End-to-end nocturnal monitoring in clinical trials

In this episode, Legislate meets Mikesh Udani, co-founder and CEO of Albus Health, an Oxford university spin-out, developing an end-to-end solution for nocturnal monitoring in clinical trials. Mikesh shares some highlights from their 4 year journey as well as best practices for contract negotiation.

‍

Listen to the episode below:

‍

‍

Learn more about Albus Health

Learn more about Legislate

‍

Charles Brecque: Welcome to the Legislate podcast, a place to learn about the latest insights and trends in property technology, business building, and contract drafting. Today, I'm excited to have Mikesh Udani on the show co-founder and CEO of Albus health an Oxford university. Spin out, developing an end to end solution for nocturnal monitoring in clinical trials, Mikesh.

Welcome. Would you like to introduce yourself and talk a bit about what you're doing at Albus.

‍

The story behind Albus Health

 Mikesh Udani: Thanks very much, Charles, for inviting me. It's very exciting. I went through your first episode and it sounded like a great conversation. So I'm delighted to be on another episode with you.

About Albus. We, as you mentioned, we're an Oxford spin out company. We make contactless devices for automated nocturnal monitoring. When we were researchers at the university we found that monitoring of nighttime symptoms at home was a big challenge, which was leading to lots of preventable emergencies and lots of inefficiencies in clinical studies.

So to solve the problem, we made a small contactless device that sits on the bedside table that automatically monitors a range of symptoms and the air quality metrics without anyone having to do or wear anything. So it helps collect objective symptom, data from anyone anywhere and for as long as needed, without imposing any burden to the participants.

Charles Brecque: That's great. And so how long have you been doing

Mikesh Udani: It's going to be four years in two weeks. So we started the company in 2017. And we were working on this for a few months before that in those four years.

‍

What's been your favourite moment so far?

Charles Brecque: What's been your favourite moment so far?

Mikesh Udani: Four years is a long time to pick one favourite moment. There've been many, but I'd say one that definitely comes to my mind. One of the earliest ones was when we had finished a pitch and we were at a cafe just getting some food and some coffee, and then we got an email from the investor saying that they're going to invest.

That was our first. Funding that came in, which seemed fantastic and very exciting because it was the first bit of external validation that we got from what we were doing. That was very exciting. And more recently I was talking to one of our clients and they said that a participant who is using our device in their clinical study sang praises of the device every time they came in, which absolutely made my day to hear that. I'd always get to hear that the people who this was meant for the people, for who we built it are actually using it.

Charles Brecque: That's fantastic. And so you're saying that you've got clients, you've got participants who are using the product and really enjoy it. Can you give some, just high level numbers in terms of your rollout or anything to describe the impact that Albus is having.

Mikesh Udani: Yeah, absolutely. Our product is currently being used both commercially in collaborative clinical studies, as well as our own clinical studies. Commercially we launched the product earlier this year and it's been used by multiple different people along with one of the largest pharmaceutical companies in the world. They've had very positive feedback. They've now invited us to set up an office in their R and D headquarters, which we're all very excited. They're also just about to start a clinical study in children who struggle with asthma.

This is being commissioned by the department of health, and it's been done with some of the biggest opinion leaders in paediatric respiratory medicine, who are based in London and Birmingham. So this large study with 120 children is about to start in a few weeks. Which we're very excited about.

And we have a few more that are in the pipeline and in both commercial contracts, as well as our own market access studies that we are looking to roll out.

Charles Brecque: It's extremely exciting, but also I imagine extremely nerve wracking. So good luck.

Mikesh Udani: Thank you. And send all of the luck that you can send my way.

‍

What do you wish you had known before getting started?

Charles Brecque: Yeah. Hopefully this podcast. What would you wish you'd known before starting Albus?

Mikesh Udani: I wish I knew that it's always going to be hard. It's never going to get easy. I'll just have to toughen up and I'll have to build myself to be able to face the challenges in the early days. I would keep thinking that, it's very hard, but with time it would get easy.

At the time it would get more manageable, but that never happened. And from what I've heard, that never really happens. The expectation of things getting easier is perhaps not going to be beneficial. So I wish someone told me that things are always going to remain hard and you just have to deal with them and enjoy the ride.

Charles Brecque: I guess the hard things become easy, but then new hard things appear. So you've been at this for four years now, where do you see Albus in the next three to five years?

Mikesh Udani: The next three to five years, we see ourselves on course for becoming the gold standard in nocturnal symptom monitoring. It's currently used in clinical studies and commercial applications in the range of different respiratory conditions.

Over time. We want we see this being used in any chronic condition. for monitoring at home for people of all age groups to do everything from symptom monitoring and clinical studies to diagnosis, as well as prevention of emergencies and clinical care. So in two to five years we would be in a strong position to getting towards that goal.

‍

What are the key contracts you interact with?

