SOUTH SAN FRANCISCO, Calif.,
Sept. 21, 2021 /PRNewswire/
-- Vaxart, Inc. (NASDAQ: VXRT), today announced that it
has formed a Manufacturing and Quality Advisory Board.
"We are very excited to be able to tap into the vast knowledge
of this group of experts," said Andrei Floroiu, Vaxart's Chief
Executive Officer.
"Their insights around state-of-the art manufacturing and
quality processes will help us as we progress towards late stage
development and commercialization of our vaccine portfolio."
The new advisory board convened its first meeting on August 21.
Vaxart also announced last month that it created a Scientific and
Clinical Advisory Board drawn from the fields of health care,
vaccines and academic research to advise Vaxart as it
develops its ground-breaking technology.
The six leaders joining Vaxart's COVID-19 Manufacturing and
Quality Advisory Board are John Aunins, Ph.D.; John Carpenter,
Ph.D.; Benjamin Del Tito, Ph.D.;
Vijay Jethwa, Ph.D.; Robert Schiff, Ph.D.; and Clifford
Siporin, Ph.D. Their biographies can be found below:
John Aunins,
Ph.D.
Senior Advisor
Former Vice President & Chief Technology
Officer
Seres Therapeutics
President
Janis Biologics
Massachusetts
John Aunins, Ph.D., is a 32-year
veteran in the biotech field with deep experience in bioprocess
development, manufacturing support and project
leadership.
He led process and product development teams at Merck Research
Laboratories for Vaqta®, Varivax®, Zostavax®, ProQuad®, Rotateq®
and Gardasil®. The Vaqta and Gardasil process teams were awarded
with ACS Industrial Biotechnology Awards for innovation,
contribution to bioengineering and societal impact. More recently,
he has been involved in developing a new class of live microbial
biotherapeutics for treatment of disorders of the GI microbiome at
Seres Therapeutics.
He is a Fellow of the American Institute for Medical and
Biological Engineering, and an adjunct Full Professor at the
Instituto de Tecnologia Quimica e Biologica (ITQB) in Oeiras,
Portugal, and a member of the
National Academy of Engineering. He is author of over 50 articles
and book chapters and has chaired five international conferences in
vaccines and bioprocess technology. John obtained his Ph.D. in
Chemical Engineering from MIT in 1989
under Institute Professor Daniel I.C.
Wang.
John Carpenter,
Ph.D.
Professor
University of Colorado School of
Pharmacy
Co-Founder and Co-Director
University of Colorado Center for
Pharmaceutical Biotechnology
Colorado
John Carpenter, Ph.D., is
Professor of Pharmaceutical Sciences at the University of Colorado School of Pharmacy, and a
Co-Founder and Co-Director of the University
of Colorado Center for Pharmaceutical Biotechnology.
His research interests include mechanisms for protein
degradation and stabilization in pharmaceutical formulations,
during bioprocessing and in delivery systems. He has worked for
several years to define rational strategies for stabilizing
proteins and vaccines during freeze-drying and storage in the dried
solid.
He has published more than 300 peer-reviewed papers and is an
inventor on more than 30 issued patents. He is Editor for Reviews
and Commentaries for Journal of Pharmaceutical Sciences. He
serves on the Editorial Advisory Boards for Pharmaceutical
Research, The AAPS Journal, Journal of Pharmaceutical
Sciences, Current Pharmaceutical Biotechnology, Molecular
Pharmaceutics and BioPharm International. He has received several
teaching awards and The Ebert Prize.
He is a Fellow of the American Association for Advancement of
Science and the American Association of Pharmaceutical Scientists
(AAPS) and has received the AAPS Research Achievement Award in
Biotechnology. He also is the Organizer for the Colorado Protein
Stability Conferences.
Benjamin Del Tito,
Ph.D.
President
Del Tito Consulting, LLC
Senior Affiliate Consultant
Biologics Consulting
Virginia
Benjamin Del Tito, Ph.D., is
currently a consultant to Vaxart and a Senior
Affiliate Consultant at Biologics Consulting.
He has more than twenty years of experience in both large
pharmaceutical and small to mid-sized biotechnology companies
specializing in a range of products from protein therapeutics to
vaccines to diagnostics. His career has focused on the areas of
analytical development, quality control,
pre-clinical assay development and validation, quality
assurance and regulatory affairs. He is knowledgeable in global
drug development (Phase I-IV); IND, IMPD, NDA and BLA
submissions; regulatory interactions; and regulatory inspections
for both the U.S. and Europe. He
has extensive experience in building teams of development and
quality professionals for phases of drug development, including
early development, clinical manufacturing, licensure and commercial
manufacturing.
