The International AIDS Vaccine Initiative, a nonprofit research institute, said its newest facility in New York makes it more ready than ever before to deliver on the longtime hope of a safe and widely available vaccine.
The initiative recently completed a $17 million AIDS Vaccine Design and Development Laboratory at New York City’s Brooklyn Army Terminal. The new facility is five miles south of IAVI’s previous New York City home base, within the SUNY Downstate Medical Center’s Advanced Biotechnology Incubator.
At 36,000 square feet, with an option to add as much space as it needs down the road, IAVI will have far more room than the labs it occupied at the incubator. That new space will allow the initiative to expand from its current 30 staffers to 75 in New York.
IAVI has agreed to occupy that space for at least 15 years, plus an option to lease the same space for five additional years, plus a four-year option for additional available space at the former Army outpost, at the same rent it would be paying for its original space.
The initiative got a bargain lease: Its rent will start at $16 per square foot, climbing to $24 per square foot — one-third of the published asking rents for other privately owned lab spaces elsewhere in the region.
IAVI received $12 million in incentives form the New York City Economic Development Corp., and raised the remainder on its own. The initiative also received product donations from Becton Dickinson and Thermo Fisher Scientific, and raised funds from the Bill & Melinda Gates Foundation, The Starr Foundation, The New York Community Trust, the James B. Pendleton Charitable Trust, and the government of the Netherlands.
BioRegion News recently spoke with Michael Goldrich, IAVI’s executive vice president and chief operating officer, about the group’s move to BAT and its significance in the initiative’s overall AIDS vaccine effort.
Goldrich has managed scientific programs and research institutions for 33 years; before joining IAVI, he was the senior vice president for research operations at Boston’s Beth Israel Deaconess Medical Center at Harvard Medical School. Earlier, Goldrich spent five years as the chief operating officer of the Institute for Human Virology at the University of Maryland, and before that held various positions during a 25-year career at the National Institutes of Health.
Below is an edited transcript of that interview.
Why did IAVI decide not to relocate to a supercluster, such as the San Francisco Bay Area or Boston/Cambridge, Mass.?
We consider New York a supercluster. I’ve been in Boston; I’ve been at Harvard. I’ve been out in San Francisco. I know those areas very well. Quite frankly, we considered New York City a global hub for both science and for the work that we do. Remember, IAVI is a fully integrated organization, doing not only science but also public policy. We also do advocacy work, again influencing the science and the public agenda for HIV/AIDS vaccines. Where else would be better than to be right down the street from the UN, or to be right near the Council on Foreign Relations, or to be nearby a number of the other globally based organizations?
We don’t see our work as necessarily as a “biotech hub.” We see ourselves, in Brooklyn at least, in terms of the design lab, as a hub, but as a hub of a very, very globally organized network of discovery research centers. One of them is going to be out in Scranton [Pa.]. Another of them is at Oxford University. Another of them is in India. From our standpoint, that location issue was influenced by the fact New York City is an important global center. It was one of the positive characteristics that we used as part of our evaluation.
It’s also important, I should add, that for our consortium, the nature of the work we do is, we don’t have geographical boundaries. We don’t set that. So we’ve got the best science in Boston, that’s the Dana-Farber Cancer Center [and a researcher based there,] Joe Sodroski, who is a pre-eminent scientist in this field. We will go after him and fund him and get him involved. It doesn’t have to be that we have to be up in Boston, no more than to get Scripps involved, did it take us having to locate the lab in San Francisco.
How did you come to the Brooklyn Army Terminal site?
It was a combination of SUNY Downstate and the city. We actually started the process in discussions we had with state Sen. [Martin] Golden (R-Brooklyn) and the SUNY folks who had been working with him for a number of years on this concept of the BioBAT. And we then started working with them. And the city was then involved because the city owns the Brooklyn Army Terminal, therefore it had to be part of arrangements to establish this BioBAT. So early on, we worked with all those partners at state, city and SUNY, to form the terms for such an arrangement, and then lined up those terms against other opportunities. And on the basis of certain criteria, we thought we made the right choice.
Over how long does IAVI reckon its workforce will increase to that 75-person maximum?
My guess would be it would probably be at about 60 in three years or less, and then added expansion might come soon after that. It probably wouldn’t take us more than five years to expand up to 75 FTEs, but our current plan is to double the laboratory in size over the next several years.
With the move to the Brooklyn Army Terminal, what space if any will IAVI keep at the SUNY Downstate incubator?
We’re not going to keep office space. We’re going to keep a very small lab, because some of the animal work that we do in their facility needs to be continued until we can find alternative resources. So a very, very small amount of land, and we actually do have some space that we will be leasing from them in their animal facility.
And when you made the move, how much office space did you give up?
The office space was actually not quite good at SUNY Downstate. We were very fortunate they were able to help us out, quite honestly. We were more interested in land space. And the BAT is actually quite good. The scientists will finally have an opportunity to have a lot of quiet time that they need to write papers. Compared to the space they have had previously this is really quite nice space.
