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`Ph.D. Pharmaceutical Science,
`M.S. Pharmaceutical Science,
`B.S. Pharmacy,
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`Rutgers University, 1979
`Rutgers University, 1973
`Rutgers University, 1969
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`CURRICULUM VITAE
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`Glenn A. Van Buskirk, Ph.D.
`174 Wexford Way
` (908) 766-0937
`Basking Ridge, NJ 07920
`glennvb@optonline.net
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`Education:
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`Professional Experience:
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`Nonclinical Drug Development Consulting Services, LLC
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`Established this independent consultancy to provide expertise in product development, scale-up and
`launch, and SUPAC guidance to the pharmaceutical industry. Specializing in formulation development,
`analysis and international registration of oral solid and CR dosage forms, semisolid and topical drug
`products, small volume parenterals and transdermal systems. Consultancy services includes analysis
`and correction of underlying organizational, communication, project management, strategic planning,
`and portfolio gaps for preclinical technical issues.
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`Purdue Pharma LP, Ardsley, NY
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`Vice President, Nonclinical Drug Development & Technology (2004-2005)
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`Provided technical and managerial leadership to the 125 person US, 59 person UK (Napp
`Pharmaceuticals Ltd.) and the 20 person German organizations (Mundipharma GmbH) involved in
`Worldwide R&D product development. Line management of Analytical Sciences, Drug Metabolism &
`Pharmacokinetics, Nonclinical Drug Safety & Evaluation, Pharmaceutics, and, Scientific & Technical
`Writing. Held dotted line reporting relationships with site infrastructure functions including Engineering,
`HR and Research Systems (IT). These groups had overall responsibility for all technical components of
`Phase 0 to Phase IV nonclinical sections of INDs, NDAs and for collaboration with foreign affiliates on
`international submissions. The annual worldwide capital and expense budgets for Nonclinical Drug
`Development were $5 -10 million and $85 -100 million, respectively. Member of the International R&D
`Executive Team that set and oversaw project goals through review and approval of strategic and tactical
`development plans.
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`Vice President, Nonclinical Drug Development (1998-2004)
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`Provided technical and managerial leadership to the US, UK and German organizations involved in
`Worldwide product development. Responsibilities included Analytical Sciences, Discovery Interface,
`Nonclinical Operations, Pharmaceutics, and, Scientific & Technical Writing. These groups had
`responsibility for C,M&C components of nonclinical sections of INDs, NDAs and for collaboration with
`foreign affiliates on international submissions.
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`2005 – Present
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`1998 – 2005
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`1995 – 1998
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`Novartis Pharmaceuticals Corp., East Hanover, NJ
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`Vice President, External Technology Development and Liaisons (1997-1998)
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`Served as liaison between Novartis and its Technical Research & Development (TRD) academic and
`business partners. Coordinated the scientific exchange and optimized the business and professional
`relationships with external contractors. Interfaced with the Business Development and Licensing
`department for technology evaluations in the conduct of due diligence evaluations of biotech and
`conventional products. Maintained contacts with universities and innovative technology companies to
`capture evolving techniques applicable to product development needs. Operated globally to manage the
`budget of external technology collaborations and made key go/no go decisions on projects and budgets.
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`Vice President, Pharmaceutical & Analytical Development (1995-1997)
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`Directed the US development of pharmaceutical products in the combined pipeline (~100 projects)
`resulting from the merger of the former Ciba and Sandoz Pharmaceutical companies. Integrated the US
`activities with sites in Europe and Japan to assure global congruence. Provided scientific leadership to
`the Analytical Development, Clinical Manufacturing, Pharmaceutical Development and Process
`Development departments. Managed the integration of the combined 189 person US organization.
`Created a 15% cost savings within the combined organization. Led the global integration team and
`established the worldwide model, goals, objectives and key performance indicators to assure success of
`the global integration process across France, Germany, Japan, Switzerland, UK, and the US. Areas of
`dosage form specialization included immediate release, extended release, transdermal, parenteral and
`inhalation products. The organization supported seven major therapeutic areas (cardiovascular, central
`nervous system, dermatology, inflammation/bone, pulmonary, oncology and transplantation). Managed
`a combined expense and capital budget in excess of $50 million.
