Category: Health

Biopharma companies are responsible for some of the most transformative, life-changing technologies in medicine from gene therapy to immunotherapy. At the MedCity INVEST conference scheduled for May 21-22 at the Ritz Carlton hotel in Chicago, six biopharma companies will give attendees a window into some of the promising treatments under development.

MedCity News Senior Biopharma Reporter Frank Vinluan will moderate the biopharma track of the startup contest Pitch Perfect. One judge confirmed for the track is Meredith Wilkerson, an investment principal with Plains Ventures who serves as the primary subject matter expert for evaluating life sciences and biotech investment opportunities. Wilkerson will also take part in the Ask the Investor breakfast sessions on May 22 open to startups.

Space is limited so register today!

Here’s a look at the biopharma companies that made the short list for MedCity INVEST Pitch Perfect.

Amplified Sciences is developing a suite of in-vitro diagnostics with a clinical stage test that helps physicians more accurately detect risk for pancreatic cancer through its ultra-sensitive optical reporter platform. The lead assay, PanCystPro, focuses on early detection of pancreatic cancers. PanCystPro uses a proprietary platform to detect biomarker activity. It also provides a highly accurate solution enabling clinicians to better identify patients at risk for developing pancreatic cancer as well as reduce unnecessary surgeries, imaging, and associated complications, according to a company description. This is a highly sensitive and specific test. The optical reporter system (AMPSci platform) has enabled a new class of multi-omics diagnostics, all using one sample and one instrument.

Enzyme By Design is a pre-clinical stage startup focused on designing and developing oncology biologics that are highly effective at exploiting weaknesses in cancers and eradicating tumor cells but with a clear focus on patient safety and reducing side effects. In this way, it can both treat the disease and improve patient quality of life and outcomes. It has used core expertise of protein engineering to create protein molecules that target the most common pediatric cancer as well as infamously difficult to treat cancers like acute myeloid leukemia and the solid tumors pancreatic, liver, and ovarian cancers. Utilizing well-known drug mechanisms of action and patient genomic and epigenetic markers will guide our clinical strategy as we move forward to make sure that only patients likely to benefit greatly from our biologics will be receiving them. The time is now for better cancer treatment options.

miRecule, Inc. is a biotech company developing RNA therapies for cancer and muscular dystrophy. The company’s approach to drug design uses genomic patient data to create highly tailored therapeutics designed to help patients live a life free from the debilitating symptoms of their disorders.

The proprietary DREAmiRa platform utilizes genomic and outcome data from thousands of patients to identify underlying genetic changes that cause their disease. It creates a novel RNA therapeutic that can directly target and fix that genetic abnormality.

miRecule is currently applying the platform to develop first-in-class therapies, with lead programs in Head & Neck Cancer and Facioscapulohumeral Muscular Dystrophy.

Modulation Therapeutics (MTI) was founded in 2011 as a spin-off of the H. Lee Moffitt Cancer Center and Research Institute. MTI has successfully developed three novel, efficacious compounds for potentially improving the lives of refractor cancer patients with no other current options for a cure. The company has raised more than $12 million to date and has successfully progressed the IND enabling commercial development of all three compounds. MTI is raising funds to complete the current Phase 1 trial, start the phase 1 imaging trial and fund the Phase 2 therapeutic multi-dose/imaging trial in Melanoma patients not responding to SOC.

OncoSwab is an innovative healthcare startup dedicated to revolutionizing early lung cancer detection. Utilizing a non-invasive, easy-to-use nasal swab, OncoSwab’s technology aims to identify lung cancer biomarkers at an early stage to significantly improve patient outcomes. Designed for both at-home and clinical settings, the company’s diagnostic tech combines accessibility with accuracy, offering a cost-effective alternative to traditional screening methods. Co-founded by visionary scientists and supported by leading healthcare accelerators, OncoSwab is in its validation phase, collaborating with top hospitals and lung cancer specialists in the U.S. and Switzerland. Its approach leverages the science of detecting tumor biomarkers directly in the airway, where lung cancer originates, rather than relying on distal blood samples. This direct detection method enhances the test’s specificity and sensitivity, paving the way for a new era in preventive healthcare and lung cancer management.

Talus Biosciences‘ automated, highly scalable drug discovery engine discovers first-in-class small molecules capable of modulating previously undruggable transcription factors, optimizing them to achieve high potency and selectivity while minimizing toxicity. Its unique approach is designed with breadth and depth in mind, measuring all possible transcription factors across thousands of samples. Data at scale with precision requires computing to match it. The data science team applies machine learning approaches to process and mine our dataset for first-in-class TF modulators. Co-founded in 2020 by CEO Alex Federation and CTO Lindsay Pino, Talus currently has 17 employees. Dr. Federation and Henri Termeer are the co-inventors of functional regulome proteomics. The Talus Bio executive leadership team is rounded out by COO Michelle Briscoe, who joined the company in 2022.

Photo: Getty Images, 4X-image

One quirk of the most common type of pediatric brain cancer is that as a child gets older, the tumors eventually stop growing. The reasons for this tumor senescence aren’t fully understood, but pediatric low grade glioma, or pLGG, still wreaks plenty of havoc until then, says Sam Blackman, a pediatric oncologist and the co-founder and head of R&D for Day One Biopharmaceuticals.

“Whether it’s the tumor pressing on an optic nerve creating blindness, damage to the hypothalamus or pituitary gland causing profound endocrine disorders, or pressure on motor structures in the brain causing hemiparesis or loss of balance, pLGG is a thief, robbing children of the best parts of their childhood,” Blackman said during a conference call Wednesday.

