PROFESSIONAL WORK HISTORY
March 2012 to Present
Industry Consultant, Wilmington, NC
Company founded for development services in the creation of products to achieve innovative solutions for unmet medical needs. Technical experience includes product design, design of experiments, scale up, manufacturing, specification setting, validation, IND, ANDA and NDA regulatory writing, PK study design and analysis, clinical protocol development and endpoint selection, data analysis, product differentiation, market analysis and product launch. Raised $22 million for two complex clinical endpoint generic topical products and both products were successful and are in FDA review awaiting approval. Consulting to assist in developing the best product profile to meet the target market using the above skill sets is the primary focus at Live Oak Pharma.
December 2001 to February 2012
Osmotica Pharmaceutical Corp., Wilmington, NC
Oct. 2004 to Feb. 2012 Chief Scientific Officer
Responsible for all R&D operations of Osmotica Holdings Corp. and its subsidiaries and affiliates as well as global laboratory services (internal and outsourced functions from 6 different GMP locations). Critical functions include medical affairs, clinical development, preclinical development, bioanalytical and biostatistics, formulations research, analytical research/stability, and the intellectual property departments. R&D focus utilizing Osmotica’s proprietary osmotic tablet platform for delivery of pharmaceuticals and applications to the neuroscience field.
Personnel: 56 professionals/scientists/technicians in Argentina and 11 professionals in the USA
Dec. 2001 to Oct. 2004 COO and Director (Founder of US Operations)
Responsible for North America operations for Osmotica Holding Inc. and serving on the Board of Directors for Osmotica USA Corporation. The sole officer for Osmotica USA with an office staff responsible for business development, finance, regulatory affairs and quality assurance as a pharmaceutical company specializing in osmotic tablet technology platforms
and particular emphasis in neuroscience applications. Additional responsibilities include the overall R&D direction of the Holding company including R&D in Buenos Aries, Argentina.
March 1995 to December 2001
aaiPharma Inc., Wilmington, NC
Jan. 2001 to Dec. 2001 Senior Director, R&D Operations, aaiResearch, Division of aaiPharma, Inc.
Responsible for all research and development activities within aaiResearch. Groups include Formulations, GMP Analytical Research, Physical Chemistry and Project Management. Key participant in the negotiation, creation and serving on two Joint Venture Management Committees (Tanabe-Seikyu and Osmotica) with responsibility for product selection, development and partnering/licensing activities.
Jan. 1999 to Jan. 2001 Senior Director, Product Life Cycle Management, R&D
Responsible for R&D efforts involved with product life cycle management initiatives. Responsibilities ranged from project selection, definition, technology matching, and product attribute evaluations to project direction and interdisciplinary project management until partner has approval for the new product.
Aug. 1997 to Jun. 1999 Director, Formulation Development Division
Responsible for staff of 30 professionals. Technical responsibilities ranged from initial formulation identification to scale-up and transfer into a production environment. Dosage forms include tablets, capsules, controlled release, sachets, sublingual, intravenous, IM, SC, lyophilized powders, oral liquids, suspensions, and topical creams, lotions and ointments. Molecules range from small conventional chemical entities to oligopeptides, oligonucleotides, polypeptides and polymer systems with an emphasis on fast timelines.
Mar. 1995 to Aug. 1997 Senior Manager, Formulation Development Division
Responsible for a staff of nine professionals with functional responsibilities covering all Scale-up and Biotechnology projects. Responsible for implementation of a statistically based experimental design focus for all FDA registration level work in both solid oral dosage and parenteral products.
Aug. 1989 to Mar. 1995
Abbott Laboratories, Pharmaceutical Products Division, North Chicago, IL
Feb. 1994 to Mar. 1995 Project Manager, Product Development
Managed professional staff of nine people and budget responsibilities in excess of $4.4 million. Provided technical expertise on parenteral, and all Abbott enteral and softgel projects. Participated in pre-approval inspection activities for an NDA product and wrote multiple CMC sections for parenteral, enteral and softgel dosage form INDs. Managed all production support activities for Abbott softgel products and directly managed full scale validation and launch activities for a major cardiovascular product.
