Home: (336) 299-7583
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`ERIC J. BENJAMIN, Ph.D.
`3211 Morris Farm Drive
`Jamestown, NC 27282
` e-mail: ebenjamin1@yahoo.com Cell: (336) 404-8457
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`PROFESSIONAL EXPERIENCE
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` 2003 - 2011
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`TRANSTECH PHARMA, High Point, NC
` (2006-2011)
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`Vice President, Pharmaceutical Development
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`Sr. Director, Pharmaceutical Development
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` (2004-2006)
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` (2003-2004)
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`Director, Pharmaceutical Development
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`Responsible for all CMC activities related to the drug substance and drug product that are being conducted
`in-house and at contract organizations (CROs). This includes discovery support, manufacture and testing of
`drug substance, pre-formulation and formulation studies for the development of the formulation and
`manufacturing process for the drug product, the development of analytical methods and testing of drug
`product, preparation and packaging of clinical trial material and preparation of the CMC section for the
`Regulatory submissions. The department consisted of six personnel including 3 Ph.D. level.
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`• Completed CMC development for 15 new compounds including a fusion protein.
`• Filed 15 INDs/CTAs/IMPD.
`• Dosage forms included hard gel capsules, tablets, soft gel capsules, parenteral solutions and lyophilized
`powders, ophthalmic and delivery systems, such as, solid dispersions, liposomes and nanosystems.
`• Set up in-house capabilities to perform pre-formulation, analytical development and formulation and
`manufacturing process development capabilities.
`• Successfully formulated insoluble or poorly soluble drugs to improve bioavailability.
`• Filed 6 USA patent applications.
`• Actively participated in technical presentations and due diligence for licensing (in and out) of projects.
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` 1996 - 2003
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`WYETH RESEARCH, Pearl River, NY
` (1999-2003)
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` Associate Director, Solids Formulation Development
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` (1996 - 1999)
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`Section Head, Solids Formulations Development
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`Responsible for the development of formulations and processes of oral solid conventional and sustained-
`release dosage forms of new chemical entities. The section consists of thirteen personnel including seven
`Ph.D. Group Leaders/Scientists.
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`• Represented Pharmaceutical Sciences in the Global Development project teams and served as team leader
`for five projects to coordinate the CMC activities.
`• Filed INDs
`• Successfully formulated insoluble or poorly soluble drugs to improve bioavailability.
`• Developed sustained-release and pulsatile delivery products using matrix, extrusion/spheronization, spray
`coating and compression coating technologies.
`• Led the development of an oral solid delivery system for a protein.
`• Filed 9 USA patents applications.
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`SCHEIN PHARMACEUTICAL INC., Danbury, CT
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`Director, Pharmaceutical R&D
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`Responsible for the Product Development, Analytical R&D, Process/Product Improvement and Technical
`Services sections. The department was responsible for the selection and characterization of the drug
`substances, development of the formulations and manufacturing processes of oral solids conventional and
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`1991 - 1996
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`Par Pharm., Inc.
`Exhibit 1003
`Page 001
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`sustained-release generic products. The department consisted of forty personnel including seven Ph.D.
`Group Leaders/Scientists.
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`• Hired 24 qualified personnel.
`• Filed 15 ANDAs.
`Initiated preformulation and process optimization studies.
`•
`• Set up analytical lab procedures and guidelines for method validation and data evaluation.
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`SOLA/BARNES-HIND, Pharmaceutical R&D, Sunnyvale, CA
` Director, Pharmaceutical R&D
` Directed formulation development, clinical packaging, process development and packaging development of
`ophthalmic dosage forms and contact lens care products. The department consisted of thirteen personnel
`including four Ph.D. scientists.
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`1988 - 1990
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`1986 - 1988
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` Set up technology for the processing of fluid bed coating of particles.
`• Served as team leader for six multidisciplinary project teams.
`• Solved stability, formulation or processing problems with six products under development.
