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    • Your Target Product Profile Can Be the Key to Regulatory Success


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      Published On Dec 02 2014, 2:40 AM

      Target Product Profile solution. Graphic of pills in the shape of the globe.

      Regulatory strategy hinges on having the end in mind from the outset

      "Begin with the end in mind" has become a popular catchphrase, but only because it proves itself to be true time and time again. You can more easily comply with regulatory requirements by expending increased effort into your target product profile. This is the foundation of your regulatory strategy and sets the stage for future development considerations. It is the second of ten elements of regulatory strategy:

      1. Summary of guidelines/precedents from multiple agencies
      2. Target product profile
      3. Agency interaction plan and timeline
      4. Identification of regulatory data requirements
      5. Assessment of registration routes and mechanisms globally
      6. Consideration of country registration timelines to meet business objectives
      7. Early market access and reimbursement plan
      8. Consideration of external influencing
      9. Lifecycle support and supplemental application plan
      10. Risk management and post-marketing plans

      Creating a target product profile starts by having the end, that is, commercial success, in mind. It defines your product's -

      • Critical attributes
      • Value proposition that uses market assessments, evidence, and data as the building blocks to tell a quantifiable, compelling commercial story
      • Market differentiation factors vis-à-vis other products in development or already on the market

      Aside from these three critical definitions, a criteria checklist can help further outline information you should know and document about your product:

      • Scientific plausibility
      • Preclinical data
      • Toxicology/ADME/PK
      • Indications/contraindications
      • Acute vs. chronic
      • Current standard of care
      • Unmet medical need
      • Diagnostic criteria required
      • Target population or subpopulation
      • Safety profile
      • Drug interactions
      • Endpoints
      • Route of administration
      • Manufacturing/stability
      • Anticipated storage condition
      • Shelf life
      • Pediatric development

      By responding to each of these items for your compound, you complete your profile in a way that helps you visualize the market-to-market realities, especially if you plan to file for regulatory approval in multiple countries.

      Linking trials to target product profile criteria produces a data delivery plan

      The target product profile also serves as the foundation for your clinical trials-their design, location of patient recruitment. By mapping trials to each checklist criterion, you essentially optimize study design and specify your data requirements to support each attribute. Doing this can also more efficiently leverage your research budget and move your molecule forward.

      The target product profile optimizes product labeling

      The target product profile, a key element of regulatory strategy, also enhances product labeling. You can list label elements-such as indication, population, superiority/inferiority, time to effect, boxed-warning, contraindications, warnings/precautions, drug interactions, role of administration, dosing frequency, dosage form, and others-and evaluate each relative to other drugs, minimal criteria for marketability, expected attributes, and attributes that provide additional value.

      Progressing from regulatory strategy to regulatory filing

      In evaluating drugs, regulatory agencies across the globe evaluate three characteristics:

      • Efficacy
      • Safety
      • Quality

      When you have collected and analyzed clinical trial data to populate each element of your profile, you are effectively developing your regulatory strategy, smoothing the path for your regulatory filing.

      You may decide that your target population includes several countries and regions. Your focus on a target product profile enables you to thread requirements through each criterion. Although country/region-specific regulatory agencies may stipulate different requirements, you should have all the data necessary to prepare your filing documents with confidence.

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    About William Hanlon, PhD

    William Hanlon, PhD is the Vice President, Head of Global Regulatory Affairs at Covance Inc. Dr. Hanlon brings over 25 years of experience and is responsible for all project related regulatory activities involving strategic planning, medical and regulatory writing, Health Authority meetings and document submissions.