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Medical Affairs
- 1. MEDICAL AFFAIRS THE UNDERSTANDINGPHARMA SERIES Copyright © 2007. All Rights Reserved.
- 2. The central—and insome companies, the only—responsibility of Medical Affairs is operating a medical information function to field product queries. Primary Medical Affairs Capability Representative Call Volume Medical Information Pre-Launch Launch and Growth Maturity Note: This is a “directional” illustration of activity fluctuation within the medical information function. Copyright © 2007. All Rights Reserved. -Page 2-
- 3. Healthcare professionals contactthe Medical Information group to report problems they have experienced and to ask questions about product use. Primary Medical Affairs Capability Adverse Product Events News! Medical Information Medical Affairs -Page 3- Copyright © 2007. All Rights Reserved.
- 4. In some organizations,operating the Medical Information group is the Medical Affairs group’s sole responsibility. Range of Other Medical Affairs Capabilities Complex Disease States Unique Previously Scientific Aspects Unaddressed requiring explanation Medical Information Need Complex or Expensive Treatment Regimens -Page 4- Copyright © 2007. All Rights Reserved.
- 5. Favorable findings fromnon-registrational trials may, however, convince a pharmaceutical company to conduct additional registrational trials, seeking FDA approval of changes to the product label. Range of Other Medical Affairs Capabilities Clinical Trials FDA Approval Registrational Trials Non-Registrational Trials High New Findings Devoted Resources Update Product Label? Phase IIIB Moderate Indications Adverse and Usage Contraindications Reactions This product should not be Acetaminophen and codeine phosphate tablets are indicated for the relief of mild Clinical Development administered to patients who have previously exhibited hypersensitivity to moderately severe pain. to codeine or The most frequently reported Medical Affairs acetaminophen. adverse reactions are drowsiness, lightheadedness, dizziness, sedation, Low Clinical Pharmacology Each tablet contains: Warnings Precautions shortness of breath, nausea and vomiting. These effects seem to be more prominent 300 mg/30 mg *Phase IIIB General: Acetaminophen and In the presence of head codeine phosphate tablets Pre-Clinical Ph I Ph II Ph III Launch/ Maturity Codeine phosphate, 7,8- injury or other intracranial lesions, the respiratory depressant effects of codeine should be prescribed with caution in certain special- risk patients, such as the elderly or Growth didehydro-4, 5-epoxy-3- methoxy-17-methylmorphinan-6- ol phosphate (1:1) (salt) and other narcotics may be markedly enhanced, as well as their capacity for elevating debilitated, and those with severe impairment of renal or hepatic function, head hemihydrate, a white crystalline effects, such powder, is a narcotic analgesic and antitussive. It has the following structural formula: Stage in Product Lifecycle No Changes Note: This is a “directional” illustration of the roles of the difference in roles for Medical Affairs and Clinical Development. -Page 5- Copyright © 2007. All Rights Reserved.
- 6. Synthesizing all availableresearch and health economics data, Medical Affairs provides Brand teams with insights about their products. Range of Other Medical Affairs Capabilities Contribution of Insights Clinical Trial Findings Message 1 Message 2 Health Economic Research Findings Living Well Brand Team Magazine -Page 6- Copyright © 2007. All Rights Reserved.
- 7. Medical Affairs cultivatesrelationships with key opinion leaders in a number of ways. Range of Other Medical Affairs Capabilities Key Opinion Leader Relationships STUDY GRANT Study Sponsorship Preliminary Findings Medical Affairs Request for Participation in Clinical Trials and Speakers Programs Information Sharing -Page 7- Copyright © 2007. All Rights Reserved.
- 8. These programs aretypically in therapeutic areas and disease states relevant to the company’s product portfolio. Range of Other Medical Affairs Capabilities Educational Programs HIV / AIDS Cardiovascular Diseases Arthritis Oncology -Page 8- Copyright © 2007. All Rights Reserved.
- 9. The Medical Communicationsgroup within Medical Affairs designs and executes the publication plan for a product. Disseminating Information When will the relevant data be available? When should publications and press releases be scheduled? Publication Plan What publications are ideal? What assistance can we provide to the paper’s authors? -Page 9- Copyright © 2007. All Rights Reserved.