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`ADRIA LABORATORIES, Columbus, OH
` Director of Pharmaceutical Sciences
` Directed formulation development, analytical development, pilot lab., clinical packaging and stability
`sections. The department was responsible for the development of parenteral, oral conventional and
`sustained-release solids, topical and transdermal dosage forms of ethical and generic products.
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` Built a motivated and qualified staff of 38 personnel.
`• Set up technology for the development of multiparticulate sustained-release products as coated pellets in
`capsules or compressed into tablets.
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`1978 - 1986
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`SYNTEX RESEARCH, Institute of Pharmaceutical Sciences, Palo Alto, CA
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` Research Section Leader, Pharmaceutical Development
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`(1984 - 1986)
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`The section consisted of three Ph.D. scientists and six B.S./M.S. chemists who were responsible for the
`development of parenteral, nasal and ophthalmic dosage forms of drugs including peptides.
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` Group Leader, Pharmaceutical Development
`(1982 - 1984)
` Responsible for the development of orally and parenterally administered liquid and solid dosage forms.
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` Served as team leader for two projects in advanced development stage.
`Improved stability and solubility of drugs.
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`• Characterized and enhanced intranasal absorption of peptides and small molecules.
`• Conducted basic research to understand and improve the oral absorption of poorly absorbed drugs.
`• Lyophilization of drugs using aqueous and organic solutions.
`• Published 8 papers in scientific journals and obtained 5 USA patents.
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` (1978 - 1982)
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`Staff Researcher, Pharmaceutical Analysis
`The major responsibilities of the section consisted of development of stability specific analytical methods
`for new drug substances in various dosage forms, evaluation of the stability data to predict shelf life and
`storage conditions, and preparation of documents for registration (INDs/NDAs) purposes.
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`Initiated stability optimization studies and solved stability problems with three formulations.
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`Par Pharm., Inc.
`Exhibit 1003
`Page 002
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`• Developed automated HPLC methods for the on-line clean-up and analysis of drugs in creams and
`ointments.
`• Published 5 papers in scientific journals and obtained one patent.
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`PFIZER LABORATORIES, Karachi, Pakistan
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`Supervisor, Sterile Products Division
` Responsible for the manufacturing and trouble shooting of both liquid and solid sterile products.
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`1967 - 1971
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`EDUCATION
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`Ph.D. in Pharmaceutical Chemistry, University of Kansas, Lawrence, KS, 1978
`M.S. in Medicinal Chemistry, University of Oklahoma, Norman, OK, 1974
`B.S. in Pharmacy, Punjab University, Lahore, Pakistan, 1966
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`PATENTS AND PUBLICATIONS
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`• 15 Peer reviewed publications in scientific journals covering API synthesis, formulations, drug
`delivery and analytical methods.
`• 20 USA Patents for API, Formulations and drug delivery.
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`Par Pharm., Inc.
`Exhibit 1003
`Page 003
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`PUBLICATIONS AND PATENTS
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`Eric J. Benjamin, Ph.D.
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`PUBLICATIONS:
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`(1)
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`A. Magarian and E. J. Benjamin, “Synthesis of cyclopropyl analogs of stilbene and
`stilbenediol as possible antiestrogens.” J. Pharm. Sci., 64, 1626 (1975).
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`J. T. Pinto, R. A. Magarian, R. J. Wright, M. M. King and E. J. Benjamin, “Nonsteroidal
`estrogens and antiestrogens: Biological activity of cyclopropyl analogs of stilbene and
`stilbenediol.” J. Pharm. Sci., 70, 399 (1981).
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`E. Shek, J. Bragonje, E. J. Benjamin, M. J. Southerland and J. Gluck, “A stability indicating
`high-performance liquid chromatography method for the determination of triple corticoid
`integrated system in a cream formulation.” Int. J. Pharm., 11, 257 (1982).
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`E. J. Benjamin, J. Kroeten and E. Shek, “Characterization of spray patterns of inhalation
`aerosol using thin layer chromatography.” J. Pharm. Sci., 72, 380 (1983).
