---
title: 027
description: A consultant with The FDA Group.
---

[The FDA Group's Consultant Finder ](https://www.thefdagroup.com/find-consultants)

# [027](https://www.thefdagroup.com/find-consultants/027)

 Written by [The FDA Group](https://www.thefdagroup.com/find-consultants/author/the-fda-group) | Jul 12, 2022 5:21:17 AM

**CAREER HIGHLIGHTS**

- Consultant to the pharmaceutical industry on drug development from discovery to post-launch, including life-cycle planning, intellectual property, project management, compound licensing, technology due diligence, quality audits and expert witness testimony.
- Utilized Quality by Design principles to develop novel conventional and controlled-release solid dose for tablet and capsule drug delivery systems using solubility and bioavailability enhancement techniques such as hot-melt solid dispersions, supercritical fluids and lipids
- Managed the COX-2 franchise for Pfizer
- Adapted technology from the food, plastics and other industries for use in the pharmaceutical industry to solve issues related to polymer mixing including the scale-up of a hot-melt extruded solid dispersion formulation for a launched product, troglitazone
- Directed Drug Delivery Assessment group to enable compound development and product enhancement for early and late stage compounds
- Written and reviewed numerous IND’s, NDA’s and ANDA’s for international pharmaceutical companies including those based in India
- Authored numerous Good Manufacturing Practice/Good Laboratory Practice guidelines (GMP/GLP) and standard operating procedures (SOP)
- Conducted numerous quality CMC audits at CROs/CMOs and Pharmaceutical Companies including simulated FDA Pre-Approval Inspections and GxP audits
- Reviewed and advised pharmaceutical companies regarding FDA 483 Warning Letters
- Worked with more than 60 pharmaceutical companies as a consultant to solve problems
- Defined procedures and led compound licensing activities for pharmaceutical science in Michigan and served on global licensing team. Responsible for the due diligence activities for 8 licensing opportunities, which led to 3 Phase III licensing deals
- Taught graduate level courses in Pharmacokinetics and Pharmaceutics covering topics such as formulation development of solutions, tablets, emulsions, and topicals including release profiles
- Chaired local Pharmaceutical Science Technology Board and was an inaugural member
- Led Scientific Teams on ophthalmology and dermatology projects
- Provide expert opinion including deposition and testimony in patent matters relating to formulations and drug delivery technology
- Acted as Intellectual Property Liaison for scientists, management and patent attorneys
- Defined site and global IP strategy and procedures while serving on the global Intellectual Property Board composed of 3 senior scientists and 3 patent attorneys
- Supervised 6 and trained 9 scientists, 5 at Ph.D. level, in unit processes including milling, hot-melt extrusion, fluid- bed granulation, blending, tableting and coating
- Managed several scientists responsible for analytical support and technology development

 

EXPERIENCE

- **Industry Consultant** 2008-Present

South University – School of Pharmacy

- **Assistant Professor** 2008-2015

| Pfizr |   |  |
| --- | --- | --- |
|  | **Associate Research Fellow** | 2004-2008 |
|  | **Senior Principle Scientist** | 2001-2004 |
|  | **Senior Scientist** | 2000-2001 |
|  | **Scientist** | 1998-2000 |

 

Registered Pharmacist, Pharmacist in Charge 1987-1994

EDUCATION AND PROFESSIONAL DEVELOPMENT

**Doctor of Philosophy in Pharmaceutical Science, **Medical University of South Carolina, Charleston Bachelor of Science in Pharmacy, Medical University of South Carolina, Charleston

Bachelor of Science in Biology, University of South Carolina, Spartanburg

Level II and III Management Training, University of Michigan, Executive Education Center Kepner-Tregoe Certification in Problem Solving and Decision Making

ACHIEVEMENTS AND AWARDS

Member of Rho Chi Honor Society and American Association of Pharmaceutical Sciences Fellow of the American Foundation for Pharmaceutical Education (AFPE)  
Chair, AAPS Year-round Task Force on Novel Drug Delivery Technology

[View full post](https://www.thefdagroup.com/find-consultants/027)

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