SOUTH SAN FRANCISCO, Calif., Sept. 21, 2021 /PRNewswire/ — Vaxart, Inc. (NASDAQ: VXRT), today appear that it has formed a Accomplishment and Affection Advising Board.
“We are absolute aflame to be able to tap into the all-inclusive adeptness of this accumulation of experts,” said Andrei Floroiu, Vaxart’s Chief Executive Officer.
“Their insights about state-of-the art accomplishment and affection processes will admonition us as we advance appear backward date development and commercialization of our vaccine portfolio.”
The new advising lath convened its aboriginal affair on August 21. Vaxart additionally appear aftermost ages that it created a Accurate and Analytic Advising Lath fatigued from the fields of bloom care, vaccines and bookish analysis to admonish Vaxart as it develops its ground-breaking technology.
The six leaders abutting Vaxart’s COVID-19 Accomplishment and Affection Advising Lath 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 begin below:
John Aunins, Ph.D.Senior AdvisorFormer Vice President & Chief Technology Officer Seres TherapeuticsPresidentJanis BiologicsMassachusetts
John Aunins, Ph.D., is a 32-year adept in the biotech acreage with abysmal acquaintance in bioprocess development, accomplishment abutment and activity leadership.
He led action and artefact development teams at Merck Analysis Laboratories for Vaqta®, Varivax®, Zostavax®, ProQuad®, Rotateq® and Gardasil®. The Vaqta and Gardasil action teams were awarded with ACS Industrial Biotechnology Awards for innovation, addition to bioengineering and civic impact. Added recently, he has been complex in developing a new chic of alive microbial biotherapeutics for analysis of disorders of the GI microbiome at Seres Therapeutics.
He is a Fellow of the American Institute for Medical and Biological Engineering, and an accessory Abounding Professor at the Instituto de Tecnologia Quimica e Biologica (ITQB) in Oeiras, Portugal, and a affiliate of the National Academy of Engineering. He is columnist of over 50 accessories and book capacity and has chaired bristles all-embracing conferences in vaccines and bioprocess technology. John acquired his Ph.D. in Chemical Engineering from MIT in 1989 beneath Institute Professor Daniel I.C. Wang.
John Carpenter, Ph.D.ProfessorUniversity of Colorado School of PharmacyCo-Founder and Co-DirectorUniversity of Colorado Center for Biologic BiotechnologyColorado
John Carpenter, Ph.D., is Professor of Biologic Sciences at the University of Colorado School of Pharmacy, and a Co-Founder and Co-Director of the University of Colorado Center for Biologic Biotechnology.
His analysis interests accommodate mechanisms for protein abasement and stabilization in biologic formulations, during bioprocessing and in commitment systems. He has formed for several years to ascertain rational strategies for stabilizing proteins and vaccines during freeze-drying and accumulator in the broiled solid.
He has appear added than 300 peer-reviewed affidavit and is an artist on added than 30 issued patents. He is Editor for Reviews and Commentaries for Journal of Biologic Sciences. He serves on the Editorial Advising Boards for Biologic Research, The AAPS Journal, Journal of Biologic Sciences, Current Biologic Biotechnology, Molecular Pharmaceutics and BioPharm International. He has accustomed several teaching awards and The Ebert Prize.
He is a Fellow of the American Association for Advancement of Science and the American Association of Biologic Scientists (AAPS) and has accustomed the AAPS Analysis Achievement Award in Biotechnology. He additionally is the Organizer for the Colorado Protein Adherence Conferences.
Benjamin Del Tito, Ph.D.President Del Tito Consulting, LLCSenior Affiliate ConsultantBiologics ConsultingVirginia
Benjamin Del Tito, Ph.D., is currently a adviser to Vaxart and a Chief Affiliate Adviser at Biologics Consulting. He has added than twenty years of acquaintance in both ample biologic and baby to mid-sized biotechnology companies specializing in a ambit of articles from protein analysis to vaccines to diagnostics. His career has focused on the areas of analytic development, affection control, pre-clinical appraisal development and validation, affection affirmation and authoritative affairs. He is abreast in all-around biologic development (Phase I-IV); IND, IMPD, NDA and BLA submissions; authoritative interactions; and authoritative inspections for both the U.S. and Europe. He has all-encompassing acquaintance in architecture teams of development and affection professionals for phases of biologic development, including aboriginal development, analytic manufacturing, licensure and bartering manufacturing.
