Partnerships Asia Pacific Session Spotlight: Partnerships in Clinical Trials: East vs. West

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: Partnerships in Clinical Trials: East vs. West
Presented by: Mark Bach, PhD, Vice President, Head of R&D, Regulatory Affairs and Safety,
JANSSEN PHARMACEUTICALS KK, Japan

About the session:
Pharmaceutical companies are facing continuing pressure due to patent expirations, increasing regulatory constraints and other factors. These result in the need to increase productivity, increase speed to market and maintain quality. One approach to address these needs is strategic sourcing – CROs can bring value to sponsors through both strategic and tactical support for development. Sponsors headquartered in the US and Europe are entering into strategic partnerships with CROs, but the experience in Asia is more limited. How can the extensive experience in these markets inform and accelerate the development of such relationships in Asia?

Key issues include:
• How does the current APAC environment compare to the US/EU CRO industry 10 years ago?
• How is the Asia operation model different from US?
• What can be learned from the history of CRO and pharma partnership development outside of Asia?

Outsourcing of clinical trials expected to rise by 25% by 2013 – is your team prepared?

With so much uncertainty surrounding the economy, consolidation of pharmaceutical companies, lack of funding for biotechs and drug safety concerns, one thing is for sure – there is still much work to be done to bring new medicines to market and we’re all being asked to do more with less. That’s why it’s imperative to get your clinical outsourced studies right the first time around. And, the long term view from industry experts is that outsourcing will continue to dominate.

But with so much flux in the marketplace due to career shifts, Big Pharma re-orgs and smaller pharma and biotechs ready to send new products into development, there’s a learning curve when it comes to making the right outsourcing decisions. You need to be armed with the information and contacts to get moving - the alternative can cause project delays costing into the millions.

Fundamentals of Clinical Outsourcing is a conference you can’t afford to miss!
→ If you are challenged by making decisions on full-service vs. functional outsourcing, or are struggling to convert a vendor bid into a study contract, you will benefit from the collective experience shared by our expert speaking faculty.

→ If change orders due to hurried or unrealistic scope of work or poor communication with your partners have just about stopped your trial in its tracks, you’ll find solutions for these challenges as well.

→ And, if you’re worried about quality oversight of third party clinical research data, you will hear directly from the FDA on what they expect.

Download the brochure for more information on how to do more with less and get your studies right the first time around.

We understand travel budgets are limited, so we are especially pleased to offer this program regionally in both Boston this October and San Francisco in November to facilitate your attendance.

Make sure to register before August 28th and Save up to $300! Mention Priority code 0T4JXO

Pfizer to create online networking site for clinical trials

According to Forbes, Pfizer is teaming up with Private Access in order to create a social networking website that will pair potential patients to doctors and clinical trials. This site also allows for the privacy of patients, the CEO of Private Access stated the website was "privacy-enhanced search engine for personal health information.". This new social networking site will also encourage trial sponsors, patient advocacy groups and technology providers to come together. Read more here.

Medicare's Stance on Clinical Trials

This post on Health PROSe discusses how Medicare is not only important to health care delivery but it is also key to all clinical research taking place across the country. Cures and treatments for diseases all require that Medicare beneficiaries participate in clinical trials, and that was exactly what President Clinton ordered back in 2000.

This memorandum though was not followed through by the Bush administration, and it was actually dismantled. Obama's administration must recognize the important of the Medicare clinical trial policy to ensure that Medicare beneficiaries are covered. It will be interesting to see if the new administration will soon address this policy and take action.

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.

Biopharma in India is Surging

According to this article in FierceBiotech a weakened economy and the need for cutbacks is pushing big pharma companies to drive drug development and manufacturing in India. One thing though, many Indian developers are having a hard time transitioning from manufacturing generic drugs to devising new therapies. This is certainly a huge opportunity for Indian firms to thrive if they can ease the transition somehow. It will be interesting to see how things will play out over the course of the next couple of years.

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.

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.

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 West this November 9-10 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 your 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

To view the full agenda click here!

Visit the website here to place your registration.

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.

Repros Therapeutics Inc. halts clinical trial

Repros Therapeutics Inc. may face bankruptcy after suspending their clinical trials fro Proellex. The studies were postponed due to concerns for trial participants safety. The drug being tested treated chronic symptomatic uterine fibroids, anemia associated with this condition and endometriosis. Read the full article here.

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.

Get Your Clinical Trial Studies Right the First Time Around

This has been quite a year, since October we’ve watched global markets falter, a new president get elected and sweeping healthcare reform is being debated on the floors of congress. All this is impacting the pharmaceutical industry and companies are responding by aggressively reducing costs and how to get better results from all of their outsourced clinical research. We know you’re feeling the pressure rise as the volume of outsourced work continues to increase. In order to design a process that will save time in the long run it is important to have a firm grounding in the fundamentals.

For 2009 Fundamentals of Clinical Outsourcing has been updated with timely topics, in-depth roundtable discussions and increased networking opportunities to create a highly focused learning opportunity that will help you better manage your outsourcing partners and expedite clinical trials.

New for 2009!
• Keynote presentation from Ken Getz, Senior Research Fellow from the Tufts Center for the Study of Drug Development on tracking the transition from transaction to portfolio based relationships
• Genzyme and Milennium executives discuss relationship management and The Rules of Engagement
• FDA address from Michael Marcarelli the Director of the Office of Bioresearch Monitoring at CDRH tells participants what the FDA Expects regarding quality oversight of third parties

If you are ready to send a new compound into clinical development and you don’t have the in-house resources to execute the trial or if you are overwhelmed by the choices that need to be made every day to keep your products moving through development, Fundamental of Clinical Outsourcing is your best opportunity to obtain best practices, set your outsourcing strategy and manage successful relationships with proven rules of engagement.

Download the brochure today, and then visit the website to reserve your seat! I look forward to seeing you there.

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.

India: Domestic clinical trials market booms

Thomas K. Thomas of The Hindu Business Line writes, the number of clinical trials being conducted in India has doubled from 170 in 2006 to 350 at the end of 2008, according to the Central Drug Standard Control Organisation.

And going by the indications in the first six months of 2009, the number of registered clinical trials in the country is likely to touch a new high.

Already between January and June this year, 130 trials have been registered with the drug regulator. Since the drug regulator has made it mandatory for clinical research organisations to register all drug trials from June onwards, a significant jump in the actual numbers is expected this year.

What's next for India? Now a global player in both clinical trails and cros--will India take the lead?

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