Articles by Anna Rose Welch

  1. Two Tips On Navigating C&G Outsourcing Relationships In A Competitive Landscape 5/4/2021

    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.

  2. How To Approach C&G Therapy Outsourcing In The Make Vs. Buy Era 4/28/2021

    The world moves pretty fast — especially if you’ve been reading the many articles outlining the C&G industry’s feverish push to bolster and/or establish capacity.

  3. C&G Therapy Manufacturing Automation: Making The Most Of Today's Opportunities 3/17/2021

    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.

  4. What Does FDA's Biosimilar Workload Reveal About Emerging U.S. Market? 3/22/2016

    The FDA has faced questions and criticism over its slow progress with biosimilar-related policies. In the face of these questions, however, the FDA has not provided any estimates or figures about the size of the biosimilars review team or the team's workload. Now, a new review released by ERG breaks down the agency's workload volume and costs, giving clearer insights into how the U.S. regulatory landscape is unfolding.

  5. Venture Philanthropy: Is It Really Promoting Patient Centric Drug Development? 7/14/2015

    Within the last 10 years, a number of nonprofit groups, including the Michael J. Fox Foundation and the Multiple Myeloma Research Foundation, have taken a similar approach to ensuring that their targeted patient populations are being well represented in pharma R&D.

  6. FDA News Roundup: Pfizer, Eli Lilly, Vertex, And More 7/10/2015

    What FDA decisions have you missed recently?

  7. Is Pharma Truly Equipped For Transparency? 7/8/2015

    As the call for transparency grows louder in the pharma industry, the question arises: are drugmakers equipped with all they need to be transparent — especially when it comes to demonstrating their drugs’ economic value?

  8. How Are Virtual Biotechs Altering The R&D Landscape? 7/7/2015

    The term “virtual biotech” carries with it a certain revolutionary flair. Indeed, as Kent Pryor, COO of ZZ Biotech, describes, the virtual biotech represents a drastic shift in the biotech industry, and as such has a different approach to tackling the challenges of drug R&D.

  9. Will Biotech Employment Continue To Rise As The Industry Evolves? 6/30/2015

    A report from the Bureau of Labor Statistics found that nationwide employment in “pharmaceutical and medicine manufacturing” sunk from 291,795 in 2003 to 277,113 in 2013, The Philadelphia Inquirer reported recently. But it’s not the same story for biotech R&D: employment hit 142,475 in 2013 — up from 135,424 in 2007.

  10. FDA Roundup: Sanofi, Genentech, Apitope, Retrophin, And More 6/11/2015

    What regulatory decisions have you missed recently?