Archive for the ‘Pharmaceuticals’ Category

RFID speeds time to market for drugs by simplifying clinical trial process

Tuesday, March 22nd, 2011

RFID usage is exploding in all industries. The technology has the ability to revolutionize the retail industry, manufacturers have real-time visibility into production facilities around the globe, and all kinds of social media apps are being developed that utilize RFID.

But the biggest sweet spot for RFID lies in the medical and pharmaceutical sector. Sure, it’s cool to use RFID to retrieve pricing information about a product on the retail floor and to buy that product without standing in long lines. It’s fun to track your ski runs at Vail through social media apps like EpicMix. But the solutions being developed for pharma and healthcare can save lives. What’s more intriguing than that?

This week’s issue examines how RFID is expediting drug development by simplifying the clinical trial process.

“It’s a burgeoning area because one small error in their data could throw off the entire product roadmap for getting a product into production and accepted by the FDA,” says Drew Nathanson, director of research operations at VDC Research. “Drug companies have billions invested in these products, so there is a lot at stake.”

By the time a drug reaches the stage where it goes before the FDA approval, drug companies may have invested hundreds of millions — if not billions — into the development of the drug. It’s essential to have all record keeping and trial results in impeccable order when drug development reaches the approval stage. But that doesn’t always happen. To date, nearly all clinical trials have relied on bar coding to track results during each step of the trial. Like all industries, that can lead to slowed or flawed data collection and inaccurate results.

Enter RFID for clinical trials, which can not only collect data quicker and more accurately, but also track and trace samples from around the globe as they move through the clinical trial process. Joe Pleshek, CEO of Madison, Wisc.-based Terso Solutions, says that the last six months have seen a flurry of customers interested in RFID-enabled solutions for use in clinical trials. Terso produces temperature controlled cabinets and other products that can be used in those applications.

T.S. Rangarajan, an RFID expert and a principal consultant with Tata Consultancy Services, worked with a major provider of clinical trials from Switzerland on a pilot to examine the advantages of RFID technology instead of bar codes. Rangarajan notes that trial results need to be documented during each stage of the complicated trial process, meaning that drug firms must rely on numerous bar code reads, which are often inaccurate. For example, in a lab environment, bar codes can become smudged and be unreadable. Or, if the trial drug requires a temperature sensitive environment, bar codes might be unreadable because of frost or condensation build-up from refrigeration.

“Using bar codes was a very manual and tedious process for the type of data collection they needed,” he says. “The primary reason they were contemplating the use of RFID was because of the obvious need for frequent verification of the bar code at each stage during the trials.”

In addition, samples collected in the field have a very short shelf life, and typically need to be processed within 24 to 48 hours of arrival. Going beyond that window can jeopardize the authenticity of the clinical trial.

“There is generally very little time to process the sample within the lab,” says Rangarajan. “They wanted to avoid the delays that were happening with bar code scanning by allowing the samples to reach the lab, let the scanners read them, and move on.”

It’s also crucial for clinical trial providers to possess a complete paper trail (or in this case, an electronic trail) for the samples they are processing in case they are audited. Clinical trials are monitored very closely in the U.S. and in Europe, “so they wanted a fool proof method of associating samples with the people from who they were collected because of the legal issues associated with compliance,” says Rangarajan.

In the event of an audit, RFID would allow the clinical trial provider to quickly prove where the samples came from and where they were processed, and also to account for samples that were taken but were not tested or processed. That’s critical considering that some clinical trials gather data from tests that are conducted around the world, in urban centers and more remote rural areas.

RFID technology can also be beneficial when the drug being tested requires a temperature controlled environment. RFID and sensor technology can alert clinical trial providers if a certain temperature range has been violated, therefore sending a red flag that the sample might need to be discarded. Without RFID, that sample could be entered into the collected data and skew the results.

“The biggest benefit they gain is having the visibility of the sample and that its current status can be seen from anywhere in the world,” says Rangarajan. “They can actually can see where a particular sample is, just like how you track your FedEx package today. If you can track a sample through its lifecycle, that gives confidence to the drug company that the samples are being tested correctly.”

More than a billion RFID tags to combat drug counterfeiting in Africa

Wednesday, September 15th, 2010

For those that may have missed this week’s issue of RFID 24-7, here is our lead story. Let us know what you think!

RFID technology is playing a greater role in eliminating counterfeit products, from high-fashion apparel to costly pharmaceuticals. Chinese apparel maker Jossy Jo says an item-level solution has pulled the plug on counterfeits that formerly accounted for as much as three percent of sales.

And in Africa, more than a billion RFID tags and one million mobile readers could be in circulation within one to two years in an effort to curb the out of control drug counterfeiting that plagues many African nations, where counterfeit rates can reach 30 percent and higher.

The low-cost RFID authentication solution, which will rely on pen-like RFID readers/authenticators, will start to be deployed in Nigeria early next year. Developed by Verayo and SkyeTek, the solution offers authentication and security for a wide range of applications, including crucial documents and food items.

