Expertise

Pre-Clinical Safety Inc. will provide your company with many years of combined experience in various aspects of pre-clinical safety. Our ability to tap on to a wide selectionof experts in specific fields compliments our own abilities. 

Ricardo Ochoa

Ricardo Ochoa is an experienced, board certified, veterinary pathologist with expertise in drug safety evaluation and a broad background in related areas known for the highest ethical and professional standards. A skilled researcher and experienced teacher, he is comfortable in both industry and academic environments. He applies a global perspective to business endeavors, speaks multiple languages and performs with ease in multi-cultural, diverse groups.

 

Professional Experience:

PRE-CLINICAL SAFETY INC. Niantic, CT
President (2008)
NEUROGEN CORPORATION, Branford, CT
Vice President, Pre-Clinical Safety (2006-2008)
PFIZER INC., Groton, CT
Executive Director of Pathology (1991 - 2006)
THE UPJOHN COMPANY, Kalamazoo, MI
Senior Research Veterinary Pathologist (1981 - 1991)
LOUISIANA STATE UNIVERSITY, Baton Rouge, LA
Associate Professor, Pathology Department, School of Veterinary Medicine (1977 - 1981)
INSTITUTO COLOMBIANO AGROPECUARIO, Bogota, Colombia
Director, Division of Veterinary Sciences (1967 – 1976)

Current Areas of Scientific Interest:

  • Due Diligence
  • Issue Resolution
  • Early Decision Making
  • Animal Models of Therapeutic Intervention
  • Carcinogenicity Testing
  • Regulatory Toxicologic Pathology
  • Biomarker Development
  • Automated Pathology Solutions
  • Strategic Scientific Direction

William J Dougherty

Dr. Dougherty has a Ph.D. in Human Anatomy from Georgetown University in Washington DC.  He completed a post doctoral fellowship in reproductive toxicology at the Albany Medical College and was appointed Assistant Professor of Toxicology at that institution.  Dr. Dougherty has 39 years of experience in preclinical risk identification, risk assessment, risk communication and risk management in the pharmaceutical industry.

Professional Experience:

INSTITUTE OF EXPERIMENTAL PATHOLOGY AND TOXICOLOGY
International Center of Environmental Safety
Albany Medical College, Albany, NY
Assistant Professor of Toxicology (1971-1977)
  • Designed, conducted and reported general and reproduction toxicology studies in non-human primates and rodents
  • Managed a non-human primate (rhesus monkey) breeding program
AMERICAN CYANAMID COMPANY, Pearl River, NY
Group Leader, Department of Toxicology Evaluation, Medical Research Division (1977-1989)
  • Managed 3 PhD toxicologists and 4 technicians in designing, conducting and reporting toxicology studies in non-human primates, canines and rodents. These studies were support for development of anti-cancer, anti-inflammatory and antibiotic therapeutics
  • Managed the placement of studies at CROs
  • Represented the Toxicology Evaluation Department on development teams
  • Project team leader developing a diuretic that identified safety risks leading to a recommendation for terminating development
  • Toxicology representative on an alliance team partnering with a Japanese pharmaceutical company in developing an antibiotic
AMERICAN CYANAMID COMPANY, Pearl River, NY
Department Head and Manager, Department of Toxicology Evaluation, Medical Research Division (1989-1991)
  • Managed a department of 30-35 scientists, technicians and administrative people supporting development of new therapies
  • Provided scientific guidance in support of development programs
  • Participated in developing and managing budgets
  • Set goals for the department
  • Conducted performance reviews
PFIZER CENTRAL RESEARCH, Groton, CT
Senior Technical Advisor, Drug Safety Evaluation (1991-1999)
  • Partnered with Pfizer scientists, clinicians, and regulatory affairs in preparing and reviewing submission dossiers from IND through marketing applications
  • As the pre-clinical expert led teams that included pharmacologists, pharmacokinectists and toxicologists in writing pre-clinical integrated summaries for inclusion in world wide applications submitted for approval of new therapies
  • Organized and led teams to peer review submission documents to identify potential gaps or questions that may be raised by regulators and develop strategies to respond to potential questions
  • Represented Pfizer Drug Safety Evaluation at teleconferences and face-to-face meetings with the FDA, and regulators in the United Kingdom, Sweden, Belgium, Australia and Canada
  • Represented Pfizer Drug Safety Evaluation at European Mutual Recognition Procedure(MRP)
  • Represented Drug Safety Evaluation on Product Enhancement Teams
  • Member of multi-disciplinary teams that provided review, assessment and recommendations to management regarding drug candidates as potential licensing opportunities
  • Toxicology representative to Alliance Teams in co-developing new therapies
  • Toxicology representative to the Pfizer Impurities Council. The council was charged with providing recommendations to project teams on setting and qualifying specifications for impurities in drug substance and drug product thus assuring the quality of new therapies

PFIZER CENTRAL RESEARCH, Groton, CT
Research Director, Drug Safety Evaluation (1999-2006)

  • Led a team of 5-8 PhDs
  • This position was responsible for developing and implementing pre-clinical development strategies for drug candidates from Phase lll through loss of exclusivity. This included design of chronic animal studies, preparation and review of submission dossiers
  • Performance management including mentoring junior staff PhDs
  • Partnering with staff to prepare and executecareer development plans
  • Prepared and successfully executed a succession plan for my position in anticipation of my retirement
  • Member of the Drug Safety Senior Leadership Team
PFIZER, DSRD, PGRD, Groton, CT
Development & Regulatory Strategy Senior Advisor (2006- 2007)

