Image credit: Matthieu | stock.adobe.com Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the FDA for Tremfya (guselkumab) subcutaneous (SC) induction for the treatment of adult patients with moderately…
Category: Medicine
Accelerating Clinical Trial Activation
Sandra Smith, RN, MSN, AOCN, Senior Vice President, Clinical Solutions and Strategic Partnerships at WCG. Site activation of new clinical trials remains a top priority at most clinical research sites. But there…
Ginny Beakes-Read of Johnson & Johnson Discusses Regulatory Challenges
ACT: What are currently some of the greatest regulatory challenges industry stakeholders such as CROs and sponsors should be keeping top of mind? How can they be addressed? Beakes-Read: Some of the…
Pivoting Toward Sustainable Supply Chains in Clinical Research
Image credit: Corona Borealis | stock.adobe.com The clinical research industry has historically operated with a focus on effectively and efficiently delivering therapies that will benefit patients. Now, sustainability and environmental considerations are…
Allison Cuff Shimooka of TransCelerate Biopharma Discusses Innovation in Clinical Research
ACT: How is FDA promoting innovation in clinical trial design and conduct? Cuff Shimooka: It’s a timely question, having just got off a panel discussion with Kevin Bugin from FDA about innovations…
DIA 2024: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology
Image Credit: Andy Studna In a session at the 2024 DIA Global Annual meeting in San Diego, CA, Jane Myles, program director, Decentralized Trials and Research Alliance (DTRA); Joseph Unger, PhD, MS,…
Rob DiCicco of TransCelerate Biopharma Discusses the State of AI in Clinical Research
ACT: What do you think are some of the greatest opportunities for integrating artificial intelligence (AI) into clinical research? DiCicco: I think there are a couple of different ways to look at…
Pat Hughes of CluePoints Highlights Renewed Agreement With FDA, Utilizing AI in RBQM
ACT: What are you looking forward to working on and achieving with FDA under the renewed CRADA agreement? Hughes: We are so delighted to renew the agreement with the FDA; our cooperative…
Challenges and Opportunities for Industry Sponsors
Image credit: wladimir1804 | stock.adobe.com Introduction The increasing focus on diversity in clinical trials by regulatory authorities worldwide, combined with the ongoing need to expand pools of eligible patient participants, is leading…
Lokavant Launches Artificial Intelligence Clinical Trial Feasibility Solution
Image Credit: © Kaikoro – stock.adobe.com Lokavant has announced the launch of an artificial intelligence (AI) clinical trial feasibility software solution, Spectrum. According to Lokavant, the solution is the first of its…