GLENN A. MEYER, B.Pharm., Ph.D.

Address: **** ********* ****

Wilmington, NC 28403

Phone: Home: 910-***-****

Cellular: 910-***-****

OBJECTIVE:

My objective is to contribute to a pharmaceutical company, university or a

consulting firm; whether in a consulting capacity, contract research,

manufacturing based or clinically focused, to advance product development

and commercial success using a history of research based pharmaceutical

skills ranging from formulation and manufacturing to clinical protocol

design, from IP to regulatory science, to materially grow the business in

which I am working.

CURRICULUM VITAE:

PROFESSIONAL WORK HISTORY:

March 2012 to Present

Live Oak Pharmaceuticals Inc, Wilmington, NC

Company founded for consulting services in the development of ideas

and products to achieve innovative solutions for unmet medical needs

in the field of pharmaceutical products. Experienced in product

design, design of experiments, scale up, manufacturing, 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.

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. Accomplishments include development and

launch of multiple ANDA's, alternative antidepressant therapy, novel

once a day therapy in Parkinson's disease for levodopa induced

dyskinesias, and therapy for spasticity in MS (FDA SPA Agreement

reached). Responsible for new product and patent identification,

finalization of product selection, IP, regulatory strategy, product

design/optimization and clinical development for both generic and NDA

programs.

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, and strategic direction for the joint venture, Osmotica

Europe. Successfully transitioned the company to have successful NDA

and ANDA filings resulting in a profitable going concern focused on

specialty generics and unmet medical needs in neurology.

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.

Key accomplishments include achieving both a broadening of the

technology capabilities of aaiResearch (4 new technologies in-licensed

in 2Q2001) as well as initiating Phase 3 trials on a new pain therapy

product.

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. Played key

role in collaboration resulting in significant technology advancement

and major licensing contract with a marketing partner.

Aug. 1997 to Jun. 1999 Director, Formulation Development Division

Responsible for staff of 30 professionals, including five Manager's,

and 25 bachelor's, master's and Ph.D's. 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

Managed professional staff of six people and budget responsibilities

in excess of $3.7 million. Extensive expertise in the formulation,

scale up and writing of CMC sections associated with NDA filings.

Mar. 1991 to May 1993 Senior Research Pharmacist, Liquid

Products Development

Initiated feasibility studies and development efforts for softgel,

enteral and parenteral dosage forms. Project leadership

responsibilities for multiple internal projects and technical

expertise on selected parenteral and softgel projects. Coordinated

full scale re-validation of multiple softgel products.

May 1990 to Mar. 1991 Research Pharmacist, Drug Delivery

Conducted feasibility work associated with inhalation and oral peptide

delivery.

Aug. 1989 to May 1990 Research Pharmacist, Solids Product

Development

Developed formulations for clinical study and evaluated reformulation

in support of existing products. Initiated taste-making research and

investigations in characterization of the interconversion and solid

state properties of drug polymorphs.

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, SOCIETIES AND ACHIEVEMENTS:

American Association of Pharmaceutical Scientists (AAPS) - 1986 to

present

Movement Disorder Society - 2006 to present

American Academy of Neurology - 2008 to present

American College of Clinical Pharmacology - 2010 to present

List of Patents, Publications/Abstracts, Presentations:

Patents and Patent Applications:

Triple Combination Release Multi-layered Tablet, US Application Serial #

60/754,972, filed 12/29/05

Extended Release Solid Pharmaceutical Composition Containing Carbidopa and

Levodopa, US Application Serial # 60/705,839, filed 08/05/05

Osmotica 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 Application Serial # 60/533,577, filed 12/29/03

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 A. 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.

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