Welcome--this website is under development.
We will be adding new information regularly.
An information hub for doctors in the BioPharm industry,
including physicians; dentists; veterinarians; podiatrists; optometrists; PharmDs; and PhDs.
We use the term "BioPharm" as a composite term for all the industries that develop and market pharmaceutical, biologic products and medical devices for therapeutic use or diagnosis. This includes the Pharmaceutical industry (Pharma), Biotechnology (Biotech), Medical Devices, and Diagnostics.
Pharmaceuticals or "drugs" are small molecules developed by chemical synthesis. "Biologics" include sugars, proteins, or nucleic acids refined from natural products or synthesized by biologic organisms. Medical devices include products as simple as dental floss and as complex as lasers or implantable pacemakers. Diagnostics include in vitro diagnostic tests for blood, other fluids or tissue samples, electrocardiography or medical imaging including x-rays, CAT scans, MRIs, mammograms, etc.
This site will focus on physicians, veterinarians, optometrists, dentists, podiatrists, PharmDs or PhDs who provide clinical expertise for the discovery, development, and commercialization of BioPharm products. For simplicity, we will use the terms "physician," or "doctor" and "medicine" to refer to all of these professionals and specialties. Doctors play important roles in BioPharm companies and regulatory agencies as executives, employees, investigators, or consultants. We hope to provide information for doctors who currently work in BioPharm and for others who are considering careers in the industry.
Our focus on physicians, PharmDs, PhDs, etc is not meant to downplay the important roles of others in our industry. We are indebted to the training and coaching we have received from Clinical Research Associates, Regulatory Advisors, Data Managers, Biostatisticians, and Commercial and Executive colleagues. But we felt there was a lack of information directed to physicians and other doctors in the industry.
One question that I am often asked by medical students or physicians is whether they need to complete a residency program before applying for a job in industry. In my experience, most physicians in industry have some residency experience and most are Board Eligible or Board Certified. I know a few medical writers who did not complete residencies and some physicians working in venture capital firms who have MD/MBAs with little clinical experience, but they are the exceptions. Physicians are usually hired as Medical Monitors in Clinical Research or as Medical Directors in Medical Affairs or Drug Safety. Most physicians are hired for their clinical expertise which usually comes from residency training. For example, for my first industry job, I was hired to work in Medical Affairs. The company was getting ready to launch a new drug to treat CMV retinitis in people with AIDS and they needed a Medical Director to supervise the preparation of launch support materials and to train medical and commercial staff. I had completed residencies in Pediatrics and in Public Health and had designed AIDS education programs. When approval of the new drug was delayed because more clinical studies were needed, I was "loaned" to the Research Division of the company as the Medical Monitor for additional studies in patients with HIV and studies to prevent life-threatening CMV infections in immunosuppressed transplant patients. After the CMV drug was approved, instead of going back to Medical Affairs, I stayed in Research. I joined the Project Team to develop a new immunosuppressant. I was not an immunologist or an infectious disease specialist, but I had learned a lot by working with transplant specialists during the CMV program. I stayed with that project until we hired a real infectious disease specialist and I moved to help implement the new studies in the international division. Since then, I have worked on drugs for transplantation, NSAIDs for pain, antibiotics and antifungal treatments, endocrinology, CNS, reproductive health, respiratory devices, glucose monitors, acne, etc. In each case, my job was to become a "mini-specialist" and to learn enough about the new indication to be able to interpret adverse events and efficacy. That means understanding how the disease is diagnosed, what the standard therapies are, how patients are monitored, and what outcomes are expected for that disease. I think this is like a mini-residency. Sharyn, my colleague on this website, has had a similar experience; she was hired for her expertise in pediatric endocrinology but since then has worked on drugs for many other indications. Now, If you are an oncologist and you are hired by a company with a strong oncology pipeline, you might never have to learn a new field. Or if you are willing and able to move from one company to another, you may be able to stay within your specialty. Otherwise, you will learn to be a serial mini-specialist and an expert on drug development.
In some countries outside the US, there are special residency training programs to prepare physicians for positions in industry. Doctors in Belgium, Ireland, and Switzerland can be Board Certified in Pharmaceutical Medicine. Most US physicians learn about industry on the job.
There have been attempts to form professional organizations for pharmaceutical physicians in the United States. In 1993, Dr. Hans A. De Haan and others formed the American Association of Pharmaceutical Physicians (AAPP). I spoke to Dr. De Haan at the time, and he envisioned educational programs, including a program that might lead to Board Certification. But the AAPP closed and was supplanted by the The Academy of Pharmaceutical Physicians and Investigators (APPI) which later merged into a larger group called the Association of Clinical Research Professionals (ACRP). Just to add to the confusion, the ACRP included an organization for physicians called the Academy of Physicians in Clinical Research (APCR). Now, the APCR has become an independent group. The mission of the APCR is dedicated to providing meaningful education to physicians working in the field of clinical research. But, the APCR programs seem to focus more on clinical investigators conducting studies for industry than physicians employed by industry. Our site focuses on doctors who are working as employees or contractors in industry. We have included links to APCR and ACRP on the Organizations page under Resources.
