Medicines have surely helped with improving the health conditions of mankind and helping us win over diseases that were earlier considered fatal. However, there have also been incidences throughout history, when medicines, considered to be safe, caused serious sequela. The risk of adverse drug reactions is an inherent risk to all medications, including prescribed drugs, over-the counter drugs and herbal supplements, and is modulated by many factors such as dose, concomitant medications, patient’s conditions e.g., hepatic, and renal function, age, and genetic background.
With the increase in life expectancy, the aging of population is inevitable and constitutes not only a focus of societal attention but also a major health concern. As our body gradually ages, we become more prone to multi-comorbidities leading to the use of multiple medications at the same time. The potential adverse drug event risk may exceed benefits associated with the use of such drug combinations. The process of drug development is aimed at evaluating drug efficacy, however it is much less effective at detecting and quantifying risks of adverse drug reactions. Drug safety, thus, has been a critical concern in healthcare.
Adverse drug events are among the top 5 leading causes of death in the United States. However, studies also show that 50% up to 80% of adverse drug events are preventable. Adverse drug events are a significant economic burden to any country’s healthcare system, including to patients, providers, and insurers. Adverse drug event management represents up to $30 billion annually in the U.S. In addition to monetary cost, adverse drug events result in psychological and physical harms to patient contributing to decreased patient satisfaction and lack of trust in health care. To help people avoid preventable morbidity and mortality from their medication regimen with real-time data that inspire safer, more effective treatment, GalenusRx’s is committed to deliver solutions promoting trust relationship between patients and health care providers.
GalenusRx’s solution helps manage drug safety programs, empowering patients, providers, and pharmacists in a safe and effective medication management process. In the last 25 years, they have extensively published in peer-reviewed journals about the impact of their approach to help manage patients with polypharmacy.
“Not only have we demonstrated an association between various factors and patients’ outcomes, but also, we have demonstrated that it is possible to reverse and prevent adverse drug vents,” says Veronique Michaud, Founder, President and Chief Operating Officer of GalenusRx.
The Inception Story
Veronique completed her formation in pharmacy (B. Pharm.) with the desire to provide the best care possible to patients. She practiced for 8 years as a community pharmacist and was pleased with the interventions that she made daily. However, she saw too many cases of patients experiencing side effects due to their medications, and most often, due to the inappropriate combination of too many drugs. These situations distressed her at times and motivated her to engage and change the way clinical pharmacy could be practiced.
Hence, Veronique undertook and completed a master’s degree (MSc) in pharmacokinetics, to understand better how drugs are cleared from the body. This was followed by a PhD in drug metabolism to appreciate in more detail the processes involved in drug clearance (enzymes and transporters). Then she made her first post-doctoral research fellowship at McGill University, in Montreal, where she looked at genetic determinants of patients’ response to HIV drugs. Finally, Veronique completed her formation by a second post-doctoral fellowship at Indiana University in Indianapolis where she studied pharmacogenomics, i.e., factors responsible for the inter-individual variability in drug response.
After 17 years of extensive education and research, Veronique was recruited as an assistant professor at, the Faculty of Pharmacy, Université de Montréal, and established my laboratory at the Centre de recherche du Centre Hospitalier de l’Université de Montréal. Her research proposals were evaluated and rated highly by peers, and she received important funding from major granting agencies in Quebec and Canada. She recruited students and led independent drug research in her own laboratory which resulted in important peer-reviewed publications.
In 2001, while Veronique was pursuing her academic career, she was presented with the opportunity to co-found IntermedRx, a spin-off company from the Université de Montréal. Their objective was to develop a clinical decision support system that could help clinicians address the issues associated with polypharmacy and adverse drug events. They first created a table that was distributed to clinicians. This “paper tool” evolved into a web-based application that was used by pharmacists in more than 100 community pharmacies and by specialty pharmacists in 10 hospitals in Canada.
In 2013, the InterMedRx application was licensed to CareKinesis (USA). The application was used very successfully by pharmacists and demonstrated a high impact on patients’ outcomes. In 2016, InterMedRx was bought by Tabula Rasa HealthCare (TRHC) as they were entering into an initial public offering (IPO) on the NASDAQ. Veronique then moved to the U.S. to work for TRHC as VP of Scientific Affairs, and in 2019, launched the Precision Pharmacotherapy Research and Development Institute as Chief Operating Officer. During her tenure, the institute published more than 100 peer-reviewed papers.
In 2023, Veronique’s views started to differ from those of the leadership at TRHC. Their position and decisions led her to co-found GalenusRx. While being authentic and trusting their inner wisdom, Veronique and her business and life partner moved out of their comfort zone and embarked on this new journey of launching GalenusRx. An opportunity to begin again, even more cleverly!
