Fred Grossman D.O., FAPA

Chief Medical Officer and Head of Translational Medicine at Empyrean Neuroscience
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us****@****om
(386) 825-5501

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Experience

    • Biotechnology
    • 1 - 100 Employee
    • Chief Medical Officer and Head of Translational Medicine
      • Feb 2022 - Present

      Genetic engineering CNS company dedicated to developing neuroactive compounds from mycogenic and phytogenic fungi and plants including psilocybin, cannabis, DMT to treat the most severe neuropsychiatric and neurologic disorders Genetic engineering CNS company dedicated to developing neuroactive compounds from mycogenic and phytogenic fungi and plants including psilocybin, cannabis, DMT to treat the most severe neuropsychiatric and neurologic disorders

    • Australia
    • Biotechnology Research
    • 1 - 100 Employee
    • Chief Medical Officer
      • Aug 2019 - Feb 2022

      Mesoblast is a world leader in developing allogeneic (off-the-shelf) cellular medications. The Company has leveraged its proprietary technology platform to establish a broad portfolio of late-stage product candidates with three candidates in phase 3 trials including acute graft vs host disease, chronic heart failure, and chronic low back pain due to degenerative disc disease. Through a proprietary process, Mesoblast selects rare mesenchymal lineage precursor and stem cells from bone marrow of healthy adults and creates master cell banks which are industrially expanded without the need for tissue matching. Mesoblast has facilities in Melbourne, New York, Singapore, and Texas and is listed on the Australian Securities Exchange (MSB) and Nasdaq (MESO).

    • United States
    • Pharmaceutical Manufacturing
    • Chief Medical Officer
      • Oct 2018 - Aug 2019

      NeuroRx, Inc. is a clinical stage, small molecule pharmaceutical company developing a pipeline of novel therapeutics for the treatment of central nervous system disorders. The novel pipeline is based on a deep understanding of the role of the N-methyl-D-aspartate (NMDA) receptor. The lead program is NRX-100/NRX-101, the first potential sequential drug regimen for Bipolar Depression in patients with Acute Suicidal Ideation & Behavior. The pipeline also includes programs for PTSD with Acute Suicidal Ideation and Behavior.

    • India
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Consultant
      • Sep 2018 - Feb 2019

    • President & Chief Medical Officer
      • Nov 2015 - Aug 2018

      Lead innovative Global Clinical Development, Pharmacovigilance, and Medical Affairs and corporate strategy across the R & D pipeline and portfolio of products from Phase I through phase III and approvals including biologics (monoclonal antibodies including bispecific technology) and small molecules across oncology, immunology, respiratory, and dermatology therapeutic areas. Lead the company's 1st NDA, Ryaltris. Also responsible for the generics, ANDA, 505(b)(2), and biosimilar portfolio.

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Vice President, Global Clinical Development Medical Affairs, and Pharmacovigilance & Safety
      • Oct 2011 - Oct 2015

      Lead Global Clinical Development & Medical Affairs across all therapeutic areas including CNS, Respiratory, Biotherapeutics, Stem Cells, and Oncology.

    • Senior Vice President, Head of Medical Affairs and Drug Safety and Pharmacovigilance
      • Oct 2010 - Oct 2011

      Lead Medical Affairs Functions and Drug Safety and Pharmacovigilance across all therapeutic areas

    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • VP, Neuroscience Medical Strategy, US Medical
      • Jul 2009 - Oct 2010

      Vice President, Neuroscience Medical Strategy, US Medical 2009-Present- Leads diverse team of Medical professionals including Strategic Medical Team, MSL's, Medical Information, Publication and Communication, Medical Education, across the matrix and US Business in Neuroscience and co-lead strategic alliance partnerships- Leads Global lifecycle management of Abilify including phase IIIb and IV clinical studies and Health Authority negotiations, Post-marketing and Outcomes trials, IST’s, medical education, publication and education plans and thought leader interactions. Optimize label using studies and negotiating with FDA and Global Health Authosities. - Develop U.S. strategy across neuroscience portfolio of different assets including Alzheimer’s disease, depression, and schizophrenia- Support market access and negotiate with managed care and health care agencies and across US- Develop disease focused plans in neuroscience to support overall strategic needs and help develop portfolio- Advisor, Neuroscience, BMS Foundation, Charitable Contributions

    • VP, Global Medical Affairs & Health Outcomes (Oncology, Immunology, CV/Met. Virology, Neuroscience)
      • Jul 2008 - Jul 2009

      Leading diverse team in Global Medical Affairs and Health Outcomes/Database Research across entire portfolio of products including oncology, immunology, virology, neuroscience, cardiovascular, and metabolics. Develop disease platforms and strategy based on unmet medical need, design and execute studies to support strategy and label optimization, communication, and publications and medical education. Provide deep payer insights into development plans, compile economic dossiers to support reimbursement.

    • VP, Regional Head, Latin America and Canada and Lead Neuroscience Lifecycle
      • Jul 2006 - Jul 2008

      Responsible for all medical and regional research activities across region. Data generation and dissemination, medical strategy, market access, and medical support for launch products and health technology assessments. Also lead Global lifecycle and aliances for key psychiatric asset.

    • VP, Global Medical Affairs, Neuroscience, Immunology, Virology
      • Jul 2004 - Jul 2006

      Lead phase IIIb-IV and sNDA/NDA submissions (Neuroscience), create and execute global medical strategy and studies, negotiate with regulatory authorities, develop medical education and publication strategy, lead diverse team across therapeutic areas.

    • Law Practice
    • 1 - 100 Employee
    • Psychiatry Franchise Development Leader
      • Jul 2002 - Jul 2004

      Lead Global strategy for psychiatry research and development for phase I - IIIb. Managed 4 global multidisciplanary development teams, Chair L & A group, direct negotiations with FDA and health authorities.

    • Global Medical Leader
      • Jul 1999 - Jul 2002

      Phase II-IIIb for atipsychotic and neuroscience development programs; create clinical development plans and strategy.

    • Sr. Clinical Research Physician
      • Jul 1998 - Jul 1999

      Antidepressant team responsible for development program of antidepressant portfolio. Antidepressant team responsible for development program of antidepressant portfolio.

    • United States
    • Medical Practices
    • 1 - 100 Employee
    • Partner
      • Jul 1991 - Jul 1998

      As a Partner in one of the largest and most successful physician psychiatric practices in the Delaware Valley, Psychiatric Consultants LLC was associated with numerous psychiatric and medical hospitals including academic institutions in Philadelphia. The year on year growth was substantial, providing care and consultation across the Philadelphia area. As a Partner in one of the largest and most successful physician psychiatric practices in the Delaware Valley, Psychiatric Consultants LLC was associated with numerous psychiatric and medical hospitals including academic institutions in Philadelphia. The year on year growth was substantial, providing care and consultation across the Philadelphia area.

Education

  • Hahnemann University/National Institutes of Health (Psychiatry Residency/Pharmacology Fellowship)
    Psychiatry and Geriatric Psychiatry
    1986 - 1991

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