Big4Bio Interview with Halloran Consulting Group’s Laurie Halloran and Katie McCarthy

Boston-based Halloran Consulting Group offers senior-level expertise to life science companies as they navigate the regulatory, clinical, and operational challenges at each stage of their development. At the beginning of October, Halloran announced several promotions in its organization, and the expansion of operations in San Diego, setting up a West Coast office there to better serve its growing list of clients.

Soon after the announcement, Big4Bio editor Marie Daghlian interviewed Laurie Halloran, CEO, and Katie McCarthy, chief development officer, to find out more about how Halloran can help companies and the reasons it chose San Diego for its new office.

MARIE: Tell me about when and why you started Halloran and what it offers to their clients.

Laurie Halloran

LAURIE: I’ve worked in biotech for many years and after being in the CRO industry, I worked with two startups. What I realized was that the first company, which had some mid-level expertise on board, did a whole lot more, more efficiently, more effectively, and at higher quality than the second company, which hadn’t had any senior level regulatory and clinical expertise up to the point at which I joined.

I saw that there was a need for that for startup companies so they would be able to develop their products with a much better plan and much better outcomes. That’s where I decided to focus the growth of my business.

MARIE: When did you start the company?

LAURIE: I started it in 1998 and motored along for quite a few years without a big overarching plan. When I started to grow in the mid-2000s, and my partner Greg Dombal joined me in 2007, we realized that there was a very big need we could fill by providing that expertise on demand.  We gradually added on the capabilities to do what the companies needed most. And what they really needed most was a well-crafted and efficient plan, with a lot of current FDA-thinking, for how to strategically tackle the development of their products.

MARIE: So are you mostly focused on the clinical development of a product?

LAURIE: A lot of companies are sent to us by folks who know us and are in the space as advisors like lawyers and board members—strategic advisors who are not regulatory experts. They often come to us because they need to understand the time and cost, the hurdles, and marketplace for their product before it goes into clinical development, often a couple of years before that time. So we are typically helping them craft a plan that informs their interactions with regulators as early as they are ready, and also how the plan is tied to their funding.

MARIE: So you are helping companies before they enter the clinical stage.

LAURIE: It’s typically 12 to 24 months before they go into the clinic because they need to understand the path to get into the clinic, the potential strategies for development and how long that’s going to take, what the ideal patient population is, and finally, how much it is going to cost, because the investors who are going to give them the next round of funding want a much more definite plan on what the company is going to do when it gets to each milestone.

KATIE: We also pull these integrated development plans together when a venture group or a biopharma company is assessing the product from a diligence perspective, and other times so that the C-level folks can have an idea of what that development plan looks like, how much it’s going to cost, how long it’s going to take, and what those key inflection points are so they know when and where they’ll have to raise additional capital, what kind of data they’ll have at those inflection points before the raises—it gives them that strategic plan.

MARIE: You offer four services: Plan, Build, Transform, Fix. Is this the “Plan” service?

LAURIE: We have been moving away from defining our services on the website by those words – a slight refresh of the website will be out shortly that replaces those words with more of a description of the client, as we want visitors to see themselves in our services as how we work. It really depends on the phase of the company. If a company comes to us and wants our help in analyzing the potential of a product, we are looking at the product and comparing it to the competitive landscape, we’re looking at the data that might have been generated by that point, and we are giving them an idea of whether or not it has potential, and if so what kind of potential.

More and more, companies realize that they don’t need to hire 10 or 12 people and they can do a much more virtual level of development. They don’t need full time employees (FTEs) and those FTEs are very difficult to find at a senior level. So they will work with us as an on-demand team for as long as they need it and typically that ends in one of two ways: either the product is working and they have good data, often proof-of-concept data, and now they are going to raise another round and start to grow the company by hiring and building infrastructure; or they take it to the point where they get data that shows that they have to go back to the drawing board or there is no viable future product development and the data doesn’t warrant additional investment.

If they are going to grow, they might not get to the level where they want to commercialize, but they still need to build some infrastructure. So our “Transform” service as we once called it,  is designed to support a company as they mature, or grow up as an organization—where at that point we’re doing a lot of work with them alongside their development team to help them put the right infrastructure in place, the right quality measures, the right technology, the right organizational structure, the right executive leadership. As an analogy, we are kind of riding along in the sidecar building the company with them but on a consulting basis.

Our support for our clients extends through our work with mid-size companies that have products on the market and are deciding they want to build their internal capabilities so they are not so reliant on outsourcing.  The market is really changing in this way because technology has facilitated the adoption of previously outsourced activities so the company owns their data, they start up their own research sites, and they take more and more in-house so they can really build the internal capacity of the organization.

MARIE: What about the fourth service “Fix”?

LAURIE: Fix occurs where if they’ve ignored building in or augmenting the quality controls or  acquired what seemed like a good product but when they start to dig under the surface, they realize there are a lot of quality issues that exist and may impact the acceptability of the product to regulators. We help a fair number of companies prepare, whether it’s proactively or reactively, for regulatory inspections and if they haven’t been prepared and they haven’t done all their quality homework, they often find things they need to fix. Things like quality issues don’t bode well for the long-term future of a company, because they will be on a regulatory agency’s radar as having been noncompliant, so we help them get into a better place with their compliance.

KATIE: A lot of companies want to do the right thing but are ill-prepared to do that. It’s unfortunate that they didn’t come to know us sooner because we would have gotten them on the right foot earlier in their development, but we do have a number of clients who come to us with issues and need our expertise to resolve so they can move their products towards approval to meet the needs of patients. It’s amazing to see the number of companies that just don’t have the right expertise that have made missteps along the way. When we get involved, we can get these companies back on track to where they should be from a health authority / regulatory perspective.

