Topic

Executive Director of Clinical Science, Regor Pharmaceuticals, Inc.

Articles

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

FDA’s New Diversity Plan Guidance, And What It Means for Sponsors Developing Cancer Drugs

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.

Real-World Data Offers Significant Opportunities for Developing New Therapies for Hematologic Cancers

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

A Digital Twin on KRAS G12C NSCLC Patients with SCA Measured by PFS

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

Q&A With Jennifer Porter, partner, Troutman Pepper

Director of Clinical Research, Winterlight Labs

Future shows great potential for neurological language assessments in clinical trials.

How Speech-Based Digital Biomarkers are Redefining the Measurement of Disease Progression in Neurodegenerative Dementia Trials

Successful oncolytic virus immunotherapy clinical development requires unique features that focus on viral biology and host immune response.

Oncolytic Virus Immunotherapy: A Brief Overview and Considerations for Clinical Trial Planning 

Steps that investigators and sponsors can take to streamline trials and accelerate the time to market for lifesaving therapies.

Streamlining the Complex Respiratory Clinical Trial Infrastructure

Five therapeutic areas that are apt for an all-virtual approach, and that can serve as an entry point for sponsors who are hesitant yet interested in exploring the growing DCT model.

Decentralized Clinical Trials: What Therapeutic Areas are Ripe for All-Virtual?

Vanessa Tassell, Vice President of Clinical Operations at Mirati Therapeutics, will discuss how some enterprises are navigating trials by incorporating strategies to expand clinical trial access to patients who need it.