Bernhardt (Bernie) Zeiher, Md, Fccp, Facp Email & Phone Number

Cleveland, Oh, Us

I serve on the Board of Abeona Therapeutics (NASDAQ: ABEO), a biopharmaceutical company pursuing the development of cell and gene therapies for people impacted by serious diseases. Leveraging my deep experience in drug development and regulatory affairs, I am supporting management in advancement of Abeona's pipeline. I am also a member of the Science and Technology Committee.

Cambridge, Ma, Us

I serve on the Board of Amylyx Pharmaceuticals (NASDAQ: AMLX), a biopharmaceutical company pursuing the development of treatment options for those living with neurodegenerative diseases. Leveraging my deep experience in drug development and regulatory affairs, I am supporting management in advancement of Amylyx's pipeline which primarily targets neuronal cell death. I also chair the Science and Technology Committee and am a member of the Nominating and Corporate Governance Committee.

Boston, Ma, Us

I serve on the Board of Entrada Therapeutics (NASDAQ: TRDA), a biopharmaceutical company innovating to transform the treatment of devastating diseases through intracellular therapeutics. In addition to serving on the Compensation Committee, I am leveraging my deep experience in drug development and regulatory affairs, I am supporting management in advancing Entrada’s novel Endosomal Escape Vehicle (EEV™) platform.

Satellite Beach, Florida, Us

Leveraging my expertise in the development of biopharmaceutical products across a wide range of therapy areas, I advise biotechnology companies either as interim CMO, strategic consultant, or board member.

I led Astellas’ global organization of 2,750 responsible for early and late-stage development, medical affairs, regulatory affairs, pharmacovigilance, quality assurance, strategy, and operations. I presided over a period of historic R&D productivity at Astellas, delivering 6 product approvals in major markets. The team also progressed 2 other products through pivotal trials. As a result, new product revenue sustained top line performance and offset the impact of divestitures and patent expirations. I reported to the CEO and routinely interacted with buy-side and sell-side analysts.

In this role, I led a global organization of 850 responsible for early and late-stage development across all therapeutic areas and geographies. My focus in this role was to enhance Astellas’ development capabilities and I oversaw global initiatives that fostered talent development, strengthened governance, adopted new technologies, and streamlined operations. We also progressed 6 late-stage programs that are now approved or under regulatory review. I reported to the Chief Medical Officer.

I led TA strategy and pipeline delivery for the immunology, infectious disease, transplant, CNS, and pain portfolios. I also led the Development Operations group and Clinical Pharmacology team supporting the entire portfolio. One of our biggest achievements was earning FDA approval and 12 years of market exclusivity for Cresemba®, which was awarded both an orphan designation and a Qualified Infectious Disease Product (QIDP) designation. I led the overall program, as well as NDA preparation, and an FDA advisory committee presentation.

In this role, I led a global team of 20 physicians and project team leaders responsible for therapy area strategy and pipeline delivery for the immunology, infectious disease, and transplant portfolios. I redirected portfolio strategy away from Astellas’ long-term specialty in transplant to focus on areas with greater unmet need, including autoimmune disease.

I led a team of 10 project team leaders responsible for TA strategy and pipeline delivery for inflammation, immunology, and infectious disease. We secured EU approval of Vibativ® for hospital-acquired pneumonia and gained FDA agreement on the pediatric program for Mycamine®.

Conshohocken, Pennsylvania, Us

TransCelerate Biopharma is a non-profit organization consisting of 20 member companies. As an elected board member representing Astellas, I helped to prioritize and oversee implementation of solutions designed to drive the efficient, effective and high-quality delivery of new medicines.

Washington, Dc, Us

BIO is the world's largest biotechnology organization, providing advocacy, business development and communications services for more than 1,200 members worldwide. As Astellas' representative on the board, I helped to prioritize and influence policies in support of the BIO mission which is to be the champion of biotechnology and the advocate for our member organizations—both large and small.

Washington, District Of Columbia, Us

New York, New York, Us

In this role I led a team of 25 physicians and project team leaders responsible for development and medical affairs for the late-phase inflammation and immunology portfolio that included Xeljanz® and Enbrel®. Following Pfizer’s acquisition of Wyeth, and all the attendant disruption, I sustained progress on the combined organization’s pipeline.

New York, New York, Us

New York, New York, Us

Indianapolis, Indiana, Us

In this role, I was involved in early stage development of Inflammation and Immunology drug candidates, and late-stage development of Effient® (prasugrel).

Indianapolis, Indiana, Us

In this role I led 2 large multinational Phase 2 programs in critical care, one in acute lung injury and another in sepsis.

Indianapolis, Indiana, Us

University Hospitals Of Cleveland Internal Medicine Residency And Chief Residency

University Of Iowa Hospitals And Clinics Pulmonary And Critical Care Fellowship

M.D., Medicine

B.S., Biology, General