Though some pLGG tumors can be surgically removed, most patients require a systemic treatment. Chemotherapies and radiation treatment can buy patients time until tumor senescence, but at the cost of severe complications to the body and the brain. Even with these treatments, recurrence of the cancer is common. In those cases, patients haven’t had any additional treatment options. A new drug developed by Day One gives them a new choice.

The FDA has approved Day One’s tovorafenib for treating children age 6 months and older with pLGG that has either relapsed or has not responded to an earlier treatment. This cancer must have a particular genetic signature, either a BRAF fusion or rearrangement, or a mutation called BRAF V600. Brisbane, California-based Day One will commercialize its new drug under the brand name Ojemda.

Cancer care already has drugs that target BRAF mutations. Like most cancer drugs, they found their first applications in the treatment of adults. One of those BRAF-inhibiting drugs is Novartis’s Tafinlar. The combination of Tafinlar with another Novartis drug, Mekinist, last year expanded its FDA-approved uses to include the treatment of patients age 1 and older with advanced pLGG—but only if the cancer has a BRAF V600E mutation. This mutation is rarer, representing an estimated 10% to 20% of the pLGG patient population, according to Day One. Because Ojemda addresses a broader range of BRAF alterations, including the BRAF V600E mutation covered by the Novartis drug combination, the Day One small molecule can treat more pLGG patients. Ojemda is the first approved systemic therapy for treating pLGG with BRAF rearrangements, including fusions, the FDA said.

Day One studied Ojemda in an open-label Phase 2 clinical trial that enrolled 137 pediatric patients who had a low-grade glioma with a BRAF alteration. The main goal was measuring the overall response rate. The study was designed with two study arms; the FDA decision is based on efficacy results from the 76 patients in arm 1, which showed a 51% overall response rate. The median duration of response was 13.8 months. Arm 2 of the study enabled access to the Day One drug once arm 1 had fully enrolled. Results from the second arm provided additional safety data. The most common adverse reactions reported across both arms included rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, and fever. Detailed results were published last fall in the journal Nature Medicine.

Ojemda is available as an immediate-release tablet or an oral suspension, both administered once weekly. Dosing of the Day One drug is according to body surface area, which is consistent with dosing for other pediatric medications, Blackman said. Day One has set a $33,816 wholesale price for a 28-day supply. That means the annual cost of the therapy will top $440,000. Ojemda’s price is the same for all packages of the drug and will not change as a child grows and needs higher doses, Chief Commercial Officer Lauren Merendino said.

The two formulations of Ojemda can be taken at home, which minimizes disruption to the lives of patients and families, Merendino said. Day One’s goal is to establish Ojemda as the physician’s first choice of therapy for pLGG. Merendino said the drug should become available in about two weeks.

Blackman co-founded Day One in 2018 with a focus on developing drugs for pediatric cancers, which he said face an innovation gap compared to the research devoted to treating cancers in adults. The company’s name comes from “the day one talk” physicians have with patients and their families following a cancer diagnosis. Day One procures its drug candidates from other companies. Ojemda was licensed from Takeda Pharmaceutical in 2019.

The FDA decision for Ojemda is an accelerated approval, a speedier path to market for drugs addressing diseases with serious unmet medical need. Day One will need to generate post-marketing clinical data to confirm the safety and efficacy of its new drug. Chief Operating and Financial Officer Charles York said Day One is continuing partnership discussions for Ojemda outside of the U.S., but in the near term, the company’s focus is on U.S. commercialization of the medication, its first FDA-approved product.

Photo: Getty Images

Clinical trials represent a critical path to innovative treatments, life-changing cures, and medical progress. But for all their scientific rigor, most trials fail to include one crucial element: input from the very people they aim to help.

In the past, patients have had little say in how clinical trials are designed. The responsibility of trial design is usually left to academics, clinicians, statisticians, and industry experts. However, a recent study by the Health Stories Project found that 97% of patients believe it is important for biopharmaceutical companies to include patient feedback when designing clinical trials. Additionally, 83% of patients expressed interest in providing feedback. Unfortunately, most trials do not incorporate the patient voice, which leads to 85% of clinical trials failing to retain enough patients to reach completion. This lack of patient involvement has resulted in many trials providing minimal real-world benefits at best and causing harm at worst.

Fortunately, the landscape is evolving. The past decade has seen rising patient advocacy hand-in-hand with regulatory guidance that makes the message clear: patients need and deserve a seat at the table.

Trials that are poorly designed often fail when patients scrutinize them or when real-life pressures are applied. For instance, a treatment that requires daily medical visits might show success under ideal trial conditions. However, when the same constraints are placed on patients who must also balance jobs, families, and comorbidities, adherence often drops to unsustainable levels.

Excluding patients from clinical trials can have a significant impact on engagement. Patients and clinicians have different perspectives when it comes to treatment success and outcomes. Patients, who live with their conditions on a daily basis, are better equipped to determine which outcomes matter most compared to traditional experts. For instance, while mortality reduction may be statistically significant to researchers, clinical treatments that produce such effects may leave patients bedridden and unable to work or take care of their families. By tapping into these experiences and exploring the benefit-risk trade-offs, we can gain valuable insights for designing clinical trials that address the needs of patients effectively.

Involving patients from the very start

To optimize trial meaningfulness and success, researchers must engage with patients and caregivers – who are experts in their own right – through authentic conversations from the onset of trial design.

One way to ensure that a clinical trial is relevant to the everyday lives of patients is to conduct a comprehensive elicitation process. This can be done by organizing meet-and-greets between researchers and patients, during which researchers can gain a deep understanding of the individual stories and experiences of patients with the condition being studied. Additionally, researchers can benefit from self-completion exercises, which involve patients creating their own personal condition timelines and exploring techniques to express both the conscious and unconscious manifestations of their condition.

