Episode: 22 - Insider’s Advice For Starting, Growing, Exiting A Biotech Evaluating Biopharma podcast

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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 this episode: Evaluating Biopharma 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.…

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Episode: 22 - Insider’s Advice for Starting, Growing, Exiting a Biotech 35:01

25 weeks ago35:01

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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 how his organization is paying it forward to the industry. Links from this episode: Evaluating Biopharma Black Diamond Networks BioProcess360 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.…

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Episode: 21 - How AI is Changing the Antibody R&D Game 31:35

29 weeks ago31:35

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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 antibodies to treat cancer, autoimmune, and metabolic diseases. 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.…

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Episode: 20 - Optimal Talent Management in Biopharma with Mara Strandlund and Niamh Alix 19:38

36 weeks ago19:38

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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 and culture, and more. They also share tips on what goes into creating a team of exceptional talent, as well as a sneak peek into the key themes of their opening keynote. 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.…

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Episode: 19 - The Critical Role of Starting Materials & Processes in Advanced Therapies 17:20

42 weeks ago17:20

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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 and gene therapy going. 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.…

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Episode: 18 - Bispecific Antibodies: What Are They? How Do They Work? An Expert's Thoughts 23:56

46 weeks ago23:56

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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. 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.…

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Episode: 17 - Essential Program Management Considerations for Biopharma With Jamie Martin 22:56

1 year ago22:56

22:56

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 “best-in-class" tidbits they can immediately use. Links from this episode: Evaluating Biopharma 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.…

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Episode: 16 - Brian Tham on Project Management and Continuous Improvement in Biopharma 21:21

1 year ago21:21

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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.…

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Episode: 15 - Facing CMC Challenges in CDMO-Sponsor Relationships for Rare Disease Platforms with Nesredin Mussa 19:42

1 year ago19:42

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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.…

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Episode: 14 - Strategies and Approaches for Process Intensification With Dr. Stefan Schmidt 16:08

1 year ago16:08

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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.…

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Episode: 13 - Identifying Impurities In Gene Therapy With Santoshkumar Khatwani 19:38

1 year ago19:38

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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.…

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Episode: 12 - The Risks and Rewards of Speed-to-IND Strategies With Susan Jones 19:32

2 years ago19:32

19:32

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.…

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Episode: 11 - Cell Therapy Strategies: Preparing for Commercial Manufacturing of an Autologous Cell Therapy 21:49

2 years ago21:49

21:49

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.…

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Episode: 10 - Gene Therapy Analytics: How to Make the Right CMC Investments for Your Business 22:43

2 years ago22:43

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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.…

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Episode: 9 - Gene Therapy Analytics: Identifying and Overcoming CMC Challenges in Gene Therapy 24:32

2 years ago24:32