Preparing for a Product Launch in a Medical Communications Department
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0092-8615/2000 Copyright 0 2000 Drug Information Association Inc.
PREPARING FOR A PRODUCT LAUNCH IN A MEDICAL COMMUNICATIONS DEPARTMENT AMY L. WERNER,PHARMD Drug Information Product Manager, SmithKline Beecham Pharmaceuticals, and Adjunct Assistant Professor, Temple University School of Pharmacy, Philadelphia, Pennsylvania
KIM M. MURRAY,PHARMD Senior Manager, Professional Services, Immunex, and Clinical Assistant Professor, University of Washington School of Pharmacy, Seattle, Washington
This article provides an overview of the range of activities and responsibilities of the medical communications department within the product launch process and provides a basis for both experienced professionals and jirst timers to form a plan. It covers: identifying personnel requirementsfor the launch process; preparing core launch m t e r i als; interactions with and services provided to other departments; training issues; evaluating resources; and postlaunch considerations. A proactive approach to launch responsibilities and clear and timely communication with all involved parties will help eliminate surprises and ensure that the product needs are met and the launch is successful. Key Words: Medical communications department; Product launch
INTRODUCTION FOR MANY DEPARTMENTS in a pharmaceutical company, approval of a new product by the United States Food and Drug Administration (FDA) is the culmination of activities that ranged from drug discovery, Phase VII studies, pivotal clinical trials, regulatory submission, to a possible advisory committee meeting. For many departments, product approval signals the end of many years of hard work getting the product ready to market. However, to the medical communications department, FDA approval and the product launch process marks the beginning of a new and critical phase of their involvement in the support of a product. Medical communica-
Reprint address: Amy L. Werner, PharmD. Drug Information Product Manager, SmithKline Beecham Pharmaceuticals, One Franklin Plaza, PO Box 7929, Philadelphia, PA 19101.
tions departments can offer a unique perspective regarding the development and presentation of a new product for the market, and the prelaunch and launch phases for a new product provide a wealth of opportunities for the medical communications department to showcase its value as an information resource for the company. With their product and clinical experience, medical communications specialists can anticipate health care professionals’ and patients’ potential questions before they become apparent. Product information launch letters become a key source of information for health care professionals since little information may be published or in the public domain regarding clinical data for a new product. The launch process for a new product can be one of the most exciting times for a medical communications department. Preparation and planning can alleviate some of the stress associated with the demands of a product
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