By Wayne Koberstein, Executive Editor, Life Science Leader magazine
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I asked leading executives in companies of all sizes to share their views on whether the now dominant life sciences industry business model, with its focus on rare diseases affecting small patient populations, allows companies to meet their historical public health obligation. Public health is defined as national and/or global health challenges that require coordinated responses from public and private institutions, including industry. Past illustrations include the polio and HIV epidemics, which moved companies to enter into wider scientific collaborations, take on unprecedented risk, shift corporate resources, and readjust strategic priorities for the sake of public health. Here, forming a virtual roundtable, the responding leaders contribute their reflections on where the industry’s role in public health is headed in 2019. The following were the chief findings taken from all the responses together.
The public health role of life sciences companies will continue to fade in 2019, by historical standards, unless or until the next big health crisis arrives to force them into a full-scale response.
Perhaps that is too dismal a conclusion. Among the companies that responded, most support a strong industry public health role. Most certainly believe the industry will answer public health emergencies by mobilizing as it has in the past.
“The degree of importance to which our industry offers its technologies and know-how in the effort against public health threats will be driven by the seriousness and proliferation of these threats to our livelihood, both in our country and across the global community,” says CHRIS GARABEDIAN, CEO of the biotech startup accelerator Xontogeny. “The greater the ability of governments and non-governmental organizations [NGOs] to incentivize companies to develop their technologies for given public health threats without it being a distraction from the company’s core mission, the more you will see technologies applied to areas in the public health arena.”
MITCHELL STEINER, president and CEO of Veru, an oncology and urology company with a commercial female-products division, also expects the industry to engage with longer-term public health challenges and developments around the world. “One particular long-term trend that we would expect to continue in 2019 is for companies to focus on providing access not only in developed markets such as the U.S., Europe, and Japan, but also in less developed regions,” he says. “Working with public health partners to provide access to important medicines and healthcare products reflects the idea that every life should have equal value.” STEINER describes Veru as having a “hybrid” business model, providing global access to commercial products for contraception and prevention of sexually transmitted diseases, which produce revenue to support new product development as well as educational outreach.
Another pillar of global public health is likely to bring disruption in 2019 — infectious diseases. DANIEL J. ABDUN-NABI, CEO of Emergent BioSolutions, underlines the urgency: “We have witnessed numerous outbreaks of serious emerging infectious diseases for which no vaccines or therapeutics are currently available, including Ebola, MERS, Zika, Chikungunya, and pandemic influenza, among others. The biopharma industry must continue to view the threats to public health as a priority. These threats will not diminish without serious commitment and focus.”
ISABELLE DESCHAMPS, head of global public affairs, vaccines, at Sanofi, sees promise for industry playing a greater role in global health efforts: “Public health is becoming a more important responsibility in a context where the universal health coverage is a priority goal for many countries and has emerged as a core driver of the U.N.’s 2030 Sustainable Development Goals agenda. Public health is a continuous challenge that requires coordinated contributions from many stakeholders, including public and private organizations and the biopharmaceutical industry. There remains a continued threat from infectious disease epidemics, and vaccination remains at the center of public health for nations across the globe.”
Many if not most companies see their contribution to public health as rising from their own product-development or commercial focus.
A typical statement comes from Sanofi’s DESCHAMPS: “All Sanofi employees work every day with the mandate to improve human health. In our vaccines business, we do this by developing superior, innovative vaccination solutions against infectious diseases, reliably providing these high-quality vaccines, and engaging with the public health community to sustainably maximize vaccination impact on public health.” DESCHAMPS backs up the statement by citing real company action:
“The Global Polio Eradication Initiative is an example of such a coordinated effort that has been ongoing for the past 30 years. Sanofi Pasteur, the vaccines business of Sanofi, has been supporting the polio eradication program since the beginning of this major collective effort. And this will continue as it is critical for Sanofi to align views regarding the polio vaccines assumptions to reach polio eradication and prepare for the post-eradication phase.”
Still, there is plenty of precedent for another point of view. Historically, a good number of the leading pharma companies have turned on a dime to answer a national or international emergency, as BMS and Wellcome did with HIV. As long as a company could bring relevant resources to bear on the collective challenge, it would find a way to do so. The urgency and public exposure of the challenge would generally sweep shareholders and other stakeholders along to support the initiative. Companies really can be heroes — not just in what they have aimed to do but also in ways they never imagined.
