Traditionally, Indian pharmaceutical industry was predominantly a generic industry. The focus was more on selling and less on marketing. The pharmaceutical physician was essentially involved in training of representatives and supporting marketing claims. However, in recent years industry focus has moved to research and development, international alliances and globally acceptable clinical research. The changes in schedule Y and legalization of Indian GCP guidelines, have led to a paradigm shift in clinical trial conduct. These developments have expanded the role of medical department beyond generic market support to global quality clinical trials. To cope with this situation, the industry medical professionals have to broaden their knowledge base and to sharpen their skills. This article reviews the training required to become an astute industry medical professional.
The Role of Pharmaceutical Physician
The medical marketing role is a balancing act between the commercial interests of the company and the responsibility as the voice of ethics for the company. The medical advisor has to act as the medical conscience of company and ensure that relevant regulatory requirements and guidelines are adhered to. S/he provides a medical perspective to product development and medical support to marketed products throughout their life cycle. Besides, s/he is the company's expert interface with medical profession and informs the company about the needs of patients and of medical profession.
The clinical research physician's role is to act as the scientific expert to support clinical development of a new product. S/he has to prepare a clinical development program, which is compliant with the current applicable regulatory and ethical guidelines and which is supportive of the commercial goals of the company.
Challenges of Medical Function
The two roles - medico-marketing and clinical research - face challenges of meeting the expectations of time and quality.
The medical advisor has to meet the expectations of internal customers - marketing, and external customers - prescribers. The marketing department wants promotional tools to be prepared rapidly, and approved promptly and expects high quality of medical support which can convince the external customers. The prescribers look forward to medical information which is scientific, ethical and useful in making decisions.
The clinical research physician has to meet the expectations of internal customers - management and external customers - prescribers and regulators. The management desires that the clinical development program meets scientific, regulatory and commercial objectives and is completed in a time bound manner. The prescribers want the data which are objective and which unambiguously prove the claims. The regulators expect that the conduct of clinical trials is in compliance with the regulatory requirements and ethical guidelines.
These twin expectations of time and quality require the pharmaceutical physician to be knowledgeable in many disciplines and to be skillful in diverse areas.
Knowledge
The essential knowledge disciplines are - therapeutic area, market, research, communication, regulatory, ethics, information support and legal. However, the focus is different for the market support and clinical research.
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For preparation of promotional tools, the medical adviser must have in depth knowledge of disease, therapy, product positioning, and competition. He should be able to train the sales persons and handle prescriber's queries. He should be able to work within the regulatory and ethical frame work and act as the conscience of the company.
For preparation of study protocol, the clinical research physician requires knowledge of disease, therapy, clinical research, statistics, pharmacovigilance, and SOPs. He should be able to train the CRAs and the site staff and answer protocol queries. He must be capable of complying with Schedule Y and GCP guidelines.
Skills
The pharmaceutical physician has to be proficient in many skills, which include:
Personal skills
" Language - English, Business, Scientific
" Speaking
" Writing
" Teaching
" Teamwork
" Interpersonal
" Creativity
" Diplomacy
" Computer
Business management
" Planning of project
" Crisis management
" Analytical
" Decision making
" Time management
" Finance management
The diversity of functions - market support, clinical development, investigator selection, preparation of documents / marketing material, participation in marketing meetings, planning of investigator meetings, training, regulatory approval - demand that the pharmaceutical physician has to be an excellent communicator and an effective manager.
Conclusion
In the current highly competitive and extremely regulated pharma industry, the pharmaceutical physician's job is quite crucial. The job combines him/her to be competent in managing the high expectations of internal and external customers. The pharmaceutical physician, who wants to succeed in these twin functions - market support and clinical development- , should make efforts to become well-informed in different subjects and be competent to handle complex business situations.
(The author is president, ClinInvent Research Pvt Ltd. arunbhatt@clininvent.com)