Halloran’s Boston office

LAURIE: Sometimes they don’t have the time, sometimes they don’t have the expertise, and sometimes, they just need an outside perspective. The biggest thing we bring to the table are people who have worked in those exact types of roles so they can add the benefits that they’ve seen other companies employ to be good at what they do, yet efficient, and that independent perspective.

How we are different from big consulting firms is that we actually help them fix whatever isn’t working. We roll up our sleeves and get it done. That has served us well.

MARIE: Has the growth of virtual companies, where it’s just a handful of people and a lot of stuff is outsourced, helped fuel the growth of your business?

LAURIE: Oh yes. That’s a big part of our clientele. To be frank, about 90 percent of our business comes from word-of-mouth so we’re not doing much advertising, it’s really relationship based, and a lot of veterans see that it’s much more efficient and effective to go with someone they know and trust. The level of competition for talent where we are has made us a very viable alternative.

MARIE: Let’s move on to another of our “Big 4” regions, San Diego. What made you decide to open an office there?

KATIE: There’s such a need and great opportunity. There are great ideas, great entrepreneurs, and lots of companies forming.  All across California–we have a number of clients in the Bay Area, a large number of clients in San Diego, and a number of clients in between, and we’ve seen demand for the work we do.

We had a goal this year to grow our California business by 20 percent and we have already exceeded our goal. The culture of Halloran fits well in San Diego. The belief that with good science and experts in the field anything is possible is very much how we work and how we see the environment in San Diego.

MARIE: Are you hiring additional staff for San Diego?

KATIE: We are. I am in San Diego at least once a month, and recently it seems like every other week, recruiting new talent and meeting with clients. We have a small team there now, a couple of folks in Los Angeles, and a couple in San Francisco. We are looking to add some additional thought leaders and consultants and additional internal operations staff in San Diego so we have a second hub and don’t need to be flying across the country to see our clients. We want to be a little more readily available to provide the face to face thought leadership that they want.

MARIE: Face to face contact with clients is important.

KATIE: Exactly. So we are excited.

MARIE: What do you see in the coming year – the landscape for Halloran and for biopharma in general?

KATIE: We were just at the Cell and Gene Meeting on the Mesa last week- we love to be in cutting edge and innovative work to help find ways to push these ideas ahead, to help define the possible paths forward. The space is still growing and there is such a crunch on great talent. Our company continues to have a great opportunity to fill that space because our teams are highly experienced, very dedicated, and really want to be part of these amazing therapies that are being developed. I think we’re ripe for continued growth. The variety of client work and culture of Halloran is attractive for talented consultants—we’re really fortunate that despite the talent crunch, we’ve been able to attract great consultants. We’ve been growing a lot and are approaching that 100 full time employee mark—probably within the next year we’ll get there.

LAURIE: I work more with some of our larger client companies, whereas Katie spends more time with startup and early to mid stage companies. Where I see things changing quite a bit is the expansion of software as service. Technology solutions have brought a lot of opportunity to companies that are trying to be more efficient and effective, but they have also brought a fair amount of confusion because it all looks like a very shiny object when it’s demoed by the salespeople, but actually making it work, making it be part of your company and effective at getting your drug developed is harder than it looks.

BioLabs in San Diego, location of Halloran’s new West Coast office

So I see a lot of opportunity in that space. There have been some early adopters and people see the value, but it’s not common to see the products work in an integrated environment now. There are hundreds of different types of things you can use but no collective wisdom on how to do it most efficiently. That’s where I see a big opportunity.

And frankly, we love the La Jolla area. We chose to go to the place that we did because it is such a vibrant ecosystem and we found a really good synergy with Biolabs, so that is where we are. We’ve worked a bit here with LabCentral and have a good relationship with them, and I think we all saw that it was a great opportunity to collaborate with them on doing this together with some of the early stage companies.

MARIE: I agree with your take on the outlook and the confusion that exists with all the technological products that are coming out that purport to help make clinical development more efficient and cheaper. But making it work is a very different ballgame. And I guess your consultants have to be on top of it and learn all these things so they can advise.

LAURIE: Often the folks in our client’s clinical operations groups want to be efficient but they don’t have the time to figure out exactly how to do that. They can rely on us to identify the best fit for what they need now, and later by planning a roadmap of how they are going to adopt technology. And that is very appealing to them because they can understand more systematically what to do and when to do it, versus just buying something and then leaving it on the shelf, as it were.

We’ve found our ability to help clients at just about every stage. There’s always unique opportunities but because we’ve been with so many different companies—we work with about 150 companies at any given time—we have a lot of really good experience to apply in a new situation. There are not two companies that are alike. That’s been one of the challenges in this industry.

MARIE: Yes, there is no cookie cutter template to follow. Thank you for your time.

Editor’s Note: Soon after this interview took place, Halloran launched its Speaker Series, in which its experienced consultants will share insights and progressive strategies for solving some of the biggest challenges facing the life science industry.  It plans to offer several Speaker Series events throughout Massachusetts and California in 2020 with the first one scheduled for Tuesday, November 12, 2019 at BioLabs San Diego with Sheila Gwizdak, vice president of quality, on the importance of “Quality as a Culture,” as it creates an environment focused on transparency and continuous improvement through effective and repeatable processes and outcomes. Information can be found on their events page.