Scott Cleve brings an entire career dedicated to the mastery of global biopharma regulatory standards to his role as VP of regulatory operations and compliance at bluebird bio. Cleve joins the Business of Biotech podcast to discuss the regulatory trends shaping bluebird's pipeline of gene therapies for the treatment of serious, life-altering diseases. Listen now and subscribe so you never miss an episode.
Most hospital-based therapies are “patient ready,” pulled from inventory and used with minimal preparation. The success of advanced therapy medicinal products (ATMPs) requires partnership with those administering them, which is a new paradigm.
Small and midsize biopharma companies in the U.S. and Europe are under intense pressure to find more efficient and cost-effective ways to commercialize their products. In an increasingly competitive clinical trial environment, sponsors have begun to shift their focus to the Asia-Pacific (APAC) region for their studies. Here are five reasons why the APAC region may be a good fit for your global clinical trial.
There are many important considerations to address in building your new drug program. One of the most critical is funding to get you to your next milestone. In this guide, investment veterans and biopharma executives were asked which questions they often ask (and have been asked). Answer these questions well and your potential investors are that much more likely to support your company’s vision.
Due to their complexity and cost, developers of cell and gene therapies face unique manufacturing hurdles. Determining the right approach to manufacturing is crucial when bringing these advanced therapeutics from the clinic to commercialization. This paper provides a distinct perspective on how to approach manufacturing and other roadblocks at every stage of development.
To harness their full therapeutic potential, we must understand the relationship between target cell killing and other critical functions of individual T cells. This application note demonstrates how the Berkeley Lights platform can be used to interrogate antigen-specific serial killing activity of single CAR T cells and correlate this to cytokine secretion and proliferation while preserving individual T cells for downstream analyses or expansion.
Avectas, a cell engineering company, was preparing its nonviral cell engineering solution technology for commercialization and required its platform to be assessed by an experienced third party. They requested support from CCRM, a Canadian center of excellence in cell and gene therapy and a reliable partner to extend their development capacity and capabilities.
Case Study |
Thermo Fisher Scientific Bioproduction
The gene therapy division of a major pharmaceutical manufacturer was looking for ways to overcome capacity constraints due to the increased production demands for process liquids and buffers. Read how the customer benefited from the procurement of larger lot sizes that were not capable of being handled within their facility, resulting in annual savings for raw materials and QC testing.
The high cost of producing new cell and gene therapies is one of the largest issues facing the industry. After launching Kymriah and Yescarta, Novartis’s price tags were $475,000 and $375,000, respectively. Advancements in manufacturing are driving costs down, but not at the required pace.