Patient involvement in clinical trials should not be limited to just participating in the study. Patients should also be involved in defining the trial endpoints to capture their experience during the trial. Factors like the impact of the treatment on their functional limitations, emotional well-being, and social function may provide an additional perspective into the effectiveness of a treatment. To ensure that clinical trials are accessible to a wider demographic and avoid creating barriers, clinicians may consider using decentralized technologies such as wearables and smartphone apps, so that patients can easily report data from wherever they are.

Looking ahead

In the future, there will be a greater effort made by clinical trial providers to facilitate the connection of patients and healthcare providers with relevant clinical trials. For medical professionals and patients, it is important to ensure continued access to diverse healthcare systems that share de-identified data to fuel research and connect patients with suitable trials. This will enable the acceleration of groundbreaking insights and therapies, by involving patients in the development of clinical trials.

Patients are seeking cures, just like the industry and science are striving for breakthroughs. Game-changing advances can be achieved by integrating patient collaboration and priorities into the full span of trial design. In order to guide clinical trials as partners, patients must be given equal footing with research teams, rather than being treated as passive subjects. It is important for the industry to recognize that patients are both beneficiaries and creators of scientific knowledge.

Photo: 9amstock, Getty Images

Christopher P. Boone, Ph.D., is a global executive, strategist, professor, and social scientist with a unique passion for revolutionizing healthcare and life sciences through clinical research informatics, real-world evidence, and health equity. As the Group Vice President of Life Sciences Research Services at Oracle Corporation, Chris steers the function responsible for conducting research that accelerates the discovery, development, and deployment of extraordinary insights and therapies to help transform healthcare and improve patients’ lives. His academic contributions as an adjunct assistant professor at New York University’s Robert F. Wagner Graduate School of Public Service further amplify his impact.

Heart disease continues to be the leading cause of death and disability in the U.S. and worldwide. Atherosclerotic cardiovascular disease (ASCVD), which is caused by plaque buildup in arterial walls, puts patients at risk of multiple life-threatening conditions and may go virtually overlooked until a major cardiovascular (CV) event, such as a heart attack or stroke, happens.

In the U.S. alone, more than 805,000 people are at risk of a heart attack, and for approximately 200,000 of them, this may be their second life-threatening cardiac event. More importantly, nearly 20% of those people who have had a heart attack will be hospitalized again within five years due to a second event. These alarming statistics not only impact patients and their families but the workforce and economy.

Cardiologists have made significant progress in preventing heart attacks or stroke due to high cholesterol. Even so, many patients remain at risk for ASCVD due to inadequate treatment leaving them vulnerable to disease progression and potentially catastrophic events.

Statin therapy is the first-line treatment for primary prevention of ASCVD in patients. Yet, cholesterol management alone is not sufficient to prevent ASCVD-related disease, as many statin-treated patients continue to suffer from acute CV events. Most physicians have continued to focus on lowering patients’ risk of CV events with additional lipid lowering therapies rather than targeting systemic inflammation as a contributing factor to ASCVD progression. 

Every doubling of statin dose develops, on average, a further reduction in LDL cholesterol (a major culprit in ASCVD) however this “rule of 6” strategy can result in, among other consequences, an increase in side effects. Furthermore, even if the increasing statin therapy normalizes LDL levels there remains a risk for a CV event. It’s therefore very important that physicians begin to recognize the impact of inflammation as a mostly untreated contributing factor to this disease.

For more than two decades, research has shown inflammation plays a significant role in the development of atherosclerosis and ASCVD. Since then, several clinical trials have shown that physicians may further reduce the risk of CV events in patients by addressing inflammation as a crucial therapeutic target for secondary prevention in high-risk patients.

Most importantly, a recent analysis published in The Lancet found residual inflammatory risk to be a more powerful determinant of recurrent cardiovascular events, cardiovascular death, and all-cause mortality than by LDL-C. 

With this abundance of data showing the importance of inflammation in CVD, it’s time we cardiologists and physicians treat high-risk patients by adding inflammation-inhibiting therapies along with aggressive lipid-lowering medications to further reduce the progression of atherosclerosis.

The good news is that last year the U.S. Food and Drug Administration (FDA)-approved the first anti-inflammatory therapeutic option known as LODOCO^® (colchicine, 0.5 mg) to reduce cardiac event risk in patients with established cardiac risk factors. The drug is safe, and efficacious on top of conventional statin therapy. Most importantly, it is cost effective and can easily be made available to any and all patients with ASCVD whom historically may not have had access to equitable health care.

The data supporting this approval included the LoDoCo2 trial which showed colchicine significantly reduced the risk of cardiovascular death, heart attack, ischemic stroke, or ischemia-driven coronary revascularization by 31% compared with placebo. This represents an astonishing effect and one that surpasses the reductions seen in contemporary secondary prevention trials of adjunctive lipid-lowering agents. 

However, one approved anti-inflammatory treatment is not enough. 

For example, people with chronic kidney disease or hepatic dysfunction should not be prescribed colchicine. These people represent a significant population that currently remains at risk of life-threatening CV events. As such, we must continue to research anti-inflammatory agents that may work synergistically with statins, without compromise to hepatic or renal function to mitigate ASCVD.

In 2017, the CANTOS trial proved that inflammation inhibition using canakinumab, without lipid lowering medications, can significantly reduce CV event rates by helping to define the IL-1 to IL-6 to CRP pathway as a central target in CV disease. Colchicine has also been shown to reduce multiple pro-inflammatory mechanisms by suppressing the NLRP3 inflammasome and inhibiting migration of neutrophils to inflamed areas. 