Mar. 1993 to Feb. 1994 Group Leader, Liquid Products Development
Mar. 1991 to May 1993 Senior Research Pharmacist, Liquid Products Development
May 1990 to Mar. 1991 Research Pharmacist, Drug Delivery
Aug. 1989 to May 1990 Research Pharmacist, Solids Product Development
EDUCATIONAL BACKGROUND:
Ph.D. Pharmaceutical Sciences 1989
University of Connecticut Storrs, CT
Thesis Title: Characterization of the Synthesis and Hydrolysis of a Polymeric Based Indomethacin Prodrug
B.S. B. S. in Pharmacy 1984
Albany College of Pharmacy Albany, NY
ASSOCIATIONS:
American Association of Pharmaceutical Scientists (AAPS) – 1986 to present
LIST OF PATENTS, PUBLICATIONS/ABSTRACTS, PRESENTATIONS:
Patents and Patent Applications:
Controlled Release Dosage Form, US Patent #10,471,031 Issued 11/12/2019. Controlled Release Dosage Form, US Patent #10,300,032 Issued 5/28/2019. Controlled Release Dosage Form, US Patent #10,213,404, Issued 2/26/2019. Controlled Release Dosage Form, US Patent #10,213,403, Issued 2/26/2019. Controlled Release Dosage Form, US Patent #10,213,402, Issued 2/26/2019.
Composition and Method for Treating Neurological Disease, US Patent #10,213,394, Issued 2/26/2019.
Composition and Method for Treating Neurological Disease, US Patent #10,213,393, Issued 2/26/2019.
Controlled Release Dosage Form with Enhanced Pharmacokinetics, US Patent #10,172,800, Issued 1/8/2019.
Triple Combination Release Multi-layered Tablet, US Patent #9,833,412, Issued 12/5/2017. Controlled Release Dosage Form, US Patent #9,801,841, Issued 10/31/2017.
Controlled Release Dosage Form, US Patent #9,655,858, Issued 5/23/2017. Controlled Release Dosage Form, US Patent #9,585,843, Issued 3/7/2017. Controlled Release Dosage Form, US Patent #9,579,289, Issued 2/28/2017.
Triple Combination Release Multi-layered Tablet, U.S. Patent #8,685,451 Issued 4/1/2014.
Extended Release Solid Pharmaceutical Composition Containing Carbidopa and Levodopa, US Application Serial # 60/705,839, filed 08/05/05
Osmotic Device Containing Amantadine and An Osmotic salt, US Patent Number 8,252,331 Issued 11/5/13
Osmotic Device Containing Amantadine and An Osmotic salt, US Patent Number 8,252,331 Issued 8/28/12
Osmotica Device Containing a Venlafaxine Salt and a Salt Having an Ion in common, US Patent # 8,293,799 Issued 10/23/2012.
Combination Treatment for Impaired Motor function in Dementia, US Application Serial 60/452- 055, filed 03/05/03
Combination Treatment for Impaired Motor Function in Parkinson’s disease, US Application Serial # 60/452,077, filed 03/05/03
Oral Liquid Compositions, U.S. Patent 6,365,180, Issued April 2, 2002. Pharmaceutical Formulation, U.S. Patent 6,316,020 Issued November 13, 2001 Pharmaceutical Unit Dosage Form, U.S. Patent 6,312,723, Issued November 6, 2001 Method for Improving Bioavailability, U.S. Patent 6,312,712, Issued November 6, 2001 Oral Liquid Compositions, U.S. Patent 6,287,594, Issued September 11, 2001 Pharmaceutical Formulation, U.S. Patent 6,245,352, Issued June 12, 2001
Prolamine Coatings for Taste-Masking, U.S. Patent 5,609,909, Issued 3/11/97
Prolamine Coatings for Taste-Masking Orally-Administrable Medicaments, U.S. Patent 5,599,556, issued 2/4/97
Self-Emulsifying Formulations of Lipophilic Drugs, Application filed 5/9/95, File D-18875.
New Terazosin Polymorph and Pharmaceutical Composition, U.S. Patent 5,294,615, Issued 3/15/94.
System for Delivering an Active Substance for Sustained Release, U.S. Patent 5,160,742, issued 11/3/92.
Publications/Abstracts:
CSF and Plasma PK Parameters of R-baclofen: Arbaclofen vs. the Racemic Mixture, Meyer, G, Boyd, D. and Fischbein, G. Presented at the America Academy of Clinical Pharmacology, September, 2011, Chicago, IL.
Plasma and CSF Levels of Arbaclofen are Not Associated with Drowsiness, Meyer, G, Boyd, D.
and Fischbein, G. Presented at the America Academy of Clinical Pharmacology, September, 2011, Chicago, IL.
Single-dose Plasma PK Parameters of Arbaclofen, R-baclofen, and S-baclofen, Meyer, G, Boyd, D. and Fischbein, G. Presented at the America Academy of Clinical Pharmacology, September, 2011, Chicago, IL.