Charles Brecque: And with all these clinical studies and, commercial arrangements with pharmaceutical partners What are the key contracts that you interact with the most?

Mikesh Udani: The NDA is a very common one. Confidentiality agreements are one of the first contracts we sign or agreements we sign before we discuss in depth about our technology.

So that's a very common one. We're also seeing a lot of collaborative contracts and commercial contracts to supply our devices. And they are quite common as well. And then as at any company or any startup, the employment contracts and sub contracting arrangements that we do with a bunch of different parties

Charles Brecque: So with all these contracts are there any common objections or for some of these contracts patterns that you need to overcome each time?

Mikesh Udani: I wouldn't say objection so much, but some of the parts that sometimes become difficult or time-consuming are things like confidentiality on what our partners are allowed to disclose what they're not allowed to disclose, what can be put in a publication.

Things like that then for NDAs jurisdiction becomes a point of discussion very often every time we have a contract with the party that is not based in the UK or in England, they prefer the NDA to to be written and all disputes to be settled in their jurisdiction. And we would prefer it to be an our jurisdiction. But this becomes a challenge. Liability has come up in one of the projects and this is a very data intensive project where we require the partners to maintain the highest degrees of data protection and security , in all of the dealings in the project. So this is where liability also becomes important

Charles Brecque: And how do you navigate those challenges?

Mikesh Udani: I think the best thing to do is to have an in-person conversation. Contracts sometimes become quite convoluted and they're written in a language that makes it sound very. Whenever there is a disagreement it's best if the parties involved, come together in the spirit of a collaboration and understand what the objections are, where each party is coming from and agree with verbally or in written English as opposed to legalese agree what would be a suitable compromise for each party. Agree what would work in the near and distant future, and then perhaps leave the drafting of the specific clauses to those who are better versed in the language and in the nuances of the law.

Charles Brecque: I think throughout this podcast legalese has been one key thing that's been raised. And one thing that Mani said, when he spoke about legalese, is that it does have an effect on people's mindset when negotiating. So yeah, at Legislate, that's definitely one thing that we try to do, make sure that all our contracts are written in plain English, so that they're easy to understand.

They're fair. And you don't need to speak legalese to understand a Legislate contract.

Mikesh Udani: It would be amazing if there was something like that I could use where I could easily communicate what I wanted without needing a degree in law. And I could speak openly and more collaboratively with the partners.

That would be fantastic.

Charles Brecque: And so when you are going through these contract negotiations, are you working with a solicitor or do you handle it by yourself?

Mikesh Udani: We work with a law firm, but because they are incredibly expensive, I try to do as much as I can by myself. And then sometimes it becomes fairly complicated or sometimes we're dealing with a particular clause or a particular contract, which can have long-term implications.

That's where we do involve the legal firm that is helping us.

Charles Brecque: So I guess there's a risk management approach to decide. Do you get the lawyers involved or not.

Mikesh Udani: Absolutely. You've got to balance out the risk with the costs and the practicalities. Yeah, that's always a balancing act and something which is done on a case by case basis.

‍

If you were being sent a contract to sign today, what would impress you?

Charles Brecque: One thing at Legislate that we try to highlight is lawyers have a purpose but ultimately working on simple paperwork isn't necessarily the best use of their time. And so with the framework that we offer at, Legislate, business users can do that processing of contracts as well as a solicitor, but at a fraction of the cost.

So I'm conscious that we've already taken a lot of your time. I'm going to ask you the closing question we ask all our guests: If you were being sent a contract to sign today, what would impress you?

Mikesh Udani: I think if I was sent a contract today clear, simple and reasonable terms, I would be very impressed at least if that was the starting point, of course, I expect people to protect their interests and make things more convenient for them.

But as long as the intentions are clearly stated, terms are accurately stated and justified. And it's taught through in the spirit of partnership rather than extraction or exploitation, that would make things a lot simpler to deal with.

Charles Brecque: And when you say reasonable how do you define reasonable?

Mikesh Udani: For example, I generally think that if two parties are coming together for a collaboration, there is definitely something that both parties,  can benefit from. And then it's about understanding that and respecting each other's requirements, there are going to be areas where there's going to be a disagreement.

And then it's about being reasonable to say, if you give up this aspect, how much is it going to hurt you? This means a lot to us. So can you maybe compromise on this, but in return you can have X, Y and. Z having an open and clear discussion and being reasonable about what is important to each party can go a long way.

Charles Brecque: So finding balance.

Mikesh Udani: Yes.

Charles Brecque: Perfect. I think that's a consistent response that we've had on the podcast, but I think no one yet. Clearly defined what reasonable means and this is ultimately something that leads to a good contract or an impressive contract. So thank you.

Thank you very much Mikesh for your contribution to the show. It's been a pleasure having you and hopefully we can have you on again.

Mikesh Udani: Thanks a lot, Charles. It was a very enjoyable conversation and I look forward to using Legislate more often.