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`Alexander D. D’Addio, Ph.D.
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`February 2017- Present
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` October 2001 – February 2017
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`EDUCATION
`Seton Hall University
`South Orange, New Jersey
`Ph.D. Analytical Chemistry, 1983
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`Kean University
`Union, New Jersey
`B.A., cum laude, Chemistry, 1975
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`WORK EXPERIENCE
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`DADDIO Pharma Consulting L.L.C.
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`President
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`Independent consultant providing support and services for the development, commercial launch,
`and marketing of pharmaceutical products.
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`Meda Pharmaceuticals Inc., Somerset, NJ
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`Vice President, Scientific Affairs and Medical Communications October 2015 – Present
`Reports to Executive Vice President, Scientific Affairs, Meda Global Executive Team,
`Meda AB
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`Responsibilities include the design and execution of studies to demonstrate product attributes in
`support of Medical Affairs and Marketing and presentation of results. Oversight of Medical
`Science Liaisons operations, planning and execution of Advisory boards, Congresses and
`Investigator Initiated Study interactions. Oversight of Clinical Research and Operations.
`Support the development of product line extensions including NDA and non-NDA prescription
`products. Support the development and validation of commercial processes and analytical
`methods required to bring products to market. Provide technical and analytical chemistry
`support to Quality Assurance, Regulatory Affairs and Manufacturing. Identify, recommend, and
`manage activities at contract facilities for analytical method development and validation. Support
`the evaluation of new products. Assess potential and risks associated with acquisition of new
`products. Responsible for the development and review of patents and maintenance of intellectual
`property.
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`Vice President, Scientific and Analytical Affairs
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`Vice President, Technical and Scientific Affairs
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` August 2013-October 2015
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` October 2012 – August 2013
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`CIP2004
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
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`Chief Scientific Officer
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`Interim Chief Scientific Officer and Senior Director, Technical and Analytical Services
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` January 2011 – July 2011
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` July 2011 – October 2012
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` December 2001 – December 2010
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`Vice President, Product and Process Development
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`Wallace Laboratories, Carter-Wallace, Inc., Cranbury, NJ
`Director, Wallace Technical Services
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`Responsible for process development and validation, analytical method evaluation and transfer,
`qualification of vendors, and corporate support of commercial manufacturing facilities in
`Cranbury, NJ and Decatur, IL.
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`Department Head, Wallace Technical Services
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`Department Head, Research Services
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`Responsible for analytical support of pharmaceutical development and research stability
`programs, release of clinical supplies, method development and maintenance of reference
`standard program.
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`Manager, Research Services
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`Group Leader, Analytical Research
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`Responsible for supply and certification of reference standards for active pharmaceutical
`ingredients, process impurities and drug degradation products.
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`Medical Research Div., American Cyanamid Company, Bound Brook, NJ
`Research Scientist, Analytical Research and Development
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`Responsible for analytical development to support new drug substance process development.
`Implemented Vestec Thermospray/Particle Beam LC/MS and system manager of the HP LAS
`1000 chromatographic data system. Served as Chairperson of the 1987 International Cyanamid
`Technical Research Services Analytical Conference.
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` 1990 - 2001
` 2000 - 2001
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` 1996 – 2000
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` 1994 – 1996
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` 1993 – 1994
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` 1990 – 1993
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` 1984 – 1990
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`MEMBERSHIPS
`American Chemical Society
`American Association of Pharmaceutical Scientists
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`PATENTS
`U.S. Patent 6,417,206, “Antitussive/antihistaminics/decongestant compositions” July 9, 2002
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`U.S. Patent 6,462,094, “Decongestant/expectorant compositions” October 8, 2002
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`U.S. Patent 6,566,396, “Antitussive/antihistaminics compositions” May 20, 2003
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`U.S. Patent 8,071,073, “Compositions comprising azelastine and methods of use thereof”
`December 6, 2011
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`U.S. Patent 8,518,919, “Compositions comprising azelastine and methods of use thereof” August
`27, 2013
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`U.S. Patent 8,758,816, “Compositions comprising azelastine and methods of use thereof” June
`24, 2014
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`PUBLICATIONS/PRESENTATIONS
`D’Addio AD, Augustine RL, Ewing GW. An Inelastic Electron Tunneling Spectral (IETS) Study
`of Rhodium Carbonyls Rh6(CO)16 and Rh4(CO)12 Adsorbed on Alumina. Journal of Molecular
`Catalysis. 1988;43:315-325.
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`D’Addio AD, Luther GW, Meyers L. Voltammetric Methods of Sulfate Ion Analysis in Natural
`Waters. Marine Chemistry. 1978; 6:117-124.
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`“Inelastic Electron Tunneling Spectroscopy (IETS) and the Study of Supported Metal Catalysts”,
`A.D. D’Addio, and R.L. Augustine, presented at the New York-New England Catalysis Societies
`Spring Symposium, Yale University, March 1982.
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`“An Automated Content Uniformity Application: From Zymate Tablet Processing Workstation
`to Benchmate”, D.E. Martynuk, A.G. Sheth, D.J. Zuccarello, A.D. D’Addio, H.J. Mortko, K.
`Halloran, presented at ISLAR ’93, Boston, MA.
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`“Deposition Characteristics of Dymista Nasal Spray (azelastine HCl 137 μg/fluticasone
`propionate 50 μg) in an Anatomical Model of the Human Nasal Cavity”, Alexander D. D’Addio,
`PhD; Nancy M. Ruiz, MD; Larry Gever, PharmD; Michael J. Mayer, PhD; Eli O. Meltzer, MD,
`presented at ACAAI 2014, Atlanta, GA, November 2014
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`“Quantification of the Distribution of MP29-02 (Dymista-Azelastine HCl/Fluticasone Propionate
`Nasal Spray) in an Anatomical Model of the Human Nasal Cavity”, Alexander D. D’Addio,
`PhD; Nancy M. Ruiz, MD; Michael J. Mayer, PhD; William Berger, MD; Eli O. Meltzer, MD,
`presented at AAAAI 2015, Houston, TX, February 2015
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`“In Vitro Characterization of Flunisolide HFA (Aerospan®) Particle Size and Particle
`Distribution”, Alexander D’Addio, PhD; Eli Meltzer, MD, presented at AAP 2015, Washington
`D.C., October 2015
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`“In vitro Determination of the Robustness of the Emitted Dose of Flunisolide HFA pMDI”,
`Alexander D’Addio, PhD, David Skoner, MD, Aspen Allergy Conference, July 2016
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