goBalto, Matchmaking for CROs and Drug Developers

According to TheScientist.com, the number and depth of the connections between CROs and drug developers has grown so much, they now have their own match-making website. Last October, serial biotech entrepreneur Jae Chung (pictured at left) started what he expected to be a simple drug development directory. Now, just three months after its late April launch, goBalto boasts more than 7000 companies and consultants, including 2,200 CROs, all of which can be searched and rated by one another. With a couple of hundred companies and consultants adding themselves each week, "we're one of the fastest growing professional networking sites," Chung said. Finding partnerships, which used to take four to six weeks, can now take as little as two days, he claimed.

Have you had any experience with goBalto? Do you think that matchmaking and social networking have a place within the CROs universe? We'd like to hear your thoughts.

New software for clinical trials

TranSenda has a new software that will help the efficiency of all clinical trails. It'll improve the ability to manage the clinical study.

Cortex will enable organizations to leverage the power of access to centralized operational data from all applications used across all clinical studies.

Read more about the software here.

Speaker Profile: Harris Koffer, Pharm.D

Dr. Harris Koffer is President and Chief Operating Officer for Research Pharmaceutical Services (RPS), a clinical research organization providing services to the Pharmaceutical and biotechnology industries in support of clinical drug development.

Prior to joining RPS, Dr. Koffer served as Vice President, Clinical Trials and Pharmaceutical Business Development, for Quest Diagnostics; Vice President and General Manager of Covance Clinical Services and President of Covance Periapproval Services. In these roles, he was responsible for global central laboratory services as well as full service clinical research and development capabilities for Phases 1 through 4 of drug development.

In addition to over 28 years of experience in clinical drug development, he has served as Adjunct Assistant Professor of Pharmacy in Medicine at the University of Pennsylvania School of Medicine and Clinical Associate Professor of Pharmacy at the Philadelphia College of Pharmacy and Science.

Dr. Koffer has published and presented numerous papers in the fields of cardiovascular clinical pharmacology and pharmacoeconomics.

He earned both a BS in Pharmacy and a Doctor of Pharmacy degree from the Philadelphia College of Pharmacy and Science and completed a Fellowship in Clinical Pharmacology at Thomas Jefferson University Hospital in Philadelphia.

Harris Koffer will be presenting MMAX: Development, Evolution, Growth and Maturation of a Large, Integrated Drug Development Solution along with Jim Dannemiller, M.S., Wednesday, April 29 at 9:15.

Clinical trial begins for a malaria vaccine

According to The Washington Business Journal, Sanaria will begin its first human clinical trials for a malaria vaccine. The new vaccine hosts a weakened version of the entire malaria parasite. It will be tested on 104 healthy volunteers. Read the full story here.

France focuses on Clinical Trials

Global Atlanta recently sat down with Michel Abiteboul, the President of AFCROs on France. In the interview, he discussed the goals of how to bring and achieve high quality clinical trials in France. His interview is below:

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.

More suicidal monitoring needed in clinical trials?

In a recent post by Dr. Michael McKelvey, he addresses the issue of suicide monitoring in clinical trials. He states that the number seeking regulatory approval is increasing. And the FDA has recently issued guidelines for the topic. However, there needs to be a fully structured, procedurally reliable and replicated process for monitoring suicidality. What do you think? Is this an issue for your clinical trials?

Contract work for clinical trials on the upswing

The Pharma Times reported yesterday that 84% of respondents claimed that they'd be interested in contract work when it comes to clinical trials.

While the perceived benefits of contracting – better remuneration, independence and flexible working – were offset in the survey by inhibitions about job security and loss of company benefits, 55% of the respondents recognised there was an increasing shift towards contract-based employment in the sector, with more than 20% seeing it as the prevailing dynamic.

For the complete article, read here.

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.

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

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.

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.

Icon increased 2008 earnings

ICON recently increased its expectations for earnings this year. The 2008 earnings per diluted share rose from $1.27 to $1.29, up from $1.23 to $1.26.

ICON CEO Peter Gray had this to say about the increase in earnings:

“For 2008 overall, we expect to report revenues in the range of $862 to $865 million, which is a modest reduction in previous guidance reflecting the impact of currency volatility over the last six months.”

This comes at a time when most CROs are lowing their profit and revenue outlooks. For more, read the article at Clinical Trials Today.

South Africa seeing less funding for clinical trials

The Business Report of South Africa shares that the CROs in the country are seeing less funding from overseas. This is in large part due to the global financial crisis. The smaller tech companies they depend on for financing are delaying their release of money to the clinical trials. With at least 350 clinical trials based in South Africa every year, they'll have to find a way to attract more private investors to this area. Read more 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.

Outsourcing to India

The St. Petersburg Times recently examined the outsourcing of clinical trials to India. With such a large population, the CROs appear to the population as a way to obtain health care, but with the numbers of companies flooding into India to conduct clinical trials, patients' best interests may be forgotten.

One concern brought up in the article is the difference between the patients of the clinical trial in India and the target patients of the drug in the United States.

"First of all the data must be applicable to the U.S., where the population may differ in clinically significant ways," he said. "And the FDA has to have the capacity to go over and inspect the data. If not, you're asking for trouble."

Another is the lack of oversight from the Indian government on the process of the clinical trials.

Government regulators on both sides of the globe are supposed to be the final backstop on the safety of clinical trials. But that hasn't happened in India. Despite being stung by controversies involving the testing behind drugs like Vioxx, Avandia and popular antidepressants, the FDA inspects fewer than 1 percent of all drug trials in the United States. Its record overseas is even worse.

Read the complete article here.

Partnerships with CROs: Best of 2008

As 2008 draws to a close, we'd like to share the most popular articles of the year.

Enjoy!

India, China, Latin America and CEE as Clinical Trial Destinations
CRO Industry Overview
Accenture has Big Plans For Outsourcing Services
CROs Under Fire
Indian government looking into regulation of Clinical Trials

Nigeria Opens Clinical Trial Center

Announced recently at AllAfrica.com, Nigeria has opened their first clinical trial center at Lagos State University College of Medicine, Lasucom. The center was donated by GlaxoSmithKline.

Professor Clement Adebamowo, Chairman, National Health Research Ethics Committee of Nigeria (NHREC) had this to say about the new center:
"We lost our direction because we started to pay more attention to things that are not based on science and to things that are not based on reasoning. Research is a systematic investigation designed to make generalisable knowledge. We need to put in place a programme that guarantees, in a transparent manner, that any research done in Nigeria is credible. We need to invite a lot of research into the country. Research generates employment, new drugs and new discovery. There are many diseases we wish we can find cure for... Research yields exceedingly profitable results."

Reducing Costs and Time of Cancer Trials

Outsourcing-pharma.com reports that a non-profit group made up of CEOs of drugmakers working in oncology hopes to shorten the drug testing process by making a “common language” available for clinical trial contracts through a set of standardized templates.

It is speculated that this procedure can cut contract negotiation times from 300 days to 30 days. This is coming at a crucial time in the pharma industry since the number of oncology clinical trials rose by 13 percent last year. The templates were part of a 14-month project which was led by the CEO Roundtable on Cancer's Life Sciences Consortium (LSC), a task force of CEO Roundtable members in the oncology pharmaceutical/biotechnology industries in conjunction with the NCI.