Episode 001: The Continuous Learning Curve: CPI’s Simon Hawdon On Process Conversion, Product Quality, And Platform Selection Evaluating Biopharma podcast

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You Can Visit All Seven Continents. But Should You? 26:46

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For many travelers, Antarctica is a bucket-list destination, a once-in-a-lifetime opportunity to touch all seven continents. In 2023, a record-breaking 100,000 tourists made the trip. But the journey begs a fundamental question: What do we risk by traveling to a place that is supposed to be uninhabited by humans? And as the climate warms, should we really be going to Antarctica in the first place? SHOW NOTES: Kara Weller: The Impossible Dilemma of a Polar Guide Marilyn Raphael: A twenty-first century structural change in Antarctica’s sea ice system Karl Watson: First Time in Antarctica Jeb Brooks : 7 Days in Antarctica (Journey to the South Pole) Metallica - Freeze 'Em All: Live in Antarctica Learn about your ad choices: dovetail.prx.org/ad-choices…

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Episode 001: The Continuous Learning Curve: CPI’s Simon Hawdon on Process Conversion, Product Quality, and Platform Selection

cách đây 3 năm trước 21:53

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In the inaugural episode of Evaluating Biopharma podcast, CPI’s Simon Hawdon speaks with Moderator John Bonham-Carter about the benefits of converting from batch to continuous processing and the critical decisions involved in making a high-quality product. Hawdon talks about whether there is an optimal time for process conversion, key equipment features that facilitate automation, and why improved sensors are imperative for process development. Finally, Hawdon shares his predictions on when he thinks real-time release sensors will debut and why necessity will always drive industry growth.

Links from this episode:
Evaluating Biopharma
Centre for Process Innovation
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.

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#Science #Biology #Evaluating Biopharma

Episode 001: The Continuous Learning Curve: CPI’s Simon Hawdon on Process Conversion, Product Quality, and Platform Selection

Evaluating Biopharma

published cách đây 3 năm trước

Chia sẻ

MP3•Trang chủ episode

Links from this episode:
Evaluating Biopharma
Centre for Process Innovation
Erbi Biosystems

24 tập

#Science #Biology #Evaluating Biopharma

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Evaluating Biopharma

1
Episode: 23 - An Industry Veteran’s Insight on Data Governance and Provenance 16:49

cách đây 23 weeks trước16:49

16:49

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.…

Evaluating Biopharma

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

cách đây 28 weeks trước35:01

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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.…

Evaluating Biopharma

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

cách đây 32 weeks trước31:35

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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.…

Evaluating Biopharma

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

cách đây 40 weeks trước19:38

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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.…

Evaluating Biopharma

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

cách đây 45 weeks trước17:20

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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.…

Evaluating Biopharma

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

cách đây 49 weeks trước23:56

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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.…

Evaluating Biopharma

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

cách đây 1 year trước22:56

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.…

Evaluating Biopharma

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

cách đây 1 year trước21:21

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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.…

Evaluating Biopharma

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

cách đây 1 year trước19:42

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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.…

Evaluating Biopharma

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

cách đây 1 year trước16:08

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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.…

Evaluating Biopharma

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

cách đây 1 year trước19:38

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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.…

Evaluating Biopharma

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

cách đây 2 years trước19:32

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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.…

Evaluating Biopharma

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

cách đây 2 years trước21:49

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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.…

Evaluating Biopharma

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

cách đây 2 years trước22:43

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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.…

Evaluating Biopharma

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

cách đây 2 years trước24:32

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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.…

Evaluating Biopharma

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Episode: 8 - The Financial Impact of a Continuous Bioprocessing Strategy 20:08

cách đây 2 years trước20:08

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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.…

Evaluating Biopharma

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Episode: 7 - Implementing an Efficient Allogeneic Cell Therapy Manufacturing Strategy 27:22

cách đây 2 years trước27:22

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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.…

