CRO Expansion Concerns

It has been estimated that the CRO industry will expand from being $7 billion in 2006 to $19 billion by 2013. While some reports may vary, they all agree that the industry will see a huge boom in the next couple of years. This article from FierceBioResearcher delves into the reason why the boom will take place. As they explain, biotech companies are starting to become more reliant on CRO’s. Instead of doing all of the R&D work in-house, more and more companies are looking to outsource those functions. In fact for every $5 spent on R & D, $1 of that, is being outsourced. The article also cautions though, that without “significant government oversight”, there may be reason for concern when turning to CRO’s for drug trial management. As Norbert Bischofberger, Chief Scientific Officer from Gillead’s, remarks, however,

“If you want to do that all by yourself, you need an unbelievable infrastructure that we’ve never had. It’s just too expensive.”

So despite rising concern over safety, there may be no other options for the makers of drugs, except to turn to CRO’s.

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.

Patient recruitment beginning sooner in Phase I

According to this article at Clinical Trials Today, trial design and regulatory consulting is experiencing a surge in Phase I of clinical trials. Most companies going to CROs are looking to make quicker decisions, and are also looking for someone to provide thought leadership.

This article focuses on Parexel, who’s conforming to the demands of the customers and moving the patient recruitment step to the first possible phase.

Michelle Middle, vice president and leader of Parexel’s worldwide pharmacology business had this to say about the change:

“Traditionally, Parexel’s phase I work focused on healthy volunteers, but we are moving more towards early drug development, which includes proof-of-concept work. We are seeing, across the board, that sponsors are seeking patient volunteers [intent-to-treat subjects] as soon as possible in phase I. We review every potential protocol we receive from a scientific point of view and suggest to sponsors, if it is necessary, different study designs.”

The efficiency of the systems must be kept up when dealing with this new way of running the trials. Timelines must be maintained, as well as the retention of healthy patients who are participating in the trial.

Quality Control for Bioequivalence Studies

This paper from Scribd provides an informative look into quality control practices for Contract Research Organizations, specifically when conducting bioequivalence studies. It is obvious that quality control and assurance are important, especially for sponsors to have reassurance that studies are being conducted in compliance with regulatory requirements. The how is sometimes debatable. This paper operates on the premise that the best personnel for quality control in studies on subjects such as bioequivalence are scientists. As the article points out:

“Individuals appointed to manage quality should have the ability to understand the basic concepts underlying the activities being carried out and consequently audited, which improves the integrity of the study.”

While it also notes that it may be easy for scientists to get hung up on the details and overlook something basic, overall, the reward versus the risk is still high enough to support the trend of having “regulatory scientists as quality professionals.”

CROs are Profiting from the Increased Outsourcing of Drug Research and Development

MarketWatch reports that biopharmaceutical companies are increasingly seeking help from contract research organizations to save money on the expensive and time-consuming process of bringing new drugs to the market. This information comes from the latest Sector Focus Commentary by health care analysts at Turner Investment Partners. .

The analysts observed that the FDA has created stricter guidelines on safety and have diminished tolerance for side effects. This in turn will make it harder for new drugs to come into the market. Instead of building laboratories within their own facilities, pharma companies will be passing on research responsibilities over to CROs in an attempt to reduce expenses.

US Department of Defense Begins Clinical Trial

At PharmaLive, they divulge information on the new post traumatic stress disorder clinical trail the DoD will be doing for war vets returning from Operation Iraqi Freedom and Operation Enduring Freedom. This Phase II multisite clinical trial will be lead by the three leading researchers in the PTSD field: Lori L. Davis, M.D, Tom Kosten, M.D, and Mark Hamner, M.D. The first six week trial is a prospective, randomized, double-blind, placebo-controlled study of nepicastat, a dopamine ? hydroxylase (DBH) inhibitor. An eight week extension phase will follow this.

According to the article, the goal will be:

The primary aim of the study is to assess the efficacy and tolerability of nepicastat in the treatment of PTSD-induced hyperarousal, with the secondary aims of assessing its ability to improve other symptoms of PTSD, induce remission and improve quality of life.

The first patients will enroll in the study this September.

