1988-Present Jeiven Pharmaceutical Consulting Inc., Scotch
Plains, NJ President
Consulting firm specializing in clinical trial materials and
marketed products management for domestic and international pharmaceutical
and biotechnology companies of all sizes. The firm focuses its efforts
in the following areas:
GMP, GLP, and GCP Compliance Audits
Monitoring Contractor Operations
Monitoring Clinical Trials
Product Development Coordination
Packaging and Labeling Design
SOP Preparation
CMC Document Preparation
Drug Master File (DMF) Preparation
Facility Design
Equipment Validation
Stability Protocol Design
Shipping Validation
Pre-Approval Inspection (PAI) Support
1995-Present Pharmaceutical Training Seminars, Inc., Scotch
Plains, NJ President
School provides both in-house and off-site training programs
in the following areas:
GMPs, GLPs, and GCPs
Clinical Supplies: The Basics and Beyond
Advanced Topics in CTM
Patient and Site Compliance in Clinical Trials
Controlled Drug Substances Management
Train-The-Trainer
Technician Training
Project Management
1982-1988 R.W. Johnson Pharmaceutical Research Institute
1987-1988 Ortho Pharmaceutical Corporation, Raritan, NJ
Manager, Pharmaceutical Development
Responsible for the establishment and implementation of the
clinical study compliance monitoring program using state-of-the-art
microelectronics. Position involved clinical site presentations and
audits, assessment of compliance parameters, and recommendations
to improve compliance.
1982-1987 Manager, Clinical/Pre-Clinical Materials
Responsible for the Clinical Trial Materials and Pre-Clinical
(Toxicology) Formulations groups within Pharmaceutical Development.
Coordinated new drug studies, authored Standard Operating Procedures,
and provided long-term resource planning for material, personnel,
and facilities. Designed a clinical manufacturing and packaging facility
that complied with cGMPs. Supervised a staff of 22 with 1987 budget
responsibilities of $1.8 million.
1974-1982 Ciba-Geigy Pharmaceutical Corporation, Summit, NJ
Research Pharmacist
Responsible for the design of solid dosage forms, including:
preliminary formulations, stability protocols, clinical and toxicology
drug requirements, scale-up, and the Chemistry, Manufacturing and
Control sections of INDs and NDAs.
1968-1970 Sydenham Hospital, New York, NY
Assistant Chief Pharmacist
Responsible for all phases of the daily operation of the in-patient
and out-patient pharmacies, including narcotic inventory, professional
supervision and in-house training programs for the nursing staff.
EDUCATION
MS, Physiology (with honors), Rutgers University, 1971
BS and BPharmacy, Rutgers University, 1967
Medical studies, Catholic University of Louvain, Belgium, 1971-1974
LICENSES
Registered Pharmacist in New Jersey and New York
ACHIEVEMENTS (1984) Founder - Investigational Materials Discussion Group
(IMDG) - an organization of representatives from twenty pharmaceutical
companies that has met regularly since 1984 to share information
on common concerns related to clinical manufacturing, packaging and
labeling.
(1995) Founder - Clinical Supplies Support Group (CSSG) - an
organization that shares the same vision as IMDG.
Faculty member - The Center for Professional Advancement,
East Brunswick, New Jersey teaching “Preparation and Packaging of
Clinical Supplies” (since 1986), “The New Drug Company:
From Inception to Product Approval” (since 1991), “Patient
and Clinical Site Compliance” (since 1992), and “Contracting
Pharmaceutical Operations” (since 1994).
Advisory Board Member - The Institute for Applied Pharmaceutical
Sciences, A Division of the Center for Professional Advancement,
since 1990.
Conducted workshops, coordinated seminars, and presented
on such topics as clinical site compliance, Phase I clinical studies,
drug supply for international clinical trials, clinical project management,
compliant labeling and packaging, contract manufacturing and packaging,
and electronic compliance monitoring in clinical trials.
