A good plan, is work half done.

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.

Consulting Services

palleos' Consulting Services cover a product's progression in development from indication finding to trial development.

Product Definition

    Product Definition

  • Gap Analysis

  • Searching for Candidate Indications

  • Prioritizing Indications

  • Process Guidance for Indication Selection

Gap Analysis-Target Product Profile

    TPP Definition

  • Gap Analysis

  • Define (abbreviated) Target Product Profile (TPP)

  • Guided Authority Feedback on Product Definition

icon-focus-Development

    Development Plan

  • 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.

··················
·················

Prioritization

  • 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.

approval of an investigative drug product or medical device

palleos prepares a TPP through use of a two-step-approach:

··················
·················

Gap Analysis

  • 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).

medical-employment

Components of development plan may include:

Components of developplan may include