Pharmaceutical physician

A Pharmaceutical Physician is a healthcare professional, usually a medical physician, who works in drug development. They work in biotechnology companies, Contract Research Organisations (CROs), Regulatory Authorities, and pharmaceutical companies.

Role

Pharmaceutical physicians are key players in the development and lifecycle management of medicines, acting as crucial intermediaries between science, medicine, and regulatory frameworks. Their primary responsibility lies in overseeing the safe and effective development of new drugs, as well as investigating new uses for existing medications or medical devices. They engage extensively with a wide array of stakeholders, including pharmaceutical and biotech companies, CROs, government agencies, regulatory bodies, scientific communities, and patient organizations. The overarching goal of these collaborations is to bring innovative and promising therapies from the research lab to the market or to extend the use of already-approved drugs to new medical indications.

Pharmaceutical physicians contribute to the design, conduct, and monitoring of clinical trials. They work closely with sponsors—often large pharmaceutical companies or biotech firms—who fund these trials. In their regulatory role, they collaborate with agencies like the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other competent authorities in different jurisdictions. These physicians help navigate the complex regulatory processes necessary to obtain market approval for new therapies, ensuring that trials meet stringent scientific, ethical, and safety standards.

In addition to regulatory guidance, pharmaceutical physicians often lead clinical development teams, shaping the medical strategy for drug development. They may occupy various senior roles within companies, such as Chief Medical Officer (CMO), Clinical Development Physician, or Clinical Research Physician. In these roles, they not only oversee clinical trial phases but also ensure compliance with legal and safety standards while balancing commercial considerations and ensuring a return on investment for sponsors. Their tasks range from working on early-stage drug discovery to post-market safety monitoring and the medical aspects of product marketing.

Pharmaceutical Medicine as a Specialty Pharmaceutical medicine, a lesser-known yet vital medical specialty, deals with the discovery, development, evaluation, licensing, and marketing of medicinal products. It officially became a recognized specialty in the UK in 2002 under the Faculty of Pharmaceutical Medicine (FPM) of the Royal College of Physicians. The specialty has grown rapidly and is now global, with a significant number of professionals working outside the UK, reflecting the international nature of the pharmaceutical industry.

Training in pharmaceutical medicine usually involves a blend of on-the-job experience and formal education, such as obtaining the Diploma in Pharmaceutical Medicine. Over a four-year training period, pharmaceutical physicians acquire expertise in various areas, including regulatory affairs, pharmacology, drug safety, clinical development, and the healthcare marketplace.

Bringing Drugs to Market One of the primary roles of a pharmaceutical physician is to shepherd new drugs through the clinical trial process, from initial concept to market. This involves several phases of clinical testing to demonstrate a drug's safety and efficacy before it can be submitted for regulatory approval. Pharmaceutical physicians ensure that these trials meet ethical and scientific standards (in accordance with National and regional Good Clinical Practice and other applicable Clinical Trial Directives and Regulations) while navigating the logistical and regulatory hurdles involved in bringing new therapies to market. Additionally, they may conduct trials to explore new indications for existing medications through various regulatory procedures, expanding their use for different diseases or patient populations.

In summary, pharmaceutical physicians play a critical role in drug development by engaging a range of stakeholders—from regulatory bodies and industry sponsors to CROs and patient groups—to bring innovative therapies to market or explore new uses for existing treatments. Their diverse roles within companies, ranging from clinical research to medical strategy, highlight their vital position at the intersection of medicine, science, and industry.

Types

• Clinical pharmacologist or Phase I physician- works with chemists, biochemists, pharmacologists and toxicologists on first-in-human or early phase drug development. These physicians usually work with trials which expose the new drug to a patient or healthy population for the first time to evaluate safety and approperiate dosing.
• Clinical research physician (CRP) or Phase II/III physician- examines newly used chemical or biological products on patients after the initial safety phase. These physicians work on proof-of-concept clinical trial design and methodology, initiate trials, and monitor ongoing trials for safety.
• Chief Medical Officer (CMO) or Clinical Development physician (CDP)- Oversees entire clinical development program from conept, to all clinical trial phases, and the marketing authorization process of the drugs or devices. In addition to taking the responsibility of pre-marketing authorization phase of the drug's lifecycle, the CMO may also take the responsibility of post-marketing authorization phase of a drug's lifecycle, i.e., products that are already on the market. The latter invovles the resposnibility of post-market safety monitoring, and overseeing any required post-market clinical trials (e.g., Post Market Safety Assessment or Post Market Efficacy Assessment trials) or registry studies.
• Medical adviser (MA)- works with marketing and sales people to commercialize their company products.

History

Pharmaceutical physicians were first recruited after the second World War to fluctuate medical aspects of drug development. British Association of Pharmaceutical Physicians was the first industry composed of pharmaceutical physicians. It was created in 1957 in Britain.