Patients and clinical trials

Parade Magazine recently wrote a piece explaining to everyday individuals what the value of participating in clinical trials is. Not only can it provide hope for those who have chronic illnesses, but it can benefit the lives of others around them. Even though while in the trial it may not be known if one is on the medication or placebo, it is still worth the chance if the current medicines available aren't working.

New online tool to help with compliance

Thompson Publishing has released a new online tool that will allow clinical trail conductors to keep up to date with key compliance issues and continue with their operations. CT Comply is a powerful database that provides up-to-the-minute news, analysis and research tools in one place online.

J.W. Schomisch, senior managing editor at Thompson, and editor of the widely acclaimed Guide to Good Clinical Practice, states:

"CT professionals have been asking for this for years. Now, with just a few quick clicks of a mouse, CT managers can find up-to-date advice to stay in full compliance plus powerful advice to help save time and money and smoothly speed their trials."

"The huge benefit of the online format is that we're able to keep the information continuously up-to-date. That way, clinical trial professionals will always have the latest news, analysis and practical guidance at their fingertips. We've made it all very intuitive and easy to use with several ways to find what you're looking for. "

Read more here.

Merck to cut jobs

According to the New York Times, the Merck merger with Schering-Plough will eliminate 16,000 jobs from the company. After the merger, the group will be the second largest Pharma company. Pfizer will remain the largest. Read the full story here.

Outsourcing challenges

In a recent article at the National Post of Ontario, Canada, they look at the some of the risks that are associated with outsourcing clinical trials to other countries. A few of the roadbumps could be: different culture with different standards, the application quality between the two different populations, and the treatment of patients. There have been a surge of clinical trials being conducted in different countries, India, China and Argentina. Read the full article here.

How has your company overcome these challenges? What advice do you have to other companies outsourcing their clinical trials?

Top Five States for Biotech Innovation

Fierce Biotech recently released their annual study that shares the top five best places in the US and Canada that provide the best resources for innovative biotechs.

They are: Minnesota, Massachusetts, New York, Ontario, and Colorado.

Read why each state was chosen here.

Speaker Profile: Peter B. Corr

Dr. Peter B. Corr is Co-Founder and General Partner of Celtic Therapeutics Management LLLP. Dr. Corr retired from Pfizer Inc in December 2006 where he was Senior Vice President for Science and Technology. In 2002 and 2003, he also headed worldwide pharmaceutical research and development for Pfizer.



Previously, Dr. Corr served as Executive Vice President, Pfizer Global Research & Development; and President, Worldwide Development. He also served as Senior Vice President, Discovery Research, at Monsanto/Searle and then, President of Pharmaceutical Research and Development at Warner Lambert/Parke Davis.



Dr. Corr, who received his doctorate from Georgetown University School of Medicine, spent 18 years as a researcher in molecular biology and pharmacology at Washington University in St. Louis. When he left Washington University, Dr. Corr was Professor, Department of Medicine (Cardiology) and Professor, Department of Pharmacology and Molecular Biology. His research has been published in more than 160 scientific manuscripts.

Speaker Profile: Christopher C. Gallen, MD, PhD

After receiving his M.D. and Ph.D. (Biochemistry) degrees and completing a medical internship at the Emory University School of Medicine, Dr. Gallen went on to complete Psychiatry residency training at Stanford and Neurology residency training at the University of California, San Diego. He then joined the Neuropharmacology Department of The Scripps Research where he developed an international reputation in brain functional imaging, published the first definitive demonstration of human cerebral plasticity, and was as a scientific support to the successful IPO and secondary offerings of Biomagnetic Technology Inc (BTi). Dr. Gallen next took on responsibilities rising to Senior Director of Medical and Scientific at Quintiles directing several successful registration programs. Dr. Gallen then started the Premier Research Worldwide CRO, led its IPO, grew it into a successful trans-Atlantic CRO and conducted trials in a wide variety of therapeutic areas and approaches. Dr. Gallen subsequently moved to work in big pharma with responsibilities as Vice President of Medical Development at Pharmacia including three major roles, Head of Global CNS Medical Development, Head of Clinical Operations managing the “internal CRO” for conduct of all clinical trials in all Therapeutic Areas in the Western Hemisphere and eventually, after helping lead a successful re-engineering, as Kalamazoo R&D Site Head CNS and ID, Dr. Gallen subsequently became Vice President and Chief of Operations for Clinical Research and Development at Wyeth in charge of a range of global clinical development functions. In this role Dr. Gallen partnered with Accenture to help create the Alliance for Clinical Data Excellence (ACE) outsourcing of Wyeth Clinical Data Management to Accenture and to drove the successful re-engineering of Wyeth to the top quintile of clinical research performance. Dr. Gallen subsequently became President and CEO of Neuromed, a Philadelphia and Vancouver-based biopharma company developing products to manage and treat complications of pain, epilepsy and hypertension.



