Surviving Canada's regulatory environment is key to Covid-19 success, says IMC prexy
Pamela Fralick of Innovative Medicines Canada believes dealing with the PMPRB is one of the bigger challenges during the pandemic
NPC Healthbiz Weekly is presented to you in cooperation with Peak Pharma Solutions
While Canadian Pharma executives don’t know what the environment will look like following Covid-19, or when that might occur, leaders such as Pamela Fralick, president of Innovative Medicines Canada, believe the Patented Medicine Prices Review Board (PMPRB) will play a key role in Pharma’s ability to survive the pandemic.
Innovative Medicines Canada is a national association representing Canada’s research-based pharmaceutical industry. Its goal is to help improve health through the discovery of medicines and vaccines.
“We do need an environment that appreciates innovation and provides that viable business environment, one that provides a balance between regulatory controls but still encourages investment and research activities,” said Fralick (photo below) during a recent episode of the “NPC Podcast,” a program for Pharma executives hosted by Peter Brenders, founder and president of Kontollo Health. (Listen to the episode here.)
“Bottom line, I think the companies that are able to withstand Canada's very unwieldy, complex, uncertain and unpredictable regulatory environment are going to have the best chance of surviving through and beyond Covid-19,” Fralick continued.
“Really PMPRB, believe it or not, is the greatest challenge, I think, to success around the pandemic and beyond.”
While there have been challenges to the Pharma industry as a result of the Covid-19 pandemic, there are also advantages emerging.
According to Fralick, there is an opportunity for Canadian companies to play a bigger role in the the global game plan of Pharma. Fralick suggested the Canadian Pharma industry has evolved into a triple threat prior to, and during, the global pandemic.
She notes that companies invest at least 10 per cent of their revenues into research and development. Additionally, Fralick said industry leaders are competing fiercely to bring more global investment dollars to Canada, adding there is a desire to bring more investment and more manufacturing to the country. Further, Fralick called Canada an attractive country for global Pharma companies because of the talented researchers and research institutions available.
“We have a universal health system that we may like to complain about, it could be better, but it is admired by many,” Fralick said. “We have a diverse population which is ideal for the 4,500 clinical trials that are underway at any given time. We have a great situation.”
One worry that has emerged through pandemic is Canada’s self-sufficiency, said Fralick. It has been a focal point in discussions across governments during the pandemic with the concern centering around personal protective equipment, medication and vaccines, she said.
“There is definitely room for Canada to attract more investment and even manufacturing,” Fralick explained. “[However], all roads lead through the PMPRB. If we cannot achieve a better balance between the cost containment regulatory actions underway, and that desire for more investment, it is not going to happen.”
Fralick’s concern is a situation where products are no longer being launched in Canada, members of the Pharma industry becoming hesitant to come to Canada and clinical trials drying up. She adds it will force researchers to go elsewhere if there aren’t efficient clinical trials in Canada.
“I would say, to sum up, we have an opportunity. Are we ready and able to take advantage of it?” Fralick said.
The takeaway: Fralick notes Canada is in a good situation to draw more investment and innovation into the country, if the industry can get that balance right. “The pharmaceutical industry is global in nature. We understand that. So, we are fighting to bring dollars into this country,” said Fralick.
Further reading: Regulatory issues are not the only factors having impact on the pharmaceutical industry during the pandemic. Covid-19 regulations are also changing the landlord-tenant dynamics. Story here.
YOUR HEALTHBIZ WEEK 10/06/20
A U.S. federal appeals court has thrown out an order requiring AbbVie Inc., and a partner, to surrender $448 million in profits for trying to keep generic versions of the testosterone replacement drug AndroGel off the market. The ruling in an antitrust case by the Federal Trade Commission, the 3rd U.S. Circuit Court of Appeals in Philadelphia said the lower court judge who ordered the surrendering of profits by AbbVie and Besins Healthcare Inc. lacked authority under federal law.
Solid Biosciences Inc. said the U.S. FDA has lifted the clinical halt placed on a trial of its experimental gene therapy for Duchenne muscular dystrophy (DMD). The study was halted in November 2019 for the second time in less than two years after a seven-year-old boy experienced complications, including a decrease in red blood cell count and acute kidney injury.
AbbVie announced that Skyrizi (risankizumab) is now listed as a special authorization drug, or exception drug status, on the formularies of New Brunswick, Yukon, British Columbia, and Newfoundland and Labrador for the treatment of moderate to severe plaque psoriasis. The biologic is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
Swiss drugmaker Novartis said new interim data from an ongoing clinical trial for its $2.1 million-per-patient gene therapy Zolgensma showed spinal muscular atrophy patients experienced significant therapeutic benefit. Nearly two-thirds of patients aged less than six months in the STR1VE-EU study have achieved developmental motor milestones not observed in natural history of SMA type 1, a rare genetic disease, at a mean duration of follow-up of 10.6 months, Novartis said in a statement.
14th ANNUAL NATIONAL PHARMA CONGRESS UPDATE
Chronicle Companies is honoured to host the 14th Annual National Pharmaceutical Congress, a virtual series of weekly webinars. As Canada's largest stage for leaders in the pharmaceutical industry, the Congress presents industry reflections, ideas, and innovations. The Congress has been attended by more than 200 delegates every year and is an opportunity to learn and reflect with the industry's most prominent thought leaders and visionaries. Organized in cooperation with Pangaea Consultants. (Hot tip: NPC Healthbiz Weekly readers get an additional 20% discount on registration fees by using the code NPC20. Just $319 plus HST for the three-day series. (Bursaries may be available for students, retirees and transitioning executives. Contact us for details.)
