Better Biopharma

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...

In this episode of "Better Biopharma," host Tyler Menichiello is joined by Bonum Therapeutics' chief scientific officer, Diane Hollenbaugh, Ph. D., and chief business officer, Neela Patel, Ph. D. They talk about the inherent challenges of developing complex molecules like conditionally active biologics, sharing advice on CMC strategy, analytical methodology, and working with contrac...

In this episode of "Better Biopharma," host Tyler Menichiello is joined by MindImmune's president and CEO, Stevin Zorn, Ph. D. They discuss the development of the company's lead candidate, MITI-101, a monoclonal antibody designed to prevent peripheral immune cells from entering the brain and driving neuroinflammation linked to Alzheimer's disease. Keep up with everything b...

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by OS Therapies’ CEO, Paul Romness, and chief medical and scientific officer, Robert Petit, Ph. D. The three discuss the development and manufacturing of the company’s lead asset, OST-HER2, a Listeria-based immunotherapy for osteosarcoma. They also explain the unique CMC challenges around developing a safe bacterial vector. Ke...

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Fiona Elwood, Ph. D., VP and Neurodegeneration Disease Area Stronghold Leader at Johnson & Johnson. The two talk about J&J’s end-to-end organizational structure and its modality-agnostic approach to treating Alzheimer’s disease. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonl...

In this episode of “Better Biopharma,” host Tyler Menichiello is joined by Nicole Paulk, Ph. D., CEO and founder of Siren Biotechnology, a company developing a universal AAV immuno-gene therapy for cancer. They discuss the company’s decision to switch from plasmids to producer cell lines (PCLs) in production, the current funding environment for cell and gene therapies (CGTs), how companies are inn...

In this episode of "Better Biopharma," host Tyler Menichiello is joined by Adaptin Bio's CEO, co-founder, and president, Michael Roberts, Ph. D., and Duke University's Mustafa Khasraw, MD. They discuss Adaptin's Brain Bispecific T-cell Engager (BRiTE) platform, its clinical potential to deliver therapeutic T cells across the blood-brain barrier, and the development and man...

On this episode of Better Biopharma , Interius BioTherapeutics’ Sianny Christanti and Babu Medi, Ph. D., explain how the company is re-engineering a lentiviral vector to enable INT2104, its off-the-shelf, in vivo CAR T-cell therapy. They discuss the vector's design and its manufacturability, as well as the analytical and regulatory challenges of bringing this first-in-human therapy to the cli...

In this episode of Better Biopharma , Abalone Bio's CEO and co-founder, Richard Yu, Ph. D., explains how the company's functional antibody selection technology (FAST) platform differs from traditional affinity screening. Keep up with everything biomanufacturing at Bioprocess Online: https://www.bioprocessonline.com/ Follow Tyler Menichiello on LinkedIn: https://www.linkedin.com/in/tmenic...