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Exploring the Changing Landscape of Cancer Care

January 24, 2023
2:01 pm

Cancer is one of the leading causes of death across the globe and affects the lives of millions every year in the United States. As advances have been made in screening, diagnosing and therapeutics, providers have been able to utilize new technologies and precision medicine to achieve improved outcomes. The Healthcare Leadership Council hosted a webinar to highlight the commitment to medical research and discovery and the most recent accomplishments of some of its member companies. The webinar, “What’s New in Cancer Innovation?”, included three panelists:

  • Dr. Qasim Ahmad, Head of US Oncology Medical Affairs, Novartis
  • Dr. Harlan Levine, President, Health Innovation and Policy, City of Hope
  • Victoria Raymond, Senior Director of Medical Affairs, Guardant Health

Ms. Raymond described Guardant’s focus on blood-based diagnostics as a less invasive way to screen for specific cancers. This method of screening can assist in early detection as well as ensuring appropriate therapy selection. Dr. Ahmad concurred that there has been a shift from making the patient fit the treatment, to making the treatment fit the patient. He presented Novartis’s strategy to harness the power of targeted therapy, immunotherapy, cell and gene therapy, and radioligand therapy to attack cancer using multiple approaches and provide the best outcomes for patients at every stage of the disease.

Dr. Levine noted that the rate of change in oncology exceeds the ability for most oncologists to keep up with the advances in each subtype of cancer or surgical technique. He stated that while with precision medicine and genomics we are able to identify tumor types and DNA signals, we still address value-based oncology with tools that were developed decades ago as though cancer is a single specialty with only a handful of chemotherapy agents. Reliance on these generic tools will limit the benefit of emerging technology and propagate disparities.

The discussion underscored the lack of diversity across clinical trial sites, doctors, study investigators and trial participants. A map was provided as a visual to portray how one’s survival is directly impacted by one’s zip code. The need to innovate the system so that it is accessible and equitable is vital to improving cancer care. The panelists acknowledged efforts to increase diversity in clinical trials and addressing barriers that hinder trial participation and access to treatment. Educating the public on opportunities is just one piece of the puzzle. Finding easier ways for people to follow through with what they know they need to do is the next challenge.

Finally, the Inflation Reduction Act (IRA) was raised as a hindrance to cancer research, which require long-term commitments and significant investments.  There is a need for broader understanding of the investment required to subsidize clinical trials for cell-based therapies and the potential impact of the IRA in discouraging that investment. Policy measures that result in reduced research and fewer trials, ultimately limiting access to new therapies, is harmful to patients and society as a whole.

American Healthcare: The Challenge to Stay on Top

November 17, 2022
4:45 pm

The Healthcare Leadership Council hosted a webinar which highlighted the relationship between intellectual property (IP) and innovation, a linkage that is critically important in healthcare. The panel was comprised of:

  • Joe Allen, Executive Director of the Bayh-Dole Coalition
  • Eric Aaronson, Pfizer’s Chief Counsel for Corporate Affairs, Intellectual Property and Intellectual Property Enforcement Departments
  • Catherine Burch, Vice President of Innovation at ChristianaCare Health System
  • Paul Higgins, Vice President of Law, Head of Global IP Policy at Johnson & Johnson

The webinar was an open discussion covering the history and role of IP laws, as well as the importance of partnerships and collaboration in achieving new discoveries. It was acknowledged that not all that long ago the United States not the world’s global leader in life sciences, as it is today. The Bayh-Dole Act, enacted in 1980, decentralized technology from Washington bureaucracy and allowed the people creating biopharmaceutical and medical technology innovations to own and manage them, integrating incentives into the patent-and-licensing process and jumpstarting a renaissance in healthcare innovation.

The panelists agreed that the IP system encouraged investment in risk. A robust IP system provides two key benefits: (1) the assurance of intellectual property rights that are protected from bad actors who would diminish their value, and  (2) the creation of mechanism to transfer knowledge to those who can commercialize it for the greater public good. It enables collaboration between innovators, governments, universities, research partners, all of which are focused on exchanging information to speed up progress to finding solutions. Innovation is iterative and enables scientists to build off the discovery of others. Collaborations are key because it they enable to essential distribution of risk. It can require 10-15 years to develop a drug, cost upwards of $2.6 billion on average, and only about 10 percent of drugs evaluated in Phase 1 clinical trials are ever approved. Entities will not take on this level of risk without strong IP protections.