Leading with Focus
As President and COO of GalenusRx, Veronique leads the company’s scientific research, product, and development team to develop GalenusRx’s innovative suite of healthcare solutions. She has spent over 20 years thinking about how to design the perfect tool that would support clinicians in their decision-making process while establishing a drug regimen. Medications are complex, and as patients live longer with more chronic diseases, they are exposed to more drugs. On one hand, medications are the number one intervention used clinically to improve patients’ outcomes. On the other hand, adverse drug events are among the top 5 leading causes of death. The goal of GalenusRx is to develop a suite of solutions that reconcile these various elements.
Founding a successful company requires the identification of markets where the implementation of a new solution becomes a differentiator, a game changer. Competitive solutions currently available on the market have limited applications. The unique and combined features of GalenusRx solutions make offering its technology and services possible to various markets such as consumers, providers, health and life insurers, and companies involved in pharmaceutical clinical trials.
GalenusRx’s clinical decision support system (CDSS) is unique of its kind, using clinician-informed machine learning and complex algorithms to analyze multiple drugs simultaneously. For instance, other systems on the market analyze one-drug to one-drug interactions. GalenusRx CDSS considers numerous factors related to drug characteristics to prevent various adverse drug events. In particular, it generates a numerical value that allows clinicians to appreciate the appropriateness of a drug regimen. Their technology leverages unique, advanced, science-backed algorithms that look at factors such as pharmacogenomic testing, for precise, medication safety.
“The GalenusRx strategy is supported by advanced scientific research and peer-reviewed publications, offering several benefits to patients, healthcare professionals, insurers, and healthcare organizations. Hence, our solutions help clinicians to intervene on patients taking multiple drugs, making meaningful recommendations and personalized medication regimen assessments,” shares Veronique.
Dealing Head-on with Challenges
Magaret Thatcher said, “If you want something said, ask a man. If you want something done, ask a woman”. Veronique is a “doer”; this is reflected in her working style! She is both a hands-on and hands-off leader. She strongly believes in an important personal fit between team members that builds on excellence and highly competent individuals. All these characteristics are extremely important. So, she cultivates relationships with her team and invests her time to mentor them professionally and personally.
“I designed a team that can both work independently and together to achieve mission-driven objectives and goals. The team is built on 1) a capacity to achieve and, 2) a strong level of trust. I am fortunate to have a team that is highly invested in GalenusRx’s success,” she says.
Speaking about challenges, Veronique shares that changes in the culture of an organization prompt her to act. Several individuals will lose motivation when their objectives are not aligned with those of the institution, whether it is academia, government, or industry. She is one of them. She co-founded the GalenusRx company with people she trusts and believes in, and who trust and believe in her. Founding her own company with partners allowed me to develop more innovative solutions to improve and save lives.
“GalenusRx purpose: To improve health by helping people avoid preventable morbidity and mortality from their medication regimens, and mission: To provide disruptive and unique precision medication regimen technology and consulting services known as Lifesaving Insights™, which lessen the risk of preventable drug-disease and polypharmacy mis-adventuring, make me breathe every day,” she says.
Making people realize that medication-related problems are a leading cause of death has been a challenge but a driving force since the early years of Veronique’s career. She strongly suggests that Policies and practices regarding the reduction of harm related to drugs must be improved.
“Our challenge is to implement a new philosophy as it pertains to the reduction of drug-related problems and medication safety. A successful strategy while addressing problems often lies in inspiration and convincing others rather than imposing your views. I have learned that implementing long-lasting significant changes and worldwide practices takes effort, takes time, so patience, perseverance, resilience, and humility are key,” says Veronique.
A Shift Due to the Pandemic
Veronique feels that telehealth has the potential to transform and revolutionize health care by improving accessibility to care, improving patient outcomes, and reducing costs. The pandemic has allowed the development and adoption of a hybrid model of care delivery at a very fast pace. Major technologies made significant progress more quickly than expected. Moving healthcare delivery into the homes of patients represents a great opportunity for GalenusRx as it opens new avenues of care. It propelled the company into a new “space” of medication safety management (eMSM) and personalized telepharmacy services.
“We strongly believe that our eMSM solution can improve patient’s journey by offering an alternative way to connect with specialized pharmacists and their health care team. We will continue to drive innovation and help bring eMSM into a continuum of care,” asserts Veronique.
One notable change that many industries experienced during and following the pandemic is the further emergence of remote work. GalenusRx’s team transitioned from full-time in-person work to full-time remote work. This transition required them to think outside the box as they were a highly collaborative team. When they were in the office, their meetings were sporadic or team-based, and meeting individually with team members allowed Veronique to develop her leadership style, but also cultivate unique relationships with each team member. While the transition to remote work was challenging, it ultimately allowed her to develop additional elements of her leadership skills and strengthen her relationships with the team.
