Posted on by Chad Young

CSG Associates in Action: America’s Pharmaceutical Industry Leads During COVID-19 Crisis

Following natural disasters and in times of national crisis, America’s private sector steps up to aid the states. We are proud of the herculean efforts of CSG Leadership Circle and Associates, our private sector members, as together we combat COVID-19.

In these unprecedented times, America’s biopharmaceutical companies are coming together to achieve one shared goal: to beat COVID-19, a disease caused by a novel strain of coronavirus. Companies are working to research and develop new vaccines and treatments, as well as to test existing medicines to help those infected with the virus.

CSG Leadership Circle and Associate members are leading on multiple fronts to partner with federal and state officials amidst this critical fight. They include: 

  • Abbott has received emergency use authorization from the U.S. Food and Drug Administration for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in as little as five minutes and negative results in 13 minutes.

The new Abbott ID NOW COVID-19 test runs on Abbott’s ID NOWTM platform — a lightweight box (6.6 pounds and the size of a small toaster) that can sit in a variety of locations. Because of its small size, it can be used in more non-traditional places where people can have their results in a matter of minutes, bringing an alternate testing technology to combat the novel coronavirus. Abbott is ramping up production to deliver 50,000 ID NOW COVID-19 tests per day to the U.S. healthcare system. For more information, visit: abbott.com.

  • Amgen is donating up to $12.5 million to support U.S. and global relief efforts to address critical needs in communities impacted by this pandemic. For more information, visit: https://bit.ly/3boNMu6.
  • With millions of Americans losing their jobs and income due to the COVID-19 crisis, insulin affordability is as important as ever. Impacted individuals with lower incomes, or no income at all, can call the Eli Lilly & Company’s Lilly Diabetes Solution Center if they are unable to afford their Lilly insulin. The Lilly hotline — 1-833-808-1234 — is open Monday through Friday, 8 a.m. to 8 p.m. EDT. For patients needing access to other Lilly medicines, they can contact the Lilly Cares Foundation at 1-800-545-6962, Monday through Friday 8 a.m. to 6 p.m. EDT. 

Eli Lilly & Company is offering free COVID-19 drive-through testing for Indianapolis-area health care workers at its headquarters. The company announced that Lilly scientists are partnering with the Indiana State Department of Health (ISDH), with support from the U.S. Food and Drug Administration, to accelerate testing in Indiana for SARS-CoV-2, the virus that causes COVID-19. The company will use its specialized research laboratories to analyze samples taken in Indiana health care facilities, including nursing homes and emergency rooms. This should start to expand Indiana’s ability to conduct testing and receive a timely diagnosis of individuals who suspect they may be carrying the virus. As Lilly’s testing capacity expands, Lilly and ISDH will work together to maximize the impact of broader testing.

Eli Lilly and AbCellera agreed to co-develop antibody products for the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 novel coronavirus. The collaboration will leverage AbCellera’s rapid pandemic response platform and Lilly’s global capabilities for rapid development, manufacturing and distribution of therapeutic antibodies. 

The Lilly Foundation contributed $500,000 to United Way of Central Indiana’s Community Economic Relief Fund. The fund will support human services organizations and the individuals and families they serve who are affected directly or indirectly by the COVID-19 virus. The Lilly Foundation is also providing a 2:1 match for Lilly employee and retiree contributions to the fund. For more information, visit: https://www.lilly.com/news/stories/coronavirus-covid19-global-response

  • Emergent BioSolutions announced that it has entered into an agreement with Novavax, Inc. Emergent will collaborate with Novavax, utilizing its molecule-to-market contract development and manufacturing services to support bringing into the clinic Novavax’s novel experimental vaccine candidate to protect against COVID-19. Emergent will produce the COVID-19 experimental vaccine candidate, which is based on the proprietary recombinant protein nanoparticle technology platform of Novavax and utilizing their proprietary Matrix-M™ adjuvant to enhance immune responses. Emergent has initiated work for this program anticipating that the COVID-19 experimental vaccine candidate will be used in a Phase 1 clinical study within the next four months.

In addition, Emergent has initiated development of two product candidates for the treatment and prevention of COVID-19. These product candidates are being developed on Emergent’s hyperimmune platforms that have a well-established safety database. For more information, visit: https://www.emergentbiosolutions.com/.

  • Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration has approved a randomized, double-blind placebo-controlled Phase III clinical trial in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) to evaluate the safety and efficacy of intravenous Actemra® (tocilizumab) plus standard of care in hospitalized adult patients with severe COVID-19 pneumonia.

To further support U.S. COVID-19 response efforts, Genentech will provide 10,000 vials of Actemra to the U.S. Strategic National Stockpile for potential future use at the direction of the U.S. Department of Health and Human Services. Most recently, Genentech cut the amount of time to deploy 400,000 coronavirus diagnostic tests per week from an 18- to 24-month period to a six-week period. For more information, visit: https://www.insideindianabusiness.com/story/41925785/roche-doing-now-what-patients-need-next

  • Gilead Sciences, Inc. is collaborating with global health organizations to support pandemic responses. The company is working with government and non-governmental organizations and regulatory authorities to develop a strategy to provide its investigational compound, remdesivir, to patients with COVID-19 for emergency treatment in the absence of any approved treatment options, and to support clinical trials to determine whether it can safely and effectively be used to treat COVID-19. 

The company is also working with regulatory authorities to provide remdesivir to physicians for compassionate use to treat a number of severely ill patients with confirmed COVID-19 infection and severe clinical symptoms. For more information, visit: https://www.gilead.com/purpose/advancing-global-health/covid-19

  • GlaxoSmithKline and the Coalition for Epidemic Preparedness Innovations formed a new collaboration aimed at helping the global effort to develop a vaccine for the 2019-nCoV virus. In this move, GSK will make its established pandemic vaccine adjuvant platform technology available to enhance the development of an effective vaccine against COVID-19.

