Some factors related to rare-disease drug development are forcing sponsors to reconsider the economics and structure of clinical trials. The conventional clinical trial model was built for diseases with larger pools of eligible participants, but for rare diseases, small and dispersed patient populations can make these trials difficult.

Recruitment may be one of the biggest operational challenges in rare-disease trials since they may require identifying a small number of eligible patients across multiple countries and specialist centres. A study in Therapeutic Innovation & Regulatory Science involving patients and healthcare professionals in respiratory and rare diseases found that reducing travel and allowing more activities to take place remotely could make participation easier. However, preferences varied among participants, particularly around technology and face-to-face contact. A review in Drug Discovery Today found that regulatory differences between jurisdictions create another challenge for multinational rare-disease programs. These variations in definitions, criteria, and regulatory processes can make greater global alignment more difficult.

Limited understanding of many rare diseases also complicates endpoint selection and statistical analysis. A 2025 review in Drug Discovery Today found that the rarest diseases are especially difficult to study and highlighted decentralized trials, digital technologies, and greater regulatory coordination as ways to make development more feasible. The U.S. FDA’s September 2025 draft guidance for cell and gene therapies in small populations similarly encourages sponsors to consider innovative trial designs when traditional approaches may be impractical.

Natural-history studies, which track how a disease or condition progresses over time, are also an important part of rare-disease development. In 2026, the FDA renewed funding for research designed to produce high-quality natural-history data, address critical knowledge gaps, and support more efficient rare-disease drug development. A review published by Cell Press found that natural-history data can serve as external controls when randomized trials are difficult or unethical. However, regulatory acceptance depends heavily on data quality, patient comparability, and clinically meaningful endpoints.

The relationship between sponsors, researchers, and patients is also becoming more important to trial execution. The European Rare Diseases Research Alliances (EDERA) notes that eligible patients may be very few, spread across several countries, and must be followed by highly specialized teams. ERDERA’s 2026 funding model requires multinational trials to bring together appropriate expertise, sites, patient partners, and a coordinating investigator early in development.

Recruitment models are also changing as patients and caregivers increasingly find trials on their own initiative and contact research sites directly. Worldwide Clinical Trials argues that stronger relationships between sponsors, research organizations, and sites can improve communication and provide greater flexibility. Partnerships with patient organizations can also help raise trial awareness and support pre-screening.

The Takeaway: Long-term follow-up adds another layer to the economics, particularly for gene therapies intended to produce durable or permanent biological changes. A Drug Discovery Today review found that long-term follow-up for gene therapies requires sponsors to balance regulatory requirements, operational feasibility, and patient retention when designing post-authorization studies. It also identified greater international harmonization and collaboration as important priorities..

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THIS WEEK 08/18/26

• Kye Pharmaceuticals’ melatonin extended-release tablets (Slentyo) are now available in Canada for the treatment of insomnia in children and adolescents aged two to 17 years with autism spectrum disorder and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficient.

• Roche Canada announced that inavolisib (Itovebi) is now publicly funded in Quebec. It’s indicated for eligible adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer.

• Health Canada granted a Notice of Compliance for AstraZeneca’s benralizumab (Fasenra) as an add-on to standard therapy for patients aged 12 years and older with hypereosinophilic syndrome without an identifiable non-hematologic secondary cause.

• Bristol Myers Squibb announced that the U.S. FDA approved iberdomide (Zenbexus) in combination with daratumumab, hyaluronidase-fihj, and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent.

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Christopher White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Susanne Cookson
Burlington, Ont.

Editor’s Note: Susanne is President and Co-Founder at BestLifeRewarded Innovations Inc. as well as President at Cookson James Loyalty Inc.

A genuine compassion for people and a unique ability to inspire others are just two of the reasons why Susanne Cookson is considered such a valuable industry asset. And these characteristics have served her well in her 18-year journey to the position she has today, Senior Product Manager for Boehringer Ingelheim’s blockbuster CV drug, Micardis.

Cookson’s journey has indeed been an interesting one, starting with her first job in 1987 as a Cardiology Technologist for McKellar General Hospital in Thunder Bay, Ont. A number of progressive positions followed, including Manager of the Cardio-Respiratory Department at Milton District Hospital and Manager, ECG Department at Etobicoke General Hospital, a series of jobs that provided her with the invaluable opportunity to work “one on one with patients... and to be able to help them in some small way.”

Having spent nine years on the hospital side, however, Cookson felt she was ready for a change which would soon present itself as a job in health promotion at the Heart & Stroke Foundation. The role would prove to be an excellent “grooming ground” for the aspiring marketer who got a taste of government lobbying and designing healthcare strategies that helped change how stroke was managed in Canada.

Always looking for a challenge, Cookson felt she was “missing something”. As she recalls: “It was either go into government health promotion or the private sector and see if I could make a difference there.” Deciding on the latter, she determined that the company she would work for would be “a company that was ethical, and I had to work on a product I felt passionate about.”

The ideal opportunity arose at Ortho Biotech, where Cookson’s expertise was put to good use by creating educational programs and advocacy workshops to help patients gain equitable access to Eprex, a biologic for cancer patients receiving chemotherapy. She took another role to gain further experience with the sister company of Ortho Biotech, Janssen Ortho, as Specialty Sales Representative for the CNS products Risperdal and Concerta, and this would be her last at the company when an earlier resolution to achieve a “better work/life balance” became a reality. “I wanted to be closer to home,” says Cookson, who was spending up to three hours a day commuting from her home in Burlington, Ont. to Don Mills.

A move to Boehringer Ingelheim over a year and a half ago has been an absolutely positive move both personally and professionally, she says. Cookson set her sights on “a good, ethical company to work for; together with the desire to work on a product that is both going to significantly help patients and with enough of a lifecycle to be a challenging marketing experience,” and says her goals have been achieved working on the Micardis brand.

These days, Cookson is committed to leading her team in preparation for the launch of “the largest cardiovascular trial ever.” The ONTARGET trial, conducted in conjunction with McMaster University in Hamilton, has over 30,000 patients worldwide and will compare the efficacy of the ACE inhibitor ramipril vs. Micardis, as well as looking at the efficacy of a combination of the two drugs.

“I’ve never treated a job as if it’s a job—it’s part of me,” she adds. “I tend to seek out things that are challenging and of a high level of importance to me. I think it started with being afforded opportunities, starting with the not-for-profit area, and seeing what was possible and how you can really affect change with what you do. I guess that’s always followed me.”

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It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Associate Editor.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

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The rising costs of specialty drugs are putting more pressure on Canadian payers to determine whether new therapies deliver enough clinical value to justify their cost. According to TELUS Health, specialty medications accounted for 33.9% of eligible drug spending in Canada’s private drug plans in 2025 (up from 32.7% in 2024), despite being used by only 2.1% of claimants (up from 1.9% in 2024). Drugs classified as ultra-high-cost, meaning those priced at least C$100,000 annually, made up 5.2% of eligible spending. The federal government also found that the introduction of newer, higher-cost medications is a key factor in the rising drug costs. By 2023, drugs costing more than C$10,000 a year accounted for one-third of private-plan drug costs.

Private payers are responding by placing greater emphasis on appropriate use rather than broad access. Express Scripts Canada reported in its 2025 Drug Trend Report that specialty drug spending per plan member increased by 2.7% in 2024, while specialty claims rose by 9.3% and the number of members making at least one specialty claim increased by 15.7%. The report attributed the growth partly to the expanding number of specialty medications and new indications for inflammatory diseases, skin conditions, and cancer. At the same time, biosimilars are helping offset some of those costs. Express Scripts Canada reported lower spending on adalimumab and infliximab in 2024, partly reflecting biosimilar transition policies introduced in recent years. TELUS Health also noted that biosimilar use continued to rise, with 67.4% of eligible biologic claimants using a biosimilar in 2025, compared with 56.9% in 2024 and 44.6% in 2023.

Public reimbursement is also placing greater emphasis on the value a particular treatment delivers. The pan-Canadian Pharmaceutical Alliance (pCPA) says evidence guides every negotiation, including health technology assessments of a drug’s clinical value and cost-effectiveness. The organization estimates that its negotiations saved public drug plans C$4.87 billion in 2025-26. The pCPA also notes that temporary coverage for patients requires a risk-sharing agreement with the manufacturer and cost-effective pricing during the interim funding period.

That approach highlights the importance of evidence generated after regulatory approval. According to Canada’s National Strategy for Drugs for Rare Diseases, provinces and territories have committed to working on projects that improve the generation and use of real-world evidence for reimbursement decisions. The strategy’s common drug list is also designed to support the collection, evaluation, and use of real-world data. Canada’s Drug Agency has also expanded work on rare-disease registries to strengthen Canadian real-world evidence where traditional clinical data may be limited. The agency funded 18 organizations to improve registry quality and generate data that can support regulatory and reimbursement decisions. Time-limited reimbursement similarly makes continued funding dependent on additional evidence and future reassessment.

Pricing and evidence decisions are also happening earlier in the launch sequence. For example, the pCPA’s Early Negotiation Process allows negotiations for eligible Project Orbis cancer drugs to begin when Canada’s Drug Agency (CDA-AMC) or the Institut national d’excellence en santé et en services sociaux accepts the health technology assessment (HTA) submission, months before negotiations would begin through the standard pathway. The pCPA can close the file if acceptable terms are not reached, while any successful agreement remains conditional on a final positive HTA recommendation. The pCPA also extended its Targeted Negotiation Process (TNP) in 2025 to drugs using the CDA-AMC’s Pharmaceuticals with Anticipated Comparable Efficacy and Safety pathway, creating a streamlined route for products similar to existing therapies. The TNP requires cost-effective pricing and can also close without agreement if acceptable terms are not reached.

The Takeaway: The pressure is unlikely to ease as more high-cost therapies and expanded indications enter the market. Alberta Blue Cross identified the continued launch of newer, higher-cost medications as a growing pressure on private drug plans in its 2026 pipeline assessment. It also pointed to GLP-1 therapies and their expanding indications as an ongoing source of cost growth. Similarly, TELUS Health found that increasing specialty-drug utilization and the arrival of new specialty therapies are now outweighing the savings generated by biosimilars. As these pressures grow, payers are likely to demand stronger evidence of value before committing to broad or long-term coverage.

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THIS WEEK 08/11/26

• Health Canada issued a Notice of Compliance for Regeneron’s cemiplimab for injection (Libtayo). It’s indicated for the adjuvant treatment of adult patients with cutaneous squamous cell carcinoma at high risk of recurrence after surgery and radiation.

• The U.S. FDA granted accelerated approval for Replimune’s vusolimogene oderparepvec-wtpg (Tudriqev) in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who have progressed on an anti-PD-1 antibody-based regimen.

• Health Canada approved Merck’s pembrolizumab for injection (Keytruda) in combination with enfortumab vedotin as neoadjuvant treatment. Then it continued after radical cystectomy as adjuvant treatment, for adults with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.

• Takeda announced that the U.S. FDA approved oveporexton (Orzeyful), an oral orexin receptor 2 agonist, for the treatment of narcolepsy type 1 in adults.

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Christopher White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Philip Blake
Toronto

Editor’s Note: Philip retired in 2020.

Philip Blake demonstrates his passion for the pharmaceutical industry in everything he says and does. In fact, his devotion to the advancement of healthcare in Canada is equalled only by his respect for the people who work in it. Despite a dizzying travel schedule, Blake nevertheless ensures he connects with staff and customers as much as possible. Being the “face” of the company is extremely important, says Blake, who asserts, “You don’t do business by sitting in head office counting invoices and developing strategies. You do business by really being out there and working with policymakers, understanding their issues, talking with our patients/customers, physicians, and being as close as possible to the people within Bayer.”