Another challenge, shares Veronique, has been hiring team members. GalenusRx’s team has excellent rapport, and when hiring, she wants to ensure that the person will integrate well with the team, in a fully remote environment. Team members have consistently highlighted “relationship with colleagues” as one of the best parts of their job, – this led Veronique to hire based on the personality and capacity of the person rather than only on their existing skillset.
“This has been an incredibly successful tactic, and our team continues to thrive under this model. Having a working remotely environment opens the door to individuals not restrained to a geographic area or to specific familial conditions. The “hiring market possibility” is therefore largely augmented,” she shares.
Solutions backed by Technology
While GalenusRx’s focus is developing a CDSS for drug safety, they have identified several strategies to integrate their science into numerous unique healthcare areas. For example, the company’s biosimulation strategy can be used to assess the impact of novel and existing therapeutics in large, adult populations using real-world data. They can also assess the impact of novel therapeutics against the standard of care. GalenusRx’s biosimulation solution can be performed safely without causing harm to patients and includes marginalized populations, who are usually excluded from clinical trials.
One major element of their solutions is the APPRAISE™ (Actionable PolyPharmacy Risk Assessment Index for Safety and Equity), a quantitative way to assess the appropriateness of a drug regimen. Every word describing APPRAISE is important: it quantitatively identifies situations that are patient-specific while taking multiple medications, with a fundamental approach taking into consideration safety, diversity, and equity.
Reading the Industry Trends
One of the biggest trends that we see across all sectors is the role of artificial intelligence (AI). Veronique and her team continue to enhance their solutions with advancements in technology and science. AI, when used appropriately, can improve clinician knowledge and patient outcomes. However, AI cannot predict situations that have not been observed previously, or that are rather unique.
“The issues encountered in a patient taking 25 medications out of the more than 20,000 different entities on the current market (prescribed medications, over-the-counter medications, herbals, natural products, recreational drugs, etc…) are rather unique, but the solution to these problems is not unique. We use clinician-information machine learning and advanced algorithms since together, they represent a better approach to finding the best solution,” explains Veronique.
To keep up with changes in the industry, Veronique reads new research relentlessly. The healthcare industry, specifically pharma, continues to grow with new advancements in medication, medication safety, and technology solutions. As GalenusRx’s team expands, she looks for candidates with unique backgrounds and experiences to round out her already impressive team. This allows GalenusRx to stay ahead of the curve in several different therapeutic areas, such as medications used in cancer and diabetes.
They are also actively involved in research activities. They do not depend only on the discovery or reports from other research groups but also participate in the development of knowledge.
“We do not only read books, but we also write books! For instance, in the last 3 years, our team has published more than 100 original articles in peer review journals,” shares Veronique.
Gaping Industry Issues
Throwing light on the current challenges in the industry, Veronique shares that as the population ages, patients experience more chronic diseases. More chronic diseases often translate into more medication intake. The CDC reports that 70% of the U.S. population is taking at least one prescription drug while 22% is taking more than five prescription drugs, commonly defined as polypharmacy. These statistics only consider prescription drug use, not over-the-counter or herbal supplements.
Multiple comorbidities also imply that patients see multiple providers to address their numerous conditions. Very often, there is a clear lack of care coordination between the providers which results in prescribing cascades and polypharmacy. Every provider is trying to do their best to manage the disease they are responsible for. However, the 15, 20, or 25 medications that the patient is prescribed, 1-5 from each of the various providers, may not make sense when considering the resulting drug regimen. The system is fragmented which results in a fragmented patient experiencing adverse drug events. We need a quarterback that can look at the appropriateness of the drug regimen. Unfortunately, the solutions that exist are not implemented on a large scale, at the moment.
The drug industry develops medications based on efficacy. If a drug is not efficacious, it does not make it to the market. The FDA and other regulatory agencies are interested in drug safety. And as such, have requested pharmacovigilance programs. Conceptually, these programs require that many patients are exposed to drugs in order to detect signals of drug toxicity (such as the FDA Adverse Event Reporting System). In other words, some patients must have toxicity before drug safety can be evaluated.
“We believe that biosimulation studies using real-world data is a way to obtain significant information without exposing patients to drugs and side effects,” she states.
It’s Just a Start!
GalenusRx is one year old, and the company continues to grow. Its solutions entered the market in January of this year and are being implemented across several different industries. In the next five years, Veronique and her team’s goal is to continue to develop their CDSS and associated solutions, consistently implementing advancements in science and technology. They also plan to expand their biosimulation strategy to more novel therapeutics and new chemical entities to further increase their impact on drug safety. While there is still much on the horizon for GalenusRx, Veronique is proud of the innovation that her team has accomplished in the past year.
“We are also contemplating the application of our solutions worldwide. The issues observed in patients with polypharmacy are equally present in other countries. Once we have well-established the product in the USA, expansion to the rest of the world is next. We already have discussions with international partners on that matter,” concludes Veronique.