Better Biopharma

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Will Olughu, Ph.D., global CMC lead and senior principal scientist at Ipsen, to talk about process modeling and AI applications in biopharma manufacturing. Olughu explains the distinction between static process models and dynamic digital twins, as well as the challenges of implementing digital twins in GMP environments (from data interoperability to model validation and regulatory considerations).

Watch Olughu’s recent appearance in a Bioprocess Online Live event on ensuring successful technology transfer in ADC development: https://www.bioprocessonline.com/doc/ensuring-successful-technology-transfer-in-adc-development-0001

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In this episode of "Better Biopharma," host Tyler Menichiello is joined by Tonix Pharmaceuticals' chief technical officer, Siobhan Fogarty, to discuss the planning and construction of its manufacturing facility in Dartmouth, MA, which was purpose-built for the production of its horsepox-based live viral vaccine platform, TNX-801. Fogarty details the design process and the challenges Tonix faced in the facility's construction, specifically highlighting the long equipment lead times and supply chain constraints as a result of the COVID-19 pandemic.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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."

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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.

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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/

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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.

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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.

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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.

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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.

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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.

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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.

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