DRUG SELECTION AND DEVELOPMENT:

Assessment of Drug Targets

Upon initial identification of a potential drug target, VDDI Pharmaceuticals will form a team which will liaise closely with VDDI Pharmaceuticals management during the diligence assessment process. The team will be responsible for 'scoring' each target according to a filter and sieving process identified above, and which will consist of the following elements:


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.


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