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Bruce F. Mackler is a senior
advisor in FDA matters and FDA due diligence issues to
financial/investment groups and companies. He is effective in developing
and implementing FDA strategies for product approval of biologics, drugs
and medical devices in the US and the global market place. Bruce couples
his scientific knowledge (M.S., Ph.D. Immunology) with practical, hands-on
regulatory experience of 27 years of FDA legal work on traditional and
biotechnology derived products. He continues to provide FDA advice to US
and European financial (venture capital and royal fund investment groups
and stock analyst) groups, directly to biomedical product companies and is
available to assist you. His grasp of the technical and FDA issues is
augmented by his understanding of the commercial realities facing
biomedical companies and products in the marketplace including the
intended use claims, reimbursement and cost of goods. His business acumen
is on his work experience including that in a family business in the
packaging field, operationally in organizing and managing multidiscipline
research laboratories and as management of several biomedical commercial
entities. He has a proven record of accomplishments in moving technology
from the laboratory into animal and human testing and FDA marketing
submissions.
His hands-on, practical FDA work experiences includes developing of product development strategies, organizing numerous pre-IND/IDE meetings, acting as an Agent for submissions to FDA, implementing pre-clinical and clinical programs, negotiating with FDA to resolve issues and with vendors for analytical, animal, clinical (CRO, investigators and institutions) and for product manufacturing during his 27 years of FDA legal practice and now as an Advisor; This work included developing the first bio-similar drug (505(b)(2) NDA application; and as an Arbitrator in conflicts regarding FDA matters, i.e., in disputes involving compliance with current Good Manufacturing (cGMPs) and Clinical (GCP) Practices regulations and meeting product specifications.
Bruce currently serves on
the Board of Directors of several biomedical companies and is also an
active investor in biomedical start-up companies through venture groups.
He is also an angel investor with cash and services in several biomedical
startup companies. |
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