The pro-competitive nature of IP was also emphasized. Given that a drug or medicine may not be best option for every patient, having multiple solutions is important. Once the exclusivity period expires for a drug, it facilitates low-cost generic entry. There are those who like to pit the innovator versus generics, but it is really two sides of the same coin. To encourage new generics getting to market there must be support for strong IP systems, because the generic pipeline is the innovator pipeline.

The concept of march-in rights, a provision in the Bayh-Dole Act was also discussed. It was inserted to ensure that inventions didn’t sit dormant and were licensed to serve the public good; otherwise the government could “march in” and license them to entities who would move forward with production. Recently, there has been a push to use march-in rights to force price reductions for pharmaceuticals by shifting licensing from the current manufacturer to a company that could presumably make the drug cheaper. All petitions using this theory have been rejected by multiple administrations, because it is not what the Bayh-Dole authors intended. This would create a slippery slope in which holders of any intellectual property for which government funding played a role at some point in the process could have their license taken away. This would destabilize a system that has made the U.S. the technological innovation center of the world by discouraging investment in research and development.

Given the level of exchange of technologies that are required for the fast-paced collaboration and eventual production of the COVID-19 vaccine, none of the current vaccines would have occurred without an IP system that supported incentives and created an environment where information could be exchanged so that the iterative scientific process of discovery could work to the benefit everyone. Not only the discovery, but scaling the supply once a drug is approved requires researching manufacturing sites globally to find partners that are able to produce safe and effective vaccines to meet global demands. Every one of those partnerships rely on a sound and robust IP system.

Here’s How Insurers Can Take a More Strategic Approach to Community Investment

July 20, 2022
3:31 pm

This is a guest post by John Lumpkin, M.D., President of the Blue Cross and Blue Shield of North Carolina Foundation and Vice President, Drivers of Health.

Blue Cross and Blue Shield of North Carolina (Blue Cross NC) has been committed to engagement with the communities we serve for nearly a century. This work is not about writing checks or “giving back.” Instead, we think of our community support as “investing in.” In recent years, we have thought strategically about how to expand and maximize the impact of these efforts.

Good health happens where people live, work and play. We know that food, healthy housing, companionship, transportation and other resources play a far more significant role in a person’s health and well-being than what happens during those few hours per year spent in a provider’s office. And yet, not everyone has equal access to these resources. Putting people in contact with the resources they need for health and well-being is the right thing to do … it’s also the logical thing to do from a business perspective. Making these investments helps prevent, correct or manage trouble spots before they escalate into complex, expensive and painful health issues.

This investment mindset is apparent in the language we use to describe this work. Blue Cross NC made the conscious choice to abandon the common industry terminology, “social determinants of health,” in favor of “drivers of health.” We have argued for this change in part because we recognize the importance of giving agency to individuals and communities. No one’s well-being is pre-determined. With strong commitment and strategic thinking, individuals, communities and the health care industry can knock down barriers to good health.

But smart investment needs to be informed by data and guided by rigorous reasoning. Neither of these is necessarily easy to come by at this historical moment. Our industry is only just starting to acknowledge the important role a drivers of health strategy can play improving health outcomes and promoting health equity. Insurers don’t yet have the solid knowledge base to help them develop and implement the programs that will have the most impact.

The Blue Cross and Blue Shield of North Carolina Foundation was established in 2000 to improve the health and well-being of communities across the state. Further, Blue Cross NC’s Community and Diversity Engagement team offers additional widescale support for nonprofit organizations and health entities committed to connecting communities with the resources they need. To go further in addressing drivers of health through business practices and to close the knowledge gap, Blue Cross NC formally established its Drivers of Health Strategy team in 2019. The Drivers of Health Strategy team has a focus to implement innovative intervention models, measure their long-term impact and share these findings to promote informed and systemic change across our lines of business and across the industry.

Since 2020, the Drivers of Health Strategy team has launched four test and learn models, focused on food security, social isolation and transportation. More are on the way. We launched these pilots with the understanding that we couldn’t predict which would have the most significant impact. Our goal is to gather quantifiable evidence of long-term health impacts, overall member experience and savings from preventable medical expenses. Data from these models will start to roll in this year. In addition to testing these models internally, Blue Cross NC is collaborating with UNC Health Alliance and the Sheps Center at UNC-Chapel Hill to conduct a clinical research study to establish sustainable best practices for helping individuals improve health through nutritious food. Which is more effective, food vouchers or delivery? Does health coaching improve the efficacy of food interventions? What is the optimum length for a food intervention program?

