The widespread COVID-19 (coronavirus) outbreak has left no citizen, country or industry unaffected. The US economy has faced unprecedented shocks due to the shutdown and quarantine procedure that is necessary to reduce the rapidly growing spread of COVID-19. While many industries are at a standstill, the Pharmaceutical and Biotech industry is undergoing a period of rapid development and innovation in efforts to produce treatment options and a vaccine to fight off the casualties of this highly contagious virus. Alongside the WHO, Pharmaceutical and Biotech companies across the globe play a key role in the health of the world’s citizens and the return to a new normal.   

FDA’s Role

The FDA’s initiative to increase the number of fast track designations (regulatory mechanism to speed up the drug approval process) is needed now more than ever. Chloroquine, a drug that has previously been used to treat malaria and arthritis has been approved by the FDA to be tested as a treatment option for COVID-19.  Following the FDA approval of their IND application, I-Mab Biopharma has announced the development of TJM2 to treat “Cytokine Release Syndrome” associated with severe and critically-ill patients with COVID-19. The quick action from Pharmaceutical/Biotech companies and the FDA will allow the necessary treatments to be available to patients infected with the virus. 

Disruptions to Drug Development

Although the Pharmaceutical and Biotech industry are needed now more than ever to bring new therapies to market, the COVID-19 pandemic has brought on several challenges that will affect companies and patients alike. The FDA guidance issued on the conduct of clinical trials of medical products during the COVID-19 pandemic states that “quarantines, site closures, travel limitations, interruptions to the supply chain for the investigational product, or other considerations of site personnel or trial subjects become infected with SARS-CoV-2, the virus that causes COVID-19” are all circumstances that will cause disruptions to drug development. Due to this, clinical trials (that are not involved in COVID-19 testing) will take the backseat as resources are pushed towards treatment options for the virus.   

Pharmaceutical Supply Chains

While it is clear the global Pharmaceutical supply chain is under strain, it is difficult to assess the magnitude of how pharmaceutical supplies will be affected. With the rapidly growing number of COVID-19 cases across the globe, uncertainty is heightened and the end of quarantine and social distancing isn’t as near as we had previously hoped for. Many drug makers rely heavily on China for active pharmaceutical ingredients (API) and will work through their stockpile within 4 to 5 months. This will greatly impact pharmaceutical manufacturing in the present and future. The result will be disruptions to not only pharmaceutical supply chains in the upcoming months but also the patient who will experience a drug shortage for one or more of their treatment regimens.

Compassionate Use and Clinical Trials

Many patients have exhausted all of their treatment and clinical trial options and are then reliant upon Compassionate Drug Use, the use of new unapproved drugs to treat individuals who are seriously or terminally ill. Oftentimes clinical trials take place overseas and due to the travel restrictions to combat the spread of COVID-19, many companies and patients will no longer have the ability to begin or complete their trials.  This is when a compassionate use program can help these desperate patients. In addition to compassionate use, recent legislation has now opened a new access pathway to medicines for patients called the ‘ Right to Try”. The present surge of requests, IND applications and Fast Track Designations on the FDA’s desk to address this pandemic will, unfortunately, impact the ongoing R&D and drug approvals for patients in need of non-coronavirus treatment options.

The PharmaOut team remains committed to doing our part to fight COVID-19 and help keep our families safe. Our team of expert recruiters and consultants have years of experience to assist our clients in successfully continuing their business with our staffing, consulting and HR services. Please contact us if you would like to discuss how PharmaOut can be your strategic partner.

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