Anna Rose Welch
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Anna Rose Welch is the director of Cell & Gene Collaborative. In this role, she is forging close relationships with the leading voices and organizations in the cell and gene therapy manufacturing sphere. This includes establishing a peer group comprising Cell & Gene company manufacturing SMEs, conducting interviews and hosting interactive roundtables on the evolving manufacturing paradigm, and authoring thought leadership articles and blog posts via the Cell & Gene Collaborative blog.
Prior to launching Cell & Gene Collaborative, Anna Rose spent five years building an extensive network and editorial following as the Chief Editor of Biosimilar Development. In addition to penning thought leadership on biosimilar regulatory affairs, government policy, and commercialization advances, she was also an active participant in the biosimilar conferences circuit. She was appointed chair or served as a speaker and panel moderator at international conferences, including the World Biosimilar Congress USA, The Biotech Pharma Summit (EU), the CBI Biosimilars Summit, DIA Biosimilars Conference, and the Biosimilar Medicines Group Conference (EU). In 2018, she was invited to Brazil where she addressed members of the Brazilian Ministry of Health, ANVISA, and local biologics and biosimilar manufacturers on establishing national biologics and biosimilar policies. She also represented the publication on a media tour of Bangkok, Thailand in 2017, during which she reported on the country’s efforts to bolster its life sciences industry. In addition to writing for Biosimilar Development, she penned the introductory chapter to the book, Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development (Springer, 2018).
In 2018, her first book of poetry, We, The Almighty Fires, was published by Alice James Books.
ARTICLES BY ANNA ROSE
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![biosimilar industry]( "90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?")
90 Studies Prove Biosimilars’ Safety And Efficacy: What Now?3/27/2018This review sought to answer two questions which have been plaguing the biosimilar industry since day one: will biosimilar switching have any impact on safety, and will biosimilars be the harbingers of increased immunogenicity? And it has provided us with far more than just answers to these questions.
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![biosimilar industry]( "DIA Biosimilars Conference Reveals “More Questions Than Answers”")
DIA Biosimilars Conference Reveals “More Questions Than Answers”10/31/2017During the DIA Biosimilars 2017 conference, there were three topics of discussion that, arguably, could remove barriers to biosimilar development and advance it. But a phrase that was regularly used over the two days highlights one of the biggest issues standing in front of this industry: “There are more questions than answers.”
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![R&D]( "A Glimpse Into Thailand’s Ongoing Life Sciences Transformation")
A Glimpse Into Thailand’s Ongoing Life Sciences Transformation5/18/2017During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.
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![R&D]( "What Thailand Revealed About U.S. Pharma R&D")
What Thailand Revealed About U.S. Pharma R&D5/16/2017A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.
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![biosimilar industry]( "What To Know About Thailand’s Life Sciences Industry")
What To Know About Thailand’s Life Sciences Industry5/12/2017About a month ago, I was offered a tremendous opportunity: to attend a media trip to Thailand to learn about the country’s burgeoning life sciences industry. Like many people in the life sciences industry, I had no idea just how much has been going on within the country in terms of life sciences.
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![biosimilar industry]( "The 4 Most Notable Biosimilar Interchangeability Hurdles")
The 4 Most Notable Biosimilar Interchangeability Hurdles3/1/2017Though the interchangeability draft guidance seemed to be well-received by biosimilar makers, I’m hesitant to interpret the surprising post-guidance quietness to mean companies have no concerns about the bar it sets for attaining interchangeability.
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![Biosimilar industry]( "IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment")
IQPC Biosimilars Event Emphasizes Need For Regulatory Alignment2/27/2017I recently attended the IQPC Biosimilars Analytical Similarity, Clinical Studies, and Market Entry conference. This event, which took attendees into the heart of biosimilar development (the analytical and statistical work) was a great example of the scientific challenges developers may face while working with different regulatory agencies.
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![Biosimilar industry]( "Top 5 Biosimilar Developments Of 2016")
Top 5 Biosimilar Developments Of 201612/29/2016In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.
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![biosimilar industry]( "The Case For Moving The EMA To Ireland")
The Case For Moving The EMA To Ireland12/13/2016Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.
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![biosimilar industry]( "How To Approach U.S. Physicians About Biosimilars")
How To Approach U.S. Physicians About Biosimilars11/21/2016As the U.S. faces its first biosimilars for oncology, rheumatology, dermatology, and gastroenterology indications, a new publication from the Biosimilars Forum shows there’s quite a bit of work to be done to educate U.S. physicians.
