Building Florida’s Biotech Business Through Service

As a Scientist and CEO, Sue Washer Is Helping Develop the Area’s High-Tech Economy

Sue Washer is a translator, only she’s not translating between English and a foreign language. Rather, she’s translating between the language of researchers and the language of investors.

Washer’s fluency in both languages serves her well as president and CEO of Applied Genetic Technologies, based in the Progress Corporate Park in Alachua.

Her job is to help the company, as its name implies, bring gene therapy to market. AGTC is developing therapies for one disease that affects the lungs and two that affect sight.

Washer was a scientist first. After graduating from Michigan State University, she joined Abbott Laboratories in Chicago and helped develop tests to detect viruses in the blood supply.

Washer left Abbott when her husband, Maurice Swanson, became a professor in molecular genetics and microbiology at the University of Florida.

After moving to Gainesville, Washer developed business skills by earning an MBA from the entrepreneurial program at the University of Florida’s Warrington College of Business Administration.

She then worked in sales for Eli Lilly and Co., as executive director of the North Florida Technology Innovation Corp. and as president and CEO of Scenic Productions.

Washer joined ACTC as its third employee in 2001 and raised more than $15 million in venture capital in 2003, one of the highest venture capital investments in Florida at the time. Since then, she has raised additional private capital, created partnerships with pharmaceutical companies and won grants from the federal government and patient advocacy groups.

She’s also become influential in the biotechnology industry at large, serving as chairman of the board of the trade organization BioFlorida.

AGTC is testing three of its products in patients and hopes to win approval to market them within three to five years.

“It’s a very long and difficult process developing human therapies, but I enjoy it because I believe in what we’re doing to help people,” Washer says.

You have a somewhat unique position as a trained scientist who left the lab for a role as CEO/fundraiser. What encouraged you to make the switch?

I had worked on interdisciplinary teams at Abbott, bringing new products to market. I saw that the business people and the regulatory people and the scientific people, did, to some extent, speak different languages. I thought I could serve a role as translator.

I’m able to understand what the scientists are trying to do and need to do, and I understand what the investors and business development people are looking for. I talk to both groups and bring them together to create a solution for product development that makes sense.

How do you attract investors and sponsors when you’re dealing with complex biotech products?

It takes a lot of one-on-one time. I go to conferences where I know investors will be. I use my existing investors to meet new investors. It’s individual relationship-building, not mass-marketing.

What’s the status of bringing your products to market?

We have two products in phase two clinical trial development. One treats an inherited lung disease, and one treats an inherited retinal disease affecting young children. We have one product, which treats age-related macular degeneration, in phase one clinical trials.

We also have two products in pre-clinical development, which involves developing early proof of concept in animals and safety studies before we go into human trials. For our size, we have a very robust pipeline.

But one that can take years to reach the market.

You have to put our progress in the context that it takes between eight and 15 years to bring a product to market. Also, it takes anywhere between $100 million to $120 million to bring some of our products, which treat small “orphan” diseases, to market. For some large diseases, it can cost upwards of $500 million to $700 million.

It is a long road to bring a product to market because of the very high standards the federal government has in place.

What’s the commercial potential for the products you’re working on now?

Since we focus on orphan diseases, the potential for profit is not as large as “blockbuster” products large pharmaceutical companies work on such as cholesterol-lowering medications. However, we believe that if we move efficiently through the clinical trial process and maintain our cost structure, commercializing orphan indications can be financially attractive.

Why work on orphan diseases, if they’re less profitable?

We’re involved for a variety of reasons. One is because there are huge unmet needs in these areas; while each disease area is small, there are millions of patients with no current treatment options, making it a very rewarding area to work in. Also, although this is now changing, many times the larger companies have not given much attention to orphan indications because there’s not the blockbuster, $1 billion opportunity.

Finally, with an orphan disease, the clinical trial process is less expensive because you need a smaller trial group, due to the smaller patient population that’s affected. We can’t execute on clinical trials necessary for those “blockbusters” that can take 500, 600 or 700 patients.

What are the odds of success with your products?

On average for any human therapeutic, the odds are not good. About 8 percent of the products that start formal preclinical studies actually end up on the market, so there’s a 92 percent failure rate.

Even products that get to the phase we’re in, phase two, generally only have a 40 percent chance of success. For our products, we think that there’s a higher chance because the data we’ve produced to date is promising.

How prevalent is gene therapy today?

There are no gene therapy products on the market in the United States. There are some on the market in China. One has applied for licensure in Europe.