Phase II Patient Recruitment for TPI ASM8 Completed

TOPIGEN Pharmaceuticals, has announced that patient recruitment and enrollment for the Phase II safety and efficacy study for TPI ASM8 drug has been successfully completed. It is an inhaled, anti-inflammatory drug for treatment of moderate to severe asthmas. Chief Development Officer for TOPIGEN, Mark Parry-Billings, had this to say about completion at this stage:

"The completion of patient recruitment in this Phase II trial is on schedule, and represents a significant clinical achievement for TOPIGEN. We look forward to completing the study and reporting on data at the end of this year.”

Billings also had this to add:

“There is a significant clinical need for improved medications to treat this patient group, particularly those patients who do not respond adequately to conventional medication. TPI ASM8 has the potential to provide an effective and well-tolerated approach to improve asthma control in these patients, and has the added advantage over other pipeline products of being delivered simply by inhalation."

Outsourced Drug Trials Are Expected to Grow

About 25 percent of all preclinical drug testing is already outsourced to CROs, but according to this latest article in the International Herald Tribune, it is expected to grow to 50 percent in three years. Over the next five years, larger CROs are expected to absorb many specialized companies to boost their diversity. This expectation has already lift shares of CROs such as Covance and Parexel International, which were in stock market trouble this year.

Drug companies save millions of dollars each year by outsourcing clinical trials to CROs since it eliminates the need to build its own laboratories and researchers are not needed. David Windley, an analyst with Jefferies mentions as long as drug makers "keep trying to develop new drugs, then you have to do a lot of work. What they're then doing, they're turning to outsourcing in a more cost-efficient way."

Patient care not accounted for in FDA

In a recent blog post by Erik Greb, he addresses the current unmet needs of patients when participating in clinical trials. The Department of Health and Human Services is proposing that personnel who conduct, review and oversee clinical trials with humans should be trained.

Greb was surprised that this need was not already met, and took time to inform us of other standards that are not set for clinical trials. According to Erik’s post the following are not standards when it comes to clinical trials:

-The training mentioned above is not formalized
-The FDA does not know how many people are currently in clinical trials in the United States
-The FDA has only inspected 1% of clinical trials sites

CRO Industry Overview

Today I stumbled on this report that highlights the CRO industry. Some of the interesting findings revealed include that the market size for this industry is predicted to reach $24 billion by 2010 and, while there have many consolidations between companies, there are still over 1,100 organizations currently servicing this industry. Also the report stated that market leaders have emerged, such as Quintiles with 14% of the global market share, and combined the five largest companies hold a 45% market share worldwide. In addition CROs and pharmaceutical companies are starting to form strategic partnerships as a competitive advantage, as well as part of a consolidating technique. While the report does offer some predictions and future trends, it will be interesting to see where the industry as a whole will end up in the upcoming years. What are your predictions for the future?

CROs growing along with the regions they are situated in

In a recent opinion piece at the Salisbury Post, one person comments on the current hiring situation with CROs: they can’t find enough people. This could possibly be due to the lack of science and technology training in K-12 schools, but one thing is for sure. There aren’t enough knowledgeable employees trained in the needs of Pharma to populate the jobs that Research Triangle Park in the Raleigh/Durham area.

Another area that is reaping the benefits of the growing CROs industry is Larimer, Colorado. According to this article at the Coloradoan, there is a wealth of CRO organizations with many talented scientists who can begin to work on the current strain baby boomers are placing on the Pharma industry. Colorado Histo-Prep, Legacy BioDesign, RMC Bioscience, Rocky Mountain Instrumental Lab, and High Quality Research are just some of the research facilities that populate the region. Kathy Kregel believes that with these rich companies in the region, there will be more biopharma companies looking to relocate to this region, which will bring wealth of jobs for those who have training in science.

SMI Inc. Establishes Patient Recruitment Division

SMI Inc., a medical marketing company connecting over 400,000 doctors, has announced they are opening a patient recruitment division. They are doing this to accelerate the recruitment and enrollment process for clinical trials, as reported by the Philadelphia Business Journal.

With this new division, the company will:

help clinical research organizations find individuals to participate in clinical trials, and implement point-of-care marketing programs to encourage patients to enroll in appropriate clinical trials.

