Weekly Top Stories: Healthcare Quality, Apotex’s Apo-Amoxi Shortage, pCPA’s CEO

This week has brought a whirlwind of developments across the Canadian life sciences sector. Here are some important stories shaping the landscape, ranging from healthcare quality comparisons to critical budget allocations and reforms: Dr. G. B. John Mancini, a Professor of Medicine at the University of British Columbia, highlights that Canada, with its universal healthcare system, maintains high-quality healthcare. Despite Canada’s province-specific drug coverage contrasting with the more universal drug coverage under Medicare in the U.S., both countries grapple with common challenges regarding access and costs of advanced medications, which include rising out-of-pocket expenses for patients lacking drug coverage, impacting access to essential medications. Despite Canada’s commitment to high-quality healthcare, it faces an ongoing challenge in the form of medication shortages. Drug Shortages Canada has reported a persistent scarcity of Apotex’s Apo-Amoxi 125 mg (amoxicillin for oral suspension). This shortage, which began on August 9, 2022, was originally anticipated to conclude on September 1, 2023. However, the latest update extends the estimated end date to September 15, 2023. Apo-Amoxi 125 mg plays a crucial role in treating certain infections and is classified as a Tier 3 drug in Canada due to its substantial impact on the nation’s drug supply and healthcare system. To add to this, after a trial of metformin, the Canadian Agency for Drugs and Technologies in Health (CADTH) has started a streamlined drug class review of sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 2 diabetes mellitus. This is in response to requests from public drug programs to find out how best to use these drugs. CADTH has also temporarily suspended reimbursement assessments for Pfizer Canada’s elranatamab and GlaxoSmithKline’s Jemperli, and commenced a health technology evaluation for Novocure Canada’s Optune, with a specific emphasis on its use in treating supratentorial glioblastoma. But amidst these challenges, Canada is making strides with advancements in the sector. The federal government has recently allocated nearly $1.3 million in funding from Health Canada’s Sexual and Reproductive Health Fund. This funding is poised to support projects led by the Sexuality Education Resource Centre Manitoba and the Canadian HIV/AIDS Black, African, and Caribbean Network. Their shared mission is to broaden access to critical sexual and reproductive health services across the Prairies. Aside from addressing sexual and reproductive health, the government has launched public consultations for the second legislative review of the Tobacco and Vaping Products Act (TVPA). This review seeks to tackle issues associated with tobacco use while emphasizing public health and regulatory measures. Canada is also taking proactive steps to bolster its preparedness for emergencies. The National Emergency Strategic Stockpile (NESS) is undergoing a transformation aimed at enhancing the nation’s readiness for future crises. A new plan is on the horizon, set to be unveiled next spring. This reform places priority on critical aspects such as personal protective equipment, electronic inventory management, and fostering stronger collaboration with provincial partners. These measures are designed to create a more resilient supply chain and minimize waste, drawing insights from the challenges highlighted during the COVID-19 pandemic. More great news as pan-Canadian Pharmaceutical Alliance (pCPA) welcomes Douglas Clark, former Patented Medicine Prices Review Board executive director, as its first CEO starting from September 11, 2023. His role includes leading the pCPA in accordance with its existing Strategic Plan 2022–2024 and prioritizing improvements in negotiation processes and collaboration with public and private sector partners. Canada’s life sciences sector remains dynamic and continuously evolving, characterized by its dedication to quality, accessibility, and innovation. This week’s developments highlight the progress made and the ongoing challenges that continue to shape this critical sector. Feed your strategy. Every Morning. Visit us at Delphic Research or book a consultation to delve deeper into these stories and stay informed about the latest developments.
