What if Biopharma Thought “Collaborate First”? - Virginia Nido

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HANNAH LIPPITT: Hello and welcome to the Totally Clinical podcast brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and, most importantly, the people benefiting from clinical research. So, tune in, settle back and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT: This week Virginia Nido, global head of industry collaboration at Roche, joins

the Totally Clinical podcast. Now, Virginia is a recognized leader and champion for pre-competitive industry collaboration with 25 years of experience in late phase drug development. And the last eight years she's been leading a group at Roche and Genentech participating in and leading innovations in industry collaborations.

Virginia, thank you so much for joining me today. Could you start by explaining to our listeners more about your role in industry collaboration?

VIRGINIA NIDO: So yes, I am working exclusively in pre-competitive industry collaborations, and you might wonder, “Well, what is that exactly?” So, in general, we are groups of leaders and subject matter experts in drug development who want to get together and just improve how we do clinical trials for everyone in the clinical trials ecosystem. So not just for biopharma sponsors, but also for contract research organizations, for technology partners, for patients,

and we want to work with regulators. So, this is a way that we can work together with companies that, we normally think of ourselves as competitors, but in this sense, we are peers and trying to improve the quality and the efficiency of clinical trials.

HANNAH LIPPITT: So how did you start working on pre-competitive industry collaboration?

VIRGINIA NIDO: You know, it was purely by chance. In around 2013, the large industry group TransCelerate biopharma had just been getting started and they launched a project that was on a common protocol template – so creating a protocol template that could be used across therapeutic areas and across phases. And my manager at the time was actually asked to participate on this project and she didn't want to do it. So, she kind of handed it to me and I loved it.

I found it so fascinating to be kind of getting out of my day job and working with medical writing and editing and regulatory experts from a variety of different pharma companies. And I loved it so much that I made my way into starting my own team at Roche and Genentech, working on TransCelerate projects and then we expanded the group to include many other industry collaborations, such as the Innovative Medicines Initiative and now Innovative Health Initiative in the EU, groups in the US like Clinical Trials Transformation Initiative and some of the newer collaborations like Decentralized Trials and Research Alliance and the Digital Medicine Society.

HANNAH LIPPITT: Could you describe more about the main challenges in drug development that can be helped by pre-competitive industry collaborations?

VIRGINIA NIDO: There are really so many. I think it's quite interesting that in drug development, you know, we work in this very highly regulated industry and yet somehow we insist within those regulations to keep doing things our own way and it actually doesn't help. Some studies,

particularly out of the Tufts Center for the Study of Drug Development, have shown that those innovations can take a very long time to bring into our business. And in some cases, we're really better off just doing things in more of a harmonized common way, a standard way, rather than trying to innovate on everything.

So, many of the collaborations that we participate in – as Roche and Genentech – are looking at things that we've always wanted to fix, like, sort of very basic things, like, “Why do we collect investigator new information in 100 different ways?” Why can't we just all do that in the same way? We're again coming back to a way to have a common protocol template – a digitized protocol template – all the way to innovations in pharmacovigilance, in laboratory sciences, now in decentralized trials.

So, there are many, many processes that can be helped by working together and putting the best minds in the business on these types of processes that... really, there's no competitive edge, right? This isn't intellectual property. And we would be helped and patients would be helped by doing these things standardized way.

HANNAH LIPPITT: Staying on the subject of challenges, I imagine that it can be difficult to get industry collaborations to work and turn plans into action.

VIRGINIA NIDO: Yes, in fact, internal adoption of these collaboration-derived solutions is definitely the biggest hurdle. I never have trouble finding people internally at Roche and Genentech – and other companies

are the same – that want to work with their peers on these types of solutions. It's a really great way to learn and to contribute to the scientific body of knowledge of clinical trials, like “How do we operationalize these in the most efficient way?” There's no shortage of people who want to do this type of work, and together, we come up with a really great solution. But the hardest nut to crack is then getting those into the day-to-day business at very large pharma companies. I think part of that is just it's a hard ship to steer and the change management efforts that are required to make some of these changes are intense and we're not great at it, frankly, in pharma. And then unfortunately, I think part of it comes down to a bit of hubris or arrogance that, like, “Hey, our process is working fine, it's great. We should just continue to do it this way,” even though we just spent three or four years working on an industry-agreed solution, there's still a lot of barriers there, and frankly, it's just a nut I have not yet cracked.