Blake, who brings 20 years of experience to his post as President and CEO of Bayer Inc.’s Canadian operation, is a die-hard company man, having spent his entire pharma career with the company. In his first job at Bayer in the U.K., where he was born, Blake says he spent 10 years doing “every job there is on the commercial side,” before pursuing progressive appointments in Germany, Japan, and the U.S., where he focused on drug development, marketing, and brand strategy development.

He concedes, however, that pharma wasn’t his first career choice, having studied medical microbiology at university in the U.K., and working in clinical research for several years. With no aspirations to go into medicine, his interest turned to pharma when he realized “the real benefits we could bring to people would be by improving the way treatments are delivered and providing physicians with better choice.”

That continues to be a mandate for Blake, who, over the last six years in Canada, has overseen the Consumer Care Division, Diabetes Care Division, Animal Health Division, and Bayer Material Science Division in Canada. Two “exciting” developments are keeping him ultra-busy these days -- the separation of the chemical and agricultural divisions from the healthcare side and the recent acquisition of Berlex’s business,s which Blake says will strengthen Bayer’s healthcare presence significantly. Moreover, the combined pipeline of Bayer and Schering is “certainly one of the strongest in the industry with a large number of Phase I and Phase II products in major areas.”

Blake says he is proud to have been able to build Bayer into one of the top five healthcare companies in Canada, adding, “Sticking to your focus of having strong Rx&D is what’s going to build this industry now and into the future.” Canada, he says, is a country with the greatest opportunities. “It’s nice to see that policymakers and politicians remain very open to working with our industry. Many other countries haven’t developed such a sophisticated relationship,” he observes.

Blake, who is slated to be chairman of Rx&D (now Innovative Medicines Canada) in 2007, is optimistic about building on the work that’s been done by his Rx&D predecessor, whom he credits with maintaining a cohesive industry approach to working with government and provincial providers. He has “great respect” for the integrated healthcare systems in Canada, adding,g “We have to help the integrated system provide better access to Canadians for the huge advantages they can now gain from using modern pharmaceuticals. That’s the job of our industry.”

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Associate Editor.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Pharmaceutical quality systems are moving away from paper records and spreadsheets toward digital platforms as regulatory expectations change and companies incorporate artificial intelligence into quality management. According to software company MasterControl, pharma companies are turning to digital quality systems to support AI and perform remote regulatory assessments. The company noted that records must be searchable, securely shareable, and easily accessible to support these remote assessments. In August 2025, cloud software company Veeva reported that using standardized, structured quality data can improve reporting, dashboards, and trend analysis while helping pharma companies proactively identify risks and allocate resources more efficiently.

Regulatory developments are reinforcing the shift from documenting compliance to continuously measuring how well quality systems perform. For example, the U.S. FDA continued advancing its Quality Management Maturity program in 2025 and 2026 to encourage drug manufacturers to adopt quality management practices beyond current good manufacturing practice protocols. The agency has also emphasized the use of quality metrics to support continuous improvement, risk-based oversight, and more resilient pharmaceutical manufacturing.

Artificial intelligence is also transforming digital quality systems from tools for workflow automation and retrospective reporting into platforms that support proactive quality management. The European Medicines Agency’s 2025 AI Observatory report found that regulators are increasingly using AI for knowledge mining, process automation, data analysis, and decision support. The report also highlighted continued work to develop guidance for the safe and responsible use of AI throughout a medicine’s lifecycle.

The Takeaway: Digitization is also changing how pharmaceutical companies manage quality across contract manufacturers, suppliers, and other external partners. Venture capital and investment banking firm First Analysis reported that connected quality systems help pharmaceutical companies share data with suppliers and contract manufacturers, improve oversight, and maintain compliance across the supply chain. Cloud-based platforms are also becoming a standard component of modern quality operations. Cloud quality management software company Kivo noted that cloud-based quality systems enable real-time collaboration across locations, devices, and time zones.

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THIS WEEK 08/04/26

• Health Canada issued a Notice of Compliance for Novartis’ remibrutinib tablets (Rhapsido) for the treatment of chronic spontaneous urticaria in adult patients who remain symptomatic despite H1 antihistamine treatment.

• The U.S. FDA approved Otsuka Pharmaceutical’s centanafadine (Simtriyo) for the treatment of attention-deficit hyperactivity disorder in adults and pediatric patients aged six years and older weighing at least 20 kg.

• Bausch Health announced that pimecrolimus cream (Elidel) is now listed under Alberta’s public drug plan for eligible patients. Elidel is indicated for second-line therapy for short-term and intermittent long-term therapy of mild to moderate atopic dermatitis in non-immunocompromised patients three months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks. It’s also indicated for the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies.

• The U.S. FDA approved Viatris’ norelgestromin and ethinyl estradiol transdermal system (Gwyn Lo), a combined hormonal contraceptive patch with low-dose estrogen for women of childbearing potential with a body mass index below 30 kg/m².

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Christopher White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Daryl Erickson
Beaconsfield, Que.

Editor’s Note: Medical Communications Group Inc. was sold in October 2013 and is now Ashfield Canada Inc. Erickson’s son Jason Erickson is the CEO. Daryl Erickson died in September 2025.

Few industries can inspire the entrepreneurial spirit quite like the pharma industry, and nobody knows this better than Daryl Erickson, president of Medical Communications Group Inc. His rewarding 12-year career in pharmaceutical sales provided the inspiration for a successful service to the pharma industry and to practicing physicians.

Erickson’s 30-year association with healthcare started in the early ’70s when a relative introduced the aspiring high school teacher to the world of pharma. He laughs as he recalls a job interview with a woman at a placement agency who suggested, “You’re a Libra, and Libras make excellent pharma reps.” In 1973, he was hired by Horner Pharmaceuticals as a sales rep with a territory covering Ontario’s Niagara Peninsula. Erickson was euphoric with a starting salary of $7,400 and a 1972 Plymouth station wagon as a company car. “Back then, for a guy driving a Volkswagen Beetle to university--that was huge!”

By 1977, Erickson was heading up the Sales and Training Department in Horner’s head office in Montreal, planning to head back to Ontario in two years. By 1982, however, it was clear he wouldn’t be returning when Abbott came calling with an offer that he couldn’t refuse. “I learned to love Quebec, and I’ve been here ever since,” he chuckles.

After two years at Abbott, and at the age of 40, Erickson tired of the corporate life and struck out on his own. Married and with two children, he admits the move was “scary,” but in 1985 started Direct Access Communications. It was a “virtual” salesforce concept consisting of nurses who provided product information and updates to physicians via telephone. A year later, Erickson would use his background and experiences in pharma to define a new business concept that would address glaring problems in pharmaceutical sampling.

Erickson noted that unused and expired samples were spilling out of doctors’ supply cabinets as a rep. It was the catalyst for Erickson’s next business venture in 1986, Physicians’ Hotline, which streamlined the dissemination of samples and educational materials by providing samples to physicians on demand.

The process required physicians to sign up for a six-month program, then call and order samples from a catalogue by phone, which was “a tough sell.” But he credits many friends and colleagues in the industry for helping him on his way. He’s particularly grateful to his former boss at Horner, who heartily endorsed the idea, awarding him three of the company’s products and the use of their entire doctor database. The kindness of the gesture still overwhelms him.

However, the defining moment for the fledgling company occurred in a late-afternoon meeting with Janssen-Ortho. “I had six or seven products, but I knew I had to have at least 12 to make it viable,” Erickson says, and his hopes were pinned on snagging one of Ortho’s key contraceptive products. However, to his delight, the team awarded Erickson four of their oral contraceptives. He clearly remembers “calmly saying thanks, walking to the car, rolling up the windows,” and, unable to contain his excitement, “I slugged the dashboard and cracked it in half.”

Today, the Physicians’ Hotline catalogue features 190 insertions and ships around 6,000 orders a month on the program. “It’s always a thrill to hear pharmaceutical reps tell me that they see the Physicians’ Hotline book on doctors’ desks all the time when they’re making calls.”

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Associate Editor.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Canada is an important life sciences market, but its global competitiveness is under pressure. According to the Government of Canada, Canada was the world’s ninth-largest pharmaceutical market in 2025, a standing that relies on partnerships between academia, government, research centres, biopharmaceutical companies, and contract research organizations. The federal Biomanufacturing and Life Sciences Strategy notes two national priorities: strengthening Canada’s domestic life sciences sector and improving preparedness for future health emergencies.

Recent investments have expanded Canada’s capacity beyond early-stage research. In March 2025, the federal government committed $49.9 million toward STEMCELL Technologies’ $222-million project to establish two new biomanufacturing facilities in Burnaby, B.C., that will produce specialized inputs for vaccines, therapies, and diagnostic technologies. (All figures in this report are in Canadian currency.) In September 2025, the government reported more than $2.5 billion had been invested in Canada’s biomanufacturing and life sciences sector since March 2020, supporting 43 projects. In 2025, the government also provided $62 million toward Entos Pharmaceuticals’ $198.5-million Alberta biomanufacturing project to produce next-generation genetic medicines. Federal investment continued in 2026, with $127 million announced for Aspect Biosystems and Providence Health Care in British Columbia. The projects involve bioprinted tissue therapeutics, clinical development infrastructure, and advanced manufacturing.

Canada also maintains important advantages in clinical research. In early 2025, AstraZeneca expanded its Mississauga, Ont. research and development operations, with the company leading more than 210 clinical studies in Canada. According to the government, Canada’s research hospitals, academic institutions, and diverse population support clinical research, while Pan-Canadian and provincial networks also help coordinate studies across multiple jurisdictions.

The Takeaway: Access to capital remains a significant challenge. The Canadian Venture Capital & Private Equity Association reported that while overall venture capital activity slowed in the first half of 2025, life sciences continued to attract investment. According to Paradigm Capital, Canadian life sciences companies also face a higher cost of capital than many international competitors, making it harder to finance growth and commercialize innovations from within Canada.

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THIS WEEK 07/28/26

• The U.S. FDA approved Merck’s enlicitide tablets (Lipfendra) as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia.

• Health Canada approved Aspen Pharmacare Canada’s semaglutide injection (Aspen-Semaglutide), a generic equivalent of Ozempic, for the treatment of adults with type 2 diabetes mellitus to improve glycemic control, in combination with diet and exercise.

• The U.S. FDA granted Orphan Drug designation to Affinia Therapeutics’ AFTX-201 for the treatment of BAG3-associated dilated cardiomyopathy.

• GSK announced that the U.S. FDA approved zidesamtinib (Jideytro), a ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who have received a prior ROS1 kinase inhibitor.

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Christopher White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Terry Johnson
Toronto

Editor’s Note: Terry retired in 2013.

Terry Johnson remembers the days when he was one of “three guys” with a dream of creating an ad agency with a difference. Now, some 22 years, three companies, and 160 employees later, the President and CEO of Allard Johnson Communications Inc. is a well-respected presence in healthcare communications.

Johnson, who came to marketing and advertising from the pharma side, credits “100 percent dedication” to helping him build his agency empire. But 10 years spent on the pharmaceutical side in sales and product management with Warner-Lambert (Pfizer), and Johnson & Johnson (Ortho) helped set the stage for his foray into advertising.

His ad agency debut would materialize when he landed a job with Borg Advertising, Canada’s first pharmaceutical advertising agency. But one year later, it was a partnership with seasoned ad men David Lindley and Richard Billinghurst that would create the fledgling agency Lindley, Billinghurst and Johnson (LBJ). What followed would be a series of mergers, acquisitions, and new ventures that would establish LBJ as a significant player on the Canadian agency scene.

