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 (fr...

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...

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.bioproc...

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...

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...

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...

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 know...

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...

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...

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 t...

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...

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 Advance...

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...

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...

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 manu...

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...

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...

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 therapeu...

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 sha...

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...

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...

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...

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Tinglong Dai, Ph. D., Bernard T. Ferrari Professor of Business at Johns Hopkins University, and Tugce Martagan, Ph. D., associate professor at Northeastern University, to talk about the potential advancements that can be made in biomanufacturing by combining AI with operations research (OR). You can check out their recent p...

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Sean Tucker, Ph. D., founder and chief scientific officer at Vaxart, a company developing oral recombinant pill vaccines. They discuss Vaxart’s manufacturing process and how it differs from traditional biopharmaceutical production, as well as the regulatory considerations around its oral vaccines. Keep up with everything bi...

In this episode of "Better Biopharma," Tyler Menichiello is joined by Patrick Bilbo, chief operating officer at Organogenesis, a regenerative medicine company developing and manufacturing advanced wound care products. They discuss the construction of Organogenesis's new facility in Rhode Island, as well as how the industry has changed in the company's 40-year history. Keep up w...