Is the new Brooklyn lab considered by IAVI its primary or main or just one of several research labs in the global network of locations?
We consider it one hub in our discovery network, with other partners including Scripps at La Jolla, Oxford University, and a couple of the universities in India, through the department of biotechnology in India.
IAVI has five locations worldwide, correct?
Those are just our offices. Those offices help us manage in those various regions in the world. We have many more clinical research sites that we work with. We work with a number of sites in South Africa, in Rwanda, East Africa, and India.
What effect has the new lab opening in New York had on IAVI? Has that shifted work, say, from the initiative’s other international locations?
We were spending a lot of money in what our industry might refer to as outsourcing some of our scientific work. And what we were finding was — this wasn’t the pre-clinical work; this was the discovery and the early development of a candidate — we were finding that it was both very expensive and secondly, we were finding that time was our enemy, because we very often would find ourselves having to compete with priorities about these various kinds of locations for oftentimes other candidates or other products that were far more lucrative.
We felt that we could establish internally a similar infrastructure in such a way that we could actually then speed up with, and be more effective at, developing these candidates in those early pre-clinical and discovery phases. In addition, we thought that we would then also be able to provide that as a resource to the community. For example, we’re doing that right now clinically. We’re in discussions with the International Partnership for Microbicides. We’ve just completed some early negotiations with them which seem virtually certain — I wouldn’t say it’s signed yet, but it’s virtually certain that we will evaluate at one of our sites. We built the capacity in Africa to evaluate a microbicide. Also, we’re in discussions with Aeras [Global TB Vaccine Foundation in Rockville, Md. — Ed.], which is developing vaccines for TB. We’ll be using our infrastructure that we created.
In many ways, the way we look at it is, that capacity that we’ve built over a decade, both pre-clinical and clinical, should be available to the field, so that we advance the most likely and successful candidates through both stages of development. And in some cases we actually believe that it’s important for us to use that infrastructure for fields that are closely related to AIDS, like microbicides, or TB, and then to use that infrastructure for advantage in the field.
We spoke of IAVI being able, with your own infrastructure, to speed up some of the preclinical process. Have you quantified its success by how much, in terms of months or years?
Not yet. Once we get up and running in the lab, if you ask me that question in about a year, I’ll be able to give you a fairly well-defined answer to that question. Right now, we were in very temporary folding labs over at SUNY Downstate. It’s going to be a very different thing when you move from those temporary facilities that were actually located … in disparate locations, and now you put all of your staff in one location at 30,000 square feet of space, it’s a whole different life for our scientists.
What’s important, I think, to point out, is that we have the tools in place — we have project management tools that we’ve used for years in our development: What candidates have come out of pre-clinical? We actually have a pretty sophisticated project management tool that we’re already using at IAVI. And now, we’re going to extend that same tool over to the discovery portion of IAVI, which will include the design lab in Brooklyn.
You mentioned SUNY Downstate. Did that relationship necessitate expanding in New York?
Oh, no. It was always anticipated that we would expand. It was just a question of where. We established what turned out for us to be an excellent collaboration with SUNY as an academic partner. And it turned out that over time, we were very happy with that relationship. So when we started looking at alternative sites, both within New York, but also outside of New York, one of the important considerations for us was that very positive relationship.
Going forward with the new lab, how will that partnership evolve? What will the contributions of SUNY Downstate be? Bringing students to the lab? Researchers?
All of the above. Our arrangement with SUNY has been fantastic. They actually have a pretty active clinical AIDS program over at SUNY, and we’re already working with them on some of our protocols. Our answer is yes to students. Yes to fellows. We plan to bring in fellows form the developing world and actually have them work in the laboratory, and collaborate with some of the SUNY academic partners that we have.
In addition, SUNY, through a [memorandum of understanding] that we’ve signed with them, will also help us by providing at very, very favorable rates, a lot of the research services that, if we were a standalone laboratory, we would have to duplicate. Services such as animal clearance requirements; if you don’t have an academic partner, you have to really set up an entire infrastructure for that. Or things like even a hazardous waste disposal. Everything is taken to [enable] the research organization work that scientists in many academic centers often take for granted; they don’t realize what it takes to actually allow them to do their science. We’ve been very fortunate in working with SUNY and were able to work out an arrangement with them that will be quite favorable to us.
In addition to SUNY Downstate, what other partners is IAVI working with at the new facility?
We work with the Aaron Diamond AIDS Research Center, over at Rockefeller [Rockefeller University has an affiliation with ADARC; the two are independent organizations with their own boards — Ed.]. We work with the New York University scientists. We’re also working with some scientists up at Columbia. So we have a lot of individual scientific collaborations that are going on in the city. And then a couple of them are very recent ones in the area of some very innovative type of approaches to a vaccine. One of the areas we’re looking at is not just at the vectors that deliver a vaccine, but what you put in that vaccine.
Some of that work, which is very, very high risk and very frankly, often having high failure rates, we’re working with a number of scientists in the New York area to help us with respect to immunogen development and design.
