1. Lead contact/team leader. This individual is the spokesperson
representing VDDI Pharmaceuticals in communications with the company or organization
who is presenting the target for assessment. This person will
identify his/her counterpart in the drug target organization.
To ensure consistency in VDDI Pharmaceuticals representation, the team leader
must be present at all meetings with the target company, and all
communications from other members of VDDI Pharmaceuticals target assessment team
will be funneled through the team leader. The team leader is responsible
for keeping a complete log and record of all communications with
the target company, compiling data gathered during the assessment
process and placing this on central file with VDDI Pharmaceuticals.
2. Scientific Advisory Board assessment. These individuals
will have the appropriate background to be able to assess proposal
on a technical and scientific level. This person will be responsible
for identifying whether additional information is required for
assessment, as well as strengths/weaknesses of the potential target.
If additional information is required from the target company,
this will be requested through the team leader.
3. Manufacturing, product development technology transfer.
This person will be responsible for all issues related to the
product chemistry, biologic properties, manufacturing, regulatory
CMC and cost of goods forecasting.
4. Market
assessment. This individual (or individuals) will identify
the potential market for each target under consideration. In the
event that market assessment for different targets is conducted
by more than one individual at VDDI Pharmaceuticals, it is imperative that these
individuals harmonize their criteria/approach, so that assessment
is consistent.
5. Regulatory
strategy. This individual will identify the regulatory options
and possible strategies for developing the drug target by compiling
the approaches previously used to successfully develop similar
classes of drug and similar indications. This individual would
be expected to work very closely with the scientific assessor.
Information provided by the regulatory strategist is key to market/business
assessment.
6. Business strategy. This individual will be responsible
for identifying VDDI Pharmaceuticals' strategy (yield) for undertaking
the development of a target drug. They will identify the nature
of the business relationship(s), target companies for co-licensing,
identify mechanisms for funding etc. This individual would be
expected to work very closely with the market assessor.