Constantly scanning the horizon for new business opportunities, Johnson would enter the P.R. arena in 1993 when he started Veritas Communications, a leading P.R. and G.R. firm. The acquisition of Integrated Healthcare Communications would soon follow, as would the merger of LBJ with FRB (Social Marketing Firm), which resulted in the formation of LBI.FRB Communications. In 1999, the company merged with Allard & Associates in Montreal and later with Campbell & Associates Advertising, adding financial services, consumer packaged goods, and retail expertise to their portfolio.

Johnson has recently tapped into the burgeoning wellness market with a new division: Ingredients Nutritional Insight Group. Drawing on the P.R. talent of Veritas, the educational expertise of IHC, the creative know-how of Allard Johnson, and the services of a nutritional expert, the virtual company provides much-needed services to the commercial food industry. Another new startup, Pharsite, is an interactive media group designed to round out A.J.’s other offerings.

Johnson remains low-key about his accomplishments, suggesting that the ultimate measure of success is “how long you keep your clients.” He adds, “Our clients have made us what we are,” pointing to long-standing clients such as Purdue Pharma. “We owe our success to Purdue Pharma. They were the first client to say ‘we believe in these guys,’ and they’ve stayed with us for over two decades.”

But while Johnson attributes much of his business success to excellent account servicing and unparalleled creativity, he also strongly believes that agencies must take a mentoring role with product people. On the client-side, there’s little time for mentoring, and it should be every agency’s mandate to nurture product people with the experience they have. “In the old days, you could make mistakes. It was part of your training,” says Johnson, reflecting on his rookie days as a pharmaceutical marketer.

Johnson says that helping clients to “grow their products” and “hearing that they’re happy with the work you do” is key. “It sounds like motherhood, but you wouldn’t survive as long as I have in the industry if that wasn’t why you were there.”

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It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Associate Editor.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

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Artificial intelligence is moving away from pilot projects and becoming a practical business tool in pharma to improve operational efficiency and speed up tedious processes. Reuters reported that companies are already seeing the greatest benefits from AI in clinical development, patient recruitment, trial site selection, and regulatory document preparation. For example, Novartis used AI-assisted analysis to reduce a clinical trial site selection process to a two-hour meeting from four to six weeks. While drug discovery remains an important long-term goal, AI’s most immediate impact is occurring in operational areas.

Organizations are also rethinking their customer engagement strategies. Professional services firm PwC emphasizes that companies transitioning from legacy Customer Relationship Management (CRM) systems should avoid replicating existing processes and instead use this opportunity to build adaptive, AI-driven commercial models aligned with the needs of the current and future customer base. Cloud software company Veeva predicts that companies will prioritize industry-specific AI applications for mission-critical processes instead of broad AI experimentation. The company highlights launch planning, commercial workflows, and medical, legal, and regulatory (MLR) review as areas where AI can deliver measurable business benefits.

Medical affairs is undergoing a similar transformation as healthcare professionals increasingly use AI tools to access scientific information. IQVIA reports that generative AI is becoming the first option clinicians turn to for medical information, prompting pharmaceutical companies to rethink how they deliver scientific content and engage with healthcare professionals. At the same time, the company notes that medical, marketing, and compliance teams will need to adapt their workflows as AI changes how scientific information is generated and accessed.

As AI adoption expands, governance is becoming increasingly important, and it’s not just about increasing automation to speed up processes. The International Society for Pharmaceutical Engineering (ISPE) emphasizes that AI implementation in regulated environments must maintain product quality, patient safety, and regulatory compliance throughout the product lifecycle. European Pharmaceutical Review notes that fragmented data, disconnected systems, and manual workflows continue to slow regulatory operations and limit AI, especially for mid-sized pharmaceutical companies with constrained resources.

Bottom line: Successful implementation will require clear governance, validation, and human oversight.

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THIS WEEK 07/21/26

• Health Canada approved Novartis’ atrasentan tablets (Vanrafia) for proteinuria reduction in adults with primary immunoglobulin A nephropathy at risk of rapid disease progression.

• The U.S. FDA approved Celcuity’s gedatolisib (Revtorpyk). It is for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

• Shionogi announced that the U.S. FDA has accepted a Supplemental New Drug Application for cefiderocol (Fetroja). The therapy is used to treat patients at least 26 weeks of gestational age with hospital-acquired and ventilator-associated bacterial pneumonia and complicated urinary tract infections, including pyelonephritis, caused by certain Gram-negative microorganisms.

• The U.S. FDA approved Sanofi’s subcutaneous isatuximab-irfc (Sarclisa Escena) in combination with standard-of-care regimens for the treatment of patients with multiple myeloma across all existing indications for the Sarclisa intravenous formulation.

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Christopher White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Joseph (Joe) Knott
Oakville, Ont.

Having spent 35 productive years in pharma-related sectors, Joseph (Joe) Knott is a fixture in the healthcare marketing scene. Indeed, the “resident president,” as he is known to friends and colleagues, has garnered a reputation for identifying marketing trends and for his savvy networking skills.

Knott is the first to admit that in three-and-a-half decades in the industry, “I’ve seen most of it happen, and I do work a room well.” That connectivity to upper management is one of his company’s most significant assets, says the CEO and founder of the Pangaea Group of Companies, a marketing, training, and customized consulting firm.

No stranger to the presidential role, Knott honed his skills at the helm of two major pharmaceutical companies. But like most who hold the reins of power in the pharma industry, Knott paid his dues the traditional way, beginning his career fresh out of university as a territory rep for Pennwalt Inc.’s pharmaceutical division in Kitchener, Ont. He advanced through a series of positions, including divisional sales manager, national sales manager, and director of marketing, before earning a promotion to president/general manager, a remarkable achievement since “I was CEO by the time I was 35.”

His next career move to president/general manager for the pharmaceutical division of Fisons Corporation Ltd. in Toronto proved to be the last time he would work for someone else. After five years of overseeing the launch of numerous ethical and OTC products, negotiating strategic business alliances and spearheading Fisons into an era of solid growth, Knott parted ways with Fisons just before the company’s merger with Rhone Poulenc. But as one door closed, another fortuitously opened for Knott, who discovered “an entrepreneurial side of me I didn’t realize was there.” His departure from Fisons became the catalyst for a private consulting practice, J.D. Knott and Associates, and one year later, the establishment of Pangaea Consultants, a marketing, training, and customized consulting company. Today, the now 11-year-old company consists of three divisions that have evolved to meet changing industry needs. They include Pangaea Customized Consultants, devoted to “best-in-class benchmarking,” Pangaea Trade & Logistics, specializing in trade relations, and Pangaea Development & Training, the company’s marketing and sales force training and talent management arm.

But Knott maintains that one of his proudest moments had less to do with business success than a resolve to give something back to the industry. Observing the lack of mentoring for new pharma recruits, he created an educational program to provide tactical skills and insight into current challenges in the healthcare marketplace. When the program, Marketing Pharmaceuticals in Canada, was launched in conjunction with Toronto’s Humber College Institute of Technology and Advanced Learning two years ago, it was “a dream come true.” With eight CEOs to share best practices and lessons learned during the four-day intensive program, the program has been embraced by 42 companies and 128 participants, with Knott as the lead facilitator.

Working in the healthcare industry has been a wonderful experience, says Knott, who observes, “I couldn’t think of anything I’d rather be doing than what I’m doing right now.” Playing more golf and travelling, two of his favourite activities, remain on the back burner as he and his spouse, Margie, devote quality time to their blended family of seven children and two grandchildren. The rest of his time is spent selling. “Exactly what I wanted to do all my life,” he says.

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Smaller biotechnology companies are operating in a very different financing environment than they were just a few years ago. According to consulting firm EY, the financing environment for biotechnology companies has improved, but investments remain highly selective. EY’s 2026 Biotech Beyond Borders report found that the biotechnology industry raised US$68.5 billion in financing during 2025, an 11% increase from 2024, and that total market capitalization rose nearly 29%. However, the same report notes that stronger industry performance has not benefited all biotechnology companies equally. Investors continue to favour companies with more advanced assets, leaving many emerging biotechs with limited access to capital.

Deloitte also notes that life sciences companies are prioritizing investments with clear strategic value, focusing on those that deliver measurable value and support long-term growth. S&P Global reported that investors were increasingly favouring companies with stronger clinical data, with much of the funding going to Phase 2 trials because they offer a clearer path to Phase 3 or potential partnerships. Similarly, financial data provider PitchBook found that venture capital is increasingly flowing to companies with more advanced programs and clearer paths to bringing products to market.

This is prompting smaller biotech companies to rethink how they finance innovation. Life science membership association Biocom notes that companies are focusing on spending their resources more efficiently, advancing their most promising programs, and forming strategic partnerships as funding becomes more difficult to secure. This approach can benefit smaller biotechs that can efficiently advance their pipelines with fewer programs. Additionally, EY notes that companies are increasingly using royalty financing, milestone-based agreements, venture debt, and structured partnerships to diversify how they raise capital. These approaches can provide additional funding without relying as heavily on issuing new shares.

Strategic partnerships are also taking on a broader role in the life sciences industry. The Boston Consulting Group notes that companies are increasingly using partnerships to share costs, reduce risk, strengthen supply chains, and accelerate innovation. KPMG’s 2026 Healthcare and Life Sciences Investment Outlook found that strategic partnerships and milestone-based financing deals are expected to become increasingly common as companies look for more flexible ways to fund innovation. Deloitte’s 2026 life sciences outlook also highlights partnerships alongside mergers and acquisitions as leading growth strategies, while EY reports that alliance deal values reached record levels in 2025. For emerging biotech companies, survival may depend less on raising the largest financing round and more on using capital efficiently, reaching key development milestones, and building the right strategic partnerships.

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THIS WEEK 07/14/26

• The U.S. FDA granted accelerated approval to Vera Therapeutics’ atacicept-vymj (Trutakna) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression.

• Eli Lilly Canada received a positive recommendation (reimbursement with conditions) from Canada’s Drug Agency for ebrikizumab-lbkz (Ebglyss) for the treatment of moderate-to-severe atopic dermatitis (eczema).

• Teva Pharmaceutical Industries and Samsung Bioepis announced the companies have entered into a license and commercialization agreement for aflibercept (Opuviz). It is a biosimilar referencing Eylea in Canada for the treatment of neovascular (wet) age-related macular degeneration, visual impairment resulting from macular edema secondary to central retinal vein occlusion or branch retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.

• Health Canada approved Eli Lilly Canada’s tirzepatide (Mounjaro) as an adjunct to diet and exercise to improve glycemic control in pediatric patients living with type 2 diabetes aged 10 to 17 years.

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Christopher White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Liette Landry
Blainville, Que.

Editor’s Note: Liette is now Marketing Director at AVIR Pharma Inc.

To say that Liette Landry has come a long way since her days as the sole female territory manager for food giant Carnation (Nestle) is an understatement. These days, and some 19 years later, as the Director of the Oncology Business Unit for Schering Canada Inc., Landry’s first job supplying French fries to institutional kitchens seems light-years away, but she remembers every detail. Indeed, “I can remember everything, good and bad, and I am often told about my sixth sense,” jokes Landry, who admits that having “total recall” was a bit unnerving for some of her colleagues.

Her venture into the world of pharma on the advice of a Montreal neighbour was “quite an improvement” over having to get up at 5 a.m. to service her institutional accounts. Landry spent nine years at Lederle (Cyanamid) handling a variety of portfolios, from dermatology to infectious disease, and her first love, oncology. After being promoted to Oncology Product Manager, she assumed responsibility for developing, implementing, and monitoring effective marketing programs for Novantrone and Leucovorin.

By the mid-1990s, she’d set off to discover new horizons, snagging a post at Technilab Pharma as Product Manager with a portfolio of 33 brands that included brand-name and generic products. By 1997, Landry obtained a position at Rhone Poulenc Rorer Canada as Oncology Product Manager and was responsible for the progress and success of products such as Taxotere, Oncaspar, Bonefos, and Gliadel. Landry was back in her environment, oncology.