Del Tito was employed from
October 2005 to 2014 at Auxilium
Pharmaceuticals, where he oversaw the Quality Control, Quality
Assurance and Regulatory Affairs departments. Prior to Auxilium,
Dr. Del Tito served as Vice
President, Analytical and QC Operations at Neose Technologies, Inc.
Prior to Neose, Del Tito served as
Senior Director, QC Operations at MedImmune Vaccines,
Inc.
Del Tito earned a B.A. in Biology
from Millersville University, an M.S.
in Biochemistry from Western Kentucky
University and a Ph.D. in Molecular Biology from Lehigh
University. He is an Adjunct Faculty member at
Georgia State University in Atlanta,
Georgia.
Vijay Jethwa,
Ph.D.
Senior Consultant
Biologics Consulting
North Carolina
Vijay Jethwa, Ph.D., is a senior
consultant at Biologics Consulting. He has over 25 years of
industry experience in the development, validation and routine
performance of potency assays, cell-based bioassays and
immunoassays for diagnostics, PK/PD studies, drug substance and
drug product characterization, lot release and stability, as well
as immunogenicity assessments.
Jethwa started up the new GMP Bioanalytical Laboratories at the
Merck Vaccines Facility in Durham, North
Carolina. His group developed and transferred analytical
methods for the characterization and release of live virus
vaccines. Prior to joining Merck, he was at Biogen Idec for over 12
years in various capacities, including leading all CMC activities
related to biosimilar development and serving as the site head of
the cGMP Bioassay, Microbiology and Virology QC Laboratories. He
established GLP testing laboratories at Biogen, including
laboratory design, equipment sourcing and validation, supporting
antibody and PK/PD testing for various GLP/GCP studies.
Jethwa prepared and presented Quality sections for Regulatory
advice meetings and has authored, reviewed and approved sections of
several regulatory submissions (IND, IMPD, BLA, etc.).
Robert Schiff,
Ph.D.
Founder & CEO
Schiff & Company, Inc.
New Jersey
Robert Schiff, Ph.D., is founder
and CEO of Schiff & Company, Inc., a regulatory affairs,
compliance and clinical research organization established in
1982.
Prior to founding Schiff & Company, Schiff served with a
number of companies, including the Warner Lambert Company as Group
Vice President, Diagnostics Research and Development; Hoffmann-La
Roche, Inc. as Director, Department of Diagnostic Research and
Product Development; the J. T. Baker Chemical Company
(Richardson-Vicks) as Director of Research & Development,
Diagnostics Division; and the Hyland Division Travenol Laboratories
(Baxter) as Manager, Serology
Research. He also served as Assistant Professor in the Department
of Anatomy at Tufts University Schools
of Medicine and Dental Medicine. Dr. Schiff has authored over 50
publications and holds several patents on medical
products.
Schiff received his B.S. from the City
College of New York, M.S. from Iowa
State University and Ph.D. from the University of California at Davis. He was a member
of the Graduate Business faculty at Farleigh Dickinson
University, and he also lectures on International Business and
Compliance with FDA rules and regulations.
Schiff serves on the boards of several companies, is a member of
the Editorial Board of the Regulatory Affairs Professional Society,
is a Fellow of the Regulatory Affairs Professional Society and is
listed in Marquis' Who's Who in America, Who's Who in the World,
Who's Who in the East, Who's Who in Science & Engineering, and
American Men of Science.
Clifford Siporin,
Ph.D.
Founder
Greystone Pharmaceutical Consulting, Inc.
Florida
Clifford Siporin, Ph.D., is the
founder of Greystone Pharmaceutical Consulting, Inc., a full
service CRO with expertise including contract project management
and site monitoring, statistics, manufacturing, IRB, Sponsor, IRB
and site auditing, medical and scientific writing, and regulatory
affairs (FDA) and product safety issues. Siporin has over 30 years
of experience and has accomplishments in all areas of drug
development, including significant experience in drug substance and
drug product issues as they relate to manufacturing and control,
pre-clinical and clinical studies and regulatory parameters related
to drug approval, manufacturing, labeling, marketing and
distribution.