In essence, our Drivers of Health Strategy team functions as a research, development, and implementation group to help Blue Cross NC identify viable drivers of health programs that will improve outcomes for our members, make the company more competitive and attract new members. Our findings will help guide evidence-based product decisions. And, as we share our insights externally, we will help build the evidence base other insurers will need to make informed decisions about their own products and programs.

This investment-minded approach is guided by a fundamental recognition that drivers of health impact us all, not just those who face barriers to vital resources. Greater access to these resources will help prevent, reverse or better manage chronic disease. A healthier population will reduce the strain on our health system and reliance on emergency department visits. Ultimately, this proactive approach will lower health care costs for everyone.

As an industry, we are at a critical time. Making a concerted effort to move toward a more comprehensive, data-driven approach to addressing drivers of health needs will lead to more sustainable models with greater reach and a measurable impact on individual, family and community health.

Educational Effort to Increase Vaccine Adherence

June 27, 2022
3:18 pm

Vaccines are integral to preventing diseases and reducing the chance of illness for individuals. They significantly lower the risk of severe illness and hospitalization, and even death, as well as preventing the spread of diseases. Vaccines have been critical in reducing the spread of several different diseases including COVID-19 and the flu.

YourVaccinationGuide.org, created by the California Chronic Care Coalition and the Healthcare Leadership Council, provides reliable information regarding vaccines for COVID-19 and other diseases, and offers resources for obtaining vaccinations. This website works to fight misinformation and uncertainty by educating the public and promoting the success of vaccines. The site offers reliable information to reassure consumers regarding the safety of vaccines and provides supporting evidence of their effectiveness on a global scale.

Your Vaccination Guide emphasizes the importance of vaccine adherence by highlighting the significant benefit of vaccines, especially for people who are considered high-risk for severe illness. Vaccines can substantially decrease the rate of spread and infection. This protects everyone, including people of higher risk. The goal is that everyone should aim to be vaccinated from diseases. While even with a vaccine one can still contract the disease, the severity of the illness will be significantly lowered and much more manageable compared to that of an infected unvaccinated person. The site offers statistical data which makes a compelling case for the importance of being vaccinated.

YourVaccinationGuide.org is a helpful tool for those searching for more information regarding vaccinations and for people who question the need or safety of vaccination. It underscores the millions of lives saved every year, and the thorough testing for safety that takes place continuously even while vaccines are in use. This page is also available in Spanish and provides a page of frequently used terms and their definitions to assist with health literacy.

Improving Diversity in Our Clinical Trials for Long-term Health Equity

June 01, 2022
2:19 pm

Across the healthcare industry work is taking place to address health disparities. The Healthcare Leadership Council (HLC) has delved specifically into social determinants of health, broadband access, disparities in care delivery, vaccine acceptance, behavioral health, and workforce and clinical trial diversity. Amgen, an HLC member, is a leader in improving clinical trial diversity as a means to ensure better outcomes for those of diverse racial and ethnic backgrounds. This recent post below lays out the company’s comprehensive strategy, strengthened by collaboration, to address systemic issues which affect participation in research.

Improving Diversity in Our Clinical Trials for Long-term Health Equity

Darryl Sleep, Amgen’s senior vice president and Global Medical and Chief Medical Officer

Last April, Amgen stood with PhRMA as the first-ever industry-wide Principles on Clinical Trials Diversity officially took effect. The goals of these Principles are to expand participation among diverse patient populations by increasing understanding and awareness about clinical trials and improving access. Since then, we’ve already seen two very significant positive outcomes. First, improving diversity and representation in clinical trials has evolved from a niche issue into a core industry commitment. Second is the development of enthusiastic, industry-wide initiatives to improve how sponsors approach and improve diversity and representation in clinical trials. We are sharing best practices and de-identified aggregated clinical trial data to continue advancing this work via our cross-industry collaborations and partnerships. In this purpose, there is no holding back; we are all dedicated to making long-overdue changes that will result in diversity and representation in clinical trials becoming a reality and not just an ideal.

Clinical trials are a critical part of the long and careful process of developing new medicines. This research is complex and multidisciplinary and there isn’t a single accelerator that can be used to address the systemic issues that deter people from participating. Instead, we need a range of different levers to update decades-old processes and create new best practices.