It was at Schering Canada Inc. in 1999 that her intense interest in oncology was tapped as Sales and Marketing Manager. She got the opportunity to launch two breakthrough products, Caely for ovarian cancer and Temodal. This drug would greatly improve the quality of life for brain tumour patients and their families.

After two short years, she assumed the role of Marketing Director, Oncology, and Product Manager for Temodal, a position that led to a critical accomplishment—the implementation of an innovative brain tumour multidisciplinary M.E. program, developed in partnership with the Canadian Brain Tumour Consortium, and eventually incorporated as a best practice at Schering-Plough, Schering Canada’s parent company.

In her current position as Schering’s Director, Oncology Business Unit, she oversees 18 sales and marketing team members. The company has seen its oncology business sales increase with a strong double-digit growth year after year, and the business has doubled since 2002. For Landry, however, corporate success isn’t measured merely by numbers: “To me, my work is not just work—it’s my passion.”

Over the last 18 years in oncology, Landry feels proud that she has had an opportunity to help save lives and points to the “flowers, letters, and testimonials from patients and families that tell me I made a difference.” She admits that recently witnessing the cancer experience with a close family member has reinforced her dedication and commitment to what she does.

Believing strongly in “enhancing life and advancing treatment”—an excerpt from Schering Oncology’s mission statement—Landry maintains, “I really live my job.” Accomplished from a professional standpoint, Landry is an individual with boundless energy. She’s a key motivator when it comes to fund-raising activities for cancer and is well known for her participation in the annual 5 km Canadian Cancer Society’s Run for the Cure, which she “walks, not runs” with her seven-year-old daughter and her two dogs, and for raising money for Breast Cancer Research at the Schering Canada Head Office in Pointe-Claire, Qué.

Her motto is: “Living each day to the fullest, and when they ask me where I see myself in five years... easy! Doing exactly what I am doing now, working hard toward patient care.”

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Mergers and acquisitions have long defined pharmaceutical growth strategies, but in-licensing is emerging as a complementary, and in some cases preferred, path. Deloitte’s 2026 Life Sciences Outlook reports that 45% of biopharma leaders still rank M&A among their top near-term priorities. At the same time, licensing agreements are gaining momentum as companies look to access innovation without the financial and operational burden of full ownership. According to Galen Pharma, this model allows organizations to expand portfolios more flexibly, particularly when resources are constrained.

Consulting firm EY notes that licensing is attractive because it can give companies access to external innovation while limiting upfront capital exposure. The firm’s 2026 Firepower report suggests that companies are increasingly pursuing assets through multiple deal structures, with alliance deal values reaching record levels in 2025. The report also notes that while the average alliance deal size increased by 46%, upfront payments represented only about 7% of the total potential deal value. This way, companies can access innovation while limiting financial risk.

Gibson Dunn’s 2026 life sciences outlook described licensing as a “surgical tool” used by large pharmaceutical companies to address near-term pipeline gaps ahead of the 2026-2030 patent cliff. The report notes that licensing activity remained strong in 2025, as companies continued looking outside their organizations for innovation while remaining selective about where they invested. It also observed a “flight to quality,” with companies showing renewed interest in earlier-stage platforms in selected high-growth therapeutic areas while continuing to pay premium prices for late-stage, lower-risk assets.

Innovation originating in China has become one of the clearest examples of this licensing-led strategy. Reuters reported that licensing-out deals from the Greater China region rose nearly tenfold from 2021 to 2025. Analysts expect more growth in 2026 as global pharmaceutical companies seek innovative drug candidates from China while cutting costs ahead of patent expirations. EY also reported that China captured 34% of alliance investment from the U.S. and European biopharma industry in 2025, highlighting the country’s growing role as a source of innovative pipeline assets.

The takeaway: Recent deal activity highlights the growing strategic importance of licensing. For example, AstraZeneca agreed to pay up to US$18.5 billion to license weight-loss drug programs from China’s CSPC Pharmaceutical Group. Takeda followed with an oncology partnership with China-based Innovent Biologics that included a US$1.2 billion upfront payment and additional milestone and royalty payments. Pfizer also signed a global licensing and collaboration agreement with Innovent Biologics worth up to US$10.5 billion to develop 12 early-stage cancer medicines.

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THIS WEEK 07/07/26

• The U.S. FDA approved Viridian Therapeutics veligrotug-vvze (Lumvoa) for the treatment of thyroid eye disease.

• Apotex announced it is the first Canadian company to receive Health Canada’s approval for a generic semaglutide injection (Sevmia) for chronic weight management in adults.

• Health Canada approved Pfizer’s enfortumab vedotin for injection (Padcev) in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adult patients with muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.

• The U.S. FDA approved Orca Bio’s allogeneic regulatory T cell immunotherapy with HSPC and T cells-vldq (Tregzi) for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival in the treatment of adults with hematological malignancies..

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Christopher White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Pierre Montanaro
Montreal

Editor’s Note: Montanaro is now President at Altius Healthcare Inc.

A true individualist, Pierre Montanaro has brought an unbridled enthusiasm to his 25 years in the healthcare industry. Describing his style as “buttoned-down with a creative side that only a few people know,” Montanaro’s career has run the gamut from selling health and beauty aids to the upper echelons of the generic drug trade.

Montanaro says he kind of fell into the pharmaceutical business when he started in health and beauty aids as a sales rep for the Gillette Corporation. This company would be the ideal training ground for his future in healthcare. Over the next 10 years, he would hone his skills in various marketing positions with Clairol and Smith & Nephew multinational companies.

It was a call from Burroughs Welcome in 1988 that would catapult Montanaro into the position of General Manager in charge of the company’s fledgling consumer healthcare business. He would grow the company’s business to $38 million in sales from $12 million, “with little or no advertising budget to speak of.” After six or seven “good” years, Warner-Lambert snapped up the Welcome consumer business, and Montanaro would look for other challenges. He found those challenges at Marion Merrell Dow (later Hoechst Marion Roussel and then Aventis Pharma), which would ask Montanaro to create a separate consumer healthcare division.

By July 2001, the division was sold to Pharmacia, where Montanaro assumed the role of General Manager and increased Pharmacia Consumer Healthcare’s sales to over $125 million from $38 million in less than three years. When Pfizer bought out Pharmacia almost three years later, Montanaro headed for greener pastures, landing a job as Vice-President of Marketing for the generic drug maker, Pharmascience.

Montanaro, who jokingly refers to himself as “the king of the merger,” feels privileged to have survived “six [mergers] in 12 years.” But during those mergers and throughout his career, he believes his proudest achievements are the longstanding relationships he’s built along the way. “I have a lot of pride in keeping those friendships and relationships going for well over 25 years,” he says of the many team members, peers, and suppliers he’s encountered during his career.

A true philanthropist, Montanaro’s regard for others goes beyond the office confines to his charitable work for the Montreal Children’s Hospital, a medical facility with “some of the best neuro- and pediatric cardiovascular surgeons in the world.” On a regular basis, Montanaro and staff stage parties for the kids, providing pizza, videos, toys, and ice cream for the sick children on the wards, as well as donating monetary gifts to nurses for continuing medical education. “It’s a mission for me,” he adds, crediting the hospital staff with saving his daughter’s life several years ago.

These days, as Vice President and General Manager of Pharmascience Inc., one of the top four generic companies in Canada, Montanaro proudly surveys a career that’s spanned the entire life cycle of a product. From Rx, BTC, OTC, and generics, “I spent three-quarters of my career marketing consumer drugs such as Seldane, Nicorette, Nicoderm, Allegra, Polysporin, and Sudafed, to name a few, and I’ve been involved in several very innovative ad campaigns with our AORs,” not to mention the time spent in the ethical pharmaceutical industry. Montanaro says he’s happy to be part of what he considers an exciting, if challenging, industry. “I’m a high-energy guy [and] it’s a fast-paced industry. The guy who’s asleep at the switch will not be successful in the industry we’re in, I guarantee it.”

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Generative AI is moving beyond pilot projects and into routine use across the pharmaceutical industry. While its role in complex functions such as drug discovery continues to evolve, companies are increasingly deploying GenAI across core operational workflows. A recent analysis by the website European Pharmaceutical Manufacturer, an industry news and insights platform, found that life sciences organizations are using GenAI to drive productivity in areas including medical, legal and regulatory review, commercial operations, quality control, and clinical trial management. IQVIA reports a similar shift, noting that medical, marketing, and compliance teams are redesigning workflows to accommodate AI-generated content and strengthen governance frameworks.

Medical writing is perhaps one of the clearest opportunities for enhanced productivity. Deloitte notes that generative AI is helping streamline medical writing and regulatory document preparation. It is important to emphasize that GenAI is not replacing human writers. The organization highlights that GenAI should be used alongside human oversight to ensure accuracy and regulatory compliance. By automating routine authoring activities, medical writers can spend more time on other tasks, such as scientific research. Deloitte estimates that automation could reduce the workload associated with medical writing by 20% to 30%.

Generative AI is also being integrated into regulatory affairs. An article in Drug Discovery Today reports that AI can automate regulatory processes, including administrative work, dossier filling, data extraction, regulatory implementation, and quality management, improving efficiency. The Life Science Academy adds that AI is also helping regulatory teams improve document quality, monitor compliance, and strengthen regulatory planning while reducing the time spent on routine administrative work.

Medical affairs are also becoming a major area for GenAI. An article published in Pharmaceutical Medicine notes that AI is helping medical affairs teams streamline medical content generation, analyze real-world data, generate insights from large healthcare datasets, and support more informed strategic decision-making. An IQVIA white paper adds that AI is also improving literature reviews and chart reviews, key opinion leader identification, and scientific communications. These tools allow medical affairs teams to work more efficiently while maintaining expert oversight.

The takeaway: These applications all share a common characteristic: governance. A review published in Green Analytical Chemistry notes that realizing AI’s full potential depends on strong governance frameworks that support transparency, accountability, ethical use, data governance, regulatory compliance, and continuous monitoring. As AI becomes integrated into regulated workflows, organizations must place greater emphasis on data integrity to ensure productivity doesn’t compromise compliance.

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THIS WEEK 06/30/26

• Health Canada approved Allergan’s trenibotulinumtoxinE (Boey) for the temporary improvement in the appearance of moderate to severe lines between the eyebrows in adult patients.

• The Institut national d’excellence en santé et en services sociaux recommended Roche Canada’s obinutuzumab (Gazyva) for public reimbursement in Quebec. The recommendation is for the treatment of patients with active lupus nephritis who are receiving standard therapy.

• The U.S. FDA approved Merck’s pembrolizumab (Keytruda) and pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), each in combination with sacituzumab govitecan-hziy (Trodelvy), Gilead’s Trop-2-directed antibody-drug conjugate. The combination is for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10).

• PharmaEssentia USA Corporation announced U.S. FDA approval and the launch of the ropeginterferon alfa-2b-njft (Besremi Pen) device for adult patients with polycythemia vera.

NOW, LISTEN UP: Bringing Innovative Therapies to Canada

In Season 16 of the NPC Podcast, Associate Vice-President and GM of Incyte, Chris White, discusses Most Favoured Nation pricing impacts, drug access and reimbursement, and wildly authentic leadership. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2006 Inductee
Jacqueline Shan
Edmonton

Editor’s Note: Shan is now the Founder, President and CEO of PBG BioPharma Inc.

A relative newcomer to the Canadian healthcare scene, Jacqueline Shan has made a significant mark on the OTC front since she assumed the role of CEO of her Edmonton-based company, CV Technologies, three years ago. But the transition from researcher to savvy marketer responsible for launching Cold-fX, an herbal cold remedy that has eclipsed popular drugstore brands by more than two to one, was a challenge, she says.