Several systematic reviews of anti-inflammatory drugs have been performed to explore the potential beneficial effects in patients with ASCVD. Nonetheless more research is required to ensure we are providing patients with CV disease with the best care that we can by also addressing underlying systemic inflammation. 

Although considerable progress has been made in preventing heart attacks or stroke in patients, until recently, even physicians did not recognize the significant role inflammation plays in contributing to heart disease. As such, cardiologists and other physicians who treat patients with ASCVD have continued to focus on additional aggressive lipid-lowering medications with little success in further reducing the risk of a life-threatening CV event in their patients. However, it is paramount that we as clinicians address both cholesterol risk and inflammation to further reduce the risk of a heart attack or stroke successfully.

In the past year, we’ve made significant advancements with one FDA-approved anti-inflammatory drug (LODOCO) that can effectively treat heart disease in combination with lipid-lowering medications. However, it’s essential that we continue to research the potential beneficial effects of inflammatory-inhibiting agents so that more patients can prevent life-threatening cardiac events.

Photo: BrianAJackson, Getty Images

Robert L. Quigley, M.D., D.Phil., is an international healthcare consultant and a senior consultant for International SOS. He is the co-founder and executive chairman of the International Corporate Health Leadership Council, a 501(c) (6) organization. He formerly served as senior vice president and global medical director, corporate health solutions, at International SOS Assistance & MedAire, Americas Region, and was responsible for leading the delivery of high-quality medical assistance, healthcare management, and medical transportation services. Prior to joining International SOS, Dr. Quigley was a triple board re-certified cardiovascular and thoracic surgeon who directed two open heart programs within the Jefferson Health System in Philadelphia, where he was a professor of surgery at Jefferson Medical College. He holds a doctorate in immunology.

New technologies are making it easier for companies to fix prices and discriminate against individual consumers, the Biden administration’s top consumer watchdog said Tuesday.

Algorithms make it possible for companies to fix prices without explicitly coordinating with one another, posing a new test for regulators policing the market, said Lina Khan, chair of the Federal Trade Commission, during a media event hosted by KFF.

“I think we could be entering a somewhat novel era of pricing,” Khan told reporters.

Khan is regarded as one of the most aggressive antitrust regulators in recent U.S. history, and she has paid particular attention to the harm that technological advances can pose to consumers. Antitrust regulators at the FTC and the Justice Department set a record for merger challenges in the fiscal year that ended Sept. 30, 2022, according to Bloomberg News.

Last year, the FTC successfully blocked biotech company Illumina’s over $7 billion acquisition of cancer-screening company Grail. The FTC, Justice Department, and Health and Human Services Department launched a website on April 18, healthycompetition.gov, to make it easier for people to report suspected anticompetitive behavior in the health care industry.

The American Hospital Association, the industry’s largest trade group, has often criticized the Biden administration’s approach to antitrust enforcement. In comments in September on proposed guidance the FTC and Justice Department published for companies, the AHA said that “the guidelines reflect a fundamental hostility to mergers.”

Price fixing removes competition from the market and generally makes goods and services more expensive. The agency has argued in court filings that price fixing “is still illegal even if you are achieving it through an algorithm,” Khan said. “There’s no kind of algorithmic exemption to the antitrust laws.”

By simply using the same algorithms to set prices, companies can effectively charge the same “even if they’re not, you know, getting in a back room and kind of shaking hands and setting a price,” Khan said, using the example of residential property managers.

Khan said the commission is also scrutinizing the use of artificial intelligence and algorithms to set prices for individual consumers “based on all of this particular behavioral data about you: the websites you visited, you know, who you had lunch with, where you live.”

And as health care companies change the way they structure their businesses to maximize profits, the FTC is changing the way it analyzes behavior that could hurt consumers, Khan said.

Hiring people who can “help us look under the hood” of some inscrutable algorithms was a priority, Khan said. She said it’s already paid off in the form of legal actions “that are only possible because we had technologists on the team helping us figure out what are these algorithms doing.”

Traditionally, the FTC has policed health care by challenging local or regional hospital mergers that have the potential to reduce competition and raise prices. But consolidation in health care has evolved, Khan said.

Mergers of systems that don’t overlap geographically are increasing, she said. In addition, hospitals now often buy doctor practices, while pharmacy benefit managers start their own insurance companies or mail-order pharmacies — or vice versa — pursuing “vertical integration” that can hurt consumers, she said.

The FTC is hearing increasing complaints “about how these firms are using their monopoly power” and “exercising it in ways that’s resulting in higher prices for patients, less service, as well as worse conditions for health care workers,” Khan said.

Policing Noncompetes

Khan said she was surprised at how many healthcare workers responded to the commission’s recent proposal to ban “noncompete” clauses — agreements that can prevent employees from moving to new jobs. The FTC issued its final rule banning the practice on Tuesday. She said the ban was aimed at low-wage industries like fast food but that many of the comments in favor of the FTC’s plan came from health professions.

Health workers say noncompete agreements are “both personally devastating and also impeded patient care,” Khan said.

In some cases, doctors wrote that their patients “got really upset because they wanted to stick with me, but my hospital was saying I couldn’t,” Khan said. Some doctors ended up commuting long distances to prevent the rest of their families from having to move after they changed jobs, she said.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

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Since its introduction in 2021, Canada’s Biomanufacturing and Life Sciences Strategy has strengthened the sector, deepened innovation, enhanced economic growth and ensured pandemic readiness for future generations.

The Government of Canada has made investments of $2.2 billion in 38 projects to bolster biomanufacturing, vaccine production capacity and therapeutics ecosystem development. Funding committed through Canada’s Advanced Manufacturing Cluster, the National Research Council and the Strategic Innovation Fund reinforced domestic pandemic response capabilities and life sciences innovation.