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`The R. W. Johnson Pharmaceutical Research Institute (RWJPRI) ,
`A Division of Ortho-McNeil Pharmaceutical Corp. Raritan, NJ
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`Senior Director, Pharmaceutical Development -Worldwide (1989-1995)
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`Directed and coordinated the preformulation, formulation, preclinical manufacturing and clinical supply
`functions of the Ortho-McNeil Pharmaceutical and Cilag AG organizations at their Raritan, NJ, Spring
`House, PA and Schaffhausen, Switzerland locations. Managed a division of 90+ persons at three sites
`with combined capital and expense budgets in excess of $30 million. Provided managerial and scientific
`direction to 45 development projects across a large product line including immediate and extended
`release solid dosage forms, transdermal systems, topicals (creams and suppositories), parenterals,
`diagnostic products and biotechnology derived products (proteins and growth factors). Directed the
`preclinical technical writing staff responsible for the preparation of the Chemistry, Manufacturing and
`Control sections of INDs and NDAs.
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`Served as the company's first "Development Champion" for a novel oncology product, LEUSTATIN® and
`drove the product to successful filing and approval within three years. This established the model for
`subsequent Development Champions. Also served as Development Champion for the company's first
`pulmonary product and as a mentor to several other Development Champions.
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`1976 – 1995
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`Director, Technical Development (1986-1989)
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`Managed the staff, projects and budgets of the Animal Services, Chemical Development, Drug
`Metabolism, Molecular Spectroscopy and Protein Products Development departments. Coordinated
`project planning for Pre-Clinical Development including Analytical & Pharmaceutical Development,
`Chemical Development, Drug Metabolism, Drug Safety Evaluation, and, Molecular Spectroscopy.
`Served as "Team Leader" to a complex project requiring filing of an NDA and a device submission for
`LUTREPULSE® (gonadorelin acetate for pulsatile administration). Received J&J Achievement Awards
`for this effort and for efforts leading to the successful filing and approval of EPREX® (erythropoietin) in
`the US and Europe.
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`Director of Formulations (1985-1986)
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`Assistant Director, Pharmaceutical Development (1984-1985)
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`Section Head, Formulations (1982-1984)
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`Group Leader, Formulations (1980-1982)
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`Provided technical and administrative leadership to the scientific staff responsible for new product
`development, including solid, semisolid, liquid and parenteral dosage forms. Had hands-on
`responsibility of diverse projects and project team leadership of the company's first peptide drug
`(Thymopentin) that was successfully registered in Europe. Also had responsibility for formation of the
`company's parenteral dosage form group and its involvement in the development of the world's first
`therapeutic monoclonal antibody, ORTHOCLONE OKT3®.
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`Group Leader, Process Development (1979-1980)
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`Senior Scientist, Process Development (1977-1979)
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`Scientist, Process Development (1976-1977)
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`Conducted Phase III-IV product scale-up, plant introduction, process validation, product and process
`improvement and trouble-shooting for Ortho Pharmaceutical Corp. Had "hands-on" responsibility for
`new product development and introductions including: ORTHO-NOVUM 1/35®, IMODIUM® Capsules,
`SUPROL®, and IMODIUM® Liquid. Was also responsible for the major reformulation of the entire oral
`contraceptive product line (ORTHO NOVUM 1/80®, ORTHO NOVUM 1/50®, MODICON®) to allow for
`"enclosed manufacture" in new equipment thereby reducing potential employee exposure.
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`Ciba-Geigy Corporation, Summit, NJ
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`Scientist, Dosage Form Design Group
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`Developed oral, solid dosage forms including basic research, manufacturing technology, process
`optimization, manufacture of clinical materials, product scale-up, plant introduction, and stability
`assessment of dosage forms. Formulated, scaled-up and launched TEGRETOL Chewable, a pediatric
`dosage form of Ciba’s top selling anti-epileptic drug.
