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PODD 2023: Holistic Approaches to Device Design and Development

At PODD 2023, Amir Tabaian, Pfizer, sat with Dr Josh Horvath, Genentech, Courtney Nicholas Sutton, AstraZeneca, Dr Stefanie Johns, Kymanox, and Jason Durkin, Windgap Medical to discuss key approaches to enable effective and efficient combination drug product development.

May 31, 2024
PODD 2023: Holistic Approaches to Device Design and Development

Communication as the Key for Effective Combination Product Development 


“Even being in a large pharma company,” began Ms Sutton, “There’s still a lot of education to explain why a device is different than a drug and why we have a different development pathway we need to satisfy.”

She explained that while companies want to get drugs out to clinical trials, submissions and patients as soon as possible, there needs to be an appreciation for the lesser flexibility of combination product development. Locking in requirements as early as the device team wants can be challenging for drug development teams but lowers the time to development dramatically.

For Dr Johns, communication was not just about educating internal teams but also about educating regulators about the critical attributes of how devices perform and how that performance relates to the delivery of the drug. She also advised the audience to feel comfortable pushing back against regulators if they felt they were getting responses that didn’t make sense. 

“I was in a situation where we had such odd feedback that I had to call the Office of Combination Products and the director actually called me to apologize for the lack of information that was provided,”Dr Johns said, “You have to advocate for your program and just because you got bad or weird feedback from an agency it does not mean that it’s the end.”

"From a platform perspective, it’s very challenging to develop a durable platform and to define a design space that will stand the test of time. It’s a great starting point but it is often just that; a starting point."


Platform Devices are Starting Points


Mr Tabaian explained that pharma companies sometimes inappropriately approach platform devices as though they only need to build out user definitions and go through validation steps once before being able to use them for multiple products. 

This doesn’t actually work, according to Mr Durkin, because there are always slight differences when you change the drug being used in the platform device. Those changes could even be from a marketing angle, to differentiate one brand of drug from another by changing the color or shape of the device. He continued that even when introducing improvements challenges usually arise. 

Ms Sutton added, “From a platform perspective, it’s very challenging to develop a durable platform and to define a design space that will stand the test of time. It's easy to do it with the information we have today, but it seems that as soon as you draw a line in the sand of what your design space is, the next molecule inevitably falls outside of that design space. It’s a great starting point but it is often just that; a starting point.”

With that in mind, Dr Johns recommended that companies take the time to understand their platform devices’ operation ranges and what happens when drugs are outside of that range. She added that companies with platform devices should consider putting the bulk majority of information that’s not going to change into a master access file. This keeps information proprietary and confidential, makes it easier to maintain post market commercialization and enables amendments to trigger updates for NDAs and BLAs rather than requiring companies to update many individual documents. 

"Having somebody with the visibility and expertise to see the bigger picture and how everything is coming together is paramount."


Setting Yourself Up for Quick and Effective Development


Investing in strategy early leads to fewer delays throughout development. 

When creating documentation, said Dr Horvath, tell the engineers not to put the drug name all over the document because if they do you won’t be able to reuse it for something else. Simple changes like this can save a lot of time in terms of preparing a documentation package if something may become a platform later. 

“I learned that the hard way by having to redo about 300 documents a couple of years ago,” Dr Horvath told the audience.

He also advised companies to work with off-the-shelf devices in early stage development even if they weren’t an optimal fit. “Don’t spend 18-24 months developing a dry powder formulation if you can get that same API into a nebulized formulation in six months. If the way of delivery is fairly equivalent, you can see if the molecule works and save a considerable amount of time.”

For platform devices licensed to multiple customers, Mr Durkin explained that you could leverage those different sets of eyes to integrate input and feedback making your device more effective and efficient. This would also enable companies to improve their systems and processes as well.


Enabling Success by Building a Knowledgeable Culture


Mr Durking continued, “You need to have a good understanding and appreciate the duration and effort it takes to get a device to the market. If you lay out a business plan and it doesn’t account for the the twelve months it takes to get a piece of of automation in place to assemble your device and the nine months to get some tools and the three months to get a contract in place, you will lose time quickly and you business model will be less attractive.”

In response, Ms Sutton explained the importance of early engagement working with individual therapeutic area and molecule programs to educate them on the process of combination development to help shape the direction of those programs.

Dr Johns, shared her perspective as someone who is usually involved at the end of the development process for the regulatory submission. “Often, the individual project teams are so deeply focused on what they are doing, that even if they are able to communicate effectively, they aren’t necessarily able to see how the big pieces fit together,” She said. “Having somebody with the visibility and expertise to see the bigger picture and how everything is coming together is paramount.”

Dr Horvath concluded, “You can’t expect the folks in drug product development to have combination product development expertise. We are the ones who do it constantly so we need to educate people about how things work.”


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