Prioritizing the expansion of domestic production capabilities for diverse, adaptable vaccine platforms, and enabling rapid scale-up during pandemics has been well received by the private sector. It has led to Canada securing major investments from Sanofi and Moderna, which have added to already impressive industry capabilities with a plethora of Fortune 500 companies such as Abbott Laboratories, AbbVie, and Baxter International active in the market. 

International Collaboration and Partnerships

The Biomanufacturing and Life Sciences Strategy, supported by substantial investments and international collaborations, solidified the country’s global standing as a resilient hub of life sciences research.

Canada has been actively engaged in a transcontinental partnership to advance its biomanufacturing agenda. Last year, at the North American Leaders’ Summit, Canadian Prime Minister Trudeau, U.S. President Biden, and Mexican President Obrador agreed on a trilateral health cooperation focusing on launching an updated North American Plan for Animal and Pandemic Influenza (NAPAPI).

By fostering scientific collaboration and biomanufacturing innovation in North America, the Plan will better prevent and stop outbreaks. It will also provide rapid response to future health emergencies owing to efficient health systems and workforces.

Such international partnership demonstrates the country’s commitment to encouraging global cooperation and leveraging its strengths in the life sciences sector. “A Life Sciences Strategy is an essential roadmap to advance health and innovation, now and into the future,” said Lauren Fischer, Lead, Government Affairs, AbbVie Canada. “These strategies support important investment in discovery research and projects, which generate new technologies that help advance standards of care and improve the lives of people in Canada, and globally.”

Competitiveness and Planning for the Future

Government investments and policies ensure that Canada has the necessary talent, research and development pipeline, robust SME industry and security across the supply chain to support a dynamic and growing biologics manufacturing and innovation ecosystem. 

These key initiatives, coupled with the country’s proactive approach to revitalizing its biomanufacturing industry, position Canada as an ideal destination to attract foreign direct investments in life sciences. Canada offers a competitive, affordable, high quality-of-life environment to expand a business in pharmaceuticals, medical devices, or digital health. Supported by world-class hospitals and healthcare innovation, global companies are especially well-positioned to succeed. 

Thanks to a skilled labor pool with 67% of Canadians aged 25 to 64 years who have a tertiary education, Canada is one of the most highly-educated workforces in the world. “Life sciences companies are investing and reinvesting in Canada because of our compelling value proposition, including our educated and diverse talent base, our STEM ecosystem, our innovation, and so much more,” said Laurel Broten, CEO, Invest in Canada.

Canada is business-friendly with competitive tax incentives embodied by its Scientific Research and Experimental Development (SR&ED) program, the Government’s largest R&D program with $3 billion in tax incentives annually. With a sharp vision for the future, Canada has already invested in next-generation technologies that will keep any business on the avant-garde. 

Just last week, the federal budget revealed a reinvestment of $200 million in the Venture Capital Catalyst Initiative which assembled a portfolio of funds-of-funds and VC funds. The goal is to increase the availability of capital for high-growth potential life sciences companies as well as for entrepreneurs from underrepresented groups. The Canadian biotechnology sector welcomed this timely announcement and can look towards building the next cycle of growth, according to BIOTECanada, the national industry association who will be leading the Canadian delegation at the BIO International Convention in June. 

In conclusion, investing in Canada today is an opportunity to be a part of tomorrow’s robust ecosystem of multinationals and burgeoning start-ups that have already found success across the country, “From Sea to Sea.”

Services from the Trade Commissioner Service at the Consulate General of Canada in Chicago are offered free of charge to Canadian exporters and international investors. Julien Rosan, Trade Commissioner, Life Sciences, specializes in health industries and advises Canadian companies on business development opportunities in the U.S. Midwest market. Tina Kotrych, Trade Commissioner, Foreign Direct Investment (FDI), helps U.S. Midwest-based firms navigate all aspects of setting up and expanding operations in Canada.

Read also: Canada and the Midwest in Life Sciences, 75 Years in the Making

As noted in the first article in this series, traditional value-based (VBC) care models are largely focused on economic incentives to healthcare providers and facilities. Many VBC organizations lack the infrastructure in place or scale to integrate factors that impact how patients interact with the healthcare system, engage with care providers, or adhere to treatment recommendations. Failure to consider and address these needs can create obstacles to realizing the full economic and health goals of traditional VBC models. 

For example, social determinants of health (SDoH), including safe housing, transportation, and neighborhoods; racism, discrimination, and violence; education, job opportunities, and income; access to nutritious foods and physical activity opportunities; polluted air/water; and language and literacy skills, impact more than half of all health outcomes. In fact, it is estimated that aspects other than individual health exceed health-related factors with respect to driving population health outcomes. One study found that sociocultural, logistical, and financial factors impact medication adherence, which is a key driver of health outcomes.

Overcoming these obstacles requires both novel VBC models as well moving care beyond the clinic walls to meet patients where they are. Some public health initiatives have made significant strides toward improving access, quality, and cost-effectiveness of health services. For example, New York State’s 115 Medicaid Redesign Team (MRT) Waiver allows the State to implement a managed care program that provides comprehensive and coordinated health care to Medicaid recipients, improving these individuals’ overall health coverage. One component of the program, the MRT Supportive Housing Initiative, addresses housing-related SDoH by providing supportive housing to high-need Medicaid participants through rental subsidies, supportive housing services, and capital projects. 

A growing number of private-sector organizations are innovating new approaches. Here we name just a few among a growing number of companies that are delivering care in the home or outside the typical provider setting.

