Doxil

Medical affairs groups are an increasingly vital part of the modern pharmaceutical company. This review will highlight the major functions, customary organizational structure, and responsibilities of medical affairs departments. These groups perform a wide range of activities often overlapping with sales, marketing, clinical development, and customer service. Medical affairs personnel must strive for the highest scientific integrity in order to produce successful clinical trials and provide the greatest support for the market. It is important that they well understand the regulations surrounding their activities and appreciate the commercial implications of their work. How well the medical affairs group maintains this delicate balance will determine its overall success.

Key Words: Medical affairs; Drug development; Regulations; Medical science liaison

INTRODUCTION: THE NEED FOR MEDICAL AFFAIRS

PHARMACEUTICAL COMPANIES SPEND enormous resources in the quest for and development of new drugs. Often the commitment is over many years and involves various disciplines and skills. All of this effort culminates in filing marketing applications followed by approval for the researched indication. Increasingly, indications are obtained in relatively small-sized markets and expansion is planned to occur postapproval into larger sized markets often partially funded by the revenues generated by the smaller indication. In the past, these functions were performed under the auspices of the clinical groups within organizations. However, often these groups do not always consider the differences between postmarketing studies and clinical registration trials. Medical affairs can fill the need for the studies conducted postapproval. While supporting the marketplace, medical affairs can conduct efficient studies within all regulatory and Good Clinical Practices guidelines.

Launching of a new indication that has a small market share requires special expertise. This is yet another place where medical affairs has a significant role to play. Sales groups may be ill-positioned to accurately present the new product to physicians and often need help in making more expert presentations. Medical affairs groups can assist in developing appropriate positioning for new products and help to leverage the newer indications to come.

SUMMARY

Medical affairs groups are an increasingly vital part of the modern pharmaceutical company. These groups perform a wide range of activities often overlapping with such diverse entities as sales, marketing, clinical development, and customer service. The personnel involved must strive for the highest scientific integrity for this will engender not only a successful outcome in a clinical trial but also the greatest possible support for the market. It is important that they thoroughly understand the regulations surrounding their activities and, at the same time, appreciate the commercial implications of their work. How the group maintains this delicate balance will, in the end, determine its overall success.

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MAURICE J. WOLIN, PRISCILLA M. AYERS, AND ELAINE K. CHAN

Department of Medical Affairs, Chiron Corporation, Emeryville, California

Reprint address: Maurice J. Wolin, Department of Medical Affairs Chiron Corporation, 4560 Horton St. U-- 201, Emeryville, CA 94608.

Copyright Drug Information Association Apr-Jun 2001
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