Stem cells for the heart in clinical trial

The US News and World Report recently looked at a clinical trail taking place in the western United States which takes stem cells from ones body, treats them, and then injects them back into unhealthy hearts. This study is hoping to find a way to help heart failure patients rejuvenate their heart with their own stem cells. Read more about the trial here.

India Expected to Take Larger Share of Outsourcing Sector

According to this article in outsourcing-pharma.com the outsourcing sector in India is expected to grow at 43 percent due to the diminishing concerns of the about operations in that country. Predictions made by Ernst & Young show that India is still ranked highest among its outsourcing peers in cost efficiency. Also, the country's technological capabilities are far more advanced than many of the other competing countries. It will be interesting to see India will grow as expected, or if Eastern Europe or China will advance in the outsourcing sector.

Web Seminar: REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

Join us for a web seminar presented by Stephen A. Goldman, MD, FAPM, DFAPA !

Title: REMS, EU-RMP and FDAAA: Navigating the Clinical Trial Safety, Postmarketing Pharmacovigilance and Risk Management Alphabet Soup

Date: Wednesday, September 9, 2009

Time: 2:00 PM - 3:00 PM EDT

Reserve your Webinar seat now at:
http://bit.ly/PartnershipsWebinarBlog


About the web seminar:
Current pharmaceutical safety is a sophisticated system in which benefit/risk assessment begins with animal testing and continues throughout human clinical trials, licensing approval and marketing of the product. It is critical to monitor evolving safety profiles of marketed products throughout their life cycles, and optimally employ risk management tools in service of public health.

This seminar will examine current national, regional and international perspectives and approaches to clinical trial safety, pharmacovigilance planning and risk management. Current EMEA and FDA regulatory requirements and standards, in combination with the vital ICH E2E guideline, will be discussed and also examined via case examples of risk assessment, communication and minimization methods.

Outsourcing to grow 10% says WSHP

According to this article in outsourcing-pharma.com private equity group Water Street Healthcare Partners purchased AAIPharma's pharma development business. WSHP’s Peter Strothman mentioned that the key motivation for this purchase is the $115 billion growth of the outsourcing sector, and that it is estimated to grow by more than 10 percent over the next five years. AAIPharma has had plans to invest heavily in emerging trials in Eastern Europe as well as in Sao Paulo, Brazil. Now with the help of WSHP the firm might just be able to expand.

USA and Europe team together to monitor clinical trials

The FDA announced today that they're starting the Good Clinical Practices Initiative, which will unify and ensure that both countries are conducting clinical trials uniformly, appropriately and ethically. This will be a 18 month pilot program beginning on September 1st. The FDA's Center for Drug Education and Research will front the US's efforts and EMEA will front Europe's efforts. Read the full article here.

New clinical trial for congestive heart failure

According to the South Florida Business Journal, a Phase I clinical trial will begin for a treatment to congestive heart failure. If this trial is successful, it would be one of the first to combine gene and stem cell therapy for cardiovascular disease. Read more about this trial that will begin taking place next year.

Fundamentals of Clinical Outsourcing: Agenda Finalized

The team behind the longest running event for clinical development and outsourcing professionals has assembled a top-notch lineup of distinguished speakers to help companies see the big picture as well as work through the nuts and bolts. Whether you are new to the area of outsourcing, need a refresher course, or would just like to increase your network, the 5th Annual Fundamentals of Clinical Outsourcing event is your answer. In just two days, you’ll gain the knowledge to help you do more with less and get your studies right the first time around.

Hear from expert industry professionals who will demonstrate the roles involved in the clinical outsourcing process, and present a clear view on how to effectively manage both the tactical and strategic elements.

• Create your outsourcing strategy and choose a model for your outsourced project
• Identify and select your outsourcing provider based on the needs of your organization and project
• Negotiate and draft a proper outsourcing agreement
• Utilize budget outsourcing tools and templates to streamline your efforts
• Manage successful sponsor/provider relationships with proven rules of engagement
• Use metrics to stay on track and measure results for optimal project performance.

