Industry Consultant

SUMMARY OF EXPERIENCE

During my more than 40 years in the pharmaceutical industry I have been active in pre-clinical and clinical research, regulatory affairs, biometrics and data management, and quality assurance, all of which providing me with a unique and diversified background to facilitate the development, registration and approval of pharmaceuticals, biologics and medical devices.  My activities since founding Triligent International have been primarily focused in international clinical development with a commitment to improvement of quality in all aspects of the development process.  My expertise includes all areas of GxP with emphasis on clinical systems and operations.  Our company has provided focused consulting and technical support to corporate clients of all sizes.

Among other endeavors, I have directed development programs (as well as salvage programs) for clients leading to successful NDA approvals.  I also have been active in the evaluation and triage of development programs being conducted globally for clients to ensure compliance with GxP regulations.  This has involved GxP audits and training programs as well as implementation of GCP programs de novo for the Government of Thailand.  The program, involving both the Thai FDA and Thailand’s university system, and was successful in introducing GCP to both institutions and the training of their personnel to meet international standards.

My various roles have allowed me to develop an in-depth knowledge of product development from pre-clinical through post-marketing phases.  I have become expert in the conduct and evaluation of clinical programs and ensuring high quality and cost effectiveness.  My areas of focus include: overall program development; clinical operations and project management; quality assurance (clinical site, corporate, CRO, vendor, pharmacovigilance, gap analyses, etc.); system validation (evaluation, testing, implementation and monitoring); data management; and the implementation of broad-based training programs.  I also have specialized expertise in post-marketing safety surveillance programs and have been involved in the evaluation of such programs globally.  I have participated in due diligence audits for clients involving merger/acquisition activities internationally, providing clinical development, regulatory and quality assurance expertise. 

In addition, I currently serve as a member of the YourEncore Strategic Advisory Board and provide strategic consulting to the organization and their clients globally in drug/biologic and medical device development, regulatory and quality assurance.

