Episode: 14 - Strategies and Approaches for Process Intensification With Dr. Stefan Schmidt

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 shares his thoughts on the key differences between biotech and pharmaceuticals and other manufacturing industries, what this means for how development programs are managed, and what the future holds for process improvement.  

Links from this episode:  
Evaluating Biopharma 
Black Diamond Networks 
Peregrine Bio 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

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 platforms. Mussa also provides advice on how to reframe one’s thinking when facing challenges, as well as techniques on keeping grounded when the going gets tough. 

LINKEDIN URLS:
Ben Locwin 
Black Diamond Networks
Cambridge Healthtech Institute
Evaluating Biopharma
Nesredin Mussa, PhD 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

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 as you go along the process. He also breaks down life cycle strategies and talks about downtime and its impact on the costs of the intensification strategy. 

Links from this episode:  
Evaluating Biopharma 
Black Diamond Networks
evitria AG 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

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 look out for when prioritizing by phase, and how to choose the best approach to measure process attributes. Finally, he shares his thoughts on leveraging data to its fullest potential to improve processes and how data can provide a more holistic view of how the process is performing.  

Links from this episode:  
Evaluating Biopharma 
Black Diamond Networks
Sangamo Therapeutics 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

What are some strategies that companies can use to get to IND filing quickly? In this brand new conversation, Evaluating Biopharma podcast host Ben Locwin discusses the risks and rewards of speed-to-IND strategies with Susan Jones, Chief Technology Officer at Tourmaline Bio. Susan delves into her 30 years of experience in the biotech industry, how quality by design impacts IND filing, and the pitfalls of using platform approaches to accelerate early development. Finally, she shares some case studies where accelerated timelines led to unexpected outcomes, as well as advice on knowing your situation and risks, and spending time understanding your molecule first.

Links from this episode:  
Evaluating Biopharma 
Black Diamond Networks
Tourmaline Bio 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

In this episode of Evaluating Biopharma, host Ben Locwin, Vice President of Project Solutions at Black Diamond Networks, speaks with Jonathan Tsang, Senior Director, Manufacturing Sciences & Technology at Kite Pharma, who shares his experiences and provides advice on how autologous cell therapy companies can better prepare for commercial manufacturing, including: addressing the challenge of variability of patient cell behavior, process development characterization using healthy donor vs. patient cells, volume and logistical complexity of personalized therapy, and planning and implementing fast and efficient business systems to support scale-out. He also discusses critical quality attributes he looks for during process development and his thoughts on developing processes that can cope with variability in reagents, media, and more. 

Links from this episode:  
Evaluating Biopharma 
Black Diamond Networks 
Kite Pharma 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

In this episode of Evaluating Biopharma, Mike Kelly, Senior Vice President at Atsena Therapeutics, shares his experiences and provides his advice on how your company can make proper CMC investments to reduce risk and maximize ROI, including: the make or buy decision, ensuring CMC investment to provide regulators what they need, scalability considerations, identifying technologies and assays to support your strategy, controlling COGS, and building a commercially feasible program profile. He also discusses factors that smaller businesses need to consider when choosing who to work with, such as fully understanding your needs and the compatibility between the sponsor and service provider in terms of technical capability, operational capability, management experience, and problem-solving tactics. 

Links from this episode:  
Evaluating Biopharma 
Black Diamond Networks 
Atsena Therapeutics 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

In this episode of Evaluating Biopharma, Ben Locwin, Vice President of Project Solutions at Black Diamond Networks, speaks with Susan D'Costa, Chief Technology Officer at Alcyone Therapeutics, who shares her experiences and provides advice on how your company can identify and overcome CMC challenges in gene therapy, including: understanding and monitoring DNA constructs, identifying starting material challenges, prioritizing potency assays, and the impact of viral vector delivery and development of capsid tropism. D'Costa also talks about her hopes for the future of gene therapies and building better CMCs, processes, and characterization tools that will provide more accessible treatment for patients. 

Links from this episode:  
Evaluating Biopharma 
Black Diamond Networks
Alycone Therapeutics 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

Joseph Shultz, VP and technical head of biologics and vaccines at Resilience, and John Bonham-Carter, board member and VP of business development and product management at Erbi Biosystems, discuss the financial considerations biopharma companies face when implementing a continuous strategy. Shultz talks about the mindset of the senior leadership at Amgen—and then Novartis—that lead to the eventual adoption of a new bioprocessing system and how their strategies benefit multiple teams within a single organization. He also discusses the importance of setting key milestones to track successes and failures, the business parameters best suited for continuous bioprocessing, and the real and imagined hurdles associated with continuous over batch processing. 

Links from this episode:  
Evaluating Biopharma
Resilience 
Erbi Biosystems 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.

Marty Giedlin, vice president and head of technology operations at Senti Bio, speaks with moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, to share his experiences and provide advice on how allogeneic cell therapy companies can implement better manufacturing strategies. He discusses understanding and managing manufacturing expectations, letting biology drive strategic operations, and why data must drive chemistry, manufacturing, and controls. Giedlin also outlines how to best characterize starting materials, why a one-size-fits-all approach to process manufacturing is unrealistic, his predictions for the industry over the next five years, and his work developing NK-CAR treatments for various cancer cells. 

Links from this episode:  
Evaluating Biopharma
Senti Biosciences 
Black Diamond Networks 

Evaluating Biopharma boiler: Evaluating Biopharma taps into the insight and experience of biopharmaceutical leaders so today’s decision makers can leverage their knowledge, learn from their successes, and avoid repeating similar mistakes. This series offers a new guest and moderator with each episode and aims to equip executives and science leaders with the necessary information to make better business and process decisions. The Evaluating Biopharma podcast is a reproduction of content originally presented at recent Evaluating Biopharma digital and educational networking events.