Del Tito was active from October 2005 to 2014 at Auxilium Pharmaceuticals, area he oversaw the Affection Control, Affection Affirmation and Authoritative Diplomacy departments. Prior to Auxilium, Dr. Del Tito served as Vice President, Analytic and QC Operations at Neose Technologies, Inc. Prior to Neose, Del Tito served as Chief Director, QC Operations at MedImmune Vaccines, Inc.
Del Tito becoming 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 Accessory Adroitness affiliate at Georgia Accompaniment University in Atlanta, Georgia.
Vijay Jethwa, Ph.D.Senior Adviser Biologics ConsultingNorth Carolina
Vijay Jethwa, Ph.D., is a chief adviser at Biologics Consulting. He has over 25 years of industry acquaintance in the development, validation and accepted achievement of authority assays, cell-based bioassays and immunoassays for diagnostics, PK/PD studies, biologic actuality and biologic artefact characterization, lot absolution and stability, as able-bodied as immunogenicity assessments.
Jethwa started up the new GMP Bioanalytical Laboratories at the Merck Vaccines Facility in Durham, North Carolina. His accumulation developed and transferred analytic methods for the assuming and absolution of alive virus vaccines. Prior to abutting Merck, he was at Biogen Idec for over 12 years in assorted capacities, including arch all CMC activities accompanying to biosimilar development and confined as the armpit arch of the cGMP Bioassay, Microbiology and Virology QC Laboratories. He accustomed GLP testing laboratories at Biogen, including class design, accessories sourcing and validation, acknowledging antibiotic and PK/PD testing for assorted GLP/GCP studies.
Jethwa able and presented Affection sections for Authoritative admonition diplomacy and has authored, advised and accustomed sections of several authoritative submissions (IND, IMPD, BLA, etc.).
Robert Schiff, Ph.D.Founder & CEOSchiff & Company, Inc.New Jersey
Robert Schiff, Ph.D., is architect and CEO of Schiff & Company, Inc., a authoritative affairs, acquiescence and analytic analysis alignment accustomed in 1982.
Prior to founding Schiff & Company, Schiff served with a cardinal of companies, including the Warner Lambert Aggregation as Accumulation Vice President, Affection Analysis and Development; Hoffmann-La Roche, Inc. as Director, Department of Diagnostic Analysis and Artefact Development; the J. T. Baker Chemical Aggregation (Richardson-Vicks) as Director of Analysis & Development, Affection Division; and the Hyland Division Travenol Laboratories (Baxter) as Manager, Serology Research. He additionally 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 accustomed his B.S. from the City College of New York, M.S. from Iowa Accompaniment University and Ph.D. from the University of California at Davis. He was a affiliate of the Graduate Business adroitness at Farleigh Dickinson University, and he additionally lectures on All-embracing Business and Acquiescence with FDA rules and regulations.
Schiff serves on the boards of several companies, is a affiliate of the Editorial Lath of the Authoritative Diplomacy Professional Society, is a Fellow of the Authoritative Diplomacy 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.FounderGreystone Biologic Consulting, Inc.Florida
Clifford Siporin, Ph.D., is the architect of Greystone Biologic Consulting, Inc., a abounding account CRO with adeptness including arrangement activity administration and armpit monitoring, statistics, manufacturing, IRB, Sponsor, IRB and armpit auditing, medical and accurate writing, and authoritative diplomacy (FDA) and artefact affirmation issues. Siporin has over 30 years of acquaintance and has accomplishments in all areas of biologic development, including cogent acquaintance in biologic actuality and biologic artefact issues as they chronicle to accomplishment and control, pre-clinical and analytic studies and authoritative ambit accompanying to biologic approval, manufacturing, labeling, business and distribution.