• Ounce of Care is a private-sector solution that, similar to New York’s MRT program, also provides coordinated care within affordable housing properties and includes services such as referrals to primary care, support in enrolling in Medicaid and food and utility assistance programs, and on-site community health events.
• Valera Health provides telemedicine mental health services that allow patients to access care at the time and place of their convenience. This greatly reduces barriers to care, which is especially important given the growing mental health crisis in the United States. 
• Aware Recovery Care brings substance use disorder services, including ambulatory detox, medication assistance, and addiction treatment into the home. This both lowers care costs and improves the quality of life for individuals needing these services.
• Vesta Healthcare connects home care with primary care to better serve individuals with complex health needs using tailored care management plans and 24/7 support. These strategies can include proactive and remote monitoring of blood pressure, oxygen, weight, and other metrics that allow care providers to know when there is a change in health status and to provide timely and effective interventions that can help obviate the need for hospitals and nursing homes and help people stay at home. 

Care providers themselves are also pursuing novel models for engaging with the patients they serve. Mass General Brigham is deploying new patient centricity approaches that integrate virtual appointments, remote patient monitoring, meal services, and in-home clinician visits. This large integrated health system has an initial goal of moving 10% of its medical patients to this in-home care model. 

Continued innovation— in both the public and private sectors — will be needed to increase patient engagement in meaningful ways. As individuals and governments invest in new models and initiatives, it’s essential to remember that patient engagement can come in many forms. Meeting patients where they are (virtual, home, clinic) and connecting through their preferred communication channel (patient portal, in-person, digital apps) are critical for facilitating productive and trusted patient–provider relationships. Toward this end, we must acknowledge that patient engagement is not possible without something or someone with which to engage. Technical infrastructure and provider time both are essential for supporting open communication and ensuring that patients know how to engage and the benefits to themselves of doing so. Achieving this goal requires finding ways to balance patients’ 24/7 access to care without overburdening providers and to empower patient engagement without straining the system. Similarly, providers need to be equipped with resources to effectively engage patients. While group education sessions offered during regular working hours may work for some people, they are not an option for everyone. Engagement efforts must acknowledge and address barriers associated with where people live, their work hours, their family responsibilities, and their ability to travel.

Finally, while understanding SDoH is a great start to improving health outcomes and many companies have put in the resources to do so (UniteUs, FindHelp, Violet Health, etc.) those at the clinic level need to be able to understand these data and make them actionable in a timely and effective manner. Collaborative and coordinated engagement among providers, policymakers, advocates, payers, patients, and caregivers is the best way to achieve the patient engagement we need to make VBC accessible to and effective for all.

Photo: Hong Li, Getty Images

Jason Helgerson is the Founder and Chief Solutions Officer for Helgerson Solutions Group, a health care consultancy firm focused on helping organizations successfully transition to a value based world. HSG works with private companies, governments and non-profit organizations that need assistance in implementing value-based payment approaches and new care models that will lead to improved patient outcomes and lower overall costs. HSG is also a trusted advisor for private equity and venture capital firms as they look for new investment opportunities and work with companies to drive growth and profitability. Prior to founding HSG, Jason was New York’s Medicaid Director. Jason ran the $70 billion program for over 7 years and was recognized as one of the nation’s most effective healthcare leaders. Jason is a senior advisor to Windham Venture Partners. Prior to New York, Jason was Wisconsin’s Medicaid Director where he led the state’s nationally recognized Badgercare Plus program. When Jason left public service to found HSG, he was the nation’s longest standing Medicaid Director.

Glen Moller is a veteran of the healthcare industry, having led health plan, provider, and health services businesses in both public and privately-funded environments. Glen has managed several successful turn-arounds and is experienced leading high growth companies in rapidly evolving sectors.

Glen was previously CEO and Board Member of ArroHealth, Inc., a provider of risk adjustment services and population health analytics that he led to became one of the fastest growing healthcare companies in the nation. Prior to ArroHealth, Glen served as Medicare CEO at Centene Corporation, and before that as President of Fidelis Senior Care, a PE-backed Medicare Institutional Special Needs Plans. As COO at the Express Scripts Insurance Company, Glen led a Medicare program and national Prescription Drug Plan, now the largest in the country. He started his career at Oxford Health Plans.

Glen earned a B.A. in Economics and English from Boston College and an M.B.A. from Harvard Business School. He serves on the Board of Directors of Nuvem Health.

On Tuesday, Headspace announced that it is going toe-to-toe with the likes of Talkspace and BetterHelp by bringing its digitized mental health services directly to consumers — starting with text-based mental health coaching. Teletherapy services are also slated to become available to consumers later this year on the Headspace app.

Headspace — which was founded in 2010 and has primarily sold its platform to employers — helps users improve their mental health through meditation and mindfulness exercises. In 2021, the company completed a $3 billion merger with Ginger, a provider of digital mental health coaching, therapy and psychiatry services.

On the Headspace app, U.S. consumers can now access one-on-one guidance from the company’s mental health coaches. These coaches help users address life challenges that may not require a therapist, such as everyday stress, a breakup or starting a new job.

“Coaching can be an incredibly effective intervention for many people who could use a little extra support, yet there isn’t any company today that’s made this kind of care available to consumers at scale — creating a huge opportunity at a time when people continue to struggle with their mental health,” said Christine Hsu Evans, president at Headspace.

Headspace’s mental health coaches meet with members via text-based sessions, which the member can schedule at any time. Users who schedule a coaching session through the app’s consumer channel can expect to schedule an appointment within 48 hours after completing a few onboarding questions, Evans explained. 

In partnership with the member, Headspace’s coaches work to build a goal-oriented mental health plan that is tailored to the member’s goals, she said.

