Pharmaceutical New Products, Formulations, Life-Cycle & Pharma Industry Expert

Expertise

Summary 

• Pharmaceutical industry focus of new product development through life-cycle management, supplying over 30 years of industry experience in; efficient development, scale-up, transfer, problem solving, and commercial manufacture of pharmaceutical products.
• Formulation Scientist and Manager with emphasis in: CMC documentation, technology transfer, drug delivery, and process analytical technology.
• Appling technical expertise to problems, providing successful solutions, increasing the efficiency of development activities for formulation and process development.

Specific Areas

• Formulation research and development.
• Manufacturing process research and development.
• Technology and site transfers.
• Preformulation.
• Clinical supply formulation and manufacture.
• Due diligence-acquisition and divestment.
• Documentation, report writing/management.
• IND, CTX, NDA, MAA documentation.
• Formulation and manufacturing problem solving.
• Foreign Trade Zone management for research and Development.
• Process analytical technology.
• cGMP, Quality by Design, ICH Q8 and Q9, risk assessment.
• SOP management.
• Validation/continued process verification.
• Product knowledge management.
• Identification of IP opportunities.

Experience

CPC, President, Present

• Providing services to the pharmaceutical industry in the areas of due diligence, preformulation, clinical supply formulation and manufacture, commercial product formulation, manufacture, documentation, and analytical methods.

AstraZeneca Pharmaceuticals LP, Wilmington, DE

• On-Market Technical Manager, 2016 - 2019
• Manager-Drug Delivery, Outsourcing & Technology/U.S. Technology Manager, 2006 - 2016
• Manager, PAT/Physical Sciences, 2004 - 2006
• Manager, Formulation Group , 2000 - 2004
• Senior Formulation Research Pharmacist/Formulation Research Pharmacist, 1989 - 2000

• Supported in-licensing, out-licensing, divestment due diligence.
• Lead, assessed impact, and supported complex technical improvements or change activities assuring product performance and robustness including CPV assessments.
• Manage product knowledge for products throughout lifecycle.
• Provided support of regulatory filings including IND, CTX, NDA, MAA, license renewals, manufacturing changes.
• Provided support for marketed products, products in development and manufacturing sites.
• Provided input to company research and technology program.
• Prepared and reviewed reports for various products.
• Gave guidance to Quality Assurance for deviations.
• Managed several products for On-Market technical support (6).
• Managed Safety and GMP training in Product Development.
• Represent company with various consortia and forward information to the appropriate groups.
• Gave input for new technologies and practices for formulations, manufacturing processes, development processes.

Key Accomplishments

• Formulated SEROQUEL IR tablets.
• Formulated CRESTOR tablets.
• Prepared and reviewed CMC documents for IND, CTX, NDA, MAA filings.
• Managed development team for CRESTOR tablet development.
• Managed manufacturing team for SEROQUEL IR and CRESTOR clinical supplies including comparator blinding.
• Supported over 30 Due Diligence opportunities including reports.
• Supported SEROQUEL IR technology transfers (4) and CRESTOR (1).
• Developed database to track clinical trial materials for Product Development including product, formulation changes, clinical study numbers, and drug substance lot.
• Developed SOP database that resulted in no SOPs being out of date for over 25 months (facility closed at end of 25-month period) and facilitated a reduction of unneeded SOPs by 5%.
• Developed SOP assignment and approval procedure for increasing quality of SOPs and decreased revision time.
• Managed FTZ and worked with outside counsel on setting up FTZ, wrote training documents, and setup spreadsheet to manage inventory resulting in a savings of $750K per annum.
• Provided expertise to Abbott Labs for development of CERTRIAD (rosuvastatin/choline fenofibrate.
• Organized information gathering requests for AAPS meetings for colleagues that could not attend and assigned requests to those attending. Organized information in a wiki for all to access in company.
• Lead team charged to increase efficiency and effectiveness of documentation practices (not fully implemented as facility closed before project complete).
• Supported Innovation Team in finding new patent opportunities in Product Development.
• Supported projects exploring the use of PAT using a team approach with members from Analytical Development.
• Co-authored procedure for reducing total effort needed for risk assessments from preparation to final report by at least 25%.
• Used innovative methods to assess effects of short periods of high temperature and humidity on stored products with less testing.

A.H. Robins Company, Richmond, VA, Senior Research Pharmacist, 1986 - 1989

• Responsible for the formulation and initial stability batch manufacturing for tablets, capsules, and liquids for clinical supplies and market image (ethical and consumer products).
• Provide technical assistance for clinical manufacturing.

Key Accomplishments

• Formulated DIMACOL tablets (formerly a capsule formulation).
• Organized the procurement, training, and maintenance of thermal analysis equipment.
• Product Development representative to A.H. Robins Research and Development Division Safety Committee.

Honors & Publications

Credentials

• Pharmacist Immunizer (APhA certification)

License

• Pharmacy (North Carolina, Virginia, Delaware, Pennsylvania)

Academic and Professional Affiliations

United States Pharmacopeia

•  Excipients Monograph 1 Expert Committee
•  Excipients Monograph 2 Expert Committee
•  Excipients Nomenclature Joint Subcommittee
•  Excipient Performance Expert    Committee
•  Excipients Science Strategy Joint Subcommittee
•  Element Specific Chapters Joint Subcommittee

American Association of Pharmaceutical Scientists

• Annual meeting abstract reviewer
• Nominations Committee
• Dale E. Wurster Research Award in Pharmaceutics Selection Committee
• Webinar Programming Screening Committee

International Consortium for Innovation & Quality in Pharmaceutical Development (IQ Consortium)

•  Drug Product Leadership Group
•  GMPs in Early Development Working Group
•  PAT/RTR Working Group
•  Pediatric Working Group
•  Pediatric Risk Assessment Sub Team

International Society of Pharmaceutical Engineers

• Reviewer for various ISPE published materials

Product Quality Research Institute

• Technical Group for Risk Management

Philadelphia Pharmaceutical Forum

• Program Committee

Awards

•  AstraZeneca PAR&D Innovation Award

Publications and Patents

• Author and Co-Author of scientific papers and peer reviewed articles
• U.S. and international patents

Education

• Ph.D. Pharmacy (Pharmaceutics), University of Iowa, Iowa City, IA
• M.S. Pharmacy (Radiopharmaceutics), The University of North Carolina at Chapel Hill, NC
• B.S. Pharmacy, The University of North Carolina at Chapel Hill, NC