Clinical Trials in an Emerging Brazilian Market

China and India have taken advantage of the need for outsourced clinical trials through contract research organizations, but a new study published by Frost & Sullivan shows that the Brazilian market is emerging as the future of clinical trials.

Daniela Putti, Industry Analyst at Frost & Sullivan mentions

“Higher costs, competition from generics, and lack of productivity from R&D have been challenging pharmaceutical companies worldwide to better manage R&D costs and deadlines as well as improve quality of the whole drug discovery process. To responsibly address these issues, pharmaceutical and biotech companies are seeking for more accessible and efficient clinical trial locations such as emerging countries like Brazil. Here these companies and Contract Research Organizations (CROs) may likely find promising market features and growth opportunities for clinical trials.”

How will this affect current outsourced clinical trials in other countries?

inVentiv Clinical Solutions expands into Europe

In a recent news release by Globe Newswire, it was announced that Fernando Martinez, PhD, was appointed to be the director of clinical operations at inVentiv Clinical Solutions at their new office in Madrid. They plan to expand beyond Madrid into other regions of Europe including the emerging market countries of eastern Europe.

Kendle International

Earlier this week, Smart Cap Investor took a look at the CRO Kendle International. It's one of the leading CROs in the world. Based in Cincinnati, Ohio this CRO employs over 4,000 people in 48 locations in 28 countries. It has reached its $724.7 market cap by strategically placing itself where the future opportunities lie. Ithas locations in Australia, China, India, Singapore and Latin America and benefits from the current of outsourcing clinical trials. For more information, read Small Cap Investor's article here.

Some clinical trial results not published

In a recent article in the UK's The Guardian, they divulge that in a recent study involving 90 drugs from 1998 to 2000, 43% of the drugs never had a report published on the results of their clinical trials. Reports are typically published within five years of a drugs release date to give doctors and patients critical information so they can make the right decisions when it comes to prescribing and taking the drugs.

The study performed showed that results from 909 different clinical trials did not have their results published. Also noted was the fact that typically those trials with more statistically significant results were published more often than those with non-significant results.

What do you think about this? Those conducting and participating in clinical trials have the right to have their undertaking shared with those who are about to take the drugs they're testing. Do you think this will change anytime in the future?

Quintiles will become largest Asia-Pacific clinical development center

In 2009, Quintiles will relocate to a facility that is 80,000 square feet, which will double its size. The facility will open in Singapore, where since 1995, they have done more than 1,000 studies. Clinical Trials Today has the in depth story.

Anand Tharmaratnam, M.D., head of clinical development for Quintiles Asia Pacific, had this to say about the expansion:

“Firstly, a significant proportion of our customers are in Singapore and all of them are within a seven-hour direct flight from Singapore. Singapore is also connected by direct flights to a lot of our U.S. and European offices. Secondly, we are able to hire talent with multinational company experience in Singapore, and we are able to attract foreign talent to relocate to Singapore who find it a stable, secure and welcoming environment to live in as a foreigner. Thirdly, it is an attractive place from which to manage a business with very high ethical and transparent governance standards with an effective tax structure. Fourth, it is increasingly becoming a global hub for scientific excellence and innovation.”

Guidelines to choosing your CRO

In a recent article at ClinPage, Jodi Andrews goes over a few key factors that should go into choosing a CRO.

Experience -- Look at things such as: How many projects do they have at once? Average experience of staff members working on YOUR trial.

Flexibility -- What's the speed of communication with your CRO? Are staff members able to deviate from the company plan to modify the trial to your specific needs?

Cost considerations -- Do the company's CEOs have an eye on some of the projects? Is there enough oversight on the trial they'll perform? Is there a process for quality oversight? Is the big too low?

These are all things to consider when you're looking to outsource your clinical trial. From the amount of experience your CRO has to the involvement of their management, its important to find the right balance for your needs.

Do you have any other considerations not listed above that you look at when choosing a CRO?

Indian Share of the Clinical Trial Market

Contract Research Organizations, and the outsourcing of clinical trials, from markets outside the U.S. has proved to be a booming industry. India, especially has seen the effects of this increase in industry size. As reported here in in-Pharma Technologist.com, it is expected that by 2011 India will hold a 15% share of the market. In 2007 it was reported that the Indian CRO industry was valued at $200 million, however, by 2010 that value is expected to increase to $500 to $600 million. Data from KPMG indicates that the reason for this boom is that it is considered to be the cheapest market for clinical trials along side Russia.

