Janice Parente: The Ethics Of Innovation

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By Maria Cootauco

Janice Parente was 35,000 feet in the air, somewhere between Vancouver and Montreal when she first got a taste of what the world of pharmaceuticals had in store for her.

The industry is now Parente’s forte, on which she has built two successful contract research organizations (CRO) in the past 17 years.

“I had just finished initiating a breast cancer study in Vancouver and was on a plane back to Montreal,” said Parente, the president and managing director of ethica Clinical Research Inc.

“The woman sitting beside me was talking on the phone and mentioned the very name of the doctor I had just met with. Intrigued, I told this woman I had just visited that same doctor and the two of us spoke all the way to Montreal.”

The woman turned out to be Dr. Julia Levy of QLT Inc., a biopharmaceutical company based in Vancouver, who offered Parente a job that was later negotiated into a consultancy.

“That was the foundation of my first CRO, which I ran for 10 years before selling it in 2002,” Parente said.

Today, the Hamilton-born Parente spearheads ethica, a full-service CRO that provides services needed to design, recruit, manage and monitor Phase I-IV clinical studies and provides data management and biostatistical services.

Veritas IRB is ethica’s other division, a non-profit ethics review service of studies conducted North and South America.

“It was one of the best decisions I ever made,” Parente said of her decision to found ethica.

“Over the years, running a CRO in this country, I became increasingly concerned and frustrated with the direction and attitude of the industry concerning the quality of work being conducted and lack of safeguards for research participants.

The emphasis was, and still is in many cases, on doing the work quickly and at the lowest possible cost.”

Parente believed in the need for a CRO that was “more thoughtful and about the work it was doing and that was research participant-centric in its processes and values.”

With ethica, Parente is grateful for the opportunity to have to the freedom to turn away businesses that she believes conflicts with her personal and company values.

“I sold my company so that I could have this philosophy,” she said.

As an extension to the company’s deeply rooted commitment to conscientious research, ethica became the first Canadian company, and the only CRO in the world, to be accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP).

“We haven’t looked back since,” Parente said of the milestone.

As a result of getting accredited, she believes ethica is having an impact on the way research is now being conducted in Canada.

“Sponsors of research are using, as part of their risk-management process, good CRO’s who do good quality work and aren’t just looking at revenue stream when they accept studies,” Parente explained.

“In this industry, we’ve seen many examples of this. You truly get what you pay for when you outsource your research to CRO’s. That’s it in a nutshell … The emphasis seems to be on looking for contractors who can do it fast and cheap like fast food.”

Ethica has made it an imperative to serve up carefully prepared research, dishing out transparency in its research and a commitment to integrity.

“(AAHRP accreditation) is an assurance of quality given the rigorous standards that are part of the accreditation process,” Parente said.

“This higher level of quality ultimately leads to better, more reliable and rigorous data and a reduced likelihood of unforeseen delays in the regulatory approval process.”

Most recently, Pfizer became the first pharmaceutical company to achieve AAHRPP accreditaion for its Clinical Research Units in Conneticut, Brussels and Singapore.

“I guess ethica and Pfizer share a lot in common,” Parente said.

“I know the word is overused, but being mavericks, being trendsetters. So hopefully people will see that accreditation is important and follow our lead.”

The process took ethica one year to revise its current standard operating procedures to the standards of AAHRP.

Maintaining the accreditation is an ongoing process for the company, with employees dedicated only to maintaining the accreditation in the quality assurance department.

Parente is buoyed by a small shift she’s been seeing in the industry of CRO’s considering accreditation. One CRO has even approached ethica for assistance with the process.

“Other CRO’s probably don’t see it as anything of added value and I think that is a very short-sighted view of what the industry holds for the future,” Parente said.

Meanwhile, ethica has been reaping the benefits of operating under the stringent regulations of AAHRP. According to Parente, some sponsors will only work with an accredited organization board.

“I think when you work with an accredited organization like ethica and you don’t know what accreditation means, you will quickly find out about the quality of service, the depth of knowledge within the organization and the accountability that we have to our clients and AAHRP,” Parente said.

Over the past two years, ethica has expanded its global reach by developing emerging markets in India and South America.

“Why is the industry moving there? I think it’s dollars and cents” Parente opined.
“The profitability really is much greater in the emerging countries.”

Parente also points to the fact that a “purer” sample can be found in the populations of countries that have not seen as many drugs over the years as developed countries. Additionally, the sheer number of patients available for studies makes developing countries an attractive choice for the pharmaceutical industry.

“For example, diabetes in India, the study could be done in basically one month,” Parente said.

“If you tried to do that study in North America, it would probably take you a year to enroll the same number.”

This year, the company acquired unique artificial technology from Matrix Pharma that allows ethica to extract new insights from its clients’ clinical data. The technology uses computational algorithms to analyze complex clinical data sets and identify relationships within the data that elude the conventional statistical tools that are routinely used in the industry.

“It’s like having Einstein working down the hall,” Parente said.

“This technology was employed to determine why 20% of colon cancers were unresponsive to chemotherapy and radiotherapy.”

For all the success Parente has found in the field of pharmaceuticals, an attitude fuelled by moxie and hard work has been a common theme governing Parente’s professional achievements.

Taking that fateful flight from Vancouver to Montreal may have been a catalyst, but Parente’s work ethic was present long before then.

When she graduated from high school, Parente’s father offered her simple advice.

“He said, ‘I want you to go to school to get an education, not a job.’” Parente recalled.

“That’s why I stayed in school so long. When I finished my post-doc, I was still quite young and tired of being poor. My first salary was very, very low, but at the time, I felt like I’d won the lottery.”

Having been at the helm of ethica since 2002, Parente has cultivated the key to her company’s success – its ability to innovate and evolve.

“I took the advice of my father,” she said.