Delphic Research Group Welcomes Mitchell Pratt as Manager, Growth

Delphic Research Group Inc. (“Delphic Research”) is pleased to announce that Mitchell Pratt has joined the team as Manager, Growth, starting immediately. Mitchell brings a mix of experience in government relations, consulting, and startup environments. His unique blend of expertise aligns with Delphic Research’s mission to leverage Artificial Intelligence and data-driven insights to transform the regulatory knowledge space. Mitch will add to the momentum of Delphic Research’s client growth and broaden applications of Delphic Research’s proprietary ai technology, ‘Argus’, into new industry verticals. Before joining Delphic Research, Mitch worked for an early-stage startup where he focused on customer success, communications, and product partnerships. Prior to this Mitch worked as a part of EY Canada’s Business Transformation Consulting team helping clients solve problems with data driven storytelling. His experience is rounded out by work at Impact Public Affairs where he led client engagements across a broad spectrum of industries and at Crestview Strategy where he got his introduction to government relations. Mitch’s multifaceted background, coupled with his strong skills in public affairs, stakeholder relationship management, and political communications, make him a valuable asset to our team. His commitment to purpose-driven work and his eagerness to produce research that positively impacts communities globally align seamlessly with Delphic’s vision. About Delphic Research Group Inc. Delphic Research is on a mission to elevate the government affairs profession through knowledge. Staying on top of the information one needs to maintain a current and accurate understanding of the political, policy and regulatory risks, trends, and opportunities has never been more difficult than it is today. Our innovative, subscription-based service leverages technology to monitor thousands of sources where information of relevance may emerge, synthesizes that information into actionable insights, and delivers that knowledge to our customers in a digestible format, with a focus on relevance and impact. More signal, less noise, greater value.
Beyond Google Alerts: The Fallout From Canada’s Online News Act (Bill C-18) Just Made Your Job Harder

Government affairs professionals know that staying informed isn’t a luxury — it’s necessary. Yet, much of their traditional toolkit — Google alerts, early morning scans from media monitoring companies, and manual click-throughs of key sources — is inadequate in our rapidly-changing information landscape. Canadian news content is about to vanish from the world’s two biggest tech platforms now that the Online News Act (Bill C-18) has received Royal Assent. C-18 will require internet platforms and search engines to pay Canadian online news companies for linking their content. Even though enforcement is expected to be six months out, big tech companies are announcing sweeping changes. Fearing a contagion that might spread further, Google and Meta declared they would stop sharing Canadian news links on their platforms. This isn’t unique to Canada. Australia faced down the same threat in response to similar legislation of its own, resulting in a compromise of sorts. The US Congress had similar legislation before it last year, and a bill is currently winding its way through the California state legislature. The EU had already adopted measures in response to the same concerns that motivated legislators in those jurisdictions. So, what’s going on? Well, as the Public Policy Forum’s report, “the Shattered Mirror” (and the Shattered Mirror: Five Years On) highlights, when it comes to the threat that local news outlets face when up against these companies, the tech giants are eating their lunch. This is, in part, due to the substantial shift in advertising revenue away from local news and towards digital platforms, even though these digital platforms don’t actually produce the content they use to generate those advertising dollars. In 2022, 80% of all online ad revenue in Canada went to Google and Meta. Traditional news outlets are feeling the squeeze, leading to the closure of more than 450 outlets since 2008. Just last week, two of Canada’s biggest news media conglomerates announced they were exploring a merger to survive this challenging environment. The fallout from Bill C-18 highlights a growing issue for those in government affairs: the way we monitor information is in flux. This situation mirrors the conflict between big tech and the Canadian government, and intra-tech rivalries like Meta’s launch of Threads to compete with Twitter. The sources we have relied on are changing, as are the tools we use to access them. Meanwhile, shifts in the news media industry are affecting the type of issues that are getting coverage at all. In a world where local journalism is on life support, much of the information government affairs professionals need doesn’t even make the news anymore. It is getting harder to monitor an array of sources and piece data together to uncover intelligence that affects your business. Government affairs professionals will need to focus on directly monitoring a wider range of authoritative sources with a critical eye for the truth. No matter who wins these battles — big tech or government (or somewhere in the middle) — the whole thing highlights that our profession is in the midst of an irreversible transformation. Old tactics and tools are not cutting it and as the landscape continues to change, so must we. Want to learn more about what Delphic Research is doing to solve this problem? Contact me at danny.chang@delphicresearch.ca
Delphic Research Selected for Prestigious Beta Category at Collision

