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Transcript

5. Market access

4. Licencing

0. General

2. candidate development

3. proving impact

1. Stratgey

sociotal

routes

Core m odules

R4A currciculum

Intro

TPP

Preclin

clinical

access

regs

Finding

recruit

ethics+regs

design

Economic

path to market

delivery

strat+data

Market ready

Patietn ready

Explore

Strat+data

landscape

activities & pathways

strategy and data

SA

CT regs

seeking MA

buisness case

on label

off label

engagement

Funding for funders

training

existing support

where & when

principals

agreements & contracting

strategy

post auhtporosation

approvals & access

clinical

preclinical

princiapls

Direct data

as a tool

The TPP

Indirect data

Need identification

TPP to RDP

applying for funding

Landscape

Introduction

Intro

Candidate identification

Screening

Validation

foundational modules

funding

patients

manage

colab

Target Product Profile

Direct data

The TPP

Indirect data

Need identification

TPP to RDP

What is a TPP?

Using a TPP?

Gap Analysis

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

Topic

5. Market access

4. Licencing

0. General

2. candidate development

3. proving impact

1. Stratgey

Intro

Direct data

sociotal

The TPP

Indirect data

routes

TPP to RDP

Need identification

Core m odules

R4A currciculum

Intro

TPP

Preclin

clinical

access

regs

Finding

Candidate identification

Screening

recruit

ethics+regs

design

Economic

path to market

delivery

strat+data

Market ready

Patietn ready

Validation

Explore

Strat+data

landscape

activities & pathways

strategy and data

SA

CT regs

seeking MA

buisness case

on label

off label

foundational modules

funding

patients

manage

colab

Funding for funders

applying for funding

Landscape

Introduction

engagement

training

strategy

post auhtporosation

approvals & access

clinical

preclinical

princiapls

existing support

where & when

principals

agreements & contracting

as a tool

What is a TPP?

GAP analysis

Using a TPP

Module 2: TPP

What is a TPP?

A target product profile is a description of the medicine or device you want to make. It outlines the key characteristics the product should have in order to meet the needs of a specific target population.The world health organisation (WHO) says: They describe (1) the preferred and (2) the minimally acceptable profiles for vaccines, therapeutics, diagnostics or medical devices criteria. They also provide information for funders and developers on the performance and operational characteristics expected of products if they are to meet WHO’s needs.

Learn more here:

Biocurate fact sheet

WHO page

Book chapter

Direct data

The TPP

Indirect data

Need identification

TPP to RDP

The TPP

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Definition: the people you are trying to reach with a medicine e.g people with a specific disease or of a particular age

What is a TPP?

GAP analysis

Using a TPP

Module 2: TPP

Gap analysis

When creating a TPP, it is important to carry out a gap analysis. This process involves asking (and answering) questions about what data you have now and what data you need in order to apply for marketing approval for a drug. The gap is likely to be quite large, so breaking it down into smaller questions can help. What pre clinical work needs to be done? What patient populations are we going to focus on?

Learn more here:

Article

Walk through and example

Direct data

The TPP

Indirect data

Need identification

TPP to RDP

The TPP

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Definition: sign of from regulators that you are allowed to sell the drug in a particular country or area

What is a TPP?

GAP analysis

Using a TPP

Module 2: TPP

Using a TPP

Once you’ve created a TPP and carried out you Gap analysis, you can pull them together into a research development plan. a) TPP asks ‘what do you want to make’. b) GAP asks ‘what do we need to make that’. c) RDP asks ‘how are we going to do it’.

Learn more here:

Example TPP and webinar

Direct data

The TPP

Indirect data

Need identification

TPP to RDP

The TPP

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  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like!Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

Let the communication flow!

Got an idea?

Here you can include a relevant fact to highlight

  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like!Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

Let the communication flow!

Got an idea?

Here you can include a relevant fact to highlight

  • What is a TPP?

In this submodule you'll learn about what a TPP is and how to use it

The TPP

Click on a topic to get started

  • Gap Analysis

  • Usign a TPP

  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like!Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

Let the communication flow!

Got an idea?

Here you can include a relevant fact to highlight

  • Generate experiences with your content.
  • It’s got the Wow effect. Very Wow.
  • Make sure your audience remembers the message.

With Genially templates, you can include visual resources to wow your audience. You can also highlight a particular sentence or piece of information so that it sticks in your audience’s minds, or even embed external content to surprise them: Whatever you like!Do you need more reasons to create dynamic content? No problem! 90% of the information we assimilate is received through sight and, what’s more, we retain 42% more information when the content moves.

Let the communication flow!

Got an idea?

Here you can include a relevant fact to highlight