Susan Haigney

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, PhD, Parexel, answer questions on the use of real-world evidence for both small-molecule and large-molecule drug development. In addition, they tackle a question on supply chain security problems that arise during transportation of pharmaceutical goods.

In this episode of the Ask the Expert video series, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, talks to Piet Christiaens, PhD, scientific director, E&L expert at Nelson Labs, and Dennis Jenke, PhD, principal consultant for Nelson Labs and chief executive scientist, Triad Scientific Solutions, about extractables and leachables and the testing required for each.

The biological reagents provider is moving to a 5000-square-foot site in Cambridge Technopark to accommodate the company’s growth.

The licensing agreement between the two companies gives Pfizer the rights to develop, manufacture, and commercialize 3SBio’s bispecific antibody, SSGJ-707, which is in clinical trials for the treatment of a variety 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 if and when identity testing is necessary to be performed on a final product when the API is sourced from a third party.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

The investment is part of CGT Catapult’s Cross-Catapult Investment Pilot and will accelerate the pre-clinical development of Spliceor’s trans-splicing gene therapy platform.

Genascence’s first-in-class gene therapy blocking interleukin 1, GNSC-001, will enter a Phase IIb/III study in 2026.

The company’s gene therapy, AAVB-039, for the treatment of Stargardt disease progresses to a Phase I/II clinical trial.

Northway Biotech will develop and scale production of AATec’s ATL-105 for the treatment of non-CF bronchiectasis.

Scientists at MIT and other institutions have discovered compounds that activate a defense pathway inside host cells that could be used as antiviral drugs.

FDA will review GSK’s application to expand the use of its respiratory syncytial virus vaccine, Arexvy, to adults aged 18–49 who are at increased risk.

The consortium will focus on the delivery of a fully automated robotics cell and gene therapy manufacturing platform.

The next-generation monoclonal antibody could potentially be used to prevent and treat active COVID-19 infections, according to its developer, providing a non-vaccine option.

In this episode of the Ask the Expert video series, Simona Guidi, Associate Director, Cell and Gene Therapies at ProPharma, discusses the options available for controlling adventitious contamination in cell processing and the use of closed processing systems for cell therapy production.

EDQM is providing the 12th edition of the European Pharmacopoeia as an all-digital, redesigned, user-friendly issue.

The agency has recommended conditional marketing authorization for Zemcelpro (dorocubicel/unexpanded umbilical cord cells) to treat adults with hematological malignancies (blood cell cancers).

The Purolite AP+50 affinity chromatography resin has a 50-micron bead size that offers dynamic binding capacity of the AP resin platform while providing durability for monoclonal antibody capture.

Korro Bio CEO and president Ram Aiyar, PhD, delves into his company’s partnership with Novo Nordisk as a means of reaching a larger patient population with new ideas and approaches.

BioPharm International® spoke with Robert Cornog, senior director, Product Development, at Quotient Sciences about how commercial manufacturing and tech transfer impact biopharmaceuticals at the development stage.

Korro Bio CEO Ram Aiyar discusses his company’s platform that tunes the RNA editing process to target a wider range of rare diseases.

BioPharm International® spoke with William O. Bullock, Senior VP, Economic and Statewide Development, North Carolina Biotechnology Center, about the growing biotechnology industry in North Carolina.

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.