Most PharmDs also complete post doctoral training in clinical specialities such as oncology or clinical pharmacology. Some PharmDs pursue training in disparate fields like law or get an MBA.
Similarly, some PhDs pursue Post Doc positions to better position themselves for jobs in industry. There is an interesting website sponsored by a group called the Cheeky Scientist that offers opinions about how and why PhDs might want to explore roles in industry.
In the section called ROLES, we will discuss the positions doctors fill as Executives and in Discovery, Development, Regulatory Affairs, Medical Affairs and Commercial departments.
There are several key differences between medical practice and working in industry. Medical practice usually concentrates on one patient at a time; BioPharm focuses on groups of people. There is a very strict regulatory framework that guides almost all BioPharm activity; and, in industry physicians work as part of collaborative, multidisciplinary teams. In the section called TEAMWORK we will explain how BioPharma physicians interact with other professionals to accomplish certain tasks and to develop key regulatory documents. Colleagues from Regulatory Affairs, Toxicology, Pharmacology, Clinical Research, Biostatistics, Data Management, Manufacturing, Sales and Marketing and clinical investigators are dependent on the clinical knowledge of physicians to get their jobs done just as we are dependent on their specialized knowledge and skills to conduct studies and get products approved.
In TRAINING we will provide short introductory summaries of key BioPharm topics. Some of the TRAINING materials, such as the discussion on the Phases of Clinical Trials, or Pharmacokinetics may seem simplistic to those who work in clinical trials, but may be new information for physicians in other areas.
In RESOURCES, we will provide links to organizations of interest and suggest sources for continuing medical education (CME) related to the industry.
Under the Home page, we have added pages called STORIES where we will ask our contributors to write a short summary of how they got into industry.
This site will focus on FDA regulations and US activities. But we will add information about international regulations such as ICH Guidelines, World Health Organization data standards since they are used worldwide, including in the US. We will also discuss some the educational programs that are available for physicians in Europe.
Working in BioPharma is exciting and clinically challenging. BioPharm doctors work with leading academic researchers in fields like cardiology, transplantation, cancer, etc. We learn from them and they learn from us.
They are experts in their field, but we bring an in-depth understanding of the regulations and procedures that must be followed to get new products approved marketed.
Pharmaceuticals or "drugs" are small molecules developed by chemical synthesis. "Biologics" include sugars, proteins, or nucleic acids refined from natural products or synthesized by biologic organisms. Medical devices include products as simple as dental floss and as complex as lasers or implantable pacemakers. Diagnostics include in vitro diagnostic tests for blood, other fluids or tissue samples, electrocardiography or medical imaging including x-rays, CAT scans, MRIs, mammograms, etc.
This site will focus on physicians, veterinarians, optometrists, dentists, podiatrists, PharmDs or PhDs who provide clinical expertise for the discovery, development, and commercialization of BioPharm products. For simplicity, we will use the terms "physician," or "doctor" and "medicine" to refer to all of these professionals and specialties. Doctors play important roles in BioPharm companies and regulatory agencies as executives, employees, investigators, or consultants. We hope to provide information for doctors who currently work in BioPharm and for others who are considering careers in the industry.
Our focus on physicians, PharmDs, PhDs, etc is not meant to downplay the important roles of others in our industry. We are indebted to the training and coaching we have received from Clinical Research Associates, Regulatory Advisors, Data Managers, Biostatisticians, and Commercial and Executive colleagues. But we felt there was a lack of information directed to physicians and other doctors in the industry.