Company was selected to participate in the prestigious beta category Delphic Research is thrilled to announce its upcoming participation at the globally recognized Collision Conference 2023. Widely acclaimed as the largest tech gathering in the world, with over 20,000 attendees annually, Collision represents a convergence of cutting-edge innovation, ground-breaking ideas, and technology trends shaping the future. We are profoundly honored to be representing the title in the distinguished ‘Beta’ category, a reflection of our continued growth, product market presence, and pioneering contributions in the realm of government affairs. This participation not only highlights our promising strides in the industry but also offers a fantastic platform to showcase our unique and transformative approach towards democratizing government affairs through knowledge. The “Beta” designation at the Collision Conference signifies a company that is in the later stages of development and has a product on the market. This recognition is particularly meaningful as it demonstrates Delphic Research’s continued growth, the milestones it has reached and the impact of its innovative solutions in the world of government affairs. Jason Grier, President & CEO of Delphic Research, expressed his excitement about the company’s participation in the prestigious event, “Being recognized as a Beta company at the Collision Conference is a testament to the hard work and innovative spirit of our team. We are eager to showcase our unique approach to information synthesis and our commitment to democratizing government affairs through knowledge.” Delphic Research, founded by Jason Grier, a 30-year veteran in the government affairs space, aims to elevate the profession of government affairs through knowledge. The company draws on a rich tapestry of backgrounds, including government, artificial intelligence and machine learning, life sciences, journalism, and higher education technology, all focused on one goal – revolutionizing government affairs. Press Contact: Joshua Wright joshua.wright@delphicresearch.ca
Changing Technologies, Changing Industry: How Artificial Intelligence and Machine Learning are Driving Innovation in the Life Science Sector

ith the rapid uptake and influence of Artificial Intelligence (AI) within nearly all facets of life, now is the time for those of us in the healthcare and life sciences sectors to query the relationship between this tectonic-shifting technology and healthcare professionals. The life sciences sector has often been a pioneer of new technologies, leveraging human innovation to increase efficacy, decrease time to market, and improve data management. The rapid uptake of AI and Machine Learning (ML) across all sectors provides the next opportunity for life science companies to lead charge. Major influential bodies have already been exploring and discussing the implications of these advancements in technology; specifically, for AI and Machine Learning (ML). Despite their similarities, AI and ML can pose vastly different implications for the healthcare sector. While AI involves the development of technology designed to imitate human behaviour as effectively as possible, ML is a subset of AI that focuses less on general imitation and instead on training a machine to carry out a specific task. Both, however, carry far-reaching implications for the future of healthcare. The United States Food and Drug Administration (FDA) addresses the new technologies in its recently published discussion paper on the use of AI and ML in the development of drugs. This accompanies another whitepaper regarding AI in drug manufacturing, which serves as a starting point for various stakeholders to discuss the potential implications of AI within the pharmaceutical industry and beyond. So, what does the FDA think about these technologies? In the discussion papers, they anticipate three ways AI will have a direct impact on the advancement in drug development, and by extension, the role of healthcare professionals: Despite outlining these various benefits, the FDA has expressed significant concerns for a world with blind faith in AI. Emphasizing the vital role that humans play in the effective implementation of AI, the FDA believes that AI should not be completely unregulated, but rather, that regulations should work under the influence of humans to carry out various tasks more efficiently. In particular, the discussion paper notes that human-led governance is necessary to maintain accountability and transparency over AI when it comes to Life Sciences. Initial excitement over the capabilities of AI may result in a world with lax regulation and inaccuracies in drug development. The FDA stresses the importance of careful, human-led planning when using AI in drug development. Discontinuation may be necessary if the maintenance of AI becomes counterproductive to an institution’s ability to benefit people. Further, any benefits of efficient scraping and data analysis are mitigated when datasets themselves are flawed. AI may not always see through these flaws, thus generating biased, unrepresentative, or inaccurate results. The FDA urges the importance of human eyes thoroughly looking over data collected and selected by AI to ensure that bias is eradicated from the beginning. Beyond this whitepaper, life sciences professionals are presently evaluating the immediate impact of Large Language Models, such as Chat-GPT and GPT 4, in healthcare. In a webinar run by FirstWord HealthTech about the use of Generative AI in healthcare, Najat Khan, Janssen’s Chief Data Science Officer, discussed how AI can effectively address pressing problems with greater efficiency than humans. Machine learning can generate reports and knowledge graphs with greater ease and accuracy, allowing professionals to focus their energy on achieving large-scale innovations. AI also significantly helps to tailor drugs to patient needs by scouring through electronic records more quickly than a human. However, Dr. Khan expressed the same warning shared by the FDA; namely AI, within the context of healthcare, is only truly as good as the data it is fed. As the world embraces AI and ML, healthcare professionals and data scientists still play a vital role in ensuring that data sets are accurate and diverse. At Delphic Research we are encouraged by the advances that the life science industry is experiencing as a result of these new technologies. We continue to be vigilant, monitoring for developing technologies and their applications, keeping clients updated on the trends that they need to know.
