The Pharma Marketing Glossary

"Closed loop marketing (CLM) is the process by which a pharmaceutical company develops marketing strategies and deploys them through one or more channels to reach their customers (the prescribers) and gain a sound understanding of what happens in the marketplace. It's being able to understand what's working and what's not working. It's being able to understand objective data and refine the processes in a closed loop format so over time you continue to improve effectiveness both in marketing and sales." -- Source: Proscape Life Sciences President and Co-Founder Derek Pollock

"A new approach to pharmaceutical sales and marketing, Closed Loop Marketing redefines the interaction between sales representatives and physicians. The tools that are part of Closed Loop Marketing give sales representatives access to accurate, up-to-date data about a physician before each visit, allowing them to tailor product information to match each physician's patient profile and interests. Using Closed Loop Marketing, sales representatives can automatically feed data about each physician interaction directly to brand teams through a central sales portal, giving the brand team information required to refine marketing and strategy." -- Source: Microsoft

• "Closed-Loop Marketing: A New Role for eDetailing"

Under new regulations that govern the drug approval process, FDA's Center for Drug Evaluation and Research (CDER) will no longer issue "approvable" or "not approvable" letters when a drug application is not approved. Instead, CDER will issue a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.

"These new regulations will help the FDA adopt a more consistent and neutral way of conveying information to a company when we cannot approve a drug application in its present form," said Janet Woodcock, M.D., director of the agency's Center for Drug Evaluation and Research (CDER). "Thorough and timely review of drug applications is a priority of the FDA, and these new processes will make our communications with sponsors of applications more consistent."

Taking the place of "approvable" and "not approvable" letters, a "complete response" letter will be issued to let a company know that the review period for a drug is complete and that the application is not yet ready for approval. The letter will describe specific deficiencies and, when possible, will outline recommended actions the applicant might take to get the application ready for approval.

Currently, when assessing new drug applications, the FDA can respond to a sponsor in one of three types of letters: an "approval" letter, meaning the drug has met agency standards for safety and efficacy and the drug can be marketed for sale in the United States; an "approvable" letter, which generally indicates that the drug can probably be approved at a later date provided that the applicant provides certain additional information or makes specified changes (such as to labeling); or a "not approvable" letter, meaning the application has deficiencies generally requiring the submission of substantial additional data before the application can be approved.

"Complete response" letters are already used to respond to companies that submit biologic license applications. The process for drugs and biologics will be consistent under the new regulations.

• Complete Response Letter Final Rule.

Percent of doses of a drug taken as prescribed while patient is actively taking drug.

"An estimated half of those for whom treatment regimens are prescribed do not follow them as directed. Until recently, this was termed "non-compliance", which was sometimes regarded as meaning that not following the directions for treatment was due to irrational behavior or willful ignoring of instructions. Today, health care professionals more commonly use the terms "adherence" to or "concordance" with a regimen rather than "compliance", because these terms are thought to more accurately reflect the diverse reasons for patients not following treatment directions in part or in full. However, the preferred terminology remains a matter of debate. In some cases, concordance is used to refer specifically to patient adherence to a treatment regimen that is designed collaboratively by the patient and physician, to differentiate it from adherence to a physician only prescribed treatment regimen.Despite the ongoing debate, adherence is the preferred term for the World Health Organization, The American Pharmacists Association, and the U.S. National Institutes of Health Adherence Research Network." -- Source: Wikipedoia

• "Effective Pharma Adherence Programs Start With the Patient"

The Accreditation Council for Continuing Medical Education's (ACCME') definition of CME describes what content is acceptable for activities that are certified for credit:

Continuing medical education consists of educational activities which serve to maintain, develop, or increase the knowledge, skills, and professional performance and relationships that a physician uses to provide services for patients, the public, or the profession. The content of CME is that body of knowledge and skills generally recognized and accepted by the profession as within the basic medical sciences, the discipline of clinical medicine, and the provision of health care to the public.

A broad definition of CME, such as the one found above, recognizes that all continuing educational activities which assist physicians in carrying out their professional responsibilities more effectively and efficiently are CME. A course in management would be appropriate CME for physicians responsible for managing a health care facility; a course in educational methodology would be appropriate CME for physicians teaching in a medical school; a course in practice management would be appropriate CME for practitioners interested in providing better service to patients.

Not all continuing educational activities which physicians may engage in however are CME. Physicians may participate in worthwhile continuing educational activities which are not related directly to their professional work and these activities are not CME. Continuing educational activities which respond to a physician's non-professional educational need or interest, such as personal financial planning or appreciation of literature or music, are not CME.

CME that discusses issues related to coding and reimbursement in a medical practice falls within ACCME's definition of CME.

All CME educational activities developed and presented by a provider accredited by the ACCME system and associated with AMA PRA Category 1 Credit™ must be developed and presented in compliance with all ACCME accreditation requirements -- in addition to all the requirements of the AMA PRA program. All activities so designated for, or awarded, credit will be subject to review by the ACCME accreditation process as verification of fulfillment of the ACCME accreditation requirements.

• ACCME.

FDA regulations require prescription drug ads to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising is designed to dissipate or correct erroneous beliefs resulting from a false claim. Corrective advertising emerged in public debate in the United States in the 1970s as a hypothetical remedy for deceptive advertising, having first been proposed by Georgetown University law students in 1969 as a way of dispelling the effects of deceptive advertising.

Corrective advertising is one remedy FDA may request in response to false or misleading prescription drug promotion. In 2009, for example, Bayer HealthCare Pharmaceuticals produced and aired corrective DTC advertising for Yaz, a birth control pill, following a warning from FDA regarding misleading claims.

Source: FDA-CorrectiveDTCadStudy.pdf

Customer relationship management is a term that refers to practices, strategies and technologies that companies use to manage and analyze customer interactions and data.

The CRM approach tries to analyze data about customers' history with a company, in order to better improve business relationships with customers, specifically focusing on retaining customers, in order to drive sales growth. One important aspect of the CRM approach is the systems of CRM that compile information from a range of different channels, including a company's website, telephone, email, live chat, marketing materials, social media, and more.