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
Why are we involved in the Pharma industry? We’re in a society where humans live past the age of mid thirties, and this is the first time that that has ever happened in history. Our industries have created the conditions that make modern public health possible. Our industry is essential in giving humans an extra 60 years of living.
The macro challenges facing our economy have begun to present a problem. Massive amounts of money became available, and that’s funded the bubbles that fueled our growth. The practice of giving sub-prime loans grew. Then the bonds fell, and hundreds of billions of dollars were lost. Our real economy has been disrupted. Pharma’s point of view in all of this is that it will affect two main sectors: pharmaceutical and biotech. Pharma will mainly be facing internal industry. Small molecule products are where the funds come from, which the patents will be expiring. They won’t be replacing the revenue lost. The growth of the Pharma industry has been because of price increases. The research and productivity has to be increased to counter this diminishing aspect of revenue.
R&D productivity has been a problem. Success rates have been decreasing. Shifting tests overseas have helped the cost some. Vaccines have been focused on as a result. Blockbusters going off patent and Pharmaisn’t producing enough products to meet their needs. We’ve seen sales go up, R&D expenditures have increased, and time lines have gotten shorter. Productivity has been halved.
Why is productivity declining in Pharma?Elliott Levy of Bristol –Myers Squibb sees two sets of assets that will be affected: external and internal. In external realm, the growing knowledge and interest in safety is a focus. We’ve developed ways to identify safety factors when testing drugs when they’re in development. We’re operating in an environment where the standards for safety has gone up. The competitive marketplace for drugs has become overcrowded. Hurdles for introduction to the market have gone up. Jack H. Dean added his insights on the direction of safety issues. The industry has become too sensitive about preclinical safety. Many of the drugs that are marketed today wouldn’t be here. The other thing is that the easy things have been done. We’re battling very complicated diseases. We put too big of bet on molecular tools, we’ve forgotten the importance of the medical chemists. We’ve only explored about 10% of the chemical space. Clinical and preclinical safety presents hold backs.
The panel was also asked what they see the communications and human insights into the science? Elliot Levy stated that everyone is trying to find the right structure to expose maximum scientific talent. Drug discovery process and operational side of things, then pushes compounds that have limited potential in the market place. Do we need to become more global to exploit this? Need to tap intellect around the world. Negatively, it’s very difficult to manage global communications.
Where are our patients going to come from was another question posed to the panel. The experts believed that we have to go to places around the world where everyone else has the same problems, like diabetes. Basic R&D has been outsourced to the biotech industry. Now, we see that half of the products from internal efforts in pharma and half from biotech. Quarter of the money spent comes from biotech, making them the low cost producer. The credit crunch has closed down world IPO market. Levels of disinvestment have affected the venture capitalists, and many bioteches are running out of cash. IPO market will probably not open up in next year, and there will be a wipe out of the biotech industry before the credit crunch is over. Universities could be the place to go in their absences. It’ll be needed to apply. To fill the gap may be impossible. Large scale Pharma between 2009-2010 will only be able to replace 39% of their Pharma revenue.
Dr. Levy stated that in the short term, larger Pharma companies will be able to inquire best talent from biotech. They’ll replenish the pipelines. In the long term, if bioteches fold, scientists will migrate to companies. But won’t happen, because no jobs for developers. So what will this do for productivity? Pharma R&D is over capacity. Could be there is no great impact. What can CROs bring to productivity? Technology solutions are less important then talent and capability development. The industry can become much better. There are too many studies that take longer than originally planned. Companies need to decide what their core competences are. Could CROs fit into this picture?
Dr. Levy stated that in the next few years, a few macro trends not moving in same direction. Data needed, Pharma avoids fix cost investments. This favors CRO industry. Decreasing amount of spend from companies, lower money over all for CRO factors.
Dr. Dean stated that the companies will try to maintain flexibility in costs. They’ll be forced to rely on a flexible cost structure. They quality CROs who deliver good relationships and products will be favored. Cross functional integration into the cooperation will be sought after. R&D will not increase. CRO penetration of the pharma industry will continue to accelerate as companies right size them selves because of focus on core competencies.
Updated:
Here is an interview with Christopher Gallen regarding this keynote panel:
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.
India is known for their acceptance of outsourcing in their country. Due to the low costs of financing trials here, big Pharma has also started to look to India for outsourcing clinical trials. Time recently took a look at the business of CROs in India. Typically, it costs $1 billion to bring any particular drug to the market, and most of that money is devoted to the part of testing on humans. In India, not only is it cheaper to conduct the human trial, but there are also less strict regulations when testing the drugs. There are currently 400 clinical trials taking place in India.Although there are numerous doctors who are proficient in English to support the effort, few of those doctors have graduated from world class institutes, and even fewer of the people working on the clinical trials have been properly trained.
One of the allures of participating in clinical trials for Indian citizens is the healthcare that’s involved. Since India has no public health care system, the care given during a clinical trial is often better than not receiving any at all. Sadly, most of the citizens who sign up for the clinical trials are illiterate.And with Pharma pushing for trials to go faster, often times health standards are not the highest.The booming business will lead to medical breakthrough for India, but how will it affect their citizens in the long term?
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