The COVID-19 pandemic is profoundly impacting the lives of millions and leaving a path of social and economic challenges that affect how we live, learn, and work. These unprecedented times show that innovation is more important now than ever. At the forefront of the COVID-19 response are pharmaceutical, biotech, medical device, and healthcare companies in California developing vaccines, diagnostics, and personal protective equipment (PPE).
How is COVID affecting Biocom’s members?
The pandemic has disrupted the operations of many our members and forced them to make difficult decisions to pause ongoing trials and reconsider timelines for data readouts, regulatory reviews, and product launches due to impaired access to the healthcare system, travel restrictions, patient willingness to participate in trials and shifts in resources to fight the pandemic. With hospitals overcapacity and shelter-in-place mandates in place, many patients are facing significant obstacles to obtaining care. Moreover, patients experiencing income disruption may have trouble affording their medications. Our members are working to ensure continuity of care for these patients and anticipate obstructions.
What are your most important current policy and advocacy goals?
From the onset of COVID-19, Biocom understood the importance of taking quick action to unite California’s life science industry to create a unified and informed response. We are working at the federal, state, and local levels of government to ensure our member companies can fully engage in the fight against COVID-19 and continue to work on equally important health challenges. Biocom advocates for language within local orders to assure life science companies can continue their work. On the federal level, we are pushing for additional funding for the Paycheck Protection Program (PPP) and the Economic Injury Disaster Loan (EIDL) program and clarity on Small Business Administration (SBA) affiliation.
How has the regulatory landscape changed as a result of COVID-19
The Food and Drug Administration (FDA) is providing temporary flexibility on certain policies to expedite the development and review of medical countermeasures for COVID-19. The agency has issued more than 100 emergency use authorizations (EUAs) for diagnostics, PPE, ventilators, and other drug products. The FDA is also monitoring over 144 active trials, 457 development programs of therapeutic agents for COVID-19, and issued over 50 guidance documents.
The FDA is working closely with global regulators to expedite the development and availability of safe and effective COVID-19 vaccines. The agency is optimistic that there will be multiple successful vaccines and that certain populations may benefit from one vaccine more than another.
Despite the increased workload during the pandemic, the FDA is on target to meet user fee goals. The agency is closely monitoring the impact of the pandemic on clinical trials and wants to work with stakeholders to determine which new policies, procedures, and lessons learned should be permanent moving forward.
Do you see any changes – becoming the “new normal” – on the regulatory horizon as the result of COVID?
The pandemic has taught the FDA new ways to accelerate and prioritize certain reviews that could be implemented broadly. COVID-19 policies such as providing more flexibility on remote monitors and telehealth check-ins may continue for new clinical trials going forward. The agency encourages industry to consider domestic manufacturing and wants to work with stakeholders to understand what the current supply chain looks like and what is needed to transition.
How is Biocom supporting California’s Life Science Industry?
Biocom launched a Coronavirus Resource Center to highlight our members working to combat the disease, share the latest business continuity and policy announcements throughout California, and to facilitate donations between our members with medical supplies and expertise to our frontline healthcare workers. Biocom also released a Return to Work Guide for California’s Life Science Industry called The Path Forward to provide guidance on three key areas associated with safely returning to work: workplace preparedness, workforce preparedness, and testing and tracing. Lastly, we are designing virtual programming with the industry’s top thought leaders to provide our members with key insights on how to navigate the challenges presented by the pandemic.
During these uncertain times, we need to ensure our members can continue to operate and focus on life-saving science. While the path forward is still somewhat unknown, we are encouraged by the collaboration, innovation, and dedication of our members.
Brittany Blocker is the Manager of Regulatory Affairs at Biocom. Biocom works on behalf of over 1,300 members to drive public policy, build an enviable network of industry leaders, create access to capital, introduce cutting-edge workforce development and STEM education programs, and create robust value-driven purchasing programs. Biocom provides the strongest public voice for research institutions and life science companies that fuel the California economy.