Erik R. Larsen

Erik Larsen is an experienced Quality Assurance Director with global expertise supporting drug development programs and regulatory submissions. He has extensive experience working with regulatory agencies and their expectations through audits and industry forums. He has conducted audits in 12 countries covering multiple GxP disciplines in big pharma and with CRO's, specializing in GLP, Animal Welfare and Risk analysis. He has led teams in six countries and is known for working well in multi-cultural, diverse groups. He has a Masters in Biology with 31 years of Pharmaceutical experience, including 11 years conducting GLP toxicology studies in numerous species.

Professional Experience:

PFIZER INC., Groton, CT
Director, Research and Development Oversight (2005 - 2009)
  • Managed the Research & Development Oversight GLP/AW function with responsibility for direct management of staff at multiple locations including the EU.
  • Developed and implemented the Pfizer GLP/Animal Welfare oversight audit program within the Corporate Regulatory Compliance function in US, UK, Japan and France. Established training and process development for the conduct of audits based on the new program.
  • Managed the CRO audit program working with the Pfizer Outsourcing teams with responsibility for Peer review of all GLP and Animal Welfare (AW) audit reports.
  • Managed the audit schedule for the R&D GLP audits and risk model with responsibility for assuring the conduct of all GLP/AW audits were completed and met corporate standards.
  • Member of the Corporate Risk and Scheduling team responsible for the global audit schedule and risk approach.
  • Managed the development and implementation of a new audit approach for the Pfizer external Animal Welfare audit program in partnership with the Pfizer Animal Welfare/Attending Veterinarian function.

PFIZER INC., Groton, CT
Director, Research Quality Assurance (RQA) - Global Strategic Initiatives (GSI) (2003 - 2005)

  • Developed and implemented the GSI function for Global RQA; monitored and interpreted regulatory trends, and provided trend analysis to QA leadership and clients; including US, Japan, UK and France.
  • Provided leadership to RQA Management initiatives in the development of the RQA Strategic Plan and a risk-based audit program (in partnership with global toxicology).
  • Member of the design and implementation team established by executive management for the development of a new corporate audit program.
  • Mentored Japan QA management and provided training to Japan colleagues and staff to facilitate the development of the global GLP audit program.
  • Member/officer PhRMA BioResearch Monitoring Steering Committee and GLP Work Group.

PHARMACIA, Kalamazoo, MI
Director, Quality Standards & Operations (QSO) (2002-2003)

  • Team member of a new Corporate quality function within Pharmacia with responsibility for the quality function for the planning, conduct, and reporting of GxP audits (i.e., GCP, GLP, GMP and computer audits), including audits of internal Quality functions.
  • Conducted and reported GxP audits for functions within the global sphere of Pharmacia, including Italy, Sweden and US.
  • Member/officer PhRMA BioResearch Monitoring Steering Committee and GLP Work Group. 

PHARMACIA, Kalamazoo, MI
Director, Global R&D Quality Assurance (2001)

  • Managed the Global GLP Compliance program for the Italy, US-Kalamazoo and Sweden Pharmacia sites and conducted global audits to train EU and Japan staff.
  • Responsible for Worldwide Animal Health GCP Compliance program.
  • Worked with Japanese colleagues to assure GLP compliance in Japan.
  • Member/officer PhRMA BioResearch Monitoring Steering Committee and GLP Work Group.

PHARMACIA AND UPJOHN, Kalamazoo, MI
Director, Global Pre-Clinical Quality Assurance (1999-2001)

  • Managed the Global GLP Compliance program at all Pharmacia and Upjohn sites (Japan, Italy, Sweden, US) with direct responsibility for management of sites and personnel in US, Italy and Sweden, and worked with Japanese colleagues to assure GLP compliance in Japan.
  • Established and developed the initial GCP QA program to support Worldwide Animal Health R&D Operations, included staffing/training of new personnel for the program.
  • Conducted global audits to train EU and Japan staff.
  • Member PhRMA BioResearch Monitoring Steering Committee and GLP Working Group.
  • IACUC non-voting member providing input and consultation on regulatory requirements, agency interactions and inspections.

PHARMACIA AND UPJOHN, Kalamazoo, MI
Director, Pre-Clinical Quality Assurance (1996-1999)

  • Managed the GLP compliance program for all US-based operations and worked with Japanese colleagues to assure GLP compliance in Japan.
  • Provided leadership to all internal regulatory inspections and site visits (i.e., FDA, USDA, Michigan Dept of Public Health and Agriculture, AAALAC).
  • Conducted global audits to train EU staff and train Japanese staff and assess facilities.
  • Planned, conducted and reported internal and external audits and inspections.
  • IACUC member providing input and consultation on regulatory requirements, agency interactions and inspections.

THE UPJOHN COMPANY, Kalamazoo, MI
Senior Compliance Specialist, Pre-Clinical Quality Assurance (1988-1996)

THE UPJOHN COMPANY, Kalamazoo, MI
Research Biologist, Pathology and Toxicology Research (1977-1988)