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Testing & Processing Omics, Cannabinoid analysis, Pesticide analysis, Terpene & residual solvent analysis

The Genetics – and IP – Guru

Genetic researcher and “the patent guy”... What triggered your move into the cannabis industry?

Back in 2014, I was a patent agent at Sequenom, which had begun to divest itself of the patent portfolio that I had helped them prosecute and build. I felt that it was a big mistake – especially as key pieces of intellectual property (IP) were being lost. I thought, “This company is not long for this world!” – and I left. As it turns out, Sequenom was subsequently bought out by LabCorp, and their stock plummeted – so I guess I was vindicated on that score!

Crucially, at around the same time, I was contacted by Steep Hill to do an IP review of their science – to see if they had anything patentable. The connection actually arose out of a good friendship between the then CEO, David Lampach, and my cousin; they grew up together. They were talking about IP… “Oh! My cousin’s a patent guy!” And that’s how it all started.

What did you find?

Well, I starting digging into what amounted to a treasure trove of data that nobody was looking at – real IP. I asked, “Are you doing any research based on this?” And they looked at me like I had a third eye. At that point, they offered me the position of Director of Genetic Analysis and Intellectual Property…

Sounds like a cool position to be in – like a child in a giant sandbox!

It was a dream job – all scientists yearn for such positions, I guess. But it was a little more like being a child in a huge sandbox with parents telling them all the places they are not allowed to play! Research is expensive and despite the need for more genetic information (very few people understood the genetics of cannabis back then – in fact, very few people understand it now!), there is little-to-no governmental support – and there’s also no guarantee of generating valuable IP at the end of the long road.

It’s hard to run a successful business when you’re dumping lots of money into a bottomless R&D pit; we operate on small margins, and doing research so that we can first educate and then offer services to the industry becomes an expensive proposition. Going back to the analogy, my bosses hired me and gave me a huge sandbox to play in – but they didn’t realize how expensive my toys were!

My bosses hired me and gave me a huge sandbox to play in – but they didn’t realize how expensive my toys were!

But you’ve still done some fine research…

It is true that we have done a lot of great work. But we were horribly underfunded at an important time (and I know I’m not the first or last scientist to say that!). I believe we put our market-leading position in jeopardy because of a lack of investment in R&D; we stagnated and others caught up. Since then, it’s no secret that there have been some management changes – and we now have a much more focused game plan.

Science often happens in fits and spurts… And we’re about to publish some very interesting research in the terpene synthase gene space that I like to think will make an epic splash and help regain our position at the head of the pack.

How does your R&D filter back into service offerings?

There’s a direct correlation between R&D and the genetics services we offer. Our sequencing and ongoing search for gene targets allows us to build markers – or at least assign genes to functions – in essence, we can help producers get to where they want to go. On the chemistry side, the link is less clear. The industry is focused on cannabinoids and a handful of terpenes – and you’ll occasionally hear the word flavonoids thrown in – but we’re also looking at esters, aldehydes, ketones, alcohols. There’s a lot of interesting chemistry in the plant that contributes to aroma and flavor ­– and possibly effect – but until the industry understands (and cares about) the importance of these compound classes, we’ll struggle to translate such knowledge into a service offering. However, we need the chemistry to inform the genetics…

And are you applying knowledge from other areas of agricultural research?

Absolutely. With genetics, you build on what’s gone before. After all, gene structure is pretty well conserved across species; if a gene confers an important function in life – for example, flowering – it is duplicated and retains similar structure. The sequence will vary – sometimes significantly – but the function remains. And so you can look at a given DNA sequence, consider the representative protein sequence, and then look for homology in other plants. Going back to terpene synthases – all plants share one conserved protein motif. Once you’ve found a conserved domain or motif, it allows you to seek out gene families and do a lot of other interesting work to broaden the picture. We always go back to well-studied plants to gain information/annotate genes and gene systems. For our terpene work, we explored many other aromatic plants – basil, strawberry, tomato… In short, we learned that terpenes are really complicated – and that you can come to a lot of mistaken conclusions when looking at the DNA sequence in isolation. And that’s why the chemical analysis is so important. The chemical output clearly varies according to environmental inputs – within the boundaries of the genetics at play.

