Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.
After roughly four years of writing about biosimilars, I can finally say I attended the Annual Biosimilar Medicines Conference. This conference was valuable to get a closer look at Europe as well, not only to see where things are working, but also where they're not.
As we see more real-world evidence (RWE) released in the gastroenterology community, I wanted to learn how one patient advocacy organization is approaching biosimilar education, what challenges the organization is facing, and how the industry and FDA can better reach patients and physicians.
Last week, I had the pleasure of chairing the first day of the BioTech Pharma Summit: Biologics and Biosimilars conference in the gorgeous Porto, Portugal. (Don’t ask me how much I spent I spent on port wine in the days before the conference.) The conference was — shockingly — the first European biosimilar conference I have attended in my tenure as a biosimilars editor. (Even though Europe is leaps and bounds — and then more bounds — ahead of the U.S. with biosimilars.)
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This article focuses on concentration assays associated with late-stage development and biotherapeutic drug chemical manufacturing and control.
Validating host cell protein ELISAs is an essential part of biologics development. But what makes these coverage assays so vital, and what could we improve? Read how this 2D DIBE approach combines the best of existing methods.
Biologics developers and manufacturers demand an accurate and reliable assay for host cell protein (HCP) quantitation. Let’s take a close look at why analytical scientists turn to the ELISA, and how it fits into process development.
At the CBI Biosimilars Summit in January, I had the pleasure of moderating a panel comprising three experts, including Jesse Peterson, clinical development manager at Fairview Specialty Pharmacy. The topic of conversation was stakeholder education, which Peterson is well-equipped to speak about, given his position at regional specialty pharmacy. In his role, Peterson works with experts across the pharmacy operations team and manages relationships with the health system’s payer partners and manufacturers. He is responsible for sharing updates on the future of the specialty pipeline internally and with payers, as well as identifying areas where potential savings could be realized.
A few months ago, I read a fabulous Q&A in Managed Care Magazine featuring oncologist Gary Lyman and co-director of the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center. In this day and age, we regularly come across surveys or discussions emphasizing how much more work we have to do in the education realm to ensure physicians’ comfort with biosimilars. But after reading Lyman’s interview on one cold, dreary January day, I felt buoyed. That’s not to say there isn’t more work to be done, of course. But it was reassuring to see a prominent member of the oncology community express such comfort and confidence in biosimilars.
In the first of what will be two articles, I walk you through a high-level model forecast Engert shared to demonstrate that the value-capture possible after developing a biosimilar is much higher than what we may assume. In order to receive these rewards, however, there are five steps Engert outlines that a company must take to properly manage the risks that arise.
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