“Researchers at America’s biopharmaceutical companies are working around the clock to contain the spread of the novel coronavirus and deliver treatments to those impacted by this deadly disease. Today, we renew our commitment as an industry to help those in need, protect our workforce and ensure any treatments we develop in response to this pandemic are accessible and affordable for everyone. These are the principles that always guide our industry, and they serve as the foundation for our response to this global health crisis.”
~ Jim Greenwood, President and CEO of BIO.
Our Life Sciences industry and community is working fast and furious in an effort to do everything possible to address the pandemic. Biopharmaceutical and Medical Device companies are working closely with Federal and State organizations as well as the World Health Organization to develop vaccines, improve tests and investigate the usefulness of antiviral drugs, as well as other forms of treatment, in combating COVID-19. Some of the industry’s other areas of focus and concern are:
- Medical Equipment, Supplies and Personal Protective Equipment
• The shortage of ventilators, personal protective equipment and other medical supplies is prevalent. Federal and State governments and agencies have called upon the leaders of Life Sciences organizations, large and small, to support the front lines by delivering healthcare-related supplies to the hospitals and clinics directly confronting the pandemic.
• Companies and institutions are assessing their equipment and supplies to determine amounts in excess of current needs in order to make donations.
- Impact on Research and Clinical Trials
• The duration and geographic location of outbreaks could adversely impact both new trial initiations and those trials that have already commenced. The degree of these disruptions will likely be determined by the location of a company’s clinical trial and clinical research organization (CRO) and the effects of the pandemic within that region.
• Many clinical trials are facing major challenges including: quarantine/security measures, site closures, travel bans, supply interruptions, as well as site personnel or trial subjects being impacted or infected by COVID-19. This could lead to difficulties in meeting protocol-specified procedures and, of course, the timeline of expected inflection points.
• The Food and Drug Administration (FDA) recently issued guidance and recommendations to assist company sponsors and institutions regarding the continuance of trials, the safety of trial participants, maintaining compliance with good clinical practice (GCP) and minimizing the risks to trial integrity. Download the FDA’s guidance here.
• Company management and their investigators are assessing protocol modifications and workarounds so patients relying on the clinical trial treatments can continue to receive potentially lifesaving treatments safely.
• Likewise, the impact protocol modifications, workarounds and deviations will have on expected endpoints, as well as the impact on the company’s cash and capital resources, will have to be assessed, continuously monitored and adjusted.
- Employment and Funding Support
• The normal “day-to-day” structure of most healthcare companies and their professionals has been diverted in order to reach a common goal. New Jersey-, New York- and Pennsylvania-based Life Science companies, like most other industries, are facing business interruptions, implementing contingency plans and assessing the impact on cash flow and capital resources.
• The Senate approved stimulus Coronavirus Aid, Relief and Economic Security (CARES) Act currently pending in the House of Representatives includes a Paycheck Protection Program that may benefit many Life Sciences companies. The details of the Paycheck Protection Program are summarized here.
• The U.S. Economic Development Administration maintains a Coronavirus response page, accessible here.
• New Jersey has established a website to facilitate the immediate hiring needs of healthcare organizations in New Jersey. To post open positions on the site, click here.
• On March 26, the New Jersey Economic Development Authority (NJEDA) announced a new package of relief programs that will make more than $75 million in aid available to small- and mid-sized businesses. For more information on the NJEDA’s initiatives, click here.
• New York has a site centralizing volunteer opportunities related to the pandemic, here.
• Pennsylvania has established a page with Coronavirus-related resources specifically for health care professionals, here.
• The National Institutes of Health (NIH) has issued multiple grant notices for applicants and recipients of NIH funding. The NIH urges applicants and recipients of funding to receive current notices, available here.
Friedman LLP is in contact with BIONJ, Life Sciences PA and NewYorkBIO and continues to support our clients and the Life Sciences industry. We encourage you to visit Friedman’s COVID-19 Resource Center for information on Federal and State stimulus and assistance, tax changes and compliance, business interruption and contingency planning as well as other updates relating to COVID-19.
Please contact a Friedman professional if you have any questions about the impact of COVID-19 on your business.