Expert in Pharmaceutical Manufacturing, Research and Development, Education & Training
Expert's career in industrial pharmacy includes solid oral form manufacturing at a major prescription drug manufacturer where he improved already marketed products and developed new drug products for basic new drug entities through pilot production scale-up and routine followup trouble-shooting of production problems thereafter.
Expert began his career in pharmaceutical manufacturing as a manufacturing pharmacist upon enrollment in graduate studies in industrial pharmacy at a major university college of pharmacy. He supervised compounding and manufacturing of a variety of non-prescription (OTC) oral liquid and solid dosage forms, as well as liquid and semi-solid topical preparations (creams, lotions and ointments), and nasal solutions (drops and sprays) in accordance with FDA procedures. Additional functions included filling and packaging, labeling, inventory control, and distribution to institutional outlets such as University Health Services.
His industrial and systems engineering background have proved particularly valuable during his career in pharmaceutical manufacturing. As president of a generic drug manufacturing firm, he developed the business plan, secured finances for, designed plant layout, equipped, furnished, initiated start-up of and managed the pharmaceutical manufacturing plant. He managed procurement marketing to local, state and federal government clients, and supervised pharmaceutical manufacturing operations. He also designed and advised principals on pharmaceutical manufacturing feasibility studies domestically and internationally, including FDA regulatory requirements and procedures.
For more than 16 years, Expert has designed and developed various solid and liquid oral dosage forms from concept to pharmaceutical pilot production scale-up and followup trouble-shooting of production problems. His R&D experience includes stability testing of bulk active drug ingredients, experimental mixtures for preparation of intermediates, containers and closures under various environmental conditions of temperature, humidity, light, and vibration. He is experienced in the selection, sourcing, purchasing and evaluation of raw materials – binders, granulating agents, colorants (food grade dyes and lakes), lubricants, solvents, disintegrating agents, glidants, etc. – as well as equipment and apparatus for dissolution, disintegration, friability and hardness testing; comminuting, screening, mixing and blending powders and granulates; production of conventional, chewable and specialized tablets, capsules, and oral and topical liquids and semi-solids; counting, filling, packaging and labeling for major brands and generic drug manufacturing.
Expert’s experience in pharmaceutical research and development included research administration as Technical Assistant to the Vice President for Medicinal Products Research and Development, Secretary of the Corporate Medical Research Committee, Project Leader of Pharmaceutical Research, and Senior Research Scientist. In addition to his scientific research performed, he devised the corporation’s first systems manual for coordinating world-wide pharmaceutical research projects and programs and supervised the clinical formulation unit. He prepared or supervised preparation of new drug IND formulation and labeling submissions. He also designed new research and development facilities for consolidation of previously geographically separate domestic pharmaceutical product R&D operations at a multi-national drug manufacturer. As Project Leader and Senior Research Scientist, he stream-lined procedures for a broad variety of conventional and controlled release oral and topical liquid and solid dosage forms, from new drug physical pharmacy characterization testing and compatibility screening through dosage form design and development, product stability testing, disintegration and dissolution testing, friability testing, specialized testing as required, container and closure evaluation and selection, through pilot production scale-up and trouble-shooting in manufacturing of new and established pharmaceutical products.
The Expert patented a controlled release delivery system tablets and capsules at Pfizer, one of the world’s largest pharmaceutical manufacturers. Before industry, he studied the effects of variables on the release properties of controlled release particles as the subject of his doctoral dissertation and subsequently designed, researched and developed his invention in the pharmaceutical industry. With this invention, Expert salvaged an entire existing product line of an unstable cardiac medication, extended its commercial shelf-life, and achieved predictable drug release patterns for these products. His controlled release technology has been used in various sustained release formulations for new medical entities and for existing product improvements. Expert's controlled release technology utilizes a balance of hydrophilic/hydrophobic matrices prepared by direct compression, and is modifiable for use with wet or Expert granulation techniques, to accommodate differing compressibility and release properties of active drugs and excipients.
As the pharmaceutical expert on a World Bank consulting team, he advised the Ministry of Health and evaluated the Ethiopia's plans for upgrading and expanding its national pharmaceutical supply logistics program components, including its own in-country manufacturing facilities, R&D and Quality Control facilities, manufacturing plant expansion, procurement, quality control, importation, demand forecasting, and country-wide distribution of pharmaceuticals.As leader of medical and pharmaceutical supply logistics management team, he reviewed the Government of Jamaica's pharmaceutical procurement, warehousing, distribution and cold chain and supervised other team pharmacists in their conduct of component analyses and compilation of associated components of final report to the U.S. Agency for International Development; and provided recommendations for improvements in all aspects of the USAID-funded pharmaceutical management project. He also collaborated with the College of Arts, Science and Technology on formulation research on oral re-hydration salt products.On assignment with the U.S. Department of State, he made recommendations to Jordanian pharmacists at the Jordanian Pharmaceutical Association on the rationale and procedure for incorporating clinical training of pharmacists in their professional curriculum in Jordan.He evaluated client proposals and established a checklist for use in preparing grant proposals to the U.S. Centers for Disease Control and Prevention Community Based Care Transitions Program aimed at preventing the re-hospitalization of patients, using medication therapy management methodology and adherence, compliance and persistence systems by a pharmaceutical consulting firm specializing in the management of diabetes and co-morbid conditions.
