Capital Financing
- Developed strategy and guidance for startup companies to approach venture capital companies for funding.
- Provided a broad array of strategic, operational and management expertise to assist several startup 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.
Combination Products
- Developed strategy and guidance for a combination product which exhibited poor stability and aberrant release behavior.
- Provided technical support to a device manufacturer preparing for rapid market entry. This included technology transfer of the manufacturing process as well as the qualification of alternative CMO and sterilization services. Product was subsequently launched on schedule
Compression Products
- Provided expert guidance for a large volume direct compression product which exhibited flow and compression issues during routine manufacture.
- Provided the technical guidance to a startup firm to achieve a novel solid oral dosage form consisting of three layers. The product also included a novel slow release system which used ion exchange resin. The product formed the intellectual property for a series of patents for the startup firm.
Contract/Generic Manufacturing
- 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.
- Lead the technical team to resolve dissolution variability for a solid oral dosage form. The investigation revealed that although all components met quality requirements the crystalline structure of the API was subject to variability based on loss on drying limits set for the material. This resulted in variation during the wet granulation process and subsequent final dosage form variability.
Cosmeceuticals
- Established a product review project for a cosmetic face wash to improve shelf life and strengthen supply chain aspects.
Drug Delivery
- 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.
- Lead the equipment and process team leading up to the establishment of a new transdermal manufacturing facility.
International Experience
- The demand for active pharmaceutical ingredient importation from Asia has been managed by SommaTech’s bilingual and GMP compliance savvy audit teams.
Ophthalmic
- Conducted due diligence and capability assessment of several ophthalmic manufactures for client acquisition and product introduction.
- Provided technical support to a major ophthalmic device manufacturer during combination product development.
- Led the technical and regulatory team for an ophthalmic startup firm evaluating the commercialization of a new patented approach for device development and drug delivery.
Osmotic Products
- 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.
Pilot Plants
- Benchmarked and developed curricula based matrix for a new hands-on pilot plant based training program for a major university.
- Instituted a “scale-up or scale-out” approach for major generic firm in order to minimize capital investment while assuring maximum process flexibility.
Solid Dosage Formulation
- 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
- 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.
