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During the 11 years that Dr. Elizabeth G. “Tibby” Posillico has been President and CEO of Elusys Therapeutics, Inc., she oversaw the development of a product she hopes no one ever needs.
Elusys received marketing approval for ANTHIM®, an injectable treatment for anthrax inhalation, from the U.S. Food and Drug Administration in September, giving the company the green light to move forward with the government-funded drug. ANTHIM® is indicated in adult and pediatric patients for the treatment of inhalational anthrax in combination with appropriate antibacterial drugs and as a prophylactic to prevent inhalational anthrax when alternative therapies are not available.
“Hopefully this drug will never have to be used, but I know for a fact that I would take it in a heartbeat if I were ever exposed to anthrax,” says Dr. Posillico.
Dr. Posillico handled the complexities of working with the federal government and the challenges of managing the company’s sometimes-bumpy transition from an R&D organization to a clinical stage business. In an interview with Ashton Tweed, Dr. Posillico discusses the biggest obstacles to building a new company culture, what she might have done differently, and the attributes she looks for in an employee.
The company’s always focused on antibody-based therapies for infectious disease. One of the early technologies upon which Elusys actually was founded utilized two antibodies linked together. One of the bispecific antibody constructs we started working with used an anthrax antibody to remove anthrax toxins from the bloodstream of animals. It worked very well together with the second antibody, but it also worked very well by itself. We decided to focus our efforts on the development of what became ANTHIM® (obiltoxaximab), and that required government funding. Fortunately, we were very successful with that. We’ve received over $250 million from the government for the development of the drug.
Elusys was actually working a little bit with anthrax prior to that, but clearly after those anthrax scares there was a huge push by the government to develop more anthrax countermeasures and funding became available. So we were in a good place at the right time to get funding, although it didn’t all come as quickly as it could have.
Working with the government involves a lot of bureaucracy – there are rules of the road and certain criteria you have to meet, but once we got familiar with it and figured out how to deal with them, we became quite proficient at working with the government. But it’s not for everybody. A lot of companies find it very onerous and they’re not willing to put up with the multiple reporting requirements. But we had to do that in order to move this drug forward.
We received a procurement contract from the government, so we’re in the process of manufacturing the product now and generating revenue, which is great. We’re looking forward to getting another contract in 2017. Now that we’re in a position where we have some income we can look at some other opportunities for the company.
One of the biggest challenges probably has been the transition from being an R&D company to being a clinical development company, moving into late-stage clinical development and recognizing that you need new talent. Your R&D people will not become clinical development people, so you have to be willing to make changes. That may be redeploying people, it may be letting people go, and it’s obviously hiring new talent.
But the real challenge is integrating the new personnel and new expertise, and creating a new culture and mentality within your company to accommodate these new people and new skillsets. You really have to create a fundamentally different organization with integrated project teams and people working together candidly and not feeling like their area is threatened or that they need to control all the decisions in their area.
R&D people can—and it’s just sort of the nature of the beast—get very isolated in their areas. I had to bring in some experienced regulatory people, some experienced quality people, and also project management personnel. A lot of these people came from Big Pharma and weren’t from a small biotech environment. I think some of the R&D people were a little overwhelmed by that and didn’t know how to embrace that or felt threatened that these people were very different.
So, we actually worked with a development coach on teambuilding because you can ask people to sit on a team but that doesn’t necessarily mean they’re working in an interdisciplinary way and supporting each other. You have to have a much different, more broad, integrated kind of communication when you’re developing a drug that’s going be regulated by the FDA and that has all kinds of new requirements and approvals that you have to achieve. We had to change the way we operated so that, for example, we had an integrated product development team and not just manufacturing people and R&D people.
We had to confront each other on how to communicate better. We were able to candidly talk to each other and be able to say: “I don’t agree with you. I don’t agree with this, but…”
So we learned how to communicate in a much more straightforward manner.
Some people also wanted to hold on to information. They wanted to be the decision makers, they wanted to be the one who wrote the papers, key documents and reports. They felt threatened if other people got involved, and it just didn’t work. We had to bring in a senior-level project manager to lead our development team so that no one department was leading the development process but rather participants from all departments were interacting and contributing and making decisions together. We had to change the structure of how we did product development.
The process was pretty confrontational at first, but being candid and honest with each other was what it took for people to realize that we need to get this stuff out of the way so we could focus on the job at hand.
We had to sit down and say to someone: “Listen, sometimes I find that you’re not being straightforward with me. Sometimes you agree to do something, but it’s clear that you’re not really agreeing and you’re not really on board.” We had to be forthright with each other and be able to take criticism.
Everybody got their share of positives and negatives, and it wasn’t easy—it was like having a very in-depth 360 review with all of your senior team. It was a little bit like, “Get on the bus or there probably isn’t going to be room for you.” There were some people that weren’t able to get on board and I had to replace them. If someone isn’t participating or is not willing to change how they interact with others maybe he or she isn’t the right person for the role.
We were overly patient with some people who were causing problems. We should have addressed some of those issues more quickly, but we were trying to be fair and reasonable, and I think everybody wants to do that.
I would have brought in more experienced personnel more quickly. I should have recognized that my R&D guys didn’t necessarily have the skills to move into a new area and start doing more advanced drug development. So recognizing when to make the change to bring in the new talent is important and I could’ve done that more quickly, I think.
The other thing I learned is that things don’t always go swimmingly and issues come up. But you can’t go on and on about how this doesn’t work or this isn’t good. You have to say, “Okay, this is the way it is now. What are we going do about it? How are we going move forward?” We have limited time and resources to get things done, so it’s all about execution.
I think once I got the right people in place it probably took a year and a half, maybe two years. It takes time for these things to happen, but I have almost no personnel issues in terms of people not getting along now and I used to have them routinely.
Everybody is very much on board with what we are doing and willing to execute, they’re willing to do what it takes. I can ask anybody, “Can you help me out with this? Would you do this? Would you work late tonight?” They would say, “Sure.” They’re all willing to help out to get us where we need to go, so I’ve been fortunate, very fortunate with the people I work with.
I really enjoy people who are straightforward and honest, who aren’t afraid to say, “I’m wrong.” They don’t try to make themselves something that they’re not. In my company I’m really grateful to have a lot of people who don’t play games with each other; we’re not trying to make ourselves look one way or the other. We’re just focused on getting the job done. So they’re straight-shooters and people who have the experience that they say they have.
I think women make good CEOs because we can handle multiple things well and in general tend to have good emotional intelligence in dealing with people. But there aren’t that many female CEOs yet, so we have to learn to work with predominately male counterparts. There are instances where I might have thought my gender played a role in the way I was treated but I believe it is best to operate as an individual to the best of your abilities regardless of your gender and not make excuses.
Ashton Tweed would like to thank Elizabeth Posillico for this interview. If your company needs help from members of the Ashton Tweed Life Sciences Executive Talent Bank, we can supply that assistance either on an interim or a permanent basis. Additionally, if you are among the many life sciences professionals affected by the changes in the industry, Ashton Tweed can help you find the right placement opportunity — from product discovery through commercialization at leading life sciences companies — including interim executive positions and full-time placements. In either case, please email Ashton Tweed or call us at 610-725-0290. Ashton Tweed is pleased to continue to present insightful articles of interest to the industry.