Better Biopharma

2026 Regulatory Updates And Operation TrialBlazer

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by former FDA staffers Eva Temkin, partner at Arnold & Porter, and Elizabeth Trentacost, senior associate at Arnold & Porter. They reflect on 2026 regulatory developments and discuss the implications and nuances of Operation TrialBlazer. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Focusing On Quality Unit Independence With Tatyana Matveeva, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tatyana Matveeva, Ph.D., an expert in cGMP manufacturing and regulatory compliance. They discuss cell and gene therapy (CGT) manufacturing and the importance of maintaining quality unit independence within organizations, as well as some recent compliance violations at established manufacturing facilities. When it comes to CGT production, Matveeva advocates for a quality-by-design approach to protect patients and ensure compliance with regulatory requirements. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Developing Multi-Targeted T-Cell Engagers With Deck Bio’s Johanna Kaufmann

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Deck Bio’s chief scientific officer, Johanna Kaufmann, to discuss the company’s multi-peptide-MHC-targeted T-cell engager platform for solid tumors. Kaufmann explains the platform and reflects on the company’s journey through preclinical development. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Fixing AAV Recovery With Siren Biotechnology’s Nathalie Clément, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nathalie Clément, Ph.D., Siren Biotechnology’s SVP of vector development. The two discuss the historical challenges of purifying AAV vectors and the developments that have allowed for greater product yields. Clément shares where she believes the greatest gains can still be made to improve vector recovery and offers advice for teams seeking to optimize downstream unit operations. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Digitalizing The Biopharma Ecosystem With Kat Kozyrytska

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Kat Kozyrytska, a technology advisor and portfolio strategy leader. Kozyrytska shares her thoughts on how technology companies fit into the broader biopharma ecosystem. They discuss how AI is blurring the traditional boundaries between tech providers and therapeutics developers, as well as the increasing shift of tacit knowledge from human minds to the cloud. Kozyrytska also weighs in on how biotech companies should think about building, buying, or collaborating on AI platforms. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Modulating Multispecific Manufacturability With AP Biosciences’ JJ You, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Jhong-Jhe You, Ph.D., VP of antibody discovery at AP Biosciences. You explains how molecular complexity and aspects of antibody design can influence a product’s manufacturability and developability. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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The Facility Master Planning Playbook With Herman Bozenhardt

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by friend-of-the-show Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance. Bozenhardt shares practical advice for teams planning a new biomanufacturing facility or retrofitting an existing one. He explains how thoughtful facility master planning can mitigate costly design mistakes and improve site flexibility, ensuring facilities remain adaptable to future technologies, new products, and evolving regulatory expectations. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Cell Therapy Without The Cells: Building A Therapeutic Secretome With Noveome Biotherapeutics’ Larry Brown, Sc.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Larry Brown, Sc.D., chief scientific officer at Noveome Biotherapeutics, to discuss ST266, a first-of-its-kind secretome therapy. This cell-free biologic is essentially a collection of proteins and other factors produced by amnion-derived epithelial cells and is being studied for necrotizing enterocolitis. Brown explains the story behind this novel therapy, the GMP manufacturing process Noveome developed to produce it, and the CMC challenges it faces from a regulatory perspective. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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The Editors’ Roundtable: A Midyear Look At The 2026 Life Sciences Industry

In this special edition of “Better Biopharma,” host Tyler Menichiello is joined by chief editors from across the Life Science Connect ecosystem to discuss what’s shaping the pharmaceutical industry in 2026. The editors reflect on recent developments in their respective spaces and make predictions on what the rest of the year has in store. They also highlight some exciting projects happening across their publications. This roundtable features Katie Anderson, chief editor at Pharmaceutical Online; Jeff Buguliskis, Ph.D., deputy chief editor at Outsourced Pharma; Ben Comer, chief editor at Life Science Leader and host of The Business Of Biotech podcast; Ray Dogum, chief editor at Drug Discovery Online; Rachel Grabenhofer, chief editor at Clinical Supply Leader; Erin Harris, chief editor at Cell & Gene and host of Cell & Gene: The Podcast; Dan Schell, chief editor at Clinical Leader; and Anna Rose Welch, chief editor at Advancing RNA. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Validation Challenges Facing Advanced Single-Use Technologies

In this episode of "Better Biopharma," host Tyler Menichiello is joined by BioPlan Associates’ director of research, Katrina Cordovado, as well as Joshua Nelson, Ph.D., a senior material qualification specialist at Takeda, and Paul Priebe, a consultant and single-use expert, to continue their conversation from the Bioprocess Online Live event, "Closing The Adoption Gap For Advanced Single-Use Materials." Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Aligning Upstream And Downstream Development (Part 2)

