 that California would extend its deadline for total e-pedigree integration to 2011, Congress is considering a bill that would make e-pedigree standard throughout the United States.

, entitled "Safeguarding America's Pharmaceuticals Act," calls for a closed-loop, track-and-trace pedigree system using item-level serialization. Basically, every drug that goes through the supply chain will need to be tracked as it travels from point to point.

The major impact will be at the state level, as the bill says that no state or non-federal body can establish a pedigree system separate from the federal standards. That means that e-pedigree regulations in California and Florida would have to be modified or killed altogether.

Grants to small pharmacies that can't afford the technological upgrades to install an electronic pedigree system

Phased implementation to give breathing room to lagging companies

Item-level serialization using RFID, or bar codes—either two-dimensional (2D) or traditional.

"This kind of tracking is inevitable," said John Beans, vice president of marketing at serialization solutions provider Blue Vector. "It's yet another signal that everyone wants drugs tracked at the item level."


California's law is partially in line with the proposed federal legislation in that it mandates that all drugs passing through the state have some form of serialization, so they can be tracked from the pharmaceutical manufacturer right up to the point of dispensing.

However, the federal law specifies that the pedigree begin with the authorized distributor of record, not the pharmaceutical company. This is more in line with Florida's pedigree law.

Most industry concern has centered on time and cost of implementing the e-pedigree system. Pharma companies struggled to get every line and distribution center compliant with California law by the original deadline of January 2009—and most failed. The extension to 2011 buys a little more time, and the federal law, if passed, will probably buy them more. Still, companies will need to have every drug tagged well in advance to avoid having unserialized drugs in the supply chain when the due date comes.


"An approach that is consistent across the country is a good idea," said Brenda Kelly, director of marketing at Supplyscape, a supply chain software provider. "The devil is in the details, and having the different supply chain segments agree on a single approach is important."

Early adopters of e-pedigree in the pharma industry had to figure out serialization for themselves. Purdue uses ultra-high frequency tags to track every bottle of Oxycontin, while Pfizer uses high frequency RFID chips to track Viagra, and other companies use 2D bar codes. Meanwhile, distributors have been forced to install systems that handle everything—while racking up huge infrastructure bills.

"If you're going to adopt technology, then you want to do it with an eye toward making sure that the technology not only meets the compliance requirements, but also gives a company a foundation for business value going forward," Kelly said.

Many companies have taken a phased approach, serializing some products and adding a pedigree to everything. This improves patient safety and shows an effort to move forward.

"Now that the time frame has shifted, they have a lot more work to do, because everything must be serialized by that deadline," Kelly said. "Partial compliance is not an option."

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News Analysis

New bipartisan bill calls for the standardization of an electronic pedigree across the US pharma supply chain. Is this a good thing, or just more work for pharma?

Congress to Consider National ePedigree Standard

Last week, GlaxoSmithKline paid $720 million in cash for Sirtris Pharmaceuticals, a company that is gaining a lot of publicity for what is being called "the red wine drug."

The biotech's lead therapy is SRT501, a compound based on resveratrol, a natural product found in food products such as red wine. Resveratrol is thought to affect the action of a group of enzymes called 

, which are linked to aging and cell death.

SRT501 activates SIRT1, an aging-related sirtuin. In doing so, it mimics the effects of exercising, producing more mitochondria, boosting metabolism, and reducing glucose and insulin levels in Type II diabetes.

The company is currently considering seven sirtuin-based products.

"Because we are a small biotech company, we decided early on to focus in on Type II diabetes," said John Lacey, associate director of corporate communications for Sirtris. "We know that SIRT1 has other indications that we could go after."

Two Phase I studies have been completed and both studies showed a lowering of glucose following an oral glucose tolerance test. The drug has shown to be safe in early trials with no adverse events. Other indications are in the works for mitochondrial disorders and oncology.

"We are a company focused on diseases of aging," said Christoph Westphal, CEO of Sirtris. "We have the potential of targeting the genes that control the aging process and to develop drugs to treat diseases of aging, which are the major killers of Western society—diabetes, Alzheimer's, cancer. This opportunity is enormous, the markets are very large and the potential to improve patients' lives is extraordinary."

According to Westphal, the only change at Sirtris will be to take the company off the public market. He will continue to run the day-to-day operations of the company.

Small biotech company is creating a buzz with a diabetes drug that incorporates a component found in red wine. Pharm Exec talks to Sirtris CEO Christoph Westphal about the merger and the battle against diseases of aging.

GSK Snags Sirtris for $720M

Last week, the Clinical Research Information eXchange (CRIX) announced the launch of a 

 on which pharma companies can create open source applications for use in clinical trials.

CRIX is a not-for-profit organization established by pharma companies and technology experts to eliminate the redundant in-house applications that every pharma company must build to run its trials. Rather than keep everything behind closed doors, CRIX members—including Pfizer, Novartis, and Amgen—are pooling data in an effort drop costs and save time.

"Silos exist within pharma companies because the pragmatic requirements to get a submission done and research completed outweigh the pace and ability to implement standards even if they were fully there," said Jim Bland, executive director of CRIX. "At the same time, we are seeing large and small pharma alike making redundant investments."


The first application released is a common repository for investigator information called Firebird. Investigators need only provide their information once in an online portal and the system autopopulates their 1572 forms (investigator statement of credentials) to submit to FDA.

"When we started talking to pharma and life science companies, it became quickly evident that if they are going to exchange documents and data for the purpose of registering investigators for trials, why not build a broader platform that could be used for other business tools such as exchanging contract documents, images, or clinical trial data?" Bland said.

Users of the system have access to an open source digital signature program, a document sharing tool, and the aforementioned investigator registry. The group expects its pharma companies to add systems they have already built onto the platform, sharing the tools with their peers.

"If you look at the pharmaceutical software market right now, the serious components—the clinical trial management and adverse event processing—are 50 percent of the investment in research and all three of those markets are held very closely by three competitors," Bland said.


While CRIX does not expect Big Pharma to ditch the expensive infrastructure that it has invested in over the years, it is offering a subset of services that can be used with their systems. On the opposite end, start-up biotechs that lack the capital to invest in systems can find value in what CRIX offers.

But what does this mean for clinical trials solution providers such as Oracle or e-Trials?

"I think a number of these companies are going to try to integrate their products with our platform in some way," Bland said. "Clearly what will happen is that we are going to be driving the market in terms of driving innovation and competition. If an organization can subscribe to a CTMS on the CRIX platform for $100 for month and it costs 10 times that to buy Oracle's CTMS, then I think people are going to be asking questions about the value of the proprietary commercial system."

According to Diana McKenzie, VP of information systems infrastructure at Amgen, this is an opportunity for industry to demonstrate its commitment to connecting healthcare from an information technology perspective.

"CRIX is creating a platform that leverages standards that are common to healthcare and to the industry on which applications can be developed that pharma can share, saving time and money," McKenzie told Pharm Exec.

Amgen is specifically piloting the investigator registry and said that this one process literally saves the company from a couple hundred thousand dollars up to a million, depending on the site.

CRIX has formed a number of advisory committees to broaden its reach beyond biopharma. It is reaching out to CROs and academics to understand their needs. In the near future it plans to work on applications for adverse event reporting and is looking at tools for labeling modification.

Bill Gates and Co. officially released Office for Business Applications (OBA) for the life sciences industry. This set of tools allows software developers to build applications that seamlessly connect back-end enterprise systems with MS Office programs.

Pharmaceutical Executive-04-30-2008

Congress to Consider National ePedigree Standard

GSK Snags Sirtris for $720M

Pharma Bands Together to Share Information