However, many products are in phase two trials like our products are. These studies are showing that gene therapy works. I think the whole field is poised to really become successful.

Do you have patients in trials who have benefited from the products?

Yes, we do. It’s been very exciting over the last couple of years. I’m not just excited for the products that we’re working on but for the field in general to be showing such good progress.

What happens after the clinical trials?

When you file for approval of a product, you have to do three engineering runs and show three times in a row that you can make the material and that it’s consistent as far as purity and potency. That’s part of your application for approval. That’s the last thing you do before you file with the government for approval of your product.

At that stage, you move into a manufacturing and distribution mode, getting ready for market launch.

You have a relatively small office. Where do you spend the millions that are needed to bring products to market?

The lion’s share goes to the clinical trials. We have contracted with four universities for the trials—the University of Massachusetts, Cincinnati Children’s Medical Center, Oregon Health Science Center and a university in Dublin, Ireland.

Let’s talk about your staff. How many people work here in Alachua?

In addition to our administrative office, we have scientific laboratories here. We have seven employees. At one point, we had 26 employees. During that time, we were heavily in the research stage, developing the products and doing the preclinical testing.

Has Gainesville’s reputation as a good place to raise families helped you attract employees?

We’ve attracted employees from San Diego and San Francisco and Chicago and other places just because it’s very expensive to have a family in big cities, especially on the West Coast.

People have commutes of two hours each way there. Coming to a place where the commute is 10 to 15 minutes each way and still be able to have a job that’s very challenging and rewarding is very attractive.

Just because the cost of living is very reasonable here doesn’t mean that you can pay people less. You have to pay competitively, no matter what.

You attract people here because the quality of life is high. Especially now, people can come here and see that it’s not just one company, it’s many. They can see that if the one company doesn’t work out, there’s another place for them to work.

What’s the potential for further job growth?

If our trials continue to be successful, we would dramatically ramp up our research phase. We would expand our product pipeline, meaning our research and clinical group would both need to grow to handle more products. We probably would be back up to the range of 25 to 35 employees.

If one or more of your products reaches market, do you expect to do manufacturing here?

We have been manufacturing our clinical trial material through a contract manufacturer, and that’s who we will continue to use.

What have you’ve learned in managing this company over the years?

While we always knew that you have to have Plan B, we learned that Plan B has to be as developed as you have resources to make it. Many companies don’t succeed with their first idea. What matters is how quickly and efficiently you’re able to retool and come up with the next answer, the next product.

For one of our products, we had to retool the delivery mechanism. It’s a common issue. In the beginning of gene therapy, people thought it was going to be easy.

Like in a lot of technologies, the idea seems so cool and so straightforward that you rush forward because everyone around you wants to get it commercialized quickly.

If all start-up companies had a little bit more time and resources to spend early in their development, things would go more smoothly later on.

You’re never going to be able to fix that completely because you never have enough time; you never have enough money; you never have enough resources.

How does your role as a chief executive affect your family life?

My husband and I have two children, Geneva,15, and, Christopher, 17. One of the things I like about being in Gainesville versus Chicago is that playing the role of mother and executive is easier.

My commute is nothing. There’s a lot of flexibility these days. Everybody has their smart phones and Internet access. I think it’s much easier now than even 10 years ago to be a mom and have a successful career.

We have great employees and investors who know that I can be online from anywhere and working. I don’t necessarily have to be here in the office to do that.

You’re in the middle of your two-year term as chairman of BioFlorida. What is the role of that group?

BioFlorida is the statewide chapter of the international trade association called Bio, which represents health science companies and has conferences and meetings throughout the world.

The goal of BioFlorida is to help companies network with each other and support each other in developing products.

It also creates awareness within the state and specifically within the legislature and executive branch to make sure that our voice is heard in making Florida a good place to do business in the health science industry.

We provide educational opportunities for people within companies who need to know how to move their technologies forward.

Finally, BioFlorida promotes creation of an environment in Florida to develop an educated workforce. We recently created the BioFlorida Institute, which works at the elementary, middle and high school level as well as the university level to make sure that curriculums provide students with the skills they need to be good employees in the health science sector.

What keeps you motivated to come to work every day?

As corny as it may sound, the things that we’re working on are really going to help people. That’s exciting, and I have a great team of people to work with every day.

The other thing that’s really exciting to me is that I enjoy that interaction between the science and the business community, helping find solutions to move the technology forward.

 

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