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

  1. Bicher HI, Dalrymple GV, Ashbrook DW, Smith RH.  Effect of Ionizing Radiation on Liver Microcirculation and Oxygenation.  In: Oxygen Transport to Tissue II. Ed. Grote, Plenum Press, New York, 1976.
  2. Bicher HI, Ashbrook DW, Harris DH, Dalrymple GV.  Changes in Platelet and Microcirculation Function Induced by Ionizing Radiation to the Liver.  Int J Radiation Oncology, Bio and Phys 1 (7-8):679-685, 1976.
  3. Purdy RE, and Ashbrook DW. Evaluation of Cardiovascular Drugs in the Unanesthetized, Unstrained Rat. J Pharm Pharmacol 30:436-441. 1978.
  4. Ashbrook DW, Purdy RE, Hulburt DE, Rains LA, Reidy JP, Stratford RE.  A Novel Response to Propranolol: Contractile Response in the Isolated Rabbit Ear Artery.  Life Sciences 26: 155-163, 1980.
  5. Ashbrook DW. Characterization of the Interaction Between Propranolol and Alpha-Adrenoceptors of Rabbit Vascular Smooth Muscle.  Doctoral Dissertation; University of California, Irvine, CA, 1980.
  6. Purdy RE, Ashbrook DW, Hurlburt DE, Reidy JP, Stratford RE, Watanabe MY.  Effect of Reserpinization, Surgical Denervation, and In Vitro Chemical Denervation with 6-Hydroxydopamine on the Contractile Response of Isolated Rabbit Ear Artery to Propranolol.  Blood Vessels 18 (4-5): 153-160, 1981.
  7. Purdy RE, Ashbrook DW, Stupecky GL, Watanabe MY.  Qualitative and Quantitative Differences Between the Post-synaptic -Adrenoceptors of Rabbit Ear Artery and Thoracic Aorta. J Pharmacol Exp Ther 224 (3):543-551, 1983.
  8. Ashbrook DW. Carnitine Supplementation in Human Carnitine Deficiency.  In Clinical Aspects of Human Carnitine Deficiency, Ed:  Pergamon Press, New York, 1986:120-134.
  9. Suki W, Walshe J, Ashbrook D, Gentile D, Tucker T, Ash S, Ahmad S.  Multicenter Evaluation of a CAPD Bagless System.  ASAIO Transactions.  Trans Amer Soc Artif Int Organs 32:572-574, 1986.
  1. Vacha GM, Giorelli, D'Iddio S, Valenti G, Bagiella E, Procopio, Di Donato S, Ashbrook D, Corsi M. L-Carnitine Addition to Dialysis Fluid. Nephron 51:237-242, 1989.
  1. Golper T, Wolfson M, Ahmad S, Ashbrook D.  Multicenter Trial of L-Carnitine Injection in Patients on Maintenance Hemodialysis I: Carnitine Concentration and Lipid Effects.  Kidney International. 38:904-911, 1990. 
  1. Golper T, Wolfson M, Ahmad S, Ashbrook D.  Multicenter Trial of L-Carnitine         Injection in Patients in Maintenance on Hemodialysis Patients: II: Clinical and Biochemical Effects.  Kidney International. 38:912-918, 1990.
  2. Schulz, H, Jobert, M, Gee, K and Ashbrook, D.  Soporific effect of the neurosteroid     pregnanolone in relation to the substance’s plasma level: a pilot study.  Neuropsychobiology 1996; 34(2):106-112.
  1. Monaghan, EP; Navalta, LA; Shum, L; Ashbrook, DW; Lee, DA.  Initial human experience with ganaxolone, a neuroactive steroid with antiepileptic activity.  Epilepsia 1997 Sep; 38(9):1026-31.
  1. Sundstrom, I; Ashbrook, D; Backstrom, T.  Reduced benzodiazepine sensitivity in patients with premenstrual syndrome:  a pilot study.  Psychoneuroendocrinology 1997; 22(1):25-38.
  2. Sundstrom, I; Andersson, A; Nyberg, S; Ashbrook, D; Purdy, RH; Backstrom, T.  Patients with Premenstrual syndrome have a different sensitivity to a neuroactive steroid during the menstrual cycle compared to control subjects.  Neuroendocrinology 1998; 67(2):126-138.  Next Generation Pharmaceutical 2008; 12:
  3. View from 37,000 Feet—Weathering Change in the Pharmaceutical Industry.  Next Generation Pharmaceutical 2008; 13: 67.
  4. Ashbrook, D.  The Advantages of Contract Research.  Next Generation Pharmaceutical 2008; 4(2):98.

 