I want to use the one-year anniversary of the PhRMA Principles to share some highlights about the data-driven efforts we’ve taken at Amgen to lead the way in breaking down barriers and help us find new medicines supported by clinical trials that are representative of all patients who suffer from serious illnesses.

We have a dedicated team
While the push for more diversity and inclusion in clinical trials is not new to Amgen, we accelerated our efforts in 2020 with the formation of RISE (Representation in ClInical ReSEarch), a team dedicated to addressing the systemic issues that deter people from participating in research, especially those who have been historically excluded due to race, ethnicity, sex, age, and other factors. We have significant momentum with our goals as programs and teams across Amgen, including RISE, Global Medical, Advocacy, Compliance, and Global Development, trial execution and data & analytics teams work together to create greater equity through diversity and proportional representation in clinical trials.

Ongoing learning to gain understanding and insights
Communication and information-sharing are fundamental to driving change. The output from our Health Equity Summit: Disrupting Health Disparities through Partnership and multiple Community Advisory Boards focused on direct insights from Black, Indigenous and People of Color (BIPOC) which provided information on barriers, strategies, and tactics that can apply across communities. We are using these insights to directly inform the design and implementation of a long-term, study-agnostic community engagement plan – a critical step in building sustainable, trusted relationships. Additionally, our patient-focused advisory councils with representation of racial and ethnic minorities will inform our clinical trial design and execution.

Building foundational capabilities
Logistical and financial barriers, gaps in awareness, and lack of trust all impact participation in clinical trials. We are partnering with organizations and diverse suppliers to thoughtfully build our enrollment support capabilities, including providing transportation, and other potential support capabilities, as well as finding optimal ways to support staff at clinical trial sites. Taking a holistic approach to tackling these industry-wide issues will help us move the needle.

New partnerships and collaborations
Collaborative partnerships play a significant role in advancing understanding of the science and our ability to positively engage patient communities in clinical trials. Toward that end, we are engaged in a number of efforts including:

  • A pilot program of the American Cancer Society Cancer Action Network to test a trial eligibility screening intervention intended to increase and diversify patient enrollment in cancer clinical trials, including navigators to help patients address logistical and financial challenges to enrolling and completing those clinical trials.
  • The CEO Roundtable on Cancer’s Going for Gold initiative, in partnership with Historically Black Colleges and Universities (HBCUs) and Hispanic Serving Institutions (HSIs), that focuses on equitable cancer care.
  • A collaboration with The Digital Medicine Society (DiMe) to drive inclusion in digital clinical trials by providing the tools and framework necessary to successfully engage underrepresented populations during the planning process for clinical trials that include a technology device for participation.
  • Creation of the HBCU BioTech Fellowship program, a professional development program that will prepare and empower 50 students (and soon-to-be graduates) from Historically Black Colleges and Universities for careers at Amgen.

Measuring progress in our own trials
We have undertaken important steps including a baseline study that will help us measure progress for trials currently underway as well as for new trials on the horizon. Additionally, we have a number of tools in development to help us measure and evaluate best practices for improvement in enrollment of participants from diverse racial and ethnic backgrounds.

Recognizing differences in disease incidence, exposure and response to medicines
We have long been committed to unlocking the potential of biology for all patients suffering from serious illnesses using advanced human genetics to unravel the complexities of disease. Accordingly, we are using data on human diversity in our own labs and with research partners. Together, we will better understand incidence of obesity, cardiovascular disease from risk factors such as elevated Lp(a), inflammatory diseases such as atopic dermatitis and lupus, and multiple cancers in diverse populations.

In addition, we are seeking to understand and actively address the social determinants of health (SDOH) that contribute to wide health disparities and inequities that impact disease burden and access to healthcare.

Reaching the finish line will allow us to get new medicines faster to patients who need them. It will also help doctors assure their patients that the medication they’re being prescribed was studied in people like them, with results that indicate they are likely to benefit. We’re not there yet, but we’re taking informed steps with care, with the scientific expertise for which we are known, and with humility. Every day, we dedicate ourselves to serving patients by transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. As we work to fulfill our own values and PhRMA’s Principles, we’ll get closer to serving all patients, beginning with clinical trials that include people of all races and ethnicities who will benefit.

For more information, please visit Clinical Trial Diversity & Representation.