Issue link: https://www.e-digitaleditions.com/i/1300450
www.biopharminternational.com October 2020 BioPharm International eBook 3 Bio/Pharma Industry Works Overtime to Find COVID-19 Therapies Bio/Pharma companies are galvanized to develop COVID-19 therapies under FDA's acceleration program. A s part of the bio/pharmaceutical indus- try's global response efforts for COVID- 19, companies are also racing to develop therapies to treat COVID-19 in parallel with vaccine development efforts. FDA launched its Coronavirus Treatment Acceleration Program (CTAP) (1) in April 2020 to accelerate the devel- opment of these therapeutics. As of Sept. 25, 2020, more than 590 drug development programs are in planning stages. FDA has reviewed more than 310 trials, as of the end of August 2020, of potential therapies for treating COVID-19 (2). Also in September 2020, FDA published industry guidance around assessing symptoms in indi- viduals undergoing clinical trials for COVID-19 thera- pies (both small-molecule and biological). The guidance encourages sponsors to establish a minimum number of key symptoms to identify in trial subjects. Sponsors should establish their list of key indentifying symp- toms from a list of common COVID-19-related symp- toms provided by the Centers for Disease Control and Prevention (3). B a c ke d b y F DA s up p o r t , b io/p h a r m a c o m - panies are exploring new research ideas as well as look ing at molecules already in development or commercialized for potent ial t reat ment against COVID-19. A summary of biologic-based development efforts follows. mAb CANDIDATES Lenzilumab Humanigen, a clinical-stage biopharmaceutical com- pany, is developing lenzilumab, a proprietary gran- angellodeco - stock.adobe.com FELIZA MIRASOL Regulatory Sourcebook Pandemic Response