“Contributing to public health is already at the core of what we do,” says RACHEL KING, CEO of GlycoMimetics, which is developing carbohydrate-based drugs for hematologic disorders, cancer, and cardiovascular disease. “Our primary goal is to develop new treatments that can have tremendous impact on both length and quality of life. I do not see this changing in 2019. This being said, a key question for the industry — and for the nation — is where the industry is focusing its efforts, because that focus can make a big difference in how we impact public health and who benefits from the innovation that comes out of our industry.”
As a distinguished research fellow in discovery at AbbVie, DALE KEMPF leads the company’s pro bono research efforts toward prevention and treatment of neglected tropical diseases. He says AbbVie’s commitment to public health starts at the top of management, is integral to its business strategy, and targets areas where the company can do the most good.
“This approach has resulted in several advances for public health, including significant research on treatments for neglected tropical diseases [NTDs] and expanded access to our medicines,” KEMPF says. “More than 400 of our most experienced scientists spend part of their time working with partner organizations each year to help advance the development of medicines for NTDs. Our scientists spend over 30,000 hours annually to provide technical and advisory expertise, test proprietary compounds, and collaborate on drug discovery and development projects with partners.”
Reflecting tradition and moral imperatives, life sciences companies see themselves as having a unique mission compared to other industries, largely due to their role in public health.
“The biopharmaceutical and healthcare industries are fundamentally different from many other industries, like manufacturing cars or clothing, where there is likely to be less of a clear reason to truly care about the interests and well-being of the ultimate consumer, the patient,” says STEINER of Veru. “In healthcare, a deeper understanding of patients, the value of a life, and market needs is particularly critical to commercial success.”
The industry’s uniqueness is tied directly to its role in public health, in the view of ANTHONY MACK, CEO of Virpax Pharmaceuticals, a developer of local paindrug delivery. “Biopharma companies have a deep understanding of the R&D of novel products, making the industry essential to the advancement of public health initiatives. Though other industries might have large roles in public health, biopharma lies at the heart of addressing public health concerns through drug and device development.”
Oxurion is developing treatments for diseases in the back of the eye, primarily diabetic eye disease and rare eye disorders. Its CEO, PATRIK DE HAES, emphasizes the company’s public commitment: “Our company’s current business model consists of an essential public health component. We are committed to increasing access to therapies for patients, including those in underserved communities. It is also our goal to ensure that patients with rare retinal disorders have equal access to innovative therapies.” Oxurion has partnered with Prevent Blindness at the 2018 Focus on Eye Health National Summit and Retina Global. Both partnerships help the company sustain its mission to “save the world from blindness specifically related to retinal disorders.”
Some companies have built their business model on an important and neglected area of public health, such as antimicrobials or contraceptives. JESSICA GROSSMAN is CEO of Medicines360, a nonprofit women’s health company that concentrates on creating access to its products for underserved women. She says, “This industry has the power to impact public health by lowering costs to make products affordable and available to underserved patients. For example, we have R&D capabilities that other industries may not. We also have strength in advocacy, in many forms. In Medicines360’s focus area of women’s health, advocates have been working tirelessly for decades to gain and protect access to reproductive healthcare. This work has helped create demand for additional birth control options.”
Neem Biotech targets antibiotic resistance as one of its chief areas of focus. The company’s CEO, GRAHAM DIXON, believes the industry is beginning to respond to the antibiotics crisis, though it struggles against powerful economic disincentives. “A concerted effort is being made by biotech and relevant pharma companies to find alternatives to existing antibiotics and to encourage adoption of the antimicrobial stewardship agenda,” says DIXON. “At a political level, high-level initiatives continue to be organized across global geographies to bring about behavioral change that spares existing antibiotics. Increasingly, discussion is also focusing on how the antimicrobial market’s economic model can be adapted to allow numerous early stage antimicrobial discoveries to be translated into commercializable products.”
KING of GlycoMimetics believes small biopharmas’ lean budgets and constant need to raise capital mean they can only develop new treatments that attract financing: “This need to raise money is not inconsistent with advancing public health, but it gets to the core issue of what our public policies incentivize. Incentives matter greatly and can have a transformative impact on how investments are directed in biopharma and thus on which diseases are targeted for R&D.”