Expert may consult nationally and internationally, and is also local to the following cities: Tampa, Florida - Saint Petersburg, Florida - Orlando, Florida - Clearwater, Florida - Cape Coral, Florida - Palm Bay, Florida - Lakeland, Florida - Melbourne, Florida - Deltona, Florida - Largo, Florida
|Year: 1966||Degree: Ph.D.||Subject: Industrial Pharmacy||Institution: University of Florida, College of Pharmacy|
|Year: 1961||Degree: B.S.Pharm.||Subject: Pharmacy||Institution: Florida A&M University, College of Pharmacy|
|Year: 1977||Degree: Certificate in International Business||Subject: International Business||Institution: Howard University Business Development Center|
|Years: 1973 to Present||Employer: Undisclosed||Title: Pharmaceutical Health Care Consultant||Department:||Responsibilities: For several decades, he has been a consultant in pharmaceutical and medical supply logistics management, with special interest in pharmaceutical manufacturing development, ensuring essential drug supply and promoting rational drug therapy in medically under served communities and developing countries. He has advised ministries of health and private enterprises on pharmaceutical supply, feasibility studies, manufacturing operations, plant layout and design, and education, and training of pharmacists and other health workers. He has consulted for private enterprises, agencies and organizations including the U.S. Agency for International Development, the U.S. Department of State, the World Bank, the FDA, the American Public Health Association, and colleges of pharmacy. He has participated in program/project evaluations and development in Africa, the Caribbean and the Mid-East. His pharmaceutical training and resource materials were used in some 70 developing countries through USAID funding.|
|Years: 1988 to 1998||Employer: Merck & Co., Merck-Medco Managed Care||Title: Managed Care Pharmacist; Pharmacist Lead; Training Coordinator; Pharmacist Newsletter Editor||Department: (Now Medco Health Systems)||Responsibilities: He tele-consulted with physicians nationwide on inappropriate drug selection and drug dosing for patients in special populations; counseled patients on adverse drug effects, proper and safe drug use; conducted drug utilization reviews; initiating brand-to-generic and brand-to-brand therapeutic interchanges per clinical protocols; and evaluating and dispensing prescriptions. (*He Retired as a Merck & Co. employee; Merck-Medco is now separate as Medco Health Solutions)|
|Years: 1978 to 1988||Employer: Universal Pharmaceuticals, Inc.||Title: President; Owner/Manager||Department: Pharmaceutical and Medical Supplies||Responsibilities: He designed, established and managed a generic pharmaceutical manufacturing operation, with solid dosage formulation R&D laboratories, manufacturing facilities and analytical laboratories, along with separate drug and medical supply wholesale distribution and retail divisions.|
|Years: 1973 to 1978||Employer: Howard University||Title: Dean and Professor of Pharmaceutics||Department: College of Pharmacy||Responsibilities: He was chief academic administrative officer for the College, with fiscal, staff development and management responsibility; and student affairs, curriculum, teaching, research and service supervision and oversight responsibility. He established the first undergraduate pharmaceutical research programs in the College. He developed and supervised student training programs in the pharmaceutical industry, agencies in the National Institutes of Health, some 15 hospitals and some 30 community pharmacies in the Washington, DC/Baltimore metropolitan areas. He was elected first secretary-treasurer of the Council of Deans of the American Association of Colleges of Pharmacy (AACP) and served as regional chairman of the Joint AACP/National Association of Boards of Pharmacy district. He participated in the major national pharmacy professional organizations, representing the College.|
|Years: 1969 to 1972||Employer: Florida A&M University||Title: Dean and Professor of Pharmacy||Department: College of Pharmacy||Responsibilities: He was chief academic administrative officer for the College, with fiscal, staff development and management responsibility; and student affairs, curriculum, teaching, research and service supervision and oversight responsibility. He established the first undergraduate pharmaceutical research programs in the College. He developed and supervised student training programs in hospitals and numerous community pharmacies throughout the State of Florida, establishing a satellite office in Miami. He was a member of the initial Executive Committee for the Program in Medical Sciences involving FAMU, Florida State University and the University of Florida College of Medicine. He served as regional chairman of the Joint AACP/National Association of Boards of Pharmacy district. He participated in national professional organizations, representing the College, and supervised the final redesign, construction and dedication of a new ultramodern facility for instruction, research and administration for the College of Pharmacy, including research and manufacturing labs.|
|Years: 1966 to 1969||Employer: Pfizer, Inc.||Title: Project Leader of Pharma R&D; Senior Research Scientist; Technical Asst to VP for Research||Department: Pharmaceutical Research and Development, Medicinal Products Research and Development Division||Responsibilities: He served as secretary of the corporate worldwide Medical Research Committee and developed plans for and designed new Pharmaceutical Product R&D Laboratories to enable consolidation of all Pharmaceutical R&D functions with the Clinical, Chemical, Biological and Pathology research operations in Groton, CT, transferring Rx product R&D from the Brooklyn, NY, main production area. He also devised the first corporate systems manual for worldwide R&D for basic new agents reaching Phase III development. He also supervised clinical supply production, inventory and distribution, as well as established the first physical pharmacy laboratory in the Pharmaceutical Product R&D Department. His first year's R&D culminated in a patented sustained-release technology for pharmaceutical tablets and capsules utilizing hydrophilic and hydrophobic matrices. As a research scientist, he conducted formulation research primarily on oral solid dosage forms through stability studies and pilot plant production scale-up in manufacturing. He served as a trouble-shooter in oral solids pharmaceutical product manufacturing.|