Previously, he served as Vice President of Drug Development at
G.D. Searle and Co., where he was directly responsible for all
development phases for in-licensed compounds, line extensions and
new dosage forms. He also served in various senior level positions
at Warner Lambert Company/Parke
Davis. This included responsibility for consolidating all
phases of drug development for anti-infective drugs in the
U.S. and worldwide. Siporin also served with distinction in several
senior-level positions at Pfizer.
Siporin completed his doctorate in Microbiology from the
University of Dayton.
About Vaxart
Vaxart is a clinical-stage biotechnology company developing a
range of oral vaccines based on its proprietary delivery platform
called VAAST™. Vaxart vaccines are designed to be administered
using tablets that can be stored and shipped without refrigeration
and eliminate the risk of needle-stick injury. Vaxart believes that
its proprietary tablet vaccine delivery platform is suitable to
deliver vaccines, positioning the company to develop oral versions
of currently marketed vaccines and to design vaccines for new
indications. Vaxart's development programs currently include tablet
vaccines designed to protect against coronavirus, norovirus,
seasonal influenza, and respiratory syncytial virus (RSV), as well
as a therapeutic vaccine for human papillomavirus
(HPV), Vaxart's first immuno-oncology indication. Vaxart has filed
broad domestic and international patent applications covering its
proprietary technology and creations for oral vaccination using
adenovirus and TLR3 agonists.
Note Regarding Forward-Looking Statements
This press
release contains forward-looking statements that involve
substantial risks and uncertainties. All statements, other than
statements of historical facts, included in this press release
regarding Vaxart's strategy, prospects, plans and objectives,
results from pre-clinical and clinical trials, commercialization
agreements and licenses, and beliefs and expectations of management
are forward-looking statements. These forward-looking statements
may be accompanied by such words as "should," "believe," "could,"
"potential," "will," "expected," "plan," and other words and terms
of similar meaning. Examples of such statements include, but are
not limited to, statements relating to the Advisory Board's impact
on Vaxart's business and future outlook; Vaxart's expectations
regarding clinical results and trial
data; and Vaxart's expectations with respect to the effectiveness
of its product candidates. Vaxart may not actually achieve the
plans, carry out the intentions, or meet the expectations or
projections disclosed in the forward-looking statements, and you
should not place undue reliance on these forward-looking
statements. Actual results or events could differ materially from
the plans, intentions, expectations, and projections disclosed in
the forward-looking statements. Various important factors could
cause actual results or events to differ materially from
the forward-looking statements that Vaxart makes, including
uncertainties inherent in research and development, including the
ability to meet anticipated clinical endpoints, commencement and/or
completion dates for clinical trials, regulatory submission dates,
regulatory approval dates, and/or launch dates, as well as the
possibility of unfavorable new clinical data and further analyses
of existing clinical data; the risk that clinical trial data are
subject to differing interpretations and assessments by regulatory
authorities; whether regulatory authorities will be satisfied with
the design of and results from the clinical studies; decisions by
regulatory authorities impacting labeling, manufacturing processes,
and safety that could affect the availability or commercial
potential of any product candidate, including the possibility
that Vaxart's product candidates may not be approved by the FDA or
non-U.S. regulatory authorities; that, even if approved by the FDA
or non-U.S. regulatory authorities, Vaxart's product candidates may
not achieve broad market acceptance; that a Vaxart collaborator may
not attain development and commercial milestones; that Vaxart or
its partners may experience manufacturing issues and delays due to
events within, or outside of, Vaxart's or its partners' control;
difficulties in production, particularly in scaling up initial
production, including difficulties with production costs and
yields, quality control, including stability of the product
candidate and quality assurance testing, shortages of qualified
personnel or key raw materials, and compliance with strictly
enforced federal, state, and foreign regulations; that Vaxart may
not be able to obtain, maintain, and enforce necessary patent and
other intellectual property protection; that Vaxart's capital
resources may be inadequate; Vaxart's ability to resolve pending
legal matters; Vaxart's ability to obtain sufficient capital to
fund its operations on terms acceptable to Vaxart, if at all; the
impact of government healthcare proposals and policies; competitive
factors; and other risks described in the "Risk Factors" sections
of Vaxart's Quarterly and Annual Reports filed with the
SEC. Vaxart does not assume any obligation to update any
forward-looking statements, except as required by law.
Contacts
Vaxart Media
Relations:
|
Investor
Relations:
|
Mark Herr
|
Matt Steinberg
|
Vaxart,
Inc.
|
Finn
Partners
|
mherr@vaxart.com
|
IR@Vaxart.com
|
(203)
517-8957
|
|
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SOURCE Vaxart, Inc.