“It’s a lower-cost, more accessible level of care that can help the majority of our members stay on track with goals and feel supported,” Evans stated.

Nearly half of Americans don’t get benefits through an employer. Due to this, Headspace has “heard loud and clear” from its consumer members that they want the company to move beyond offering them only mental health and mindfulness content, Evans added.

By establishing a direct-to-consumer channel, Headspace can now offer its services to anyone, she declared.

This means that the company is now competing with other mental health apps that offer their services directly to consumers. Evans believes that Headspace can stand out from the crowd, though. 

“Most technology-enabled mental health care providers offer a therapy-centric or therapy-only model, where your mental health care ends when your session is over. And the reality is, most people don’t need a therapist — but many could benefit from the skills-based approach taken with mental health coaching, making coaching a great first step for people dealing with everyday stress, anxiety and life challenges,” she explained.

In her view, mental health coaching is “quickly achieving widespread adoption and acceptance” among the healthcare community. 

Photo: Headspace

Since generative AI came on the scene, it’s been racing ahead at a steady clip and making its mark on every industry. Adoption of AI-based technologies tends to happen at lightning speed – for instance, ChatGPT (which now boasts over 180.5 million users) acquired 1 million users within 5 days of its launch, a milestone that Netflix took 3.5 years to reach. 

True, some of the initial hype surrounding AI failed to pan out as fast as some of us anticipated – like self-driving cars, which many of us had assumed we’d be driving by now. However, the use of AI tools in the healthcare space has already become widespread, playing a pivotal role in enhancing patient care. 

AI technologies are making disease diagnosis faster through computerized medical data and genome assessment. It is being used to personalize treatment and medications, streamline imagery data analysis, increase efficiency in data collection for clinical trials, and in many other practical applications. AI is even being used in mental health support when assessing patients and providing both short and long-term treatment plans.

But what can those developing AI technologies do better? How can we fully harness AI’s potential to further improve healthcare going forward? 

The secret sauce is collaboration

Collaboration is having an enormously positive influence on the future of healthcare AI. Leaders in the field and AI technologists have joined forces, sharing data sets and knowledge under newly introduced regulations and guidelines such as the EU Artificial Intelligence Act. This teamwork ensures that the best and brightest minds work closely together for everyone’s ultimate benefit. 

Collaboration isn’t merely a nice-to-have or a trendy fad when it comes to AI in healthcare. It’s an absolute must for managing sensitive patient data, handling ethical dilemmas and biases, and ensuring equitable access to care. 

Here are four ways in which collaboration positively impacts the use of AI in healthcare:

Upholding ethics

Collaboration allows for more ethical use of AI in healthcare. In doing so, it ensures responsible and informed decision-making that can safely maximize AI’s benefits. Collaboration in AI ethics and healthcare is exemplified by initiatives such as AI-READI, a project aimed at creating and sharing an ethically-sourced dataset of type 2 diabetes that strictly adheres to FAIR (findable, accessible, interoperable, and reusable) principles. 

Projects like AI-READI are part of a concerted effort to establish ethical standards and guidelines for AI applications in healthcare. In doing so, they promote the accountability, transparency, and awareness needed to ensure responsible AI implementation and uphold patient trust.  

Addressing biases

Fairness and equity are essential in healthcare settings. However, bias is an ongoing challenge when dealing with AI algorithms. Collaborative efforts are already underway to confront bias in AI systems within healthcare contexts. 

For example, Stanford researchers are working across disciplines and actively engaging with various stakeholders to create more trustworthy and inclusive AI solutions for healthcare applications. Through algorithmic auditing, data augmentation, and model interpretability, one of the university’s research groups seeks to mitigate bias in datasets and ensure equitable outcomes across different demographic groups. These researchers are working together to assess the causes and consequences of biases in AI systems used for data collection, user interactions, and algorithmic decision-making. 

Collaboration facilitates the development of tools and resources used to detect and mitigate bias. It allows organizations to improve transparency, fairness, and accountability in healthcare AI applications. 

Ensuring access

Collaborative AI can be used to help alleviate healthcare disparities among vulnerable and underserved populations. Healthcare providers, researchers, and technology experts are pooling their expertise to develop innovative solutions that can overcome geographical and resource constraints. 

One such example is AI4Lungs, which seeks to bridge gaps in the earlier detection and improved treatment of respiratory diseases. This initiative and others like it help ensure that AI tools are capable of meeting the unique needs of the populations they serve. In this way, AI collaboration in healthcare settings can significantly improve healthcare access and enhance patient outcomes on a global scale. (The author’s company is a member of the AI4Lungs consortium.)

Safeguarding data

Protecting patients’ privacy and safeguarding their data are non-negotiables. This is particularly important given the increased use of AI in automating the data collection process for clinical trials. 

However, evolving regulatory requirements pose a serious challenge, while emerging security threats put patient data at risk. Collaboration brings together key figures in data governance, privacy, and encryption to create stringent frameworks and robust safety standards. In doing so, it helps foster trust among patients and healthcare providers. 

The U.S. AI Safety Institute at the NIST is one such body that carries out research to detect vulnerabilities in patient data protection. The institute develops standards to ensure patient data is handled securely throughout its lifecycle, from collection to analysis and storage. By bringing together policymakers, researchers, and healthcare providers, collaborative efforts can address the complex challenges of protecting the confidentiality and integrity of sensitive patient information.  

A more collaborative future

Today’s rapid technological advancements, combined with the growing complexities of the healthcare industry, underscore the need for a more unified and collaborative approach. This ensures that practical, regulatory, and ethical considerations are addressed, while still allowing healthcare to leverage AI’s transformative potential.

