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Joseph Morott
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Joseph Morott

Unverified

PhD ·

About

Dr. Joseph T. Morott is a highly qualified pharmaceutical sciences expert with nearly two decades of specialized experience in drug formulation, development, and regulatory compliance. He holds a Ph.D. in Pharmaceutical Sciences with an emphasis in Pharmaceutics from the University of Mississippi School of Pharmacy, where he graduated with a 3.8 GPA and received the Honors Convocation Graduate Achievement Award in Pharmaceutics. His doctoral research focused on hot melt extrusion technology and drug release mechanisms in polymeric matrices, establishing a strong foundation for his subsequent career in pharmaceutical development.

Dr. Morott's professional experience spans the entire drug development lifecycle, from early-stage research through NDA and ANDA filings and commercialization. His expertise encompasses controlled release systems, osmotic pump technology (OROS), hot-melt extrusion, abuse-deterrent formulations, and DEA-regulated controlled substances. Throughout his career at leading pharmaceutical organizations including Mylan Pharmaceuticals, Catalent Pharma Solutions, Balchem Corporation, and Pegasus Laboratories, he has served as a subject matter expert, resolved complex formulation challenges, and contributed to regulatory remediation efforts including 483 and Warning Letter responses.

What distinguishes Dr. Morott as an expert witness candidate is his unique combination of deep technical knowledge and exceptional communication skills, refined through a decade in television broadcasting prior to his pharmaceutical career and further developed as a Hot-Melt Extrusion instructor. He has consistently demonstrated the ability to translate complex scientific concepts into clear, accessible information for diverse audiences, including non-technical stakeholders, customers, and industry professionals. His experience in customer relations, cross-functional collaboration, and technical presentation, combined with his authoritative knowledge of pharmaceutical manufacturing, regulatory compliance, and drug delivery systems, positions him to provide credible, comprehensible expert testimony in pharmaceutical litigation matters.

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Specialties

Customer Relations
Strategic Problem Resolution
Statistical Analysis
Process Optimization
Project Leadership
Drug Development Lifecycle
Controlled Release Systems
Controlled Substances (DEA)
Drug Delivery Systems (OROS, HME)
Formulation Science
Clinical Data Analysis
Scientific Presentation
Media Relations
Cross-Functional Collaboration
Technical Communication
Adult Learning/Education
NDA/ANDA Filings
483/Warning Letter Remediation
DEA Compliance
GMP/GLP
Documentation Practices
Controlled Substance Handling
Controlled Release Formulations
DEA Compliant Practices
Formulation Strategies
Scale-up Activities
OROS Technology
Hot-Melt Extrusion (HME)
Screw Configuration
Process Analytical Technology (PAT)
Immediate Release
Controlled/Sustained Release
Osmotic Pumps (OROS)
Tamper Resistant/Abuse Deterrent Formulations
Powder Blending
Pan Coating
Fluid Bed Processing
Wet & Dry Granulation
Tablet Compression
Encapsulation
DEA Regulations for Controlled Substances
Regulatory Documentation Practices
Regulatory
Project Managment
Tech. Transfer
Media
Veterinary Medicine
13
Years Experience

Work Experience

Senior Scientist
Pegasus Laboratories
20232025

Subject matter expert in controlled substance handling and controlled release formulations, implemented DEA compliant practices, designed internal professional development platform.

Senior Scientist
Catalent Pharma Solutions
20212023

Led formulation strategies from bench to commercialization for NDA and ANDA filings, acted as primary scientific liaison for customers.

Pharmaceutical Applications Development Scientist
Balchem Corporation
20192021

Provided technical support and scientific consultation to customers across global markets to resolve complex formulation and processing issues.

Formulation Scientist
Mylan Pharmaceuticals Inc.
20152019

Subject Matter Expert for OROS technology, resolved potential pre-launch product failure, contributed to 483/Warning Letter remediation and ANDA documentation.

Hot-Melt Extrusion Instructor
Hands-On Tablet Technology Course
20132015

Designed and implemented interactive lab section on Hot-Melt Extrusion for industry professionals, educated attendees on HME applications and principles.

Education

Ph.D. in Pharmaceutical Sciences in Pharmaceutics
University of Mississippi School of Pharmacy
20102015

GPA 3.8, Dissertation on hot melt extrusion technology, Recipient of Honors Convocation Graduate Achievement Award in Pharmaceutics.

Bachelor's Degree (B.S.) in Professional Chemistry
Belmont University
20082010

Credentials & Licenses

Ph.D. in Pharmaceutical Sciences

University of Mississippi School of Pharmacy

Bachelor's Degree (B.S.) in Professional Chemistry

Belmont University

Publications

Investigation of the combined effect of MgO and PEG on the release profile of mefenamic acid prepared via hot-melt extrusion techniques
Pharmaceutical development and technology·2017
Development of taste masked caffeine citrate formulations utilizing hot melt extrusion technology and in vitro–in vivo evaluations
Pharm Dev Technol.·2016
A novel floating controlled release drug delivery system prepared by hot-melt extrusion
European Journal of Pharmaceutics and Biopharmaceutics·2016
Mefenamic acid taste-masked oral disintegrating tablets with enhanced solubility via molecular interaction produced by hot melt extrusion technology
J Drug Deliv Sci Technol .·2015
Stability enhanced hot-melt extruded amorphous solid dispersions via combinations of Soluplus® and HPMCAS-HF
AAPS Pharm Sci Tech·2015
Development of an antifungal denture adhesive film for oral candidiasis utilizing hot melt extrusion technology.
Expert Opinion on Drug Delivery·2015
The Effects of Screw Configuration and Polymeric Carriers on Hot-Melt Extruded Taste-Masked Formulations Incorporated into Orally Disintegrating Tablets
Journal of Pharmaceutical Sciences·2014
mPEG-b-PCL/TPGS mixed micelles for delivery of resveratrol in overcoming resistant breast cancer
Expert Opinion on Drug Delivery·2014
Influence of process and formulation parameters on dissolution and stability characteristics of Kollidon® VA 64 hot-melt extrudates.
AAPS PharmSciTech·2014
Evaluation of the recrystallization kinetics of hot-melt extruded polymeric solid dispersions using an improved Avrami equation
Drug Development and Industrial Pharmacy·2014
Formulation optimization of hot-melt extruded abuse deterrent pellet dosage form utilizing design of experiments
Journal of Pharmacy and Pharmacology·2013
Melt extrusion: process to product
Expert Opinion on Drug Delivery·2012