Economics

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…

A Healthy Biosimilars Market Promotes Innovation and Affordability

Innovative drug manufacturers require an opportunity to recoup capital and opportunity costs that they incurred to develop new medicines. Once patents have expired, competitors should be empowered to promote widespread affordability. An exclusivity period followed by a competitive market would promote the otherwise incompatible objectives of incenting innovation and promoting affordability. That careful balance exists for small-molecule medicines but not yet for biologics. The innovation side of the biologics market is working as intended, but a robust market for lower-cost…

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…

Discussions at Phacilitate 2020 on Business, Manufacturing, and Future Trends

Presenters in the three main program tracks at the Phacilitate Leaders World conference in Miami, FL, this past January represented sponsor-developers of cell/gene-therapy (CGT) products, contract service providers, and technology suppliers to the industry. Topics include process and product development strategies for advanced therapies, regulatory and inspector expectations, automation and closed-system processing, the choice between in-house and outsourced manufacturing, quality assurance and control, analytical methods, viral vectors, and artificial intelligence and Industry 4.0. At the end of each session, presenters…

New Directions in Bioprocess Development and Manufacturing

The biopharmaceutical industry continues to grow at a rapid pace. That growth is accelerating even more because of keen investor and research interests in cell and gene therapies. My focus below is on several key growth areas in the field, specifically aspects of development and biomanufacturing. This discussion builds on my 2018 column on top trends in bioprocessing (1). In that article, I identified five key trends that continue to resonate now: rapid development of high-productivity upstream processes advances in…

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…

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…

eBook: Speed to IND — Balancing Risk and Reward

With so many biopharmaceuticals obtaining breakthrough or fast-track designations, companies that use accelerated strategies to be first in human studies can be left with significant quality and manufacturing challenges that must be solved later on. Despite regulatory encouragement to create solid design spaces and define parameters according to quality by design (QbD), those may go by the wayside given the pressures of speed. The reward is the investigational new drug (IND) application itself — but if companies lock in subpar…

Streamlining the Path to Clinical Manufacturing

Careful consideration of lot size is crucial for multiyear success of a cell therapy business. RoosterBio’s product design and acceleration business works with the company’s customers to help make plans that are appropriate for their stages of product and clinical development. We use the following major considerations in creating a sound multiyear strategy with intermediate milestones: Understand what the future looks like and work backward Use reasonable to conservative assumptions to estimate a range of needs Invest in the right…