Bernhardt (Bernie) Zeiher, Md, Fccp, Facp

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

Board Member | Strategic Advisor | Physician Executive | Former Chief Medical Officer | Biopharmaceutical Industry Expert @ Abeona Therapeutics
1330 Avenue of the Americas, 33rd Floor, New York, NY 10019, US
Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's Location
Port Clinton, Ohio, United States, United States
Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's Contact Details

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp work email

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp personal email

About Bernhardt (Bernie) Zeiher, Md, Fccp, Facp

With over 20 years of experience in the pharmaceutical industry, I am passionate about addressing unmet patients’ needs in under-served and serious diseases. During my career, I have participated in the development and approval of 15 products. As the Chief Medical Officer at Astellas and now as a strategic advisor to pharmaceutical industry clients, I strive to create a culture of empowerment and accountability, encourage diversity and inclusion, and foster talent. This enables teams to deliver for patients and society. What excites me every day is the opportunity to do good for others and make a profound difference in patients’ lives. Specialties: Strategy | Governance | Drug Development | Clinical development | Medical Affairs | Critical Care | Oncology | Immunology | Pain | Infectious Disease | Transplant | Small Molecules | Gene Therapy | Cell Therapy | Protocol design | Phase 1 | Phase 2 | Phase 3 | Phase 4 | FDA Advisory Committee | EMA | PMDA

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's Current Company Details
Abeona Therapeutics

Abeona Therapeutics

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Board Member | Strategic Advisor | Physician Executive | Former Chief Medical Officer | Biopharmaceutical Industry Expert
1330 Avenue of the Americas, 33rd Floor, New York, NY 10019, US
Employees:
51
Bernhardt (Bernie) Zeiher, Md, Fccp, Facp Work Experience Details
  • Abeona Therapeutics
    Member Board Of Directors
    Abeona Therapeutics 2024 - Present
    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.
  • Amylyx Pharmaceuticals
    Member Board Of Directors
    Amylyx Pharmaceuticals 2024 - Present
    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.
  • Entrada Therapeutics
    Member Board Of Directors
    Entrada Therapeutics 2023 - Present
    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.
  • Self Employed
    Strategic Advisor
    Self Employed 2022 - Present
    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.
  • Astellas Pharma
    Chief Medical Officer
    Astellas Pharma 2019 - 2022
    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.
  • Astellas Pharma
    Chief Medical Officer And President, Development
    Astellas Pharma 2018 - 2019
  • Astellas Pharma
    President, Global Development
    Astellas Pharma 2015 - 2018
    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.
  • Astellas Pharma
    Evp, Therapy Area Head For Immunology, Infectious Disease, Transplant, Cns, Pain
    Astellas Pharma 2014 - 2015
    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.
  • Astellas Pharma
    Svp, Therapeutic Area Head For Immunology, Infectious Disease, And Transplant
    Astellas Pharma 2012 - 2014
    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.
  • Astellas Pharma
    Vice President, Therapeutic Area Leader For Inflammation, Immunology And Infectious Diseases
    Astellas Pharma 2010 - 2012
    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®.
  • Transcelerate Biopharma Inc.
    Member Board Of Directors
    Transcelerate Biopharma Inc. 2014 - 2022
    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.
  • Biotechnology Innovation Organization
    Member Board Of Directors
    Biotechnology Innovation Organization 2019 - 2021
    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.
  • Phrma
    Advisor, Biomedical Advisory Committee
    Phrma 2014 - 2019
    Washington, District Of Columbia, Us
  • Pfizer
    Vice President, Inflammation Disease Area Lead
    Pfizer 2009 - 2010
    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.
  • Pfizer
    Executive Director, Inflammation And Pain Clinical Development
    Pfizer 2006 - 2009
    New York, New York, Us
  • Pfizer
    Senior Director, Inflammation And Pain Early Clinical Development
    Pfizer 2005 - 2006
    New York, New York, Us
  • Eli Lilly And Company
    Medical Director
    Eli Lilly And Company 2002 - 2005
    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).
  • Eli Lilly And Company
    Head, Critical Care Clinical Research
    Eli Lilly And Company 2001 - 2002
    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.
  • Eli Lilly And Company
    Clinical Research Physician
    Eli Lilly And Company 2000 - 2001
    Indianapolis, Indiana, Us
  • Merck
    Associate Medical Director
    Merck 1998 - 2000
  • Respiratory & Critical Care Consultants, Pc
    Pulmonary & Critical Care Staff Physician
    Respiratory & Critical Care Consultants, Pc 1996 - 1998

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp Skills

Clinical Development Immunology Pharmaceutical Industry Biotechnology Infectious Diseases Drug Development Inflammation Clinical Trials Ctms Oncology Medical Writing Pain Management Drug Discovery Cro Therapeutic Areas Gcp Medical Affairs Life Sciences Biopharmaceuticals Lifesciences Pharmacovigilance Regulatory Submissions

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp Education Details

  • Case Western Reserve University School Of Medicine
    Case Western Reserve University School Of Medicine
    University Hospitals Of Cleveland Internal Medicine Residency And Chief Residency
  • University Of Iowa Roy J. And Lucille A. Carver College Of Medicine
    University Of Iowa Roy J. And Lucille A. Carver College Of Medicine
    University Of Iowa Hospitals And Clinics Pulmonary And Critical Care Fellowship
  • Case Western Reserve University School Of Medicine
    Case Western Reserve University School Of Medicine
    Medicine
  • The University Of Toledo
    The University Of Toledo
    General

Frequently Asked Questions about Bernhardt (Bernie) Zeiher, Md, Fccp, Facp

What company does Bernhardt (Bernie) Zeiher, Md, Fccp, Facp work for?

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp works for Abeona Therapeutics

What is Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's role at the current company?

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's current role is Board Member | Strategic Advisor | Physician Executive | Former Chief Medical Officer | Biopharmaceutical Industry Expert.

What is Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's email address?

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's email address is be****@****las.com

What schools did Bernhardt (Bernie) Zeiher, Md, Fccp, Facp attend?

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp attended Case Western Reserve University School Of Medicine, University Of Iowa Roy J. And Lucille A. Carver College Of Medicine, Case Western Reserve University School Of Medicine, The University Of Toledo.

What skills is Bernhardt (Bernie) Zeiher, Md, Fccp, Facp known for?

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp has skills like Clinical Development, Immunology, Pharmaceutical Industry, Biotechnology, Infectious Diseases, Drug Development, Inflammation, Clinical Trials, Ctms, Oncology, Medical Writing, Pain Management.

Who are Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's colleagues?

Bernhardt (Bernie) Zeiher, Md, Fccp, Facp's colleagues are Olga Kourennaia, Matthew Davis, Dagmar Ostermann-Held, Mary Steben, Maggie C., Kayla Staeble, Shrm-Cp, Donald Wuchterl.

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