|Years: 1963 to 1966||Employer: University of Florida, College of Pharmacy||Title: Staff Pharmacist, Manufacturing Pharmacist/Pre-Doctoral Student||Department: Department of Pharmacy and University Health Service||Responsibilities: As a doctoral student in industrial pharmacy and staff pharmacist employee at the University Health Service, he supervised pharmaceutical pilot plant, conducted formulation research, designed and developed, manufactured and supervised the labeling and packaging of oral tablets, oral liquids, nasal solutions, ointments and creams in accordance with FDA guidelines, for distribution in the University Health Service. He also was a part-time dispensing pharmacist in UHS where he performed registered pharmacist duties, including supervising pharmacy interns. His doctoral research specialization was sustained-release pharmaceutical delivery systems technology.|
|Years: 1961 to 2006||Employer: Various Community Pharmacies||Title: Registered Pharmacist||Department: Alabama, DC, Florida, Maryland and New York||Responsibilities: He performed routine prescription analysis, filling and dispensing of prescriptions, drug utilization review, therapeutic substitution, inventory control and management, and counselling patients on proper use and handling of prescription and non-prescription medication and natural products.|
|Years||Country / Region||Summary|
|Years: to Present||Country / Region: Ethiopia; Jamaica, BWI; Jordan; Kenya||Summary: He has technology transfer and project evaluation experience in the Caribbean, East Africa and the Middle East on USAID, the World Bank and the U.S. Department of State projects.|
|Associations / Societies|
|He is a long-standing member of the American Pharmacists Association; was a Charter member of the American Association of Pharmaceutical Scientists; was elected Honorary Member of the Florida Society of Hospital Pharmacists (in perpetuity)|
|Licenses / Certifications|
|From 1961 - present, he is a Registered Pharmacist in Florida; from 1962 - present, he is a Registered Pharmacist in Alabama.
|He was appointed and served as the editor-in-chief of the Pharmacists Newsletter at Merck-Medco for three years until he retired from the company. He also served as president or executive director of the National Pharmaceutical Foundation for 17 years; as secretary-treasurer of the Council of Deans of the American Association of Colleges of Pharmacy; and as a delegate to the American Pharmaceutical Association.|
|Awards / Recognition|
|He was one of 10 national finalists for a Robert Wood Johnson Health Fellowship, sponsored by the National Academy of Sciences Institute of Medicine. He is listed in Who's Who in America, Who's Who in the World, American Men and Women of Science, Outstanding Young Men of America and other biographical references and has been invited to appear in others. He has received numerous honors and recognitions from organizations and his alma mater, Florida A&M University.|
|Publications and Patents Summary|
|He has more than 30 publications, one patent, a recent book on prescription drugs, and one book in process on contemporary issues in the pharmaceutical industry and federal regulatory agencies affecting consumer safety, affordability and access to prescription medication in the U.S.|
|Expert Witness Experience|
|He has no direct experience serving as an expert witness. However, he has prepared toxicology reports for legal counsel for use in drug-injury-related litigation.|
|Training / Seminars|
|He has substantial experience in developing and supervising the development and implementation of courses and curricula, training experiences and seminars for pharmacy students and pharmacists during and after his university assignments as dean and professor at two colleges of pharmacy. He has also developed training materials for health care personnel for the U.S. Agency for International Development who distributed same to some 70 developing countries. Many of these materials were developed in conjunction with the American Public Health Association and the U.S. Department of State during short-term international health consultancies.|
|He has long-term experience in locating vendors/suppliers in every professional position since becoming a registered pharmacist in 1962. In dosage formulation research and manufacturing in the pharmaceutical industry (Pfizer and Universal Pharmaceuticals), as well as in consulting activities, he has had to locate vendors for pharmaceutical raw materials/excipients, furniture, apparatus and equipment for laboratory testing, comminuting, mixing, blending, granulation, drying, tableting, encapsulation, filling, emulsifying, manufacturing, testing, counting, labeling, containers and closures, packaging, materials handling, warehousing, etc., as needed for specific products, operations and applications, including administrative and office equipment and furniture. This also applies to his practice in community pharmacy and his domestic and international health consultancies in pharmaceutical and medical supply logistics management.|
|German||He has limited conversational speaking ability in German but can read and write German with moderate proficiency.|
|Spanish||He has limited proficiency in speaking, reading and writing Spanish but can speak, read and write with good proficiency basic instructions for taking oral medicines in Spanish.|