Raleigh/Durham seeing CROs move in

According to The News and Observer in Raleigh and Durham, North Carolina, CROs are moving into the area quickly. Quintiles Transnational is currently building their new headquarters in Durham, and seeing an increasing amount of new contracts due to more drug companies outsourcing their research and drug testing. Companies are also shifting responsibility to CROs because they are able to cut costs, shift risk and meet stricter regulations that are being enforced. The article here credits the big drug companies wanting to stay ahead of the generic medicines competition.

All of the growth comes with an increased need in staffed professionals. The article states that within two years, it’s not uncommon for salaries of those working with clinical trials to be around $60,000. As a result, the companies have to move to where the people are. PRA International moved from Virginia to Raleigh and hire 500 more people. Array Biopharma moved to Morrisville, NC in February to test cancer drugs.

The Move to Strategic Partnering for CROs

In 2007, biopharma companies spent $8.5 billion around the world on contract clinical studies. Budgets spent on development went from 14% in 2001 to 17% in 2007. This sector also has an astounding growth rate at 6% each year since 2002. Instead of turning inside their companies to research and develop, biopharma companies look outside to CROs that prove to be faster when conducting clinical trials. Contract Pharma took a chance to look at how clinical companies are moving their trials to specialized research organizations.

Lately, the CROs are doing all the work, as many of the biopharma research teams have not grown even through more research is going on. Partnering with CROs is a way to improve performance and efficiency in clinical trials.

The benefits of strategic partnerships are numerous if the correct CRO is chosen. The goal, according to the authors of this article, is to build a team of complementary competencies to take full advantage of expertise and operating efficiency that each party brings to the table. After the right clinical outsourcer is found, it is important to make a senior level committee that meets at least twice a year in order to discuss the progress of the trial.

One of the enormous benefits of a partnership is the high levels of performance and efficiency that occur during the clinical trial. After the partners have worked together, they’re going to gain a certain amount of autonomy, trust and make use of the partner’s key strengths; this will lead to a more powerful partnership of the two teams.

Proper Steps to Choosing the Correct CRO

In a recent article at Applied Clinical Trials, they took time to look in depth at the correct way to choose an clinical research outsourcer, and what steps should take place after the correct outsourcer is chosen.

The first step to starting a clinical trial is choosing the outsourcer. Gathering information to choose the outsourcer should be done in three steps. The planning phase happens with the biotech company chooses a CRO. There are two models of CROs a biotech company can choose from: one stop shop or full service (they complete every part of the process) functional outsourcing (establishing functions that the CRO can prepare). Protocol is also written during these stages. Next is the conduct phase. This is where the biotech company collaborates with the study sites and the trial sites have to attract the subjects. Should the conduct phase be operated by the CRO, it is necessary that they recruit the subjects in a timely manner and ensure that there are subjects throughout the trial. During the final evaluation phase, there should be a rapid evolution of study results, due to the processes that were planned an carried out in the conduct phase. Both the sponsor medic and the CRO’s medical writer should be in full cooperation in order to ensure a timely write-up and final report.

When it comes to the selection of the CRO, it is important to correlate the size of the CRO with the study you wish to perform. A smaller, new CRO will focus more attention on the project due to the success and recognition they will receive in the future, but a larger CRO will be able to handle larger test subjects and they could be more skilled to deal with the requests of the biotech companies.

As for the relationship with the CRO, the sponsor must maintain the relationship with the CRO and keep an open path of communication through out the process. It is beneficial for the sponsor to choose a CRO that has already developed a relationship with the investigators. It is also advisable to allow the CRO to work according to their own standards. The CRO must always be held accountable for the success of the study. With that said, it is also vital for the relationship between the biotech sponsor and the CRO to be a full partnership.

A structured communication plan should be documented, and each team should be accountable for upholding the plan throughout the clinical trial. There should also be a document that states the deliverables and the dates for the CRO. The CRO should also ensure that staff turnover does not interrupt the collection of data for the study.

The article concludes with this paragraph on finding success in the clinical study:

Outsourcing a clinical study by a biotech sponsor clearly demands a high level of professionalism and care when choosing the CRO partner. The success of the trial and the biotech–CRO relationship depend on a well thought out protocol and study conduct plan. These truths are more evident when the sponsor is a small biotech taking the large first step into clinical research. The importance of this decision must be reflected in management's commitment to allocate sufficient resources and provide ample support to the sponsor study management. Considerable efforts need to be taken to ensure that the trial is conducted using best practices to ensure its successful outcome.