GROSSMAN of Medicines360 continues to describe how a company can build public health into its mission: “As a nonprofit pharmaceutical company, we’re investing proceeds from sales to sustainably offer our products at a stable, low price to the healthcare providers who care for the underserved. We’re anticipating continued evolution across the industry in coming years, especially with ongoing debates surrounding policy, women’s health, and access to medicines. Now more than ever, we’re seeing organizations like ours taking matters into their own hands to address unmet needs in public health.”
The companies most involved in public health recognize they must work with governments, NGOs, and other entities to tackle public health challenges.
DESCHAMPS of Sanofi aptly summarizes the larger public health context for the industry and her company. “Public health policies refer to the decisions, plans, and actions undertaken by governments and multilateral organizations to achieve specific health goals. In other words, public health programs are developed so that people everywhere have access to healthcare products and services. Yet to implement such programs, questions of organization, financing, and delivery must be addressed. Both policy and public health programs are intrinsically linked to Sanofi, as a licensed vaccine without a policy or a recommendation is of little use, and a policy without implementation has little impact.”
KEMPF cites AbbVie’s partnership with nonprofit drug R&D organization Drugs for Neglected Diseases Initiative (DNDi) as critical. He says the partnership is one focused on the collaborative development of NTD medicines, driven by patients’ needs. “Effective partnerships also have to have clear and measurable goals so that we can ensure that our efforts are providing a real benefit,” he says. AbbVie is a signatory to the London Declaration on Neglected Tropical Diseases, which aims for control or elimination of 10 neglected diseases by 2020. The company also has committed to the United Nation’s sustainable development goal to address all neglected diseases by 2030.
As another example of such collaboration, STEINER of Veru describes his company’s situation: “In our case, strong long-term relationships with government organizations and NGOs that support patient education and access have been very important. Within the public health sector, various organizations supply critical public health products like our female health products, at no cost or low cost, to those who need but cannot afford to buy such products for themselves. International organizations such as the U.N. can help companies introduce healthcare products in areas of need by providing methods to avoid the need for country-by-country regulatory interactions.”
As noted by KEVIN SULLIVAN, CEO of infectious disease-focused Appili Therapeutics, public health collaboration begins at the development-funding level. “Companies strive to balance support from return-oriented funds and philanthropic organizations with a public health mission. Support from organizations like NIAID (National Institute of Allergy and Infectious Diseases) or BARDA (Biomedical Advanced Research and Development Authority) that provide access to nondilutive funding makes the investment opportunity to serve public health needs financially feasible. In addition, this support often enables accelerated R&D, attracting return-oriented funds to companies that have picked wisely. While partnering with government agencies and nonprofits can present logistical challenges, it also brings opportunities to build global distribution networks that can increase market access. In this way, public health issues also can impact the late-stage development, manufacturing, and commercialization strategies that are among the hallmarks of value creation for our industry.”
KING and GROSSMAN both value public support for companies’ public health initiatives. KING would like to see something like the extended exclusivity provisions of the Orphan Drug Act and advantages of the Breakthrough Therapy Designation extended to development of other difficult-to-fund products. GROSSMAN favors retaining public programs that help lower costs and make medicines more accessible for women. Both CEOs also look to partner with other companies that share their public health missions.
Yet, in public health, missions and incentives can change suddenly, without warning. DESCHAMPS of Sanofi sounds the most compelling note of caution for the immediate and distant future. “The question of outbreak or pandemic preparedness is key: Is facing the increasing resistance to antibiotics, global warming, urbanization and international movements [travel, migration] how we manage the epidemic risks?” she asks. “It seems that we have not learned the lesson. We are waiting for the epidemic to occur, media to amplify it, and a global echo to be reached before having everyone mobilizing, a budget released, and industrial partners involved. Then, the epidemic ends, followed by the end of the funding, and everything comes to a halt until the next one. This vicious cycle is based on a purely reactive model, which is always late and is not sustainable.”
Help spread the word: An international epidemic is one that can travel in an airline seat or a shipping container, and the solutions that work do not involve building a wall. In the case of HIV infection, global cooperation led to better management of blood supplies, disease education, prevention, and rational safety measures. It also prevented more extreme, irrational, and counterproductive restrictions of civil liberty. What public health emergency could the industry face in 2019? The answer could come at any moment.