Analysis of Vacuum – and Beam-sensitive Pharmaceutical Compounds in the Electron Microscope, Neilly, J.P., Zaluzec, N.J., Meyer, G.A. Miller, M.F., (In): Proceedings of the 52nd Annual Meeting of the Microscopy Society of America, G.W. Bailey and A.J. Garrett-Reed, eds., San Francisco, San Francisco Press, 1994 pp. 666-667.
Characterization of Hydroxypropylcellulose-Indomethacin Grafts as a Function of Molecular Weight, G.A. Meyer, R.T. Lostritto, J.F. Johnson, J. App. Polymer Sci., 42, 2247-2253, (1991).
Development of a Novel Moisture Uptake Device, Presented at the AAPS Midwest Regional Meeting, May 6, 1990, Chicago, IL.
Characterization of the Synthesis and Hydrolysis of a Polymeric Indomethacin Prodrug, Glenn
- Meyer, Thesis from University of Connecticut, Copyright 1989.
Mathematical Modeling of the Hydrolysis of a Model Polymeric Prodrug, Pharm. Research, 6(9), S-144 (1989), Presented at AAPS National Meeting, November 1989, Atlanta, GA.
A Method of Self Calibration of Molecular Weight Distribution Determinations for Liquid Crystalline Polymers, G.A. Meyer, J.F. Johnson, H.H. Chin, L.V. Azaroff, J. Liq.
Chromatography, 11(8), 1595-1603 (1988).
Characterization of the Synthesis and Hydrolysis of a Polymeric Indomethacin Prodrug, Pharm. Research, 5(9), (1988), Presented at AAPS National Meeting, November 1988, Orlando, FL.
Characterization of a Polymeric Indomethacin Prodrug, Pharm. Research, 4(9), (1987), Presented at AAPS National Meeting, November 1987 Boston, MA.
Presentations:
Assessing the issues of pivotal clinical trials and the “fit” for conducting the trial in international clinical centers, Presented at Outsourcing Clinical Trials – Southeast, May 16, 2012 Durham, NC
Accelerated Development of a Small Molecule with a Biotech Company, Presented at POMA Annual Meeting, February 15, 2001 Orlando, FL.
Perspectives on Product Life cycle Management in the New Millennium, Invited speaker at South Africa’s Academy of Pharmaceutical Sciences 21st Annual Meeting, Grahamstown, South Africa, September 10-13, 2000
Perspectives on the Contract Research Organization Role in the New Millennium, Invited speaker at South Africa’s Academy of Pharmaceutical Sciences 21st Annual Meeting, Grahamstown, South Africa, September 10-13, 2000
Accelerated Small Molecule Development with a Biotech Company for Effective Outsourcing, Presented at Bio/Pharmaceutical Outsourcing Conference (sponsored by CBI) March 22-24, 2000, Philadelphia, PA
Product Life Cycle Management for the Pharmaceutical Industry, Presented at DIA 12th Annual Euromeeting, March 8-10 2000, Nice, France
Accelerated Development of a Small Molecule with a Biotech Company, Presented at PDA West Coast Regional Meeting, December 8, 1999, San Francisco, CA.
Successes and Lessons Learned About Contracting Small Molecule R&D at a Biotech Company: Biogen & AAI, Inc.; Presented at DIA 2nd Annual Workshop on Niche Service Providers and Virtual Drug and Device Development Companies, January 25-26, 1999, Philadelphia, PA.
Optimization of a Fluidized Bed Process to Increase Drug Load and Blend Density for an Encapsulation Process, Presented at AAPS Annual Meeting, November 1998, San Francisco, CA.
Impact of Multiple Eutectic Temperatures on Physical and Chemical Parameters for Acyclovir Sodium Lyophilized Powder for Constitution; Presented at NSF Industry/University Cooperative Research Center for Pharmaceutical Processing Seminar on Freeze Drying of Pharmaceuticals and Biologicals, September 23-26, 1998, Brownsville, VT.
Use of Experimental Design to Demonstrate the Influence of Particle Size for a Wet Granulation Formulation of Acyclovir Tablets, Presented at AAPS Eastern Regional Meeting, June 6, 1997, New Brunswick, NJ.
Product Development: The Rush to Phase I and Value Maximization AAI Continuing Education Seminar Series; Invited Speaker entitled “The Race to Phase I and a Final Formula”, October 20-21, 1997, Burlingame, CA.
Rational Approaches to Pharmaceutical Scale Up: Design and Implementation; Invited Speaker entitled: “Encapsulation Processes” and “How to use PAI Preparation as a Guide for Conducting Scale up: A Product Development Perspective”, March 25-26, 1996, Morristown, NJ.