EDUCATION AND TRAINING
2018 Regulatory Affairs Professionals Society Board Re-Certification (RAC)
2016 Regulatory Affairs Professionals Society Board Re-Certification (RAC)
2014 Regulatory Affairs Professionals Society Board Re-Certification (RAC)
2012 Regulatory Affairs Professionals Society Board Re-Certification (RAC)
2010 Regulatory Affairs Professionals Society Board Re-Certification (RAC)
2006 Regulatory Affairs Professionals Society Board Re-Certification (RAC)
2002 Regulatory Affairs Professionals Society Board Re-Certification (RAC)
1998 Regulatory Affairs Professionals Society Board Certification (RAC)
1980 Ph.D., Medical Pharmacology and Toxicology
University of California, Irvine; California College of Medicine (now UCI School of Medicine)
1973 B.Sc., Biology with minor in Radiation Health Physics
University of Arkansas, Little Rock
RESEARCH EXPERIENCE
2005 - Present Chief Executive Officer
Triligent International, Irvine, California
Principal responsibilities include: Corporate administration; product development consulting (strategic planning, regulatory affairs, clinical trial design Phases I-IV); inspection readiness evaluation and training; due diligence audits (mergers and acquisitions); project management; and global GxP quality assurance auditing (clinical, vendor, data, pharmacovigilance, 21CFR Part 11, directed and for-cause).
International consultant on Good Clinical Practice and Excellence in Clinical Research including prospective programs, in-life and recovery programs for registration in the US, EU and Asia.
2002 - 2005 Chief Executive Officer
GPA International, Newport Beach, California
(Corporate Name Change)
Principal responsibilities include: Corporate administration; product development consulting (strategic planning, regulatory affairs, clinical trial design Phases I-IV); due diligence audits (mergers and acquisitions); project management; and global GxP quality assurance auditing (clinical, vendor, data, 21CFR Part 11, for-cause).
Therapeutic expertise: Neurology, cardiovascular, infectious disease, dermatology, endocrinology, gastroenterology, HIV/AIDS, immunology, nephrology, oncology, orthopedics, pediatrics, radiology, rheumatology, vascular disease, wound healing and urology
1996 - 2002 President and CEO
Global PharmAlliance, Inc., Newport Beach, California
Principal responsibilities include: Corporate administration; pharmaceutical development services (domestic and international) including: project management; strategic planning; clinical trial design and management (Phase I-IV); chief quality assurance auditor (GLP, GCP and GMP) and training; pre-clinical development strategy; pre-clinical project management; and regulatory affairs (IND, NDA and Foreign Submissions). Multiple therapeutic areas including: Neurology, cardiovascular, infectious disease, dermatology, endocrinology, gastroenterology, HIV/AIDS, immunology, nephrology, oncology, orthopedics, pediatrics, radiology, rheumatology, vascular disease and urology.
1995 -1996 Vice President, Biometrics
CoCensys, Inc., Irvine, California
Responsible for establishment and implementation of international clinical data management strategy, structure and operations. Successfully developed and managed project team comprised of internal resources and external vendors that implemented and validated the program.
1993 -1995 Vice President, Development and Scientific Affairs
CoCensys, Inc., Irvine, California
Primary responsibility for global strategic planning, technical program design, resource allocation and budgeting operations as well as direct management of intramural (intra-corporation) and extramural (external programs e.g., NIH, WHO) projects and resources.
Responsible for oversight of regulatory affairs, product development, manufacturing, formulation, toxicology, clinical research and data management programs. Responsible for the international CNS drug development program including design, placement and management of worldwide clinical research.
1991 -1993 Vice President, Scientific and Regulatory Affairs
CoCensys, Inc., Irvine, California
Pivotal role in strategic planning, program and procedural development, training and management operations as company transitioned from an academic setting to an early stage pharmaceutical company. Significant role in design and build-out of corporate headquarters and research laboratories.
Chief architect of the CoCensys international CNS drug development program including areas of pre-clinical, clinical (Phases I-III) and regulatory affairs. Primary responsibility for program design, operations, and management of intramural and extramural resources. Expert in GCP, GLP and cGMP regulations as well as ICH guidelines. Responsible for development and administration of international development budget. Instrumental in development and filing of corporation’s first IND.
Organized and managed international clinical research teams and programs (Phase I-II). Developed integrated team approach for US and ex-US clinical research programs.
1988 -1991 Vice President, Scientific Affairs
Sigma-Tau Pharmaceuticals, Inc., Newport Beach, California;
Gaithersburg, Maryland
Founded U.S. subsidiary of the Italian pharmaceutical company, Sigma Tau, S.P.A., and established the company as a fully integrated research and development operation. As founder and chief operating officer in the US, I identified, designed and established company facilities in California and Maryland. I had primary responsibility for recruitment and line management of scientific and support staff for cardiovascular and CNS research areas. Annual international research and development budget in excess of $50 million was administered through my office.
