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Why CGT Manufacturing Still Faces Process Characterization and Scale-Up Challenges, According to MilliporeSigma’s Sebastián Arana

Human-Based Preclinical Models May Improve Toxicity Prediction in Oncology Development

Thermo Fisher Scientific’s Dr Anil Kane Discusses How AI and Strategic Partnerships Are Reshaping Contract Drug Development at BIO 2026

Trop-2-Directed ADC Sacituzumab Govitecan Earns FDA Approval in First-Line Metastatic Triple-Negative Breast Cancer

Formulating for Function: Strategies to Maximize Stability of Emerging Biologics

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At BIO 2026, Dr Howard Berman, ReAlta Life Sciences’ CEO, explains how an astrovirus-derived anti-inflammatory peptide targets multiple pathways that drive neonatal hypoxic-ischemic encephalopathy (HIE).

AI models can deliver transformative insights into drug manufacturing, but only when fed complete, traceable, and representative datasets.

At BIO International Convention 2026, Sabeen Mekan, MD, Vice President of Clinical Development at Zymeworks and panelist for The Next Generation of ADCs: Building Kinder, Gentler Cancer Therapeutics, discusses why safety is becoming an increasingly important differentiator in antibody-drug conjugate development and how biomarker-driven patient selection may help guide future treatment decisions.

MilliporeSigma Global Head of Process Solutions Sebastián Arana outlines why manufacturing flexibility, not just capacity, is now the strategic priority for biomanufacturers at BIO 2026.

The BioPharm Brief: Fibrosis, Bispecific ADCs, and Billion-Dollar Deals
This episode explores a first-in-class antibody entering the clinic for kidney fibrosis, the world's first approved bispecific ADC, and a major acquisition that strengthens AbbVie's immunology pipeline.

At the BIO International Convention 2026, oncology drug development expert Mohit Trikha, PhD, CEO, Kivu Bioscience, discusses the promise and limitations of organoids and other human-based preclinical models, emphasizing the need for stronger validation, cross-functional collaboration, and early regulatory engagement to improve clinical trial success rates.

Dr Wyatt McDonnell, Infinimune CEO and co-founder, posits that translatable, decision-linked single-cell data, and not data volume, are what drive effective therapeutic antibody development in this second segment of an interview at BIO 2026.

Mediar Therapeutics has dosed the first participants in a Phase 1 trial evaluating MTX-439, a first-in-class monoclonal antibody targeting SMOC2 for fibrosis associated with chronic kidney disease. The study marks the company's third anti-fibrotic program to enter clinical development and highlights growing interest in fibrosis-directed biologics.

China's National Medical Products Administration has approved izalontamab brengitecan (iza-bren) for recurrent or metastatic nasopharyngeal carcinoma, making it the first bispecific antibody-drug conjugate to receive regulatory approval anywhere in the world.

AbbVie has entered a definitive agreement to acquire Apogee Therapeutics for $10.9 billion, adding zumilokibart, a subcutaneous half-life extended IL-13 monoclonal antibody in Phase 3 development for atopic dermatitis, asthma, and eosinophilic esophagitis.

Speaking at BIO 2026, Infinimune's Dr Wyatt McDonnell explains how the company’s human-derived antibody platform enables multi-objective optimization that AI alone and transgenic models cannot replicate.

The BioPharm Brief: Triple Threats, TL1A Bets, and AI Brains
Innovent advances a trispecific antibody into phase 3 multiple myeloma testing, Bionyra enters the crowded TL1A race in inflammatory bowel disease, and Insilico Medicine partners with SK Biopharmaceuticals to apply AI to neuroimmune and CNS drug discovery.

At BIO International Convention 2026, Dr. Sabeen Mekan of Zymeworks, Inc., discusses how advances in ADC conjugation, payload selection, and antibody engineering could improve tolerability and therapeutic index for cancer patients.

Innovent Biologics has dosed the first patient in TriadicMM-1, a pivotal phase 3 trial evaluating IBI3003, a GPRC5D/BCMA/CD3 trispecific antibody, for relapsed or refractory multiple myeloma — marking the second trispecific antibody globally to reach pivotal phase 3 development in this setting and the first with independent intellectual property rights in China.

Newly launched Bionyra Pharma has raised $165 million in Series A financing and secured exclusive global rights to two TL1A-targeting biologics from China's TrueLab Biopharmaceutical — an anti-TL1A monoclonal antibody and a TL1A×IL-23p19 bispecific antibody — in a deal worth up to $985 million, positioning the company to compete in an IBD drug class already drawing attention from Merck, Roche, and the Sanofi/Teva partnership.



