The two companies have partnered with GLOBALPCCA an investments and healthcare solutions group, to address the counterfeiting problem in Africa. In turn, the National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria has approved the use of the RFID-based system to authenticate pharmaceutical products and has signed on with GLOBALPCCA to manage the program. According to Dr. Steve Ams, the CEO of GLOBALPCCA, the Nigerian government will require all pharmacies to adopt the system once some pricing concerns and the logistics of tagging product at the source of manufacture is worked out.

Josh Peifer, director of business development at SkyeTek, says that the goal is to allow consumers or pharmacists to scan RFID-tagged product at the point of sale before the customer makes a purchase. In addition, pharmacists will have the ability to scan the product when it is received, assuring that products are authentic and were not swapped out during transport in the supply chain. Peifer says that the simple to use pen-like reader, which is battery operated and lasts for 12 hours on a single charge, uses Verayo’s PUF authentication protocol and flashes a green light if the product is authentic, and a red light if the product was tampered with.

The solution includes Verayo’s PUF technology based unclonable RFID ICs paired with SkyeTek’s compact RFID readers to provide a secure, easy-to-use authentication solution at the lowest cost. Per GLOBALPCCA’s specifications, SkyeTek created RFID readers in several form factors: a small pen-sized form factor for consumers to carry in their pocket or handbag to authenticate products at the point-of-sale, and a tray-sized form factor for pharmacies to authenticate products before sale to consumers.

“We are excited to partner with Verayo and incorporate its innovative PUF technology with our RFID readers to provide consumers with the ultimate anti-counterfeiting solution,” says Daniel Frydenlund, CEO of SkyeTek. “It has been a privilege to work with GLOBALPCCA in implementing this solution in a way that will ultimately help people in Africa fight this counterfeiting threat.”

NAFDAC intends to make the readers available to consumers free of cost, and expects that pharmaceutical manufacturers, importers, distributors and retailers will absorb the cost of implementing the program. In addition, the Nigerian government will fund part of the project.

“The goal is to make sure not a single drug [increases] in price because of added technology,” says Ams. “We are working with NAFDAC to make sure that is the case.”

“Counterfeiting is a huge problem seeking a solution,” says Anant Agrawal, CEO of Verayo. “The only way to address this problem is by empowering the consumers so that they themselves can authenticate the product they are buying. Working with SkyeTek and GLOBALPCCA, we have created what I believe is a very simple, secure and yet low-cost RFID authentication solution. We believe this solution will help consumers in Africa easily and securely authenticate everyday products and lead a safer life.”

As for the Jossy Jo application, the solution from Jawasoft China and UPM Raflatac provides real-time data for logistics operations and streamlines cooperation between Jossy Jo and its franchisees. The solution is an efficient brand protection tool, helping prevent counterfeit products from reaching stores. Jossy Jo currently uses more than two million ShortDipole RFID tags a year from UPM Raflatac to track and trace their garments.

The solution covers Jossy Jo’s entire operations, from production planning where production tasks are generated and assigned, to specific plants. RFID labels are sent to each production plant and attached to every garment during the production phase, boosting quality control as faulty garments can be easily traced back to the point of production.

EU-funded project will demonstrate RFID use cases for small business

Wednesday, May 5th, 2010

Last month, RFID technology got a boost when the Korean government indicated that it will require half of all pharmaceuticals to carry RFID tags by 2015. Now, RFID is getting a shot in the arm from the European Union.

The EU is funding a project in six countries to measure the return on investment for RFID at small to medium sized businesses. The project will roll out this month and run for two years, conducting tests at eight locations across multiple industries. The project’s goal is to allow SME’s to fully understand and leverage the potential benefits of RFID, which allows real time data collection without physical or line of sight contact.

The project is being managed by UEAPME, the European craft and SME employers’ organization. Dubbed the “RFID-ROI-SME” project,  the goal is to boost the adoption of RFID technology by wide SME communities, while at the same time creating business opportunities for innovative RFID solution providers in the EU.  Benefits will then be disseminated to wider SME communities in the form of case studies, best practices and blueprints.

“The potential benefits of RFID technology are vast and stakeholders are becoming more and more aware of these,” says Sebastiano Toffaletti, coordinator of the project. “However, the adoption of RFID on a large scale by European SMEs has not materialized yet. The goal of our project is to facilitate this transition, by raising awareness of the potential benefits with practical examples across different countries and sectors. Not only for individual companies, but also for the European economy as a whole is it important to remain at the forefront of this technological change.”

Korea will tag half of all pharmaceuticals

Wednesday, March 31st, 2010

There’s big news out of Korea today, with the Korean government reporting that half of the prescription drugs in that country will carry RFID tags within five years. The report in the Korea Times says that RFID tags will be placed on drug containers by 2015 in an effort to create a wireless tracking system that enables better inventory control and a reduction in prescription mistakes. The Korean government estimates that tagging pharmaceuticals will save manufacturers about $1.6 billion annually, while also cutting down on counterfeiting.