We still have a lot to learn. We have to sequence a lot of strains, do a lot of chemical analysis, and throw it all into the blender (my word for big data crunching) and see what comes out at the other end.

It’s a very interesting research story – and I can’t wait for the paper to be published…

Steep Hill is perhaps best known as a cannabis testing lab. How’s the regulatory landscape looking?

The short answer: good science is not necessarily the order of the day in the current regulatory framework. The reasons are complex and evolving, and I’m becoming more actively involved in making sure that we have appropriate – and feasible – guidelines. We want to do the best science that we can do, and earn our stripes because we helped the industry identify problems preemptively. I’ll write my long answer for your next issue’s In My View section!

“Leading the Science of Cannabis. Globally” is a Steep Hill motto. Where are you leading us, Reggie?

We need to go deeper down the rabbit hole. Conversations are still centered around THC, CBD and a few terpenes, which means we’ve really not progressed that far in the last few years. Today, we throw a couple of extra acronyms in – THCVA (tetrahydrocannabivarinic acid), for example – but we need more chemistry knowledge. And not only that, we need to pay more attention to the plant in the field.

When people go pheno-hunting (and I’m not trying to say this in a disparaging way – this is what I hear from breeders and cultivators), they’ll crack a bunch of seeds, let the plants get to a certain height, and then they’ll walk the field, rubbing stems and smelling their fingers. Now, that seems pretty archaic to me! Growers are making assumptions about cannabinoid content based on plant history and smell (notably, you cannot smell cannabinoids). That might be fine for some parts of the industry, but for therapeutic strains we need more chemical targets, we need to agronomically optimize all aspects of growth, and then we can start breeding the best of the best. Isn’t that how it works with any other important cash crop? If the cannabis industry doesn’t step up and do it – somebody else will.

You’ve been vocal about patent issues in the cannabis world….

There is a storm brewing. In September 2018, I gave a seminar to the US Patent and Trademark Office. I was a little sensational with my title – “Accidental Infringement” – but it certainly got their attention. Once again – similarly to the testing landscape – a lack of (scientific) knowledge is leading to serious problems. Patenting the chemical phenotype of a plant without any explanation of the genetics or process leads to problems; disparate genetics can produce the same – or very similar – chemical output, which leads to potential infringement; this can’t be what the Patent Office intended.

I am a scientist and my drive is information and data. For me, it’s always been about uncovering knowledge and sharing it .

You’ve become an influential figure in the field. How?

I’ve been thrust into this somewhat uncomfortable position where people see me as some sort of a guru – but that’s a pretty foreign concept for me. I am a scientist and my drive is information and data. For me, it’s always been about uncovering knowledge and sharing it – and like most scientists, at first, I was also driven by being the first to a discovery and first to publish.

How do I best serve the industry? That’s what I ask myself. And that’s because the industry has served me. When I first came into the field, my father suffered a very serious stroke. When I got the phone call, someone in the lab put me in touch with an oil formulator; two days later, I had a box of oil from a company called GI Grow (for free). My father was recovering slowly, but recovered much faster with the high-CBD formula oil. Over the years, as I did more research, I started asking the formulator: how about a little CBC or CBG? And every time I made a suggestion – using my father as a guinea pig (I am a scientist, after all) – they would assist without hesitation. Now, that’s personalized medicine!

The experience changed my view of the industry. I was no longer focused on making a name for myself. Instead, I wanted to ensure that we released as much knowledge into the world as we could – to help the whole industry improve and make better medicine. I hope that’s my legacy.

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About the Author
Reggie Gaudino

President, Director of R&D, and Director of Intellectual Property, Steep Hill Labs, Berkeley, California, USA.

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