One question that I am often asked by medical students or physicians is whether they need to complete a residency program before applying for a job in industry. In my experience, most physicians in industry have some residency experience and most are Board Eligible or Board Certified. I know a few medical writers who did not complete residencies and some physicians working in venture capital firms who have MD/MBAs with little clinical experience, but they are the exceptions. Physicians are usually hired as Medical Monitors in Clinical Research or as Medical Directors in Medical Affairs or Drug Safety. Most physicians are hired for their clinical expertise which usually comes from residency training. For example, for my first industry job, I was hired to work in Medical Affairs. The company was getting ready to launch a new drug to treat CMV retinitis in people with AIDS and they needed a Medical Director to supervise the preparation of launch support materials and to train medical and commercial staff. I had completed residencies in Pediatrics and in Public Health and had designed AIDS education programs. When approval of the new drug was delayed because more clinical studies were needed, I was "loaned" to the Research Division of the company as the Medical Monitor for additional studies in patients with HIV and studies to prevent life-threatening CMV infections in immunosuppressed transplant patients. After the CMV drug was approved, instead of going back to Medical Affairs, I stayed in Research. I joined the Project Team to develop a new immunosuppressant. I was not an immunologist or an infectious disease specialist, but I had learned a lot by working with transplant specialists during the CMV program. I stayed with that project until we hired a real infectious disease specialist and I moved to help implement the new studies in the international division. Since then, I have worked on drugs for transplantation, NSAIDs for pain, antibiotics and antifungal treatments, endocrinology, CNS, reproductive health, respiratory devices, glucose monitors, acne, etc. In each case, my job was to become a "mini-specialist" and to learn enough about the new indication to be able to interpret adverse events and efficacy. That means understanding how the disease is diagnosed, what the standard therapies are, how patients are monitored, and what outcomes are expected for that disease. I think this is like a mini-residency. Sharyn, my colleague on this website, has had a similar experience; she was hired for her expertise in pediatric endocrinology but since then has worked on drugs for many other indications. Now, If you are an oncologist and you are hired by a company with a strong oncology pipeline, you might never have to learn a new field. Or if you are willing and able to move from one company to another, you may be able to stay within your specialty. Otherwise, you will learn to be a serial mini-specialist and an expert on drug development.
In some countries outside the US, there are special residency training programs to prepare physicians for positions in industry. Doctors in Belgium, Ireland, and Switzerland can be Board Certified in Pharmaceutical Medicine. Most US physicians learn about industry on the job.
There have been attempts to form professional organizations for pharmaceutical physicians in the United States. In 1993, Dr. Hans A. De Haan and others formed the American Association of Pharmaceutical Physicians (AAPP). I spoke to Dr. De Haan at the time, and he envisioned educational programs, including a program that might lead to Board Certification. But the AAPP closed and was supplanted by the The Academy of Pharmaceutical Physicians and Investigators (APPI) which later merged into a larger group called the Association of Clinical Research Professionals (ACRP). Just to add to the confusion, the ACRP included an organization for physicians called the Academy of Physicians in Clinical Research (APCR). Now, the APCR has become an independent group. The mission of the APCR is dedicated to providing meaningful education to physicians working in the field of clinical research. But, the APCR programs seem to focus more on clinical investigators conducting studies for industry than physicians employed by industry. Our site focuses on doctors who are working as employees or contractors in industry. We have included links to APCR and ACRP on the Organizations page under Resources.
Most PharmDs also complete post doctoral training in clinical specialities such as oncology or clinical pharmacology. Some PharmDs pursue training in disparate fields like law or get an MBA.
Similarly, some PhDs pursue Post Doc positions to better position themselves for jobs in industry. There is an interesting website sponsored by a group called the Cheeky Scientist that offers opinions about how and why PhDs might want to explore roles in industry.
In the section called ROLES, we will discuss the positions doctors fill as Executives and in Discovery, Development, Regulatory Affairs, Medical Affairs and Commercial departments.
There are several key differences between medical practice and working in industry. Medical practice usually concentrates on one patient at a time; BioPharm focuses on groups of people. There is a very strict regulatory framework that guides almost all BioPharm activity; and, in industry physicians work as part of collaborative, multidisciplinary teams. In the section called TEAMWORK we will explain how BioPharma physicians interact with other professionals to accomplish certain tasks and to develop key regulatory documents. Colleagues from Regulatory Affairs, Toxicology, Pharmacology, Clinical Research, Biostatistics, Data Management, Manufacturing, Sales and Marketing and clinical investigators are dependent on the clinical knowledge of physicians to get their jobs done just as we are dependent on their specialized knowledge and skills to conduct studies and get products approved.
In TRAINING we will provide short introductory summaries of key BioPharm topics. Some of the TRAINING materials, such as the discussion on the Phases of Clinical Trials, or Pharmacokinetics may seem simplistic to those who work in clinical trials, but may be new information for physicians in other areas.
In RESOURCES, we will provide links to organizations of interest and suggest sources for continuing medical education (CME) related to the industry.
Under the Home page, we have added pages called STORIES where we will ask our contributors to write a short summary of how they got into industry.
This site will focus on FDA regulations and US activities. But we will add information about international regulations such as ICH Guidelines, World Health Organization data standards since they are used worldwide, including in the US. We will also discuss some the educational programs that are available for physicians in Europe.
Working in BioPharma is exciting and clinically challenging. BioPharm doctors work with leading academic researchers in fields like cardiology, transplantation, cancer, etc. We learn from them and they learn from us.
They are experts in their field, but we bring an in-depth understanding of the regulations and procedures that must be followed to get new products approved marketed.
