J. Kelly Ganjei, CEO of AmplifyBio, recently participated in a fireside chat panel at Advanced Therapies Week, a conference event in Miami hosted by the Phacilitate event group that brings together thought leaders in cell and gene therapy development for education, collaboration, and networking opportunities, where he shared insights into the intricacies of advanced therapy manufacturing, drawing from his extensive experience in the field, having built and led one of the earliest CDMOs in the marketplace for cell and gene therapies.
The panel, part of an industry event, provided a platform for Ganjei to discuss the evolution of manufacturing strategies over time, as well as how fundraising has evolved for our clients over the last 18-24 months (about two years). He shared important lessons learned being on the developer, VC, and service provider side of the table over the years and emphasized the critical importance of developing a proactive approach to commercialization, albeit phase-appropriate.
Key Points From the Fireside Chat:
Ganjei began by recounting his past experience as a drug developer early in his career, on the venture capital side later, and then as the CEO of the leading cell and gene therapy CDMO that was acquired in 2020/2021. Ganjei’s discussion focused on the challenges of raising capital early, trying to establish meaningful milestones, and how the VC perspective has changed over the years with more forward-looking perspective, including their experience around manufacturing challenges. Underestimations of the challenges faced during tech transfer processes and the challenges of picking the right CDMO further complicate CMC issues. He emphasized the historical trend of clients having and/or providing limited details about their products, often because they are still trying to figure out if the composition of their products can lead to “we’ll fix it later,” which increases the possibility of a commercial disaster. There was further discussion around finding the cheapest provider versus finding the most economical provider that can assist with your commercial journey.
Noteworthy points addressed during the discussion included:
Early Consideration of Commercialization:
Ganjei stressed the importance of thinking about commercialization at an early stage in product development, but balancing that with phase-appropriate decision-making. He urged developers to adopt a commercial mindset during the R&D phase to avoid potential pitfalls in later stages.
Sophisticated Approach to Tech Transfer:
Ganjei discussed the shift from a process-centric focus to a product-centric mindset, enabling a more sophisticated approach to drug development, and one that will facilitate tech transfer. This involves reintegrating R&D with CMC and addressing challenges in comparability assays and potency measures.
Hybrid Outsourcing Model:
A key aspect highlighted was AmplifyBio’s innovative hybrid outsourcing model, offering clients flexibility in choosing between traditional CDMO models, hoteling approaches or more hands-on engagement. This approach, Ganjei emphasized, provides a cost-effective and capital-efficient solution to clients who are still seeking to maintain control of their product manufacturing needs.
“We wanted to provide not just capacity, but the right capacity – the creation of an environment where you can utilize SMEs, resources and technology, essentially a sandbox environment to focus on commercialization early,” said Ganjei in a notable quote. “In building AmplifyBio, we looked and thought there was the possibility for three models to work together in the same footprint. We have clients that come in and say we have no desire to do any manufacturing. We’re going to work with you hand in hand on the tech transfer process.”
The fireside chat underscored AmplifyBio’s dedication to providing forward-thinking solutions in the rapidly evolving landscape of advanced therapy manufacturing. The hybrid outsourcing model, coupled with a proactive commercial mindset, and our access to a wide array of technology platforms, positions AmplifyBio as a strategic partner for developers seeking innovative and reliable manufacturing solutions.
AmplifyBio is a drug development and commercialization partner for advanced therapies. Launched out of Battelle in 2021, we provide industry-leading preclinical toxicology, safety, and pharmacology testing in an agile environment with analytics capabilities that serve the dynamic safety requirements of modern modalities. AmplifyBio further expanded in 2022 to offer R&D services with a particular focus on drug characterization services that de-risk scale-up and manufacturing. In 2023, we opened our first fully customizable manufacturing suites for lease in staffing models that range from full “hoteling” to more traditional outsourcing partnerships. In any service program, AmplifyBio clients harness decades of experience in drug development, safety testing, and manufacturing support services to reduce risks, timelines, and costs of bringing life-saving cures to patients.