Navidea Biopharmaceuticals Appoints Michel Mikhail, Ph.D. as Chief Regulatory Officer
27 September 2021 - 9:30PM
Business Wire
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB)
(“Navidea” or the “Company”), a company focused on the development
of precision immunodiagnostic agents and immunotherapeutics, today
announced the appointment of Michel Mikhail, Ph.D. as Chief
Regulatory Officer of Navidea, effective October 1, 2021.
Dr. Mikhail has more than 30 years of experience in the
pharmaceutical industry and a track record of achievement in
R&D and international regulatory affairs at large multinational
research-based pharmaceutical companies. Prior to joining Navidea,
Dr. Mikhail worked in global regulatory consulting for various
pharmaceutical and biotech companies from January 2016 through
September 2021. Before acting as a consultant, Dr. Mikhail served
in senior regulatory executive roles at BioNTech AG, Fresenius
Kabi, Ranbaxy Europe Ltd. (now SunPharma), Pharmacia & Upjohn
(now Pfizer), Knoll AG (now Abbvie), SmithKline Beecham (now
GlaxoSmithKline), and Boehringer Ingelheim. Dr. Mikhail is a global
expert in Regulatory Affairs dealing with the U.S. Food and Drug
Administration (“US-FDA”), the European Medicines Agency (“EU-EMA”)
as well as national agencies in Europe, Japan’s Pharmaceuticals and
Medical Devices Agency, China’s National Medical Products
Administration, among other regulatory agencies worldwide. He is a
Chartered Expert in Pharmacology-Toxicology. Dr Mikhail served on
the Safety working group and Efficacy working group of the European
Federation of Pharmaceutical Industry Associations and as a Topic
Leader for new guidelines. He served on the Regulatory Group of the
European branch of the Pharmaceutical Research and Manufacturers of
America, on the European Biosimilars Group, the Regulatory and
Scientific Affairs Group of the European Generic medicines
Association (now Medicines for Europe), as well as on different
associations and organizations. Dr. Mikhail is a lifetime member of
The Organization for Professionals in Regulatory Affairs, and has
contributed as volunteer at the Drug Information Association and
the Parenteral Drug Association. Dr. Mikhail was part of the
Transatlantic Trade and Investment Partnership negotiations aiming
at harmonization of regulatory requirements and relying on each
other’s inspections between the EU-EMA and US-FDA. Dr. Mikhail
served as a volunteer member of the Expert Committee of the
Governmental Federal Institute of Risk Assessment in Berlin,
Germany and served as a volunteer member of the Expert Committee
for Toxicology of the United States Pharmacopoeia in Maryland, USA.
Dr. Mikhail holds a Ph.D. from the University of Paris and a Ph.D.
from the University of Hannover.
Dr. Mikhail said, “This is an exciting opportunity to join
Navidea’s leadership team, to expand the product portfolio
leveraging on the diagnostic imaging and the therapeutic Manocept
platform. I look forward to working with the US-FDA, the EU-EMA and
regulatory agencies around the world and with the Navidea
development teams and partners to deliver on Navidea’s drug
development initiatives, ensuring they are completed and approved
on time and to the highest quality standards that can lead to
positive patient impact. I am proud to join a world-class team to
support Navidea’s anticipated growth, as we execute on our mission
of helping patients have the right effective medicine from the
start to treat their disease, minimizing exposure to unwanted side
effects and saving cost for the payers."
Navidea Chief Executive Officer Jed Latkin said, “We are very
pleased to welcome Dr. Michel Mikhail to our executive leadership
team, as he brings over 30 years of expertise in the field of
global regulatory affairs and drug development. He has experience
in accompanying drug development through regulatory agency meetings
and scientific advice, from start until successful completion of
Phase 3 clinical trials as well as indication expansion and
successful approval by regulatory authorities. We look forward to a
successful development and implementation of regulatory strategy
for development and expansion of our Manocept platform to enhance
patient care and contribute to covering unmet medical needs for
drug imaging technology and therapeutic use in rheumatoid arthritis
and beyond.”
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) is a
biopharmaceutical company focused on the development of precision
immunodiagnostic agents and immunotherapeutics. Navidea is
developing multiple precision-targeted products based on its
Manocept™ platform to enhance patient care by identifying the sites
and pathways of disease and enable better diagnostic accuracy,
clinical decision-making, and targeted treatment. Navidea’s
Manocept platform is predicated on the ability to specifically
target the CD206 mannose receptor expressed on activated
macrophages. The Manocept platform serves as the molecular backbone
of Tc99m tilmanocept, the first product developed and
commercialized by Navidea based on the platform. Navidea’s strategy
is to deliver superior growth and shareholder return by bringing to
market novel products and advancing the Company’s pipeline through
global partnering and commercialization efforts. For more
information, please visit www.navidea.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. We have based these forward-looking statements largely on
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outcome of any pending litigation; our ability to successfully
complete research and further development of our drug candidates;
the timing, cost and uncertainty of obtaining regulatory approvals
of our drug candidates; our ability to successfully commercialize
our drug candidates; dependence on royalties and grant revenue; our
ability to implement our growth strategy; anticipated trends in our
business; our limited product line and distribution channels;
advances in technologies and development of new competitive
products; our ability to comply with the NYSE American continued
listing standards; our ability to maintain effective internal
control over financial reporting; the impact of the current
coronavirus pandemic; and other risk factors detailed in our most
recent Annual Report on Form 10-K and other SEC filings. You are
urged to carefully review and consider the disclosures found in our
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Navidea Biopharmaceuticals, Inc. Jed Latkin Chief Executive
Officer 614-973-7490 jlatkin@navidea.com
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