While her vision wasn’t to be a marketer, “I was inspired because I saw this great outcome from the research for Cold-fX, and I thought there was a responsibility to apply that science to human life.” She adds, however, “I always tell myself I will go back to the lab again, [since] science is my true passion.”

Shan’s love affair with all things scientific started at the young age of 15 when she enrolled at Beijing’s most prestigious medical school. After emerging with a doctorate in pharmacology, her passion for research, coupled with the Chinese government’s growing interest in Western medicine, brought her to the doorstep of the University of Alberta, where she studied for a doctorate in physiology. Running research projects under the watchful eye of renowned U of A researcher Dr. Peter Pang, the two would uncover a component of ginseng that helps the body fight infection. The herbal ingredient formed the basis of Cold-fx, the cornerstone of a successful business venture based on patented natural therapeutics.

Shan, who’s been in Canada for almost 20 years now, says her exposure to herbal medicines started as a child in China. “When I was a child, I was malnourished. My mother and grandmother often gave me tinctures and herbal teas. I was very curious as to why and how they worked.” But even at medical school in China, “I couldn’t find much about how herbal medicine works. “It was based mostly on empirical observation,” she adds. Clinical research similar to that in mainstream medicine has been lacking for herbal compounds, primarily due to skepticism and limited investment, says Shan. She sees herself as a trailblazer in changing the approach to illness from curative to preventive.

Shan proudly notes that there are nine peer-reviewed clinical studies demonstrating the efficacy of Cold-fX, which is now on shelves at Shoppers Drug Mart, Loblaws, and Costco. A multicentre clinical trial of Cold-fX, involving leading infectious disease experts, is now underway in major cities across Canada. “Research is about the unknown, and 99 percent of the time you don’t find anything, and one percent of the time when you find something, it’s an accomplishment.” Shan believes the company’s other products, Remember-fX, a “ginsenoside” compound designed to enhance acetylcholine, and hence memory, and Cell-fX, a chondroitin-based remedy for joint health, will be similarly well-received in the marketplace. She concedes there’s still a need to educate the medical community about natural remedies. “Once you design your studies the right way and use the right medical approach, mainstream medical people don’t see there’s a difference really. It’s not that people don’t accept it; it’s that they haven’t been exposed to it.”

There’s no word yet on who will endorse the company’s other two offerings, but Shan is clearly pleased with the company’s growth—sales just shy of $32 million in 2005—since enlisting hockey commentator Don Cherry to promote Cold-fX. Since then, she’s become a hockey fan, of sorts, although she admits she’ll never be an expert on the game. Sitting with Don Cherry and hockey legend Mark Messier during the playoffs, “I learned a lot,” says Shan. “But sometimes they laughed at me when I made a wrong comment.”

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NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

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Recruiting the right patients for clinical trials has historically been slow, expensive, and heavily dependent on geography, but the model is changing. According to a 2025 review in the Journal of Medical Internet Research, the rapid growth of digital clinical trials is being driven by web-based recruitment platforms, AI-assisted patient matching, and remote monitoring technologies designed to connect participants with the right studies regardless of where they live.

Covid-19 proved to be the unexpected catalyst that pushed these tools from the margins into mainstream research practice. More evidence was provided in the highlights from the 2025 Disruptive Innovations to Modernize Clinical Research (DPHARM) annual conference, which emphasized that sponsors are redesigning studies around patient needs and using decentralized trial elements to make participation more accessible to more patients.

This shift toward decentralized recruitment is changing how patients access clinical studies. According to an article published by Health, virtual visits, wearable devices, mobile applications, and remote data collection tools are allowing participants to engage in research without frequent travel. These approaches can improve convenience and make clinical research accessible to people who would normally face participation barriers due to location.

Artificial intelligence is becoming an important part of that process. IQVIA notes that AI and real-world data are helping sponsors design more efficient studies by identifying recruitment barriers, assessing patient burden, and evaluating how protocol design choices may affect enrollment and retention. As an example, a 2026 study in Nature Communications reported a strong performance from an AI-powered clinical trial matching system, TrialMatchAI, with 92% of oncology patients receiving at least one relevant trial recommendation within the top 20 results.

Recruitment strategies are also evolving due to growing expectations regarding participant diversity, and Canada presents unique recruitment challenges. Health Canada’s draft 2025 guidance on Sex- and Gender-Based Analysis Plus (SGBA Plus) encourages sponsors to consider factors such as sex, gender, race, ethnicity, age, disability, geography, and socioeconomic status when designing recruitment strategies. The guidance also highlights decentralized and hybrid trial approaches, community-based engagement, telemedicine, remote data collection, and other strategies that may help improve participation among historically underrepresented populations. Health Canada’s draft guidance on decentralized clinical trials further notes that these approaches can help connect more diverse participants to research, and improve recruitment and retention for remote populations.

The Canadian recruitment discussion also includes considerations for Indigenous communities. The Population Health Research Institute notes that Indigenous Peoples have historically been underrepresented in health research. Still, several initiatives are aiming to improve participation through community-led engagement and partnership models. The Accelerating Clinical Trials Canada consortium, for example, has identified Indigenous inclusion as a main objective alongside efforts to expand trial access in remote and rural communities. This reflects how decentralized and community-based approaches can help reach populations that have traditionally been excluded from research.

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THIS WEEK 06/23/26

• Health Canada approved Eli Lilly Canada’s tirzepatide injection (Zepbound) for the treatment of moderate to severe obstructive sleep apnea in adults with obesity in combination with a reduced-calorie diet and increased physical activity.

• Bristol Myers Squibb Canada announced an update to the Canadian product monograph for lisocabtagene maraleucel (Breyanzi), a CD19-directed chimeric antigen receptor T cell therapy, reducing the duration of certain post-treatment monitoring and activity restrictions for eligible patients following infusion.

• The U.S. FDA approved Spero Therapeutics and GSK’s tebipenem pivoxil (Utebzi), an oral antibiotic for the treatment of complicated urinary tract infections, including pyelonephritis, caused by certain susceptible pathogens, in adult patients who have limited or no alternative oral treatment options.

• GSK announced that Health Canada approved depemokimab (Exdensur) for two indications:

  • As an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma characterized by an eosinophilic phenotype and inadequately controlled by medium- to high-dose inhaled corticosteroids plus another asthma controller.

  • As an add-on maintenance treatment with intranasal corticosteroids in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) inadequately controlled by systemic corticosteroids and/or surgery.

NOW, LISTEN UP: Learning to do more with less—Leandra Wells on how to rethink pharma strategy

In Season 16 of the NPC Podcast, Leandra Wells, founder of Brighthive Innovation Group, discusses tech enablement, transforming organizations on lean budgets, and prioritizing healthcare in Canada. Hear her in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2004 Inductee
Rudy Fernandes
Mississauga, Ont.

“I’m having a ball,” says Rudy Fernandes, who is now in semi-retirement after a long and prosperous 43 years in the pharma biz. These days, Fernandes heads up his own consultancy business, but his commitment to the pharmaceutical industry is stronger than ever. He was vice-president of business development and market access for Wyeth Pharmaceuticals from 1997 to 2003, and vice-president of marketing and sales for Ciba-Geigy Canada Ltd. (Novartis) from 1975 to 1996.

“Being involved in the industry in healthcare is critical to making sure the right things are done and that the industry voice is heard,” says Fernandes. “Very often, we are considered to be the rich little kid on the block, but we bring a lot of value to the healthcare field. Without drugs, it would be very difficult for physicians to treat people effectively and efficiently.”

Fernandes’ long and varied career has included numerous memberships and appointments to industry-based committees. As a former chair of the ethics subcommittee of the Pharmaceutical Manufacturers Association of Canada (PMAC), he helped to develop industry guidelines that are still in use today. He is a frequent contributor to several prominent healthcare journals on the value of the pharmaceutical industry and has participated in televised debates concerning healthcare issues.

However, “most of the memorable things I did were more by accident than by design--like going into marketing to start with,” says Fernandes. A microbiologist by profession, he first broke into pharma as a sales rep for CIBA in India, quickly making his way up the corporate ladder to district and then field operations manager in charge of about one-quarter of the country. When he emigrated to Canada, he had to start all over, but again rose through the ranks to snag a plum position as VP. Indeed, says Fernandes, “I was the first person, I think, who started as a rep and became a VP of marketing and sales at CIBA.”

Always up for a challenge, one of Fernandes’s most daunting tasks was to turn the tide for the Lopresor range of products when prescription sales dipped by 35% in the highly competitive US cardiovascular market. As product director, cardiovascular, for Ciba-Geigy Corporation, USA, Fernandes helped develop an effective relaunch of the product, resulting in record sales growth and market dominance, with peak sales of $300 million.

Fernandes remains modest about his achievements. “I was only the person waving the flag, the person with the water bottle at the game, but I think what I contributed was a strategy of turning the ship around, just being focused, getting the internal people excited. One of the mistakes we make is trying to influence external customers and not the most important customer we have, the internal customer: the reps, the field managers. If they are sold, success is just around the corner.”

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NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Real-world evidence (RWE) has been a research asset, but it is also increasingly becoming an important commercial tool for the pharmaceutical industry. Canada’s Drug Agency (CDA-AMC) notes that pharmaceutical companies are using patient registries, post-market studies, and other RWE initiatives to help address evidence gaps that may remain after clinical trials. Health Canada also recognizes that RWE can be particularly valuable when longer-term follow-up is needed, conventional clinical trials are impractical, or additional information is required to support reimbursement reviews.

RWE is also changing how pharmaceutical companies approach evidence gathering. Pharma Exec reports that many manufacturers are developing evidence strategies that continue throughout a product’s lifecycle rather than seeing data collection as something that ends with regulatory approval. The publication notes that RWE is increasingly being used to support reimbursement discussions, show comparative effectiveness, and provide data on adherence, long-term outcomes, health care utilization, and overall treatment value for payers and life sciences organizations.

Canada provides some of the clearest examples of how RWE is becoming embedded in reimbursement decision-making. The CDA-AMC introduced time-limited reimbursement recommendations that allow reimbursement while additional evidence is generated to address any remaining uncertainty. Under this model, a drug may receive public reimbursement while the manufacturer conducts additional studies to address remaining evidence gaps. The product is then reassessed using the new data generated during that period. The approach connects reimbursement to ongoing evidence generation instead of treating approval and reimbursement as separate events.

Rare disease therapies have become one of the strongest examples of RWE’s commercial importance. The CDA-AMC recently launched a 2026/2027 funding program to strengthen rare disease registries, recognizing the need for higher-quality RWE to support reimbursement and health technology assessment (HTA) decisions for rare disease therapies. The agency notes that the initiative is intended in part to address evidence gaps and uncertainties relevant to payer needs. Furthermore, the CDA-AMC’s 2025 funding program prioritized initiatives that supported future RWE generation for regulatory, HTA and payer decisions, including drugs that had recently undergone or were undergoing pan-Canadian Pharmaceutical Alliance negotiations.

The growing market for glucagon-like peptide-1 (GLP-1) therapies also reveals a growing trend in the use of RWE. The CDA-AMC’s 2025 recommendation for semaglutide (Wegovy) linked ongoing reimbursement to measurable outcomes. According to the guide, patients must demonstrate at least a 5% reduction in BMI or total body weight after the first year of treatment to continue receiving coverage. At the same time, Health Canada’s approval of the first generic version of semaglutide in 2026 reflects competition in the GLP-1 market. The department noted that several additional generic semaglutide applications are under review and that generic availability is expected to cut costs for patients and the healthcare system. These types of reimbursement conditions increase the importance of tracking outcomes in routine clinical practice.