Primary responsibilities included global strategic planning and integration of all operating units in support of US registration strategies. Functional areas of responsibility included development of CNS and cardiovascular clinical research programs from Phase I through multi-national Phase III pivotal trials.
Provided project management and oversight between the European parent organization and US scientific and regulatory communities.
1986 -1988 Vice President, Clinical Research
Chantal Pharmaceutical Corporation, Los Angeles, California
Primary responsibility for strategic planning, design, implementation and conduct of international clinical trials (Phases I-III). Managed the multidisciplinary international clinical development program for the corporation. Responsibilities included oversight and coordination of all intramural and extramural research programs including product development and clinical research for anti-androgen and other topical dermatological products.
1982 -1986 Sr. Staff Clinical Coordinator, Medical Department
Kendall McGaw Laboratories Inc., Irvine, California
Primary responsibility for the design, implementation, monitoring and analysis of clinical research programs from Phase I through NDA submission. Project director and operational manager for major therapeutic NDA program in nephrology. Specialist in pediatric research. Responsible for project management of internal and external resources.
1980 -1982 Senior Toxicologist, Research and Development Department
American McGaw, Irvine, California
Responsibility for the design and operational aspects of all pre-clinical toxicological programs in R&D. Managed research staff in conduct of basic science and focused development projects. Developed specific toxicological models for chronic administration of drugs.
ACADEMIC APPOINTMENTS
1980 -1986 Assistant Professor/Guest Lecturer
Department of Pharmacology, Southern California College of Optometry, Fullerton, California
Primary responsibilities included conduct of graduate level courses in general and ocular pharmacology.
PROFESSIONAL SOCIETIES
Memberships in professional societies including Regulatory Affairs Professionals Society (RAPS), Research Quality Assurance (RQA; UK), and Drug Information Association (DIA).
BOARD APPOINTMENTS
2015 – 2018 YourEncore Strategic Advisory Board
2011 - 2016 Los Angeles Maritime Institute Board of Directors
AWARDS AND HONORS
2005 Consultant, Thai FDA and Minister of Health for Thailand; GCP Implementation, Training Programs and Quality Assurance Programs for Thai FDA and University System.
2004 Consultant, Thai FDA and Minister of Health for Thailand; GCP Implementation and Training Programs
2003 Invited Symposium Speaker: Navigating the Regulatory Maze in International Studies. Global Clinical Trials, CBI, Boston, MA, August 2003.
2003 Invited Symposium Speaker: Preparing for an FDA Audit. Drug Information Association Annual Meeting, San Antonio, TX, June, 2003.
2003 Consultant, Thai FDA and Minister of Health for Thailand; GCP Implementation, Training Programs and Quality Assurance Programs.
2002 Invited Symposium Speaker: The Role of Quality Assurance in Offshore Clinical Trials; The Key to Success in South East Asia. Going Offshore for Clinical Trials. Miami, FL
2002 Invited Symposium Speaker: Identification of Fraud and Scientific Misconduct During a Site Audit. Drug Information Association Annual Meeting, Chicago, IL
2002 Invited Speaker. University of California Berkeley Extension, Japan Division: Implications of Fraud and Scientific Misconduct on Drug Development. San Francisco, CA
2002 Consultant, Thai FDA and Minister of Health for Thailand; GCP Implementation, Training Programs and Quality Assurance Programs.
2001 Invited Symposium Speaker: Identification of Fraud During the Site Audit; A View from the Trenches. Drug Information Association Annual Meeting, Denver, CO.
2001 Consultant, Thai FDA and Minister of Health for Thailand; GCP Implementation, Training Programs and Quality Assurance Programs.
2001 Invited Speaker, American Society of Gene Transfer: Clinical Gene Therapy Training Course, Seattle, WA
2001 Invited Symposium Speaker: Good Clinical Practice Update 2001. Gaithersburg, MD
2000 Invited Symposium Speaker, National Seminar: Thailand Center of Excellence in Clinical Trials. Cha Am, Thailand
2000 Consultant, Thai FDA and Minister of Health for Thailand; GCP Implementation, Training Programs and Quality Assurance Programs.
1990 Invited Symposium Speaker, Current Concepts of the Aging Brain, New York, New York
1982 Invited Symposium Speaker, Third Asian and Western Pacific Regional Meeting of Pharmacologists.
1980 Chancellor's Patent Fund Award
1979 Graduate Dean's Dissertation Fellowship Award
Chancellor's Patent Fund Award
1978 American Society of Pharmacology and Experimental Therapeutics Graduate Student Award
PUBLICATIONS
ABSTRACTS
Representative samples of my experience in the areas of quality assurance, system validation and training are summarized below: