I traveled to Disneyland Orange County for AACC ADLM back in July to connect with a few folks and walk the floors of the exhibit hall. I was on my way out when Derek Hamre from Launchworks CDMO stood up at his table and got my attention with the best elevator pitch I have ever heard. And that landed him a spot on my podcast. I’ll share what it was at the end of this post.*
Imagine this scenario. You’re in an academic lab or small biotech and you’ve developed a diagnostic test for a molecule or a disease. How do you go about commercializing your test?
Do you need to get a bunch of regulatory approvals? What else do you need to think about? After all, you’re in a small research lab stepping into a whole new world. It turns out there are people who do this for a living and can help you plan out your strategy.
Launchworks is a CDMO for molecular diagnostics. Services range from commercialization strategy and supply chain management through to fulfillment. A company might come to them with a locked down bill of materials and work instructions for kitting tens to hundreds of thousands of units at a time, or maybe they are early in the process and need help thinking through strategy from the beginning.
…one of the reasons that we are pretty present at ADLM, AACC is the RUO kits. Those that are taking an idea from the R&D space and bringing it to the market and that commercialization process is a big, you know, lift for a lot of companies, even if they're bigger. Um, but especially for smaller companies when they have 5, 10 workers that have never gone through the commercialization process.
Beyond that, what level of regulatory approval do they want? In some cases, a kit might be sold as RUO (Research Use Only), but a customer’s customer might want to take it further:
And a lot of our customers, so we won't make those claims, obviously, our customers will go through the FDA filings or whatever, um, but some of our customers will just not want to go through the FDA process, so they'll make their kit RUO and then maybe one of their customers will buy the kit and then go through the FDA or 510K, PMA process… …so allowing another customer or their companies that they're working with to go through that process on their behalf might be the pathway for them.
Regardless of the regulatory path chosen, Derek described the four main areas where a CDMO can help get a product to market.
Risk mitigation
Commercialization strategy
Manufacturing process
Supply chain
You’d like to avoid surprises in any of those areas. Taking supply chain, for example, it would be important to know if a supplier might be closing shop in the near future. Will you be able to maintain quality as you scale up?
I asked Derek about the logistics of assembling and shipping hundreds of thousands of units from different vendors. Everything is done in-house. Mixing buffers, putting kits in bags, labeling and shipping. Launchworks has about a 30,000 to 40,000 square foot facility in Beverly, Massachusetts.
Prior to this I knew that there were CDMOs for pharma, but not for diagnostics. ADLM was an eye opener in terms of the world of clinical chemistry. And this isn’t the only episode I recorded as a result of that visit. More in a couple weeks.
*I don’t remember his exact words, but it was along the lines of “We’re helping visitors to ADLM become vendors at ADLM.”
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Commercializing Your Diagnostic