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THIS WEEK 06/16/26

• Health Canada approved GSK’s mepolizumab (Nucala) as an add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease characterized by raised blood eosinophils inadequately controlled by the combination of an inhaled corticosteroid, a long-acting beta2-agonist, and a long-acting muscarinic antagonist.

• Canada’s Drug Agency issued a positive recommendation to reimburse UCB’s bimekizumab injection (Bimzelx) with conditions for the treatment of adults living with moderate to severe hidradenitis suppurativa with an inadequate response to conventional systemic therapy.

• Eli Lilly announced that abemaciclib (Verzenio) is now publicly reimbursed in Québec for eligible patients living with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.

• ExCellThera and its wholly owned subsidiary Cordex Biologics announced exclusive licensing and supply agreements granting Medexus the Canadian commercialization rights for dorocubicel (Zemcelpro), also known as UM171 Cell Therapy. It’s for the treatment of adults with hematological malignancies who require allogeneic hematopoietic stem cell transplantation following myeloablative conditioning and for whom no other suitable donor cells are available.

NOW, LISTEN UP: Healthcare Investing and Life Sciences Innovation in 2026. Here’s Bloom’s view

In Season 16 of the NPC Podcast, CEO of Bloom Burton’s Brian Bloom discusses the themes of the 2025 Bloom Burton conference, return entrepreneurs in the Canadian Life Sciences landscape, and accelerating drug discovery with AI. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2004 Inductee
Sheila Gittelman
Montreal

Editor’s note: Sheila is now a Media Consultant at S.G. Media.

In the 22 years that Sheila Gittelman has spent in healthcare advertising, she says she’s been “blessed” to work in an industry characterized by so much professionalism. “I really do love my job—it’s not only the people I work with directly,y but also people I work with in media, the reps and publishers.”

Gittelman, a self-admitted late bloomer in the industry, launched her career in her 30s after many years as a stay-at-home mom. In 1982, serendipity led her to Gall Communications when her then-husband introduced her to the company's founder, Jim Gall. At Gall, then the agency of record for Hoffmann-LaRoche and Pfizer, she became “a master of all trades,” learning media planning from the ground up and discovering a love for numbers. “I never thought math was a strength of mine—I was never a ‘math maven,’ but I enjoyed what’s involved with media planning,” she observes.

As the company evolved from a partnership with Sudler & Hennessey to S&H’s eventual acquisition of Gall, Gittelman found that the lessons she learned at Gall had served her well. “Through [Jim] I learned that the pharmaceutical industry is all about professionalism. In terms of my work, he taught me that there’s more than what meets the eye, how to go beyond the superficial numbers and dig up the type of information or creative solutions that help clients build successful brands.” She learned quickly that readership numbers were insufficient to determine a brand’s best buy. “It’s also looking at what my competitors have been doing and what their plans have achieved. It’s taking that plus the readership and putting together a plan and analyzing it against all the readership data, revising it, and coming back until you finally get what you want.”

Gittelman laughs at the early years when the readership studies were relatively new. “I’d get calls each month when the PMCQ dinner was happening or when the readership data was coming out, and everybody wanted to call me and tell me how great their numbers were. I would say, you know what, I have the numbers just as well as you do. If you have something new you want to show me, I’d be glad to see you, but don’t come in and tell me about the numbers.”

Gittelman admits that not everyone may appreciate her straightforward honesty, but concedes she has difficulty being anything but. However, she adds, “I enjoy a good laugh. Laughter is like jogging on the inside. Someone once said that when I’m not there, they miss my smile. I think life is wonderful, my job is wonderful, and the people I work with are wonderful. How could you not smile coming into work every morning?”

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Artificial intelligence is steadily expanding its role in the pharmaceutical industry, reaching far beyond the high-profile realm of drug discovery. Increasingly, companies are applying AI to operational functions that have traditionally been less visible but no less critical, including pharmacovigilance, quality management, and manufacturing.

The shift reflects a broader transition from experimental use cases to enterprise-wide adoption. According to the International Society for Pharmaceutical Engineering (ISPE), AI is now being embedded across the product lifecycle, from development and clinical research to supply chains and post-market surveillance, prompting companies to confront new challenges around governance, compliance, and integration within highly regulated environments.

Pharmacovigilance has perhaps become one of the most active areas for AI adoption in the life sciences. Deloitte reports that millions of adverse events are reported annually and that reporting volumes continue to increase by approximately 10% to 15% each year. The company notes that processing these reports remains a manual, costly, and often decentralized process that creates challenges for safety and compliance teams. IQVIA notes that AI can be useful in pharmacovigilance by streamlining adverse event intake and case processing, reducing resource burdens, and improving the efficiency of handling growing volumes of safety data. According to the organization, companies are increasingly exploring the use of AI to support these activities.

The industry is also implementing AI in quality control and manufacturing operations. Deloitte reports that AI-enabled systems can analyze factory data to identify potential quality issues and production bottlenecks and recommend corrective measures. These capabilities can help manufacturers detect problems earlier and address them before they disrupt operations or affect product quality. The ISPE notes that AI is being used across the entire quality control process, including automated visual inspections, batch comparison, real-time process monitoring, and predictive maintenance. These tools may help support continuous quality assurance..

The takeaway: As adoption expands, governance may be as important as the technology itself. The OneTrust consultancy writes in its Governing AI in 2026 white paper that regulators increasingly expect companies to document and disclose AI use, assess risk, maintain oversight, monitor system performance, and demonstrate accountability throughout the AI lifecycle. Similarly, Healthcare Management Forum argues that effective AI governance requires oversight of issues such as bias, transparency, explainability, ethics, data handling, and safety to help ensure that AI systems remain trustworthy and aligned with organizational objectives.

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THIS WEEK 06/09/26

• Novartis Canada announced the successful conclusion of negotiations with the pan-Canadian Pharmaceutical Alliance for the public reimbursement of asciminib tablets (Scemblix) for the treatment of adult patients with newly diagnosed Philadelphia chromosome‑positive chronic myeloid leukemia in chronic phase.

• Apotex launched sitagliptin tablets and sitagliptin/metformin hydrochloride tablets in the U.S.

• The U.S. FDA approved Wockhardt’s cefepime and zidebactam (Zaynich), an intravenous antibiotic for the treatment of adults with complicated urinary tract infections, including pyelonephritis, caused by susceptible Gram-negative pathogens.

• Health Canada granted market authorizations for mosunetuzumab for injection (Lunsumio) and mosunetuzumab injection (Lunsumio SC) for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies

NOW, LISTEN UP: Healthcare Investing and Life Sciences Innovation in 2026. Here’s Bloom’s view

In Season 16 of the NPC Podcast, CEO of Bloom Burton’s Brian Bloom discusses the themes of the 2025 Bloom Burton conference, return entrepreneurs in the Canadian Life Sciences landscape, and accelerating drug discovery with AI. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2004 Inductee
Jean-Michel Halfon
Tel Aviv, Israel

Editor’s note: Jean-Michel is an Advisory Board Member at the Center for Emerging Markets and a Member of the Board of Directors at Teva Pharmaceuticals.

What’s it like at the helm of the Canadian operations of the world’s leading research-based pharmaceutical company? Jean-Michel Halfon won’t tell you in 25 words or less, but he could write a book about the challenges of today’s CEO. “Change” is the most distinguishing factor in today’s healthcare environment, and managing change has been a fascinating aspect of his career, says Halfon, who learned to adapt early in his first job in sales with Pfizer France in 1977. Then a recent graduate with a degree in industrial and systems engineering and an MBA, Halfon admits the transition to sales and marketing wasn’t easy, but “it was a unique and fantastic science of people management” and a necessary springboard to his rise in the ranks at Pfizer. Despite a brief stint as Director of Marketing for Merck in the late ’80s, Halfon returned to Pfizer, where he went on to direct the Pfizer France pharmaceutical business as Pharmaceutical Division Manager and as development team leader for eight years at Pfizer Europe headquarters in Brussels. He then moved on to Pfizer World Headquarters in New York to head a product global development team, followed by his current position as president and CEO of the Canadian operation, a position he’s held since 1999.

Looking back at his 27-year career, Halfon notes that the role of the CEO has evolved dramatically. Whereas five or 10 years ago a CEO would have to coordinate the marketing and sales process, “today I really don’t spend more than 10 to 20 per cent of my time doing that. My role now is to try and work with the other players of the healthcare system to find new solutions, new ways of doing things, and to propose reforms.” At the same time, the responsibility is his to ensure performance, but the environment nevertheless influences this performance. “I work first for my company and also for the environment where I work.”

A large chunk of that “environmental” work is spent on the boards of numerous industry and community organizations including the Canadian Genetics Diseases Network, The Biotechnology Research Institute (National Research Council, Montreal), and the Montreal Neurological Institute. He is also this year’s chair of Canada’s Research-Based Pharmaceutical Companies (Rx&D, now Innovative Medicines Canada) which has a new “innovative agenda” to foster conditions for research, information, and investment growth in Canada. That doesn’t leave much time for a weekly game of tennis or weight training exercises, two of Halfon’s favourite ways to unwind. But he is undaunted by the demands on his time, much of it spent on issues related to the shifting healthcare landscape. “Change is sometimes difficult, and we are all reticent to change. But there are a lot of pleasures in change and, when we see change as a pleasure, then life is different.”

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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For decades, the pharmaceutical industry concentrated much of its manufacturing in a few global strongholds, betting on efficiency, scale, and stability. That model is now under strain.

A convergence of tariff pressures, geopolitical uncertainty, and pandemic-era supply disruptions is forcing drugmakers to reconsider where, and how, they produce critical medicines. The latest U.S. tariffs on pharmaceutical imports and active ingredients have only accelerated a shift already underway, as companies weigh the risks of dependence and reassess their reliance on offshore suppliers.

According to a report by Logistics Viewpoints, reliance on a small number of countries for active pharmaceutical ingredient (API) production remains a key vulnerability for the industry. With an estimated 70% to 80% of global API production located in India and China, manufacturers face ongoing exposure to geopolitical tensions, supply chain disruptions, and policy-driven trade changes. Pharma Manufacturing reports that an analysis by the United States Pharmacopeia found that 58% of key starting materials (KSMs) used in U.S.-approved APIs are sourced from a single country. The same analysis found that 50% of U.S.-approved APIs depend on a single country for at least one KSM.

Tariff pressures are also prompting life sciences companies to reevaluate supply chain and investment strategies. A KPMG LLP survey of senior executives conducted in 2025 found that organizations were increasingly pursuing domestic investment, reshoring initiatives, and alternative operating models in response to evolving tariffs. While global supply chains are unlikely to disappear, many companies are exploring ways to diversify manufacturing and reduce dependence on any single location. This may be particularly challenging for APIs, where relocating production may require years of regulatory validation, manufacturing qualification, and supply chain realignment.

According to recent Government of Canada announcements, Canada continues to invest in domestic life sciences and biomanufacturing capacity as part of its strategy to strengthen the sector. The federal government has directed funding toward projects designed to expand domestic manufacturing capabilities, strengthen pharmaceutical supply chains, and support the production of next-generation medicines within Canada. Recent examples include Ottawa’s $62 million contribution to Entos Pharmaceuticals to support the construction of a biomanufacturing facility and research and development centre in Edmonton, and a $79 million investment in Aspect Biosystems to strengthen clinical development and biomanufacturing capabilities for bioprinted tissue therapeutics.

The takeaway: These investments are part of Canada’s efforts to rebuild domestic manufacturing capabilities after the lessons learned during the Covid-19 pandemic. Canada’s Biomanufacturing and Life Sciences Strategy acknowledges that years of decline in domestic biopharmaceutical manufacturing left the country without enough large-scale production capacity during the pandemic. Since 2020, the federal government has invested across multiple projects aimed at expanding domestic vaccine, therapeutic, and biomanufacturing capabilities. Milestones such as Moderna’s mRNA vaccine manufacturing facility in Laval, Que. and continued investments in biomanufacturing projects across the country demonstrate a growing emphasis on strengthening domestic production capacity and supply chain resilience.

