Bernhardt Zeiher, MD
Navigator to Greater Impact
Antimicrobial resistance has been well chronicled as a global health risk. This risk is compounded by reductions in R&D spending on new antibacterial and antifungal agents. Incentives, such as the 2012 Generating Antibiotics Incentives Now (GAIN) provisions of the Food and Drug Administration Safety and Innovation Act (FDASIA) were designed to address this issue, although recent pipeline data suggests that the risk associated with drug resistant pathogens remains.
Few individuals show a greater commitment to addressing this significant unmet patient need than Bernie Zeiher. With more than 17 years in the pharma industry, Bernie leads drug development with a pragmatic and collaborative style to transform vision into implementation—using passion, strategy, and organization in a coordinated approach. This approach has helped enable Astellas to accelerate the pace of innovation to meet the unmet medical needs of patients.
Most recently, Bernie led the development team during the 2015 U.S. Food and Drug Administration (FDA) approval process of CRESEMBA® (isavuconazonium sulfate), a drug used to treat adults with invasive aspergillosis and invasive mucormycosis—both rare and serious infections. Under the GAIN provisions, CRESEMBA was granted Qualified Infectious Disease Product (QIDP) designation for both indications enabling more regular interactions with FDA and an accelerated review process.
Bernie and his team were able to address a number of significant challenges in the development of CRESEMBA. One of the most significant: Changing the primary endpoint and gaining FDA agreement on the non-inferiority margin in the ongoing Phase III invasive aspergillosis study.
Following FDA approval on March 3, 2015, Astellas immediately shipped more than 70 vials of CRESEMBA to reach appropriate patients.
In 2015, Bernie became President of Development and has global responsibility for all phases of drug development. Today, he continues his focus on efficiency in early development, efforts to address areas of high unmet medical need—especially in oncology—and building capabilities in new therapeutic areas such as muscle diseases and regenerative medicine.