Susan Haigney

BioPharm International® spoke with Jon Ellis, CEO, Trenchant BioSystems, about the commercial landscape for cell therapies and how digitization is impacting the industry.

The industry is diversifying pipelines from traditional small-molecule drugs to embrace complex and exciting new modalities.

BioPharm International® spoke with Oury Chetboun, CEO of Seekyo Therapeutics, to get his perspective on what impact new modalities and technology innovations are having on biopharmaceutical development.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss how to address an FDA warning letter citation for a failure to establish a quality control unit.

The company’s technology was used to create CAR-T cells that demonstrated the expression of complex CARs in a single DNA donor.

BioPharm International® spoke with Ryan Larson, PhD, SVP, Head of Research at Umoja BioPharma about how emerging modalities in cancer treatments, including cell therapies, are evolving.

Dr. Vinay Prasad, MD, MPH, a hematologist-oncologist, has been chosen to lead the Center for Biologics Evaluation and Research at FDA.

BioPharm International® sat down with Noah Kopcho, field application scientist at Gyros Protein Technologies, to talk about the challenges in the production of AAV vectors.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about how automation can accelerate and improve the formulation of high-concentration biologics.

BioPharm International® spoke with Lun Xin, associate director at WuXi Biologics, about high-concentration biologics and some of the biggest challenges associated with their formulation.

BioPharm International® spoke with Alexander Seyf, CEO and co-founder of Autolomous, about the impact geopolitical changes in Europe might have on the bio/pharmaceutical industry.

Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.

Black Hawk’s subsidiary, BH Merger Sub, will merge with Vesicor as part of the agreement.

The investment agreement will support the company’s ongoing clinical trials for its treatment for the rare genetic condition, spinocerebellar ataxia.

CAR T-cell therapies, TILs, and other advanced therapies are pushing progress in the treatment of cancers.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discuss EMA’s revised guidelines on data protection in marketing authorization applications.

The first patient has been dosed in a Phase II clinical trial for the company’s MB-105 first-in-class CD5-targeted CAR-T cell therapy.

Pharmaceutical Technology® Group spoke with Erik Wiklund, CEO of Circio, about the impact of the post-COVID-19 world on the pharmaceutical industry and how that has shifted the talent pool.

The agency has approved BMS’ Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma.

BioPharm International® interviewed Edwin Stone, CEO of Cellular Origins, about the bio/pharmaceutical trends from 2024 that continue to impact the industry in 2025.

Novartis will invest $23 billion during the next five years to expand manufacturing and R&D in the US, which will include seven new facilities and a new research hub.

At INTERPHEX 2025, the Pharmaceutical Technology® Group spoke with Joe Katakowski, director of Research at the RTW Foundation on how challenging it is to develop treatments for ultra-rare diseases.

Andrew Moreo, head of Process Development and Pre-clinical Manufacturing at Andelyn Biosciences, talks with BioPharm International® about the benefits and challenges of gene therapies developed to treat cancer.

Martin A. Makary, confirmed by a bipartisan vote of the US Senate, has been sworn in as FDA’s new commissioner.

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

Sarah Hein, co-founder and CEO of March Biosciences, sat down with BioPharm International® to talk about novel modalities for cancer treatment.

In response to a presidential Executive Order, the Department of Health and Human Services is planning to reduce its workforce, including cutting FDA staff by 3500 full-time employees, and reorganize some key departments.

BioPharm International® spoke with Helen Baker, director of Formulation Design at Quotient Sciences to find out how drug development can be optimized to ensure a more secure supply chain.

Dirk Margosch, Vice President Visual Inspection, Assembly & Secondary Packaging at Vetter Pharma-Fertigung GmbH & Co KG, provides advice on final product inspection for small batch sizes. He also discusses how to maintain cold chain during visual inspection.

The company gave a first look at its completed expansion at its manufacturing site in Gliwice, Poland during DCAT Week 2025 in New York City.