In this episode of Evaluating Biopharma, host Ben Locwin and Scott Endicott, executive leader of Healthcare Solutions Integration, talk about data governance and data provenance—why they matter and how the industry can achieve them. With 30 years of experience, Endicott has a deep understanding of training AI and ML models, particularly when patient data is included, and offers advice on how to navigate the challenges of data governance and provenance in the near-term future. Links from...

In this month’s episode of Evaluating Biopharma, host Ben Locwin and Chris Major, founder and partner of BioProcess360 Partners, discuss the best ways to start a company to address technology gaps, why it is beneficial to collaborate with competitors (instead of going against each other), and the challenges encountered when planning to de-risk portfolios in advance. Major also talks about how he approaches funding, the best practices and lessons he learned about time-to-exit strategies, and h...

In this month’s episode of Evaluating Biopharma, host Ben Locwin and Tony Arulanandam, SVP and head of R&D at Cytovia Therapeutics, discuss how AI is impacting the antibody R&D field, how companies are using AI to generate better sequences and improve efficacy, and methods on approaching regulators and tackling regulatory challenges. Arulanandam also talks about how he got started in biotech, getting therapies to underserved patient populations, and his thoughts on the promise of anti...

In this month’s special episode of Evaluating Biopharma, host Ben Locwin interviews Mara Strandlund, chief people officer at National Resilience, and Niamh Alix, chief human resources officer at Prime Medicine, about the upcoming Talent in Biopharma Leadership workshop at the 2024 Bioprocessing Summit. Their conversation covers a wide variety of topics about talent management, including prioritizing talent retention, building agility into talent acquisition strategies, the importance of brand...

In this month’s episode of Evaluating Biopharma, host Ben Locwin and Joaquim Vives, head of production of advanced therapies at Banc de Sang i Teixits, discuss cell and gene therapies and what sets them apart from other therapeutics in terms of their processes. Vives also talks about the top characteristics of good starting materials and particular modes of handling logistics. He also delves into correlating a particular donor for a certain patient and shares where he sees the future of cell ...

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. ...

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 ...

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 ...

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. ...

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 al...

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 developm...

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 ...

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 o...

Arthi Narayanan, innovation team leader of pharma technical operations at Genentech, and John Bonham-Carter, board member and VP of business development and product management at Erbi Biosystems, discuss how process analytical technology, artificial intelligence, and machine learning support intensified bioprocessing and improve inefficiencies. Narayanan talks about the expected outcomes predictive modeling will likely produce in the coming years, why data is the “power” of bioprocessing, and...

Parrish Galliher, an independent bioprocess consultant, speaks with moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, about the context-dependent issues that arise when scaling-up protein production. Gallaher uses a case study involving scaling challenges in E. coli bioprocesses that produced a product at 50% potency. He also talks about the three main focus points every company should prioritize when assessing process development limitations, how to design ...

In the biopharma space, nearly every moving part is contingent upon a functioning supply chain. In this month’s episode, moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, speaks with Rich Musa, director and head of supply chain at Cipla Therapeutics, about anticipating supply chain disruptions and planning for shortages. Musa talks about maintaining materials inventory, structuring robust supplier contracts, securing backup suppliers, and investing in a thir...