October 7, 2024

Accelerating CAR T-cell therapy clinical trial timelines with comprehensive biomarker-driven strategies

Chimeric antigen receptor (CAR) T-cell therapy is one of the fastest-growing sectors within oncology therapeutic development. This advanced form of immunotherapy can deliver “designer” T-cells to specifically recognize, and attack, cancer based on unique tumor-associated antigens, offering a highly targeted and personalized approach. Recently, adoptive cell therapy (ACT) has received considerable attention due to the success of CAR T-cell therapy in treating hematological malignancies. This article focuses on CAR T-cell therapies in cancer and discusses how biopharmaceutical companies can leverage a comprehensive biomarker strategy for their drug development programs to accelerate clinical trial timelines and better predict clinical outcomes.
October 7, 2024

Six FDA recommendations on NAMs

Summary

To help guide best approaches to new approach methods, the FDA has released "Potential Approaches to Drive Future Integration of New Alternative Methods for Regulatory Decision-Making," the latest report detailing recommendations from a NAMs subcommittee of the FDA Science Board. Download the full report for the six recommendations.

<span>Three ways to strengthen the immune system</span>
October 7, 2024

Three ways to strengthen the immune system

What if instead of referring to the next few months as flu season, we reframed our perspective and referred to this time as immune system empowerment season? While it doesn’t necessarily roll off the tongue, it certainly represents a more proactive and action-oriented approach in fighting off many of the illnesses associated with fall weather. 

Kathryn E. Wengel

Kathryn E. Wengel has served as a director of the Company since March 25, 2021. Ms. Wengel has served as the Executive Vice President, Chief Technical Operations & Risk Officer, an Executive Committee member, and an Executive Officer of Johnson & Johnson, a leading healthcare company, since July 2018. Since joining Johnson & Johnson in 1988, Ms.

Paul B. Rothman, M. D.

Paul B. Rothman has served as a director of the Company since June 6, 2023 and as Chairman of the Quality and Compliance Committee since June 2024. Dr. Rothman, a rheumatologist and molecular immunologist, was previously the Dean of the Medical Faculty for Johns Hopkins University School of Medicine and CEO of Johns Hopkins Medicine, during which time he oversaw both the Johns Hopkins Health System and the School of Medicine. Prior to serving at Johns Hopkins, Dr. Rothman held various leadership positions at Columbia University and the University of Iowa.

Richelle P. Parham

Richelle Parham has served as a director of the Company since February 8, 2016 and Chairperson of the Compensation and Human Capital Committee since June 2023. Ms. Parham currently serves as President of Global eCommerce and Business Development for Universal Music Group, a music-based entertainment company, a position she has held since June 2021. In October 2019, Ms.

Peter M. Neupert

Peter M. Neupert has served as a director of the Company since January 1, 2013 and previously served as the Board’s lead independent director from July 2019 until June 2023. Mr. Neupert was an Operating Partner at Health Evolution Partners, a health only, middle market private equity firm, from January 2012 until June 2015. Prior to that, Mr. Neupert served as Corporate Vice President of the Microsoft Health Solutions Group from its formation in 2005 to January 2012. Mr. Neupert served on the President George W.

Garheng Kong M.D., Ph.D.

Garheng Kong has served as a director of the Company since December 1, 2013 and Lead Independent Director since June 2023. Dr. Kong also serves as the Chair of the Nominating and Corporate Governance Committee for the Company. Dr. Kong is the managing partner of HealthQuest Capital, a healthcare-focused investment firm, a role he has held since he founded HealthQuest Capital in 2012. He was previously a general partner at Sofinnova Investments, a healthcare investment firm, a position he held from 2010 to 2013. Before joining Sofinnova, Dr.

Kirsten M. Kliphouse

Kirsten M. Kliphouse has served as a director of the Company since October 12, 2022. Ms. Kliphouse previously served as the President of Google Cloud Americas, a public cloud vendor that offers a suite of computing services, a position she held from March 2022 to June 2023, where she was responsible for leading and growing the sales, go-to-market, customer engagement, channel, and services organizations. At Google Cloud, she also served as the Global Chair of the Aspiring Leadership Academy and Women@Google Cloud. Prior to her position as President, Ms.