- 10. In some companies,publication planning is a more strategic undertaking, with greater emphasis on defining the data needed to make the publications effort effective. Disseminating Information 1 2 3 Determine 5 4 6 Refine Key 1 2 3 4 5 6 Key Messages 7 Messages 8Obtain 9 10 11 Determine 12 13 Determine Press 7 Additional Release Schedule Select Availability tions 14 Information Publica of Data 15 16 Obtain 17 18 19 20 8 9 10 11 12 13Fill Data ule Make Data Meet with S el ect s Gaps Sched leaseAdditional Decisions Authors 21 tion Re Information Publica Press 14 22 23 24 25 26 27 28 15 16 17 18 19 20 ule Meet with Sched lease Health Economics Press Re Authors 21 And Outcomes Studies 22 23 24 25 26 27 What are the key clinical messages? When will data be available? 28 What data are required to support them? When should publications and press releases be scheduled? What gaps are there in available data? What publications are ideal? How can those gaps be filled? What assistance can we provide to the paper’s authors? -Page 10- Copyright © 2007. All Rights Reserved.
- 11. The Medical Communicationsgroup also plays a role in medical writing for products in Phase IIIB and Phase IV trials. Medical Writing Disease State / Drug Introduction Hypothesis NEJM Results Conclusion “Dear Dr.” Presentation Posters Abstracts Letters Slides Presentati Posters on Slides Copyright © 2007. All Rights Reserved.
- 12. Medical Affairs mayalso be part of a promotional review committee, helping the Legal, Regulatory, and Compliance teams verify the accuracy of the clinical messages developed by the Brand team. FDA-Approved Package Insert Indications The most frequently Adverse Contraindications and Usage = reported adverse Reactions Acetaminophen and This product should reactions are codeine phosphate not be administered drowsiness, tablets are indicated to patients who have lightheadedness, for the relief of mild to previously exhibited dizziness, sedation, moderately severe hypersensitivity to shortness of breath, Clinical pain. codeine or Warnings Precautions nausea and vomiting. Pharmacology Each tablet contains: acetaminophen. General: These effects seem to 300 mg/30 mg Acetaminophen and be more prominent in Acetaminophen.......300 presence of In the codeine phosphate ambulatory than in mg head injury or other tablets should be nonambulatory intracranial lesions, prescribed with caution patients, and some of Codeine the respiratory in certain special- riskthese adverse Promotional Phosphate*……......30depressant effects of mg patients, such as the reactions may be Codeine phosphate, 7,8- codeine and other elderly or debilitated, alleviated if the patient *WARNING: May be narcotics may be didehydro-4, hemihydrate, and those with severelies down. habit forming. markedly enhanced, impairment of renal orOther adverse Review a white as well as their hepatic function, head capacity for elevating injuries, elevated cerebrospinal fluid intracranial pressure, Committee Brand Team Compliance Regulatory Legal Verified, Clinically-Accurate Commercial Messages -Page 12- Copyright © 2007. All Rights Reserved.
- 13. Finally, Medical Affairscontributes valuable market intelligence. Fielding of Medical Ongoing Safety Monitoring Non-Registrational Trials Queries 90 80 70 60 50 40 30 20 10 0 1st Qtr 2nd Qtr 3rd Qtr 4th Qtr Health Economics and Support for Value Outcomes Studies Non-Promotional Studies Proposition Continuing Medical Field Operations Market Intelligence Education -Page 13- Copyright © 2007. All Rights Reserved.
- 14. Medical Affairs isa global function. Example of Organizational Structure Global Development CEO Global Commercial Global Development VP Sales and Funding Global Medical Affairs Marketing US Medical Affairs Europe Medical Affairs Asia Medical Affairs Set Broad Strategy Ensure alignment across markets / avoid redundancy Define criteria for funding studies As appropriate, define global publication plan and pursue global KOL development. Copyright © 2007. All Rights Reserved.
