Invest in vs profits How to support the development and commercialization of pandemic therapies.

Wen: Baiziwan Wu Yanzu 2020 new crown pneumonia pandemic swept the world, in general, the world is not fully prepared to deal with.
, however, the outbreak has led to changes in investment in infectious diseases, drug development methods and regulatory policies, which could lead to lasting innovation and help mitigate the impact of future pandemics.
opportunities and challenges brought about by these changes, governments and pharmaceutical companies are working together to find innovative solutions to the outbreak.
, the international community must learn from the response to the new crown outbreak and increase support for the development and commercialization of infectious disease therapies.
new, by reviewing past pandemics, the pharmaceutical industry is prepared for future pandemics.
based on an analysis of successful practices during past pandemics, we can better stimulate innovation in response to pandemics by identifying currently available financial and income opportunities and bridging potential financial gaps between investment and business sustainability.
of past pandemic therapies is limited, and only a few have successful approaches to prevention and treatment.
the H1N1 pandemic may be the best example of a successful response: vaccines were obtained 4-6 months after development began and one month before the second peak of the second pandemic in the United States.
a total of 11 vaccines have been pre-certified and widely distributed by the World Health Organization (WHO).
GSK, the largest supplier of pandemic influenza vaccines, reported sales of $2.95 billion in the first year after the pandemic began.
in the development of the H1N1 vaccine in 2009, the proven influenza vaccine technology platform was used to accelerate the clinical development of the H1N1 vaccine.
regulators allowed drug companies to register pandemic influenza vaccines as seasonal vaccines that alter strains, eliminating the need for initial safety testing and speeding up regulatory review and approval.
makes pandemic influenza vaccines developed and distributed on a large scale faster than new crown vaccines.
Chart 1. The first H1N1 influenza vaccines were developed and produced in 2009 from: Novartis Vaccines, Zhongkang Industrial Capital Research Center and Pandemic Influenza Vaccines contrasted with the Ebola Virus (EBV) vaccine, and the commercial success of the EBV vaccine has so far been limited.
the Ebola virus pandemic, vaccines were already being developed due to several small-scale outbreaks.
production increased rapidly after the epidemic began in 2014, but slowed after the outbreak was contained.
five years after the first Ebola outbreak, Merck and Co launched ERVEBO in December 2019.
Global Alliance for Vaccines and Immunization (GAVI) has authorized $187 million by 2025 to buy vaccine stocks in response to future outbreaks.
all other recent pandemics, such as SARS, Middle East Respiratory Syndrome (MERS), zika virus (ZIKA), have had little success in encouraging successful innovation.
, however, given the unprecedented scale of the neo-crown outbreak and its global impact on human health, society and economy, the two pandemics cannot be compared to neo-crown pneumonia.
, many governments, pharmaceutical companies and research and development institutions have invested significant resources and efforts to quickly identify prevention and control methods.
As of the end of September, according to BioWorld and WHO, there were 763 products under development worldwide, including vaccines and therapeutic drugs, innovative and redirected drugs, about half of which were in clinical trials.
the results of the new crown vaccine remain to be seen, the initial clinical results and investment efforts are encouraging.
The current limitations of innovative incentives for pandemics are currently limited to Governments and non-governmental organizations (NGOs) focusing on short-term initiatives, although there are some funds available for innovative approaches to pandemic disease prevention and treatment.
government funding comes from individual governments or from cross-government organizations such as WHO.
provided in the form of research grants or advanced purchase agreements.
For example, the European Commission has registered a commitment of 15.9 billion euros, and BARDA has committed more than $2.2 billion to five vaccine manufacturers, plus $359 million for potential new coronary pneumonia treatments.
government funds often have agreed price caps and/or donation requirements (especially for low-income countries) to ensure wide access to potential treatment.
non-governmental organizations (NGOs) can provide direct grants for pandemic research and contribute to public-private partnerships, such as CEPI (Alliance for Innovation in Epidemiological Prevention), as well as to the Global Alliance for Vaccines and Immunization (Gavi), which combines non-governmental organizations and government funding.
the Gates Foundation donated $50 million to the New Crown Pneumonia Treatment Accelerator, $25 million to the development and distribution of diagnostic reagents, and $50 million to GAVI.
, however, NGO funding is often limited, focusing on access to treatment in low-income countries and spread across several focus areas, which limits long-term sustainability.
private investors include venture capital and big pharmaceutical companies that want to work together to develop or license candidate drugs from other companies.
, however, such investments are relatively rare because of uncertainty about return on investment and limited business success in the past, as investors are generally cautious about funds focused on infectious diseases.
only 5 per cent of venture capital ($2.2bn out of $42bn) has been invested in vaccine and drug research and development to prevent infections in the past three years, according to Silicon Valley Bank.
funding, partnerships are another way to support and nurture innovation by providing resources and sharing risks.
, however, prior to the neo-crown pneumonia pandemic, there was limited interest in advanced research in academia on new pathogens such as coronavirus, and limited investment interest in this basic research in the pharmaceutical industry due to concerns about return on investment.
, the current available funding and partnership mechanisms for infectious diseases are limited and short-term.
to overcome these challenges, a number of short- and long-term strategies have been proposed to help support sustained innovation in response to future pandemics.
the cross-enterprise, cross-industry effort to improve research and development and productivity has increased the need for early business capabilities, many companies are not prepared for the rapid commercialization of new therapies.
pharmaceutical companies, large and small, could coordinate efforts, focusing on identifying potential pandemic solutions and supporting promising therapies and vaccine production.
example is the National Institutes of Health's (NIH) Accelerated New Coronary Pneumonia Treatment Intervention and Vaccine (ACTIV) program, which brings together manufacturers to identify and advance the most promising treatments and vaccines.
