Therapeutic Areas

First guidance in this area from the Agency addresses the unique challenges when designing clinical studies for these drugs

Nathalie Dubois-Stringfellow, Sangamo’s chief development officer discusses the company's diverse clinical programs, strategic collaborations, including a partnership with Pfizer, and the crucial role of patient safety.

Recent study results highlight need for new metrics in ECOG scoring to mitigate variability.

In this Q&A, John Kastelein, MD, founder and chief scientific officer, NewAmsterdam Pharma, discusses the challenges and opportunities within the cardiovascular field, exploring the current landscape for lipid-lowering therapies and the unique potential advantages of CETP inhibitors.

Examining the two areas of weakness cited in FDA draft guidance.

Stakeholders must alter their mindsets when it comes to early-phase design and interpreting regulatory guidance for CGT trials.

Increased data output from the use of devices can accelerate trials for this therapeutic area in need of new therapies.

Webinar Date/Time: Thursday, May 25th, 2023 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.

Tiffany Chow, MD, a specialist in behavioral neurology and senior medical director at Alector, discusses the unique challenges of designing clinical trials for frontotemporal dementia.

Leal Health Poster Highlights Negative Impact of Patient ECOG Scores on Clinical Trial Enrollment Eligibility at 2023 ASCO GU Cancers Symposium.

Webinar Date/Time: Tue, Mar 28, 2023 11:00 AM EDT

Sanjay Shukla, MD, MS, CEO of aTyr Pharma, discusses the company's clinical operations and ongoing Phase III study for pulmonary sarcoidosis.

Challenges and strategies for improving representation.

Craig Coleman, PharmD, Professor at the University of Connecticut, and the Observational Study in Cancer-Associated Thrombosis for Rivaroxaban (OSCAR) study's principal investigator discusses the ins and outs of the study.

Rich Christie, MD, PhD, Chief Medical Officer at AiCure discusses the use of the company's technology in a clinical trial for PTSD.

Renewed interest in psychedelic research shows great promise for patients in need of more effective therapies.

Kenneth Koblan, PhD, chief scientific officer at Sunovion, discusses novel therapy development and clinical trial challenges in mental health.

Nabil Chehab, medical affairs head of lung cancer franchise at AstraZeneca, discuss strategies used in the Phase III AEGEAN trial for treating non-small lung cancer (NSCLC).

Richard Williams, PhD, chief medical officer at Kinnate Biopharma Inc. discusses clinical trial strategies and challenges.

Pursuing new tools and capabilities in sample logistics, storage, and data analysis.

Approaches sponsors, CROs, and investigators can take from the DMD experience.

As activity in this space grows, so do the hurdles in moving these products forward.

Industry now leveraging reporting system to empower patients and improve research.

Why oncology needs dosing redesign.

Pandemic has brought new sense of awareness to respiratory diseases and clinops.

Guidance will compel sponsors to consider new enrollment strategies and to be more diverse.

By integrating real-world data more deeply into the process of clinical research, life sciences stakeholders can open up new possibilities for therapeutic development and the evidence-based treatment of hematologic cancers.

Digital twins, defined as a typical demographic patient profile in a specific population, have the potential to help clinical trial design.

Porter discusses regulatory compliance, ATMP sponsors, and Philadelphia’s Cellicon Valley.