This an excellent analysis.
The comments also, however, indicate different medical specialties may take different views of the FDA proposal, with oncologists and oncology organizations, in particular, more favorably disposed to increased oversight of LDTs
Antibody drug conjugates (ADCs) are an important new modality that is showing great results in treating certain types of cancer. Manufacture of this drug class is complex insofar as it requires several GMP intermediates as inputs to the conjugation reaction to produce the drug substance. My team of technical consultants at Alira Health has a focus on biologics, and we do a lot of work with ADCs. I'm excited to announce publication of an article from my team entitled “Manufacturing challenges of therapeutic antibody-drug conjugates” by Dr. Peter Alexander and colleagues. The article appears as a featured report in the September 2023 issue of BioProcess International. Read the full article here: https://lnkd.in/gs_TyPe4
Antibody drug conjugates (ADCs) are an important new modality that is showing great results in treating certain types of cancer. Manufacture of this drug class is complex insofar as it requires several GMP intermediates as inputs to the conjugation reaction to produce the drug substance. My team of technical consultants at Alira Health has a focus on biologics, and we do a lot of work with ADCs. I'm excited to announce publication of an article from my team entitled “Manufacturing challenges of therapeutic antibody-drug conjugates” by Dr. Peter Alexander and colleagues. The article appears as a featured report in the September 2023 issue of BioProcess International. Read the full article here: https://lnkd.in/gs_TyPe4
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Tomorrow, we will announce our financial results for the 3rd quarter of 2023. All details in a nutshell: ➡️ 7 a.m. (CET): Publication of our Q3 results ➡️ 9:30 a.m. (CET): Media conference call ➡️ 2 p.m. (CET): Conference call for analysts You can find further information here: https://lnkd.in/eRmPRD-g #EMDresults #Q3 #FinancialResults
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Very interesting article, make sure you also read the full report
Roivant to Report Financial Results for the First Quarter
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This study addressed whether a one-step analysis method could improve sensitivity while making fewer erroneous assumptions in rate correction. #CTSjournal #ASCPTjournals #ASCPT https://bit.ly/3vXKtt2
Roivant to Report Financial Results for the First Quarter
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6moI was concerned how the original report of 7,406 replies/letters to the docket would be reviewed. I was thinking that this might be a task for AI/LLM. I look forward to learning more about the breakdown of these letters.