Translating product strategy into executable development plans

 

Wilco Consulting LLC © ALL RIGHTS RESERVED.

Wilco Consulting LLC (Wilco) provides product development services created for the biotechnology industry that can be broadly applied in regulated and complex environments.  Wilco collaborates with clients in strategy translation to create an executable development plan and then oversees the execution of that plan on the client’s behalf to generate data for fact driven evaluation.  By employing a planning cycle methodology focused on the generation of data confirming critical product attributes, assets can quickly reach value inflection points; thereby, allowing clients to employ resources efficiently while rapidly increasing the valuation of their portfolio.


Core Service Areas


PRODUCT DEVELOPMENT PLANNing 

Creation of an integrated activity based plan to achieve scientific and business objectives including:  funding procurement and licensing, clinical and nonclinical studies, process development and manufacturing, market research, and publications.


PROGRAM EXECUTION

Execution of the product development plan, leading or participating on a development team, and overseeing vendor activities. 


FUNDING PROCUREMENT

Work with clients to secure private funding, venture capital, and US government collaborations.


Asset evaluation and due diligence

Evaluation of drug candidates from pre-IND to phase I-III clinical development for technical feasibility (manufacturing, regulatory strategy, general program management) and development of businesses cases justifying, or not, their advancement.


Product profile and Development Plan creation

Creation of drug candidate product profiles and development plans that support investment in development.


Vendor Selection

Assist clients in assembling the right team and selecting and contracting with vendors to execute activities within the budget, timeline, and quality requirements defined in the product development plan.


Quality oversight

Oversight of vendor and activity deliverables to the appropriate levels of regulatory and quality standards based on the phase of development.


Regulatory, Quality, and operations systems

Establish basic systems and documentation required for compliance with cGXP and financial/management requirements for US funding agencies.  Build customized, or improve existing, systems and processes for managing general operations and project specific objectives.

 

Project management

General management of activities to meet or exceed established budgets and timelines.