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THIS WEEK 06/02/26

• The U.S. FDA approved AbbVie’s pivekimab sunirine-pvzy (Decnupaz) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm.

• BeOne Medicines announced that Canada’s Drug Agency and the Institut national d’excellence en santé et en services sociaux issued positive reimbursement recommendations for tislelizumab for injection (Tevimbra) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma.

• The U.S. FDA granted accelerated approval to Gilead Sciences’ bulevirtide-gmod (Hepcludex) for the treatment of adults living with chronic hepatitis delta virus infection.

• Shionogi announced the U.S. FDA approved ensitrelvir (Xocova), an oral antiviral, for post-exposure prophylaxis of Covid‑19 in patients at least 12 years of age, after contact with an individual who has Covid-19..

NOW, LISTEN UP: Overcoming Misconceptions about the Canadian Pharma Market

In Season 16 of the NPC Podcast, Canadian General Manager of argenx’s John Haslam discusses the big impact of rare disease, making key antibodies in the autoimmune space, and pricing strategy reform in Canada. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2004 Inductee
Robert Lavoie
Montreal

Editor’s note: Bob died in 2017. His son Michel Lavoie is now President at Dermtek Pharm, and his daughter Marie-Claude Lavoie is Vice President.

Robert Lavoie remembers the day he was bitten by the pharma bug. As a young advertising rep for Thomson newspapers, Lavoie lamented the fact he could only afford retread tires for his MGB sports car. But an encounter at an auto shop with “a fellow with the latest car, a suit, and great tires on his car,” would change all that. “He instructed the attendant to change his tires, and when they asked him what he wanted to do with the old ones, he said, ‘throw them out.’ So, I asked him what he did, and he said, ‘I’m a pharmaceutical salesperson.’ I said, “Terrific, that’s what I want to do.”

Lavoie applied for and landed his first job as a dermatology sales rep at Westwood Pharmaceuticals, a division of Bristol-Myers Squibb. The job lasted nine years; when anxious to explore other avenues, he left for a company that distributed products for an American firm. “I always thought there was a place for Canadian products,” says Lavoie, recalling a not-so-positive reaction from his employer. “Their philosophy was, we don’t get involved with formulations.”

In 1986, after 18 years in the industry, and with four products in tow, including Soluver, an innovative wart-removal product, and three other products for seborrhea and psoriasis, Lavoie decided to strike out on his own and formed Dermtek, making the rounds of dermatology offices in Canada from Corner Brook. Nfld. to Nanaimo, B.C. But the early days were fraught with uncertainty, he says, remembering the drive from Quebec to Toronto to detail dermatologists. “I had quit my high-salary job and [gave up] my large company car, and I bought a Volkswagen Jetta. I was trying to convince these derms that our products were the best, so they would have to tell patients to ask their pharmacist to order them, and for a brief second I thought, ‘what have I done?’”

Lavoie recalls that the big challenge in starting Dermtek was that “people in the industry never thought it would fly. Even some dermatologists said ‘you’ll never succeed, you’re up against the big companies.’” But many of his mentors were also dermatologists, “and they really steered me,” says Lavoie, who believed in his products: “The products were really superior, they were innovative, and they had an edge.”

In 1990, Lavoie expanded his lineup to include the blockbuster sunscreen product Ombrelle, which was eventually sold to cosmetics giant L’Oreal in 1997, and his “product of fame” Reversa, a glycolic-acid-based product that virtually pioneered the anti-aging movement, sparking a host of similar preparations.

Looking back on his 36 years in the pharma industry, Lavoie believes that the measure of success is being able to solve problems. “You have to become good at it, and when you have a small company, you have to solve them yourself.” He cites a quote from a friend and well-known dermatologist who told one Toronto newspaper: “A few good ideas and a lot of hard work are what made Robert Lavoie a success.”

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It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

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NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

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While artificial intelligence (AI) adoption in healthcare is accelerating, many organizations are still struggling to bridge the gap between impressive pilot projects and real-world implementation.

That’s according to Florencia Herra Vega, Chief Executive Officer of Toboggan Labs in Montreal. On a recent NPC Podcast episode, Herra Vega noted that many technologies fail because they cannot properly integrate with existing healthcare systems or access the right data once deployed. “You can simulate an environment where something looks really impressive for a patient or a doctor, but once you put it into the real world, it has to interface with all kinds of systems,” she said. “If it doesn’t have access to the right data, even a great system can end up abandoned or, in the case of AI, actually become harmful because it starts hallucinating or making things up.”

According to Herra Vega [pictured below], the challenge is even greater in regulated environments, where companies cannot afford to experiment recklessly with technologies that interact with patients or clinicians. She said the healthcare industry requires a very different development process than unregulated sectors because organizations must balance innovation with safety and compliance requirements. “Trying to figure out how to innovate while also understanding and respecting the boundaries to innovation is what makes technical work interesting in the first place,” she said.

Herra Vega added that many organizations are now realizing they moved too aggressively into AI deployment without building appropriate governance structures. “Some organizations are suddenly realizing that they pushed it too far, and they need to get everything under control. That they need a governance layer,” she said.

Many organizations misunderstand how AI productivity gains work at scale. While individual employees can become significantly more productive by adopting AI tools, she noted that organizational bottlenecks often remain unchanged. “Certain individuals who adopt AI really heavily and get very good at it become incredibly productive,” Herra Vega said. “But that doesn’t mean the organization around them becomes more productive.” She explained that uneven adoption across teams can create new workflow problems because one employee may suddenly produce far more output than the rest of the organization can process. Organizations need to think about AI implementation as a team-wide operational challenge rather than simply an individual productivity tool, she said.

The takeaway: Looking ahead, Herra Vega suggests a cautious yet dynamic evolution for life sciences. “If you ask me to say what’s going to happen with software development in the next 12 to 24 months, I would just throw up my hands and run screaming across the street,” she said. “But with life sciences, because it’s so regulated, naturally, there are brakes on the speed of change. And I am interested in what those brakes will look like.”

She anticipates a surge in therapeutic and technological advancements. “What happens when there is a flood of approvals of new technologies that potentially is just wildly bigger than anything we’ve ever had before?” Herra Vega said. She added that clinician education, supply chains, and the delivery of complex therapies will become major areas of innovation over the next several years.

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THIS WEEK 05/26/26

• Apotex launched Apo‑Semaglutide Injection, a generic equivalent of Ozempic, set to roll out to pharmacies across Canada in the coming weeks.

• The U.S. FDA approved Galderma’s adapalene and benzoyl peroxide acne treatment (Differin Epiduo Acne Gel) for over-the-counter use in individuals aged 12 years and older.

• Canada’s Drug Agency recommended Roche Canada’s obinutuzumab (Gazyva) for public reimbursement. This recommendation is for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.

• The U.S. FDA approved AstraZeneca’s baxdrostat (Baxfendy) as a first-in-class aldosterone synthase inhibitor for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

NOW, LISTEN UP: The inevitability of AI in healthcare

In Season 15 of the NPC Podcast, CEO of Toboggan Labs, Florencia Herra Vega, discusses AI compliance and innovation, applying AI across the whole team rather than individually, and useful technologies for quick solutions. Hear her in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2004 Inductee
John Stewart
Pickering, Ont.

Editor’s note: John is now retired.

John Stewart says he is probably best known for being around the healthcare industry “for a long period of time.” But to many in the industry, his most significant achievement has been raising Purdue Pharma’s profile during his 30-year career with the company. Stewart notes that when he first joined the company fresh out of grad school, Canadian sales hovered around $1 million annually. “This year we will do, give or take a few million dollars, $200 million,” he reports. In association with that increase, the company has bumped up its capabilities and functions, including Rx&D development, a fully capable manufacturing operation, and, “more traditional to Canada,” medical sales and scientific departments. “The Canadian organization has moved from one that was originally very small and one of the countries that would have been listed under the category ‘all others’ to the third largest group right now in terms of revenue,” he says.

Stewart explains that the platform on which the company built much of its success was the long-acting opioid, MSContin. In the early ‘80s, the product gained rapid acceptance with the palliative care movement in the UK. The Canadian arm subsequently picked up the clinical research operations under Stewart, who was then vice president of scientific affairs, and the product went to market in 1986. “It was quite an achievement to see that the Canadian organization could add all the value that it did,” says Stewart, who also observes, “We did substantially more clinical research than had been required in the U.K., and many of the Canadian trials were used by our U.S. company to get the product approved there.” On the patient side, “to hear the lead investigators, and then patients themselves, say that this is the greatest breakthrough in analgesic products in the last 20 years was both reassuring and good news,” he adds.

These days, much of Stewart’s time is devoted to Rx&D [now Innovative Medicines Canada], a cause he’s been active in throughout his career, most notably as the former chair of Rx&D’s Board of Directors and Executive Committee, past chair of the Patented Medicine Prices Review Board (PMPRB) Committee, and a member of the National Political Action Plan (NAP) Committee. He sees his role on the board as helping “like-minded others” make a significant difference to the issues facing Rx&D. “I am a scientist by nature as well as having been in marketing and sales, and I can talk about pharmaceuticals and the therapeutic benefits they provide. In that position, I am very willing to wade into the healthcare debate wherever it is about the appropriate role of drug therapies in the healthcare industry.”

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NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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Canadian pharmaceutical launches have become significantly more complex over the last 30 years. Michael Stone, Country Manager of Merz Therapeutics, noted that companies now spend as much time evaluating reimbursement and pricing risk as they do preparing their commercial strategy. He explained that launches used to be commercial exercises focused on building a sales strategy and promoting a newly approved product. Today, however, he said companies must evaluate a much more complex reimbursement and pricing landscape before deciding whether a launch is financially viable. “You kind of have to run the table back and say, ‘Can we really profitably launch this product in Canada?’” he said on a recent NPC Podcast episode.

Stone [pictured below] added that the shift has fundamentally changed the structure of pharmaceutical organizations. “When I was first in the industry, we had an army of sales reps, a couple of medical people, and we had one pricing, reimbursement, and access person. That’s flipped over. Now we have an army of pricing, reimbursement, and access people,” he said, noting that payer and reimbursement teams now play a much larger role in launch strategy.

According to Stone, that environment can be challenging for smaller and mid-size pharmaceutical companies, which often lack the broader revenue base that larger organizations have. “If your product fits into populations covered by public payers, you have to accept that you’re probably not going to generate considerable revenue from that product for about three years,” he said. “That makes it very difficult, especially for smaller companies that don’t have a broader basket of products bringing in revenue to offset those costs.”

Stone noted how working in big and mid-size pharma companies has given him a different perspective on how quickly organizations can operate. While he said the fundamentals of the business remain largely the same across organizations, he believes mid-sized companies move faster because they operate with fewer layers of hierarchy and internal processes. “In large pharma, when you’re putting together business cases and plans, there are a lot of layers involved. You go through lots of presentations, dry runs, pushback and back-and-forth discussions,” he said. “Whereas in mid-sized and smaller pharma companies, we get to the answer a lot quicker and can make decisions faster. The rigour still has to be there, but I think we move a lot quicker.” He added that smaller companies often rely more heavily on external consultants and partners for support, which he said can ultimately be beneficial.