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`E. J. Benjamin and D. Conley, “On-line HPLC method for clean-up and analysis of
`hydrocortisone and sulconazole nitrate in a cream.” Int. J. Pharm., 13, 205 (1983).
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`E. J. Benjamin, M. Lee, J. Tom, L. Lin, M. Henesian and D. Wu, “Stabilization of
`sulconazole nitrate in a topical powder formulation.” Int. J. Pharm., 14, 209 (1983).
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`(7) D. L. Conley and E. J. Benjamin, “Automated high performance liquid chromatographic
`column switching technique for the on-line clean-up and analysis of drugs in topical cream
`formulation.” J. Chromatogr., 257, 377 (1983).
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`(2)
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`(9)
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`E. J. Benjamin and L. Lin, “ Preparation and in-vitro evaluation of salts of an
`antihypertensive agent for prolonged activity.” Drug Development and Industrial Pharmacy,
`11, 771 (1985).
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`E. J. Benjamin, B. A. Firestone and J. A. Schneider, “A dual-column HPLC method for the
`simultaneous determination of DHPG (9-[(1,3-dihydroxy-2-propoxy)methyl]guanine) and its
`mono and diesters in biological samples.” J. Chromatogr. Sci., 23, 168 (1985).
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`(10) G. C. Visor, E. Bajka and E. J. Benjamin, “Intranasal delivery of nicardipine in the rat.” J.
`Pharm. Sci., 75, 44 (1986).
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`J. Fleitman, D. Neu and E. J. Benjamin, “Analysis of pharmaceutical dosage forms for
`oxfendazole: II. Simultaneous liquid chromatographic determination of oxfendazole and
`trichlorfon in equine paste.” J. Assoc. off. Anal. Chem. 69, 24 (1986).
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`(11)
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`Par Pharm., Inc.
`Exhibit 1003
`Page 004
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`Eric J. Benjamin, Ph.D.
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`Page 2
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`(12) S. T. Anik, E. J. Benjamin, R. Maskiewicz, G. McRae, C. Nerenberg, J. Hwang-felger, J.
`Schneider, A. Wonden and J. LaFargue, “Nasal absorption of nafareline acetate in rhesus
`monkeys. II. Effect of formulation variables.” Submitted to J. Pharm. Sci.
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`(13) E. J. Benjamin, B. A. Firestone, B. Bergstrom, I. Massey, M. Fass and I. Tsina, “Selection of
`a derivative of antiviral agent DHPG with improved oral absorption.” Pharm. Res. 4, 120
`(1987).
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`(14) E. J. Benjamin, B. Firestone and J. Schneider, “Stabilization of dipropionate ester of DHPG
`against enzymatic hydrolysis using complexation.” Int. J. Pharm. 35, 73 (1987).
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`(15) G. C. Visor, L. Gue, L. Lin and E. J. Benjamin, “Solubilization and stabilization of an
`inotropic agent by complexation with water soluble vitamins and lyophilization from organic
`solvent.” J. Parenter. Sci. Technol. (1987).
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`PATENTS:
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`E. J. Benjamin, M. Lee and L. Lin, “Stabilization of 1-imidazole in talc.” USA Patent
`4,382,091, May 1983.
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`E. J. Benjamin and G. C. Visor, “Cardiotonic phosphodiesterase inhibitors complexed with
`water soluble vitamins.” USA Patent 4,837,239, June 1989.
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`B. Vickery and E. J. Benjamin, “Intranasal administration of polypeptides in powder form.”
`USA Patent 6,815,424, November 2004.
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`E. J. Benjamin, T. Lin and S. Anik, “Aqueous steroid formulations for nasal
`administration.” USA Patent 4,983,596, January 1991.
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`E. J. Benjamin, “Nasally administered calcium channel entry blockers.” USA Patent filed
`August 1985.
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`E. J. Benjamin, W. Dulin and J. Suryawanshi, “Pharmaceutical compositions of estrogenic
`agents.” USA Patent filed June 2001, Application 20080269198.
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`E. J. Benjamin and M. Rabah, “Stabilized pharmaceutical composition containing basic
`excipients.” USA Patent filed September 2003, Application 20040122048.
