Label Analysis & Monitoring Platform (LAMP)
Label Analysis & Monitoring Platform (LAMP) Product Prospectus PRODUCT OVERVIEW The Label Analysis and Monitoring Platform (LAMP) is a multi-client subscription service from DRG that enables subscribers to compare drug labels and label claims across geographies and therapeutic areas. LAMP shows the commercial impact of label claims and the clinical trial structure that led to their approval. LAMP allows subscribers to benchmark and forecast which claims types are likely to get approved, and when; project the commercial impact of each label claim; determine how best to formulate label claims to optimize approval; and draw attention to key product differences at the claim level during sales presentations.
»» Ongoing monitoring for label revisions and rapid response subscriber alerts when label changes occur »» Access to label documents and clinical trial data
Our goal is to help our subscribers and partners leverage prescription label data to make informed business decisions about regulatory status, competitive positioning, market access strategy, trial design, and product launch strategy. Subscribers will use LAMP to accomplish the following:
KEY FEATURES OF LAMP »» Detailed label claim comparisons—across geographies (initially US and EU5, followed by other geographies) »» All label components available for comparison, including indications and uses, dosage and administration »» Label data for RA, MS, and HCV (additional conditions added weekly based on client demand)
»» Compare drug label across therapeutic areas and geographies »» Determine which labels are approved/submitted/rejected, and when »» Determine which claims are obtained/not obtained/ under review/expected to be obtained/not expected to be obtained »» Determine clinical trial development strategy based on trial results and outcomes »» Obtain up-to-date insights into landscape, by label status »» Export label data and clinical level detail
LAMP PRODUCT FEATURES Compare all aspects of FDA and EMEA label (including claims and claim types) for submitted and approved drugs Compare drugs across therapeutic areas (MS, RA, HCV) Determine the temporal rate for label benchmarking by manufacturer, claim type, geography, etc. Determine benefit of each claim—addressable population, formulary impact, HEOR value “Rapid Response” alerts for label updates and revision rejections Quick document access and downloading
INCLUDED
SUPPORTED GEOGRAPHIES Subscribers can compare prescription labels and label claims in (and across) the: »» US (FDA) »» EU5 (EMEA) »» Japan »» Other geographies to be added based on client request
FREQUENCY OF CONTENT UPDATES
OUR UNIQUE APPROACH
»» Our label, label claim, and clinical trial database is updated in real time as regulatory and market events occur
DRG leverages public and proprietary data assets to display the most current label, label claim, and clinical trial information across drug groups and indications. LAMP is unique in the following ways:
»» New therapeutic areas added weekly
KEY BENEFITS LAMP allows subscribers to compare labels and label claims. LAMP supports a number of biopharma teams: FOR REGULATORY AFFAIRS »» Comparisons across drugs categories and indications »» Regulatory status across therapeutic areas and geographies »» Replaces manual process with an online platform that always remains current FOR EARLY CLINICAL DEVELOPMENT »» Quantitative bar that exists to making a regulatory claim »» Label claims likely get approved, and when »» Claim status »» Downstream clinical and economic impact of label claims FOR HEOR TEAMS »» How individual claims impact addressable market size »» How clinical efficacy translate into HEOR value »» Differences between the US and EU label »» Label changes that have been made, and when »» How biologic claims will be impacted by biosimilar claims
»» Volume: We are building the nation’s first and most comprehensive label and label claim comparison too »» Accuracy: DRG’s label data is obtained by a team of pharmacists and quality reviewed by a team of pharmacologists »» Speed: FDA and EMEA label and label claims are applied to the tool daily and within 24 hours of change »» Actionable: Our tool provides subscribers with data than can inform regulatory, clinical development, and market access strategy.
KEY DRG CONTACTS BRIGHAM HYDE PhD, Chief Data Officer and Senior Vice President Decision Resources Group [email protected] DAN JACOB Vice President Decision Resources Group [email protected] ERIC VELEKER Product Development Lead Decision Resources Group [email protected]
»» Ongoing monitoring for label revisions and rapid response subscriber alerts when label changes occur »» Access to label documents and clinical trial data
Our goal is to help our subscribers and partners leverage prescription label data to make informed business decisions about regulatory status, competitive positioning, market access strategy, trial design, and product launch strategy. Subscribers will use LAMP to accomplish the following:
KEY FEATURES OF LAMP »» Detailed label claim comparisons—across geographies (initially US and EU5, followed by other geographies) »» All label components available for comparison, including indications and uses, dosage and administration »» Label data for RA, MS, and HCV (additional conditions added weekly based on client demand)
»» Compare drug label across therapeutic areas and geographies »» Determine which labels are approved/submitted/rejected, and when »» Determine which claims are obtained/not obtained/ under review/expected to be obtained/not expected to be obtained »» Determine clinical trial development strategy based on trial results and outcomes »» Obtain up-to-date insights into landscape, by label status »» Export label data and clinical level detail
LAMP PRODUCT FEATURES Compare all aspects of FDA and EMEA label (including claims and claim types) for submitted and approved drugs Compare drugs across therapeutic areas (MS, RA, HCV) Determine the temporal rate for label benchmarking by manufacturer, claim type, geography, etc. Determine benefit of each claim—addressable population, formulary impact, HEOR value “Rapid Response” alerts for label updates and revision rejections Quick document access and downloading
INCLUDED
SUPPORTED GEOGRAPHIES Subscribers can compare prescription labels and label claims in (and across) the: »» US (FDA) »» EU5 (EMEA) »» Japan »» Other geographies to be added based on client request
FREQUENCY OF CONTENT UPDATES
OUR UNIQUE APPROACH
»» Our label, label claim, and clinical trial database is updated in real time as regulatory and market events occur
DRG leverages public and proprietary data assets to display the most current label, label claim, and clinical trial information across drug groups and indications. LAMP is unique in the following ways:
»» New therapeutic areas added weekly
KEY BENEFITS LAMP allows subscribers to compare labels and label claims. LAMP supports a number of biopharma teams: FOR REGULATORY AFFAIRS »» Comparisons across drugs categories and indications »» Regulatory status across therapeutic areas and geographies »» Replaces manual process with an online platform that always remains current FOR EARLY CLINICAL DEVELOPMENT »» Quantitative bar that exists to making a regulatory claim »» Label claims likely get approved, and when »» Claim status »» Downstream clinical and economic impact of label claims FOR HEOR TEAMS »» How individual claims impact addressable market size »» How clinical efficacy translate into HEOR value »» Differences between the US and EU label »» Label changes that have been made, and when »» How biologic claims will be impacted by biosimilar claims
»» Volume: We are building the nation’s first and most comprehensive label and label claim comparison too »» Accuracy: DRG’s label data is obtained by a team of pharmacists and quality reviewed by a team of pharmacologists »» Speed: FDA and EMEA label and label claims are applied to the tool daily and within 24 hours of change »» Actionable: Our tool provides subscribers with data than can inform regulatory, clinical development, and market access strategy.
KEY DRG CONTACTS BRIGHAM HYDE PhD, Chief Data Officer and Senior Vice President Decision Resources Group [email protected] DAN JACOB Vice President Decision Resources Group [email protected] ERIC VELEKER Product Development Lead Decision Resources Group [email protected]
