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Dr. Janice Parente: A scientist with entrepreneurial DNA

Life-saving drugs must be tested on human subjects before they’re made available to us all. One woman is pushing hard to make sure those subjects get the humanity they deserve.

BY SARAH BARMAK
PHOTOGRAPHY BY ALDO ANDRADE

“I didn’t know I was an entrepreneur,” says Dr. Janice E. Parente. But that was before she started ethica Clinical Research, a company that is changing the drug research industry by putting research subjects before profits. The President and Managing Director of the Montreal-based contract research organization (CRO), which provides conscientious drug testing for pharmaceutical companies, came to realize she was “a scientist with entrepreneurial DNA”—and a savvy businesswoman with a conscience.


A “be the change” inheritance

According to Janice, being an entrepreneur isn’t so much about chasing profits, but having the drive to do business better. She inherited that from her grandfather, Giovanni (John) Parente, who immigrated from Italy to Niagara Falls, Ontario, eventually settling in Hamilton. Despite being arrested by the RCMP and held for almost two years in an internment camp—the Canadian government arrested hundreds of Italian-Canadian men as “enemy aliens” after Canada declared war on Mussolini’s fascist Italian government during the Second World War—he managed to build a successful construction company in Canada after his release.

Janice first saw the need for more ethical drug research practices around 1999 and 2000, when she noticed clinical researchers were experiencing mounting pressure to rush potentially lucrative drugs to market. Health Canada had no regulations to govern drugtesting facilities (and still doesn’t). In particular, the way researchers treated human participants in drug trials (like “human guinea pigs,” she says) horrified Janice.

Unlike many, Janice was in a position to make change from within. A Ph.D in molecular pharmacology with a post-doc in the same area, the academic-turned-businesswoman had been drawn to clinical drug testing early on because, she says, “it connected the lab to real patients.”

In particular, the way researchers treated human participants in drug trials—like “human guinea pigs,” she says—horrified Janice.

She founded a CRO called Integrated Research Inc, in 1992. Under her leadership, it did rigorous drug testing in part, she says, because the pharma companies sponsoring trials still gave researchers a reasonable time frame in which to complete that work. But as drug company sponsors started demanding trials move faster to get profitable drugs to market, it became harder to ensure the trials’ integrity. Janice became determined to implement more stringent procedures at her firm, such as giving researchers adequate time to conduct trials that produce solid data.

When her business partner disagreed that such standards were needed at the company, however, Janice was faced with a choice: stick to the status quo, or set out on her own. She chose the latter, founding ethica, an ethical clinical drug research firm whose guiding principle is “protecting the safety, rights, and well-being of the human research participant.” She knew it was risky, but trusted that her old clients would follow her.


Turning a profit without sacrificing values

Not only did ethica thrive—Janice is proud to say it both turns a profit and places its values first—it became the first CRO to be accredited by the Association for the Accreditation of Human Research Protection Programs (HRPP) in 2006 and Alion HRPP Accreditation Services in 2013, blazing the way for other CROs to do the same. Janice has since been nominated multiple times by Ernst & Young Entrepreneur of the Year Awards, the PROFIT W100 and the RBC Canadian Women of the Year awards. “Before we made our bold move to get accredited, changes in our industry were born of tragedy—like in the airline industry,” she says. “We changed our procedures to prevent tragedy.”


The opportunity of adversity

Her crusade to change the way clinical trials are conducted could leave a lasting legacy for pharmaceutical research in future generations. “When I leave the industry, I want it to be better off for having had us in it,” says Janice. “That means I can sleep at night knowing we’re doing the right thing. Day in, day out.”

“I think that women aren’t as trusting of themselves as men are. I think that we do a lot of second-guessing,” suggests Janice.

Standards at ethica include ensuring vulnerable research participants with limited capacities for decision-making, such as minors, are specifically protected against exploitation, and that all participants know their rights, such as the right to withdraw from the trial at any time and the right to know about all possible side effects. “The physicians have to ask the participant at every follow-up visit to the clinic, ‘Do we still have your consent?’” explains Janice. “The physician has to respect (his or her wishes).”

As to whether there’s anything Janice has learned the hard way, it’s that women should trust their instincts. “I think that women aren’t as trusting of themselves as men are. I think that we do a lot of second-guessing,” suggests Janice. But she founded ethica because she believed her gut feeling that her clients would follow her to a new company.

Though he died when she was too young to remember much of him, she credits her grandfather with her entrepreneurial drive and confidence. “He taught me that from adversity comes opportunity, and to never give up,” she says. He also passed down his instinct to improve things. “I think that if I worked as a checkout girl at Loblaws, within two weeks of working there, I would have designed a better way to bag groceries.”

 


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