- Developed strategy and guidance for start up companies to approach vendor capital companies for funding.
- Provided a broad array of strategic, operational and management expertise to assist several start-up life sciences companies achieve their drug development and clinical trial goals within a short timeframe; thereby assuring continued funding and ultimately building value in the businesses.
Clinical Material Supply
- Supported CMC review for clinical materials which were found to exhibit aberrant behavior during stability study. Crafted strategy to maintain drug supply and study continuation.
- Created an outsourcing strategy to assume control of the supply chain and maintain low cost of goods for patient base.
- Developed strategy and guidance for a combination product which exhibited poor stability and aberrant release behavior.
- Provided expert guidance for a large volume direct compression product which exhibited flow and compression issues during routine manufacture.
- Strategic guidance provided for several emerging contract and generic manufacturers with regard to modifications of unit operations to facilitate throughput and enhance capacity for each company’s strategic business plan and future expansion.
- Provided CMO review and audits as a function of product development and program management for several clients.
- Established a product review project for a cosmetic face wash to improve shelf life and strengthen supply chain aspects.
- Transdermal system with release rate issues was brought in line, including an equipment and product functionality-based calibration system.
- Provided the technical resource team required for development of a transcutaneous drug delivery system.
- Development of comparability protocols and the level of “sameness” for iontophoretic systems and devices to support process automation.
- The demand for active pharmaceutical ingredient importation from Asia has been managed by SommaTech’s bilingual and GMP compliance savvy audit teams.
- Conducted due diligence and capability assessment of several ophthalmic manufactures for client acquisition and product introduction.
- Resolution for a marketed osmotic release product with a low CPK and reduced shelf life.
- Process introduction and validation of osmotic-based oral system for market introduction.
- Provided technical input, oversight and review for FDA review of specifications for an osmotic system.
- Provided technical input, oversight and CMC review for a fixed combination osmotic system.
- Benchmarked and developed curricula based matrix for a new hands-on pilot plant based training program for a major university.
Solid Dosage Formulation
- Provided subject matter expertise and facilitated in-house training programs covering physicochemical characterization of materials, solid dosage for formulation and technology/knowledge transfer for products.
- Provided expert support for scale-up of a low melting active pharmaceutical ingredient in an oral solid dosage form. Process modifications made mitigated variability seen during dissolution testing.