Case Studies

We are experts in all facets of pharmaceutical product development.

Recent projects include product development of pre-filled syringe, auto-injector, transdermal, oral, nasal, pulmonary, and ocular delivery systems, due diligence for license, acquisition, and venture investments, portfolio strategy, and intellectual property strategy.

Problem Solving

Our experience in pharmaceutical product development is sought out for creative problem solving when research or development milestones are at risk of being missed or not achieved due to technical issues. We are brought in to solve formulation and device issues relating to precipitation on injection, aggregation in formulation, stability issues, and use our backgrounds and development experience to find creative alternatives. In addition, we provide strategic insight to management regarding probability of technical success, development uncertainties, and develop strategic plans to enhance the likelihood of success.

Pharmaceutical Product Development

We are usually engaged to provide support of biopharmaceutical research and development programs from discovery support to lead molecule selection and developability assessment. In addition, we serve as interim management for pharmaceutical drug product development, providing domain expertise to companies early in their maturity as development entities. We support strategic guidance for portfolio evaluation and technical support and leadership for formulation and device selection, development, and transfer to manufacturing.

Delivery System Development

Our first engagement with delivery system work for clients is typically evaluation and narrowing of the field of technologies and selection of the appropriate systems for feasibility assessment. The work continues with direct support of feasibility studies for preclinical candidate selection, and ultimately pharmaceutical development leadership and strategic guidance. We provide a framework for understanding process development and manufacturing system investment for unique technologies and continued technical support for evaluating, selecting, and transferring the technology to commercial suppliers.

Due Diligence

Venture capital firms hire us to provide technical and strategic insight for investments in assets, programs, and start-ups in biopharmaceutical drug development and device and delivery system development. Pharmaceutical biotechnology, and specialty pharma companies hire us to supplement internal resources with additional expertise. The deliverables for the due diligence are typically a powerpoint presentation and written report documenting the evaluation of the asset and its readiness for development and commercialization. A development risk assessment is usually included to assign relative risk across functional areas so that management has a summary of risks, impact, and mitigation strategies.