What if any industry involvement has there been in that so far?
One of our relationships, which I don’t think I can discuss since it’s very early on, is with a large pharmaceutical company, and it involves their vector in combination with one of our vectors. There’s a good example of where you take a piece of what we’re doing internally, and you combine it with what a large company is doing to increase the likelihood of success. Very often, you’ll read where they’ll say prime-boost. In some cases, you want both and you want two — in a sense, you want to be able to have two vectors, each of which might provide a different advantage in the delivery of a vaccine.
We’re about to sign a deal with a large company to do that. We work with biotech companies, quite a number of them. Particularly lately, we’ve been working with a lot of them on our innovation program. And in that program, the scientists at the design lab are heavily involved in helping us evaluate these new technologies, as well as monitoring progress because there are very, very small, but very, very high-risk discovery programs. Virtually all of them thus far have been done with biotech companies from all over the world. We recently announced one in South Africa, and another one in India. We’re about to sign an agreement in Belgium. These are all discovery efforts in very high risk, high failure types of programs.
How far in early or advanced stages are these immunogen and vector creation efforts?
I would say they’re not at a mature stage, but our vector work has been ongoing now for several years. We’ve worked, for example, with funding from the [Bill & Melinda] Gates Foundation, and looking at a variety of what we call replicating vectors, which are high risk vectors, because when they get in the body, they essentially replicate. FDA has often required a pretty comprehensive profile to reassure them that you won’t cause more harm than you might benefit. So, very often, industry will not study or advance replicating vectors, but we will. We feel that’s, again, one of IAVI’s niches — it’s to work those areas where the work is high risk, and that way to keep the clinical pipeline with a variety of different candidates.
I think the work that I would characterize at its very earliest or earliest stage is immunogen design. There, in that instance, we’re really kind of at the beginning stages of ramping up our work in immunogen and antigen design,
For the products developed by others that IAVI will test, will the initiative act as a contract research organization, in a sense, working with whoever you work with? Or would you test different drug candidates on your own initiative?
It depends. Every one of the relationships is different. So for example, we could be working with a very large pharmaceutical company as a partner. They may have a very exciting candidate that we look at and evaluate in some early pre-clinical studies, and are excited enough about it, but it may need some additional refinement and pre-clinical work. So we’ll actually work with them to establish an arrangement. Very often those arrangements must incorporate our requirements for access. As a not-for-profit, our mission has as its centerpiece the notion that we will ensure that a vaccine, when and if it’s available, is made available to the developing world at the most favorable prices, and the best circumstances possible.
When we work with the larger pharmaceutical companies, and a lot of the biotech partners in the private sector — in fact, even in the academic world as more and more of the academic sector get involved in the various kinds of complicated [intellectual property] arrangements — we will incorporate as part of whatever we do with them the guarantee of access for a successful vaccine to the developing world. For us, that’s the centerpiece of that arrangement.
Then once we’ve gone past that, all of these different relationships may differ. So on the occasion of a large pharmaceutical company, where you could imagine they have an enormous amount of scientific talent and infrastructure available, that might involve us working where we work in the same way as a CRO, but where they want the pharmaceutical partner to bring to the table their own resources. We don’t want it to be a free ride, so to speak. Quite frankly, they don’t want that, because it’s to their advantage very often when they’ve invested a lot of money in a platform to stay involved with that.
We find a mutual way to work together, so we’ll do whatever we need to do to refine in a pre-clinical stage of development that candidate, and then we, IAVI, have built over a 10-year period a clinical research centers infrastructure that’s then available for evaluating these candidates clinically.
How does your occupancy mesh with the longtime effort to turn your new building at the Brooklyn Army terminal into a life sciences campus called BioBAT?
There is an arrangement we have with the New York City EDC that if we choose to, when there is a BioBAT and it is up and developed at the other end of the building that we’re in, that we have the option to change our tenancy to BioBAT if that is what we’ve elected to do. The lease is written in such a way that we would be able to become fully a partner in BioBAT if and when that circumstance is favorable.
We believe in that concept and we believe in the notion [that] it is to our advantage to be affiliated with the BioBAT, so what we’ve said in the past is that we consider ourselves the lead program for the new BioBAT at the Brooklyn Army Terminal.
What would be the advantage of shifting your tenancy to BioBAT?
It depends. If BioBAT reaches its vision, one of the things it is thinking about is having some research cores that become pretty important for us. Now we’re spending a lot of money to do [research] out in Pittsburgh, for example, when we could do it at the other end of the building. My assumption would be that if we were part of [BioBAT], we would reap benefits in terms of cost to us. Such may not be the case, and if it isn’t, then we’ll evaluate it at that time. They also will likely have a pretty sophisticated animal facility, and there’s nothing more important to scientists than having access to their preclinical work with an up-to-date, state-of-the-art animal facility. We have it right now; we’re lucky. And that’s part of our academic relationship with SUNY. But it’s certainly not to the disadvantage to our scientists to have it at the other end of the building.