From Reaction to Pro action: Canada’s Journey to Pandemic Preparedness after COVID-19

Three years and three months after COVID-19 was declared a Public Health Emergency of International Concern (PHEIC) in January 2020, the WHO Director-General, Dr. Tedros Adhanom Ghebreyesus, has announced that COVID-19 is no longer considered a PHEIC. The decision was grounded on expert advice and trends showing decreases in COVID-19 deaths, hospitalizations and ICU admissions, as well as high levels of population immunity to SARS-CoV-2. While this is the long-awaited news the world-over had hoped for, COVID-19 remains an ongoing health issue that requires long-term management. At home, the pandemic era has had a notable impact on the action Canada is taking to prioritize the health and safety of its citizens through enhanced pandemic preparedness. The actions include: introducing legislative changes, investing in infrastructure development, and playing a significant role in global pandemic prevention. 1. Legislative and Regulatory Changes Health Canada introduced Regulations Amending the Medical Devices Regulations (Interim Order No. 3) On February 22nd, 2023, with the aim off enhancing access to COVID-19 medical devices. This Order enables the continued importation and sale of authorized devices, ensuring a steady supply to effectively address ongoing or future pandemic challenges. Currently, Parliament is the Pandemic Prevention and Preparedness Act (Bill C-293) is undergoing consideration in committee. This act aims to prevent future pandemics by addressing factory farming and the commercial wildlife trade as 75% of new or emerging infectious diseases primarily originate from animals, especially wildlife. The bill identifies suspected pandemic drivers such as live animal markets, the wildlife trade, intensive farming, and habitat loss. It includes the creation of an advisory committee, emphasizes a ‘One Health’ approach by recognizing the interconnectedness of animal, human, and environmental health, and requires measures to mitigate risks and promote transparency and accountability. 2. Innovations for Pandemic Preparedness Canada has embraced innovative strategies to enhance pandemic preparedness. Wastewater monitoring systems have been expanded to detect and track pathogen changes, enabling timely public health interventions. The country has also increased whole genome sequencing testing capacity, leveraging scientific advancements for improved accessibility and timeliness of genomic data for better pandemic response. Canada also monitors adverse events following immunization and combats misinformation by exploring new tools like artificial intelligence and social media analysis. Additionally, behavioral science findings are being applied to boost vaccine confidence, combat misinformation, and test innovative interventions. 3. New Research Infrastructure Projects In 2021, the Biomanufacturing and Life Sciences Strategy, developed in collaboration with key stakeholders and external advisors, was unveiled. The strategy aims to build strategic partnerships, promote talent development, and enhance domestic capacity for next-generation vaccines and therapeutics development to position Canada ahead of future health threats. To fortify the biomanufacturing and life sciences ecosystem, the Canadian government is committing over $2.2 billion over a span of seven years. Five multidisciplinary research hubs have already been selected through the Canada Biomedical Research Fund and Biosciences Research Infrastructure Fund competition, advancing to Stage 2 in March 2023. 4. Procurement Initiatives Canada aims to reduce supply chain interruptions by investing in domestic production capabilities. An investment of up to $29 million was made to establish a new factory in Greater Montréal, ensuring end-to-end supply chain resilience for personal protective equipment (PPE). By reducing dependence on foreign suppliers, Canada strengthens its capacity to provide a stable and uninterrupted supply of critical PPE items. The country’s ventilator stockpile has also significantly increased, with over 27,000 ventilators procured and produced domestically. Collaboration with domestic manufacturers has enhanced self-sufficiency and preparedness for future public health emergencies. 