Pharma’s AI revolution: Balancing innovation and regulation
How AI is reshaping data governance, legal frameworks, and real-world applications in the pharma industry (Issue #317, 1,538 words, 7.5 minutes)
Good morning, and welcome to the NPC Healthbiz Weekly e-newsletter from the National Pharmaceutical Congress and Chronicle Companies.
It is widely recognized that artificial intelligence (AI) is rapidly transforming the pharmaceutical industry and reshaping the future of healthcare. While AI offers promising opportunities for enhanced efficiency and improved patient care, it also introduces a range of legal and strategic challenges that industry leaders strive to address. At the 18th Annual National Pharmaceutical Congress, an expert panel examined the complex relationship between AI and the life sciences sector.
The panel, Artificial Intelligence and the Future of Human Health, discussed AI’s role in legal frameworks, intellectual property, privacy concerns, and broader implications for pharmaceutical operations.
Erik Prieditis, Head of Commercial Operations at Galderma, confessed to some initial hesitation regarding AI, particularly after considering the legal perspectives, but ultimately embraced it. He emphasized the transformative power of large learning models in business operations, particularly in pharmaceutical sales and marketing. He described a case where his team utilized AI to analyze structured and unstructured customer data, enabling deeper insights into business performance and customer needs. He said the key to success was aligning a cross-functional team around the case, starting with legal and regulatory compliance. By building three persona-based AI models, they were able to address the challenges of inconsistent analysis and inaccurate market strategies.
“We quantified the benefits of this approach in terms of productivity, consistency, and output, seeing significant improvements across the three personas we focused on,” Prieditis said. “By passing data between these GPTs, we enabled a conversation between analysts and marketers to optimize outputs. We were excited to establish an ROI, showing that we could achieve notable gains when generative AI was used in a compliant and controlled manner. By testing it against traditional practices, we saw improvements in customer engagement, promotional effectiveness, customer experience, top-line growth, and expense management.”
“Privacy is central to everything in the life sciences: how companies operate, how patients consent, and how data sets are used,” said Eileen McMahon, Partner and Chair of Intellectual Property and Food and Drug Regulatory Practices at Torys LLP. “It’s crucial to consider whether we have full consent from patients when their data is scrubbed and integrated into a database.”
McMahon added that many AI-driven healthcare solutions rely on datasets stored outside Canada, raising concerns about compliance with various international privacy laws. She also warned about the potential of AI-generated documents that might inadvertently disclose confidential information and emphasized the need for caution when integrating AI into legal and regulatory processes.
Data strategy serves as a roadmap to guide the utilization of AI and achieve desired outcomes. AI initiatives can be unreliable and ineffective without a solid data strategy, reported Shaminder Singh, Director of Business Development at Bayshore Specialty Rx. “A solid data strategy begins with careful data collection and compliance. It’s crucial to ensure that the data you’re gathering is relevant and accurate,” Singh said. “The principle of ‘garbage in, garbage out’ applies here. If you don’t establish the right framework from the start, it will undermine the success of your AI strategy. Data quality and governance are key to ensuring long-term effectiveness.” He emphasized the importance of investing in the right talent and tools to ensure that AI is used effectively and that the output provides the best results.
THIS WEEK 02/11/25
The U.S. FDA approved Supernus Pharmaceuticals’ apomorphine hydrochloride injection (Onapgo) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
Boehringer Ingelheim Canada announced that intravenous and subcutaneous supplies of spesolimab for injection (Spevigo) are now available in Canada for the treatment of generalized pustular psoriasis in patients 12 years of age and older who weigh at least 40 kg.
Dr. Reddy’s Laboratories SA has entered into a license agreement with Shanghai Henlius Biotech, Inc. for the development and commercialization of HLX15, Henlius’s investigational daratumumab biosimilar candidate to Darzalex & Darzalex Faspro. HLX15 is a recombinant anti-CD38 fully human monoclonal antibody injection for treating multiple myeloma.
The U.S. FDA has approved AbbVie’s intravenous aztreonam and avibactam (Emblaveo) combined with metronidazole for treating complicated intra-abdominal infections in adult patients.
