“Probably most people have come in contact with West and they wouldn’t even know it,” he told Drug Delivery Business News.
Over the 40 years he’s been with the company, Reynolds has seen its design philosophy evolve in response to the changing landscape of medical technology. About two years ago, West segmented its business to focus on three sectors – biologics, generics and pharmaceuticals – but it wasn’t always that way.
“I think that historically West has tried to be everything for everybody by developing products with a common specification and service package,” Reynolds said. “I think what we’ve seen over the last few years is that our markets are changing and our customers are changing and their needs change.”
There are differences in what a small biotech company requires for a thousand-unit product and what a big generic company needs to produce hundreds of millions of units, he pointed out.
And companies are beginning to understand how important the vehicle delivering their drugs is to the final product.
It used to be “really all about the drug,” Reynolds said, “and if the drug works, you can deliver it with a shovel.
“Then I think, over time, people realized that it’s not enough to just focus on the drug molecule, you have to think about the way that’s contained and the way that it’s delivered,” he said.
One trend that Reynolds has seen emerge in medicine is the transition of point of care from a hospital or a clinic into the home environment.
“That obviously puts pressure on the drug delivery system to be tailored to the specific needs of the patient, rather than, let’s say, a nurse or doctor in a hospital that’s very used to giving an injection,” Reynolds explained. “We’ve done extensive testing with a lot of our products where we actually go and talk to patients, talk about their challenges and their needs. We have to make sure that it’s really designed around the needs of the patient and it’s something that they not only can use, but they really want to use.”
There’s another trend that Reynolds has seen developing the drug-delivery arena – the need for systems that can deliver higher-dose volumes of biologics.
Moving beyond a 1ml formulation, drugs are being developed at volumes that are too painful for a patient to inject using a conventional auto-injector, Reynolds pointed out. That has spurred on the growth of wearable injectors that can stick to the body and deliver a higher dose of drug over a longer period of time compared to a once-daily injection.
Reynolds pointed to Amgen‘s (NSDQ:AMGN) Repatha antibody product, which was approved with West’s SmartDose pre-loaded wearable injector in 2016.
“I think that was really a first of its kind, in terms of the higher dose volume wearable injector,” he said. “We do see a lot of increasing interest in that type of delivery technology driven by the complexity of today’s biologics, but also the recognition that that’s potentially a more patient-friendly delivery technology than either multiple injections or in some cases we’re seeing products that may be delivered by IV going into a wearable type technology.”
As drugs continue to ramp up in cost and sophistication, Reynolds believes that companies will place a heightened focus on reducing the defect level in their products. And improving the quality of the drug container system is “a really critical part of that,” he said.
“The growth of biologics and the growth of products in that area, it’s really quite exciting. Some of the things that people are doing now with cell therapy and gene therapy products, it’s really going to open up whole new areas of treatments for patients,” Reynolds noted. “We’re just excited to be part of it and supporting our customers by helping them take their products to market.”