5. Canada and its role in future global pandemic prevention Canada has demonstrated strong leadership in international pandemic preparedness, leveraging its public health expertise and commitment to global health diplomacy. The country has actively collaborated with international partners, provinces, and stakeholders throughout the pandemic. Canada is also playing a pivotal role in developing a new international instrument, known as a pandemic instrument, in collaboration with other countries and the WHO. The pandemic instrument aims to strengthen global pandemic prevention, preparedness, and response efforts through enhanced cooperation, collective action, and accountability. Canada has made incredible strides over the last three years to monitor and identify weaknesses within our pandemic preparedness and response systems and proactively seek solutions that are now considered world-leading. Canada is actively contributing to global efforts to prevent and respond to pandemics, emphasizing the importance of collective action and the need for continuous improvement in global health security. In 2003, The last time that Canada had been involved in the major SARS pandemic, that took 44 Canadian lives, it led to multiple inquiries and precautionary principles and pandemic planning exercises whose learnings were largely ignored when the time came during COVID-19. Can we expect Canada’s response to Disease X to be better? Looking to the future, our current efforts can only be measured against our response to the next crisis. For example, we need to ask: how will the Government of Canada balance its response to the ongoing COVID-19 health challenges alongside potential future pandemics such monkeypox, declared a PHEIC on July 23, 2022? Will it be able to maintain essential public health services and normal healthcare operations? How we assess Canada’s response to COVID-19 can only truly be known by our level of preparedness for the next pandemic; by our ability to stay vigilant with continuous monitoring of developments across a myriad of entities, and how we apply the valuable lessons we have just learned.
Delphic Research Raises $1.1 Million in Seed Funding to Revolutionize Government Affairs Through Data-Driven Knowledge

PRESS RELEASE TORONTO, Canada – June 5, 2023 – Delphic Research, a rapidly emerging leader in the government affairs technology sector, announced today that it has closed a $1.1 million seed funding round. This funding will be used to enhance Delphic Research’s proprietary knowledge engine, Argus, and expand its growing customer base in both Canadian and international markets. “With these new funds, Delphic Research is incredibly grateful to have investors who share our vision of transforming the government affairs sector through knowledge,” said Jason Grier, President and CEO of Delphic Research. “Government affairs professionals influence all aspects of business and organizations, and yet, how information is accessed is becoming more complex every day. We are committed to equipping them with the best possible tools to monitor and respond to the constantly evolving political and regulatory landscape.” The government affairs sector plays a crucial role in shaping public policy and government priorities. With 20% of all workers in Canada employed in the public service and over 20 million people employed by state, local, and federal governments in the U.S., the need for effective, efficient monitoring and analysis tools is more urgent than ever. This is especially true given the increasing complexity of the regulatory and policy climate and the rising volume of issues that professionals in the field need to track. A recent survey by Fiscal Note revealed that nearly half of all respondents ranked the volume of issues they need to track as their number one concern, with 80% admitting to missing critical legislation or regulatory announcements at least once. In response to this challenge, Delphic Research has developed a solution that monitors thousands of sources, synthesizes that information into actionable insights, and delivers knowledge to customers in a digestible format. Reaching our seed round funding milestone will allow Delphic Research to accelerate its ambitious product development roadmap, expand its team, and continue delivering indispensable insights to its growing customer base. The company’s subscription-based service utilizes innovative technology to deliver an optimized user experience, minimizing extraneous information and maximizing valuable insights for its clientele. By doing so, it enables customers to efficiently allocate their time and resources, resulting in cost savings. Additionally, the service guarantees that subscribers remain up to date on pertinent developments, ensuring they maintain a well-informed stance. About Delphic Research Group Inc.: Delphic Research is on a mission to elevate the government affairs profession through knowledge. Its innovative, subscription-based service monitors thousands of sources where information of relevance may emerge, synthesizes that information into actionable insights, and delivers that knowledge to customers in a professional and digestible format, with a focus on relevance and impact. For more information, visit www.delphicresearch.ca or book a consultation to discover the Delphic Advantage. Press Contact: Lindsay Broadhead | VP Communications | lindsay.broadhead@delphicresearch.ca