In Part 2 of this conversation on “Better Biopharma,” panelists from the Bioprocess Online Live event “Optimizing Process Development Through Upstream And Downstream Integration” continue their discussion about how upstream and downstream development teams can work together to accelerate timelines and reduce risk and bottlenecks in process development. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Aligning Upstream And Downstream Development (Part 1)

In this episode of “Better Biopharma,” panelists from the Bioprocess Online Live event “Optimizing Process Development Through Upstream And Downstream Integration” continue their conversation about how upstream and downstream development teams can work together to accelerate timelines and reduce risks and bottlenecks in process development. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Reprogramming T Cells And Reducing Manufacturing Costs With RegCell’s Michael McCullar, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello speaks with Michael McCullar, Ph.D., CEO at RegCell, a cell-therapy company developing regulatory T cell (Treg) therapies for autoimmune diseases. They discuss RegCell’s origins and its disease-agnostic approach to product development, as well as the ongoing efforts to improve the commercial viability of cell therapies by reducing manufacturing costs through automation and point-of-care models. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Scaling Regenerative Medicine Production With PolarityBio’s Nikolai Sopko, MD, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nikolai Sopko, MD, Ph.D., chief operating officer, chief scientific officer, and director at PolarityBio, a biotech company developing SkinTE, an investigational autologous regenerative skin therapy for diabetic foot ulcers. The two discuss the challenges of scaling autologous therapy manufacturing, as well as the success PolarityBio has found in doing so through its parallel processing approach. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Pursuing Quality While Maintaining Process Control With Richard Moroney, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Richard Moroney, Ph.D., managing director at Stat Consulting. Moroney shares his thoughts on how organizations should think about and approach process control. His philosophy is one of continuous process improvement, as he believes there is "no ceiling" on quality control. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

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Unlocking The Therapeutic Power Of Fibroblasts With Pete O’Heeron And Hamid Khoja, Ph.D.

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by FibroBiologics’ CEO and founder, Pete O’Heeron, and chief scientific officer, Hamid Khoja, Ph.D. They discuss the powerful but often overlooked fibroblast, a type of connective-tissue cell that has tremendous therapeutic potential, according to O’Heeron and Khoja. They explain the company’s mission to realize this therapeutic potential and make fibroblasts a mainstay in the cell therapy space, rivaling the prominence of stem cells. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

Supporting The Bioprocessing Workforce In The AI Era With Sanofi's Eric Doerr

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Eric Doerr, a drug substance technical lead in the manufacturing science and technology (MSAT) group at Sanofi. The two discuss how the industry can support the next generation of biomanufacturing workers in North America, comparing incentives and initiatives in both the U.S. and Canada, where Doerr is based. Doerr also shares his thoughts on the need to proactively train workers in using AI to ensure that it serves as an enabling tool, rather than a disruptive force. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

Putting Pressure On CDMOs With Herman Bozenhardt

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Herman Bozenhardt, a consultant and industry veteran who has spent decades advancing the fields of biopharmaceutical manufacturing, engineering, and regulatory compliance. Bozenhardt outlines his concerns with the current outsourcing environment, noting a rising rate of noncompliance driven by poor facility maintenance and a shortage of reliable workers. He offers advice to sponsor companies working with CDMOs to help ensure their assets don’t fall victim to poor partnerships and operational mismanagement. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

Data Governance And Regulations For AI Use In GMP With Peter Baker

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Peter Baker, former FDA investigator and president of Live Oak Quality Assurance. They discuss Annex 22, the EMA’s GMP annex addressing the use of artificial intelligence (AI) in regulated manufacturing, including where it is sufficient and where it is lacking. Baker reflects on his time at the FDA and offers his own advice on AI and technology adoption and validation in GXP. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header

The Editors’ Roundtable: A 2025 Retrospective Of The Life Science Industry

In this special edition of “Better Biopharma,” host Tyler Menichiello is joined by fellow chief editors from across the Life Science Connect ecosystem to reflect on the year and share their industry outlooks for 2026. This editorial roundtable features Katie Anderson, chief editor at Pharmaceutical Online; Jeff Buguliskis, Ph.D., deputy chief editor at Outsourced Pharma; Ben Comer, chief editor at Life Science Leader and host of The Business Of Biotech podcast; Ray Dogum, chief editor at Drug Discovery Online; Erin Harris, chief editor at Cell & Gene and host of Cell & Gene: The Podcast; and Anna Rose Welch, chief editor at Advancing RNA. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenichiello/ Subscribe to our newsletters: https://www.bioprocessonline.com/user/edit/subscriptions Tell us how we can improve. Take our 60-second survey: https://docs.google.com/forms/d/e/1FAIpQLSfZGJluCmEhm1MBQvcm7_gtBEXuTx5v42LJ1mx9bCUKo8fwfg/viewform?usp=header