Author: Danielle Pillsbury
Exploring ADC pharmacokinetics using QSP [APAC Webinar]
The Pharmacokinetics (PK) of ADC therapeutics typically show a discrepancy between the PK of total antibody and that of conjugated antibody, carrying one or more payload molecules. This discrepancy is often attributed to deconjugation, however recent evidence suggests that the underlying mechanisms may be more complex. In this webinar, we will present how quantitative systems … Continued
Enhancing Regulatory Writing: The Power of Style Guides
TranscriptMany pharmaceutical industry professionals once considered standardizing regulatory writing style conventions unnecessary and time-consuming. However, the industry now recognizes its benefits for maximizing efficiency during regulatory submission development. The benefits of using style guides and lexicons in medical writing include: The Certara Drug Development Solutions Document Quality group is experienced in creating and maintaining style guides and … Continued
Molecular Glue Drug Development Summit 2024 Recap
Transcript: Hello, and welcome to Certara Talks. I’m Doctor Suzanne Minton, and I’m a director of content strategy at Certara . Today, I’m talking to my colleague, doctor Joshua Apgar. Joshua, welcome to Certara talks. Would you like to introduce yourself? Sure. Thank you. I’m, Josh Apgar, one of the co founders at applied Balmain, … Continued
AACR Annual Meeting 2024
Supporting the Approval of a Treatment for a Neglected Tropical Disease
In this video, Dr. Mark Sullivan, Managing Director of Medicines Development for Global Health, explains how Certara’s model-informed drug development expertise was used to support developing moxidectin as a treatment for onchocerciasis “river blindness.” Transcript The role that Certara has played has really been a as an as a integral part of our drug development … Continued
Certara to Report First Quarter 2024 Financial Results on May 7th, 2024 and Participate in the BofA Securities Healthcare Conference
PRINCETON, N.J.— April 9, 2024– Certara, Inc. (Nasdaq: CERT), a global leader in biosimulation, today announced that it will release financial results for the first quarter of 2024 after the market close on Tuesday, May 7th, 2024. Company management will host a conference call to discuss financial results at 5:00PM ET. Investors interested in listening … Continued
Effective Strategies for Achieving Better Results with Agencies
For pharmaceutical companies, agencies play a crucial role in creating interactive content that effectively communicates product value to payers. However, in times of shrinking budgets, it becomes even more essential to ensure efficient collaborations with agencies to achieve optimal results. Traditional workflows often face challenges due to agency dependence, lengthy development cycles, and obstacles in … Continued
The 5th Annual Regulation – Biostatistics Conference
Optimizing the Quality of CDISC SDTM Compliance [APAC Webinar]
Since the FDA passed regulations requiring submitted datasets to be compliant with the CDISC Study Data Tabulation Model (SDTM), clinical trial sponsors have faced a dilemma. Should they design electronic case report forms (eCRFs) in line with SDTM from the outset? Or should they retrospectively convert data to CDISC SDTM at the end? A retrospective … Continued