ABSTRACTS

  1. Ashbrook DW, Bicher HI, Harris D and Dalrymple GV. Autoregulatory Mechanisms Controlling the Supply of Oxygen to Microareas of Tissue.  Texas Reports on Biology and Medicine.
  2. Ashbrook DW, Bicher HI, Smith R and Dalrymple GV.  Effect of Ionizing Radiation of Liver Microcirculation Suppression of Oxygen Autoregulation as a Possible Coadjutant to Radiation Therapy.  ISOTT Proceeding, 1975.
  3. Ashbrook DW, Boyd CM, Dalrymple GV.  Effect of Microspheres on Cerebral Circulation.  Nuclear Medicine, 1975.
  4. Ashbrook DW, Purdy RE.  Continuous IV Administration and Aortic Blood Pressure Measurement in the Unanesthetized, Unrestrained Rat.  The Pharmacologist 18:188, 1976.
  5. Purdy RE, Ashbrook DW, Krueger CG Young S. In Vivo and In Vitro Evaluation of the Vasodilating Agent Prazosin.  The Pharmacologist 19:212, 1977.
  6. Ashbrook DW, Purdy RE. Effect of Prazosin on Norepinephrine and Calcium Induced Contractile Responses in Blood Vessels.  International Union of Pharmacology, Paris, France July, 1978.
  7. Ashbrook DW, Purdy RE, Krueger CG.  Effect of Prazosin on Isolated Rabbit Blood Vessels.  Third International Symposium on Vascular Neuroeffector Mechanisms, Brussels, Belgium, July, 1978.
  8. Ashbrook DW, Purdy RE.  Alpha-Agonist Actions of Beta-Blockers in Vascular Smooth Muscle.  The Pharmacologist, August, 1980.
  9. Purdy RE, Ashbrook DW.  Effect of Reserpinization, and Denervation on the Contractile Response of Isolated Rabbit Ear Artery to Propranolol.  The Pharmacologist, August, 1980.
  10. Dreher ML, Spratt NS, Miller GA, Ashbrook DW, Yoshimura NN.  Evaluation of the Nutritional Quality of a High Branched Chain Amino Acid Mixture by an Expanded Protein Efficiency Ratio Procedure.  Institute of Food Technologist, June, 1981.
  11. Purdy RE, Ashbrook DW, Watanabe MY.  Evidence for Two Classes of Post-Synaptic -Adrenoceptors in Blood Vessels.  4th International Symposium on Vascular Neuroeffector Mechanisms, Tokyo, Japan, 1981.  Blood vessels 18 (4-5): 224, 1981.
  12. Ashbrook DW. Phthalate Ester Plasticizers: A Toxicological Evaluation.  Third Southeast Asian and Western Pacific Regional meeting of Pharmacologist; Bangkok, Thailand, May, 1982.
  13. Purdy RE, Ashbrook DW, Stupecky GL, Watanabe MY.  Evidence for Two Post-synaptic -Adrenoceptors in Blood Vessels.  The Pharmacologist, 24:234, 1982.
  14. Ashbrook DW.  Carnitine Supplementation in Human Carnitine Deficiency.  Proceedings, Clinical Aspects of Human Carnitine Deficiency, 1985.
  15. Suki W, Walshe J, Ashbrook D, Gentile D, Tucker T, Ash S, Ahmad S.  Multicenter Evaluation of a CAPD Bagless System.  ASAIO, Anaheim, California, May, 1986.
  16. Ashbrook, D, Navalta, L, and Schary, W.  Initial Clinical Experience with a Novel Neurosteroid Anticonvulsant.  Epilepsia 36 (Suppl 4): 51, 1995.
  17.   Ashbrook, D.  The Changing Face of GCP and ICH:  Good Clinical Practice Update 2001.  National Seminar: Thailand Center of Excellence in Clinical Trials. Cha  Am, Thailand, December, 2000.
  1. Ashbrook, D.  Good Clinical Practice:  Sponsor’s Role in Quality Assurance.  Good Clinical Practice Update 2001, Gaithersburg, MD, March, 2001.
  2. Ashbrook, D.  Quality Assurance Audits in Gene Therapy Studies.  American Society of Gene Transfer:  Seattle, WA; May 2001
  3. Ashbrook, D.  Identification of Fraud During the Site Audit; A View from the Trenches.    Drug Information Association Annual Meeting, Denver, CO., July 2001.
  4. Ashbrook, D.  Identification of Fraud and Scientific Misconduct During a Site Audit.  DIA Journal, Chicago, IL; June, 2002
  5. Ashbrook, D.  The Role of Quality Assurance in Offshore Clinical Trials; The Key to Success in South East Asia.  Going Offshore for Clinical Trials, Miami, FL,  October 2002
  6. Ashbrook, D.  Preparing for an FDA Audit:  The Industry Perspective.  DIA Journal, June 2002.
  7. Ashbrook, D.  Navigating the Regulatory Maze in International Studies.  Proceedings Global Clinical Trials, Center for Business Intelligence.  Boston, August 2002.
  8. Ashbrook, D.  Preparing for an FDA Audit:  The Industry Perspective.  DIA Journal, June, 2003.
  9. Ashbrook, D.  Quality Assurance: An Investment in the Future.  DIA Journal, June 2005.
  10. Ashbrook, D.  Preparing for and FDA Inspection of International Studies:  An Industry Perspective.  DIA Journal, June 2005.   