PROFESSIONAL ASSOCIATIONS
American Association of Pharmaceutical Scientists (AAPS)
Drug Information Association (DIA)
Clinical Supplies Support Group (CSSG)
International Society of Pharmaceutical Engineering (ISPE)
PRESENTATIONS
May, 2000 Healthcare Compliance Packaging Council National
Symposium on Patient Compliance, Philadelphia, Pennsylvania Topic:
Compliance Packaging: Promise and Performance “Keys
to Validation Success”
February, 2000 International Society of Pharmaceutical Engineering,
Somerset, New Jersey Topic: Clinical Trial Materials (CTM): The Basics and Beyond
October, 1999 WorldPHARM99, Philadelphia, Pennsylvania Topic:
Understanding Technical Specifications and Release Criteria for Unit-
Dose Packaging Components Topic: Temperature Control and Monitoring for Clinical Trials
Material
April, 199I Institute for International Research, Arlington,
Virginia Topic: Techniques for Improving Pediatric and Geriatric Patient
CompliancePRESENTATIONS (continued)
May, 1998 Institute for International Research, Princeton,
New Jersey Topic: Techniques for Improving Pediatric and Geriatric Patient
Compliance
April, 1998 Healthcare Compliance Packaging Council, Philadelphia,
Pennsylvania Topic: Compliance Packaging and Clinical Trials
April, 1998 Institute for International Research, Washington,
D.C. Topic: Training a Clinical Supplies Team - Why Training Has
Become Top
Priority Topic: Successfully Auditing Your Clinical Supplies
July, 1997 Institute for International Research, Washington,
D.C. Topic: Training a Clinical Supplies Team - Why Training Has
Become a Central
Issue
August, 1996 Center for Professional Advancement, New Brunswick,
New Jersey Topic: Contracting Pharmaceutical Operations
June, 1995 Institute for International Research, Philadelphia,
Pennsylvania Topic: Contract Packaging and Labeling and Pre-Approval Inspections
September, 1994 Pharm Tech Conference, Atlantic City, New Jersey Topic: The Role of GMPs in the Manufacturing and Packaging of Clinical
Supplies
June, 1995 Pharm Tech Conference, San Juan, Puerto Rico Topic: The Role of GMPs in the Manufacturing and Packaging of Clinical
Supplies
March, 1993 Non-Prescription Drug Manufacturers Association,
Washington, D.C. Topic: The Manufacturing and Packaging of Clinical Supplies
June, 1994 Eastern Regional Meeting/AAPS, New Brunswick, New
Jersey Topic: Manufacturing and Packaging of Clinical Supplies According
to cGMPs
October, 1993 Drug Information Association Workshop: Investigational Clinical Trials Material Strategies for the ‘90s,
Rockville, Maryland Topic: Site Compliance and the Pivotal Role of the Clinical
Supplies Coordinator
May, 1993 Applied Clinical Trials Symposium, Reston, Virginia Topic: Compliant Packaging and Labeling for Clinical Trials
November, 1992 Nonprescription Drug Manufacturers Association,
Washington, D.C. Topic: Research and Scientific Development
November, 1991 Applied Analytical Industries, Inc. Clinical Investigational Materials: Design Coordination,
Production and Control, Atlantic City, New Jersey Topic: Clinical Supplies Coordination - The Elements for Success
April, 1991 National Council on Patient Education and Information,
Washington, DC Topic: A Novel Approach to Oral Contraceptive Compliance Monitoring
in the Inner-City Adolescent Population
February, 1991 Applied Analytical Industries, Inc. Clinical Supplies Production and Control Seminar, Wilmington,
North Carolina Topic: Compliant Packaging and Labeling for Clinical Trials
May, 1990 Food and Drug Administration, Drug Chemistry, Manufacturing
and Controls Seminar Rockville, Maryland Topic: Compliant Labeling and Packaging for Clinical Trials
October, 1989 American Association of Pharmaceutical Scientists,
Annual Meeting Atlanta, Georgia Topic: Electronic Compliance Monitoring in Oral Contraceptive
Clinical Studies
April, 1989 Associates of Clinical Pharmacology, Spring Scientific
Meeting New Orleans, Louisiana Topic: Packaging and Labeling Clinical Investigation Materials to Improve Site
Compliance
December, 1988 Associates of Clinical Pharmacology, Fall
Scientific Meeting Vail, Colorado Topic: International Clinical Trials
December, 1987 Associates of Clinical Pharmacology, Fall
Scientific Meeting Vail, Colorado Topic: Clinical Site Monitoring and Drug Accountability
Strategic Outsourcing: To Retain or Not to Retain (Critical
Skill Sets)? That is the Question for Many Pharma Firms, BIO/PHARMACEUTICAL
Outsourcing Report (February, 2000)
GCP Compliance Notebook: Third Party Blinding and Clinical
Trials, Clinical Trials Advisor Vol. 4, No. 18 (October, 1999)
Patient and Clinical Site Compliance: Preparing User-Friendly
Clinical Trial Materials, Clinical Research and Regulatory Affairs,
11(1), 67-69 (1994)
A Novel Approach to Oral Contraceptive Compliance Monitoring
in the Inner-City Adolescent Population, National Council on Patient
Information and Education, Washington, DC, Biannual Meeting (1989)
Electronic compliance monitoring in oral contraceptive clinical
studies. Program and Symposia Abstracts, 4th Annual Meeting of the
American Association Pharmacological Scientists, Atlanta, GA (1989)