The FDA is seeing an alarming trend of unreliable data being submitted by third parties which sponsor companies are ultimately accountable for – don’t miss crucial warning signals that will prevent your trials from moving forward. You won’t want to miss out on learning what FDA expects regarding quality oversight of third parties, direct from FDA’s own Mike Marcarelli.

Download the agenda today, and then visit the website at www.clinicaloutsourcingevent.com to reserve your seat! I look forward to seeing you there.

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New Date Capture and Reporting Service Network has been Created for Clinical Trials in Japan

According to this article in Outsourcing-Pharma.com PHT, which is a US ePro specialist, has teamed up with CRO CMIC to create a data capture and reporting service network for clinical trials in Japan.

The service will include PHT's patient reporting technologies to biopharmaceutical clients running trials in Japan, and CRO CMIC will provide clinical trials services to both industry drug sponsors and clinical trials sites. They will also supply development, trial-scale production and marketing services through its network to neighboring countries like Korea, China, Taiwan, and Singapore.

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.

ACRO Reports that Clinical Research in Developing Worlds is Up to U.S. Standards

Pharmaceutical Online reports that the Association of Clinical Research Organizations (ACRO) has released a report that says clinical trials conducted in the developing world meet the same safety, ethical and quality standards as those conducted in the developed world. Based on the report's findings, ACRO, which represents the leading global Clinical Research Organizations (CROs), is urging several steps to ensure that a robust global research infrastructure continues to facilitate accelerated drug development.

With the changing landscape for CROs, the report has several key findings:

• Global trials speed drug development – The report concludes that globalized trials can reduce development time by half while lowering costs and maintaining quality and safety. For example, phase III cancer trials are conducted three times as fast if both U.S. and global sites are used, compared to U.S.-only sites. What takes 5.8 years to enroll takes 1.9 when a global trial is implemented.
• Research quality standards must be met worldwide – The report found that trials in emerging countries, such as China and India, are subject to the same standards as those conducted in the U.S. and Western Europe. CROs train research staff around the world in good clinical practice (GCP) principles and proof of compliance is required by drug regulators in every major pharmaceutical market.
• Clinical research improves local economies – Clinical research offers huge advantages for host countries, including an influx of advanced equipment, trained personnel and high-paying jobs. The presence of CROs also results in improvements in local health systems. Clinical trial sponsors in Poland, for example, fund 30 percent of hospital cancer therapy.
• Emerging market equals growth market – CRO activity in Central European countries, South Korea and Taiwan is very robust, medical infrastructures are advanced and capabilities are just about on par with Western Europe.

For more information about this report and about ACRO, please visit the article referenced here.

Clinical Research Safety And Ethical Standards In Developing World Up To U.S. Levels

India’s CDSCO wants tighter rules for clinical trial imports

PharmaTimes reports that India’s Central Drugs Standard Control Organisation (CDSCO) wants to tighten up conditions for the import of larger quantities of drugs for use in clinical trials.

Write Peter Mansell reports that, the CDSCO has issued a proposed guideline that calls for additional documentation and evidence when contract research organisations (CROs) or other companies/institutions apply to import “appreciably large” volumes of drugs.

The regulations do not specify what “small quantities” are, and recently there have been a number of cases of manufacturers, CROs and other importers “submitting applications for the import of reasonably large quantities of active pharmaceutical ingredients and/or drug formulations which do not comply with the provisions of Rule 33”, , the CDSCO notes.

According to the CDSCO, the rationale behind the guideline is to facilitate drug R&D/contract research and to “boost the scientific and technological activities in this knowledge-based industry”.

