Some time in the next decade doctors may routinely prescribe Hematide, a new drug administered once a month, instead of the current leading therapy that requires as many as three doses a week to boost the red blood cell counts of dialysis patients suffering from anemia.
Arlene Morris
When that day comes, Arlene Morris, a Carlow University alumna from the class of 1974, will have played a major part in navigating the complex process of bringing a new pharmaceutical to market.
“We believe Hematide will prove to be much more convenient and easy to use than the current therapy,” says Morris, who is president and CEO of Affymax, Inc., a company based in Palo Alto, Calif., that was spun out of GlaxoSmithKline in 2001 to develop a pipeline of synthetic peptide-based drug candidates for the treatment of anemia in dialysis and cancer patients.
“Right now, we are in Phase Three development of clinical trials for treatment of anemia in dialysis and predialysis patients. Phase Three trials are conducted on a larger population. Our objective in these trials is to show efficacy; but most important is to show that the drug is safe in comparison to other therapies."
Morris, who has headed Affymax since 2003, says that if all goes well with the phase three trials, the plan is to file a new drug application with the Food and Drug Administration (FDA) in 2010. Final FDA approval will take another year or more.
Introducing a new drug to market is a long, involved process that might try the patience of Job, as well as the fortune of Gates. It may take a decade or more to go from discovery to clinical trials to patient delivery, and, in that time, the costs incurred can reach hundreds of millions of dollars.
To raise funds, Affymax, which was formed by venture capitalists, had an IPO—or initial public offering of stock—in the fall of 2006 with tremendous results.
“Our IPO was the most successful biotech offering in the last three years,” Morris says. “We traded up on the first day—which is unheard of—and yielded just under $100 million from the IPO.”
Of course, that $100 million has been plowed right back into the company to fund the trials, further the research, and pay the salaries of Affymax’s nearly 100 employees. Affymax is also fortunate to have a collaborative relationship with Takeda, the largest Japanese pharmaceutical company, to develop Hematide worldwide.
“We’ve been fortunate to have the cash and the people to build the company around,” says Morris. “It’s fun being a small company. With a small company, it’s easier to try out new ideas and decide what we need to get done. You have to be very persistent and figure out how to get the resources you need to accomplish your goals.”
Persistence is something Morris learned early. Born and raised in Washington, Pa., in a family she describes lovingly as “not very adventurous,” she was the first person in her immediate family to go to college.
“I wasn’t sure that I was going to be able to go to college because—quite honestly—my family couldn’t afford to send me” she says.
Instead of depending on her parents, Morris was able to string together grants, scholarships, and part-time jobs to put herself through college. She worked the switchboard in Frances Warde Hall and held similar posts, but then she landed a job that made a diff erence in her life. She began working as an administrative assistant for chemistry and physics professor, Cornelius W. Kreke, PhD.
“He taught me how to organize how I worked, and that has aided me greatly throughout my career,” she says.
Working for Kreke increased her interest in science, biology, and chemistry in particular. She came to Carlow with an interest in science, but left with a desire to make science a part of her career.
“When I came to Carlow, I thought I would go into nursing because my mother had been in nursing, but I quickly discovered it wasn’t for me,” she recalls. “I always did very well in science. I had a high school chemistry teacher who was very encouraging. Carlow emphasized teaching and provided a nurturing, small environment that I thrived in.”
In addition to Kreke, she credits two other faculty members as being great influences: biology professors William Uricchio, PhD, and Mary Ann Sestili, PhD.
Of Sestili’s class, Morris says, “I learned to be a better writer from her genetics class. We were reading and writing papers about science and I loved it.”
Sestili isn’t convinced all of her students loved the work at the time, but she clearly is delighted that she made an impression on Morris.
“You have no idea how something you do affects someone,” says Sestili, who says she tried to address her students as colleagues. “I patterned the genetics class after an experience I had in graduate school. We were assigned to read scientific papers, then engaged in round table discussions with the entire class and professor. He was trying to get us to think as scientists—to take a concept and be able to address it as scientists. That had a profound effect on me, and it spilled over into how I taught the genetics class.”
“She was a great teacher and a great role model,” says Morris, who, at the time, was appreciative of both.
Following graduation from Carlow, Morris went to work for 17 years at Johnson & Johnson (J&J) starting her career as a pharmaceutical sales representative and rising to vice president of business development. Although it’s quite common to see women in that field now, Morris says it wasn’t at that time.
“I was told point blank that ‘we don’t hire women to do this,’” she recalls. “That is a challenge that I am up for—when someone tells me that I can’t do something.”
At J&J, Morris thrived in the business world. She was getting to use the science she learned at Carlow, but she was learning so much about the business of pharmaceuticals.
William “Bill” Weldon, chairman and CEO of Johnson & Johnson, was Arlene Morris’ fi rst supervisor during her days at Johnson & Johnson.
“J&J was great. I received fantastic training there,” she says. “My first supervisor was Bill Weldon (the current chairman and CEO of J&J), and I learned so much. That’s where I developed my analytical and financial skills. It was the right place for me.”
Weldon, who joined J&J in 1971, and has been in his current post since 2002, says that he and Morris have stayed in touch over the years. “It is gratifying to know that her experiences at Johnson & Johnson have helped her in future endeavors,” he says.
As great as the experience was, Morris says that she began looking for new challenges.
“I needed a chance to grow and stretch,” she says. “At some point, you get a feeling that you want to try something new.”
The desire for something new led her to become vice president of business development for Scios, a pharmaceutical company located in Mountain View, Calif., for three years, then to Coulter Pharmaceutical for five years, where she was senior vice president of business development. After that, she spent two years as president and CEO of Clearview Projects, a biopharmaceutical consulting company, before gaining the job at Affymax.
Throughout her career, she has developed a philosophy that women can succeed in science and in business.
“Science can lead to a great career in business. Don’t let anyone tell you that you can’t do it,” she says. “I am living proof that you can. Science led me into this business.”
And she has a simple message for those who encouraged her—even the ones whose intent was to discourage her.
“I thank the people who said I’m reaching too far, as well as the ones pushing me to reach further,” she says. “I achieved everything I have because of them.”
In a few years, it’s a good bet that dialysis patients will have the most cause to be thankful that Arlene Morris excelled in science.
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The Middle States Commission on Higher Education is an institutional accrediting agency recognized by the
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