Info & Opinion
June 26, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Unassuming though it may be, the blister pack is a vital element of the modern clinical trial. In an era of global studies with complex dosages, there are a limited number of firms that can teach a master class in clinical operations or drug supply and make kits at scale.
That’s why the U.S. office of Almac recently announced buying a new blister pack-making machine from PharmaWorks, which makes equipment to package life science products for the consumer market. Almac is moving toward industrial levels of speed and efficiency in blister pack production for industry research. The top velocity that Almac formerly could churn out in America was 500 blister packs per hour. Now it can produce 2,000 per hour.
Large phase III projects are the ones that the new machine will typically support. The machine can bundle up to four different medications into one pack. Sponsors appreciate the ability to be able to ship the blister packs as quickly as possible. “We are seeing a growing need in the U.S. for higher throughput machinery,” says Martin Lamb, VP of business development at Almac Clinical Services.
Lamb says the humble blister pack could merit a little respect from clinical trial professionals. “I think it is something that is overlooked in clinical trials—the value of good pack design.” A well-executed pack, he points out, can help patients stick to the trial protocol. “It aids patient compliance,” he says. A clear pack can easily display that a scheduled dose has been removed. A bottle can’t do that.
One of the more practical tasks the new equipment can help with, Lamb reports, is a single pack-making run that will be used on multiple projects. “Rather than make 500 supplies for one trial, we might produce 500 per trial for 10 trials,” Lamb says. “We are producing much higher volumes now.”
In his own career to date, the biggest research project that Lamb has undertaken was a 30-country global trial with 36,000 patients. If the packs had been produced in a traditional, non-automated manner, the job would have required the application of 11 million labels by hand.
Almac figured out a way to use bar codes on the blister packs with country-specific language instructions on their shipping cartons. That meant one pack could be shipped to any country in the world. “We had to write software and develop an online printing system to apply the final information, a variable randomization code, as part of the packaging process,” notes Lamb.
So there was no need to fill a local sports stadium with the employees needed to affix 11 million stickers. Lamb says the unnamed client “ended up paying a quarter of what they would have paid using traditional approaches. If you suspect you might have something like this, don't be afraid to speak to Almac or someone like Almac early. It can save huge amounts of time and money.”
Naturally, the Almac team is aware of the complexity of shipping biotechnology products requiring refrigeration. So it can give additional thought to designing blister packs in a way that maximizes the payload of each box to keep the freight charges as low as possible.
And while the packs themselves don’t meet child-proof specifications on their own, the new equipment can seal medications into cards that are fully child-resistant.
The surge in trials proceeding in emerging markets, Lamb says, has wrought a significant shift. When he started out in the industry, 16 years ago, an “international” trial meant one that was seeking patients in one country in Europe and the U.S.
Says Lamb: “Now a global study is truly global. Nearly every trial we're involved in now includes some element of emerging markets. That's something we've seen massive growth in in the last five years. Certainly Asian markets are the fastest-growing. It's growing much faster than the rest of the world.”
Because Almac has a group specializing in the work, the process of prototyping the packs has been streamlined to the point where there is a same-day turnaround to show sponsors or other CROs a sample. “We have a full computer-aided design team,” Lamb notes. ”We've gone away and come back with the sample during the meeting. The client can get an idea of how convenient it will be for the clinical site and the patient.”