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R4A idea 1
Abby Stock-Duerdoth
Created on November 30, 2023
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Transcript
R4A currciculum
1. Stratgey
0. General
2. candidate development
3. proving impact
4. Licencing
5. Market access
Intro
Intro
Direct data
The TPP
Indirect data
Need identification
TPP to RDP
TPP
Candidate identification
Screening
Validation
Finding
Market ready
Patietn ready
Explore
Strat+data
Preclin
Core m odules
recruit
ethics+regs
design
delivery
strat+data
clinical
sociotal
routes
Economic
path to market
buisness case
on label
off label
access
landscape
activities & pathways
strategy and data
SA
CT regs
seeking MA
regs
Funding for funders
applying for funding
Landscape
Introduction
funding
engagement
training
patients
foundational modules
strategy
post auhtporosation
approvals & access
clinical
preclinical
princiapls
manage
existing support
where & when
principals
agreements & contracting
as a tool
colab
Target Product Profile
TPP to RDP
Need identification
Direct data
Indirect data
The TPP
Topic
Topic
Topic
What is a TPP?
Topic
Topic
Topic
Topic
Topic
Gap Analysis
Using a TPP?
Topic
Topic
Topic
Topic
Topic
Topic
R4A currciculum
1. Stratgey
0. General
2. candidate development
3. proving impact
4. Licencing
5. Market access
Intro
Intro
Need identification
Direct data
TPP
TPP to RDP
Indirect data
The TPP
Validation
Finding
Candidate identification
Screening
Market ready
Explore
Preclin
Patietn ready
Strat+data
Core m odules
design
recruit
clinical
strat+data
delivery
ethics+regs
buisness case
on label
path to market
off label
routes
sociotal
Economic
access
landscape
regs
activities & pathways
strategy and data
SA
CT regs
seeking MA
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
Module 2: TPP
What is a TPP?
Indirect data
Need identification
TPP to RDP
Direct data
The TPP
The 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.
GAP analysis
Using a TPP
Learn more here:
Biocurate fact sheet
Book chapter
WHO page
Module 2: TPP
Gap analysis
Indirect data
Need identification
TPP to RDP
Direct data
The TPP
The TPP
What is a TPP?
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?
GAP analysis
Using a TPP
Learn more here:
Walk through and example
Article
Module 2: TPP
Using a TPP
Indirect data
Need identification
TPP to RDP
Direct data
The TPP
The TPP
What is 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’.
GAP analysis
Using a TPP
Learn more here:
Example TPP and webinar
Got an idea?
Let the communication flow!
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.
- Generate experiences with your content.
- It’s got the Wow effect. Very Wow.
- Make sure your audience remembers the message.
Got an idea?
Let the communication flow!
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.
- Generate experiences with your content.
- It’s got the Wow effect. Very Wow.
- Make sure your audience remembers the message.
The TPP
In this submodule you'll learn about what a TPP is and how to use it
Click on a topic to get started
- What is a TPP?
- Gap Analysis
- Usign a TPP
Got an idea?
Let the communication flow!
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.
- Generate experiences with your content.
- It’s got the Wow effect. Very Wow.
- Make sure your audience remembers the message.
Got an idea?
Let the communication flow!
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.
- Generate experiences with your content.
- It’s got the Wow effect. Very Wow.
- Make sure your audience remembers the message.