Advertise on podcast: Better Biopharma

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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