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Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials

Zymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.

GUEST COLUMNISTS

Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic
Tr1X Bio Co-founder and CEO David de Vries explains how moving Type 1 regulatory T Cell (Tr1) therapies into new indications reshapes every facet of first-in-human trial design.
PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients
Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know
Forced to cease using Anthropic's Claude for its Elsa generative AI assistant, the FDA is switching to Gemini. Legal experts Kimberly Chew, Esq., and Michael Yang, Esq., explain the implications for trade secrets and data security risks.
How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment
The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.
Patient-Powered Drug Trials Are Getting The FDA Greenlight
Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.
When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down
Regulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.
How Deep Learning Is Changing Clinical Trial Design, Execution, And Analysis In 2026
Deep learning is reshaping clinical trial design, execution, and analysis. Learn how to deploy it safely, measurably, and at scale with help from life sciences consultant and MIT industry advisor Partha Anbil.
The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development
Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

CLINICAL TRIAL WHITE PAPERS

If Data Integrity Matters, Paper Is Not An Option
Ditch outdated paper assessments to ensure data integrity. Digital capture improves regulatory compliance, reduces administrative burden, and enhances the patient experience in clinical trials.

Serbia: Europe's Emerging Clinical Trial Powerhouse
1/22/2026

Discover why Serbia is becoming a top strategic choice for sponsors, including details of the country's strengths in key therapeutic areas, streamlined processes, and operational advantages.
Gene Therapies For Rare Diseases: Platforms, Modalities, And Delivery Systems
10/6/2025

Examine the treatment landscape for rare diseases and the rapid evolution of gene therapy across three key dimensions: editing platforms, delivery modalities, and delivery vehicles.
Sickle Cell Cure Within Reach, But At A Steep Cost
7/10/2025

Treatment options for sickle cell disease (SCD) and newly available gene therapies represent a potential cure. However, the latter are costly and thus remain out of reach for many SCD patients.
Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI Innovation
10/23/2025

A consultative, tech-enabled CRO can help mid-size pharma achieve targets by supplementing skillsets, expanding global reach, and designing an effective clinical, regulatory, and operational strategy.
A Guide To Patient Reimbursements And Payments
9/13/2024

Delayed or inadequate payments can harm patient retention and site efficiency. Learn how sponsors can mitigate financial toxicity, streamline reimbursement, and ensure a positive experience for all involved.

More Clinical Trial White Papers

CLINICAL TRIAL APP NOTES & CASE STUDIES

EU's New Clinical Trial Regulation: What Does It Hold For Sponsors And Sites?
7/23/2024

The Clinical Trials Information System (CTIS) is a centralized platform for Clinical Trial Application (CTA) and marketing authorization submissions, and supervision of clinical trials across the European Union/European Economic Area (EU/EEA). The regulation, which came into effect on January 31, 2022, aims to simplify and streamline routine clinical processes.
Enhancing ER Patient Recruitment
6/26/2024

Scout's custom information delivery mechanism for clear, accessible patient education facilitated trial enrollment in a high-pressure emergency room setting.
Enhance Access And Improve Retention In Rare Disease Trials With HTS
4/17/2025

Home Trial Support (HTS) provides a solution to improving participant recruitment and retention during musculoskeletal studies.
Paperless Online Remote Source Document Verification
2/2/2026

Learn how Clinical Trial Organizations, Monitoring Teams and Clinical Sites can benefit from the way Judi transforms rSDV from a logistical hurdle into a strategic asset.
Delivering A Registrational GI Trial Through Ongoing Protocol Shifts
10/17/2025

A biotech developing bispecific antibodies partnered with a flexible CRO to launch its first U.S. GI oncology trial, requiring strategic insight and full-service clinical support.
Streamlining The Clinical Trial Workflow From Protocol Design To Regulatory Submission
1/27/2026

Learn how to create a direct line from clinical planning and protocol design to clinical trial disclosure to optimize efficiency across the entire trial lifecycle.

More Clinical Trial App Notes & Case Studies

NEWSLETTER ARCHIVE

More Newsletters

RECRUITMENT AND DIVERSITY

This section includes some helpful resources regarding patient recruitment and diversity in clinical trials, including this link to the FDA's guidance on diversity action plans.

The Art Of Finding And Keeping The Right KOL

Learn from Incyclix CEO Patrick Roberts how the company identifies its KOLs, tailors engagement to their expertise, measures collaboration success, and sustains successful long-term partnerships.
PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients

Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment

The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.

FOCUS ON PATIENTS

What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman

Origami Therapeutics CEO Beth Hoffman shares how the company took both a measured and a gut-feeling approach to finding the right partner to supports its development of protein degraders for neurodegenerative diseases.
PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients

Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.
Patient-Powered Drug Trials Are Getting The FDA Greenlight

Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.