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Biosketch
Dr. Mackler’s 28 years of FDA legal/regulatory experience in biomedical
products includes biologics, drugs, nutraceuticals, medical and in vitro
diagnostic devices, food and cosmetics manufactured by traditional and
biotechnology processes (recombinant proteins, genomics, cell and gene
therapy). Dr. Mackler has advised financial groups on integrated FDA,
technical and business issues, when performing due diligence assessments
on biomedical opportunities prior to their making initial investments and
during bridging. These due diligence activities integrate his business
acumen from working in sales/manufacturing in a family business, owning
and managing several bioservice businesses and being a researcher for 15
years (graduate, fellow, NIH and University), followed by 28 years in a
FDA legal / regulatory practice with premier law firms, and now as a
resource for numerous financial groups.
He also serves on several Boards of Directors and Scientific Advisory
Boards of biomedical companies, and is an active investor through
financial groups and as an angel investor. He has served as interim COO
and Regulatory Affairs Vice-President in several start-up biomedical
companies.
Dr Mackler has a Ph.D. and M.S. in the area of Immunology/Microbiology and
has authored more than 100 published scientific papers and abstracts in
immunology, immunopathology, and various disease models, as well as
numerous additional articles and briefing papers on FDA and FDA-related
legal and regulatory issues. Dr. Mackler still advises biomedical
companies and venture capital groups on FDA regulatory approval
strategies, pre-INDs, on problems regarding manufacturing / QA/QC
facilities, and how to effectively interact with FDA. He has assisted
companies in developing regulatory approval strategies for US and global
markets, pre-clinical and clinical study strategies to facilitate clinical
studies and market entry.
He has assisted companies in the integration of new technologies into FDA
product development strategies and achieved the approval of a number of
biologics, drugs and medical/diagnostic devices. These activities have
included actually serving as agent and holding INDs and IDEs for clients
and assistance in organizing clinical studies and troubleshooting
regulatory problems. During his regulatory activities, he meets regularly
with FDA staff and maintains a dialogue with them in the biologic, drug
and devices areas and has a hands-on approach to solving regulatory
problems ranging from pre-clinical, clinical and marketing submissions, as
well as pre-and post-marketing promotion and advertising.
Dr. Mackler has advised and counseled a number of traditional and
biopharmaceutical companies developing drug products to treat diseases
including multiple sclerosis, ALS, stroke, spinal cord injuries as well as
endocrine hormones, ophthalmics, anti-infectives, pulmonary delivery, to
name a few of the clinical areas, using traditional organic (new chemical
entities & generic) compounds, and biotech-derived therapeutics
(monoclonal antibodies, cytokines, fusion proteins), classic and new
technology-driven vaccines, and cellular and gene therapy. Dr. Mackler has
assisted venture funded US biomedical companies in initiating early stage
safety and proof of concept clinical studies of drugs, biologics and
devices in Europe, Eastern Europe and India, along with manufacturing
strategies to export investigational products.
Dr. Mackler has experience drafting and evaluating numerous FDA regulatory
documents (e.g., IDEs/PMAs, INDs/NDAs, DMFs, and BLAs, 510(k)s),
Accelerated and Fast Track Approvals, Orphan Drug Designation
applications, and USDA submissions. He has, as a U.S. agent, held IDEs/INDs
and secured Treatment-INDs with substantial reimbursement, and has written
Orphan Drug Development/SBIR grants and Designation applications;
therefore, he is familiar with the nuances of these regulatory procedures.
He lectures regularly at industry conferences and workshops, and
internally for companies and financial groups to update or train personnel
on FDA legal and regulatory matters.
Dr. Mackler is an Advisor with TVM-Capital in Boston & Munich, Paul
Capital Royalty Fund (Advisor) in New York City, Apax Partners (London &
Israel), Index Ventures (Geneva), ABN AMRO Capital/Life Sciences
(Amsterdam), UNUS Ventures (Birmingham, AL), D.E. Shaw Group (New York &
Houston), NGN Capital (Heidelberg), Gilde Healthcare Partners (Utrecht)
CANACOORD ADAMS (Toronto & New York) and other venture capital groups,
performing in depth FDA due diligence evaluations prior to investing, and
assisting portfolio companies with FDA strategy. He has written/edited the
FDA ALERT (HellerEhrman), Life Science Due Diligence and Regulatory
Newsletter and the TVM-Capital Regulatory Bulletin (copies available on
this website for downloading).
Dr. Mackler received his J.D. from the South Texas College of Law (magna
cum laude, 1979), his Ph.D. (Immunology/Microbiology) from the University
of Oregon Medical School (1970), his M.S. (Immunology/Microbiology) from
the Pennsylvania State University (1965), and his B.A. (Biology) from
Temple University (1964).
He was a member of the District of Columbia Bar, and was admitted to
practice before the Federal District and Appeals Court and before the U.S.
Supreme Court. Dr. Mackler founded and grew the Association of
Biotechnology Companies (ABC) into over 250 members, before it merged to
form the current Biotechnology Industry Organization (BIO). He was the
organizer of the annual ABC BioConference, which is now the annual BIO
Conference.
He also was a founder of BioConferences International, Inc., which
partnered with Genetic Engineering News [GEN] to run BioEast, BioWest &
BioEurope, regulatory workshops and focus groups. Since his retirement
from the active practice of FDA law, he has organized an advisory group to
assist financial groups with due diligence assessments, provide regulatory
assistance to their portfolio companies and to other biomedical companies
where he also accepts fees and/or equity.
Contact information:
Dr. Bruce F. Mackler (Ph.D., J.D.)
Private Office Tel.: 858-459-0236
Cellphone: 301-529-6984
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