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.