Pharma Pulse 2/12/25: Uncovering Emerging Quality Risks, The Critical Role of Diversity in Cancer Clinical Trials & more

Central Monitoring is Uncovering Emerging Quality Risks in Clinical Trials

Central monitoring, a practice recommended by the FDA over 11 years ago, has become a cornerstone of clinical trial oversight. Its two main features are key risk indicators and statistical data monitoring. KRIs focus on predefined risks, typically at the site level, enabling targeted monitoring. SDM involves unsupervised analysis of all data collected during the trial, uncovering patterns and anomalies at patient, site, and country levels; these may have gone unnoticed.

The Critical Role of Diversity in Cancer Clinical Trials

As we embark on the new year, it is fitting to reflect on our progress in oncology and the challenges that remain. Among the most pressing issues in cancer care and research is the critical need for greater diversity in clinical trials. This is not merely an aspirational goal but an essential component of achieving equitable health care outcomes and advancing the science of oncology. Cancer does not affect all populations equally. Significant disparities exist in cancer incidence, progression, and treatment outcomes across different racial, ethnic, and socioeconomic groups. These disparities are often rooted in a complex interplay of genetic, environmental, and systemic factors. To address them effectively, we must ensure that the populations most impacted by cancer are adequately represented in clinical trials.

Lilly Sells $6.5 Billion of Bonds for Cancer Drug Purchase

Eli Lilly & Co. tapped the US investment-grade bond market on Monday to help finance its roughly $2.5 billion purchase of a cancer drug from Scorpion Therapeutics Inc.

Synedgen Announces Appointment of Dr. Laura Saward as Chief Scientific Officer

Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced the appointment of Dr. Laura Saward, PhD, as the company’s Chief Scientific Officer.

Dr. Saward is an accomplished biotechnology executive with more than 25 years of experience in therapeutic drug development from preclinical to licensure. She will lead Synedgen’s scientific strategy to further the company’s development pipeline and government partnerships.

Ian Baer on LinkedIn

I’ve been talking to brands about the importance of “dark social” for a decade now. If you’re unfamiliar with the term, or want to know why it’s going to be mission critical for healthcare (and most other) marketers in the years ahead, I think you’ll enjoy this. Thanks as always to Miranda Schmalfuhs for bringing the most important conversations to the surface.

Have news you want us to share in Pharma Pulse? Reach out to Editor Miranda Schmalfuhs