Audit Data Services

Timely Data Resources’ Market Research Director, Michon Mahoney, has worked in the pharmaceutical industry with secondary audit data for over 15 years. Her extensive experience includes working with many secondary sources, including IMS Sales, Medical and Prescription Audits (US); IMS Global Medical and Sales Audits (MIDAS), Pipeline databases, Wolters Kluwer audits and databases, various oncology databases, pricing databases, and the services, databases and reports published by analyst services (DataMonitor, Decision Resources, Frost & Sullivan, etc.). We can help you figure out what data sources you will need, and with proper secondary data vendor authorization, we can write audit data queries, run the data for you, and then analyze it to help you learn what it really means. Recent projects have included the translation of US market definitions for a number of therapy areas into several global market definitions, running and analyzing global IMS MIDAS data, and providing suggestions as to which data measures to use for forecasting purposes. We are also currently using secondary data to determine the competitive threat posed from products in the pipeline for a client. Let us help you with your secondary data projects.

Epidemiology Studies

TDR analysts will fully characterize the epidemiology of a disease or condition, including (depending on data availability):

• Incidence and prevalence
• Segmentation by severity
• Diagnosis and treatment rates
• Annual number of deaths
• Trends in diagnosis and death rates

Countries and Regions are determined by the client. The data gathered in this analysis can be used to support forecasting, new product planning, and business development activities.

Methodology and Deliverables

The Timely Data Resources (TDR) epidemiology team will utilize all available sources to identify epidemiology data. In addition to data in the Incidence and Prevalence Database (IPD), which has already been reviewed and evaluated by the client, sources that may be used include but are not limited to the following:

• Review of full articles of epidemiology papers that are listed in the IPD
• Literature searches on appropriate key words
• Government sources such as the WHO, CDC, and the US NIH
• International foundations devoted to topic and related disorders
• Syndicated market research reports

TDR epidemiology analysts will identify the original source data and will fully appraise all information including text, tables, figures, and references to ensure that only useful, accurate and relevant data are included. Data will be reviewed and approved by our expert epidemiologist for inclusion in the database. The most valid data will be identified, and reasons for data rankings or weightings will be provided. The database will be built in an Excel spreadsheet format for each target country, and all data will be fully referenced to its source. If requested, a PowerPoint executive summary outlining the methodology, highlighting key findings, and identifying any data caveats will also be provided.

Publication Plans and Literature Benchmarking

Market conditioning is used to create excitement about and demand for a new product prior to launch and to build knowledge, awareness and interest for marketed products. Development and execution of a publication plan ensures that a company will have the market support required for conditioning the market. A foundation for creating new publication plans or updating existing plans is literature benchmarking, whereby the market story and message of competitor products created through the pattern of existing publications in professional and medical journals is mapped against the market environment. TDR provides benchmarking analyses that include determining the number of articles, authors, messages and specific journal placements that currently are available in the market. Armed with this analysis, our clients can develop publication plans that are cognizant of competitive presence and can work to ensure that their products will be seen above the crowd.

Examples:

• A company in Phase III trials with a third product in an established drug class wanted to know how the marketing story for the first two products evolved over time, including key messages, publication volume, most important journals, and most important authors for the year prior to launch, the year of launch, and for two years post launch. This information was used to develop and implement a publication plan utilizing messages that would stand out from the crowd, as well as to select potential authors and journals. TDR analyzed over one thousand articles for this literature benchmarking project.
• A company with a marketed product with an established positioning and message platform wanted to determine how their publication history could support their current messages and plan, and to determine where emphasis needs to be placed for future publications. TDR analyzed hundreds of articles for this literature benchmarking project.

Compilation of Secondary Data

For market research departments already stretched to the limit, TDR provides help condensing hundreds of pages of secondary data, including syndicated reports, analyst reports, completed custom market research studies, and third party audit data such as IMS and Verispan into a single manageable and useful document or database. We can also supplement existing data with literature and Internet searches to fill in gaps. With TDR’s experience in handling large scale searches and large volumes of data, we can quickly and easily condense and organize large volumes of information.

Example:

• A market research manager leading an international development team for a Phase III product had large volumes of syndicated data and custom market research, some that were ordered for other products that may have some relevance in her market area, some that she has purchased and commissioned, and some from her international colleagues. TDR signed the appropriate third party vendor agreements and confidentiality agreements to receive all of this data, and then analyzed it and condensed it into a single PowerPoint presentation with sections such as epidemiology, current treatment practices, patient segmentation, physician segmentation, competition, etc. Within each section, data from all of the different sources is summarized onto a few pages. The market research manager uses these PowerPoint slides for presentations, and used them to quickly determine where there is conflicting or missing information that needs to be addressed.

Analogue Analyses

Competitive intelligence involves understanding and applying industry best practices when developing a market strategy. When defining the product launch plan, looking beyond the typical competitors can expose successful strategies that may be applied to launching products with new mechanisms of action and new indications. TDR provides analyses that reach outside the box by summarizing best practices of market success stories. This analysis includes extensive review of secondary data and Internet sources to uncover results of research, literature placement, educational programs, marketing and selling strategies of blockbuster products.

Example:

• A company launching the first disease modifying therapy for a particular indication wanted to understand how disease modifiers for other conditions had been successfully explained and positioned. TDR reviewed secondary data, supplemented this with Internet searches, and then summarized this data into a resource document. Our client used this information to learn from the successes and mistakes of other companies that had introduced first in-class disease modifiers, and to learn more about the language used by competitors to describe their disease modifying therapies.

Market Assessment

Timely Data Resources (TDR) market assessments are developed by obtaining, reviewing, analyzing, and summarizing available published information. Market assessments for products in early stages of development typically include the topics outlined below. However, market assessments are customized to meet the specific needs of the client company. The contents of the market assessments are also dependent upon the quantity and quality of information that is publicly available for analysis and inclusion. The principals of TDR have developed market assessments and strategic plans for products in both preclinical and clinical development, in virtually all therapeutic areas. These assessments have been used to make strategic decisions regarding further development and marketing, or to prioritize indications according to market potential and likelihood of success.

NHANES Drug and Patient Profile (NDPP)

Customized profiles for drugs and diseases

New and informative ways to profile populations and medication users

Clients have asked for answers to questions about medications and populations that they were not finding in their typical audit sources. We realized we can run customized queries in the NHANES data set (based on 10,000 respondents) to provide the answers to these important questions ...

Interesting questions and the answers we’re finding…

• Demographics and lifestyle variables like citizenship, language spoken at home, income, poverty income ratio, military service, dietary habits, alcohol and cigarette consumption.
• Actual serum and urine laboratory test results so that we can build our own criteria for blood pressure or cholesterol or creatinine level, fasting glucose, A1C, 2-hour glucose tolerance test, etc.
• Estimates of both the diagnosed and undiagnosed populations.
• Prevalence data (number of patients) for chronic conditions like asthma, emphysema, chronic bronchitis, angina, congestive heart failure, liver conditions, thyroid problems, cancers (33 types).
• Dermatology, audiometry, ophthalmology, illegal drug use, dietary habits, depression , use of dietary supplements, hospital utilization and access to healthcare services, housing characteristics, osteoporosis, sleep disorders, sexual behavior, vision, and smoking.

Source

The National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to assess the health and nutritional status of adults and children in the United States. The survey is unique in that it combines interviews and physical examinations. The sample size varies by year, but there were 10,349 in the 2005-2006 survey. The 2007-2008 survey had 10,149.
More information: http://www.cdc.gov/nchs/nhanes/about_nhanes.htm