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`1970 – 1976
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`Professional Activities:
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`American Association of Pharmaceutical Scientists
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`• Fellows Selection Committee, 2008 - 2010
`• Regulatory Affairs Section Fellows Committee, 2006 - 2007
`• PT Section Chair Elect, 1989
`• PT Section Chair, 1990
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`Added two successful focus groups: Sterile Products and Microwave Drying
`• Co-Chair of AAPS Workshop on Scale-up of Oral, Solid Dosage Forms, 1991
`• Co-Chair of Workshop on Scale-up of Extended Release Dosage Forms, 1992
`• Served on Task Force on Fellows Selection Criteria, 1992
`• Member-at-Large, 1993-1995
`• Co-Chair of Workshop on Scale-up of Liquid and Semisolid Disperse Systems, 1993
`• Co-Chair of Workshop on Scale-Up of Adhesive Transdermal Drug Delivery Systems, 1996
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`American Pharmaceutical Association
`Controlled Release Society
`Eastern Regional Industrial Pharmaceutical Technology Section
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`Planning Committee, 1978-1981
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`General Chairman, 1982
`Industry Liaison Committee, UMAB/FDA Collaboration, 1995-1996
`International Pharmaceutical Excipient Council
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`Co-Chair, Excipient Information Source Committee, 1993-1995
`Land O Lakes Pharmaceutical Conference
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`Co-Chair, 1982 Conference
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`Co-Chair, 1983 Conference
`NIPTE, Awards Selection Committee, 2011-2012
`PhRMA, Pharmaceutical Development Committee, 1992-1995
`PQRI Steering Committee, 2008 – present
`Rutgers College of Pharmacy Advisory Board, 2004 - present
`USP Council of Experts – Nominating Committee, 2009-2010
`USP Council of Experts
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`Small Molecules 1 (Antibiotics, Antiinfectives, Antimicrobials) - 2010-2015
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`Expert Committee – Microbiological Assay Modernization (2012-present)
`USP Executive Committee – Governance, 2011-2015
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`Patents:
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`U.S. Patent 4,299,501
`Continuous Process for the Preparation of Semisolid Dispersions
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`EPC 02714794 / US0202461
`Local Anesthetic, and Method of Use
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`EPC 2258347 10010924.8 - 1216
`Tamper Resistant Products for Opioid Delivery
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`Publications & Presentations:
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`See attached files
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`New Product Registrations:
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`Ciba-Geigy Corp. (1970-76)
`TEGRETOL® Chewable*
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`RWJPRI:
`IMODIUM® Capsules*
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`IMODIUM® Liquid
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`SUPROFEN® Capsules*
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`Thymopentin Injection (Italy)*
`ORTHO NOVUM 1/35®*
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`ORTHOCLONE OKT3®
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`TERAZOL® 7 Vaginal Cream*
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`TERAZOL® 3 Vaginal Suppositories
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`PROTOSTAT®
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`ERYCETTE® Topical Solution
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`PERSA-GEL W®
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`LUTREPULSE® Injection*
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`EPREX®/PROCRIT® Injection*
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`TRI CYCLEN®
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`ORTHO CEPT®
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`SYSTEN® Transdermal Patch
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`LEUSTATIN® Injection*
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`RENOVA®
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`TOPAMAX® Tablets
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`Novartis (Ciba/Sandoz) 1995 - 1998
`TEGRETOL XR®
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`DIOVAN® Capsules
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`FORADIL® Capsules for Inhalation
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`VIVELLE® Transdermal Systems
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`FEMARA® Tablets
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`SANDOSTATIN LAR® Injection
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`MIGRANAL® Nasal Spray
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`CO-DIOVAN® Tablets
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`Purdue Pharma, L.P.
`OxyContin® 160 mg Tablets
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`Palladone Capsules*
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`Norspan® Transdermal System (NDA submitted)
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`SENOKOT Reformulation & Reintroduction
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` * ) Indicates projects with significant personal responsibility)
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`Awards and Honors:
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`Received four J&J Achievement Awards in recognition of extraordinary accomplishments in the
`following:
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`• Design of the Ortho Pharmaceutical Pilot Plant
`• Leadership of the LUTREPULSE® Project Team
`• Leadership of the EPREX® C,M&C Team
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`Improved formulation (personnel safety) of oral contraceptive product line
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`American Association of Pharmaceutical Scientists
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`Elected AAPS Fellow, 2005
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`Elected AAiPS Fellow, 2005
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`Awarded Special Presidential Citation for SUPAC Guidance Documents, 1998
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