Evaluating Biopharma

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Episode: 06 - Process Intensification: PAT, AI, ML to Support Intensified Bioprocessing 19:15

cách đây 2 years trước19:15

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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 how to leverage predictive modeling to accelerate tech transfer. She also discusses the importance of accepting and trusting new technologies, the mindset surrounding data and employee acquisition that often leads to success, and how to manage workforce integration. Links from this episode: Evaluating Biopharma Genentech 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.…

Evaluating Biopharma

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Episode: 05 - Navigating Scale-Up Challenges in Protein Production 20:45

cách đây 2 years trước20:45

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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 scale-down studies to pinpoint causal factors, and how to use high-throughput screening for media optimization. Finally, he advises hiring first-rate process development experts to mitigate scaling issues from the start. 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.…

Evaluating Biopharma

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Episode 4: Anticipating Disruptions: Identifying and Planning for Shortages 19:42

cách đây 2 years trước19:42

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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 third-party supply chain analysis. He also outlines the proper way to forecast materials, manage risk versus loss, and prepare suppliers to meet demand requirements in a dynamic environment. Links from this episode: Evaluating Biopharma Cipla Therapeutics 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.…

Evaluating Biopharma

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Episode: 3 - Cell and Gene Therapy: Managing the ‘Build or Buy’ Decision 22:36

cách đây 2 years trước22:36

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Dave Backer, founder of DB Biologics and former chief commercial officer at Oxford Biomedica, speaks with moderator Ben Locwin, vice president of project solutions at Black Diamond Networks, about the complex business and technological decisions companies face when navigating supply chain issues in the cell and gene therapy (CGT) market. Today’s companies must decide whether to build new facilities and produce their own supplies, continue buying from CDMOs despite excessive lead times, or choose a hybrid model. In this episode, Backer outlines the critical factors every CGT company should consider before venturing into manufacturing. He talks about why companies must think of plasma, lentivirus, and autologous cell therapy lines as separate entities, the value of developing solid partnerships with CDMOs, and how a hybrid model can protect intellectual property while still maximizing productivity. Links from this episode: Evaluating Biopharma Oxford Biomedica 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.…

Evaluating Biopharma

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Episode: 2 - Operational Efficiencies: Lower Operational Costs by Reducing Clinical GMP Sampling 25:12

cách đây 3 years trước25:12

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In this episode, Josefine Persson, Genentech associate director, and Ben Locwin, Black Diamond Networks vice president of project solutions, discuss how the cost of oversampling from clinical GMP runs versus development sources equates to high expenses and lost opportunities in moving a new project into GMP manufacturing. Persson also talks about the role judicious sampling plays in testing and verifying process operations and how she worked with various Genentech departments to reduce product sampling volumes by more than 50 percent. She goes on to discuss the importance of changing the company mindset to encourage behaviors based on department needs rather than wants, especially with smaller indication products. Finally, Persson details how conservative clinical GMP sampling dramatically impacts direct and indirect costs, increases speed to market, and reduces environmental impact. Links from this episode: Evaluating Biopharma Genentech 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.…

Evaluating Biopharma

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Episode 001: The Continuous Learning Curve: CPI’s Simon Hawdon on Process Conversion, Product Quality, and Platform Selection 21:53

cách đây 3 years trước21:53

21:53

In the inaugural episode of Evaluating Biopharma podcast, CPI’s Simon Hawdon speaks with Moderator John Bonham-Carter about the benefits of converting from batch to continuous processing and the critical decisions involved in making a high-quality product. Hawdon talks about whether there is an optimal time for process conversion, key equipment features that facilitate automation, and why improved sensors are imperative for process development. Finally, Hawdon shares his predictions on when he thinks real-time release sensors will debut and why necessity will always drive industry growth. Links from this episode: Evaluating Biopharma Centre for Process Innovation 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.…

Evaluating Biopharma

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Episode 000: Introducing the Evaluating Biopharma Podcast 2:07

cách đây 3 years trước2:07

2:07

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. 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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Evaluating Biopharma « Episode 001: The Continuous Learning Curve: CPI’s Simon Hawdon on Process Conversion, Product Quality, and Platform Selection

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Evaluating Biopharma «
Episode 001: The Continuous Learning Curve: CPI’s Simon Hawdon on Process Conversion, Product Quality, and Platform Selection