Pharmaceutical R&D Consultant & Drug Development Scientist

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
• Served as the pharmaceutical science member of COX-2 lifecycle team composed of members from Marketing, Regulatory, Clinical PK, Medical, Legal
• Chaired celecoxib reformulation team composed of members from above groups
• Developed proposal and obtained endorsement for multimillion dollar proof of concept studies leading to a program in late stage development
• Defined pharmaceutical science strategy for COX-2 programs and obtained endorsement from senior leaders in marketing, medical, regulatory and legal
• Provided guidance to pharmaceutical science COX-2 teams regarding above strategy
• Pioneered endorsed idea, which used an alternate formulation approach reducing cost ($8 M) and time (2 years), required to reach the market
• 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
• Served on global drug delivery group to define strategy for external collaborations based upon a careful review of the current portfolio
• Invited presenter at 5 national drug delivery conferences
• Fostered business relationships with 50 drug delivery companies including execution of 30 confidential disclosure agreements which led to 5 partnerships
• Designed, developed and maintained a global database of 300 drug delivery technology companies by directly contacting each company
• 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
• Serve as the single point of accountability and technical expert for projects from Preclinical to Phase III stages of development. Responsible for managing the timelines and resources including a multimillion dollar budget
• Led multi-disciplinary global teams composed of 8 – 12 colleagues in analytical, formulation, chemistry, regulatory, quality assurance and supply chain areas
• Led teams in the resolution of several manufacturing issues and developed guidelines to improve the manufacture practices
• 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
• Ensured intellectual property protection by interfacing with scientist and patent attorneys on a daily basis. Recognized expert in defining compound IP strategy
• 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

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