2019

Ask the Expert: Preparing for and Managing Regulatory Inspections

An “Ask the Expert” webinar on 27 November 2018 featured Ray Marzouk, vice president of quality at Avid Bioservices, a biologics contract development and manufacturing organization (CDMO) in Orange County, CA. With six successful preapproval inspections behind it, Avid prides itself on a 13-year industry-leading regulatory track record. Marzouk’s Presentation Preparing for the Inspection: Implement a standard operating procedure (SOP) for inspections that includes instructions for the receptionist, host, scribe, subject matter experts (SMEs), and document finders. Prepare SMEs for…

Ask the Expert: Custom Media Services: Bioproduction Media Optimization Through Spent-Media Analysis

On 29 November 2018, Matthew Smonskey (senior scientist in the Gibco Custom Media Services team at Thermo Fisher Scientific) presented an “Ask the Expert” webinar on resources available to help developers identify media limitations and options for designing custom media formulations that maximize protein yield. Smonskey’s Presentation  Gibco’s goal is to solve its clients’ bioproduction problems: e.g., creating a chemically defined medium, increasing end-point titer, modifying protein quality attributes, and so on. Designing custom media using spent-media analysis might solve…

Ask the Expert: A Modular Chromatography Platform with a Lattice-Supported Bed

In an Ask-the-Expert webinar on 4 December 2018, Jason Chiu (product marketing scientist at JSR Life Sciences) introduced the Chromassette chromatography cassette platform. This stackable, modular technology and resin-support device presents a productive and disposable process that can scale to any volume using any resin. An internal scaffold provides a uniquely supported resin bed, and the system is fully interchangeable with conventional column formats. Chiu’s Presentation The Chromassette platform offers linear scalability, superior pressure-flow properties, high-productivity separations, and rapid and…

Elucidation: Better Biomarkers Could Power Precision Medicine for Autoimmune Disease

Precision medicine has long been a tantalizing goal for the pharmaceutical and healthcare industries. Fields such as oncology and rare diseases have benefited greatly from implementation of genome-guided care. Drug developers likewise have made strides with biomarker-aided discovery programs and stratification for clinical trials. Current indications suggest that autoimmune diseases will be the next major focus of personalized medicine. The goal of precision medicine often is described as “getting the right drug to the right patient at the right time.”…

Biosimilars: Challenging the Justifications for Clinical Testing

The Biologics Price Competition and Innovation Act (BPIA) of 2009, describes the need for clinical trials as follows (1): “(cc) a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics) that are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and intended to be used and for which licensure is sought for the biological product.” However, all the above studies are left…

Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data

When a new medicine is approved, there is under a 25% chance that the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA) will impose, as part of conditional approval, studies conducted to satisfy postmarketing requirements. US regulations governing such studies are found in the 2011 guidance document regarding “Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act (1).” EMA regulations are found in the 2017 “Guideline…