Author Archives: Sanjin Zvonic

Business Model Considerations for Development of Cell Therapies

The cell therapy industry continues to make progress, as measured by increasing numbers of clinical trials and patients treated (1). Although discussions of the differences between “off-the-shelf” (allogeneic) and “patient-specific” (autologous and matched allogeneic) therapies continue, we are confident that both will find success. The best way to approach development for a cell therapy product is to consider these three fundamental drivers that guide development: Speed to market (Which pathway will allow for fastest access to the commercial market?) Operational…

Technology Transfer to a Contract Development and Manufacturing Organization (CDMO)

Technology transfer (TT), the transfer of technical know-how from a product sponsor company to a contract development and manufacturing organization (CDMO), is the cornerstone of a fruitful working relationship between the parties. It is critical for successful advancement of the sponsor’s product development and commercialization efforts. Having worked with more than 100 clients over 14 years, PCT has performed nearly as many TT programs, underscored by the key success factors listed below. Communication: Upon establishing a collaborative sponsor– CDMO staff…

Managing the Challenges of Cell Therapy Product Delivery in Clinical and Commercial Settings

      Unlike traditional pharmaceuticals, cell therapy products (CTPs) require geographically dispersed networks of cell/tissue collection, manufacture, distribution, and clinical treatment facilities. Regardless of source (allogeneic, autologous) or formulation (e.g., fresh, frozen, scaffold), the vast majority of CTPs are clinically administered on a per-patient basis. A CTP will be clinically effective, and therefore commercially viable, only if it is robust enough to be delivered to the patient in an efficient, controlled, and reproducible manner. In the context of CTPs,…

Bench to Bedside

Over the past decade, the cell therapy field has matured into the next generation of medical technology. In both the United States and the European Union, physicians now have an option to write prescriptions for manufactured engineered cell therapeutics, as they routinely do for prescription medications. And the number of available commercial cell therapies is expected to grow. However, unlike traditional pharmaceuticals, engineered cell therapeutics require geographically dispersed networks of cell collection, engineering, manufacture, distribution logistics, and treatment facilities, thus…