When I was in my last year of medical school I decided that I wanted to specialize in Public Health. I asked one of our clinic instructors, a physician who held a senior role in the New Jersey Health Department for advice. I expected that she would be enthusiastic and supportive of my plan.
Instead she said, “Oh no! You’d be a disaster. No one should go into an administrative specialty like Public Health until they have practiced "real" medicine for several years. You'd make up rules that would not make sense.” I was disappointed to say the least. But I took her advice. I finished a residency and fellowship in Pediatrics and went into practice. But I kept thinking about Public Health.
Thirteen years after graduation, I had the chance to enter a Masters in Public Health (MPH) program at UC Berkeley followed by a two-year residency in the California Department of Public Health. I spent the next few years working as an Assistant County Health Officer with responsibility for Communicable Disease Control and Immunization Programs.
As part of my work, I spoke about communicable diseases on local TV and to community groups. I was asked to give a talk about AIDS to the Human Resource Directors of several large Silicon Valley companies. After my talk, one of the attendees asked me whether I knew anything about cytomegalovirus (CMV) and if I would be interested in working in the pharmaceutical industry. I knew a fair amount about CMV infections but nothing about working in industry.
Several months later, after multiple interviews, I joined the Medical Services Department at Syntex Laboratories in Palo Alto. One of my jobs was to oversee the preparation of educational materials for a new antiviral drug being developed to treat CMV retinitis, a sight-threatening disorder that occurred in people with severe immunosuppression. To help get me started, my Department Head set up a training program where I could learn company procedures and FDA regulations. I was assigned to work in Medical Information for a few weeks; then Postmarketing Safety; then Medical Writing. After a few months I was assigned to the Medical Advertising Review Committee where I worked with, and learned from, marketing, legal and regulatory colleagues. It was an incredible introduction to the industry and to the role of a physician in a Pharmaceutical Marketing company. Then, when we learned that the CMV drug would require additional clinical trials before approval, I was "loaned" to Syntex Research to help complete those studies.
I stayed in the Research part of the company for several years. I wrote protocols and investigator brochures; monitored clinical trials; reviewed and reported adverse events; spoke at medical conferences; wrote final reports; helped file the NDA; and presented safety data at the FDA Advisory Committee that led to approval for ganciclovir, the antiviral drug. I was also assigned to development teams for other drugs and directed a Project Team that designed three pivotal multinational trials for a new immunosuppressant, mycophenolate mofetil. I then had the opportunity to work in the International Clinical Trials group and initiated the Canadian, European, and Australian renal transplant studies for mycophenolate. After a few years in Research, I returned to the marketing company as VP of Medical Affairs. In this position, I was responsible for overseeing the Medical Services Department and a Clinical Research group that was conducting Phase 4 trials and analgesic studies for an NDA for a new OTC drug.
Since then I’ve worked on US and international clinical trials (Phase I-IV) for drugs, biologics, devices and diagnostics. I've worked on analgesics, antidepressants, immunosuppressants, Parkinson’s treatments, hepatic, oncology and endocrinology drugs, breast implants, and glucose monitoring. When Syntex was acquired by Roche, three colleagues and I founded a clinical research organization (CRO) called Pacific Research Associates. At Pacific Research we helped over 60 pharma, biologics, device and diagnostics companies. Some of these were large pharma organizations, but most were small start-up companies undertaking early studies for novel treatments. When Pacific Research Associates was acquired by ICON plc, I had the opportunity to work in a large, global CRO for a few years.
I still work as an independent medical consultant. Over the past few years, I've reviewed and summarized preclinical and clinical data to file an IND for a New Zealand company; helped file successful NDAs for an NSAID analgesic; an orphan drug for Cushing's disease; and an antifungal drug for onychomycosis. Most recently, I contributed to a PMA Application for a novel medical device for pulmonary disease.
Instead she said, “Oh no! You’d be a disaster. No one should go into an administrative specialty like Public Health until they have practiced "real" medicine for several years. You'd make up rules that would not make sense.” I was disappointed to say the least. But I took her advice. I finished a residency and fellowship in Pediatrics and went into practice. But I kept thinking about Public Health.
Thirteen years after graduation, I had the chance to enter a Masters in Public Health (MPH) program at UC Berkeley followed by a two-year residency in the California Department of Public Health. I spent the next few years working as an Assistant County Health Officer with responsibility for Communicable Disease Control and Immunization Programs.
As part of my work, I spoke about communicable diseases on local TV and to community groups. I was asked to give a talk about AIDS to the Human Resource Directors of several large Silicon Valley companies. After my talk, one of the attendees asked me whether I knew anything about cytomegalovirus (CMV) and if I would be interested in working in the pharmaceutical industry. I knew a fair amount about CMV infections but nothing about working in industry.
Several months later, after multiple interviews, I joined the Medical Services Department at Syntex Laboratories in Palo Alto. One of my jobs was to oversee the preparation of educational materials for a new antiviral drug being developed to treat CMV retinitis, a sight-threatening disorder that occurred in people with severe immunosuppression. To help get me started, my Department Head set up a training program where I could learn company procedures and FDA regulations. I was assigned to work in Medical Information for a few weeks; then Postmarketing Safety; then Medical Writing. After a few months I was assigned to the Medical Advertising Review Committee where I worked with, and learned from, marketing, legal and regulatory colleagues. It was an incredible introduction to the industry and to the role of a physician in a Pharmaceutical Marketing company. Then, when we learned that the CMV drug would require additional clinical trials before approval, I was "loaned" to Syntex Research to help complete those studies.
I stayed in the Research part of the company for several years. I wrote protocols and investigator brochures; monitored clinical trials; reviewed and reported adverse events; spoke at medical conferences; wrote final reports; helped file the NDA; and presented safety data at the FDA Advisory Committee that led to approval for ganciclovir, the antiviral drug. I was also assigned to development teams for other drugs and directed a Project Team that designed three pivotal multinational trials for a new immunosuppressant, mycophenolate mofetil. I then had the opportunity to work in the International Clinical Trials group and initiated the Canadian, European, and Australian renal transplant studies for mycophenolate. After a few years in Research, I returned to the marketing company as VP of Medical Affairs. In this position, I was responsible for overseeing the Medical Services Department and a Clinical Research group that was conducting Phase 4 trials and analgesic studies for an NDA for a new OTC drug.
Since then I’ve worked on US and international clinical trials (Phase I-IV) for drugs, biologics, devices and diagnostics. I've worked on analgesics, antidepressants, immunosuppressants, Parkinson’s treatments, hepatic, oncology and endocrinology drugs, breast implants, and glucose monitoring. When Syntex was acquired by Roche, three colleagues and I founded a clinical research organization (CRO) called Pacific Research Associates. At Pacific Research we helped over 60 pharma, biologics, device and diagnostics companies. Some of these were large pharma organizations, but most were small start-up companies undertaking early studies for novel treatments. When Pacific Research Associates was acquired by ICON plc, I had the opportunity to work in a large, global CRO for a few years.
I still work as an independent medical consultant. Over the past few years, I've reviewed and summarized preclinical and clinical data to file an IND for a New Zealand company; helped file successful NDAs for an NSAID analgesic; an orphan drug for Cushing's disease; and an antifungal drug for onychomycosis. Most recently, I contributed to a PMA Application for a novel medical device for pulmonary disease.