R4A idea 1
Abby Stock-Duerdoth
Created on November 30, 2023
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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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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Sed diam nonummy nibh
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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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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
Lorem ipsum dolor sit amet
- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
Lorem ipsum dolor sit amet
- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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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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- Euismod tincidunt ut laoreet
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Lorem ipsum dolor sit amet
- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
Lorem ipsum dolor sit amet
- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
Lorem ipsum dolor sit amet
- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
Lorem ipsum dolor sit amet
- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
Lorem ipsum dolor sit amet
- Consectetuer adipiscing elit
- Sed diam nonummy nibh
- Euismod tincidunt ut laoreet
- Dolore magna aliquam erat
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- Consectetuer adipiscing elit
- Sed diam nonummy nibh
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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