Representative samples of my experience in the areas of quality assurance, system validation and training are summarized below:

 

  • Routine Clinical Audits at Investigator Sites
    • US
    • Canada
    • Central America (Mexico, Costa Rica)
    • Western Europe (UK, Ireland, Denmark, Sweden, Finland, Norway, Netherlands, Belgium, Germany, France, Switzerland, Austria, Spain, Italy)
    • Eastern & Southern Europe  (Russia, Poland, Czech Republic, Hungary, Lithuania, Estonia, Croatia, Greece, Serbia)
    • Middle East (Israel, Bahrain, UAE)
    • Africa (Morocco, Algeria, Kenya, Tanzania, South Africa, Botswana)
    • Asia (Thailand, China, Japan, Malaysia, Philippines, Indonesia, Taiwan, Korea, Singapore)
    • South Asia (India)
    • Oceana (Guam, Okinawa)
    • Australia, New Zealand
    • South America (Argentina, Chile, Brazil, Peru, Colombia)
  • Data Systems and: Part 11 Compliance; Validation (Evaluation and Implementation); Program Oversight; Project Recovery
    • US
    • Europe (UK, Sweden)
    • Australia
    • Asia (Taiwan)
    • Australia
  • Corporate:  GAP Analyses; Records Systems including Trial Master Files; Pharmacovigilance/Safety; Quality Systems; Data Systems and Data Management/Statistics; Archive Development and Record Management; Post-Marketing Safety Surveillance Program Evaluation
    • US
    • Asia (China, Philippines, Thailand, Japan, Indonesia)
    • Australia
    • EU
    • Africa (Algeria, Morocco)
    • So. America (Colombia, Argentina, Chile)
    • Mexico
    • Costa Rica
    • Israel
  • Vendor Qualification Audits/Ongoing Compliance Audits
    • CRO (Clinical Systems; GAP Analyses; Data Systems; Data Management/Statistics; QA Systems)
      • US
      • Canada
      • Mexico
      • So. America
      • Europe (UK, Germany, France, Netherlands, Denmark, Sweden, Switzerland) 
      • Australia
      • Russia
      • Asia (Thailand, Philippines, Hong Kong, Singapore, Korea, Japan, Taiwan)
      • So Asia (India)
    • Clinical Laboratory (Compliance; GAP Analyses; System Validation; Quality Systems)
      • US 
      • Canada
      • So. Asia (India)
      • Mexico
      • So. America
      • EU
      • Australia
      • Russia
      • Asia (Thailand, Philippines, Hong Kong, Singapore, Korea, Japan, Taiwan)
      • So Asia (India)
    • Manufacturing (Compliance; Quality Systems; Record Management)
      • US
      • Canada
      • Europe (Germany, France, UK, Switzerland, Sweden, Denmark, Italy)
      • Australia
      • Asia (Taiwan)
      • So Asia (India)
    • Preclinical (GLP; Toxicology)
      • US
      • Canada
      • EU
      • So Asia (India)
  • Training Programs
    • Investigator/Site Training
      • US
      • Europe
      • Africa
      • Asia
      • So America
    • Governmental Training Programs
      • Thailand (Implementation of GCP standards (including Part 11 compliance) for all Thai clinical trials conducted by the University System); Consultant to the Thai FDA for regulatory, data systems and quality assurance.
    • Corporate Training Programs (GCP; Part 11 Compliance; Data Systems; Drug Safety and Pharmacovigilance; and Quality Assurance/Quality Systems)
      • Australia
      • Europe
      • Africa (So Africa)
      • Asia (Taiwan, Japan, Singapore, Hong Kong, Philippines)
      • US

 

  • For Cause Audits (Suspected Fraud or Malfeasance: Clinical Research;  Pharmacovigilance; Medicare Fraud; and Data/Data Systems)
    • Africa
    • Australia
    • Canada
    • China
    • India
    • Israel
    • Italy
    • Japan
    • Korea US 
    • Poland
    • Serbia
    • Singapore
    • Russia
    • UK
    • US

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