Susan Haigney

Real-world data can be utilized to ensure quality and effectiveness of drug products.

In this episode of the Ask the Expert video series, Susan J. Schniepp, Regulatory Compliance Associates, and Siegfried Schmitt, Parexel, give their opinions on why those working in the pharmaceutical industry should lend their voices to draft regulations.

Recent developments show how innovations and treatments for cancer are rapidly advancing.

Michael Ritchie, chief commercial officer at Champions Oncology, explains what makes radiopharmaceuticals unique in the treatment of cancer.

The company will also highlight its sustainability strategies and quality solutions at the event.

Pharmaceutical Technology® spoke with Juliana Maynard, PhD, Head of Translational Imaging at Medicines Discovery Catapult, to find out what makes radiopharmaceuticals unique and how MDC’s collaboration with Crown Bioscience can help developers of these treatments for cancer.

Artificial intelligence, machine learning, and novel instruments are helping drug developers evaluate complex data from bioanalytical studies.

Pharmaceutical Technology® spoke with Juliana Maynard, PhD, Head of Translational Imaging, at Medicines Discovery Catapult, to find out what makes radiopharmaceuticals unique and how MDC’s collaboration with Crown Bioscience can help developers of these treatments for cancer.

This article takes a look at the developing use of AI in pharmaceutical development and manufacturing.

This review of the nitrosamines contamination problem in pharmaceuticals takes a look at how the crisis started and developed.

A draft reflection paper on patient experience data is up for public consultation until Jan. 31, 2026.

Pharmaceutical Technology® spoke with Bryan Miller, Director of Scientific and Technical Operations at Crown Bioscience UK, to learn more about Crown Bioscience’s collaboration with Medicines Discovery Catapult on a new development platform for radiopharmaceuticals.

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.

Advancements for novel cancer therapies are booming. This video takes a look at some of the latest efforts in the cancer research and therapy arena.

Pharmaceutical Technology® spoke with Todd Sprouse, associate director, Analytical Services, and Erik Feldmann, PhD, principal technical advisor, Client Solutions & Proposals, both with Cambrex, to find out more about the challenging situation.

The two organizations are collaborating on an integrated translational biology platform for the development of radiopharmaceuticals.

Bram Baert, global head of Regulatory Affairs at Lonza CHI, gives his perspective on the impact of the EC’s decision on the use of TiO2 in drug products.

Susan J. Schniepp, Distinguished Fellow, Regulatory Compliance Associates, joins PDA CEO Glenn Wright and Melissa Seymour, Executive Vice President, Global Quality, Eli Lilly and Company, to talk about the regulatory and quality topics discussed at the 2025 PDA Regulatory Conference.

Digital solutions help pharmaceutical manufacturers navigate the complex supply chain.

EMA and WHO have collaborated for a decade, with WHO utilizing EMA’s scientific expertise to fulfill its mandate to improve access to safe and effective medicines.

Unichem Pharmaceuticals has issued a voluntary recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg after the incorrect label was placed on the wrong product.

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 laboratory services provider is responding to growing demand for packaging and microbiological testing by expanding its laboratory space at its Wiesbaden, Germany, facility.

To find out how FDA’s new draft guidance, Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development, may impact the development of radiopharmaceuticals as cancer treatments, Pharmaceutical Technology® spoke with Michael Ritchie, chief commercial officer of Champions Oncology.

The company will be adding a 160,000-square-foot dedicated manufacturing facility at the FUJIFILM site in Holly Springs, NC.

Pharmaceutical Technology® spoke with C. Michael White, distinguished professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and chair of the Kratom Consumer Advisory Council, about recent government actions regarding kratom and concentrated 7-hydroxymitragynine (7-OH) products.

FDA’s recommendation to control 7-OH products under the Controlled Substances Act should help prevent competition between legitimate pharmaceutical medicines and those companies looking to circumvent FDA regulations, says Michael White, Distinguished Professor and Chair of the Department of Pharmacy Practice at the UConn School of Pharmacy and Chair of the Kratom Consumer Advisory Council.

The guidance document provides recommendations for identifying an optimized dosage for radiopharmaceutical therapies for cancer treatment during clinical development.

The company will highlight how its GMP services combine engineering, consulting, equipment qualification, and facility validation to better integrate its services during Farmaforum, which is being held in Madrid from Sept. 17–18, 2025.

Based on an analysis done by the European Medicines Agency on the feasibility of alternatives, the European Commission maintains use of titanium dioxide in drug products.