Christopher Gallen will be hosting the panel discussion "Leading Through Change: Innovation and Future of the BioPharmaceutical Industry," Wednesday, April 29, 2009 at 8:30 AM.

Partnerships with CROs & Other Outsourcing Providers: Special Invitation

Partnerships with CROs & Other Outsourcing Providers

The #1 Event for Clinical Development & Outsourcing Professionals
April 28-30, 2009
Rosen Shingle Creek
Orlando, Florida

We'd like to invite you to the 18th Annual Partnerships with CROs event! This event has set the standard in outsourcing and clinical development conferences and we are proud to bring you THE event that explores best practices on forming, managing, and sustaining clinical outsourcing partnerships.

Network with 1400 Clinical Operations, Outsourcing and Business Development Executives Under One Roof!

As a reader of the Partnerships with CROs blog, you will receive a 20% discount off of the registration rate (use code XP1400BLG when registering). To register, please call 888.670.8200, email: register@iirusa.com, or visit our website at www.cropartners.com.

Patient recruitment costs continue to increase in clinical trials

According to Earth Times, the patient recruitment step in clinical trials accounts for 23% of the clinical trial time line. They also contribute to the increasing costs of performing clinical trials.

Emerging means for screening potential patients, such as genetic tests, mean that companies must plan for higher lab-testing costs and a lower rate of prospective patient enrollment. And the Canadian Medical Association Journal (CMAJ) in February published an article claiming that drug development costs had increased at a rate 7.4% higher than inflation.

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:

ICON teaming up with MedAvante

To improve clinical trials dealing with central nervous systems, ICON has teamed up with MedAvante. This alliance will allow a better look into the trials, as they are often difficult to monitor. It will also allow for the two groups to offer new services to drug companies developing drugs to treat central nervous system disorders. For the full story, read here.

Partnerships with CROs now has a Twitter! Follow us here.

Expert Opinions on the Current State of the CRO market

I came across this podcast from Outsourcing-Pharma.com where Barath Shankar, Frost & Sullivan analyst offers his opinion on the state of the contract research market now that it is having to evolve and adapt to the turbulent environment. The podcast is about 5 minutes long, so take a few moments to listen to it.

Listen to the podcast

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.

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?

Staffing services now offered by PharmaNet

CRO PharmaNet has expanded its services to now provide clinical trial staffing which will include on-demand staffing, strategic alliances, functional service staffing and quality control services.

PharmaNet president and CEO Jeffrey P. McMullen said "Our solutions-based staffing business provides another entry point with large pharmaceutical clients by offering them a new alternative with PharmaNet quality built-in."

For more on the story, read here.

India Expected to Draw More Clinical Trials by 2012

Even though there are several reports indicating the trend of outsourcing clinical trails to India, trials conducted in India only represent two percent of the worldwide total according to this article in Fierce Biotech.

The research group RNCOS also expects the number to surge to 5 percent by 2012 as more companies look to conduct low-cost trials in India. According to RNCO,

"companies can cut up to 30 to 40 percent time required to complete various phases of clinical trials choosing India as the outsourcing destination."

Take a look at RNCO’s full release here.

Merck and PPD Partner in Outsourcing Deal

Clinical Trials Today reports that CRO PPD has entered into a strategic collaboration with Merck to expand its global laboratory business. Under the agreement, PPD will have access to Merck’s 130,000 square foot facility in Wayne, PA as well as 80 employees who will operate there.

In return, PPD will provide Merck with range of assay development and immunogenicity testing services as well as traditional central laboratory and sample storage services over the next five years. This is the beginning of a trend of strategic agreements we have seen between CROs and big pharma. We have seen this in August 2008 when Covance partnered with Eli Lilly in a $1.6 billion contract research deal.

Will we see this trend continue between CROs and big pharma in 2009?

Brazil is critical base for PPD's CROs efforts

ClinPage recently featured some of the CROs that are dominant in the Brazil market. With over 300 employees in the region and at any given time 150 trials running, PPD, a Wilmington, North Carolina-basd company, dominates the region. They entered Brazil in 1995 when they bought Q&Q Suporte a Pesquisa Clinica, the first established CRO in Brazil. From there, PPD grew organically and spread through other countries in Latin America such as Mexico, Argentina, Chile and Peru.

For more on PPD, 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.

Regulatory Changes in India

Bio-IT World reports that in an attempt to broaden examination of the clinical research process within its borders, “India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS).”

The Indian Council of Medical Research has been regularly working towards establishment of a mandatory clinical trials registry to improve the reliability of data. The growth in clinical research in India continues, and so the importance of clinical monitors and research associates increases. India will have to play close mind to regulations over the next years since CRO growth is expected to increase in rapid numbers.