I am a physician who has worked in the BioPharm industry for the past 30+ years. I did not plan on a career in industry and only learned about pharmaceutical opportunities after several years of medical practice.
I was a biology major in college, went to Medical School in Philadelphia, and then completed a residency in Pediatrics, a fellowship in Pediatric Habilitation and practiced pediatrics in Pennsylvania and California.
After 13 years of practice, I returned to school for a Masters degree in Public Health and complete a second residency program in Public Health and Preventive Medicine. I was working in a County Public Health Department when HIV/AIDS was first recognized. I helped organize HIV testing sites and gave talks to explain HIV/AIDS to community physicians and companies in Silicon Valley. At one talk, I met the head of Human Resources from Syntex, a local pharmaceutical company. She asked if I would be interested in working in industry to help develop and launch new antiviral drugs. I saw this as an extension of my Public Health career.
I was hired as an Associate Medical Director in Medical Services at Syntex Labs, the US marketing company. My first job was to work with medical writers and editors to develop educational materials for a new antiviral to treat cytomegalovirus infections in people with HIV. I learned how FDA regulations influenced every activity in industry.
Then, when additional studies were needed to get the CMV drug approved, I was transferred to Clinical Research help with clinical trials, compassionate use, and Treatment INDs. Other physicians and CRAs taught me about working with investigators and writing protocols. Biostatisticians and Data Managers taught me about designing case report forms and preparing tables, figures, and data listings. Regulatory Directors taught me about informed consent forms, adverse event reporting, and writing Investigator Brochures and Final Reports. I had the opportunity to design and monitor clinical trials, to present data at medical conferences, and to represent the company at the FDA Advisory Committees.
We successfully completed the clinical studies and the anti-CMV drug called Cytovene® (ganciclovir) was approved. Then, I was given monitoring responsibilities for a new immunosuppressant for organ transplantation and had to opportunity to oversee clinical trials In Canada, Europe, and Australia. Since then I’ve worked on studies (Phase I-IV) for drugs, biologics, and devices including antivirals, analgesics, Parkinson’s treatments, COPD, diabetes testing, marijuana, hepatic, oncology and endocrinology drugs, and onychomycosis.
After Syntex was acquired by Roche, three colleagues and I founded a clinical research organization (CRO) called Pacific Research Associates. We helped many small BioPharmaceutical companies plan, conduct, analyze and report their clinical trials.
I still work as an independent medical consultant and I also teach courses about Clinical Research and Medical Writing at U.C. Berkeley Extension in San Francisco.
I was a biology major in college, went to Medical School in Philadelphia, and then completed a residency in Pediatrics, a fellowship in Pediatric Habilitation and practiced pediatrics in Pennsylvania and California.
After 13 years of practice, I returned to school for a Masters degree in Public Health and complete a second residency program in Public Health and Preventive Medicine. I was working in a County Public Health Department when HIV/AIDS was first recognized. I helped organize HIV testing sites and gave talks to explain HIV/AIDS to community physicians and companies in Silicon Valley. At one talk, I met the head of Human Resources from Syntex, a local pharmaceutical company. She asked if I would be interested in working in industry to help develop and launch new antiviral drugs. I saw this as an extension of my Public Health career.
I was hired as an Associate Medical Director in Medical Services at Syntex Labs, the US marketing company. My first job was to work with medical writers and editors to develop educational materials for a new antiviral to treat cytomegalovirus infections in people with HIV. I learned how FDA regulations influenced every activity in industry.
Then, when additional studies were needed to get the CMV drug approved, I was transferred to Clinical Research help with clinical trials, compassionate use, and Treatment INDs. Other physicians and CRAs taught me about working with investigators and writing protocols. Biostatisticians and Data Managers taught me about designing case report forms and preparing tables, figures, and data listings. Regulatory Directors taught me about informed consent forms, adverse event reporting, and writing Investigator Brochures and Final Reports. I had the opportunity to design and monitor clinical trials, to present data at medical conferences, and to represent the company at the FDA Advisory Committees.
We successfully completed the clinical studies and the anti-CMV drug called Cytovene® (ganciclovir) was approved. Then, I was given monitoring responsibilities for a new immunosuppressant for organ transplantation and had to opportunity to oversee clinical trials In Canada, Europe, and Australia. Since then I’ve worked on studies (Phase I-IV) for drugs, biologics, and devices including antivirals, analgesics, Parkinson’s treatments, COPD, diabetes testing, marijuana, hepatic, oncology and endocrinology drugs, and onychomycosis.
After Syntex was acquired by Roche, three colleagues and I founded a clinical research organization (CRO) called Pacific Research Associates. We helped many small BioPharmaceutical companies plan, conduct, analyze and report their clinical trials.
I still work as an independent medical consultant and I also teach courses about Clinical Research and Medical Writing at U.C. Berkeley Extension in San Francisco.