Based on your requirements and individual challenges, we provide comprehensive consulting services for product development. In the course of a product's development we constantly focus on the core features of a product: The target product profile combining product features and goals for development.
Palleos' Consulting Services cover a product's progression in development from indication finding to trial development.
Searching for Candidate Indications
Process Guidance for Indication Selection
Define (abbreviated) Target Product Profile (TPP)
Guided Authority Feedback on Product Definition
Create a Product Development Plan
Define Chemistry, Manufacturing and Controls (CMC) requirements
Define requirements for clinical trials
Indication Identification and Prioritization (IIP) – define what comes first!
Palleos employs a stepwise process for the identification an prioritization in association with a compound whose indication has not yet been assigned by ist developer. The process balances ressources and comprehensiveness
Identification of „Initial Indications“
identification of initial indications by search of publica domain
in accordance with potential indications as communicated by product owner („structured brainstorming“)
Extraction of „Focus Indications“
systematic approach to reduce and focus the list of initial indications
Includes both scientific and medical research.
list of focus indications to be analyzed with respect to aspects that are usually part of a Target Produkt Profile (TPP).
Will be performed by use of a score cards that will result in a list of prioritized indications based on scores.
The Target Product Profile –
the road to commercial success!
A Target Product Profile, or TPP, is a document that is installed to facilitate the process that navigates toward the approval of an investigative drug product or medical device.
It is understood as a dynamic document that should be updated during the drug/device development process. To ensure this a TPP gives detailed and up-to-date information regarding the commercial and intended therapeutic goals of the product, in relation to the intended development plan that is needed to achieve these goals. In our experience, a TPP represents a realistic rather than an optimistic view of the goals of product development.
Palleos prepares a TPP through use of a two-step-approach:
Gap Analysis based on applicable guidelines
Identify missing information toward the intended development goal
Focus on relevant aspects with regard to assembly of a viable development plan
Target Product Profile (TPP)
Assembly of a Target Product Profile (TPP)
Strong focus on the intended final market position of the product, the target population, and competitors
Palleos offers an abbreviated TPP (assessment of the targeted therapeutic field, comparison with available competitor products) and extended TPP
The development plan – bridging complexity, pragmatism and regulatory requirements!
The Development Plan represents a detailed summary of the entire preclinical and clinical research strategy to define the critical path for the development program of an investigational product (i.e. drug or medicinal product).
By nature, it is a complex document that details the entire clinical research strategy of an IP, describing the clinical studies that will be carried out for a pharmaceutical entity, created by a pharmaceutical company. The development plan is derived from information within the Target product Profile (TPP).
Components of development plan may include:
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