HANNAH LIPPITT: Could you explain more about some of the tactics and levers you've used around change management to inspire adoption of some of these solutions?

VIRGINIA NIDO: Yes, and I'm proud that Roche has really been on the forefront of figuring out how to do this. So, one of the things that we are extremely tenacious about is communication and awareness raising. So,

on my team, on industry collaborations for Roche, we are extremely consistent and diligent about getting the word out. And we celebrate when we have new appointments, for example, who are working on work products or workstreams for our various collaborations. We talk a lot about bringing those innovations in-house and how we've done it. We also have great senior management support and champions at the highest levels of our organization for this type of work and when we have successes, they make a big deal out of it. So all of those things are very useful.

I would say the other key tactic that we've used is ensuring that the subject matter experts who work on these collaborations, that it's also part of their day job. So, it's not really pulling them away from their day-to-day work, but it's synergistic. It's augmenting their day-to-day work. They're talking about it with their internal teams as these solutions are being developed. So then when it comes time to adopt, it's not like a big surprise. Everyone knew this was coming and Roche's business goals are aligned with what the external collaboration is trying to accomplish.

HANNAH LIPPITT: For those who work in the industry. How can industry collaborations help with their career development?

VIRGINIA NIDO: Working on a pre-competitive industry collaboration is such a great career development opportunity. In fact, I think every single person who I've worked with at Roche and Genentech who have done

this have said that it is the best and number one career development opportunity that they've ever had. So, imagine meeting on a regular basis with people who are as passionate about and as expert in the same topic as you. And they're all bringing that from a different perspective, either from a different company or a different type of organization, from a patient group, a site, an academic research organization, a technology vendor. You all have the same goal in mind, but everyone's bringing a slightly different viewpoint to the table. It's an incredibly good learning experience, and also many of these collaborations result in publications and even can end up in guidance and policy for health authorities. So, it really brings in a piece of policy and advocacy as well. So, I would really recommend this to anyone who wants to get a broader view of the drug development industry in their particular area of expertise.

HANNAH LIPPITT: You mentioned passion there. Why do you believe people are so passionate about this area?

VIRGINIA NIDO: I think when you are doing this type of work on a day-to-day basis, you see inefficiencies and it can get frustrating. So, working with people who are like-minded and want to solve these problems for the greater good and ultimately

for patients, we all have the goal in mind of getting very high-quality therapeutics that are safe and effective out to patients who need them faster. We want to improve and even extend patients' lives. We don't want to be inefficient. So, working together on these shared challenges is such a meaningful way to contribute to the work that we're all trying to do.

HANNAH LIPPITT: Looking to the future, in which direction do you see industry collaborations moving and what do you believe the impact on clinical development will be?

VIRGINIA NIDO: There are more and more of these types of pre-competitive industry collaborations popping up over the past five years or so, and some of them are really in

very interesting niche areas. So for example, I started my own industry collaboration in 2021, I co-founded it with a group of, again, like-minded individuals who are really passionate about post-trial data sharing, and it was not very hard to set up this industry collaboration because we really knew what our goals were, what we had in mind, what we wanted to do. So, it wasn't so hard to get those people together and launch this and get going on it. So, I think that more of these types of industry collaborations will be popping up, and I'm hopeful that regulators will be very willing to work with us. We want regulators at the table. They want to learn, too. And rather than going to the FDA or to EMA or to other global health authorities as an individual company, you know, that can get tricky, but if we're going together with the same aims that we want to make regulators lives easier, too, I think they'll be much more likely to work with us and listen to us.

HANNAH LIPPITT: And where can our listeners find you if they’re interested in learning more about industry collaboration?

VIRGINIA NIDO: I would love to talk with anyone about how to participate in or even start your own industry collaboration, so please find me on LinkedIn. I'm always happy to chat.

HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review so more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!