GSK is also donating $10 million to The COVID-19 Solidarity Response Fund, created by the United Nations Foundation and World Health Organization (WHO), to support WHO and partners to prevent, detect, and manage the pandemic, particularly where the needs are the greatest. For more information, visit: https://www.gsk.com/.

  • Johnson & Johnson announced that its Janssen Pharmaceutical Companies have entered a collaboration with the Beth Israel Deaconess Medical Center to support the development of a preventive vaccine candidate for COVID-19. The parties have commenced preclinical testing of multiple vaccine prospects, with the aim to identify by the end of the month a COVID-19 vaccine candidate for clinical trials. 

Johnson & Johnson donated 1 million masks, as well as goggles, protective suits, thermometers and respirators. For more information, visit: https://www.jnj.com/caring-and-giving/how-johnson-johnson-is-helping-support-coronavirus-relief-efforts.

Merck is matching employee donations to the CDC Foundations’ Emergency Response Fund. For more information, visit: https://www.merck.com/about/featured-stories/how-we-are-responding-to-the-global-pandemic-COVID-19.html.

  • Mylan, Inc. has restarted production of hydroxychloroquine sulfate tablets at its Morgantown, West Virginia manufacturing facility to meet the potential for increased demand resulting from potential effectiveness of the product in treating COVID-19. Mylan’s hydroxychloroquine sulfate tablets are approved by the U.S. Food and Drug Administration for the treatment of malaria, lupus erythematosus and rheumatoid arthritis. Although the product is not currently approved for use in the treatment of COVID-19, it is listed by the World Health Organization as a drug under investigation for efficacy against the coronavirus. The company is also taking steps to initiate production of this product outside the U.S. in the coming weeks. For more information, visit: https://www.mylan.com/.
  • Pfizer completed a preliminary assessment of certain antiviral compounds that were previously in development and that inhibited the replication of coronaviruses similar to the one causing COVID-19 in cultured cells. Pfizer is engaging with a third party to screen these compounds under an accelerated timeline. Upon completion of such screening, the company could be in a position to move forward with development, depending on the results. For more information, visit: https://www.pfizer.com/health/coronavirus.
  • Sanofi and Regeneron dosed the first patient outside of the United States with the rheumatoid arthritis drug Kevzara as part of a second global clinical trial assessing the medication as a treatment for COVID-19, the disease caused by the novel coronavirus pandemic.

Furthermore, Sanofi will be able to provide millions of doses of hydroxychloroquine for patients with the illness caused by the novel coronavirus if the old malaria drug proves successful in clinical trials. The company had made a choice to overproduce its drugs to ensure supplies for hospitals in Europe and the United States facing an unprecedented crush of patients suffering from respiratory complications that is threatening to overwhelm healthcare systems. For more information, visit: https://www.sanofi.us/en/about-us/our-stories/our-response-to-covid-19.

The Bill and Melinda Gates Foundation has brought together a group of life-sciences companies to accelerate the development, production and delivery of COVID-19 treatments, tests, and vaccines. The effort will bring together the companies’ resources and knowledge in order to respond to the pandemic. CSG Associates serving as part of this group include Boehringer Ingelheim, Eli Lilly & Co., Gilead Sciences, Inc., GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer and Sanofi.

Trade associations representing the biopharmaceutical industry are working to assist the states and their member companies. Association for Accessible Medicines (AAM) member companies are working to ensure pharmacies across the country are able to provide the medicines patients need for their health. Generic medicines account for 90% of all prescriptions filled. AAM represents the manufacturers and distributors of generic prescription drugs 

The National Institutes of Health and others are working to develop innovative vaccines and treatments for COVID-19. AAM members are partnering with health organizations and governments around the world to evaluate the use of currently available generic medicines for the treatment of patients with COVID-19. For more information, visit: https://accessiblemeds.org/resources/blog/aams-covid-19-response-health-care-needs.

Biotechnology Innovation Organization created a resource for the biotechnology community through which companies that have supplies, capacities and resources can share them with companies, researchers, and health care providers who need them. Called the Coronavirus Hub, the resource enables users to post requests for urgently needed items, as well as the availability of supplies and capacity. The portal is a real-time connection through customized announcements and is searchable by keywords. Connections for medical supplies will be facilitated in partnership with Healthcare Ready to ensure an organized and optimized allocation of items in need, and thus will not be publicly available or searchable. For more information, visit: hub.bio.org.

More than half of PhRMA member companies have research and development efforts under way or are providing donations of medicines and critical medical supplies as well as providing financial donations to support patients and first responders in addressing this evolving crisis. 

In addition, PhRMA and its member companies are: 

  • Rapidly screening its vast global libraries of medicines to identify potential treatments and have numerous clinical trials underway to test new and existing therapies;
  • Dedicating its top scientists and using investments in new technologies to speed the development of safe and effective vaccines;
  • Sharing the learnings from clinical trials in real time with governments and other companies to advance the development of additional therapies;
  • Expanding its manufacturing capabilities and sharing available capacity to ramp up production once a successful medicine or vaccine is developed;
  • Collaborating with government agencies, hospitals, doctors and others to donate supplies and medicines to help those affected in the U.S. and around the world; and
  • Working with governments and insurers to ensure that when new treatments and vaccines are approved, they will be available and affordable for patients.

For more information, visit: https://catalyst.phrma.org/helping-those-affected-by-the-coronavirus.

Associates in Action articles highlight CSG Associates’ philanthropic efforts and public-private partnerships throughout the states.

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