- 15. Within individual markets,such as the US, Medical Affairs is sometimes organized by business unit, brand, or therapeutic area, so that the range of Medical Affairs services can be tailored to the complexity of the product and disease state. US Sales and US Medical Affairs Global Development Marketing CEO Option A Option B Option C Medical Medical Brand A Director, Medical Brand B Medical Director, Medical Director, Director Director, Director Business Unit Funding VP Sales and DirectorTherapeutic Area Brand Global Medical Affairs B Brand Brand C Marketing US Medical Affairs Europe Medical Affairs Asia Medical Affairs Copyright © 2007. All Rights Reserved.
- 16. Although the preciseway in which Medical Affairs defines its areas of specialization varies, for our purposes it is useful to arrange them in three broad groupings: Medical Research, Medical Services, and Medical Liaisons. VP US Medical Affairs Medical Director Medical Services Medical Research Medical Liaisons Medical Information Center Non-Registrational Clinical Corporate Accounts Medical Communications Trials Therapeutic Area Education and Training Health Economics and Outcomes Copyright © 2007. All Rights Reserved.
Editor's Notes
- #2 Welcome to the Understanding Pharma Series Course on Medical Affairs.
- #3 The central—and in some companies, the only—responsibility of Medical Affairs is operating a medical information function to field product queries. This function responds to and tracks questions and concerns regarding company products. As would be expected, the medical information center fields the greatest call volume in the time around the time of the market launch of a new product. Its activities, however, can span from the period preceding product launch throughout the remainder of the product life cycle.
- #4 Healthcare professionals contact the Medical Information group to report problems they have experienced and to ask questions about product use. Larger organizations operate a call center in which people with healthcare expertise receive these calls, respond to straightforward queries, and forward more complex calls to the appropriate experts in the Medical Information group. Because the call center mechanism is often used, people sometimes use the term “call center” as shorthand for the medical information function. Adverse events communicated to Medical Information are tracked and reported to the FDA. When important new information about a product arises, Medical Affairs is also responsible for communicating that information to prescribers.
- #5 When important new information about a product arises, Medical Affairs is also responsible for communicating that information to prescribers. The FDA mandates that pharmaceutical companies have an adverse event tracking mechanism for their products. In some organizations, operating the Medical Information group is the Medical Affairs group’s sole responsibility, however, in others, Medical Affairs has more far-ranging responsibilities. The role of Medical Affairs is typically most expansive in companies with one or more of the following characteristics: They treat complex disease states. Their products have unique scientific aspects requiring explanation. Their products have complex or expensive treatment regimens. They produce highly innovative products addressing a previously unmet need. All of these characteristics are likely to heighten the need—and demand—for clinical information.
- #6 Favorable findings from non-registrational trials may, however, convince a pharmaceutical company to conduct additional registrational trials, seeking FDA approval of changes to the product label.
- #7 Synthesizing all available research and health economics data, Medical Affairs provides Brand teams with insights about their products. The Brand team then leverages these findings as they develop product messages.
- #8 Medical Affairs cultivates relationships with key opinion leaders in a number of ways. Medical Liaisons Shares product information with KOLs Seeks their participation in clinical trials Encourages them to educate potential prescribers about the disease and appropriate therapies And sponsors studies of interest to them .
- #9 These programs are typically in therapeutic areas and disease states relevant to the company’s product portfolio. It’s critical to note, however, that Medical Affairs has no control over the actual content of the program.
- #10 The Medical Communications group within Medical Affairs designs and executes the publication plan for a product. Within a number of companies, publication planning means determining simply “when” and “where.” When will the relevant data be available? When should publications and press releases be scheduled? What publications are ideal? What assistance can we provide to the paper’s authors? These types of publication planning efforts are often outsourced to a Medical Communications vendor.
