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(a) User
specification
[Has the client - management or the board of
directors- given any sort of specification?]
"The board
has taken a strategic
review of the direction of this company (Atlantis Biotechnology)
and has identified that over the next 5 years, their is an urgent need to get more drugs into the
company development 'pipeline'.
The
company intends to take drug candidates from discovery to successful
clinical trials in humans. It then wishes to license its technology to multi national drug
companies. The company understands that this can only be done when a successful NDA
has been filed.
The business
development group in Atlantis Biotechnology has identified a discovery
of a made by Wahoo University in an extract of the plant species Dianella revoluta."
(b) Scope
to be covered
[Details of the project. The scope could be
very large, but here we may only cover a small part, returning at later
stages to define and implement further work]
New Drug Application
"Develop and
submit an
application for registration of an extract of Dianella revoluta as a
treatment for Parkinson's Disease."
Stages in the project
1. Set up licence & patent agreements
The University holds the patent on the
molecule. Check the status of the patent. Ensure that
Atlantis Biotechnology
is licensed to commercialize the molecule.
Atlantis Biotechnology
requires exclusive rights for 15 years.
2. Conduct market survey
Research the potential market for a
drug of this type. How large is the market?
3. Review the basis for the claim.
Atlantis
Biotechnology staff to conduct a check of the experimental evidence
backing the claim.
4. Proof of concept
Arrange for an independent laboratory
to confirm proof of concept. This may mean that the molecule is taken
from the University to a Contract Research Organization and the
experiments on which the claim is made are repeated.
5. Develop formulation
The molecule needs to be incorporated
into a suitable drug delivery vehicle.
6. Develop toxicology testing plan
Test the molecule and its drug
delivery vehicle for safety in animals.
7. Develop clinical testing plan
Phase 1a testing (Escalating safety
doses in human volunteers - safety study)
Phase 1 testing (Efficacy study)
Phase 2 testing (large scale efficacy
study)
8. Produce product information file
9. Address regulatory requirements
10. Produce NDA & submit to FDA
Inclusions:
Part
(a) above
Exclusions:
Part (b)
under 2. above, is to be completed later
under separate contract.
Resources needed
All internal staff
groups not directly involved in production will be involved - Drug
Development Group, Research Methods Group, Quality Control, Quality
Assurance, Administration and Finance. External consultants as required
Temporal scope
To be completed by 31 March , 1999
Quality audit
An independent
project management organization will review project status every 12
months and report directly to the board of directors.
Standards
The following
standards are to be met: Code of Good Laboratory Practice (GLP),
Code of Good Clinical Practice (GCP),
Budget
For
the project is $USD3.45 million
Risk management.
Patent protection, intellectual
property are to be considered. |