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`B. Joseph, M. Ashraf and E. J. Benjamin, “Orally bioavailable CCI-779 formulations.”
`USA Patent filed February 2006, Application 20080161336.
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`(1)
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`(2)
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`(5)
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`(6)
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`(7)
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`(8)
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`Par Pharm., Inc.
`Exhibit 1003
`Page 005
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`Eric J. Benjamin, Ph.D.
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`(9) N. Warne, E. J. Benjamin, A. Nagi and R. Chatlapalli, “Delayed release formulations for
`oral administration of a polypeptide therapeutic agent and methods of using same.” USA
`Patent filed September 2003, Application 20100062058.
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`Page 3
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`(10) E. Benjamin, R.B. Baudy and M. Brandt. “Pharmaceutical composition for intranasal
`administration of [2-(8,9-dioxo-2,6-diazabicyclo[5.2.0.]non-1(7)-en-2-yl)alkyl]phosphonic
`acid and derivatives and method of use thereof.” USA Patent filed January 2005,
`Application 20050004079.
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`(11) E.J. Benjamin, M. Ashraf and A. Jain, “Amorphous rapamycin 42-ester with 3-hydroxy-2-
`(hydroxymethyl)-2-methylpropionic acid and its pharmaceutical compositions.” USA Patent
`7,271,177 September 2007.
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`(12) E.J. Benjamin, M. Ashraf and A. Jain, “Amorphous rapamycin 42-ester with 3-hydroxy-2-
`(hydroxymethyl)-2-methylpropionic acid and its pharmaceutical compositions.” USA Patent
`7,446,111 November 2008.
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`(13) E.J. Benjamin, M. Ashraf, W. Cloud, “Oral administration of [2-(8,9-dioxo-2,6-
`diazabicyclo[5.2.0.]non-1(7)-en-2-yl)alkyl]phosphonic acid and its derivatives.” USA
`Patent filed October 2003, Application 20050142192.
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`(14) M. Ashraf and E.J. Benjamin, “Oral Formulation”. USA Patent filed September 2003,
` Application 20040077677.
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`(15) M. Ashraf and E.J. Benjamin, “Directly compressible pharmaceutical composition for the
`oral administration of CCI-779”. USA Patent filed January 2004, Application 20050152983.
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`(16) E.J. Benjamin, W. Dulin, “Sustained release pharmaceutical compositions”. USA patent
` filed October 2004, Application 20050095292.
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`(17) A. M. Majali, R. Rothlein, Y. Tien, J. Webster and E. J. Benjamin,”RAGE fusion proteins,
` formulations, and method of use thereof”. USA Patent filed May 2006, Application
`20080045455.
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`(18) E.J. Benjamin and G.R. Devi, “Crystalline forms of 3-biphenyl-4-yl-(2S)-[(4'-trifluoromethyl-
` biphenyl-4-carbonyl)-amino]- pro- pionic acid, and methods of use”. USA Patent filed August
` 2007, Application 20070185204.
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`(19) E.J. Benjamin, “Pharmaceutical composition, methods of preparation thereof, and methods of
` treatment”. USA Patent filed April 2007, Application 20070082952.
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`Par Pharm., Inc.
`Exhibit 1003
`Page 006
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`(20) E.J. Benjamin and T. Thorsteinn, “solid compositions comprising an oxadiazoanthracene
` compound and methods of making and using the same”. USA Patent filed September 2009.
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`(21) E.J. Benjamin, T. Thorsteinn and S. Rapuro, “Solid compositions comprising a glucokinase
` activator and methods of making the same”. USA Patent filed June 2010.
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`(22) E.J. Benjamin and D. Almariago, “Compositions and method for treating glaucoma by
` administration of 3-(5-Chloro-pyridin-2-yloxy)-N-(5-hydroxy-adamantan-2-yl)-benzamide”.
` USA Patent filed January 2011.
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`Par Pharm., Inc.
`Exhibit 1003
`Page 007