No Need to Fear the EU Clinical Trial Directive

Many in the clinical trial industry were worried that the EU Directive would have a negative affect on the industry. In the latest study from the British Medical Journal as reported by Outsourcing-pharma.com, they reassure that so far there have been no negative repercussions, at least for Denmark. The main reason for the concern stemmed from worries that the amount of paper work that the Directive would require might result in public institutions being overwhelmed and unable to keep up. As the study reassures:

“academic researchers can match the demands for the good clinical practice quality standard that industry have adhered to for many years.”

Drug Approvals

Much has been said in the news regarding drug recalls such as this latest article from NY Times, where they discuss how certain drug imports from an Indian drug maker have been stopped. Also, as we mentioned yesterday, one tool CROs can use are LIMS to help with the authorization processes set in place by regulatory agencies. In relation to these news items, PharmaVoice mentions here, that there is a real need for technology to be updated in order to combat drug safety concerns. As of September 2007, the FDAA was updated to require certain sponsors to submit a “proposed REMS”. In addition, the EU is requiring a PSURs to be submitted every 6 months for the first 2 years. The PharmaVoice article summarizes:

“This will require companies to invest in more advanced pharmacovigilance technologies and to develop new processes for the analysis of adverse events both in the postmarketing environment and during development.”

Role of LIMS

This article from Bio-IT World reminds that it is important for CRO’s to use high-performance laboratory information management systems (LIMS). Sponsor companies and CRO’s who use LIMS, will see a lower “barrier entry” when dealing with regulatory agencies in respective countries. LIMS are helpful in gathering, analyzing and storing data for the CRO’s sponsors. It is especially important to be aware of regulations since on average bringing a new drug to market takes 15 years, and costs $2 billion.

NiKem is Accepted by the FMR

Contract Research Organizations, for the most part, are inherently global. NiKem Research Srl, is not an exception. As announced here, they recently received good news from the French Ministry of Research (FMR). The FMR has approved them to reach the status of “Crédit d’Impôt Recherche”. This allows the CRO, NiKem, to conduct Research and Development activities for private French companies. Guesseppe Giardina, CEO of NiKem, released this statement:

"The approval as a C.I.R. certified company by the French Ministry of Research is an important step forward for NiKem. We believe that our already significant business volume with French pharmaceutical and, most importantly, biotech companies will grow: in fact, our high quality standards are now combined with competitive prices and tax credit options. Thus, we expect to at least double our revenues in France in the next three years."

Phase I Trial Outsourcing in India by 2010?

Outsourcing-pharma reports that Phase I outsourcing of trials to India may be allowed in 2010. Currently Phase I trials are not allowed in India, but the Central Drugs Standard Control Organisation (CDSCO) is considering changes stances.

Allowing Phase I trials to be outsourced to India would boost India’s thriving clinical outsourcing industry as well as offer pharma companies a cost-cutting route. These are some of the areas that the CDSCO will be focusing in on: fixed timelines of 2-6 weeks for each application, internet based new drug application (NDA) status and the recruiting subject experts and reviewers.

Will the recent new of infant deaths in India change the progress of this proposal?

Indian government looking into regulation of Clinical Trials

According to this article at Sify Business, the Indian government is looking to allow CROs to conduct Phase 0 and Phase 1 clinical trials. This could begin occurring as soon as 2009 or 2010, after they've implemented an infrastructure to monitor the trials.

Presently, India only allows Phase I and Phase III trials if the company conducting the trial has gone to another country and conducted Phase O and Phase I trials there. But, new regulations could change this as well.

A recent gathering of Confederation of Indian Industry, those who are working with clinical trials took time to address current issues hindering the success of clinical trials in India. Some of these problems addressed were:
-Infrastructure
-Technical expertise
- Drug analysis
- Stringent clinical trial monitoring systems
- Mandatory regulations of CROs
- A way to keep track of patients so they don't participate in more than one clinical trial

Drug Industry's Rush to Outsource

India has now become the prime destination for drug companies looking to make a buck overseas with the plethora of brainpower and ability to save millions--maybe billions--of dollars for the company's research.

