Susan Haigney

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.

BioPharm International® spoke with Alison Moore, chief technical officer, Codexis to find out the latest about the RNA therapy market and to get perspective on how enzymatic RNA synthesis is used to synthesize RNA molecules.

PharmTech Group sat down with Joseph Principe, chief commercial officer at Abzena, ahead of DCAT Week 2025 to get his perspective on how the geopolitical climate is impacting the industry.

PharmTech Group spoke with Peter Belden, president of Tjoapack US, ahead of DCAT Week 2025 to discuss recent innovations in bio/pharmaceutical packaging.

As part of our coverage of this year’s DCAT Week, BioPharm International® spoke with Hamilton Lenox, chief commercial officer at LGM Pharma about the expanding pharma market and the challenges such demand creates.

Lonza will develop a GMP-compliant process for Exogenus’ exosome-based lead candidate, Exo-101, at its Sienna, Italy site.

BioPharm International® spoke with Jason Bock, founder and CEO of CTMC, to find out about the newest cancer treatments, specifically developments in tumor-infiltrating lymphocytes.

The partnership will advance the accessibility, scalability, and affordability of RNA-based vaccines.

EMA’s CHMP recommended conditional marketing authorization for linvoseltamab to treat adults with relapsed and refractory multiple myeloma.

Sponsor companies and contract development and manufacturing companies must ensure that the suppliers they use are following sustainability guidelines to truly produce ‘green’ products.

Contractors are working with sponsor companies to establish and maintain sustainable manufacturing practices in pharma.

Contract manufacturers have special expertise in the characterization and validation of biopharmaceutical manufacturing processes.

The new AI co-scientist is a multi-agent AI system that acts as a virtual scientific collaborator to aid scientific research.

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 the implications of FDA’s new draft guidance on complying with 21 CFR 211.110.

Feb. 11, 2025 marks the 10th anniversary of the International Day of Women and Girls in Science.

The optimization of processes for the development and manufacture of biopharmaceuticals is pivotal for producing quality products.