India’s CDSCO wants tighter rules for clinical trial imports

Education on clinical trials to begin in Qatar

According to the Gulf Times, Sidra Medical and Research Center of Qutar will start to educate the public on the importance of clinical trials. It will educate the public on the importance of volunteering for these trials both in terms of the purpose of the clinical research and the effects it will have on both future patients and generations.

Professor David Kerr, who has an international reputation for the treatment of and research into colorectal cancer, stated, “As we are building a research institute into a hospital, we are also building research partnerships with some of the leading institutions around the world, so that we can initiate research that can start even before the building is ready, so that we can begin to start benefiting our citizens in advance medicine.”

Clinical Trial Cost & Contract Management Agenda Finalized

Greater scrutiny of financial ties to clinical investigators coupled with increased accountability and drug safety puts more pressure on contracting executives to clearly outline responsibilities from the start.

Attend Clinical Trial Cost & Contract Management and take back to the office the necessary tools to streamline processes and better define accountability and responsibilities.

* Gain the upper hand in your contract with a workshop dedicated to contract approach and development
* Avoid embarrassing and costly violations regarding financial ties to clinical investigators with a firm grasp on Fair Market Value (FMV)
* Bring your drug to market before your competitors by fine tuning you’re strategy for handling Intellectual Property (IP)
* Improve the quality of you’re 3rd party clinical research data with warning signals and outline methods direct from an FDA representative
* Improve ROI by defining best practices for handling site payment disputes with your CRO

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Swine Flu vaccines approaching time for clinical trials

According to the Guardian, many labs have progressed with the Swine Flu vaccine to the stage of clinical trials. The WHO did point out that this doesn't necessarily mean that the final flu vaccine is ready for use by the general public.

GlaxoSmithKline recently stated:
"We have started production. We are talking to the different health authorities and the governments around the world to find out what level of clinical trials will be required, for instance, how long, [and] how many people would be involved."

Read the full article here.

Clinical Research Trials in India

Here's an interesting presentation I came across from Dr. Shreyashi Ganguly in the Curious Insanity blog. The slide-show get some of his points across on the fastest growing industry segment of outsourcing clinical trials. Take a couple of moments to view it below. Enjoy!

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?

Insourcing Is The New Outsourcing In Biopharma

Stephanie Wells of Life Science Leader writes, The growth of insourcing means that the future of contracted work is likely to be a blended approach. In some cases, the CRO would provide traditional external services, like general toxicology studies or Phase II clinical studies. In other cases, when a client is working in a new area and has not yet developed the necessary infrastructure, partnership with a broadly capable CRO means that many necessary services in the new field can be performed on an insourcing basis, including the help of an insourced “navigator” group of ex-FDA personnel who can guide the new compound through studies that ensure it has the best chance of proceeding efficiently through the regulatory process.

What do you think of insourcing? It is the new standard?

Insourcing Is The New Outsourcing In Biopharma

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.

How to find the best cost-effective treatments

According to Red Orbit, Congress has allotted $1.1 billion to begin finding the best treatments for certain ailments that are also cost-effective. A report came out addressing the top 100 medical issues addressed by Congress. The report said this of clinical trials:

“Clinical research provides health care providers with information on the natural history of disease, clinical presentations of disease, and diagnostic and treatment options,” according to the report.

“All too often, the information necessary to inform these medical decisions is incomplete or unavailable, resulting in more than half of the treatments delivered today without clear evidence of effectiveness.

“This uncertainty contributes to great variability in managing clinical problems, with costs and outcomes differing markedly across the country.”

Chinese CROs trial express customs clearance

PharmaTimes reports that, three contract research organizations (CROs) operating out of China’s Zhangjiang Hi-Tech Park are trying out a new express customs clearance model that could eventually be extended to other CROs in the Park. Its been well-known that customs clearance for CROs has been a difficult process for many CROs, with the new customs clearance model high import/export volume and strict storage requirements could be alleviated.

What other processes can help CROs allevaite tight customs clearance requirements?


Chinese CROs trial express customs clearance