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EDUCATION
1980 Doctor of Medicine, University of California, Los Angeles, CA
1983 Residency in Internal Medicine, USAF Medical Center Keesler AFB, MS
1977 PhD, Microbiology,
University of California, Los Angeles, CA
Thesis: Comparative Immunology of Graft Rejection
1972 Bachelor of Arts,
California State University, San Bernadino, CA
MILITARY EDUCATION
1984 Air Command and Staff College , Biological Warfare Course
MEDICAL LICENSES
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- Annual reports and protocol presentations to CBER, CDER, National Institutes of Health and National Cancer Institute
- Outside inspections of IND's and NDA's for corporate partners
- Preparation of PMAs and 510K for in-vitro diagnostic devices
- Preparation of MAA and PLAs for radioimmunodiagnostic agents and ASI
- Preparation of INDs
PHARMACEUTICAL INDUSTRY EXPERIENCE
Senior Vice President and Partner, Clinical Research and Regulatory Affairs, Emerging Technology Partners
- Collaborate with basic scientists to define their intellectual property and demonstrate proof of principle
- Develop research and development strategies to transfer their technology from the lab into animal, then clinical studies
- Orient scientists into a business enviornment
- Work with the university technology transfer office on property transfer agreements
- Prepare business plans
- Present and negotiate with interested biotechs, investors and with the FDA
1992-Present Principle, DHM Consulting, Independent biotech-pharmaceutical consulting service
- Medical-legal consulting on pharmaceutical industry issues
- Due diligence for venture capital
- Freelance biomedical writing (major assignments for medical media companies)
- Freelance Clinical Research: clinical trial design and monitoring; adverse event monitoring; clinical summary preparations, etc.
- Biotech start-up development
1997 Medical Director, Medical Marketing and Continuing Medical Education company
- Medical communications
- Continuing Medical Education, medical marketing
- Developed, coordinated and authored conference and symposia articles and literature
- Reviewed presentation slides for accuracy for client-pharmaceutical companies
1996-1997 Vice-President, Clinical Research, a Nuclear Medicine Company
Director, Departments of Medical Research and Clinical Data Management Programs:
- Radioimmunoscintography and Radioimmunotherapy of cancer using radiolabeled monoclonal antibody
- Overall management of Phase I-III clinical trials
- Adverse Event management
- Prepared Annual Safety Reports
- Authored Integrated Summary of Safety for Biologic License Approval
- Managed 20 department staff members
- Coordinated with outside contractors, Contract Research Organizations, consultants, industry and academic experts
- Responsible for department budget
- Successfully submitted a Biologic License Approval 12-97 for radioimmunoscintigraphy of infectious diseases
1995-1996 Director, Department of Medical Research, Regulatory Affairs and Clinical Data Management of Clinical Programs, a biotech company.
- Radioimmunoscintography and Radioimmunotherapy of cancer using totally human monoclonal antibody
- Adverse Events management
- Prepared Annual Safety Reports
- Authored Integrated Summary of Safety for Biological License Aapproval
- Overall management of Phase I-III Clinical Trials
- Applied Specific Immunotherapy, vaccines and ex vivo cell expansion
- Nono-specific immune therapy of bladder cancer
- In vitro diagnostic devices
- Hyperimmune globulin for treatment of cancer and infectious diseases
- Managed 20 professional staff members (PhD, MD, Nuclear Medicine Imaging specialist, Regulatory Affairs specialists, etc.)
- Coordinated with outside contrators, Clinical Research Organizations, consultants, industry and academic experts
- Responsible for department budget
1991-1995 Director, Clinical Research, a Vaccine Company
- Coordinated all Immunology Programs and certain vaccines under development
- Overall management Phase I-III Clinical Trials
- Adverse Event Management, preparation of annual safety reports
- Interacted with Regulatory Department and FDA on Adverse Event Program for new recombinant protein vaccine
- Established independent Adverse Event Advisory Board
- Authored the Standard Operating Procedure manual
- Project Team Leader (Anti-receptor antibody for Immune Response Modulation and Rabbit antihuman Thymocyte Ig for grafts; aplastic anemia)
- North American Development of all Recombinant Pox Vaccines
- Hyperimmune Ig for Cytomegalovirus
- Bacclius Calmet Guerin for bladder cancer and TB vaccine
- Vaccinia Melanoma oncolysate vaccine
- Assisted in budget preparation for entire Medical Department
- Authored Final Study Reports, FDA submissions and answered FDA inquirieS
- Provided medical advice on marketed products to customers
- Processed and collected Adverse Effects Reports
- Authored Policies and Procedures Manual for the Medical Department
- Transferred Professional Medical Education Programs from Marketing Department to Medical Department
- Directed the Continuing Medical Education Program
- Evaluated Potential Licensing of Technology: Hemoglobin, Colostral Ig, Factor 9, immune toxins, etc.; preparation of Return-on-Investment and Statement of Interest reports
Member of the following company committees:
- Corporate Development Committee for Immune Proteins
- BCG Working Group
- POX-Japanese Encephalitis Vaccine Project Team
- POX-Malaria Vaccine Project Team
- Lyme Vaccine Project Team
- Corporate Cancer Vaccine Working Group
- Corporate HIV Vaccine Working Group
- Strategic Planning Committee on FDA Reform
1989-1991 Associate Director, Antibacterials, an International Pharmaceutical Company
- Won company-wide Quality Award (April 1990)
- Chairperson, PAF Antagonists in the Treatment of Septic Shock; Working Group to Explore Opportunities
- Member, Good Government Committee; Political Action Committee
- Safety Officer (prepared Annual Safety Report); Prepared individual Adverse Events Reports for Regulatory Department (Fleroxacin New Drug Application)
- Assisted in Supplementary Submissions and presentations to FDA: Expanded Anaerobe Coverage; Biliary Surgery Prophylaxis; Pediatric Meningitis QD (once-a-day dose of antibiotic); Acute and Subacute Endocarditis (Ceftriaxone)
- Director, Lyme Disease treatment program; developed protocols for Indications and FDA presentations
- Protocol Industry Advisor to ACTG 145 "Ceftriaxone for Neurosyphilis in AIDS Patients"
- Physician in Charge; evaluated Adverse Events, Immediately Reportable Adverse Events; prepared reports for FDA (5-Flu-Cytosine IV)
1986 Founder and President, Medical Membrane Technologies, a medical device start-up company (Blood Chemistry Analyzer, using Biosensors)
CLINICAL PRACTICE, Board Certified, Internal Medicine (Active)
1983-1987 Medical Clinic and Clinical Research Physician, Letterman Army Institute of Research, Blood Research Division
PROFESSIONAL ORGANIZATIONS
- American College of Physicians, Fellow
- New Jersey Medical Association
- AMA Health Access America: Legislative Contact Person
- American Federation for Clinical Research
- Drug Information Association
A list of all publications, abstracts and research reports, authored by this medical expert, are available upon request to Legal Nurses OnLine®.
You may contact Lisa Morgan, RN, President of Legal Nurses OnLine®,
MedXperts.com™ and LegalNurses.com at the following E-mail address:
MorganRN@legalnurses.com
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