The takeaway: Looking ahead, Stone believes the pharmaceutical industry is entering a transformative period driven by innovations such as glucagon-like peptide-1 receptor agonists (GLP-1s). “At first, everyone saw GLP-1s as diabetes products, but now they’ve moved into weight loss, and you can see the tremendous spin-off opportunities these products have created,” he said. “Weight loss is no longer seen as an aesthetic issue. It’s being viewed as a chronic disease, and I think we’re really only at the very beginning of that.” Stone also pointed to historically challenging therapeutic areas such as lupus and Alzheimer’s disease, which he described as graveyards of product development, but said meaningful progress is emerging in both fields. He added that future progress will depend on demonstrating the broader value of innovative therapies, not only for patients but for the healthcare system overall. “These innovations are not only saving lives and extending lives, but they’re saving the healthcare system money as well,” he said.

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THIS WEEK 05/19/26

• Novo Nordisk Canada and Rexall launched Novo Nordisk Care, a strategic partnership to provide convenience, support, and home delivery of semaglutide injections (Ozempic and Wegovy) and semaglutide tablets (Rybelsus) for Canadian patients.

• The European Commission granted marketing authorization to expand the approved indication for Pfizer’s marstacimab (Hympaviz) . Patients 12 years of age and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) with FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) with FIX inhibitors.can now be treated.

• The U.S. FDA approved BeOne’s bee-KAHL-zee; sonrotoclax (Beqalzi) a foundational, next-generation BCL2 inhibitor. It is for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.

• Taiho announced the U.S. FDA has approved decitabine and cedazuridine (Inqovi) plus venetoclax as a treatment for adults with newly diagnosed acute myeloid leukemia who are 75 years or older or who are ineligible for intensive induction chemotherapy.

NOW, LISTEN UP: The inevitability of AI in healthcare

In Season 15 of the NPC Podcast, CEO of Toboggan Labs, Florencia Herra Vega, discusses AI compliance and innovation, applying AI to the whole team instead of individually, and useful technology for quick solutions. Hear her in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2004 Inductee
Dave Rimell
Ottawa

Editor’s note: Dave Rimell died in April 2021.

Mention the name Dave Rimell and heads nod in recognition. Always a fixture on the healthcare scene, his boundless energy and unique talents as an innovator and a mentor made him something of an icon over his 30-year career. “I didn’t really choose healthcare as a career, I guess it chose me,” says Rimell, reflecting on his early success at Maclean Hunter, where he earned the President’s Trophy for top salesman in 1967. The year after that, Rimell found himself at MD Magazine for a two-year stint, but a brainstorming session with the dean of the parliamentary press corps and the ex-general secretary of the Canadian Medical Association would send him down a new and exciting career path. That meeting sparked the birth of Medifacts, the first company in Canada to pioneer the electronic medium as a vehicle for continuing medical education.

“When I think about my greatest challenges, there are almost too many,” says Rimell, whose biggest task was to gain credibility for the concept among industry marketers as an effective means of communicating commercial messages to physicians. Rimell would also need to overcome the hurdle of convincing physicians to try a new learning experience, as well as ensure a pipeline of cassette players for physicians who didn’t yet have one. He went on to establish the company as the largest annual non-entertainment producer of audio cassettes in Canada, following that with a symposium and a seminar business and his own video production studio and computer software services.

But Rimell maintains that the highlight of his career was when the College of Family Physicians of Canada adopted the Medifacts continuing ed program as part of their curriculum for independent studies. “I’ll never forget the day that Dr. Don Rice, then executive director of the College, came to Ottawa and said, ‘We are so concerned that companies are producing material for our membership and we have no control over it. What do you say we form an editorial advisory board of the College for Medifacts?’ I almost fell off my chair.”

Despite his professional successes, Rimell says his proudest moments occurred outside the healthcare industry in a volunteer capacity, doing what he loves most: mentoring young people. A dedicated boys’ baseball coach for years while in Montreal, a move to Ottawa (where Medifacts was located) left him without a charitable cause. But then a radio advertisement for the Big Brothers Association caught his attention, and he remembers thinking, “That seems to be my ticket.” After an interview, Rimell was matched up with his little brother, a nine-year-old boy named Scott. Over a period of 33 years, Rimell devoted far more than the requisite four hours per week to his little brother, taking him to the family cottage on weekends and offering him a place to stay when his birth mother passed away.

“He has fond memories of those days,” says Rimell, who notes that Scott, now 42, is all grown up with a wife and son of his own. Their relationship continues to be an enduring one. “I think joining the Big Brothers was one of the most important things I’ve ever done,” he adds.

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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For decades, Canada’s healthcare system has been designed to treat illness rather than prevent it, a mismatch that continues to shape how pharmaceutical companies, policymakers, and clinicians approach care.

Ian Howard [pictured below], chairman of Leverage—The Sponsorship Company and a former chief of staff to the federal health minister, says he has been struck by how much attention goes to illness rather than prevention and how deeply that imbalance is embedded. “There are two sides to health,” he said on a recent NPC Podcast episode. “One is the illness side—the downside of healthcare. The other is wellness, trying to avoid the things that eventually catch up to us.”

His time in government changed his assumptions about the public sector. Howard said he entered that environment with common biases, but found them misplaced. “I was surprised by the quality and the dedication of most public servants,” he said. “And I found the work more rewarding than I had ever imagined.” He added that, unfortunately, the lack of communication between healthcare providers and policymakers has remained a concern.

During his time in government, Howard remembers speaking regularly with industry players, but rarely with the medical community. “The lack of any significant communication between the healthcare providers themselves and the health policymakers has always surprised me and continues to surprise me,” he said. “I assume there’s been some improvement in that, but listening to my kids who are doctors, I don’t think so.”

That belief in stronger communication among stakeholders helped shape the success of Dermatology Update. Howard said the conference, which celebrated its 40th anniversary in 2024, persisted because it was built on the idea that dermatologists and the companies providing therapies should not be treated as separate communities. Howard said the late Dr. Stuart Maddin had a vision to create a truly collaborative meeting between medicine and the pharmaceutical industry. Dr. Maddin’s model abandoned the traditional format in which educational sessions were reserved for healthcare providers while industry representatives were either excluded or expected to remain silent observers if they were allowed to attend. “Dr. Maddin’s idea was that we’re equals in this and we’re going to act like equals,” Howard said. “That’s proven to be a very successful formula.”

Howard also said that Dermatology Update has benefited from the close-knit nature of dermatology in Canada. With a relatively small number of practising dermatologists, the specialty has a strong social and professional network, which supports collaboration. He emphasized that the field has significantly changed over the last 40 years, with women dermatologists now representing a much larger segment of the specialty than previously. “Women are taking over the dermatology business,” he said. “Not slowly, but surely and fast.”

The takeaway: Looking ahead, Howard believes the growing politicization of medicine, particularly around vaccination, could have serious consequences over the next year. “That doesn’t mean that there aren’t some aspects of vaccination that have to be monitored,” he said. “But just feeding on the mistrust of medical decisions is going to come back and bite us in a serious way sometime in this next year.” At the same time, he expressed optimism about advances in dermatology. “We’ve seen the first glimpse of a cure in some of the major dermatological conditions,” he said. “The first on my list of predictions would be a cure, which is either a cure in the classical sense of the word or continued total remission, for psoriasis. We’ve already seen a glimpse of that through immunologic therapies. [A cure] It’s coming at a faster speed than we expected.”

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THIS WEEK 05/12/26

• British Columbia will reimburse Takeda’s teduglutide for injection (Revestive) for eligible pediatric and adult patients with Short Bowel Syndrome who are dependent on parenteral support.

• The U.S. FDA approved Arvinas’ vepdegestrant (Veppanu) for the treatment of adults with estrogen receptor-positive/human epidermal growth factor receptor 2-negative, estrogen receptor 1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.

• Lannett Company and Sunshine Lake Pharma announced the U.S. FDA has approved insulin glargine-aldy (Langlara) as a biosimilar to Lantus (insulin glargine) for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with type 2 diabetes mellitus.

• The European Commission approved Bristol Myers Squibb’s deucravacitinib (Sotyktu) alone or in combination with methotrexate for the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic therapy.

NOW, LISTEN UP: The inevitability of AI in healthcare

In Season 15 of the NPC Podcast, CEO of Toboggan Labs, Florencia Herra Vega, discusses AI compliance and innovation, applying AI to the whole team instead of individually, and useful technology for quick solutions. Hear her in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.

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 23 years. In the selection committee’s view, they represent a cross-section of the qualities that make our business unique and fulfilling. NPC Healthbiz Weekly will acknowledge past Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2026 Canadian Healthcare Marketing Hall of Fame by clicking here.

2004 Inductee
Donna Day
Markham, Ont.

Although her first career choice was nursing, “it was the pharmaceutical industry that really captured my passion,” says Donna Day. Just four years into her nursing career, Day followed that passion, snagging an interview with Astra Pharmaceuticals, and the company promptly selected her to become one of their first female sales reps in Toronto.

As a female in a male-dominated industry, however, there were challenges.

“One of the strangest and funniest times of my career came during my first visit to a small pharmacy in a tiny rural community in central Ontario. I had only been on the job for a month when confronted by a very irate pharmacist who wanted to know where my predecessor, the previous representative in the territory, had gone. It seems he was quite upset that I had “taken the job from a man with a family to support.’ After that shock, I worked my heart and soul to provide the highest level of service I could to that pharmacy. He turned out to become one of my best customers, and though retired, on occasion, we still laugh at his ‘old style’ ways.”

Her training and background opened new and exciting windows of opportunity two years after joining Astra. Day recalls being faced with a choice between clinical research, sales management, and marketing, but it wasn’t a tough decision because marketing was “where I belonged.” After honing her skills as group product manager, Day moved on to take a position as territory manager for a company specializing in respiratory products. In 1991, she moved to Solvay, where her career evolved into other challenging areas, including project management, new product launches, and opportunities in senior product management for some of Solvay’s key products.

Indeed, the introduction of new drugs that dramatically improve patients’ lives has had the biggest impact on healthcare in her time, says Day. She adds that some of her “biggest successes” have come from the introduction of products that have made a significant difference in the quality of life for many people. “When I graduated from nursing, a gastric ulcer for many patients meant, at the very least, one of the most serious surgeries you could imagine. Now that we have new drugs, such as proton pump inhibitors, the surgical rate has dropped dramatically while quality of life has soared.”

Currently, Day says she enjoys the challenge of moving from product management to marketing research. “I have a natural curiosity about everything. For me, the fun comes in figuring out what makes things tick, and I love meeting new people and hearing what they have to say. I get to work with practically everyone at Solvay in this new role, and the position covers every product area, both current and those in R&D. My dream for the future is to make a contribution doing what I love most.”

Subscribe now

NEXT WEEK

It’s easy to get your no-charge subscription to NPC Healthbiz Weekly. We’ll send each issue to your phone or inbox at 6:00 a.m. sharp each Tuesday.

You are receiving this newsletter because you are a client of Chronicle Companies, attended a National Pharmaceutical Congress live event or webinar, or previously requested a subscription to one of our newsletters. If you no longer wish to subscribe to this newsletter, please email the subject line “Unsubscribe NPC Healthbiz” to health@chronicle.org.

NPC Healthbiz Weekly is published by Chronicle Companies, 701 Ellicott Street, Buffalo, N.Y. 14203. Canadian Office: 1460 The Queensway, Suite 212, Etobicoke, Ont. M8Z 1S4

Mitchell Shannon, Publisher; R. Allan Ryan, Editorial Director; John Evans, Jeremy Visser, Editors; Cristela Tello Ruiz, New Business Development; Amy Elder, Intern.

Content is copyright (c) 2026, Chronicle LifeSci America Corp., except as indicated. Are you interested in contributing to this newsletter or learning about the Chronicle’s services? Please write to us at health@chronicle.org.

Thanks for reading NPC Healthbiz Weekly. Be sure to subscribe to receive new posts directly to your inbox.

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