For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.
- AI Amplifies Capabilities But Also Risks: Learn The Legal Consequences Of AI In Clinical Research
- Is It Time To Replace RECIST — Or Just Add AI?
- India Opens The Fast Lane For Drug Development
- U.S. Pharma Tariffs And MFN Become Law After April 2 Update
- Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens
- What Really Moves The Needle In Primary Immunodeficiency Research And Treatment
- Clinical Trials Have A Native American Problem
GUEST COLUMNISTS
-
![Hospital, holding hands and kid in bed, healthcare, cancer-GettyImages-2120554524]( "Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens")
Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem ListensPatient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
-
![Young female scientist works at work bench in laboratory-GettyImages-899074182]( "What Really Moves The Needle In Primary Immunodeficiency Research And Treatment")
What Really Moves The Needle In Primary Immunodeficiency Research And TreatmentKedrion Biopharma's Nisha Jain details how researchers can improve trials for primary immunodeficiency and shares four factors for improvement.
-
![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access SuccesseGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
-
![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
-
![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
-
![MRI scanning in control room-GettyImages-2176245578]( "There's A Gap In Brain Tumor Research — Here's How We Fix It")
There's A Gap In Brain Tumor Research — Here's How We Fix ItBrain tumors are some of the most biologically complex and least improved indications. Biochemistry researcher and scientist Catherine Bladen, Ph.D., argues sustained focus is a key to driving real-world progress.
-
![Glioblastoma in Left Frontal Lobe with Midline Shift-GettyImages-2226756753]( "Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic")
Lessons Learned While Taking Glioblastoma Drug From Bench To ClinicMimiVax CEO Mike Ciesielski recounts the company's transition from academia to industry, hitting on topics like vendor partnerships, FDA conversations, and manufacturer selection.
-
![pharmaceutical inspection identifies pills-GettyImages-2154549420]( "The Much-Feared FDA Form 483, Part 3")
The Much-Feared FDA Form 483, Part 3This final installment in this three-part series offers an example of how the misperception of the 483 as a surrogate for overall quality of a firm can lead to policy errors in attempting to mitigate pricing problems with generic drugs.
CLINICAL TRIAL WHITE PAPERS
-
![GettyImages-1068004492 women]( "Decentralized And Community-Based Solutions Driving Women's Healthcare")
Decentralized And Community-Based Solutions Driving Women's HealthcareClinical trials should reflect the affected population by reducing participation barriers and bringing trials to patients to increase inclusion and improve real-world data.
-
Open-Label Study Assessing Relative And Absolute Bioavailability1/26/2026
Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
-
Planning For High-Performance Hematologic Oncology Clinical Trials5/7/2024
Running successful clinical trials in hematologic malignancies necessitates a deep comprehension of a swiftly evolving treatment framework that is growing more nuanced, intricate, and patient-centered.
-
The Answer To Your Pharmacovigilance Challenges: AI-Powered Adverse Event Detection11/7/2025
A proven, AI-powered safety platform can accelerate adverse event detection and safety data extraction to ease the burden on safety professionals and better protect patients.
-
Reimagining Medical Monitoring In Clinical Research4/11/2025
Clinical trials are undergoing a transformative shift driven by evolving regulations, advanced technologies, and decentralized methodologies.
-
A 2025 Survey Report Uncovers The Top 5 Clinical Trial Cost Insights4/22/2025
In this 2025 survey of over 100 U.S. clinical trial participants and caregivers, we reveal that most individuals join trials seeking life-saving treatment, not financial gain.
CLINICAL TRIAL APP NOTES & CASE STUDIES
-
Early-Stage Development In Rare Pediatric Oncology4/11/2025
Learn about the strategic approach a biotechnology company utilized to address significant hurdles in launching a Phase 1 clinical trial for a novel therapy targeting a rare pediatric cancer.
-
Overcoming Participant Compliance Challenges In A Medical Device Study9/9/2024
Uncover how Catalyst Clinical Research enhanced participant compliance and streamlined scheduling for a TENS device study using the TrialKit platform, with crucial support from CDS.
-
Faster Trial Planning and Site Selection4/15/2025
Address the challenges of identifying the most suitable trial sites and investigators while optimizing feasibility planning, reducing screen failure rates, and improving patient retention.
-
Accelerating Early Phase Oncology Study Development4/17/2025
Explore a close collaboration to co-develop a comprehensive, adaptive protocol designed to support key decisions across multiple trial phases for an innovative cancer therapy.
-
Pioneering The End-To-End Decentralized Trial Experience4/16/2025
This collaboration highlights the potential of decentralized clinical trials (DCTs) to transform trial execution, as well as offering a replicable model for future research.
-
Market Approval For A Novel Non-Hodgkin Lymphoma (NHL) Therapy4/11/2025
Explore a collaboration that underscores the importance of strategic planning and regulatory engagement in the approval process.
NEWSLETTER ARCHIVE
- 04.17.26 -- Continue To Choose New AI-Related Projects
- 04.16.26 -- Lessons Learned While Taking Glioblastoma Drug From Bench To Clinic
- 04.15.26 -- Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial
- 04.15.26 -- STREAM Edition: Continue To Choose New AI-Related Projects
- 04.14.26 -- Manipulating Costs And Technology Prices In Clinical Research
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.
-
![Elderly man sitting in hospital-GettyImages-1740621426]( "Assigned Slot Allocation Offers A Fair Solution For Oncology Phase 1 Trials (Part 2)")
In part two of this series on slot allocation, Nehal Lakhani, MD, Ph.D. proposes assigned slot allocation as an alternative to competitive placement and discusses how the approach might benefit patients and sites.
-
![Patient sitting in waiting room-GettyImages-629772380]( "Slot Allocation Is A Problem For Patients And PIs In Phase 1 Oncology Trials (Part 1)")
Given the shift in the size and scope of oncology Phase 1 trials, cohort management and slot allocation strategies must change, too. Nehal Lakhani, MD, Ph.D. explains why competitive slot allocation is no longer optimal for patients or PIs.
-
![translate foreign language with internet software-GettyImages-2215567295]( "Bridging Language And Medicine: Best Practices In French Regulatory Medical Writing")
Poor translations are not just clunky. They can be risky. Medical-linguistic consultant Farah Ayadi, PharmD, explains its implications for safety, regulatory submissions, and downstream operational or financial outcomes.
FOCUS ON PATIENTS
-
![Insulin pen, medical equipment-GettyImages-1447329677]( "Reformulating An In-Clinic IV To At-Home Injection Puts Patients At The Center")
For Soligenix, reformulation was not a detour but a necessary step toward optimizing a therapy for real-world use. Discover how the team reformulated its drug delivery from in-clinic to at-home administration.
-
![Hospital, holding hands and kid in bed, healthcare, cancer-GettyImages-2120554524]( "Clinical Trials Succeed When Patients Talk — And The Entire Ecosystem Listens")
Patient advocate and founder of MIB Agents Ann Graham knows intimately the importance of including patient feedback into trial design. She explains value of — and offers practical advice — for doing just that.
-
![Kidney issues, medical-GettyImages-1360864678]( "First-In-Human Porcine Kidney Transplant Trial Builds On Expanded Access Success")
eGenesis CEO Mike Curtis discusses the first-in-human trial of EGEN-2784, which they're studying whether a porcine kidney can restore near-normal quality of life while awaiting a human transplant.