According to Business Week, "five Western companies have formed drug discovery partnerships with Jubilant, including Eli Lilly, Amgen, and Forest Laboratories. Lilly is also partnering with Piramal, as is Merck. Every month deals are signed with India's elite pharmaceutical companies. The goal is to take promising compounds discovered by the multinationals, run tests to weed out the weakest candidates, and develop some of the others into marketable drugs. Eventually the Indian partners also hope to rack up scientific breakthroughs that lead to entirely new medicines for diseases such as Alzheimer's, cancer, or diabetes."

So can this work? With American businesses happy to cut jobs in the USA for cheaper labor East; will there be another hit on the American economy? Alternatively, the positive effects of using cheap labor could build up the pharmaceutical industry allowing businesses to save money and, perhaps, expand their Western workforce.

Your thoughts?

Gryphon Investors Invests in CROs

PharmaTimes reports Gryphon Investors has announced an agreement with two US suppliers of clinical services to pharmaceutical and biotechnology industries.

Gryphon has invested funds in Synteract, which is a CRO with expertise in oncology and central nervous system drugs, and Vince Associates, which is a leading provider of services that specialize in sleep disorders research. Nick Orum, head of Gryphon’s Business Services Group mentions that the agreement has been a “year-long effort … to become an active participant in the dynamic, growing field of outsourced drug development services”.

Clinical trial for autoimmune drug halts

Recently, the Birmingham Business Journal reported that a clinical trial for BioCryst Pharmaceuticals found that tested drug BCX-4208 was shelved due to the trial showing that it had no effect on psoriasis. The test included 66 patients who suffered from severe psoriasis.

The drug did prove to meet this objective:
The study showed the drug met another objective by suppressing the number of immune T-cells which act as gatekeepers for the body in determining whether to accept transplanted organ.

Technology and Clinical Trials

Wall Street Journal posted this interesting article about firms that conduct clinical trials and their use of technology. Apparently many firms, including contract research organizations, are still are not using electronic means for documentation, and instead much of the information is still being recorded using the simple pen and paper method. As stated, IDC ran a report that concluded that only 45% of phase I-III clinical trails conducted last year used EDC. That is up somewhat 69

in comparison to only 20% in 2003. It should be noted however that the number of firms using EDC is expected to increase to 80% by 2011. As quoted in this article, Bob Weiler, CEO of Phase forward remarked that:

Clinical trials have taken so long to go electronic because “if you go back two or three years, many doctors did not have broadband connections,”

Tips to get to Clinic Faster

As this article informs, Medelis, an oncology CRO, is providing a free downloadable abstract titled Preclinical Trials: A Nuanced Approach to Get Into the Clinic Faster. The purpose of the abstract is to provide tips specifically for Chief Medical Officers to help them and their organization get to clinic faster. As the Medelis website reports, some of the topics covered include:

- Critical factors for a CMO to understand and evaluate during this step in the drug development process

- Regulatory assessments and how to avoid hitting a preclinical wall

- The nuances and complexities of rodent models, tumor selection, and other variables

- How to keep the preclinical, regulatory and clinical teams involved in feasibility dialogue

- The typical preclinical study process and the questions a CMO should be asking at each step

- Additional requirements unique to oncology preclinical trials

- What to look for in an outside preclinical team

Acurian expands patient model

Acurian, a patient recruitment solutions provider, has announced a change in their business model. This company is already widely known for their performance contracts based on the customers’ ability to leverage the Acurian database. Now their model will include advertising based strategies focusing on determining how sponsors buy patient recruitment advertising. They’ve already begun this model, and there are two large, centralized performance based contracts according to this post at Market Watch.

Update: Indian Institute and the death of babies in clinical trials

Last month, we informed you of the controversy including deaths of children in India that are though to be the result of drugs used in clinical trials.

The FDA News has updates to this story. The AIIMS (All India Institute of Medical Sciences) is claiming that the 49 infants who died were already ill when they came to the experiment. Daiich Sankyo and Novartis, two of the sponsors who were conducting studies, claimed none of their patients died as a result of the trial. The deaths occurred in the Institutes Department of Pediatrics beginning in 2006. There were 4142 subjects in the trials, and the children who died, as stated earlier, were already suffering from sever diseases. The foundation has not released how many children died in the treatment arms and control arms of the trial. The trial was for hypertension drugs.