicore's CRO sees 2008 profit

At the CRO, Omnicore Clinical Research, operated by Omnicore, they reported an adjusted profit of $17.6 million profit from the 2008 year, up from $13.1 million in 2007. Before the profit was adjusted, they saw business totaling $49.1 million. For more, read this article.

Tough Economy Slows Down CRO Growth for now

According to this article in Clinical Trials Today recent layoffs in the pharmaceutical industry has slowed down CRO growth in short term, but in the long run improving efficiency and controlling costs will result in more opportunities for CROs.

Oncology is expected to become a huge focus in the future, so CROs with strong oncology franchises should reap the benefits from that trend soon. It is said that the oncology market will grow to approximately $80 billion in global sales by 2012. European CROs are also making headway as the two Italy-based CROs, Phidea and Marvin Research have completed their merger.

What are some other trends that can help boost CRO growth in the near future?

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!

Read the Newsletter

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.

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.

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?

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.

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