ARTICLES BY ANNA ROSE WELCH
A Different Perspective On The Current C&G Manufacturing Capacity Constraints5/10/2021
If you talk to anyone today about the decision behind constructing their own manufacturing facility, you’re likely to run into one of two big reasons spurring companies to make the investment in their own manufacturing footprint.
Two Tips On Navigating C&G Outsourcing Relationships In A Competitive Landscape5/4/2021
It can be a bit overwhelming to keep tabs on all the movement occurring in the C&G industry today. You can’t open a newsletter or read an article without learning about company launches or acquisitions, clinical/manufacturing/regulatory milestones (or pitfalls), new partnerships, or facility ribbon cuttings/shutterings. While most of the glitzier headlines on C&G manufacturing highlight firms’ decisions to keep manufacturing in-house, outsourcing still plays — and will always play — a critical role in the development of these complex therapies.
C&G Therapy Manufacturing Automation: Making The Most Of Today’s Opportunities3/17/2021
While the future for automation in the C&G manufacturing process will no doubt be bright, a conversation with this cell therapy executive also emphasized just how important cultivating talent and carefully analyzing supply chain costs will be in the automation puzzle before us.
Will It Be Biologics Business As Usual In 2021, Or Will Biosimilars Mean Business?1/20/2021
In this fourth installment of the Editorial Board 2021 Outlook, it's clear that stakeholders are relying more heavily on biosimilars and that it’s more important than ever for biosimilar companies to keep carrying the torch for more competition, cost-savings, value, and responsible pricing.
The Biosimilar Toolbox: How To Ratchet Up Biosimilar Competition In 20211/6/2021
As you’ll read in the following responses, increased competition in 2021 is on the minds of many. How that competition unfolds has yet to be determined. But if one thing is clear, it’s that the industry has many exciting tools at its disposal to bolster biosimilar competition in 2021.
The Top 5 Biosimilar Developments Of 202012/30/2020
Though 2020 felt like an endless descent into Dante’s Nine Circles of Hell, I wanted to end the year as I typically do: with a column highlighting the most important and positive biosimilar developments from the past 12 months.
Will These Big Biosimilar Questions Be Answered In 2021?12/23/2020
Biosimilar Development is back with the highly anticipated second installment of its Editorial Board 2021 Outlook series! Here, the experts address the biggest questions they have going into 2021, as well as some of the events, policies, and corporate strategies they hope will help answer these questions.
The Past, Present, & Future of Biosimilar Manufacturing10/14/2020
A recent publication entitled "Approval of Biosimilars: A Review of Unsuccessful Regulatory Filings" revealed the most common manufacturing issues the FDA and EMA flagged in biosimilar applications. Here, the lead author discusses his findings from the past, current manufacturing challenges, and which technologies could be most impactful for the future biosimilar industry.
Biosimilar Industry Advancements To Watch In 20201/8/2020
Multi-biosimilar competition in the U.S. oncology space, as well as the FDA’s regulatory progress toward a more competitive insulin market were popular topics among the whole group. But these are hardly the only big events to note in this progressing industry.
The Top 7 Biosimilar Developments of 201912/30/2019
I normally only do the top five developments for the biosimilar industry in this annual column. But it turned out, upon reflection, that 2019 was an even more eventful year than it may have seemed as we were making our way through. So, you’re getting a whopping seven this year.