Previously, he served as Vice President of Biologic Development at G.D. Searle and Co., area he was anon amenable for all development phases for in-licensed compounds, band extensions and new dosage forms. He additionally served in assorted chief akin positions at Warner Lambert Company/Parke Davis. This included albatross for accumulation all phases of biologic development for anti-infective drugs in the U.S. and worldwide. Siporin additionally served with acumen 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 aggregation developing a ambit of articulate vaccines based on its proprietary commitment belvedere alleged VAAST™. Vaxart vaccines are advised to be administered application tablets that can be stored and alien after algidity and annihilate the accident of needle-stick injury. Vaxart believes that its proprietary book vaccine commitment belvedere is adequate to bear vaccines, accession the aggregation to advance articulate versions of currently marketed vaccines and to architecture vaccines for new indications. Vaxart’s development programs currently accommodate book vaccines advised to assure adjoin coronavirus, norovirus, melancholia influenza, and respiratory syncytial virus (RSV), as able-bodied as a ameliorative vaccine for animal papillomavirus (HPV), Vaxart’s aboriginal immuno-oncology indication. Vaxart has filed ample calm and all-embracing apparent applications accoutrement its proprietary technology and creations for articulate anesthetic application adenovirus and TLR3 agonists.
Note Apropos Forward-Looking Statements This columnist absolution contains advanced statements that absorb abundant risks and uncertainties. All statements, added than statements of absolute facts, included in this columnist absolution apropos Vaxart’s strategy, prospects, affairs and objectives, after-effects from pre-clinical and analytic trials, commercialization agreements and licenses, and behavior and expectations of administration are advanced statements. These advanced statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan,” and added words and agreement of agnate meaning. Examples of such statements include, but are not bound to, statements apropos to the Advising Board’s appulse on Vaxart’s business and approaching outlook; Vaxart’s expectations apropos analytic after-effects and balloon data; and Vaxart’s expectations with account to the capability of its artefact candidates. Vaxart may not absolutely accomplish the plans, backpack out the intentions, or accommodated the expectations or projections appear in the advanced statements, and you should not abode disproportionate affirmation on these advanced statements. Absolute after-effects or contest could alter materially from the plans, intentions, expectations, and projections appear in the advanced statements. Assorted important factors could account absolute after-effects or contest to alter materially from the advanced statements that Vaxart makes, including uncertainties inherent in analysis and development, including the adeptness to accommodated advancing analytic endpoints, admission and/or achievement dates for analytic trials, authoritative acquiescence dates, authoritative approval dates, and/or barrage dates, as able-bodied as the achievability of abortive new analytic abstracts and added analyses of absolute analytic data; the accident that analytic balloon abstracts are accountable to differing interpretations and assessments by authoritative authorities; whether authoritative authorities will be annoyed with the architecture of and after-effects from the analytic studies; decisions by authoritative authorities impacting labeling, accomplishment processes, and affirmation that could affect the availability or bartering abeyant of any artefact candidate, including the achievability that Vaxart’s artefact candidates may not be accustomed by the FDA or non-U.S. authoritative authorities; that, alike if accustomed by the FDA or non-U.S. authoritative authorities, Vaxart’s artefact candidates may not accomplish ample bazaar acceptance; that a Vaxart assistant may not attain development and bartering milestones; that Vaxart or its ally may acquaintance accomplishment issues and delays due to contest within, or alfresco of, Vaxart’s or its partners’ control; difficulties in production, decidedly in ascent up antecedent production, including difficulties with assembly costs and yields, affection control, including adherence of the artefact applicant and affection affirmation testing, shortages of able cadre or key raw materials, and acquiescence with carefully activated federal, state, and adopted regulations; that Vaxart may not be able to obtain, maintain, and accomplish all-important apparent and added bookish acreage protection; that Vaxart’s basic assets may be inadequate; Vaxart’s adeptness to boldness awaiting acknowledged matters; Vaxart’s adeptness to access adequate basic to armamentarium its operations on agreement adequate to Vaxart, if at all; the appulse of government healthcare proposals and policies; aggressive factors; and added risks declared in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not accept any obligation to amend any advanced statements, except as appropriate by law.
Contacts
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SOURCE Vaxart, Inc.
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