Business

Risk-Based Biologics: CMC Flexibilities in the EU Regulatory System

Pharmaceutical companies and regulatory agencies strive to foster scientific excellence in drug development and evaluation so that members of the public can access the high-quality medicines that they need. Recent European Medicines Agency (EMA) approvals for COVID-19 vaccines highlight those organizational accomplishments and showcase the application of risk-based chemistry, manufacturing, and controls (CMC) flexibilities that are embedded within the European Union (EU) regulatory system. Many of the CMC flexibilities outlined herein were established for PRIME (priority medicine), a scheme that…

The Talent Enigma in Digital Biomanufacturing

Demand for talent in the biopharmaceutical industry already had been climbing before the COVID-19 pandemic, showing an increase of 26% from 2018 to 2020. By the end of 2021, a further 32% surge was observed in the United States and Europe, against a 10% rise in the supply of expertise. Bolstered at first by the need to manufacture SARS-CoV-2 vaccines and therapeutics and now by the threat of new pandemics, current market drivers include increases in investment, initial public offerings…

How To Achieve DSCSA Compliance by November 2023

As the world surges into the new year, pharmaceutical companies that manufacture pharmaceuticals in and/or for the United States seeking to comply with the Drug Supply Chain Security Act (DSCSA) may find themselves scrambling to meet the 27 November 2023 deadline requiring them to track and trace prescription drug products within the supply chain. Congress enacted the 60-page DSCSA in November 2013 as Title II of the Drug Quality Security Act (DQSA) to protect patient safety. That provided the pharmaceutical…

The Best Places to Work in Biotech: Perspectives on Job Satisfaction in the Biopharmaceutical Ecosystem

In late spring of 2022, the combined BPI editorial and marketing teams sent out a “Best Places to Work in Biotech” survey to BPI readers. Similar surveys appear every year from a number of other organizations. Our focus was less data driven than many others, instead inviting commentary on factors that are becoming essential to job satisfaction and employee retention. One strong conclusion to draw from our reader responses is that people in biopharmaceutical careers want to play a key…

Increasing Clinical Trial Inclusivity: Technology-Enabled Community Connections

Clinical trial inclusivity strengthens analyses, speeds trial completion and Food and Drug Administration (FDA) approvals, and lowers administrative costs of clinical studies. However, a mounting body of evidence shows that eligibility criteria often limit enrollment inclusivity and compromise trial data. For example, a retrospective review of 302 drug submissions to the FDA examined the impact of insufficient data on drug approvals. Nearly 16% of the reviewed studies had insufficient data to determine safe dosages, and over 13% revealed inconsistent results…

US Patent Law: A 20-Year Retrospective

The past 20 years have been extraordinary for intellectual property law. Most of the transformations can be attributed to changes in the statute, US Supreme Court jurisprudence, almost complete turnover in judges in the Court of Appeals for the Federal Circuit (“Federal Circuit,” below), and advances in technology that could not have been anticipated in 2002. An understanding of those changes requires a retrospective of patent law over those 20 years. At that time, the Federal Circuit was 20 years…

From Immigrant to Entrepreneur: Lessons Learned in Building an Innovative Business

As an entrepreneur, I stepped away from a fulfilling position in a large and established company to go out on my own and build something new. My decision to leave the advanced research department at Illumina, Inc. to create a start-up might seem like an extreme leap, but I am very familiar with the risks of starting over. After earning my bachelor of science degree in biotechnology from the University of Tehran, I immigrated to the United States. I left…

20 Years of Chemistry, Manufacturing, and Controls Strategy. A Conversation About the CASSS CMC Forum Series

Formerly known as the California Separation Science Society, the CASSS organization has maintained a close relationship with BioProcess International since its inaugural year. In particular, the CMC Strategy Forum series began the same year that BPI’s original staff joined Informa to develop a new international trade publication covering biopharmaceutical development and manufacturing. Beginning with our February 2004 issue, BPI has been proud to publish dozens of reports from this influential series of meetings over the years. Their success around the…

Surveying the Biosimilars Regulatory Landscape

BPI’s history coincides with that of biosimilars development. Although nonpeptide biosimilar products did not begin receiving commercial authorization until the 2010s, health authorities and drug makers already had been exploring the complex concept of biosimilarity. In the May issue of BPI’s first volume, Theresa L. Gerrard (then an independent consultant who also had been director of the Division of Cytokine Biology at the US Food and Drug Administration Center for Biologics Evaluation and Research, FDA CBER) wrote: The potential for…

Reflections on Career Opportunities in the Biopharmaceutical Industry

Mindset is important to working in the biopharmaceutical industry. Three distinguishing behaviors will enable new entrants to build rich and fulfilling careers: keeping an open mind, serving a purpose for the benefit of a greater good, and making risk-based decisions. The range of experiences in our own careers can help to illustrate the broad array of opportunities that you can find in the life sciences when such a mindset is applied. Below, we discuss some of those experiences and lessons…