Evaluating Biopharma Evaluating Biopharma

In this episode of Evaluating Biopharma, host Ben Locwin speaks with Dr. Stefan Schmidt, CEO of evitria AG, about bispecific antibodies. Dr. Schmidt goes into detail about current trends (from a CRO’s perspective) regarding the discovery and development phases of bispecific antibodies, why they are being made, and potential manufacturing issues. He also discusses the future of bispecific antibodies and concerns over intellectual property immunity influencing consistency and production. E...

In this episode of Evaluating Biopharma, host Ben Locwin and Jamie Martin, PMP, senior consultant at Black Diamond Networks, discuss the tips and tricks of successful program management. Martin shares his mental checklist of must-haves to ensure a successful start, techniques on what to do when things fall off-track, and the keys to continuous success as the program is running. He also provides advice for listeners who may have newer programs or are new to program management, as well as the “...

In this episode of Evaluating Biopharma, host Ben Locwin speaks with Brian Tham, principal consultant at Peregrine Bio, LLC, on how various projects are run in the pharmaceutical industry, how to improve the outcome and processes of projects, and how to continue improving processes and operational excellence. They also delve into the history of how the car manufacturing industry influenced the quality management models and standards of the biotech and pharmaceutical industries. Finally, Tham ...

In this month’s episode of Evaluating Biopharma, host Ben Locwin speaks with Nesredin Mussa, PhD, president of Dynamica Biologics, about navigating the challenges of securing successful CDMO-sponsor relationships for a rare disease manufacturing and testing paradigm, the key contributing factors that may pose within the partnership between the sponsor and CDMO, and how small companies can manage with the enhanced regulatory demands due to the nascent nature of these particular therapeutic pla...

rocess intensification can be an overwhelming experience. In this episode of Evaluating Biopharma, host Ben Locwin speaks with Dr. Stefan Schmidt, CEO of evitria AG, about strategies and approaches that can help you understand and figure out how to navigate process intensification. Schmidt discusses ways to produce consistent results while using different equipment and technologies, how to find a balance between volume and capacity, and his experiences of putting proper support infrastructure...

In this episode of Evaluating Biopharma, host Ben Locwin speaks with Santoshkumar Khatwani, Director – Analytical Development, Late-Stage CMC Analytical Team Lead at Sangamo Therapeutics, about impurities in gene therapy processes and the ways to identify them. Khatwani discusses how to determine if these impurities are from the product, the process, or the host cell. He also talks about using multiple different analytical methods to help understand how good your process is or isn’t, what to ...