NOW LISTEN UP: HERE’S TOM SLOWE OF BREADCRUMB ANALYTICS
In season 13 of the NPC Podcast, Tom Slowe, CEO of Breadcrumb Analytics, gives insights into using AI to sort and sift through statistics, the importance of context with data, and why AI should only supplement human work. Hear him in conversation with podcast hosts Mitch Shannon, Jim Shea, and Mark McElwain.
REGISTER NOW FOR THE NPC LIVE WINTER WEBINAR TOMORROW AT 11 AM EDT
What kind of year ahead can we expect in the life sciences industry in Canada? That’s the question everyone is asking. Get real answers tomorrow (02/12) when the National Pharmaceutical Congress presents the 2025 Winter Webinar, featuring Dr. Bettina Hamelin of Innovative Medicines Canada, Brian Bloom of Bloom Burton & Co., and the one and only Peter Brenders in a free-wheeling panel discussion moderated by Ben Parry of Pangaea Group and Mitch Shannon of Chronicle Companies. Register for free and be prepared to ask the experts during this one-hour virtual event. Sign up using the link below.
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 22 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 the 2024 Hall of Fame Honorees over the next few weeks. Nominate a colleague for the 2025 Canadian Healthcare Marketing Hall of Fame by clicking here.
2024 Winner of the Phil Diamond Award for Community Service
Mona Sabharwal
Senior Vice President of Pharmacy Services
Rexall Pharmacy Group
Toronto
Mona Sabharwal, Senior Vice President of Pharmacy Services at Rexall Pharmacy Group, has built a career at the intersection of pharmacy practice, health policy, and patient advocacy, leading impactful changes in drug accessibility and clinical trial engagement across Canada. With over two decades in the pharmaceutical sector, she began her journey as a community and hospital pharmacist, providing first-hand patient care. Later, while working for the Ontario Ministry of Health, she helped develop policies to enhance the Ontario Drug Benefit Program, where she introduced the inclusion of patient perspectives in drug funding decision-making long before it became standard practice.
In 2010, she led the successful development and launch of the pan-Canadian Oncology Drug Review (pCODR), a watershed moment for health technology assessment in Canada. Her leadership brought about a more transparent and streamlined process that enhanced access to oncology treatments, impacting cancer patients across Canada. Eventually, she led the transition of CODR into the Canadian Agency for Drugs and Technologies in Health to help align and improve the efficiency of Health Technology Assessment activities within pharmaceuticals in Canada.
Sabharwal has had several mentors who have shown her that being a busy executive is no excuse not to give back. Dr. Anthony Fields, Chancellor at MacEwan University, with whom she worked at pCODR, continues to serve many provincial and national voluntary roles well into his 90s. Nicolas Caprio, President at Rexall, has worked for 10 years with Drug-Free Kids Canada, as he is passionate about keeping prescription drugs out of the hands of school-aged children.
With these two inspirational figures in her life, Sabharwal remains dedicated to advancing healthcare through various advisory roles. Given her experience at pCODR, she decided that the cancer space was where she could be most effective. She served on the board of directors of Kidney Cancer Canada for four years, an organization known for its strong patient support programs and thoughtful advocacy voice.
She serves on the Patient and Family Advisory Council for the Ontario Institute for Cancer Research (OICR). She acts as a strategic advisor to the Canadian Cancer Clinical Trials Group. She is a group member of the Dental Oncology Working Group at Cancer Care Ontario. Now, her personal experience with cancer has given her insights into the realities of patient care and further fueled her advocacy. Her time on both sides of the healthcare system has reinforced her belief in the power of patient partnership and the importance of more proactive patient involvement in research and care decisions.
Her contributions to these organizations and patient advocacy earned her an induction into the Canadian Healthcare Marketing Hall of Fame with the Phil Diamond Award for Community Service, which is recognition of exemplary service in the pharmaceutical community. “I am humbled and thrilled to have received a nomination for the Phil Diamond Award, and the fact I was selected from the various nominees is simply delightful,” she said. “Many individuals in the pharmaceutical sector go above and beyond their roles to create a better patient experience. I am honoured that my work has been recognized as making a difference.”
INTRODUCING DERMATOLOGY.BUSINESS and the DERMATOLOGY.BUSINESS DEEP DIVE PODCAST
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