This scheduled agenda
Wednesday 10/21 11:00 am to 1:00 pm EST
Session 1: Career Advice in the Post-Covid Life Science
Sponsored by ImpresSession 2: Industry Role and Partnerships: Have They Changed Through Covid-19
Sponsored by Digital Partners
Wednesday 10/28 11:00 am to 1:00 pm EST
Session 1: Future External Deployments, Structures and Skill Sets
Sponsored by Shoppers Specialty RxSession 2: Patient Centricity: What Does It Mean in Action?Sponsored by McKesson Canada
Wednesday 11/04 11:00 am to 1:00 pm EST
Session 1: How Do We Launch Products Post Covid-19
Sponsored by Bayshore HealthcareSession 2: Inclusion and Diversity in a Virtual and Real-Life World
Sponsored by Ashfield Healthcare Canada
This scheduled speakers
Pamela Fralick, Innovative Medicines Canada
Andrew Casey, BIOTECanada
Jason Field, Life Sciences Ontario
Ronnie Miller, Hoffmann-La Roche
Brian Bloom, Bloom Burton
Pat Forsythe, Eisai
Danielle Portnik, Mallinckrodt Pharmaceuticals
Marissa Poole, Sanofi Genzyme
Eileen McMahon, Torys
Paul Petrelli, Jazz Pharmaceuticals
Jim Hall, Covis Pharma
Carol Stiff, Santen Pharmaceuticals
Zal Press, CADTH
Brian Canestraro, Intercept Pharmaceuticals
Sylvie Pilon, Emergent Biosolutions
Peter Brenders, Kontollo Health
David Renwick, Emergent Biosolutions
Arima Ventin, Allergan
Ross Glover, Taiho Pharma
others to be announced; see updated list at pharmacongress.info
Profits from the 2020 National Pharmaceutical Congress support Sandi’s Fund for Camp Liberté. More than $50,000 has been raised for Canadian health charities through the National Pharmaceutical Congress.
Watch a “greatest hits” encore presentation from a past NPC event
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 avocation and are an inspiration to others.
More than 100 honourees have been selected during the past 18 years. They stand for, in the view of the selection committee, 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.
2012 Inductee
Wendy Adams
Galderma Canada Inc.
Markham, Ont.
Editor’s note: Wendy Adams has been an employee of Galderma Canada Inc. for more than 23 years, and has held the position as General Manager since 2008.
Whether it is on the baseball field, on the basketball court, or in the hockey arena, sports and the competition in sport are what Wendy Adams enjoys. It’s not so different from competition in the business world where corporate leaders like Adams aim to be strategic.
Starting her career as a sales representative at Marion Merrell Dow in 1989 after completing her degree in commerce at Carleton University in Ottawa, Adams shone early on, being named Medical Sales Representative of the Year, a mere two years after starting with the company.
“I got to work with really smart professionals,” says Adams. “The kick off to my pharmaceutical career was based on good, fundamental grounding.”
She later moved to Product Manager at Marion Merrell Dow where she gained marketing experience. When the company was moving to Montreal, Adams opted to stay in Toronto and embarked on a new challenge with Galderma Canada, joining the dermatology-focused company in 1995.
In 2008, Adams was appointed General Manager of Galderma Canada Inc., after holding a number of senior sales and marketing roles at the company. One role she held leading up to becoming GM was National Key Accounts Manager, a job that entailed targeting pharmacists to increase the visibility of the company’s OTC products. Under Adams, Cetaphil® sales have risen dramatically.
At Galderma, her first major accomplishment was the launch of Differin®, the first new topical retinoid to treat acne in over 20 years, preceded by the U.S. launch. The subsequent entry of Differin XP in 2007 was the first Galderma Rx product to generate $1,000,000 in sales in less than one year after its launch. Today, it is one of the company’s best-selling brands.
A highly visual field like dermatology is a good fit with the digital era, and teledermatology presents an initiative that will help contain costs, observes Adams.
“Teledermatology can be used to reach patients in areas where there are no dermatologists,” says Adams. “Waiting lists are long. It’s time-saving and economical if patients don’t have to take time off work to drive to cities to see dermatologists.”
Another phenomenon that Galderma Canada will need to focus on is the growing diversity of the Canadian population, according to Adams. Clinical trials in Canada will need to ensure patient recruitment reflects the country’s increasing ethnic skew. “We have to consider if our products will work well on different skin types and consider pigmentation challenges,” says Adams.
“Work is rewarding when you are able to balance it with your home life. My husband works from home and he is a huge help with managing the family,” she says. A mom of two boys who are both hockey players, Adams cheers on her children when they play, and they, in turn, cheer on their mother when she takes to the ice.
NEXT WEEK
The 10/13 edition of NPC Healthbiz Weekly will feature Dr. Shafiq Qaadri, a family physician, on the impact Covid-19 has had on physicians and their relationships with the pharma industry. Subscribe and have the issue sent to your phone or inbox each Tuesday at 6:00 am sharp.
Stay safe and stay on your game. We’ll see you again next Tuesday.