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Pharma Teams Function and Team Organisation

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daniel susser

on 10 July 2013

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Transcript of Pharma Teams Function and Team Organisation

Kinapse Training

Functions and teams in Pharma

There are three stages before bringing a drug to market
So how are drugs companies set up to be able to produce drugs...
that are safe?
that are profitable?
that work?
Aim: Find assets for target
indications which warrant
testing in development

2. Development
Aim: Show the asset has efficacy
in target indication,
is safe, and value for money
3. Commercial
Aim: Communicate the value
of the product and sell it

3.5 years
5.5 years
10 years
Preclinical animal testing


Time: 2 years

Failure rate: 32%

Percentage of cost: 12.4%

Phase IIa and b
Phase I
Purpose:
Test ADME* & safety on healthy patients
10–30 subjects Single dose for a few days
Establish basic parameters for Phase II trials
Avg. 21 studies per programme

Phase III
Purpose:
Prove statistical significance of safety and efficacy claims
100’s of patients
Averagely 10 studies per programme
IIIa – core dossier for first filing
IIIb – studies conducted after filing

8.5 years
Regulatory review
Purpose:
Determine validity
of safety/efficacy
claims
Weigh cost and
benefits of therapy

2 years
Phase IV
Purpose:
Compare to other
treatment options
Expand Usage

Purpose: Test the safety & efficacy of the compound on animals
Development Timeline
Time: 1.5 years

Failure rate: 20%

Percentage of cost: 18.5%

0 years


Purpose:
Test efficacy on affected population
Determine proper dosing level
Phase IIa – Pilot Studies.
Phase IIb –Pivotal Studies
>100 Subjects,
Average 6 studies per programme

Time: 2 years

Failure rate: 8%

Percentage of cost: 27.2%
Exploratory development
ADME - Absorption, Digestion, Metabolism, Excretion
Time: 3 years

Failure rate: 32%

%age of cost: 38.3%
Time: 1.5 years

Failure rate: 1%

%age of cost: 3.7%
Survival rate of drugs
by this point: 7%
Full development
Approval and launch
Novel drugs are difficult to make, expensive and potentially dangerous for human consumption.
Source: CRM 2000

<12 Weeks of Treatment>

Typical Cycle Times

Typical Job Titles

Typical Departmental Involvement

Clinical
Statistics



Medical Writers




18 Weeks


Report
Findings

Analyze
Data

Collect and
Clean Data

Enroll Patients

Plan Trial and
Develop Protocol

Clinical
Data Management
Statistics
Health outcomes
Genetics
Safety
Commercial




Senior Positions:
TA Lead
Safety Lead
Commercial Lead


~15 Weeks (large variance)

Select
Investigators
and Set-Up Trial

There are six basic steps which are common for all clinical studies

Plan Trial and
Develop Protocol

Synthesize findings

Write-up Clinical Study Reports (CSR)

Report
Findings

Enroll Patients

Collect and
Clean Data

Enroll Patients
- Identify candidates
- Screen candidates
- Select patients
- Obtain informed
consent

Generate data tables
and line listings

Perform statistical analyses

Interpret results

Analyze
Data

Collect data

Transmit data

Error check/clean data

Assemble/integrate data

Finalize/lock database

Develop trial plan:
-Data
-Sample size
-Quality plan
-Analysis plan
Select investigators:
- Identify
- Screen
- Contract
Select Investigators
and Set-Up Trial

Develop protocol
-Draft protocol
-Develop Case Report Form (CRF)
Set up trial
-Obtain IRB approval
-Prepare data
collection system/
process
-Prepare trial supplies
-Conduct investigator training
Typical Departmental Involvement

Typical Job Titles

Typical Cycle Times

Typical Departmental Involvement

Typical Job Titles

Typical Cycle Times

Clinical
Data Management
Statistics
Health outcomes
Genetics
Safety
Commercial




Senior Positions:
TA Lead
Safety Lead
Commercial Lead



~15 Weeks (large variance)

Clinical
DM
Statistics



Study Manager
Statistician
Monitor
Data Manager


15 Weeks

Typical Departmental Involvement

Typical Job Titles

Typical Cycle Times

Investigator
Clinical
Safety


Monitors
Safety




35 Weeks

Typical Departmental Involvement

Typical Job Titles

Typical Cycle Times

Investigator
Data Management
Safety


Monitor
Data Manager



12 Weeks


Typical Departmental Involvement

Typical Job Titles

Typical Cycle Times

Statistics
Data Management



Statistician




3 Weeks

Typical Departmental Involvement

Typical Job Titles

Typical Cycle Times


Development Operations Representative:
Development Operations Head for the therapy area


Integrated Global Development Team

Guides the drug asset
through drug development
Accountable for all of the
Development Operations activities
in the therapy area
Clinical Programme Team

Executes clinical study
programme for each
drug asset

Development Operations Representative:
Development Operations Program Manager

Accountable for the delivery
of studies making up a
programme for an asset

Clinical Study Team

Executes single
clinical study

Development Operations Representative:
Development Operations Study Manager

Accountable for the delivery of
the study – from finalization of the
study protocol to the finalization of
the study report

To successfully guide the drug
asset through drug development

Team Accountability
Development
Operations
Head for the
therapy area

Clinical Science
Regulatory Affairs
Pharmacovigilance
Health economics
Medical Affairs
Manufacturing
Commercial
Project Lead
Project Manager
To successfully execute clinical trial programs for each drug asset


Team Accountability
Statistics
Regulatory Affairs
Clinical Science
Development operations project manager
Pharmacovigilance
To successfully execute
single clinical studies



Team Accountability
Medical writing
Statistics
Clinical Science
Development operations project manager
Data Management
Site Operations
That are profitable?
The Development Team
Project Team
Clinical Team
Trial Operations
Team (TOT)
Research
Marketing
Safety
Data Management
NCE Leader
Project
Planner
Pharmacology
Medical
Directors
Project
Manager
Global Project
Team Leader
Global Regulatory
NCE Leader
Global Clinical
Operations
Biostatistics
NCE Leader
Preclinical
Development
Intellectual
Property
Legal
Core Team
Additional
Members
Full transcript