CSR, Dossier, and Compendia Preparation

  • Prepared a phase 1 CSR for an oncology client
  • Prepared an AMCP dossier submission for a new formulation of an old product that was recently approved in oncology
  • Prepared AMCP dossiers for two different dosage formulations of the same product
    • In addition to published data and information included in the US Food and Drug Administration (FDA)–approved product labeling, this dossier contains information not included in the product labeling. This information is provided to assist decision makers with their formulary and coverage evaluations. The information presented follows AMCP version 4.0 dossier format guidelines
  • Compendia preparation
    • Conducted landscape analysis to evaluate needs for compendia submission for an oncology product
    • In another situation, developed compendia support materials
      • Reviewed clinical development plan
      • Reviewed key data presented at congresses
      • Evaluated data and messages
      • Evaluated competitor activity and compendium listings
      • Evaluated data gaps to anticipate competitor activity
      • Prioritized compendium submissions

Landscape Analysis for Treatment Guidelines and Pathways

  • Objective: To ensure a complete analysis and understanding of the managed care landscape of disease X in order to inform the development and implementation of a coherent plan
  • This analysis examined all of the priorities of stakeholders. Stakeholders included but were not limited to:
    payers, pathway development companies, FDA, patients, multidisciplinary healthcare providers, pharmaceutical clients
  • The end goal was to create a financial model that supports the way in which the product is utilized

Registry Construction, Implementation, Analysis, and Results Dissemination

We have both constructed and/or analyzed numerous registries, including shepherding the Registry protocol through WIRB approval or exemption. Our data collector is based on a HIPAA-compliant platform, which allows for both the collection of data online (using a secure portal) and through hard copy submissions, which are then scanned into the database. Our process:
  • Establish the primary objective of the Registry – what question are we looking to answer?
  • Define any directionality based on responses
  • Work with our client partner to establish the submission package for IRB/WIRB approval
  • Monitor responses and establish an opt-in / opt-out protocol
  • Curate and clean any data that is manually entered versus any multiple-choice questions
  • Develop a composite database that can be evaluated for biostatistical analysis
  • Provide analytical outcomes and make recommendations on the communications strategy for findings

Clinical Trial Booth Support at Congresses

  • Develop interactive booth panels to inform clinicians at congresses regarding clinical trials that are available for them to participate in
  • Educate them on how to get involved in clinical trials
  • Inform them of the trials available for their participation and briefly describe the trials

Outcomes Modeling

  • The approach taken to the tool was based on both indications and demographics to allow the greatest flexibility to tailor the presentation to the target customer
    • Educational presentation section
    • Outcomes tool with outcomes calculator
  • The tool focused on the HEDIS / NCQA standards and used evidence from the published literature to establish an outcomes model that supported the calculator aspect of addressing these standards
  • The tool highlighted how achieving objectives that are supported by the product’s dataset could help to address HEDIS measures and support NCQA accreditation requirements
  • The calculator aspect of the program was amplified and utilized to customize the presentation to the specific customer’s plan
  • The tool included a mechanism to capture information from the presentation and archive it for future use
    • There was a mechanism for the data to be transferred to a format the rep could e‐mail to the customer after the fact

Lexicon Development

  • Understand the manner in which a blinded description of a spasticity product (SP) is interpreted by healthcare providers (HCPs) and:
    • Identify the potential for use of various descriptors of SP
    • Develop a carefully defined lexicon to underpin all SP communications
  • Establish a lexicon structure that is distinct from those of key competitors
  • Establish terms and statements that should be “always used,” “used in context,” and “never used”
  • Define factors that drive the decision to treat spasticity and understand the vocabulary associated with those factors
  • Establish commonalities and variations in the vocabulary used by HCPs and patients to discuss spasticity and its treatment
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