- #11 In some companies, publication planning is a more strategic undertaking, with greater emphasis on defining the data needed to make the publications effort effective. To support messaging efforts by the Brand team, Medical Affairs can provide clinical and scientific insights into the product’s strengths and differentiating attributes, identifying Data required to support them Gaps in currently available data Means of filling those gaps—such as additional clinical trials or health economic analyses
- #12 The Medical Communications group also plays a role in medical writing for products in Phase IIIB and Phase IV trials. Medical Writing is often in charge of drafting “Dear Doctor” letters, which we mentioned earlier are disseminated by the Medical Information group. Their Medical Writing team may also assist with the development of Meeting presentation materials, such as slide sets Posters—that is, oversized summaries of preliminary trial results, which key opinion leaders may present at medical conferences and in other settings, in what are known as “poster sessions.” Abstracts—summaries of published journal articles
- #13 Medical Communications may also be part of a promotional review committee, helping the Legal, Regulatory, and Compliance teams verify the accuracy of the clinical messages developed by the Brand team. The range of permissible clinical messages is circumscribed by FDA-approved language in the package insert, or label. Medical Affairs can help ensure that the Brand team’s proposed messages are consistent with the insert. Medical Affairs can also help verify product messages related to claims and findings that do not require FDA approval, such such as a health-economics and outcomes analyses. In addition to obvious misstatements and exaggerations, the team will look at subtler issues, such as, Can we say our product has “fewer and less serious side effects,” implicitly comparing it to competing products, without a head-to-head study? Does this promotional piece present a fair balance of benefits and risks?
- #14 Finally, Medical Affairs contributes valuable market intelligence.
- #15 Medical Affairs is a global function. Because Medical Affairs works closely with both scientific and commercial leaders within a pharma company, the function may be positioned under either Global Commercial or Global Development. Increasingly, as regulatory scrutiny has highlighted the need for a clear separation of commercial and educational activities, Medical Affairs has been aligned with Development—or sometimes in a direct reporting relationship to the CEO. Because issues and regulations differ by market, Medical Affairs Global has a very limited role in country- or region-specific activities. Its function is similar to that of Global Marketing—that is to say, Global Medical Affairs defines a broad overall medical affairs strategy and ensures that the activities across markets are aligned and that redundant efforts are avoided. It sets general guidelines for selecting which studies to fund. Global Medical Affairs may also take the lead on activities that can truly span all markets, such as publication planning and cultivation of internationally recognized key opinion leaders. Even when Medical Affairs is, as shown, situated within the Global Development hierarchy, its activities often come out of the Marketing budget. Protections are usually in place, however, to ensure that Marketing does not impose its commercial perspective on the way those dollars are spent—particularly in regard to external educational programs.
- #16 Within individual markets, such as the US, Medical Affairs is sometimes organized by business unit, brand, or therapeutic area, so that the range of Medical Affairs services can be tailored to the complexity of the product and disease state. The brand-specific model is common in larger organizations. In such organizations, each brand frequently has its own Medical Affairs Medical Director—an eminent physician—who is aligned with the Brand Director from Marketing.
- #17 Although the precise way in which Medical Affairs defines its areas of specialization varies, for our purposes it is useful to arrange them in three broad groupings: Medical Services, Medical Research, and Medical Liaisons. The basic functions of each group will be familiar to you from the previous sections of this module: Medical Services has a number of important responsibilities: The medical information center provides a venue for healthcare practitioners (and, to a lesser extent, consumers) to raise product concerns and seek information regarding product use. Most importantly, the medical information center gathers information regarding adverse events that may be associated with a particular product—and reports those adverse events to the FDA. The Medical Communications group briefs the Brand team on key clinical findings, handles internal medical writing related to later-stage trials, and performs publication planning. The Education and Training group selects and funds speakers programs, conferences, and continuing medical education. Medical Research handles the execution of non-registrational trials. The Medical Research group is also responsible for health economics and outcomes analyses The third major “division” within Medical Affairs is its field-based team, known as Medical Liaisons. The Medical Liaisons cultivate relationships with key opinion leaders and serve as an expert resource for sales representatives and for Managed Markets account managers in the field. In some organizations, there are two categories of Medical Liaison: Although the names by which they are designated may differ, the basic principal distinction is between those dedicated to corporate accounts, such as managed care organizations, and those with special depth of therapeutic expertise whose focus is on interaction with key opinion leaders.