Chart 2. ACTIV Organizational Chart Established by NIH in the United States Source: NIH, Zhongkang Industrial Capital Research Center, in addition, collaboration in pandemic research can be established through a coalition of pharmaceutical companies, payers and/or employers to predetermine reimbursements for pandemic therapies.
employers or payers may invest in the establishment of a Pandemic Research and Mitigation Fund to ensure that programme members receive a specified number of products free of charge or at a capped price once they have obtained regulatory approval for pandemic therapies.
concept of the Embarc benefit protection program recently introduced by Cigna Life Insurance is a similar concept, with employer groups paying monthly membership fees to cover unexpected gene therapy costs.
industry can help support the development of pandemic solutions.
epidemic of new crown pneumonia has led to several examples of such collaborations, such as the production of ventilators between GE Healthcare and companies such as Ford, Vantec and General Motors, Foxconn and Medtron.
examples, one company provides technical expertise and the other provides materials and production capacity.
-term investments to facilitate an immediate response to a particular epidemic currently come mainly from governmental and non-governmental organizations, which promote research and development by investing in companies and research institutions.
, however, is a "pull-and-pull" funding mechanism, in which the Government provides a pre-market commitment to provide a certain cost for any pandemic vaccine or treatment developed.
this strategy has been used in a variety of situations, including H1N1, Ebola virus, Streptococcus pneumoniae, etc., but is usually only dependent on high-income countries and only motivates companies to go further in their development progress.
to meet these challenges, international governments or financial institutions can implement market-driven value-based advance commitments (VAC) from the Center for Global Development, a non-profit think tank.
in this model, the contribution of individual countries depends on population size and capacity to pay, thus ensuring the contribution of high, middle and low-income countries.
affordable treatment for low- and middle-income countries, while the needs of high-income countries are properly moniedized.
, prices can vary depending on efficacy and safety to encourage the development of more effective therapies.
Chart 3. The market-driven Value-Based Advance Commitment (MVAC) model indicates that another option that could address the early under-investment in research and development of the pandemic is bonds, where investors, pharmaceutical companies and non-governmental organizations can raise funds within a predetermined period of time.
funds are managed by third parties who invest their funds in typical channels, return them to investors after a predetermined time, and attach interest, unless there are opportunities associated with the pandemic.
example of this is the Pandemic Emergency Financing Facility (PEF), which was designed by the World Bank to pool funds in advance of disease outbreaks in low-income countries in order to respond quickly.
this arrangement, private investors provide up-front funding for three years.
eligible pandemics occur during this period, some funds will be allocated to Governments and pre-approved organizations to respond to pandemics.
otherwise, investors will get their money and interest back.
Chart 4. One of the main problems encountered by the Pandemic Emergency Financing Fund (PEF) mechanism, which signals long-term investment support for the ongoing study of future pandemics, is the ubiquity of research and funding for pandemics during crises, which is depleted once the threat subsides significantly.
long-term funding of pharmaceutical companies discourages pharmaceutical companies from developing vaccines or drugs.
, however, the loss of national GDP and the loss of revenues for individual companies is clearly much greater than the relatively small public investment in pandemic vaccines and medicines each year.
the ongoing new coronary pneumonia pandemic is clear evidence of this.
two different approaches to the problem, focusing on government-driven or private funding.
, ongoing government and non-governmental organization funding should focus on public research into pandemics or infectious diseases, rather than relying on private companies.
governments can provide ongoing academic funding for the development of pan-viral vaccine platforms to rapidly adapt to a new virus in the event of a pandemic.
further, the government could agree to pay for the development of vaccines for newly discovered strains, even if they are not currently pandemic, to ensure optimal preparation for each new virus.
promising candidate vaccines could be the basis for cooperation or transfer with pharmaceutical companies with clinical trials and production capacity.
approach is a joint investment fund of a large pharmaceutical company to continue funding ongoing research.
The fund, which can be managed by a small group or third party and used to invest in promising pandemic technologies, has the potential to become self-sufficient in the long term as products are commercialized and profits reinvested in new research and development projects.
ways to speed up the regulation of pandemic therapies are not yet clear ways to accelerate vaccine development, which discourages participation in research and development.
during the New Crown pneumonia pandemic, many countries are working to streamline procedures and speed up the approval of innovative and redirected drugs.
the FDA created the Coronavirus Treatment Acceleration Program (CTAP), which provides interactive feedback to pharmaceutical companies, accelerates the approval of pilot programs, and assists in finding and approving patients for clinical trials or emergency use of products.
the European Union in 2014 created the EU's largest-ever research and innovation program, the European Horizon 2020, which includes funding and accelerating vaccine development.
expires this year, the European Union has launched Horizon Europe, which will begin in January 2021.
The United States, the European Union and other countries should strive to formalize and standardize rapid pathways for pandemic products, including priority reviews, reduction of clinical trial requirements, and a framework for providing clear guidance on how to obtain rapid reviews.
public-private partnership project created by NIH in the United States, accelerated new coronary pneumonia treatment interventions and vaccines (ACTIV), also supports simplified clinical trial design and approval.
a "sleepy" public-private partnership similar to ACTIV could be awakened to quickly simplify clinical trial design and evaluation, a promising option that would ease the burden on governments while accelerating development.
the pharmaceutical industry is now looking for vaccines and drugs for new crown pneumonia.
many clinical trials have already begun, but some will become commercial heavyweights due to uncertainty about the outcome, while others will struggle with regulatory requirements. <