Business

Finding Efficiencies to Accelerate Biopharmaceutical Development

An old engineering adage says that in any technical project, you can get speed and/or quality and/or cost-efficiency — but you never get to have all three. The idea is that emphasizing any one of those parameters necessarily deemphasizes one or both of the others. For most of the biopharmaceutical industry’s early years, companies operated on that assumption. Many organizations saw speed as the weakest link that could be more or less ignored; others had money to burn. The smartest…

Biosimilars Pipeline and Market Trends

Most biopharmaceutical industry experts now consider biosimilars to be mainstream products, indicating that the field has progressed immensely over the past 10 years. Nevertheless, when comparing approvals and commercial offerings across the globe between 2013 and 2020, it becomes clear that some regions welcome these therapies more than others do. Western European biosimilars markets continue to be kind to these drugs’ production, distribution, and coverage; and companies headquartered in Asia and the Pacific Rim increasingly are getting involved in biosimilars…

Life-Science Lawsuits: Learning from the Ordeal

Life-science companies often are cast into the role of the “canary in the coal mine” — the first parties to be targeted and hit by lawsuits. Such companies depend on discovery, trial and error, and ultimately efficacy. None of that is a sure bet. At the same time, life-science companies are raising funds constantly to finance their work. Investors and lenders seeing less-than-projected or even “expected” results might sue directors and officers for mismanagement, misrepresentation, or misleading financial statements. This…

Virtual Audits: A New Reality in the World of COVID-19

The novel coronavirus disease 2019 (COVID-19) pandemic has every industry seeking out ways to accomplish time-sensitive activities using a number of virtual approaches. This is certainly true in the biopharmaceutical sector, in which good manufacturing practice (GMP) audits are required to manufacture medicinal drug products for human use. Examples include supplier/vendor audits, mock inspections, and preapproval and prelicense inspections (PAIs and PLIs) conducted by sponsors and regulatory authorities. Auditors usually perform such activities on site and only sometimes remotely. In…

Patient Access Tops the List of Advanced Therapy Milestones at Phacilitate 2020

In a highly anticipated presentation at the 2020 Phacilitate Leaders World event — part of Advanced Therapies Week, along with the World Stem Cell Summit in Miami, FL — Susan Nichols (chief executive officer for Falcon Therapeutics), highlighted 10 events from 2019 that drove conversation, investment, and innovation in regenerative medicine. Although clustered regularly interspaced short palindromic repeats (CRISPR), business consolidations, and production capacity powered the cell and gene therapy (CGT) space in 2019, a new proactive focus on patient…

A Framework for a Competency-Based Curriculum

Training departments in biopharmaceutical manufacturing facilities are at the forefront of ensuring that their employees are trained in accordance with regulatory compliance standards that govern the industry. More important, the purpose of training is to equip employees with relevant knowledge, skills, and abilities to perform their job functions competently. A competency-based curriculum has the potential to facilitate a training approach that addresses both the practical training needs and desired performance outcomes in a workplace. Competency-Based Curriculum Recently, I was involved…

Developing a Biopharmaceutical Workforce for Today and Tomorrow

Biomanufacturing is constantly evolving, developing new treatments and therapies through cutting-edge methodologies and facing increasing integration of big data and analytics. But keeping up with innovation in this segment requires a workforce with advanced skill sets. The US State of Rhode Island (RI), with a rich manufacturing history and a thriving biotechnology sector, has taken on that challenge. We are preparing a robust talent pool — the greater Providence area contains over 1.6 million people — to become the highly…

The Next Global Life-Science Leader

Canada’s life-science industry is exceptional at producing innovative research. With less than 0.5% of the world’s population, our country produces 5% of the globe’s total research publications. Canada’s citation rate ranks among the top six nations and is 43% higher than the global average (1). At the same time, our life-science industry is competing with other global jurisdictions into which investment is flowing. The US state of Massachusetts, already the number one biotechnology cluster in the world, has committed US$1.5…

A Response Plan for Viral Contamination in Bioproduction Facilities

The biopharmaceutical industry uses living biological systems as a platform for manufacturing of protein-based drugs, vaccines, and other therapies derived from or consisting of different cell types. On one hand, living systems are inherently susceptible to viral infection and may harbor endogenous viruses, so the potential for such contamination cannot be eliminated. On the other hand, the industry has an excellent patient-safety record. Viral safety is achieved through three fundamental measures: prevention (e.g., by selection), removal (by clearance and/or reduction),…

Supply and Demand Trends: Mammalian Biomanufacturing Industry Overview

Since the 1986 approval of the first recombinant therapeutic antibody, OKT3, biopharmaceuticals have become a large percentage of overall pharmaceutical company revenue. In 2018, sales of the top five selling recombinant proteins — Humira (adalimumab, AbbVie), Keytruda (pembrolizumab, Merck), Herceptin (trastuzumab, Genentech), Enbrel (etanercept, Amgen), and Avastin (bevacizumab, Genentech), all antibodies — totaled over US$48 billion. The compound annual growth rate (CAGR) for antibodies revenue was about 20% from 2004 to 2014. Those products include naked monoclonal antibodies (MAbs), Fc-fusion…