Collaboration brings together the expertise of diverse stakeholders to act as the driving force behind healthcare transformation and innovation. It ensures that AI in healthcare fully upholds ethical practices, mitigates biases, expands healthcare access, and protects patient data. Collaboration is the cornerstone that allows AI to realize its full potential in enhancing healthcare delivery and improving patient outcomes. 

Not merely an advantage, collaboration is the channel through which AI-driven healthcare innovation can thrive. When we encourage these collaborative efforts, we’re paving the way for AI in healthcare to be even more equitable, safe, and inclusive, thereby benefiting patients and industry stakeholders alike.

Photo: metamorworks, Getty Images

Itai Rechnitz is the COO and co-founder of Yonalink, the leading EHR-to-EDC streaming provider for clinical trials. He is an entrepreneur, investor, business and product leader who has led a total of four M&A’s throughout his career. Itai is an angel investor of several startups, including CalmiGO and TankU.

Immunotherapy is already a treatment option for bladder cancer, but in many cases, these therapies fail or the cancer comes back. When it returns, the next option is removing the bladder. FDA approval of a novel immunotherapy gives bladder cancer patients an alternative to surgical removal of the organ.

The FDA has approved ImmunityBio’s therapy, Anktivo, for the treatment of non-muscle invasive bladder cancer (NMIBC), which is cancer found only on the inner layer of the bladder wall. The regulatory decision announced late Monday covers adults whose disease is unresponsive to Bacillus Calmette-Guérin (BCG), a standard of care immunotherapy for bladder cancer.

BCG is a benign type of bacteria. Delivered to the bladder via a catheter, the bacteria induce an immune response that can clear cancer. But BCG therapy fails in up to 40% of patients. Other immunotherapies used to treat NMIBC include checkpoint inhibitors, drugs that block a protein used by cancer cells to avoid detection by the immune system.

San Diego-based ImmunityBio developed Anktiva to offer patients a multi-pronged immune response to bladder cancer. The therapy, which is administered directly into the bladder by catheter, is a fusion protein that enhances the therapeutic potential of cytokines, signaling proteins that can spark an immune response. This biologic drug is specifically engineered to bind to and activate the IL-15 receptor, which plays a role in modulating immune cells.

Anktiva is intended to increase the activity of two types of cancer-killing immune cells, natural killer cells and CD8 positive T cells. It does so without also activating regulatory T cells that suppress immune responses. The therapy also stimulates memory T cells that lead to a longer duration of immune response. Compared to native IL-15, ImmunityBio says Anktivo offers greater therapeutic activity over a longer period of time.

“Anktiva enhances natural killer cell recruitment as well as T cell stimulation,” Sam Chang, professor of urology and chief surgical officer of the Vanderbilt Ingram Cancer Center, and a principal investigator for the therapy’s clinical trial, said in a prepared statement. “By doing this and stimulating the innate immune memory response, we get an improved ability to kill tumor cells.”

Approval of Anktiva covers use of the new ImmunityBio product alongside BCG therapy, which is how it was tested in clinical trials. The pivotal Phase 2/3 study enrolled 77 patients who had BCG-unresponsive, high-risk NMIBC following surgery to remove tumors. The main efficacy goal was measuring complete responses to the therapy at any time as well as the duration of responses.

The complete response rate was 62%. In 58% of those with a complete response, the duration of that response was 12 months or longer; 40% of those responders had a duration of response 24 months or longer. ImmunityBio noted that the duration of response is ongoing, so the final median duration of response has yet to be determined. The most common adverse reactions reported in the study included higher blood levels of creatinine, which is a waste product from the breakdown of muscle; pain during urination; blood in the urine; a strong urge to urinate; and urinary tract infection.

Last May, ImmunityBio disclosed that the FDA turned down the application for Anktiva, citing problems at the therapy’s third-party manufacturer. No additional clinical data were requested. After ImmunityBio addressed the issues identified by the FDA, the agency accepted the company’s resubmitted application last October.

Biotech companies have pursued different ways of leveraging components of the body to fight bladder cancer. In 2022, privately held Ferring Pharmaceuticals won FDA approval for Adstiladrin, a gene therapy that uses the protein-making machinery of bladder cells to make therapeutic protein that has anti-tumor effects.

Other companies are trying to provide bladder cancer patients with additional treatment options. CG Oncology raised $380 million from its IPO to finance clinical development of cretostimogene, an oncolytic virus for NMIBC. Genetic medicines company enGene, which became public last fall via a merger deal, develops therapies with proprietary technology that enables localized delivery of gene cargos to mucosal tissues and organs. Lead program EG-70, which delivers three gene cargos to generate an immune reaction close to tumors, is currently in Phase 1/2 testing in NMIBC that’s unresponsive to BCG therapy.

Anktiva was initially developed by Altor BioScience, which ImmunityBio acquired in 2017. ImmunityBio reported a $265.5 million cash position at the end of 2023. In January, the company secured up to $320 million in financing from Oberland Capital. The deal gives Oberland the right to royalty payments on net sales of ImmunityBio’s products. The firm also made an equity investment in ImmunityBio and has the option to buy more of the company’s stock in the future.

ImmunityBio said it would apply proceeds from the financing toward commercialization of Anktiva and for ongoing clinical development of the therapy in other types of solid tumors. In addition to a Phase 2 test enrolling NMIBC patients who had not previously received BCG therapy, mid-stage clinical trials for Anktiva are underway or planned in lung cancer, colorectal cancer, ovarian cancer, acute myeloid leukemia, and glioblastoma.

ImmunityBio has not yet disclosed a price for Anktiva, which it expects will launch in mid-May.

Photo by ImmunityBio