How clinical trials are bringing breakthrough therapies to Canadian patients
Dr. Angela Genge of the Montreal Neurological Institute is using clinical trials to change patient lives (620 words, 3 min)
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Rare disease affects approximately one in 12 Canadians, and many miss out on treatments that could save or significantly improve their lives. Dr. Angela Genge, Executive Director of the Clinical Research Unit (CRU) at the Montreal Neurological Institute (also known as The Neuro), is working to change that.
In the first episode of Season Five of the NPC Podcast, hosted by Peter Brenders, Dr. Genge (photo below) opines on the role of clinical trials in bringing breakthrough innovative therapies to Canadian patients with rare diseases.
“My passion,” she said, “what’s kept me working in drug development and clinical trials has been to find therapies in those diseases that are currently not well treated. And for better or worse, that’s a lot of neurology.”
“When I started my training in the late ’80s, Multiple Sclerosis (MS) was an untreatable disease,” Dr. Genge said. “Now, MS is like our poster child for how much you can do when pharma partners with academics who develop new techniques and clinical trialists who have the patients—we now have 12 approved therapies for MS.”
Dr. Genge believes the scientific community can apply the lessons of the past to rare diseases “to get to that point in time where all rare diseases have the option of being treatable.”
“Breakthroughs in therapeutics, many of which have been driven by industry, are really making a difference for people with rare disease,” Dr. Genge explained. In her view, clinical trialists are crucial to making these therapies available to the patients who will benefit.
Of course, the nature of rare diseases is that the patients are rare, which presents an obvious challenge for running clinical trials. But according to Dr. Genge, there has been a fundamental shift in the public awareness of rare diseases.
“The most important thing is innovation in therapies, no question,” she said. “What we’re doing now we couldn’t do ten years ago—we couldn’t even do five years ago.”
“The second piece,” she said, “is the patient community itself.” According to Dr. Genge, patient groups and advocacy are driving significant interest in developing new therapies for rare diseases. This attracts attention from “biotechs and large pharmas who have identified potential therapies” and are investing in “the potential of the rare disease market.”
The patient community is also key to finding enough participants for clinical trials, especially in rare diseases. “Our patients are really our partners in this. They have a vested interest in spreading the word when we have a trial opening up.”
Thanks to The Neuro’s proactive outreach to patient networks, Dr. Genge said they often “have patients reach out from around the world.” More importantly, she said, “companies know we will find those patients.”
A bigger challenge is often bringing innovative therapies to Canada in the first place. International companies tend to “look at Canada as a difficult sell for a small market,” Dr. Genge said. “The fact that Health Canada never really implemented an orphan disease program means we’ve never had the opportunity to publicize how effective Health Canada can be with a rare disease.” In fact, she said, the lack of certain structures actually makes Canada an amicable regulatory environment to rare diseases.
Dr. Genge argued that what really matters when it comes to clinical trials is the ability of sites to deliver on patient recruitment, through their networks, and to deliver on quality, “not in terms of their clinical care, but in terms of their clinical trial experience and setup.” And in these respects, she considers the CRU at The Neuro best-in-class.
The future for Canadian rare disease patients? “It’s fantastic,” Dr. Genge said. “In my lifetime, I expect to see several fatal diseases turned into chronic diseases.” And when it comes to bringing innovative therapies to Canada, she said, “why should my patients wait?”
LISTEN NOW
Hear the whole story: In this week’s episode of the NPC Podcast, our host, Peter Brenders talks with Dr. Angela Genge of The Neuro about running clinical trials for neurological conditions and rare diseases, plus how her research unit weathered Covid-19. The NPC Podcast is made possible in co-operation with Impres Pharma and features a series of conversations with pharma industry leaders for their takes on current events.
WEEK 07/27/21
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CANADIAN HEALTHCARE MARKETING HALL OF FAME
The Canadian Healthcare Marketing Hall of Fame awards were established in 2002 to honour healthcare marketers who have contributed to our vocation and inspire others.
More than 100 honourees have been selected during the past 18 years. In the selection committee's view, they stand for a representative cross-section of the qualities that make our business unique and fulfilling. Each week, NPC Healthbiz Weekly will acknowledge one past Hall of Fame Honouree.
2017 Inductee
Allison Rosenthal
General Manager, Otsuka Canada Pharmaceutical Inc.
St-Laurent, Que.
Editor’s Note: Allison Rosenthal is currently VP, CNS Sales & Marketing at Otsuka Pharmaceuticals U.S.
It’s fairly common to hear stories of people who entered the pharmaceutical industry as sales reps and worked their way up through management. However, the career of Allison Rosenthal, General Manager of Otsuka Canada Pharmaceutical Inc., shows that the path to senior management can be different.
She entered the industry in 1994 as a clinical researcher for Bristol-Myers Squibb (BMS)—first in the field and then moving into the office.
While there, she reached out from the research ‘silo’ to connect with co-workers in many departments, including marketing.
“When there was an opportunity to become a product manager, I applied for the job. It was completely and totally unprecedented,” said Rosenthal. “Nobody had ever gone from clinical research to marketing.” She passed the interview well and worked for a time in marketing for BMS before again transferring, this time to sales, which eventually led to a position in sales management.
One project at BMS she said was particularly memorable was the relaunch of Orencia (abatacept), a biologic for rheumatoid arthritis.
“At the time, BMS had never worked in biologics before, and biologics are different [than other pharmaceuticals],” said Rosenthal. “Every different therapeutic area, and every different product, has its own uniqueness and nuances.” Because biologics are so different, they need a different marketing approach, she said.
“I thought [the relaunch] was a great opportunity to come in and figure out where we could improve, go back, re-listen, and relaunch it. And now, all these years later, it is a huge product for BMS all around the world.”
In 2012 Rosenthal took another career step, moving to Otsuka Canada Pharmaceutical Inc., which was a relatively unknown business in Canadian pharmaceuticals.
“That was a bit of a risk,” Rosenthal said. “It was neat because it was an opportunity to launch a pharma company in Canada. To do things a bit differently and attract a team. It was not just about launching a product; it was about launching a company.”
Since 2012, Otsuka Canada has grown significantly in revenue and reputation, she said. “The people I was able to attract then versus the kind of talent that comes to me looking for work [now] is very different.”
Otsuka Canada has had several product launches that Rosenthal said are gratifying. In particular, one stands out: Jinarc (tolvaptan), for the treatment of polycystic kidney disease.
“Of all the products I have launched in my career, including Orencia, Abilify, and Abilify Maintena, Jinarc has been a really gratifying one because it is a first in disease.” It is the first and only pharmacologic intervention for its condition ever approved in Canada, she said.
Rosenthal also sits on the board of Innovative Medicines Canada. In that position, she said, she hopes to help the industry develop a common voice to be better positioned to negotiate effectively with all stakeholders, whether they be government agencies, patient advocacy groups, private payers, or other groups.
“I think as an industry and industry association, we need to really figure out what we want and what could be a win-win Canadian framework for the future,” she said. “All Canadians deserve access to the innovations brought forward by our industry.”
STILL LISTENING? TRY OUR OTHER PODCASTS
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NEXT WEEK
In the 08/03 edition of NPC Healthbiz Weekly, catch Adrienne Blanchard, founder of Blanchard Law, in conversation with NPC Podcast host Peter Brenders on common misconceptions about Canadian law as it applies to Pharma. It’s easy to get your no-charge subscription and have the issue sent to your phone or inbox each Tuesday at 6:00 a.m. sharp.
Stay safe, stay sure, and stay on your game. We’ll see you again after the long weekend.